MinTankesmie

- Legemiddelfirmaer må ifølge EU gi “upartisk (objektiv) informasjon” til pasienter

Drug companies must provide “unbiased information” to patients, say MEPs (Legemiddelfirmaer må gi “upartisk (objektiv) informasjon” til pasienter, opplyste MEP-er («europa-parlamentsmedlemmer»)
BMJ 2010; 341:c5511 (5 October)
Governments would have to ensure that “objective, unbiased information” about prescription drugs is made available to the public under legislation now being drafted by the European parliament.

The information would have to include a summary of product characteristics, the labelling and package leaflet, and a publicly accessible version of the drug’s assessment report. The data would have to be available electronically on dedicated websites established by national authorities and in printed form.

The obligation was introduced into the draft legislation last week by the European parliament’s environment committee as part of moves to provide patients with better access to high quality information on prescription drugs.

Aware of the thin dividing line between advertising and information, the members of the parliament amended the European Commission’s original draft. This had made it optional for drug companies to provide information. The text now emphasises patients’ rights by specifying which data have to be made available by companies, which information is optional, and the channels through which information should be supplied. (...)

(Anm: MEP; Member of the European Parliament («europa-parlamentsmedlem» (forkortes MEP for medlem av Europa-parlamentet)). (no.wikipedia.org).)

(Anm: Legemiddelinformasjon (mintankesmie.no).)

- All legemiddelreklame skal utformes i samsvar med godkjent preparatomtale

All legemiddelreklame skal utformes i samsvar med godkjent preparatomtale
legemiddelverket.no 2.12.2011
Forskrift om legemidler sier at all markedsføring skal være i overensstemmelse med den spesielle preparatomtalen (SPC) som er godkjent av Statens legemiddelverk. Dette samsvarer med artikkel 87, pkt 2 i EU direktivet om humanmedisinske legemidler.

Denne bestemmelsen omfatter også sitater fra medisinske tidsskrifter eller vitenskapelige arbeider, som inngår i reklame til helsepersonell.

Direktivet forbyr bruk av utsagn i reklame for et legemiddel, som er i uoverensstemmelse med opplysningene i SPC, men det er ikke i strid med direktivet å benytte utsagn som ikke inngår i SPC eller er utledet /kommer fra SPC dersom disse utsagn supplerer opplysningene i godkjent SPC ved at de:

a) bekrefter eller presiserer disse opplysningene
b) er forenlige med SPC
c) ikke forvrenger eller forvansker opplysningene i godkjent SPC

For sammenliknende reklame gjelder det samme, dvs at ytterligere dokumentasjon av legemidlets egenskaper kun kan skje med henvisning til vitenskapelige arbeider som supplerer det som allerede står i SPC.

Dette innebærer at Informasjon hentet fra medisinske tidsskrift eller annet vitenskapelig arbeid ikke kan benyttes fritt i reklame for legemidler. (...)

(Anm: Legemiddelreklame (legemiddelinformasjon) (mintankesmie.no).)

- Sikkerhetsretningslinjer omgås ofte på nettsider for legemidler, ifølge studie

Safety guidelines often omitted from drug website, study finds (Sikkerhetsretningslinjer omgås ofte på nettsider for legemidler, ifølge studie)
hospitalpharmacyeurope.com 9.2.2012
Websites advertising statins for sale to the general public contain very poor levels of information relevant to safe use of the medicine and side-effects, according to research published in the journal Pharmacoepidemiology & Drug Safety.

Researchers, led by Professor David Brown, School of Pharmacy and Biomedical Sciences, University of Portsmouth, simulated a customer search and evaluation of 184 retrieved sites using evaluation tools focusing on quality and safe medicine use.

Results showed that a potential purchaser of statins is likely to encounter websites from a wide geographical base of generally poor quality.

General contraindications were absent in 92.4% of sites and contraindicated medicines were absent in 47.3%.

Key warnings on the appearance of symptoms associated with myopathy, liver disease, hypersensitivity and pancreatitis were absent in 37%, 48.4%, 91.3% and 96.2% of sites respectively.

Most websites presented a chaotic and incomplete list of known side-effects; just 13 (7.1%) presented a list compatible with current prescribing information.

Only 65.8% attempted to describe any side-effects in lay language.

"Websites offering statins for sale contain little information on the safety of these drugs, which are intended as prescription only medicines" said Brown.

"There is an inherent danger in patients seeking to self-medicate in this way without consulting a healthcare professional and being appraised of ways to use the medicine safely." (...)

(Anm: Websites Advertising Cholesterol-Lowering Drugs of Poor Quality. Pharmacoepidemiology and Drug Safety 2012;21(2) (February).)

- Legemiddelindustrien bruker dobbelt så mye på reklame som på forskning

Firms Spend Up To $500 Million In Marketing For Mega-Launches (Firmaer bruker opp til 500 millioner dollar på reklame for megalanseringer)
publications.mediapost.com 12.6.2008
Until recent years, a drug that exceeded $500 million in annual revenue within three to five years of launch was considered a home run. But mega-launches such as Lipitor, Celebrex, Vioxx and Viagra--all of which produced upwards of $1 billion in their first 12 to 18 months--have raised the bar big-time. (...)

Amerikaner efterfrågar mer läkemedel efter reklam
lakemedelsvarlden.se 10.3.2008
En tredjedel av alla amerikaner har bett sin läkare skriva ut läkemedel som de hört om via reklam, och 44 procent av dessa fick ett recept på den efterfrågade medicinen. Det visar en ny undersökning gjord av bland annat Harvard School of Public Health.

Det är tidningen USA Today som tillsammans med The Kaiser Family Foundation och Harvard School of Public Health gjort en rundringning till 1695 amerikaner för att undersöka deras attityder till reklam för receptbelagda läkemedel. (...)

I Europa har EU-kommissionen nyligen presenterat ett förslag om att låta läkemedelsföretag ge information om receptbelagt till allmänheten via radio och TV. (...)

Läkemedelsreklam kan få mjukare regler
sr.se 15.2.2008
EU-kommissionen föreslår att reglerna för reklam för receptbelagda läkemedel ska mjukas upp. Så kallad information om mediciner ska få förekomma i radio, tv och tidningar enligt förslaget. (...)

Big pharma’s promotional spend double that of R&D – study
pharmatimes.com 7.1.2008
The US pharmaceutical industry is spending almost twice as much on promotion as it does on R&D, contrary to the claims made by drugmakers, according to a new report.

The study, which was carried out by researchers at York University in Toronto, Canada and is published in PLoS Medicine, is based on the 2004 reports from the international market research firms IMS Health and CAM Group. The two bodies obtain their information from different sources, however, with the former surveying pharmaceutical firms, while CAM consults doctors. (...)

The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States (Kostnader for legemiddelpushing: Et nytt estimat over utgifter til legemiddelreklame i USA)
PLoS Med 5(1): e1 doi:10.1371/journal.pmed.0050001
(...) IMS, a firm specializing in pharmaceutical market intelligence, is usually considered to be the authority for assessing pharmaceutical promotion expenditures. (...)

Pharmaceutical Research and Manufacturers of America (PhRMA), an American industrial lobby group for research-based pharmaceutical companies, also contends that pharmaceutical firms spend more on research and development (R&D) than on marketing: US$29.6 billion on R&D in 2004 in the US [5] as compared to US$27.7 billion for all promotional activities.[4] (...)

Finally, IMS data seem inconsistent with estimates based on the information in the annual reports of pharmaceutical companies. For example, in an accounting study based on the annual reports of ten of the largest global pharmaceutical firms, Lauzon and Hasbani showed that between 1996 and 2005, these firms globally spent a total of US$739 billion on “marketing and administration.” In comparison, these same firms spent US$699 billion in manufacturing costs, US$288 billion in R&D, and had a net investment in property and equipment of US$43 billion, while receiving US$558 billion in profits [9]. (...)

There is a significant discrepancy between the two sets of data in the cost of detailing: US$7.3 billion for IMS and US$20.4 billion for CAM. (...)

In the case of samples, there is also a large difference between the IMS (US$15.9 billion) and CAM (US$6.3 billion) estimates. (...)

Conclusion
From this new estimate, it appears that pharmaceutical companies spend almost twice as much on promotion as they do on R&D. These numbers clearly show how promotion predominates over R&D in the pharmaceutical industry, contrary to the industry's claim. While the amount spent on promotion is not in itself a confirmation of Kefauver's depiction of the pharmaceutical industry, it confirms the public image of a marketing-driven industry and provides an important argument to petition in favor of transforming the workings of the industry in the direction of more research and less promotion. (...)

Media möter regering i domstol
lakemedelsvarlden.se 5.6.2008
Kanadas största tidningsutgivare, Canwest Mediaworks, har stämt Kanadas regering för att den inte tillåter reklam för receptbelagda läkemedel. Förbudet kränker mediernas rätt till yttrandefrihet, anser Canwest Mediaworks. Fallet tas upp denna månad. (...)

- De fleste legemiddelannonser i medisinske tidsskrifter fulgte ikke FDAs retningslinjer

Most Drug Ads Did Not Follow FDA Guidelines (De fleste legemiddelannonser fulgte ikke FDAs retningslinjer)
pharmalot.com 29.8.2011
Last year, the FDA acknowledged the difficulty in policing advertisements aimed at healthcare professionals and consumers by creating its ‘Bad Ad’ program, which the agency recently maintained is having a positive effect (read here). But just how bad were pharmaceutical ads before the FDA launched this program?

To gain some clarity, researchers examined 192 pharmaceutical ads that ran in biomedical journals in November 2008 - less than two years before the ‘Bad Ad’ program began - and found that only 18 percent were compliant with FDA guidelines. And more than half failed to quantify serious risks, including death, according to their study, which was published PLoS One.

To be more specific, of those 192 ads, which were promoting 82 unique meds, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines (read here). Meanwhile, 57.8 percent of the ads did not quantify serious risks, 48.2 percent lacked verifiable references and 28.9 percent failed to present adequate efficacy quantification. (...)

Many advertised drugs in the sample presented potential risks - 31 contain black box warnings and 33 place patients at risk for death or serious morbidity. And 36 ads, by the way, referenced “data on file” and 40 lacked verifiable references, due either to an absence of any references or to the presence of references only to data on file or the product’s package insert, the researchers found.

Which journals qualified for their review? The Journal of the National Cancer Institute; JAMA; Gastroenterology; Annals of Internal Medicine; Archives of General Psychiatry; Blood; Circulation; Hepatology; Journal of the American College of Cardiology; Journal of Clinical Oncology, and The New England Journal of Medicine (n=35). (...)

“The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget,” Deborah Korenstein, lead author of the study and associate professor of Medicine at Mount Sinai School of Medicine, says in a statement (here is the complete study).

(Anm: Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing. PLoS ONE 6(8): e23336 (August 17).)

- Tilsyn med legemiddelindustriens muntlige markedsføring ("lukkede rom")

Tilsyn med legemiddelindustriens muntlige markedsføring
legemiddelverket.no 30.8.2011
Legemiddelindustrien (LMI) er uenig i Legemiddelverkets tilsynsvirksomhet med muntlig legemiddelreklame og har klaget virksomheten inn til Helse og omsorgsdepartementet (HOD). Klagen tas ikke til følge og i avgjørelsen redegjør HOD for Legemiddelverkets hjemler.

Legemiddelverket har tilsynsansvar for legemiddelreklame uavhengig av hvor aktiviteten finner sted. Møter med legemiddelindustrien som finner sted på arbeidsstedet til helsepersonell, for eksempel på legekontor, omfattes også av regelverket. I den forbindelse er det også viktig for Legemiddelverket å innhente opplysninger om denne møtevirksomheten. Ved tilsyn på legekontor fører Legemiddelverket ikke tilsyn med leger, kun med legemiddelindustriens markedsføring.

Ikke rettstridig
Helse-og omsorgsdepartementet kan ikke se at det vil være rettstridig av Legemiddelverket å være tilstede på møter som avholdes hos tredjepart, så lenge dette baseres på frivillighet fra tredjepart. I en slik situasjon kan det heller ikke anses som myndighetsmisbruk å benytte den innhentede informasjonen som grunnlag for deltakelse i slike møter. På denne bakgrunn finner departementet det derfor både akseptabelt og ønskelig at Legemiddelverket er til stede på møter som avholdes hos tredjepart.

Prinsippet om åpenhet
Avtalen mellom LMI og Legeforeningen trekker i retning av at leger bør gi myndighetene adgang til å overvære møter i legens lokaler, og departementet uttrykker at det vil være uheldig dersom legemiddelindustrien kan avholde reklamemøter som Legemiddelverket ikke har mulighet for å føre tilsyn med og dermed kunne skape "lukkede rom". (...)

SLV-agenter inntar legekontorene
Tine Dommerud
dagensmedisin.no 12.2.2009
Statens legemiddelverk (SLV) går aktivt til verks for å sjekke forholdet mellom leger og legemiddelindustrien. Det nye er at de dukker opp uanmeldt på møter mellom lege og industriens representanter på legekontoret. (...)

Intensiverer arbeidet
Steinar Madsen opplyser at Legemiddelverket vil intensivere dette arbeidet i 2009 gjennom å øke aktiviteten og foreta flere inspeksjoner.

- I tillegg til å være til stede på møter på legekontorer, er vi også til stede på møter i legemiddelindustriens regi, og på møter i Legeforeningen der legemiddelindustrien er til stede.

- Hva med møter mellom sykepleiere og industrien - særlig med tanke på forskriving av p-piller?

- Også på dette området har vi en satsing i år. Vi har registrert at når det gjelder skriftlig dokumentasjon, har det vært for mangelfull informasjon om bivirkninger.

På reklameoppdrag
Madsen forteller at SLV også har innskjerpet prinsippet om at når en lege opptrer på vegne av et firma på et møte, er legen en del av et reklameopplegg.

- Vi har sett eksempler på leger som har vært med på utprøving av legemidler som omtaler dette på møter før legemidlene har fått markedsføringstillatelse. Dette er en før-markedsføring - og en omgåelse av regelverket. Firmaet har ansvar for at møter de arrangerer, følger regelverket. Vi ønsker ikke å stanse fri medisinsk debatt, men firmaene har et totalansvar for sine markedsføringsopplegg, inkludert sine egne eller innleide leger. (...)

- Legemiddelfirmaer setter folkehelsen i fare

Tillgång till internet ökar läkemedelsmissbruk
sverigesradio.se 13.5.2011
Ökad tillgång till Internet kan kopplas till ökat missbruk av receptbelagda läkemedel i USA. Amerikanska forskare vid Massachusetts General Hospital och University of Southern California har sett att de stater som satsade på utbyggnad av bredbandsuppkoppling under åren 2000 och 2007 även hade den största ökningen av inskrivningar för vård för läkemedelsmissbruk, framför allt för narkotikaklassade smärtlindrande mediciner.

Samtidigt hade missbruksbehandlingen för alkohol, kokain och heroin, droger som inte finns tillgängliga online, i dessa stater inte ökat. I vissa fall hade vårdbehovet till och med minskat.

Antalet internetapotek, som säljer läkemedel utan att följa de regler om läkarföreskrifter som finns, har ökat de senaste åren.

Det här är första studien som tydligt visar att det finns en koppling mellan internetåtkomst och ökat läkemedelsmissbruk.

(Anm: Growing Internet Use May Help Explain The Rise In Prescription Drug Abuse In The United States, Health Affairs, May 2011 (May).)

Internet ökar läkemedelsmissbruk
lakemedelsvarlden.se 13.5.2011
En bättre tillgång till internet är inte bara av godo. Enligt en amerikansk studie leder det också till ett ökat missbruk av läkemedel.

OKONTROLLERAT De amerikanska stater där bredbandsuppkopplingen ökade under åren 200 och 2007 fick också ett ökat problem med missbruk av receptbelagda läkemedel. Det visar en studie publicerad i Health Affairs, som forskare vid Massachusetts General Hospital och University of Southern California har gjort.

De stater som satsade mest på utbyggnad hade också störst ökning av personer som skrevs in för vård av läkemedelsmissbruk. Framför allt handlade det om narkotikaklassade smärtstillande preparat. Forskarna konstaterar också att missbruket av alkohol, kokain och heroin ökade inte i samma utsträckning under tidsperioden i de aktuella staterna.

Mellan åren 1999 och 2003 ökade onlineförsäljningen av receptbelagda läkemedel i USA från 160 miljoner dollar till 3,3 miljarder. Författarna menar att även om tillgången på legala internetapotek har förbättrat situationen för många patienter så efterlyser de en ökad övervakning av läkemedelsförsäljning via internet. (...)

(Anm: Growing Internet Use May Help Explain The Rise In Prescription Drug Abuse In The United States, Health Affairs, May 2011 (May).)

Study examines high-speed Internet use, Rx abuse (Studie gransker utstrakt internettbruk, og misbruk av reseptbelagte legemidler)
modernhealthcare.com 13.5.2011
Is there a link between the expansion of high-speed Internet connectivity and rising rates of prescription-drug abuse?

Possibly, according to a study, "Growing Internet Use May Help Explain The Rise In Prescription-Drug Abuse in the United States" published online in the policy journal Health Affairs.

"Our findings provide a first glimpse that growing Internet use may partially explain why U.S. prescription-drug abuse rates have risen dramatically while other substance-abuse rates have not," the authors noted in a news release. "Based on our findings, recent efforts by the (U.S.) Food and Drug Administration to shut down illegitimate pharmacies not only seem warranted but may also lead to substantial reductions in prescription-drug abuse."

The report is based on comparisons of U.S. Federal Communications Commission data on several states' rates of Internet penetration from 2000 to 2007 and U.S. Substance Abuse and Mental Health Services Administration data on admissions to substance-abuse programs. (...)

(Anm: Growing Internet Use May Help Explain The Rise In Prescription Drug Abuse In The United States, Health Affairs, May 2011 (May).)

US drug companies paid $15bn in fines for fraudulent marketing in past five years (Amerikanske legemiddelfirmaer har betalt 15 milliarder dollar i bøter for straffbar markedsføring de siste fem år)
BMJ 2010; 341:c7360 (21 December)
Legemiddelfirmaers ulovlige markedsføring har økt i løpet av de siste fem år, hvilket ifølge Public Citizen, en uavhengig amerikansk vaktbikkjeorganisasjon, fører til store bøter når firmaer blir saksøkt. De har kalt legemiddelindustrien “den største bedrager av staten.” (Illegal marketing activities by drug companies have risen over the past five years, leading to major penalties when companies are prosecuted, says Public Citizen, an independent US watchdog organisation. It has called the drug industry “the biggest defrauder of the federal government.”)

Selv om rapporter om legemiddelfirmaers misgjerninger er rapportert tidligere, oppsummerer Public Citizens nye rapport situasjonen. (Although reports of drug companies’ misdeeds have been reported before, Public Citizen’s new report summarises the situation.)

Industritalsmenn sa at problemene lå bak dem og at industrien har fått strengere retningslinjer på plass. (Industry spokespeople said that the problems were behind them and that the industry had put stricter guidelines in place.)

Sidney Wolfe, direktør for Public Citizens helseforskningsgruppe, fortalte BMJ at legemiddelindustrien i løpet av de siste fem årene har gått forbi forsvarsindustrien og alle andre industrier i antall sivile og kriminelle forlik av handlinger mot den føderale regjeringen og statlige regjeringer. I rapporten fremgår at 165 legemiddelfirmaers forlik utgjør 19,8 milliarder dollar (£12.8bn; €15bn) i bøter i løpet av de siste 20 årene, 73 % av forlik og 75 % av bøtene skjedde i løpet av de siste fem årrene. (Sidney Wolfe, director of Public Citizen’s health research group, told the BMJ that in the past five years the drug industry moved ahead of the defence industry and all other industry sectors in the number of civil and criminal settlements of actions against the federal government and state governments. The report said that of 165 drug company settlements comprising $19.8bn (£12.8bn; €15bn) in penalties over the past 20 years, 73% of settlements and 75% of penalties occurred in the past five years.)

Dr. Wolfe sa at økningen i antallet av saker skyldes i hovedsak legemiddelfirmaenes sterke bruk av ulovlig markedsføringspraksis, slik som promotering av forskrivning av legemidler utenfor preparatomtale, og myndighetenes økte håndhevelse, som fikk mer innsideinformasjon fra varslere, som kan motta betydelige belønninger. (Dr Wolfe said that the rise in the number of cases was largely because of drug companies’ greater use of illegal marketing practices, such as the promotion of off-label uses of drugs, and increased enforcement by authorities, which were getting more insider information from whistleblowers, who can receive substantial rewards.)

Han uttalte, “Det eneste som kan stoppe dette er . . . dersom noen puttes i fengsel, fordi dette er kriminelle lovbrudd og de setter folkehelsen i fare.” (...) (He said, “The only way it will stop is . . . if someone goes to jail, because these are criminal violations and they endanger the public health.” )

Rapidly Increasing Criminal and Civil Monetary Penalties against the Pharmaceutical Industry: 1991 to 2010 is available at www.citizen.org/hrg1924. (...)

(Anm: Pharmaceutical Industry Is Biggest Defrauder of the Federal Government Under the False Claims Act, New Public Citizen Study Finds - Civil, Criminal Settlements Have Increased Dramatically; Off-Label Promotion Largely Responsible. (citizen.org 15.12.2010).)

(Anm: Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010. (citizen.org 15.12.2010).)

Läkemedelsindustrin i fokus för utredningar om bedrägeri
lakemedelsvarlden.se 20.12.2010
Den amerikanska försvarsindustrin är inte längre den bransch som fälls för flest bedrägeri- och mutbrott. Enligt en ny rapport är det läkemedelsindustrin.

SKUMT Läkemedelsindustrin har gått om försvarsindustrin som det främsta målet för federala bedrägeriutredningar i USA. Det konstateras i en rapport från organisationen Public Citizen.

De senaste fem åren har branschen betalat närmare 15 miljarder dollar i böter och i uppgörelser med staten.

Studien omfattar brott mot marknadsföring samt bedrägeri mot Medicaid, det vill säga saltade räkningar till den statliga sjukvårdsförsäkringen.

De som betalat mest är GlaxoSmithKline, Pfizer, Eli Lilly och Schering-Plough som enligt rapporten stått för 10, 5 miljarder av de utbetalade böterna och uppgörelserna.

I några fall har företagen samtidigt som man tillbakavisat påståendena om bedrägeri och mutor, betalat ut stora summor i uppgörelser med regeringen i stället för att driva ärendena vidare.

Pfizer är det enskilda företag som hittills betalat ut mest. (...)

(Anm: Uredelighet og fusk i medisinsk forskning. (mintankesmie.no/).)

- Tror att man inte påverkas

Besök från industrin påverkar förskrivningen
lakemedelsvarlden.se 27.11.2008
Läkare som får information av läkemedelsproducenter förskriver mindre rationellt än de som inte får sådan information. Det visar en undersökning av vårdcentraler i Göteborg.

MARKNADSFÖRING Läkemedelsföretag är skyldiga att informera om sina produkter men informationen fungerar också som ren marknadsföring. När Daniel Carlzon, ST-läkare vid sektionen för klinisk farmakologi på Sahlgrenska universitetssjukhuset, tillsammans med kollegor gjorde en enkätundersökning fick de ett tydligt resultat.

Läkare som får information från industrin förskriver mindre rationellt än andra.

- Av 21 vårdcentraler svarade 17 att de regelbundet tar emot besök från industrin, de flesta minst en gång i månaden. När vi tittade på förskrivningsdata såg vi att dessa i lägre utsträckning valde läkemedel från rekommendationslistorna, säger Daniel Carlzon. (...)

En sak Daniel Carlzon reagerat på är att besöken från industrin nästan alltid sker på lunchtid i samband med att företaget bjuder på mat.

- Det är som att personalen inte betraktar det som utbildning som ska ske på arbetstid utan något som inte ska störa arbetsdagen, säger han. (...)

Industrireklam påverkar läkare att förskriva mer
dagensmedicin.se 26.11.2008
Läkemedelsföretagens information på vårdcentraler påverkar läkarnas förskrivningsmönster. Det visar en studie från Göteborg. (...)

Läkare på vårdcentraler som får läkemedelsinformation från industrin förskriver mindre ra-tionellt, jämfört med kollegor som inte får sådan information.

– Det man kan fråga sig är hur denna information gynnar patienten och samhället som helhet, säger Daniel Carlzon, ST-läkare vid sektionen för klinisk farmakologi på Sahlgrenska universitetssjukhuset i Göteborg. (...)

Ett av dessa mål var förhållandet mellan mängden ACE-hämmare och ARB-läkemedel för behandling av högt blodtryck, där de senare är betydligt dyrare än de förra.

Två andra mål var andelen generisk omeprazol av alla förskrivna protonpumpshämmare och andelen simvastatin av det totala antalet statiner, för behandling av höga blodfetter. De tre återstående målen rörde behandling med antidepressiva läkemedel. (...)

”Tror att man inte påverkas”
– Som förskrivare tror jag inte att man är medveten om att man faktiskt påverkas. Det är samma sak som med tv-reklam. Man tror att man inte påverkas, men en vacker dag vaknar man upp i en Hästen-säng i alla fall. Men frågan är om jag sover skönare för det, säger Daniel Carlzon. (...)

- Internett og lege-pasient-forholdet (sosiale medier etc.)

Bredbånd øker misbruk
aftenposten.no 27.5.2011
Bredbånd til alle har sine skyggesider. Nå viser en fersk undersøkelse utført av forskere ved Massachusetts General Hospital at de stater som forserte utbyggingen av bredbånd i årene 2000–2007, også opplevde den største økningen i sykehusinnleggelser grunnet legemiddelmisbruk, heter det i en artikkel publisert i Health Affairs. Innleggelser etter misbruk av kokain og heroin – som ikke kan kjøpes over nettet – økte ikke i det hele tatt i samme periode. (...)

(Anm: Growing Internet Use May Help Explain The Rise In Prescription Drug Abuse In The United States, Health Affairs, May 2011 (May).)

Pharmaceutical Marketing and the New Social Media
NEJM (November 24)
Facebook and Twitter, the largest social media Web sites, have more than 350 million users worldwide, and surveys indicate that 60% of Americans turn first to the Internet when seeking health-related information.¹ It is therefore surprising that the pharmaceutical and medical-device industries have been slow to establish a social media presence. The drug industry allocated less than 4% of the more than $4 billion it spent on direct-to-consumer advertising to Internet outlets in 2008, and only a tiny fraction of that was for social networking sites.² In the next year, however, the proportion may change substantially. (...)

Internettet og læge-patient-forholdet
ugeskriftet.dk 16.8.2010
For snart ti år siden forudså mange, at Internettet ville skabe en ny patienttype, som man – alt efter temperament – kaldte ”ekspertpatienten”, der kunne gå i frugtbar dialog med lægen, eller ”overinformerede problempatienter”, som med stabler af udskrifter fra mere eller mindre lødige hjemmesider ville belaste konsultationen og udfordre lægens faglige autoritet. En omfattende litteraturgennemgang tyder på, at konsultationen påvirkes, om end foreløbig i begrænset omfang. Nettet giver mange fordele, f.eks., at patienter kan finde sammen i værdifulde netværk og støttegrupper. Men der er også problemer – ikke mindst, at kun 3 % af internetbaseret sundhedsinformation ikke er profitorienteret. Desuden påpeger forskerne, at patienter af mange grunde ikke afslører deres søgen på nettet overfor lægen. Det kan evt. føre til, at lægen og patienten får en forskellig dagsorden. (...)

Medicinalfirmaer sælger sig selv på sundhedssider
24.dk 15.8.2010
Kun tre procent af alle danske hjemmesider med sundhedsinformation er upåvirket af kommercielle interesser. Det offentlige må stærkere på banen, mener Forbrugerrådet

Gule, tykke negle på flere tæer, nogle steder smuldrer den. En hurtig Google-søgning afslører, at det er symptomer på negle-svamp, og at det skal behandles hos en læge.

Er det sådan, du reagerer, når du har en sygdom? Så er du ikke alene. En artikel, der offentliggøres i Ugeskrift for Læger i dag, viser, at 40 procent af danskerne ser internettet som det vigtigste sted at få information om sundhed og sygdom.

Men det er ikke problemfrit, advarer en af forskerne bag artiklen. (...)

Government Reins in Drug Promotion on Facebook (Staten strammer in på reklame på Facebook)
adage.com 10.8.2010
Novartis Warning Indicates Social Media Will Be Tough Arena for Pharma

NEW YORK (AdAge.com) -- In a sign that internet advertising is coming under more regulatory pressure, the Food and Drug Administration recently warned drug company Novartis that one of its Facebook promotions violated government policy. (...)

How to get marketing through unbranded websites right
social.eyeforpharma.com 9.8.2010
If correctly implemented, unbranded websites can be a valuable information resource for consumers and a valuable marketing tool for pharma brands. Andrew Tolve reports.

In early May, the FDA posted a warning letter to Novartis citing two unbranded websites for violating a raft of regulations, including promoting drugs for unapproved uses, failure to disclose associated risks, and making unsubstantiated dosing claims.

The warning letter raised a red flag for companies throughout the industry with unbranded websites, many of whom worried their own sites might be next. (...)

A second reason to consider an unbranded site is if you’re in a disease state that struggles with compliance issues.

An unbranded site like J&J’s Children with Diabetes can offer education, support, and tools around managing therapies. (...)

- Skjult reklame

Internet ökar läkemedelsmissbruk
lakemedelsvarlden.se 13.5.2011
En bättre tillgång till internet är inte bara av godo. Enligt en amerikansk studie leder det också till ett ökat missbruk av läkemedel.

OKONTROLLERAT De amerikanska stater där bredbandsuppkopplingen ökade under åren 200 och 2007 fick också ett ökat problem med missbruk av receptbelagda läkemedel. Det visar en studie publicerad i Health Affairs, som forskare vid Massachusetts General Hospital och University of Southern California har gjort.

De stater som satsade mest på utbyggnad hade också störst ökning av personer som skrevs in för vård av läkemedelsmissbruk. Framför allt handlade det om narkotikaklassade smärtstillande preparat. Forskarna konstaterar också att missbruket av alkohol, kokain och heroin ökade inte i samma utsträckning under tidsperioden i de aktuella staterna.

Mellan åren 1999 och 2003 ökade onlineförsäljningen av receptbelagda läkemedel i USA från 160 miljoner dollar till 3,3 miljarder. Författarna menar att även om tillgången på legala internetapotek har förbättrat situationen för många patienter så efterlyser de en ökad övervakning av läkemedelsförsäljning via internet. (...)

(Anm: Growing Internet Use May Help Explain The Rise In Prescription Drug Abuse In The United States, Health Affairs, May 2011 (May).)

Beklager Facebook-innlegg
dagensmedisin.no 24.9.2010
Statens Legemiddelverk (SLV) beklager at de i sommer la ut et innlegg på Facebook som omhandler en fase 3-studie av et slankemiddel.

I artikkelen, som er publisert på forskning.no, men som Legemiddelverket postet på egen vegg, hevdes det at den nye slankemedisinen er uten alvorlige bivirkninger. (...)

Legemiddelverket sier innlegget ble lagt ut ved en inkurie, og avdelingsdirektør Johnny Jakobsen sier rutinene Legemiddelverket har for publisering, ikke ble fulgt i dette tilfellet. (...)

(Anm: inkurie; forglemmelse, uoppmerksomhet. Kilde: Store norske leksikon.).)

Lundbeck kritiseres for skjult reklame
berlingske.dk 18.10.2009
Hjemmesiden depnet.dk vil hjælpe deprimerede i hverdagen. Men siden oplyser ikke, at læger og psykiatere aflønnes af Lundbeck Instittuttet, der står bag siden.

14.000 månedlige brugere af hjemmesiden depnet.dk bliver ikke oplyst om, at læger og psykiatere i sidens brevkasse betales for deres svar af Lundbeck Instituttet, der står bag hjemmesiden. Det oplyser DR's 21 søndag.

Instituttet er oprettet af medicinalfirmaet H. Lundbeck A/S, som tjener millioner af kroner på de antidepressive piller Cipramil og Cipralex. Nederst på siden står der med småt, at det er Lundbeck Instituttet, som står bag depnet.dk.

DR har undersøgt mere end 500 brevkassesvar fra 15 læger og psykiatere på depnet.dk. (...)

Should You Get Your Drug Information From An Actor? (Bør du motta din legemiddelinformasjon fra en skuespiller?)
Dr. Andrew Weil - Founder and director of the Arizona Center for Integrative Medicine
huffingtonpost.com 21.8.2009
Sally Field is a talented actor. But what qualifies her to promote Boniva, an osteoporosis drug that is of limited benefit, has worrisome side effects, and for which there are natural alternatives that merit careful consideration? (...)

FDA Tells Drug and Device Makers to Give Balanced Picture of Risks in Ads, Labels
JAMA. 2009;301(24):2541. (June 24)
The US Food and Drug Administration (FDA) is advising the makers of medications and medical devices to avoid misleading consumers with marketing strategies that deemphasize the risks of these products.

Promotional materials that omit or minimize risk information are the most frequent reason the agency issues enforcement letters to companies, and the FDA says it has received requests from industry for clarification about what it considers a violation. In the new guidance (http://www.fda.gov/cder/guidance/7427dft.pdf), the agency emphasizes that simply including risk information is not enough to satisfy its requirements; rather, the agency weighs whether marketing materials leave consumers or clinicians with a balanced impression of a product's risks and benefits. (...)

Unbranded Ads Also Unpopular
brandweek.com 28.9.2008
The money pharmaceutical companies are spending on ads is in decline for the first time ever.

This has caused a dramatic collapse in an area that companies have always proudly backed: unbranded health education campaigns. Spend in the first half of the year for such ads, which describe an ailment but don't plug the branded solution, fell 3% to $2.4 billion, according to Nielsen Monitor-Plus. (...)

The sharp drop is unexpected for two reasons. First, the major drug companies signed a pledge in 2005 to make their advertising more educational. Second, some companies have expressed interest in unbranded campaigns because they're not required to list all the risks and side effects that their drugs have.

"In a period of contraction, where these companies are under such pressure to maintain profits in the short-term, marketing budgets get scrutinized pretty carefully," said Matt Giegerich, CEO of CommonHealth in Parsippany, N.J., an agency which handles GlaxoSmithKline and Ortho-McNeil.

Unbranded ads, designed to grow the category as a whole, are less closely tied to sales because consumers may walk out of the pharmacy with a competitor's product, said Giegerich. (...)

Medicinreklamer skjult som information
forbrugerraadet.dk 4.6.2008
Forbrugerne kan snart få reklamer for Viagra og blodtryksmedicin serveret i bedste sendetid. EU-Kommissionen har nemlig fremsat forslag om, at det skal være tilladt at reklamere for receptpligtig medicin. Forslaget er helt uacceptabelt, mener Forbrugerrådet. (...)

"Hvis forbrugerne skal have mulighed for at vælge lægemidler på et oplyst, informeret grundlag, er det særdeles vigtigt, at de modtager informationer fra uafhængige kilder og ikke fra lægemiddelindustrien, som udelukkende har interesse i at tjene mest muligt. Det kan vi simpelthen ikke byde forbrugerne. Derfor opfordrer vi på det kraftigste udvalget til at sige nej til Kommissionens forslag", siger Sine Jensen. (...)

Sygelig information
forbrugerraadet.dk 5.2.2008
Føler du dig lidt syg for tiden? På medicinalfirmaernes hjemmesider findes alt om sygdomme og symptomer. Når du har fundet ud, af hvad du fejler, er det tid til lægebesøg. Måske sender lægen dig hjem med en recept. Og muligvis er firmaet bag medicinen, den samme som firmaet bag hjemmesiden. Ny international kampagne sætter fokus på sygeliggørelse og medicinreklamer (...)

I virkeligheden er hjemmesiderne skjult information, hvor firmaerne præsenterer deres egne produkter som behandlingsmetoder.
Den internationale forbrugerorganisation, Comsumers International, har derfor lavet en kampagne rettet mod medicinalfirmaerne og de kreative reklamemetoder. (...)

Læs mere på: www.marketingoverdose.org og www.consumersinternational.org
Læs Forbrugerrådets anmeldelse i 2007 af to medicinfirmaer: http://www.forbrugerraadet.dk/breve/alle/brev234/

Læs Forbrugerrådets kommentar Når raske bliver gjort syge: http://www.forbrugerraadet.dk/debat/alle/debat048 (...)

Ironisk kamp mod pille-producenter
ekstrabladet.dk 5.2.2008
Medicialfirmaerne skal ikke forsøge at prakke folk piller på via reklame på deres hjemmeside. (...)

Problematisk
I Forbrugerrådet finder man medicinalfirmaernes skjulte markedsføring forkert:
- Det er selvfølgelig vigtigt, at forbrugerne kan få den information de har brug for. Men det er problematisk, at den kommer fra firmaer som tjener penge på det. For de har kun et sigte med deres markedsføring: At sælge deres produkter, siger Sine Jensen, sundhedspolitisk medarbejder i Forbrugerrådet.

Ofte handler medicinalfirmaernes kampagner om livsstilsrelaterede lidelser. Når forbrugerne søger information på firmaernes hjemmesider, bliver de gjort opmærksomme på forskellige sygdomssymptomer, føler sig syge og søger derfor læge. Lægen har også fået besøg af en sælger fra samme producent. (...)

- Facebook beveger seg mot åpne kommentarer på sider for legemiddelfirmaer

Facebook moving ahead with open comments on pharma pages (Facebook beveger seg mot åpne kommentarer på sider for legemiddelfirmaer)
pharmatimes.com 15.8.2011
From today (August 15), most pharmaceutical company pages on Facebook are due to be open to comments for the first time, something which could strain the industry's difficult relationship with social media.

Many pharmaceutical companies only agreed to set up on Facebook in return for the ability to moderate and block comments on their pages, a privilege which was not accorded companies in other industries. The social media platform says it will however still allow comment disabling on some branded pages that refer to a specific drug.
Some drugmakers - including AstraZeneca and Johnson & Johnson - say they have decided to remove pages as a consequence of the policy change, according to a Washington Post article.

Pharma has always been wary of social media because of stringent rules governing the information it can impart to consumers, and has been much slower than other sectors in embracing Facebook and other social media platforms.

Drugmakers say they are concerned that commenters may reference side effects or proffer medical advice, or mention brands without 'fair balance', although critics of the stance argue their reluctance stems more from a lack of understanding about social media and fears about loss of control over brand image.

As of this morning (UK time), some company pages were still blocked from comments, while others are already allowing them. For example, Pfizer's page appears with a lengthy explanation of the reasons why it may have to delete comments from its wall, but the comment functions are still not active. Pages for GlaxoSmithKline, AstraZeneca and Novartis were also comment-free this morning.

The industry has also said it lacks clear guidance from regulatory authorities on what it can and cannot communicate via social media. The US FDA has not yet released its own guidelines although it has suggested they may be completed before the end of this year.

For its part, Facebook now maintains that as a social media platform it is interactive by definition, and restricting comments undermines the entire purpose of the platform.

The message is that comment-free pages are essentially advertising, not social interaction, and the change in policy is necessary to encourage dialogue between drugmakers and their customers. (...)

Legemiddelreklame (Direct to consumer advertising - DTCA)

US paediatricians call for ban on tobacco advertising and limits on alcohol and drug advertising (Barneleger ønsker forbud mot tobakksreklame og begrensninger på alkohol- og legemiddelreklame)
BMJ 2010; 341:c5286 (27 September)
The American Academy of Pediatricians has called for a total ban on tobacco advertising in all media, limits on alcohol advertising, and limits on content related to tobacco, alcohol, prescription drugs, and illegal drugs on television and in movies for children.

In a policy statement published on 27 September the academy said, “Two legal drugs—alcohol and tobacco—pose perhaps the greatest danger to children and teenagers. Both represent significant gateway drugs and are among the earliest drugs used by children and teenagers” (Pediatrics doi:10.1542/peds.2010-1635). (...)

(Anm: FROM THE AMERICAN ACADEMY OF PEDIATRICS. Policy Statement—Children, Adolescents, Substance Abuse, and the Media. (September 27).)

Risker med effektiv marknadsföring
lakemedelsvarlden.se 3.12.2008
Sofistikerad och allt effektivare marknadsföring kan försätta patienter för större risker. Det hävdas i en artikel i senaste numret av BMJ.

SNABBT Marknadsföring av nya läkemedel är mycket effektiv. När Merck till exempel fick sitt nya diabetesläkemedel, sitagliptin, godkänt av FDA hösten 2006 tog det 14 dagar innan 188 miljoner amerikanska patienter tagit del av företagets marknadsföring av den nya behandlingen. En månad efter godkännandet skrev 14 procent av de amerikanska allmänläkarna ut preparatet vid behandling av typ 2-diabetes. Vid årsskiftet 2007/08 var sitagliptin det näst vanligaste orala läkemedlet vid behandling av sjukdomen. (...)

What can we learn from drug marketing efficiency?
BMJ 2008;337:a2591 (2 December)
The time it takes new drugs to penetrate the market is shrinking. David Kao suggests how drug companies’ techniques could be used to improve safety surveillance systems

Institutions responsible for monitoring drug safety have been criticised widely after the withdrawal of drugs such as rofecoxib because of safety concerns. An estimated 20 million patients received prescriptions for rofecoxib over five years before the drug was withdrawn, and events attributable to rofecoxib may number in tens to hundreds of thousands.¹ Regulatory bodies such as the US Food and Drug Administration have simultaneously been under pressure to reduce drug approval times to ensure timely availability of new drugs. However, concerns have been expressed that deadlines for approving drugs have reduced the focus on safety.^{2 3 4} (...)

Internet replaces doctors in USA, DTC in Europe, as patients’ first stop for pharma info (Internett erstatter leger i USA, DTC i Europa, som pasienters første stopp for legemiddelinformasjon)
pharmatimes.com 13.10.2008
The Internet has now replaced doctors as the main source of health and medical information for US consumers, while in Europe many adults use a search engine rather than a health site when first looking for such information, new research reveals.

More than 145 million US adults now use the Internet to research health information, according to the studies by Manhattan Research. As health care coverage and even routine visits to the doctor become less affordable to many Americans, the Internet has this year emerged as the first line of defense for people seeking to manage their health care independently, says the firm. (...)

(Anm: DTCA (Direct to consumer advertising); legemiddelreklame direkte til forbruker. (medilexicon.com).)

FDA Web Site on Drug Ads Developed by Drug Industry PR Firm (FDA-nettsted for legemiddelreklame utviklet av PR-firma som tilhørerer legemiddelindustrien)
cspinet.org 15.9.2008
Should Pharma PR Pros Write the Government’s Advice to Consumers?
WASHINGTON—Drug ads can be confusing and often deceptive, so it makes sense that the Food and Drug Administration would develop a web site aimed at helping consumers separate fact from fiction. But to develop such a site the FDA turned to a nonprofit front group erected by Shaw Science Partners, a public relations firm that specializes in launching new drugs such as Viagra, Celebrex, Zoloft, Cymbalta and the now-withdrawn Rezulin. (...)

FDA Tapped Pharma Consultant For DTC Web Site
pharmalot.com 15.9.2008
The agency hired a non-profit that is run by Michael Shaw, an advertising consultant to the pharmaceutical industry, to help design a new consumer campaign about direct-to-consumer advertising, Integrity in Science Watch reports. (Here is the press release). (...)

Prescription Drug Advertising Subject of New FDA Web Site for Consumers
reuters.com 5.9.2008
ATLANTA, Sept. 5 /PRNewswire/ -- EthicAd, a nonprofit organization devoted
to improving public health through consumer education, announces the launch of a new FDA Web site created to help the general public better understand
direct-to-consumer (DTC) advertising of prescription medications. The site,
"Be Smart About Prescription Drug Advertising," is hosted by the FDA's Center
for Drug Evaluation and Research and was developed by the FDA in partnership
with EthicAd. For details, visit www.FDA.gov/CDER/ethicad/index.htm or link
to the site via FDA's homepage, www.fda.gov. (...)

Direct to consumer advertising of prescription drugs
Editorials
BMJ 2008;337:a985 (2 September)
Are there public health consequences when regulators turn a blind eye to cross border advertising that contravenes national laws? Although Canada prohibits direct to consumer advertising of prescription drugs, no steps are taken to prevent US advertising from reaching the Canadian public. (...)

Direct to consumer advertising from the United States reaches Canadians via cable television and US magazines sold in Canada. Law and colleagues found that cross border advertising increased prescribing of a minimally effective drug with a poor safety profile,² which subsequently led to its withdrawal.³ (...)

Reklam ger nya användare
lakemedelsvarlden.se 10.6.2008
Reklam för antidepressiva läkemedel gör att fler påbörjar en medicinering men påverkar inte nödvändigtvis användningsnivåerna bland dem som redan behandlas. Detta är slutsatsen i en studie som publicerats i The B.E. Journal of Economic Analysis & Policy. (...)

Merck to pay $58m in settlement over rofecoxib advertising (Merck betaler 58 millioner dollar for rofecoxib-reklame)
BMJ 2008;336:1208-1209 (31 May)
Merck & Company has agreed to pay $58m (£29m; €37m) to settle allegations that advertising for its analgesic rofecoxib (Vioxx) played down potential health risks.

The civil settlement ends investigations by 29 US states and the District of Columbia into Merck’s previous advertising practices for the drug. Tom Corbett, attorney general of Pennsylvania, said that the agreement is the largest in a multi-state consumer protection case involving drugs. (...)

Kritik mot reklamförslag
lakemedelsvarlden.se 28.5.2008
EU-kommissionens förslag om hur företag ska få informera allmänheten om receptbelagda läkemedel får mycket kritik av remissinstanserna. Totalt har 192 europeiska organisationer tyckt till om förslaget. Hälften av dem tycker inte att industrin är en bra förmedlare av information. (...)

Lawmakers call on drug companies to curb ads (Lovgivere ber legemiddelfirmaer om å dempe legemiddelreklamer)
reuters.com 22.5.2008
WASHINGTON (Reuters) - Two top Democratic lawmakers called on several drug companies on Tuesday to voluntarily curb advertisements targeting consumers, including withholding any ads for new products for two years.

In a letter to the chief executives of Merck & Co Inc, Pfizer Inc, Johnson & Johnson and Schering-Plough Corp, Reps. John Dingell and Bart Stupak asked the companies to also refrain from marketing products to consumers until certain studies are completed. (...)

DTCA for PTCA — Crossing the Line in Consumer Health Education?
NEJM 2008;358:2197-2200 (May 22)
(...) To many consumers, the stent ad may not have seemed surprising or out of place — no different from television ads touting the virtues of drugs for acute coronary syndromes, arthritis, depression, prostatic enlargement, fibromyalgia, restless legs syndrome, and, of course, erectile dysfunction. But in making the leap from pharmaceuticals to medical devices, the ad campaign raises important questions regarding the net societal benefit of medical advertising directed at the lay public. (...)

Merck Agrees To Pay $58M To Settle Multistate Lawsuit That Claimed Advertisements for Vioxx Played Down Health Risks (Merck samtykker å betale 58 millioner dollar for å forlike flerstatlig søksmål som hevder at reklamer for Vioxx tonet ned helseririsko)
Kaisernetwork.org 21.5.2008
Merck on Tuesday agreed to a $58 million settlement with 29 states and the District of Columbia to end investigations over allegations that it downplayed cardiovascular risks caused by the COX-2 inhibitor Vioxx in direct-to-consumer advertisements dating back to 1999, the AP/Philadelphia Inquirer reports (Raffaele, AP/Philadelphia Inquirer, 5/21). Merck withdrew the painkiller from the market in 2004 after research found it doubled the risk of heart attack and stroke. The company has agreed to a $4.85 billion settlement, which is pending, to end a majority of the lawsuits that followed the findings, the South Florida Sun-Sentinel reports (Burstein, South Florida Sun-Sentinel, 5/20). Under Tuesday's settlement, Merck agreed to submit to FDA for seven years all new television ads for its drugs and follow through with agency-suggested changes before airing them. A spokesperson for Pennsylvania Attorney General Tom Corbett (R) said that the settlement does not require court approval (AP/Philadelphia Inquirer, 5/21).

Merck to pay Florida 3.5 million in Vioxx lawsuit (Merck betaler Florida 3,5 millioner dollar i Vioxx-søksmål)
sun-sentinel.com 20.5.2008
Florida will receive about $3.5 million as part of a settlement Merck & Co. reached Tuesday to end a multi-state investigation into the company's marketing of the painkiller Vioxx.

The pharmaceutical giant agreed to pay a total of $58 million to 29 states and the District of Columbia in an agreement that requires the company to submit future television commercials for its drugs to the Food and Drug Administration for approval. The settlement with Florida was filed Tuesday in Broward Circuit Court by state Attorney General Bill McCollum's office. (...)

Merck agrees to $58M settlement over Vioxx ad claims (Merck samtykker å betale 58 millioner dollar for påstander i Vioxx-reklamer)
philly.com 21.5.2008
HARRISBURG, Pa. - Merck & Co. has agreed to pay $58 million as part of a multistate settlement of allegations that its ads for the once-popular painkiller Vioxx deceptively played down the health risks.

The agreement announced Tuesday also calls for Merck to submit all new TV commercials for its drugs to the Food and Drug Administration for review before they can be aired. (...)

House Committee Leaders Warn Pharmaceutical Companies To End Use of 'Misleading' Advertisements (House Committee Leaders Warn Pharmaceutical Companies To End Use of 'Misleading' Advertisements)
kaisernetwork.org 21.5.2008
House Energy and Commerce Committee Chair John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) in a recent letter warned four pharmaceutical companies to end the use of "misleading and deceptive" direct-to-consumer advertisements for medications, CQ HealthBeat reports. The lawmakers sent the letter to Johnson & Johnson, Merck, Pfizer and Schering-Plough, as well as the Pharmaceutical Research and Manufacturers of America.

In the letter, the lawmakers asked the pharmaceutical companies to end the use of health care professionals in DTC ads and to wait for two years before they air such ads for new medications, among other requests. According to Dingell, the lawmakers sent the letter after pharmaceutical industry representatives failed to assure them of their efforts to reduce adverse effects of DTC ads at a May 8 hearing of the subcommittee. (...)

TV drug ads may have to zoom in on side effects (Reklame for legemidler kan bli krevd å zoome inn på sideeffekter)
ap.google.com 16.5.2008
WASHINGTON (AP) — Ville forbrukere få det samme varme, berusende budskapet fra en legemiddelannonse som lovet å løfte humøret dersom den også inntrengende ba dem rapportere sideeffekter som selvmordstanker og diaré? (— Would consumers get the same warm, fuzzy message from a drug advertisement that promised to lift their mood if it also urged them to report side effects like suicidal thoughts and diarrhea?)

I et forslag, som tilsynsmyndigheter vil vurdere fredag, er anført at det må inngå en kjøper-vær-årvåken beskjed i den rosenrød meddelelse for legemiddelreklame. (...) (Under a proposal regulators will consider Friday, that buyer-be-vigilant message would have to accompany the rosy messages of pharmaceutical promotions.)

TV-reklamer er blitt en hjørnestein for den farmasøytiske industri siden tilsynsmyndighetene åpnet slusene for et tiår siden. Firmaer bruker anslagsvis 3,5 milliarder dollar på reklameinnslag sist år. (TV promotions have become a cornerstone of the pharmaceutical business since regulators opened the floodgate a decade ago. Companies spent roughly $3.5 billion on spots last year.)

Men noen lovgivere og forbrukertalsmenn sier annonsene kan reklamene kan fremme overforskrivning av legemidler før alle sideeffekter er kjent. Ved å oppmuntre pasienter til å rapportere negative reaksjoner til FDA, håper de at tilsynsmyndigheter vil være i stand til å fange opp sikkerhetsproblemer tidligere. (...) (But some lawmakers and consumer advocates say the advertisements can encourage over-prescribing of medications before all their side effects are known. By encouraging patients to report negative reactions to FDA, they hope regulators will be able to catch drug safety problems sooner.)

En gallupundersøkelse publisert tidligere i år av Consumer Reports fant at bare 35 prosent av forbrukerne visste at de kunne rapportere sideeffekter til myndighetene. (...) (A Consumer Reports poll published earlier this year found that only 35 percent of consumers knew they could report drug side effects to the government.)

Industrin säger nej till marknadsföring
lakemedelsvarlden.se 9.4.2008
Information om receptbelagda läkemedel i tv, radio och tryckta medier är ingen bra idé. Den europeiska läkemedelsindustriföreningen, EFPIA, sällar sig till skaran av kritiker till EU-kommissionens DTC-förslag.

DTC EU-kommissionen har nyligen lagt fram ett förslag om att låta läkemedelsindustrin informera om receptbelagda läkemedel Direct to consumer, DTC. En tidigare rapport från kommissionen har visat att den hälso- och läkemedelsinformation som den enskilde EU-medborgaren får tillgång till idag skiljer sig åt – med möjliga negativa effekter på folkhälsan som följd. Förslaget skulle kunna vara en lösning på problemet.

Men många har varit kritiska till förslaget, bland annat Läkemedelsverket och internationella konsumentorganisationer. Nu går även industrin själv emot förslaget, genom den europeiska läkemedelsindustriföreningen, EFPIA.

I grunden är EFPIA positiv till grundtanken – lika information till alla – men inte till det kontroversiella tillvägagångssättet. EU-kommissionens förslag går ut på att låta företag vända sig direkt till patienterna via radio, tv och tryckta medier och informera om alla sorters läkemedel, även receptbelagda. (...)

Direct-to-Consumer Ads Change Doctor-Patient Relationship, Op-Ed Says
kaisernetwork.org 6.2.2008
Direct-to-consumer marketing of prescription drugs -- "now a mainstay of newspapers, magazines, and TV and radio broadcasts" -- has "altered the doctor-patient relationship" by "forcing" physicians to "respond to people's demands for heavily touted drugs," rather than "taking the initiative in suggesting treatment," Los Angeles Times columnist David Lazarus writes. (...)

Direct to consumer advertising of drugs in Europe (Legemiddelreklame direkte til forbruker i Europa)
Editorials
BMJ 2007;335:526 (15 September)
Evidence on its benefits and harms is available but is being ignored

The promotion of prescription drugs to the public ("direct to consumer advertising") is currently used only in the United States and New Zealand. A systematic review of the clinical and economic consequences confirmed that this form of advertising influences patient demand and doctors' prescribing behaviour, but evidence of health benefits or improvements in underuse was lacking.¹ (...)

Drug Manufacturers Spend Billions On Direct To Consumer Ads - Many, Such As Vioxx, Attacked As Misleading
cherryhill.injuryboard.com 25.8.2007
The August 16, 2007 issue of the New England Journal of Medicine contained a study that did not get the media attention it deserved. Studies were done of the amount of money big drug companies spent on "direct to consumer ads" and found the amount increasing each year. The latest year for which data is available was 2005 when $29.9 billion was spent. Total real spending on promotion grew from $11.4 billion to $29.9 billion from 1996 to 2005, at an average annual rate of 10.6% The percentage of sales spent on promotion for the industry as a whole increased from 14.2% in 1996 to 18.2% in 2005. In the past 9 years, spending on direct-to-consumer advertising and free samples has risen as a share of total promotion, whereas investments in detailing and advertising in professional journals have fallen as a share of the total. (...)

FDA to study images' impact in drug ads
seattlepi.nwsource.com 21.8.2007
WASHINGTON -- Federal regulators plan to study whether relaxing, upbeat images featured in TV drug ads distract consumers from warnings about the drugs' risks. (...)

Spending up, enforcement down for drug ads
nj.com 16.8.2007
Ten years after a rule change allowed drug companies to advertise directly to consumers, the overall amount spent promoting medicines is 2.6 times what it was in 1996, researchers said yesterday. (...)

Pharmaceutical Industry's Spending on Drug Promotion Grew by Average of 10.6% Annually Over Past Decade, Study Finds
kaisernetwork.org 16.8.2007
Total spending on advertising by the pharmaceutical industry has increased by an average of 10.6% annually since 1996, when a rule change allowed drug companies to advertise directly to consumers, according to a study published on Wednesday in the New England Journal of Medicine, Reuters/Newark Star-Ledger reports. (...)

(Anm: A Decade of Direct-to-Consumer Advertising of Prescription Drugs. NEJM 2007;357:673-681 (August 16).)

Citizens' alliance condemns EC report as "undocumented" and "biased"
BMJ 2007;334:1290 (23 June)
An international alliance of consumer groups, insurers, and professional associations has stepped up its attacks on the European Commission's current round of public consultation over drug advertising. (...)

Kendte sælger medicin
forbrugerraadet.dk 8.5.2007
Danske medicinalfirmaer bruger kendte ansigter til at sælge deres medicin, i hvad Forbrugerrådet kalder en udspekuleret kampagne.

Medicinalgiganten Wyeth er et af de firmaer, der benytter sig af kendte i deres markedsføring. Skuespilleren Nikolaj Lie Kaas reklamerer således for deres lykkepiller både over for læger og befolkningen. (...)

Pillereklame gir bøter
kampanje.com 10.4.2007
Schering og Organon er bøtelagt for over en halv million kroner for ulovlig, misvisende p-pillereklame. (...)

Höga böter för Pfizer för vilseledande läkemedelsreklam
sr.se 3.4.2007
Läkemedelsbolaget Pfizer tvingas betala motsvarande en kvarts miljard kronor till amerikanska staten för olaglig marknadsföring av en medicin. Det här ses som en viktig seger för den tidigare vice vd:n på Pfizer Peter Rost, som bidrog till att avslöja missförhållandena.

Peter Rost har beskrivits som insidern som starkt bidrog till att skandalen avslöjades. Ett dotterbolag inom det dåvarande Pharmacia, där Rost var chef, tänjde på gränserna när det gäller ett av sina preparat, tillväxthormonet Genotropin.

Olagliga belöningar betalades ut för att få preparatet rekommenderat inom sjukvården i USA och det marknadsfördes också i strid med amerikansk lag, som en kur mot åldrande.

– Till slut har Pfizer fått erkänna att det jag har sagt var korrekt och riktigt. De har fått förklar sig skyldiga till viss brottslighet. Det är alltid skönt att få rätt, säger Peter Rost. (...)

Vi konsumerar mer antidepressiva läkemedel
dn.se 26.3.2007
Svenskarna konsumerar allt mer av antidepressiva läkemedel, Och kvinnor tog dubbelt så mycket läkemedel mot depression som män förra året. Det visar Apotekets försäljningsstatistik. (...)

- DET HÄR MEDICINERNA ger en god effekt och förhindrar återfall, Depression har en hög överdödlighet och måste behandlas, säger Erik Widerlöv, psykiater på Läkemedelsverket. (...)

- Frågan är då om man i dag under- eller överförskriver. Jag tror att man underförskriver. Det finns många deprimerade patienter och patienter med ångestsyndrom, som går obehandlade eller underbehandlade, säger Erik Widerlöv. (...)

Ingen reklamer, tak!
forbrugerraadet.dk 26.3.2007
EU overvejer at lade medicinalindustrien reklamere over for forbrugerne. Forbrugerrådet frygter sygeliggørelse.

"I New Zealand og USA, hvor det er tilladt at reklamere direkte, er forbruget af lægemidler steget kraftigt, siden man liberaliserede reglerne. Vi frygter, at forbrugere tager medicin, de reelt ikke har brug for," siger Margrethe Nielsen, sundhedspolitisk medarbejder i Forbrugerrådet. (...)

Medicinal-industrien sygeliggør raske mennesker (business.dk)
business.dk 15.3.2007 (Berlingske Tidende)
Forbrugerrådet har anmeldt to medicinalfirmaer for ulovligt at reklamere i Danmark og yderligere listet 23 danske hjemmesider fra medicinalindustrien, som rådet mener er med til at sygeliggøre raske mennesker. (...)

Ulovlige medicinreklamer
forbrugerraadet.dk 15.3.2007
Forbrugerrådet anmelder to medicinalfirmaer for ulovlig markedsføring. Men medicinalindustrien står bag flere kritisable kampagner. (...)

Kampagne eller reklame?
forbrugerraadet.dk 12.3.2007
Psykiatrifonden kører en kampagne mod depression - men det er medicinalfirmaet Wyeth, der betaler.

Depressionskampagnen bliver anklaget for at bilde folk ind, at de er deprimerede – og lokke dem til at bruge Wyeths piller.

- Med det samme du har lidt ondt i livet, skal du gå til din læge og få behandling. Og så lægger de lidt oven i hatten, fordi de også siger, man helst skal få stillet sin diagnose meget tidligt. Wyeth har jo behandlingsmulighederne, og der er jo ikke noget odiøst i, at industrien tjener penge. Men det bliver det, i det øjeblik de skubber til en masse mennesker, som ikke burde behandles, siger Margrethe Nielsen, sundhedspolitisk medarbejder i Forbrugerrådet, til Politiken.

Både Wyeth og Psykiatrifonden er uforstående over for kritikken. (...)

Researchers Critical of TV Drug Ads (Forskerne kritiske til legemiddelreklame)
JAMA. 2007;297:939-940 (March 7)
Advertisements of prescription drugs on television offer limited educational value and may oversell the products in ways that could conflict with promoting population health, said researchers in a research report released on January 29.

The study's authors, led by Dominick L. Frosch, PhD, assistant professor of medicine at the University of California Los Angeles David Geffen School of Medicine, concluded that drug ads on television offer limited information about disease causes and about who is at risk; show actors losing control over their social, emotional, or physical lives without medication; and minimize health benefits of lifestyle modification (Frosch DL et al. Ann Fam Med. 2007;5:6-13).
(...)

ADVERTISING - A Niche Strategy Now Under Stress

ADVERTISING
A Niche Strategy Now Under Stress
nytimes.com 6.6.2007
Could a widely praised approach to drug marketing now be at risk of backfiring? That is a question confronting GlaxoSmithKline and its diabetes treatment Avandia, which is now clouded by concerns over the drug’s safety. (...)

Offentlig helseinformasjon

Bryter etiske regler
ukeavisenledelse.no 16.2.2007
Brudd med etiske regler, fastslår leder for Rådet for legeetikk Trond Markestad om leger som på den ene siden lar seg sitere i pressemeldinger fra legemiddelselskap – og blir betalt av dem.

– Dersom leger lar seg sitere på vegne av industrien eller stiller seg til disposisjon for legemiddelselskaper så minner det om skjult reklame og er slik jeg ser det i strid med Legeforeningens etiske regler, sier Markestad til Dagsavisen. (...)

Leger lar seg bruke i markedsføring
dagsavisen.no 16.2.2007
(...) I fjor høst deltok den profilerte fastlegen Åge Bjertnes på en internasjonal kongress om influensa i Frankrike. Kursavgiften, reise og opphold ble dekket av legemiddelgiganten Roche. Hva denne reisen kostet vil ikke Roche fortelle, men bekrefter at slike kongresser koster mellom 15.000 og 25.000 kroner per deltaker.
I forrige uke mottok Dagsavisen, og en rekke andre redaksjoner, en pressemelding fra Roche om et legemiddel som kan brukes til behandling ved influensa. Roche kan formidle pressekontakt med flere leger, deriblant Bjertnes, som har fast legespalte i Adresseavisen.

– Dette er et så viktig legemiddel at jeg føler at utsatte pasientgrupper bør kjenne til det for å korte ned sykdomsforløpet og begrense komplikasjoner ved influensa, sier Bjertnes om legemiddelet.

Han legger til at å dra på kongresser er faglig viktig og at legemiddelindustrien på denne måten har en stor rolle i å formidle kunnskap om ny medisin til leger, siden statens legemiddelverk dessverre ikke gjør den jobben godt nok. (...)

I markedsstriden mellom ulike prevensjonsmidler som oppsto da et kjent merke gikk ut av produksjon i fjor høst, sto Ole Erik Iversen, overlege i gynekologi og professor ved Haukeland sykehus, som kontakt i en pressemelding for en av konkurrentene. (...)

PhRMA comes out fighting in defence of DTC advertising
pharmatimes.com 2.2.2007
The US drugmakers industry association has responded to a hard-hitting report which criticises direct-to-consumer advertising of medicines on television by saying that it ignores the great strides companies have made in making ads that are more educational.

The Pharmaceutical Research and Manufacturers of America was reacting to a study published in the Annals of Family Medicine which claims that of the ads shown on US television from June 30 to July 27, 2004, 82% made some factual claims and made rational arguments (86%) for product use, but few described condition causes (26%), risk factors (26%), or prevalence (25%). Emotional appeals were almost universal (95%) and no ads mentioned lifestyle change as an alternative to products, though some (19%) portrayed it as an adjunct to medication. (...)

Take This, You'll Like It
washingtonpost.com 30.1.2007
Study Says TV Ads Promote Drug Sales Through Emotion, Not Information (...)

Few Prescription Drug Television Commercials Mention Risk Factors, Other Nondrug Treatments, Study Finds
kaisernetwork.org 30.1.2007
Pharmaceutical company television advertisements largely use emotion rather than educating consumers about the risks and causes of a condition or other treatment options, according to a study published Monday in the Annals of Family Medicine, the Washington Post reports. (...)

TV drug ads don't sway docs
upi.com 26.1.2007
CHARLESTON, S.C., Jan. 26 (UPI) -- Direct-to-consumer drug advertising may make consumers more aware of new treatments but not necessarily drive higher U.S. drug sales. (...)

Drug ad come under scrutiny
iht.com 22.1.2007
Drug advertising aimed at U.S. consumers, a fast-growing business that reached $4.5 billion last year, will face hard scrutiny in the new Congress, industry critics in both the U.S. House and Senate say.

The consumer ads will be on the grill early this session at hearings on the user fees that manufacturers pay to speed the reviewing of new drugs by the U.S. Food and Drug Administration. The user fee law will die in the fall unless Congress acts to renew it.

The pharmaceutical industry — which often gets what it asks for from Congress and the executive branch — is seeking to renew the law and to add a new set of user fees that would pay the salaries of additional government employees to evaluate all consumer drug ads before they are shown on television. (...)

Forbrugerrådet angriber reklamer for medicin
business.dk 12.1.2007
Sundhedsminister Lars Løkke Rasmussen bør holde godt øje med medicinalindustrien, så den ikke får adgang til at reklamere direkte til forbrugerne. Det kan nemlig øge udgifterne til lægemidler betragteligt, mener Forbrugerrådet.

Forbrugerrådet frygter, at medicinalindustrien i fremtiden vil kunne markedsføre lægemidler under dække af, at det er information. (...)

Kamp mod medicinreklamer
forbrugerraadet.dk 15.1.2007
Sundhedsministeren bør sikre, at medicinalindustrien ikke får adgang til at reklamere direkte til forbrugerne. (...)

Det er i dag ulovligt at reklamere for receptpligtig medicin i Danmark, men i øjeblikket arbejder den europæiske arbejdsgruppe Pharmaceutical Forum på en række lovforslag om "information til patienter", som kan ændre reglerne for markedsføring.

Arbejdsgruppen er overvejende domineret af medicinalindustrien, og dermed kan industrien nærmest gøre, som det passer den og give sig selv adgang til at reklamere direkte til forbrugerne, mener Forbrugerrådet.

- Det er det, industrien har villet i mange år. Det er voldsomt meget, de får lov til at præge, hvordan informationen til patienter skal foregå. Skellet mellem information og markedsføring er svær. Vi ser, at de allerede udfordrer det i dag," siger sundhedspolitisk medarbejder i Forbrugerrådet, Magrethe Nielsen, til Berlingske Tidende. (...)

Helsekonsumentene Ola og Kari
ukeavisenledelse.no 5.5.2006
Det norske folket sluker helse- og livsstilsstoffet i mediene. Omtalen av sykdommer gjør imidlertid at hver fjerde nordmann blir bekymret for egen helse.
- Vi er helsekonsumenter så det holder, sier informasjonssjef Hans Petter Strifeldt i legemiddelprodusenten Pfizer.

Firmaet har undersøkt folks holdninger til helsespørsmål, helsevesenet og egen helse og firmaet Norstat som har gjennomført selve undersøkelsen, har spurt et representativ utvalg på 4000 nordmenn.

”Folk flest har ikke fått for mye av helse og sykdommer i norske medier, til tross for en tidvis voldsom fokusering på alt fra slanking til truende epidemier. Lesere, seere og lyttere med høy utdanning og inntekt er imidlertid langt mer skeptiske til dette stoffet enn andre, mens medieomtalen av sykdommer fører til at spesielt de med lav utdanning og inntekt blir bekymret for helsa si”, skriver fagbladet Journalisten i sin siste utgave.

- De siste ti årene har det blitt stadig mer av denne typen stoff i norske medier, og det er tydelig at mediebrukerne vil ha det, mener Strifeldt.
Statistisk sentralbyrå har kvalitetssikret Pfizer-undersøkelsen som skal utføres årlig for å måle utviklingen av Helse-Norge over tid. (...)

Skriftlig legemiddelreklame - til å stole på?

Villedende legemiddelreklame
kampanje.com 11.5.2006
Norske leger blir lurt av villedende reklame for legemidler. Ifølge en ny undersøkele er mye av reklamen overdrevet og noen ganger direkte gal.

Undersøkelsen, som er publisert i Tidsskrift for Den norske lægeforening, viser at 52 prosent av påstandene i legemiddelreklamen som er evaluert ikke er i overensstemmelse med reklameforskriftene. Knapt halvparten viste seg å være riktig, skriver Dagbladet.

– Det er betenkelig at over halvparten av reklamen ikke holder mål. For en stor del av reklamen har det blitt tøyd og dratt i påstandene slik at produktet virker bedre enn det er. Unøyaktighetene går alltid i legemiddelets favør, aldri motsatt, sier Lars Slørdal, professor i farmakologi ved NTNU og overlege ved avdeling for klinisk farmakologi ved St. Olavs Hospital i Trondheim, til Dagbladet.

I undersøkelsen er 261 påstander i legemiddelreklame vurdert, og hele 135 av dem ble vurdert til å ikke være i tråd med reklameforskriftene. 15 påstander var direkte gale. (...)

Skriftlig legemiddelreklame - til å stole på?
Tidsskr Nor Lægeforen 2006; 126: 1314-7
Sammendrag
Bakgrunn. Legemiddelreklamen påvirker legers arbeid og faglige oppdatering. Vi har undersøkt om informasjonen i skriftlig reklame er i tråd med forskrift om reklame for legemidler.

Materiale og metode. Alle reklameforsendelser for legemidler som tre allmennpraktikere mottok i løpet av en tremånedersperiode, ble samlet inn. For hvert av de 50 preparatene som det ble mottatt flest reklameforsendelser for, ble den forsendelsen som hadde flest litteraturreferanser valgt ut. Den refererte litteraturen ble fremskaffet, og påstandene i reklamen ble evaluert i forhold til forskrift om reklame for legemidler.

Resultater. Totalt 294 reklameforsendelser for i alt 77 ulike preparater ble samlet inn. I de 50 utvalgte forsendelsene var det oppført 191 litteraturreferanser. Av disse var det mulig å fremskaffe 93 %. Legemiddelfirmaene bidrog med 72 % av de referansene de ble forespurt om. I de utvalgte reklameforsendelsene ble det identifisert 261 påstander som krevde dokumentasjon. Av disse ble 135 påstander (52 %) vurdert til ikke å være i overensstemmelse med reklameforskriftene, inklusive 15 påstander (6 %) som var direkte gale.

Fortolkning. Bare halvparten av påstandene som ble fremhevet i reklamen var korrekte og inneholdt klinisk relevant informasjon. Få påstander var direkte gale, men en betydelig andel gav et overdrevet positivt bilde av det aktuelle preparatet. Skriftlig legemiddelreklame fremstår derfor som en uegnet kilde for faglig oppdatering. (...)

GlaxoSmithKline (GSK) sponser Thor Hushovd

Legemiddelfirma sponser Thor Hushovd
hegnar.no 11.1.2007
GlaxoSmithKline har inngått sponsoravtale med Thor Hushovd, som sliter med astma. - Hushovd er en fantastisk idrettsmann, sier administrerende direktør Åge Nærdal.

Thor Hushovd har astma, og trenger astmamedisin for å fungere som toppidrettsutøver. Dette er bakgrunnen for at han har inngått sponsoravtale med GlaxoSmithKline (GSK).

I et intervju med NTB i oktober forklarte han fjorårets suksess blant annet med null sykdom.

- Operasjon av bihulene for to år siden og daglige doser med astmamedisin er årsaken til dette, sa Hushovd i intervjuet.

- Thor Hushovd er en fantastisk idrettsmann som vi er stolte av å samarbeide med, sier administrerende direktør Åge Nærdal i GSK.

Målet med samarbeidet er å få oppmerksomhet om at de aller fleste med astma kan få kontroll over sykdommen sin med moderne astmamedisiner - så god kontroll at sykdommen for mange ikke behøver å føre til noen begrensning i livet. (...)

Spending on Prescription Drug Ads Increased by 9 % in First Half of 2006

Spending on Prescription Drug Ads Increased by 9 % in First Half of 2006
kaisernetwork.org 6.10.2006
Daily Health Policy Report
Pharmaceutical companies increased spending on advertisements by 9% in the first half of 2006, an indication that they "no longer feel constrained" by criticism that their "splashy campaigns minimized medicines' risks" after the September 2004 withdrawal of the COX-2 inhibitor Vioxx, AP/Long Island Newsday reports. According to TNS Media Intelligence, pharmaceutical companies spent $2.46 billion in the first half of 2006, compared with $2.26 billion a year earlier, as companies increased spending on magazine ads and ads to promote their images and disease management programs. Magazine ads accounted for 34% of pharmaceutical company spending on ads, compared with 29% a year earlier, and television ads accounted for 59%, compared with 64% a year earlier. TNS Research Director Jon Swallen said that pharmaceutical companies increased spending on magazine ads because such ads cause fewer problems with compliance with new voluntary guidelines recently adopted by the industry. The guidelines require pharmaceutical companies to improve accuracy and balance of information about the benefits and side effects of medications. In addition, many new ads include physicians who directly discuss the side effects of medications (Agovino, AP/Long Island Newsday, 10/5). (...)

Leger setter foten ned for legemiddelreklame

Doctors put their foot down over drug advertising
news-medical.net 18.6.2006
The American Medical Association (AMA), the largest doctors group in the U.S., has announced a new policy on the direct-to-consumer advertising of prescription drugs and implantable medical devices.

The group is also calling for a temporary moratorium on the advertising of newly approved drugs and guidelines for pharmaceutical companies to follow when preparing advertising to the public.

AMA President-elect, Dr. Ronald M. Davis says a temporary moratorium on the advertising of prescribed drugs and medical devices will benefit both the patient and physician and give doctors the opportunity to become better educated on the pros and cons of prescription drugs before prescribing them.

They will then, he says, be better equipped to determine which drugs are best suited to their patients' medical needs.

Doctors have complained about patients who demand inappropriate drugs after being persuaded by a drug company's advertisement.

Drug manufacturers say the advertisements aim to educate the public and advise patients to consult with their doctors. (...)

Glaxo, Sepracor Increase Public Ads, Drawing Customers, Critics
bloomberg.com 1.6.2006
-- A luminous green moth floated onto U.S. television screens in April 2005 and quickly became a well- known emblem of Lunesta, a prescription sleeping tablet.

Sepracor Inc., Lunesta's maker, spent a record $270 million over the next 11 months on consumer advertising in the American market for sleep aids. Sanofi-Aventis SA spent about $90 million on Ambien, the best-selling prescription sedative, according to Nielsen Media Research in New York.

Kampen om å selge piller bidro til en økning på 7 prosent, til 4,8 milliarder, for legemiddelreklame til amerikanske forbrukere i 2005. Forbruket steg etter at den farmasøytiske industri hadde godkjent en ny plan for å kontrollere annonser. Legemiddelprodusenter fikk kritikk fra talsmenn for forbrukerne og medlemmer av kongressen som sa at annonsene oppmuntret til overforbruk av reseptbelagte legemidler. (...) (The battle to sell pills contributed to a 7 percent increase, to $4.8 billion, in U.S. consumer drug advertising in 2005. Spending rose even after the pharmaceutical industry adopted a new plan to police the ads. Drugmakers were responding to criticism from consumer advocates and members of Congress who said the ads may encourage overuse of prescription medicines.)

"The new spending data just reconfirm the obvious: That the new policy was toothless and that spending on these ads continues unabated,'' said Gary Ruskin, executive director of Commercial Alert, a Portland, Oregon, nonprofit group critical of advertising.

Ruskin's organization, co-founded in 1998 by consumer advocate Ralph Nader, and a coalition of 38 other groups on May 24 urged Congress to ban direct-to-consumer drug pitches. Unnecessary prescriptions drive up medical costs and expose people to side effects of medicines, the groups said. (...)

Norsk psykiatrisk forening (NPS)

Annonsering skapte debatt
Tidsskr Nor Lægeforen 2006; 126: 2708
Man burde ikke tillate annonser fra legemiddelindustrien i Fagnytt, mente en rekke psykiatere under årsmøtet til Norsk psykiatrisk forening.

- Nå som vi har kuttet kontakten med industrien, burde det også gjelde annonsering, sa én. En annen sa seg enig, og påpekte at annonseringen ville kunne så noe tvil om habiliteten i forhold til legemiddelindustrien. En tredje sa seg ikke enig, og mente at så lenge Tidsskrift for Den norske lægeforening tok imot annonser, så burde man følge samme mal som moderforeningen.

Debatten oppsto under gjennomgangen av budsjettet for 2007, der det ble påpekt at det var budsjettert med annonseinntekter i forbindelse med Fagnytt.

Annonsedebatten omhandlet derfor både økonomi og etikk. Enkelte av debattantene ga uttrykk for at man burde bestemme seg for om dette var en ren etikkavgjørelse eller om det dreide seg om budsjettet.

- Vil det bli problemer med budsjettet om annonseinntektene faller bort? Har det noe å si for utgiftene med å sende ut Fagnytt på papir? lurte en årsmøtedeltaker på. (...)

Rikshospitalet

Uryddig praksis
Leder
dagbladet.no 2.5.2006
Rikshospitalet selger reklame for legemiddelindustrien, ifølge Dagbladet. På nettsidene til hudavdelingen møter de besøkende reklame for legemidler fra de største legemiddelfirmaene på markedet. Det er en enkelt sak å klikke seg videre for å lese om produktene de tilbyr. Det går fram av opplysninger på nettestedet at de ansatte eier Hudpedagogisk senter (HPS) som eies av de ansatte på hudavdelingen. Inntektene fra annonsesalget går til «forskning og faglig utvikling».

Dette betyr at de ansatte driver en privat bedrift innenfor rammen av det statlige helseforetaket. Denne bedriften kommer vi i kontakt med ved å henvende oss til landets fremste sykehus. Samtidig får vi lese annonsene for legemidler som nettopp kan komme i betraktning om besøket på nettstedet også ender med behandling. (...)

Dette er en sammenroting av privat og offentlig som er høyst tvilsom. Lederen for Rådet for legeetikk, Trond Markestad, mener praksisen er i strid med legeforeningens etiske regelverk. Rikshospitalet hevder rett nok at ordningen er godtatt for å bøte på avdelingens skrantende økonomi. Men det er ikke noe holdbart argument. Kan vi tenke oss at f eks sjåførene i den kommunale bedriften Oslo Sporveier danner et firma som tar inntektene av annonser på trikker og busser til «faglig utvikling»? (...)

Folk kommer til Rikshospitalet fordi de har en sykdom eller trenger opplysning om behandling. Da må de slippe å møte annonser som fungerer som inntektskilde for et firma drevet av de ansatte. Og de ansatte bør i arbeidstida være mer opptatt av å helbrede pasienter enn å drive annonsesalg. (...)

Rikshospitalet selger seg
hegnar.no 28.4.2006
Rikshospitalet selger seg til medisinprodusenter.

Rikshospitalet får penger fra legemiddelindustrien mot at sykehuset legger ut reklame for selskapene på sin egen hjemmeside. Dette er eneste muligheten som finnes for å få nok penger, mener sykehuset.

Annonser fra flere legemiddelfirmaer ligger på nettsidene til Hudavdelingen ved Rikshospitalet. Novartis, 3M Pharma og Astellas er blant selskapene som får pryde nettstedet med sine logoer. Besøkende kan klikke på logoene og lese om produktene som tilbys.

- Slike annonser kan være i strid med Legeforeningens etiske regelverk, sier Trond Markestad, leder i rådet for legeetikk i Den norske lægeforening, til Dagbladet.

Han mener annonsene må bort, fordi de skaper mistanke om en uheldig kobling mellom legemiddelindustrien og sykehuset.

- Jeg har selv godkjent disse annonsene. Vi er ikke begeistret for dem, og vi skulle gjerne sett vi kunne unngå dem. Men Rikshospitalet skal spare 300 millioner kroner i forhold til fjorårets budsjett. Dette er den muligheten vi har, sier Rikshospitalets kommunikasjonsdirektør Trine Lind.

Legemiddelindustrien synes annonseringen er uproblematisk så lenge det ikke reklameres for konkrete produkter.

Men verken administrerende direktør i Legemiddelindustriens landsforening, Pål Christian Roland, eller Markestad i Legeforeningen, mener det nytter å skylde på dårlig økonomi.

- Jeg har vanskelig å tro at inntektene fra denne type annonser kan monne særlig på Rikshospitalets budsjett. De bør heller vedkjenne seg praksisen man har lagt seg på, sier Roland. (©NTB)

Norsk Farmaceutisk Tidsskrift

Norsk Farmaceutisk Tidsskrift
hsmedia.no (15.3.2006)
Ønsker dere å påvirke farmasøytene i Norge til å velge nettopp deres produkt overfor pasienter og kunder? Da er Norsk Farmaceutisk Tidsskrift det rette annonsemediet for dere siden dere her kan annonsere både for reseptfrie og reseptbelagte legemidler!

Bladet utgis av Norges Farmaceutiske Forening, og har et opplag på 2900 ex. med 12 utgaver i året. Tidsskriftet distribueres til alle av foreningens 2000 medlemmer og ca 700 andre abonnenter, og leses av farmasøyter i apotek, sykehusapotek, farmacøytiske avdelinger og industri, undervisning og forskning.

Opplag:3.065

Foreningens egne internettsider finner du på www.farmaceutene.no (...)

Läkemedelsverket

Ny lag om läkemedelreklam lägger mer ansvar på Läkemedelsverket
Läkemedelsvärlden 2006(4) (April)
Läkemedelsverket får nu ett helt annat lagstöd för att granska läkemedelsföretagens marknadsföring. Nyordningen kan innebära att fler tvister blir rättssak. (...)

Celebrex (Celebra i Norge)

Celebrex Ads Are Back, Dire Warnings and All
nytimes.com 29.4.2006
The ads for the Pfizer painkiller Celebrex feature a man holding a boy's hand as they walk up a stadium staircase. "52 steps won't keep you from taking him out to the ballgame," they say.

But a heart attack would.
Each ad includes a boldface warning that begins, "Important Information: Celebrex may increase the chance of a heart attack or stroke that can lead to death."

As it resumes ads for the controversial medicine, Pfizer, the world's biggest drug maker, is offering consumers a decidedly mixed message. But 16 months after the company stopped advertising Celebrex over concerns about its heart risks, Pfizer has returned to the consumer ad market in hopes of reviving sales of the drug, which plunged last year during the ad moratorium.

The new campaign in magazines has raised the ire of consumer groups, who say that Celebrex is so dangerous that Pfizer should stop selling it, not encourage patients to use it.

The campaign is more evidence of the drug industry's dependence on consumer advertising to prop up sales, said Dr. Sidney Wolfe, a frequent critic of drug makers. "There's no objective evidence of any unique benefit with this drug, and there is objective evidence of a unique risk," said Dr. Wolfe, the director of health research for the consumer advocacy group Public Citizen.

Pfizer stopped advertising Celebrex in December 2004, after Merck stopped selling Vioxx, a similar drug, because of its heart dangers. Four months later, federal regulators ordered Pfizer to put a so-called black-box warning on Celebrex, detailing its risks. (...)

Statlig kontroll av legemiddelreklame

Simpler Rx Warnings Urged For Ads
cbsnews.com 31.3.2006
(AP) Saying "less is more," a coalition of advertising and public relations groups wants to strip most of the warnings from prescription drug ads aimed at consumers.

Current direct-to-consumer advertisements "over-warn and under-inform," according to a petition submitted Friday by the Coalition for Healthcare Communication to the Food and Drug Administration. "The result is more confusion than communication."

"Our goal is simpler, clearer messages that communicate both the risks and benefits of prescription medicines, more informed doctor-patient dialogue and improved patient compliance," said John Kamp, executive director of the coalition. The organization represents trade associations specialized in medical advertising, communications, marketing and publishing. It also receives some financial support from the drug industry.

A consumer advocate countered that prescription drug ads should contain clearer, not less, language.

"To pull away or remove those fine details, we are against that. I guess we are saying, 'more is better,"' said Bill Vaughan, a senior policy analyst at Consumers Union. "Have the key facts up front, but some of us would like to read to the end to be aware of the consequences and be sensitive to some of the things we might want to report to our doctors."

The Coalition for Healthcare Communication suggests in its petition that consumers would be better served by skimpier ads that still relay enough information to prompt them — without scaring or confusing them — to discuss with their doctors an advertised drug's risk and benefits. The ads would simply carry a boilerplate warning that all prescription drugs have potential risks and benefits, it said.

"While some may think it desirable to tell consumers about all side effects and contraindications, no matter how clearly this information is communicated to consumers, a significant number will lack the education or background to comprehend or act on it," the petition, signed by Kamp, reads in part.

The FDA has six months to respond to the petition, the latest of several filed since the late 1980s that seek to alter how the agency regulates drug ads aimed directly at consumers. An agency spokeswoman did not immediately return messages left to seek comment. (...)

Drug companies temper ads, fear more FDA rules (Legemiddelfirmaer toner ned annonser, frykter ytterligere FDA-regler)
azstarnet.com 14.3.2006
(...) The possibility of more government regulation looms. Late last year, the U.S. Food and Drug Administration held two days of public hearings on drug advertising and is now reviewing comments on the subject. The FDA said it is too early to say whether any new rules will be instituted, but some say it is likely.

Only 18 percent of consumers believe pharmaceutical ads can be trusted "most of the time," according to a study released last year by the Kaiser Family Foundation. That's down by almost half since 1997, when one-third of people surveyed said you could trust ads most of the time. (...)

Drug ads pour in for review
philly.com 23.2.2006
The FDA said it had seen "a huge increase" in advertising submitted for scrutiny under a voluntary industry program. (...)

Drug companies spent about $4 billion on TV and radio commercials in 2004. But facing public distrust because of drug safety, companies cooled their ad spending last year. Hoping to preempt legislative restrictions, the Pharmaceutical Research and Manufacturers of America, or PhRMA, promulgated its first voluntary ad code in August. (...)

Most of the FDA's 15 warning letters last year - its sternest reprimand over drug advertising - were prompted by inadequate warnings about a drug's risks, Abrams said.

He cited an ad for Quadrament, made by Cytogen Corp. of Princeton, that he said falsely claimed to eliminate chemotherapy pain. "These are very, very sick patients, and to promise them hope like this is not in the interests of public health," Abrams said.

A separate FDA division responsible for reviewing ads for biological drug products issued just five warning letters last year, slightly fewer than its prior average, said Maryann Gallagher, acting director of the Advertising and Promotional Labeling Branch of the FDA's Center for Biologics Evaluation and Research. (...)

Drug industry's new code criticised for lacking teeth
BMJ 2005;331:1225 (26 November)
The pharmaceutical industry published a tougher code of conduct this week after criticism that self regulation was failing to stop the circulation of misleading claims about products. The revised code from the Association of the British Pharmaceutical Industry follows a critical health select committee report in April (BMJ 2005;330: 805 [Free Full Text]).

As evidence that self regulation wasn't working well, the report cited examples of breaches of advertising regulations; cover-ups of negative medical information; and giving misleading information to prescribers. MPs also criticised the long delays taken by the industry to investigate complaints. (...)

Professor Andrew Herx-heimer, emeritus fellow at the UK Cochrane Centre, said, "It's a very determined sales job on the new code—just like a drugs promotion. But what does it mean in substance? You need to look at what is missing. This is very competent window dressing but not much has changed at all." (...)

FDA investigates direct to consumer adverts
BMJ 2005;331:1102 (12 November)
Testimony on direct to consumer advertising in hearings held last week by the US Food and Drug Administration was widely divergent. Consumer advocates blasted prescription drug adverts as misleading while industry representatives said that they educate the public. (...)

FDA to Revisit Drug Marketing
Los Angeles Times 2.11.2005
After easing rules that have allowed pitches for prescription medicines to boom, the agency now wants to hear how ads can be regulated.

WASHINGTON — Concerned about the direct marketing of prescription medication to consumers, the Food and Drug Administration began collecting ideas Tuesday on how such advertising could be regulated.

"A lot has happened in the last decade with direct-to-consumer advertising, and we believe it's time to receive additional input," said Dr. Janet Woodcock, the FDA's deputy commissioner for operations. "It's critical, from a public health standpoint, that the advertisements are truthful and balanced."

Since 1997, when the FDA relaxed the rules on marketing prescription medicines, ads for treatments of such ailments as depression, erectile dysfunction and chemotherapy-related anemia have moved from medical journals to television networks and consumer magazines, creatively describing the benefits of a more cheerful mood, enhanced virility and increased energy while fighting cancer.

Today, direct-to-consumer advertising is a $4.1-billion-a-year industry, and numerous studies have demonstrated that such marketing increases sales of specific drugs.

But debate over the effectiveness and accuracy of the ads has polarized consumer groups, which are seeking stricter regulations, and drug manufacturers, which contend that such marketing is free speech. (...)

FDA TO HOLD NEW DTC ADVERTISING HEARINGS
adage.com 5.10.2005
First Regulations Expected; Celebrity Endorsers May be Banned

NEW YORK (AdAge.com) -- More than two years after the last public hearing on direct-to-consumer advertising failed to produce any guidelines to regulate the $4 billion ad category, the Food and Drug Administration will try it again.

The agency will hold a public hearing Nov. 1 and 2 in Washington to discuss the issue. Some think the hearings could lead to the first-ever formal regulations for DTC promotions.

“I think the general consensus is that the FDA, this time, will finally produce something of substance,” said a chief marketing officer for a major drug maker. (...)

US drug industry's guidelines on advertising too limited, say critics
BMJ 2005;331:420 (20 August)
In the face of growing support for tighter regulations on advertising directly to consumers, the US drug industry's trade association has released voluntary guidelines of its own.

However, the guidelines fall short of a proposal by the leader of the Republican Senate majority, Bill Frist, for a two year waiting period before any new drug can be advertised directly to consumers. In July Dr Frist told the Senate that "if drug companies don't clean up their act, I believe Congress will need to act in this." (...)

Taking a closer look at drug advertisements
Lancet 2005; 366:522 (13 August 2005)
Robert Ernst was just one of millions of Americans who ask their doctors to prescribe a medication because of a direct-to-consumer (DTC) drug advertisement. In Ernst's case, the drug was Vioxx; Robert Ernst is now dead, and his widow, Carol, has sued Merck, in a case now being heard, claiming that the drug directly caused his death. Carol Ernst says she also blames herself, because she was the one who saw the advertisement and encouraged her husband to ask his doctor about it.

Regardless of the cause of Robert Ernst's death and the outcome of the trial, this story demonstrates that DTC advertisements are clearly influential. Last year, the pharmaceutical industry spent US$4•1 billion to promote drugs to the public—on television, in print, and through sponsorship of sporting and other events. So it is indeed high time that the US Food and Drug Administration (FDA) undertook its first major review of DTC advertising since 1995, an announcement reported by the Wall Street Journal last week. The review has yet to be confirmed by the FDA.

DTC advertising is a balancing act. On the one hand, patients are entitled to information about their therapeutic options. But DTC advertisements may unduly influence patients and put pressure on doctors to prescribe inappropriately. An FDA survey of doctors showed that most believe patients do not understand the risks of the drugs, and that they overestimate the drugs' effectiveness. Patients themselves said DTC advertisements do not give them enough information about risks and that they put the drugs in an unrealistically positive light.

The Pharmaceutical Research and Manufacturers of America recently announced new guidelines for DTC advertisements. One recommendation is that companies submit all new DTC advertisements to the FDA before release for broadcast—something they are not now required to do. Good plan, but the guidelines do not go far enough. The FDA must review existing advertisements as well, and Congress can certainly speed the conversion of recommended guidelines into something more rigorous, like law. (...)

WHO

WHO utbildar om läkemedelsreklam
Läkemedelsvärlden 2006(39 (April)
En halv dag eller mindre ägnas åt läkemedelsreklam på farmaci- och läkarutbildningarna. För lite menar WHO som tar fram en handbok i ämnet.

UTBILDNING Den kanadensiska forskaren Barbara Mintzes har på uppdrag av WHO och HAI, Health Action International sammanställt en rapport över vilken utbildning farmaci- och läkarstudenter får i läkemedelsindustrins marknadsföring.

Rapporten som bygger på de svar hon fått från 228 lärare från 64 länder är främst en beskrivande översikt, men den första som försöker kartlägga utbildningsnivån globalt.

Majoriteten uppgav att de ägnade en halv dag eller mindre till ämnet marknadsföring. På farmacevtiska utbildningar har man generellt mer tid för ämnet, medan cirka 30 procent av dem som utbildar läkare uppger att man ägnar högst en till två lektioner åt frågan.

Ett som Barbara Mintzes tycker, nyckelfynd i undersökningen, är att mycket få studenter tycks få någon utbildning alls i marknadsföringen direkt till allmänheten via internet.

De få timmarna står också i stark kontrast till den stora volym läkemedelsreklam som riktar sig till hälsopersonal, menar Barbara Mintzes. WHO och HAI arbetar nu med en handbok som är tänkt att distribueras globalt under 2007. (...)

Direct-to-consumer advertising (DTCA) of prescription drugs

Attention Assignment Editors, Health Reporters
healthcouncilcanada.ca 30.1.2006
Health Council paper finds no evidence to support direct-to-consumer
advertising of prescription drugs

– In the interest of patient safety and public health, the
government should curtail direct-to-consumer advertising (DTCA) of prescription drugs, concludes a paper prepared for the Health Council of Canada and released today.

The paper, entitled Direct-to-Consumer Advertising of Prescription Drugs in Canada: What are the Public Health Implications?, was written by University of British Columbia researcher Barbara Mintzes, who reviewed existing research to assess whether such advertising improves patient outcomes or patient safety.

“There is no reliable evidence that DTCA improves patient compliance in taking
medication or leads to more appropriate early diagnosis of under-treated conditions, or prevents hospitalizations and serious disease consequences,” said Mintzes, adding that higher exposure to DTCA results in increased requests for prescription medications. (...)

Eli Lilly

Eli Lilly to Pay $36M to Settle Charges
washingtonpost.com 21.12.2005
INDIANAPOLIS -- Eli Lilly and Co. said Wednesday it has agreed to plead guilty to a federal misdemeanor and pay $36 million to settle charges that it illegally marketed and promoted its Evista osteoporosis drug for two unapproved uses.

The Department of Justice said an investigation that began in July 2002 found that some Lilly sales representatives promoted Evista in 1998 as useful for preventing and reducing the risk of breast cancer and for reducing the risk of heart disease.

The Food and Drug Administration has approved neither use. (...)

Big Drug Makers See Sales Decline With Their Image
The New York Times 14.11.2005
The drug industry's image problems are beginning to hurt pharmaceutical companies where it matters most - at the bottom line.

A year after Merck's withdrawal of its arthritis medicine Vioxx led to an industrywide credibility crisis, the Food and Drug Administration is blocking new medicines that might previously have passed muster. Doctors are writing fewer prescriptions for antidepressants and other drugs whose safety has been challenged, like hormone replacement therapies for women in menopause.

Meanwhile, insurers and some states are taking advantage of the backlash against the industry to try shifting patients to older, generic drugs, arguing that they work as well as newer and more expensive branded medicines. Overall, prescriptions continue to rise slightly, but an increasing share of prescriptions are going to generic drugs. Also, consumers seem to be less responsive to aggressive drug marketing.

"A lot of the demand that the industry has created over the years has been through promotion, and for that promotion to be effective, there has to be trust," said Richard Evans, an analyst covering drug stocks at Sanford C. Bernstein and Company. "That trust has been lost." (...)

GAO: Improvements Needed in FDA’s oversight of Direct-to-Consumer Advertising
fiercebiotech.com 14.12.2006
Drug company spending on DTC advertising—-such as that on television and in magazines-—of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development. Over this period, drug companies spent less each year on DTC advertising ($4.2 billion in 2005) than on promotion to physicians ($7.2 billion in 2005) or research and development ($31.4 billion in 2005). (...)

"onslaught of advertising to promote prescription drugs... does not promote public health"

Professors speak out against advertising directly to consumers
BMJ 2005;331:1040 (5 November)
The drug industry's "onslaught of advertising to promote prescription drugs... does not promote public health" and "increases costs and unnecessary prescriptions," more than 200 US medical school professors said last week. In the United States the industry spends $4bn (£2.3bn; 3.3bn) a year on direct to consumer advertising.

The professors signed a petition organised by Commercial Alert, an Oregon based nonprofit organisation that seeks to "protect communities from commercialism." The petition was sent to the US Food and Drug Administration in response to a call for public comments before an FDA advisory committee's hearing on direct to consumer advertising held earlier this week.

The professors say in the petition: "Prescription drug advertising pressures health professionals to prescribe particular medications, and often the ones that may be less effective and more expensive and dangerous. This intrudes on the relationship between medical professionals and patients, and disrupts the therapeutic process."

That, say the signatories, wastes valuable time as doctors are forced to "explain to patients why they may have been misled by the drug advertisements they have seen." (...)

Public Citizen

Direct-to-Consumer Drug Ads Not Beneficial; Federal Government Should Do More to Educate Patients, Public Citizen Tells Senators
Public Citizen (Sept. 29, 2005)
WASHINGTON, D.C. – The adverse effects of direct-to-consumer (DTC) drug advertising outweigh the still-undemonstrated, theoretical benefits of the ads, and the federal government should do more to stop misleading ads from reaching consumers, Public Citizen told senators today.

In testimony before the Senate Special Committee on Aging, Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group, detailed how drug ads – on television, in print and on the Web – encourage doctors to prescribe pricey drugs to many patients who do not need the medication.

“Direct-to-consumer advertising is nothing less than an end-run around the doctor-patient relationship,” Lurie said. “There is little relationship between our true public health needs and the subjects of direct-to-consumer advertising. (...)

Tamiflu

Full PR klaff for influensamedisin
propaganda-as.no 1.11.2005
I hele 2004 var influensamedisinen Tamiflu omtalt kun 50 ganger i norske aviser. Så langt i år har omtalen nærmet seg 1000. Men PR-rådgiver Kim Hannisdal mener norsk presse ikke gjør jobben sin når de omtaler legemidler.

Mediebildet har de siste ukene i stor grad omhandlet fugleinfluensaen som avdekkes i land etter land. Nå dør endene på Dagsrevyen - og bilder av rumenske tollere som vasker alle biler som kjører inn og ut fra Romania ruller over TV-skjermen.

Det har gitt farmasiselskapet Roche Pharma Norge og deres influensamedisin, Tamiflu, enorm PR.

En gjennomgang Retriever Norge har gjort over pressedekningen av influensamedisinen i norske aviser så langt i år, viser at det er skrevet 918 artikler om Tamiflu så langt i år. Bare i oktober ble det registrert 664 artikler. Dermed har pressedekningen vært nær 20 ganger så stor i år, som i fjor. (...)

- Dekningen av fugleinfluensaen og Tamiflu avspeiler en skrekkblandet fascinasjon hos oss. Vi lever i et relativt risikofritt samfunn og har kontroll over mye. Men trekkfuglene kan vi ikke kontrollere. Her er det noe som kan ramme oss alle, sier kommunikasjonsrådgiver Kim Hannisdal i Argument, med bakgrunn som informasjonsansvarlig i Statens Legemiddelverk.

Han mener ikke pressedekningen har vært overdrevet og kaller influensaviruset en alvorlig trussel, som det er viktig at folk er oppmerksom på. Men Hannisdal er ikke fornøyd med dekningen legemidler får i mediene til daglig. (...)

Legemidler mot kreft

Rise of celebrity testimonials spurs FDA scrutiny
he Boston Globe 30.10.2005
WASHINGTON -- Crowds lined roadways here this month to watch seven-time Tour de France winner and cancer survivor Lance Armstrong lead cyclists on the final leg of the Tour of Hope ride. The 3,300-mile trek, sponsored by drug manufacturer Bristol-Myers Squibb, promoted clinical trials for new cancer drugs. Armstrong is a fixture in the company's print advertising campaigns to raise awareness of the disease.

For now.
The Food and Drug Administration will hold meetings Tuesday and Wednesday that could produce the first significant changes to drug advertising after months of criticism from Congress and other groups. Some say Vioxx advertisements featuring Olympian Dorothy Hamill, who has arthritis, fueled an excessive number of prescriptions before the painkiller's heart risks became known, potentially imperiling millions.

Among the FDA's questions: Do testimonials by celebrities mislead the public about prescription drug safety?

''It's hard to imagine a setting in which a celebrity endorsement of a drug conveys any meaningful information to patients in terms of either efficacy or side effects," said Dr. Alastair J.J. Wood, associate dean of Vanderbilt Medical Center.

''I don't think the messenger is what potentially presents a 'good' or 'misleading' message. It's the message. That's what you've got to focus on," said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, known as PhRMA, the drug industry's Washington, D.C., lobbying group. Tauzin is also a cancer survivor who says drug companies saved his life. ''Frankly, I think patients delivering the message are the best ones. They tell real stories. They can talk from some experience," he said. (...)

Sovemidler

Update 5: Sleeping Pill Competition May Spur Ad War
forbes.com 29.3.2006
The maker of Ambien has begun a new ad campaign it hopes will reverse a sales slide triggered by reports that some patients couldn't recall driving or eating while sleepwalking when using the prescription sleep aid.

The campaign Sanofi-Aventis SA launched Wednesday is likely the first salvo in what analysts predict will be a fierce advertising war in the market which has seen sales drop in the aftermath of the negative news. Sanofi's Ambien is expected to have a new competitor by this summer when Pfizer Inc. and partner Neurocrine Sciences Inc. are slated to debut a new pill

Analysts expect the ads to flood the media just as the commercials for erectile dysfunction treatments like Viagra, when that drug added new competition. (...)

Rådsavgjørelse - klage

Rådsavgjørelse 03.12.2007: Fornyet behandling av klage på; ”NYHET i behandling av ADHD”, NOVARTIS (R1007)
lmi.no 19.12.2007
Saken ble innklaget av Janssen-Cilag AS. Gebyr 100.000,-. (...)

Rådet viser til anke av 3. september 2007 samt notat fra advokatfirmaet BA-HR av samme dato. Innledningsvis vil Rådet bemerke at man ikke finner det tvilsomt at reklamereglene kommer til anvendelse. (...)

Opprinnelig gebyr kr. 100.000,- opprettholdes. Ankegebyr kr. 20.000,- ilegges. (...)

Diverse artikler

Marknadsföring av receptbelagda läkemedel till allmänheten är inte tillåten
lakemedelsverket.se 25.11.2011
Läkemedelsverket har tidigare i år förbjudit Boehringer Ingelheim AB att marknadsföra den receptbelagda produkten Pradaxa till allmänheten. Marknadsföringen bestod av ett pressmeddelande som publicerades på internet och som riktade sig till journalister. Ärendet har uppmärksammats i media sedan en tid tillbaka.

Läkemedelsverket blev i juni uppmärksammad på det aktuella pressmeddelandet om läkemedlet Pradaxa. Verket bedömde att pressmeddelandet är marknadsföring i lagens mening. Pressmeddelandet sprider positiv information om produkten, uppenbarligen för att skapa en ökad efterfrågan inför lansering av en utökad indikation. Texten har en tydlig reklamkaraktär där inga nackdelar utan endast fördelar med läkemedlet redovisas.

Pressmeddelandet är således inte sådan text av ren informativ och faktamässigt karaktär som ska undantas marknadsföringsförbudet. Reklam av receptbelagda läkemedel som riktar sig till allmänheten är inte tillåten. Läkemedelsverket har därför förbjudit Boehringer Ingelheim AB att marknadsföra den receptbelagda produkten till allmänheten. (...)

To medicinreklamer er dømt ulovlige
politiken.dk 16.11.2011
Forbrugerrådet har anmeldt to lægemiddelproducenter for ulovlig markedsføring.

»Klinske forsøg har vist, at din knoglekvalitet kan blive forbedret allerede efter tre måneders behandling«.

Sådan lyder det i en pjece om lægemidlet Forsteo, der er blevet uddelt til patienter med knogleskørhed på blandt andet Hvidovre Hospital.

Men det er ulovligt at lovprise medicin uden at nævne alle væsentlige bivirkninger, og derfor har Forbrugerrådet anmeldt to lægemiddelproducenter for ulovlig markedsføring. En klage, Lægemiddelstyrelsen nu giver Forbrugerrådet medhold i.

Skal kende alle bivirkninger
»Vi må slå fast, at væsentlige bivirkninger ved medicinen skal nævnes i materiale om et lægemiddel«, siger Sine Jensen, sundhedspolitisk medarbejder i Forbrugerrådet.

»Når man tager medicin skal man kende alle bivirkninger ved det for at kunne tage stilling til, om man vi løbe risikoen ved at tage medicinen. Det kan man ikke her«.

Den ene af de anmeldte foldere kommer fra virksomheden Ely Lilly, mens den anden reklamerer for medicin fra firmaet Abbott.

Lægemiddelstyrelsen har nu trukket de to foldere tilbage, og den beslutning accepterer Patrik Larsson, direktør for Eli Lilly, ifølge Ekstra Bladet. (...)

Lundbeck-partner under hård beskydning
business.dk 1.8.2011
En sag om ulovlig markedsføring af Lundbecks lykkepiller i USA har fået et benhårdt efterspil i USA. Lundbecks USA-partner risikerer at miste den amerikanske stat som kunde, og rasende investorer kræver udskiftning af ledelsen.

Sagen om den ulovlige markedsføring af Lundbecks lykkepiller til børnelæger i USA ruller videre for fuld kraft. Lundbecks amerikanske partner, Forest Laboratories, er under hård beskydning fra selskabets investorer, som kræver udskiftninger i bestyrelsen og den 83-årige topchef, Howard Solomons, afgang.

Baggrunden for det dramatiske efterspil er, at Forest Labs. sidste år erklærede sig skyldig i ulovlig markedsføring af Lundbecks lykkepiller til børnelæger og børnepsykiatere. Lykkepillen var imidlertid ikke godkendt til behandling af depressioner hos børn i den årrække, hvor den agressive markedsføring fandt sted. Det kostede Forest Labs. en milliardbøde.

Oven i det kom de amerikanske sundhedsmyndigheder så i foråret med en overraskende trussel om personligt at fratage Forest Labs. topchef, Howard Solomon, retten til at levere til det offentlige i USA - en betydelig kunde for ethvert medicinalselskab.

Det har ikke alene rystet den amerikanske medicinalbranche, fordi en ledelse hidtil har kunnet betale sig fra ulovlighederne, det har også fået flere af investorerne i Forest Labs. op af stolen for at rette skarp kritik mod ledelsen og kræve udskiftninger i toppen. (...)

Drug App Comes Free, Ads Included
nytimes.com 28.7.2011
Epocrates has won over nearly half of the nation’s doctors for its free smartphone apps that lets them look up information on drug dosing, interactions and insurance coverage while seeing a patient.

But like so much else on the Web, “free” comes with a price: doctors must wade through marketing messages on Epocrates that try to sway their choices of which drugs to prescribe.

The apps can select messages based on each doctor’s search and prescription histories, and the company has ambitious plans for expanded smartphone offerings. One possibility is a virtual sales rep that would help drug makers get their wares in front of physicians who decline to see human sales representatives.

The marketing messages are difficult to ignore. For example, a psychiatrist in Massachusetts who recently opened Epocrates (pronounced ee-POC-ra-teez) on his iPhone said that before he could look up any drugs, he had to click past “DocAlert” messages on hypertension, bipolar disorder and migraines. Two of the three showed they had been paid for by pharmaceutical companies promoting their products. (...)

Settling Risperdal claims could cost J&J $1 billion - WSJ
pharmatimes.com 13.5.2011
The Wall Street Journal is reporting that prosecutors in the USA are seeking some $1 billion from Johnson & Johnson to settle alleged claims of illegal marketing of the firm's antipsychotic blockbuster Risperdal.

The healthcare giant's previous marketing practices for Risperdal (risperidone) have been under investigation since 2004. Specifically the company was accused of claiming that the drug was safer than other antipsychotics, such as AstraZeneca's Seroquel (quetiapine) and Eli Lilly's Zyprexa (olanzapine) and of minimising the risk of diabetes associated with the treatment.

In a filing to the US Securities and Exchange Commission earlier this week, J&J noted that it had set aside an unspecified sum to settle potential civil and criminal charges. The company has since said that discussions with the US government “are ongoing and it is inappropriate to speculate”.

However, the WSJ quotes a person familiar with the situation as saying that prosecutors have been citing as a benchmark a $1.4 billion settlement that Lilly reached in 2009 to resolve a probe into its marketing of Zyprexa.

Related Links J J to appeal massive Risperdal illegal marketing award (...)

New drugs often marketed ahead of crucial data (Nye legemidler ofte markedsført før avgjørende data foreligger)
reuters.com 4.5.2011
(Reuters Health) - Data that could save money and help doctors make smarter treatment decisions are often unavailable at the time new medicines hit the market, according to U.S. researchers.

In a study out Tuesday, they found nearly a third of new drug approvals from the Food and Drug Administration included no data on how well the medications compare with existing alternatives.

"Even when these things are accessible, it's hugely time-consuming to go through it," said Joshua Gagne, a pharmacist at Harvard Medical School in Boston.
That leaves insurers and healthcare providers at a loss when trying to find the best and cheapest drugs for their patients, Gagne, who led the new work, told Reuters Health.

In 2009, Congress earmarked $1.1 billion to support drug comparison research, which would help doctors choose between various drugs. (...)

Supreme Court To Weigh Drug Confidentiality Laws
kaiserhealthnews.org 25.4.2011
The New York Times: A Fight Over How Drugs Are Pitched

Marketing to doctors using prescription records bearing their names is an increasingly contentious practice, with three states, Maine, New Hampshire and Vermont, in the vanguard of enacting laws to limit the uses of a doctor’s prescription records for marketing. On Tuesday, the Supreme Court will hear arguments in a case, Sorrell v. IMS Health, that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment (Singer, 4/24).

Meanwhile, news outlets also reported on several other drug-related issues. (...)

A Fight Over How Drugs Are Pitched
nytimes.com 24.4.2011
Before pharmaceutical company marketers call on a doctor, they do their homework. These salespeople typically pore over electronic profiles bought from data brokers, dossiers that detail the brands and amounts of drugs a particular doctor has prescribed. It is a marketing practice that some health care professionals have come to hate.

“It’s very powerful data and it’s easy to understand why drug companies want it,” said Dr. Norman S. Ward, a family physician in Burlington, Vt. “If they know the prescribing patterns of physicians, it could be very powerful information in trying to sway their behavior — like, why are you prescribing a lot of my competitor’s drug and not mine?”

Marketing to doctors using prescription records bearing their names is an increasingly contentious practice, with three states, Maine, New Hampshire and Vermont, in the vanguard of enacting laws to limit the uses of a doctor’s prescription records for marketing.

On Tuesday, the Supreme Court will hear arguments in a case, Sorrell v. IMS Health, that tests whether Vermont’s prescription confidentiality law violates the free speech protections of the First Amendment. (...)

FDA's 'Bad Ad' Program Generates One Warning Letter in First Year (FDAs "Dårlig reklame"-program genererer en advarsel det første året)
commercialalert.org 19.4.2011
Nearly a year into the Food and Drug Administration’s “Bad Ad” program, only one pharmaceutical company has received a warning letter that stemmed from the initiative and the recipient called it a “joke.”

“This program,” said Jerry Roth, president of Sanford, Fla.-based Hill Dermaceuticals, “is the phoniest thing I’ve ever seen.”

The “Bad Ad” program, launched in May 2010 by the FDA’s Division of Drug Marketing, Advertising and Communication, enlists the aid of medical professionals and health-care providers to help an understaffed FDA police the pharmaceutical community by anonymously reporting ads and sales pitches that violate FDA rules.

According to the FDA, it has received 239 complaints to the Bad Ad program from its launch in May through January of this year. Of these complaints, 129 (54%) have come from health-care providers, 73 (31%) from consumers, and the remainder from other sources. Of the 239 complaints, approximately 135 were deemed to have sufficient merit for further investigation, with approximately 50% falling within DDMAC oversight and the rest being referred to other centers within FDA.

One of the fears of the Bad Ad plan when it was first announced was that those opposed to direct-to-consumer advertising or competing companies in the same industry could manipulate the program by lodging an anonymous complaint. (...)

Forest fumes at US government ban warning for CEO
pharmatimes.com 15.4.2011
Forest Laboratories has reacted angrily to a letter sent by US officials threatening its chief executive Howard Solomon with a ban from participating in Medicare and Medicaid, which would effectively exclude him from working in the pharmaceutical sector.

Mr Solomon, who is also Forest's chairman and president, is to challenge a potential action by the Office of the Inspector General, Department of Health and Human Services (HHS-OIG), to exclude him from participation in federal healthcare programmes. The letter from HHS-OIG relates to a settlement in September last year which saw the company plead guilty to claims of illegal marketing of the antidepressants Celexa (citalopram) and Lexapro (escitalopram) and an unapproved formulation of the thyroid treatment Levothroid (levothyroxine).

Forest paid out $313 million plus interest following the probe led by the Department of Justice and the Attorney's Office for Massachusetts that began in January 2004. It also signed a corporate integrity agreement (CIA) with HHS-OIG which has now given Mr Solomon 30 days to say why he should not be excluded. (...)

J&J forks out $70m to settle global bribery probe
pharmatimes.com 11.4.2011
Johnson & Johnson has agreed to pay a total of £70 million to settle violations of the Foreign Corrupt Practices Act (FCPA) after bribing public doctors throughout Europe and paying kickbacks to Iraq to illegally obtain business.

J J unearths corrupt practices at medical devices units Recalls wreck J J financials and pharma sales fall

 

Medical journals with advertising are more likely than subscription journals to recommend drugs (Mer sannsynlig at medisinske tidsskrifter med annonser anbefaler legemidler enn abonnementstidsskrifter)
BMJ 2011; 342:d1335 (1 March)
Free medical journals with drug advertising were significantly more likely to recommend specific drugs that were advertised on their pages than were journals that relied upon subscription fees to cover their operating costs.

“Free journals almost exclusively endorse the use of the selected drugs, whereas journals that rely exclusively on subscription fees for their revenue are more likely to recommend against the use of the same drugs,” said lead author Annette Becker, MD, from the University of Marburg, Germany. The study was published in the Canadian Medical Association Journal (CMAJ 2011. Doi:10.1503/cmaj.100951).

The cross-sectional study examined all issues of 11 journals for general practitioners in Germany that were published in 2007. It classified the journals into three categories: “free journals” completely financed by paid advertising; “mixed revenue journals” financed with a mix of subscription fees and paid advertising; and “subscription journals” that were completely funded through subscription fees.

The study focused on continuing medical education articles for nine drugs or drug classes such as glitazones (diabetes), ezetimibe (hypercholesterolaemia), and varenicline (smoking cessation).

Within the data set of 465 issues of the 11 periodicals, the study identified 638 advertisements for the selected drugs, and 297 articles that made recommendations for or against their use. (...)

Direct-to-Consumer Advertising With Interactive Internet Media
JAMA. 2011;305(8):824-825 (February 23)
Direct-to-consumer advertising (DTCA) is legal only in the United States and New Zealand and has been linked with drug overutilization, public health concerns, and higher costs.¹ Despite global proscriptions, DTCA is the most rapidly increasing form of pharmaceutical marketing, with approximately $4 billion in US expenditures, outpacing physician marketing and research and development.²

The Internet has rapidly developed, with users moving from passive information using read-only “Web 1.0” technology to interactive tailored relationships using “Web 2.0” technology. This includes social networking sites and other interactive systems, resulting in new online DTCA marketing opportunities that transcend geopolitical borders. Currently, the US Food and Drug Administration (FDA) has not issued guidelines on this form of DTCA marketing. Yet electronic DTCA with Web 2.0 technology already has the potential for significant presence and may have unrealized public health effects. (...)

Pfizer fällda för produktplacering
dagensmedicin.se 18.2.2011
Pfizer blir det första läkemedelsföretag som fälls för produktplacering av ett receptbelagt läkemedel i ett tv-program.

Inzoomningar och kvardröjande närbilder av en förpackning med den receptbelagda alzheimermedicinen Aricept i tv-serien Drottningoffret, som sänts i Sveriges Television, har ställt till det för Pfizer.

Läkemedelsföretaget blev kontaktat av produktionsbolaget bakom dramaserien och fick frågan om det ville låna ut en förpackning av läkemedlet. Pfizer svarade ja. (...)

Will DTC Advertising Appear In Europe?
Pharmaceutical Technology Europe 2011;23(1)
Direct-to-consumer (DTC) advertising is firmly entrenched in the US, but has historically been considered as an inappropriate means of communication in Europe for prescription-only medicines. With European patients demanding more information on medicines, coupled with potential new legislation, will DTC finally gain a foothold in Europe?

Over the past 2 years there has been an overt drive by the European Parliament to improve patient access to information on medicines. However, there is growing concern that some of the proposals put forward will lead to direct-to-consumer (DTC) advertising.1 Historically, in Europe, DTC has been considered an inappropriate means for pharma companies to communicate with patients because it bypasses the healthcare professional. (...)

PHD Wins $1.4 Billion GSK U.S. Media Account
adage.com 20.12.2010
Incumbent MediaCom Dealt Blow in One of Biggest Media Pitches of Year

NEW YORK (AdAge.com) -- GlaxoSmithKline has awarded its $1.4 billion U.S. media account to Omnicom Group's PHD, beating out incumbent WPP's MediaCom, Publicis Groupe's Starcom and Havas' MPG, according to executives with knowledge of the review.

The review covered the planning and buying duties on the consumer health-care and pharmaceutical businesses across all communication channels, including TV, print and digital. (...)

Virksomheder sælger sygdomme på nettet
berlingske.dk 19.12.2010
Informationer om sygdomme kommer ofte fra medicinalindustrien, advarer Lægemiddelstyrelsen, som frygter kommercielle bagtanker. (...)

»Oplysninger om sygdomme blandes med behandlingsforslag, og der henvises ofte til lægemiddelstoffer. Når medicinalvirksomheden bag hjemmesiden tilmed er producent af behandlingspræparatet, er der tale om en meget direkte form for markedsføring.«

Sygdomme til salg
Det er ikke tilladt at reklamere for receptpligtig medicin i Danmark, men medicinalvirksomheder kan gennem vejledning og links gøre borgerne opmærksomme på deres produkt, og samtidig balancere på den rigtige side af loven, forklarer Steffen Thirstup:

»Når de ikke kan sælge medicinen, kan de altid sælge sygdommen.«

Flere af hjemmesiderne har meget officielle navne som eksempelvis halsbrand.dk, rygerlunger.dk og forkolelse.dk, og googler man ’rejsningsproblemer’ topper rejsningsproblemer.dk listen. En side, som er ejet af medicinalvirksomheden Pfizer.

»Læger og borgere skal være opmærksomme på, hvem afsenderen er og tænke på, om der kan være en kommerciel bagtanke. Brugen af et lægemiddel skal ske på en afvejning af virkninger og bivirkninger,« forklarer Steffen Thirstup

Lægerne bekymrede
I de praktiserende lægernes landsorganisation, PLO, er man generelt positiv over for, at patienterne orienterer sig på nettet, men finder det problematisk, hvis det er fra en medicinalvirksomheds hjemmeside, forklarer Roar Maagaard, praktiserende læge og bestyrelsesmedlem i PLO:

»De får ikke nødvendigvis hele sandheden. En ukritisk anvisning af en bestemt behandlingsform kan gøre, at patienten på forhånd har besluttet sig. Når vi ser det ske, er det svært at have en konstruktiv dialog med patienten.«

Koncernchef i Lægemiddelindustriforeningen, LIF, Ida Sofie Jensen, mener, at siderne ruster patienterne bedre til lægekonsultationen.

»Patienter har brug for så grundig oplysning som muligt, og når en konsultation hos lægen i snit kun tager seks minutter, er det vigtigt, at man også kan hente oplysninger andre steder.«

Hun afviser dog ikke, at medicinalvirksomhederne har et ønske om at tjene penge:

»Det er klart, at virksomhederne bag disse sider ønsker en indtjening. De har brugt mange penge på at udvikle et produkt, som kan gavne patienten, Men der er jo regler for, hvad de må skrive på siderne. De skal blandt andet oplyse om alternative behandlinger, og de må ikke reklamere for deres produkt.«
Ida Sofie Jensen erkender, at der har været eksempler på problemer med de sygdomssites, lægemiddelvirksomhederne har været involveret i, og har derfor taget kontakt til sundhedsministeren.

»Jeg forstår godt, at det ikke altid er lige nemt for patienterne at gennemskue, hvem afsenderen er. Der arbejdes i øjeblikket på at lave fælles regler for information om lægemidler i EU, og vi har kontaktet sundhedsminister Bertel Haarder, for at opfordre ham til at støtte forslaget i Ministerrådet,« forklarer Ida Sofie Jensen. (...)

Salget av antidepressiva til værs
tv2nyhetene.no 24.7.2010
Salget av antidepressiva er nesten femdoblet på 20 år, og Legemiddelverket mener feilinformasjon fra produsentene bidrar til overforbruk.

Nesten 300.000 nordmenn benyttet i fjor legemidler mot depresjon, mot 280.000 i 2004, skriver Aftenposten.

En rapport fra Folkehelseinstituttet viser at salget av antidepressiva har økt med 379 prosent de siste 20 årene.

Legemiddelindustriens markedsføring er en sterkt medvirkende årsak til økningen, tror overlege Steinar Madsen i Legemiddelverket.

– Feilinformasjon fra legemiddelindustrien gir økt medikamentbruk, sier Madsen.

Norsk psykiatrisk forening (NPF) etterlyser strengere regelverk for reklame for legemidler og tar til orde for at 1 prosent av legemiddel-omsetningen skal gå til et fond for nøytral informasjon og forskning. (©NTB)

«Risky Business: How TV drug ads should talk about risk
postscript.communitycatalyst.org 2.7.2010
Risky Business II: How risk should be presented in TV drug ads

Yesterday we blogged about comments Prescription Access Litigation and others made to the FDA in support of proposed rules on presenting risk information in broadcast drug ads.

Numerous other consumer and public health groups have commented, and overall offered resounding support for these proposed regs. The Patient, Consumer and Public Health Coalition offered their support for these regulations and stressed that “the goal of DTC ads is to persuade, not to educate, and so DTC ads emphasize the benefits but not the risks of prescription drugs.” (...)

Medicinalfirmaer kaster sig over sociale medier
business.dk 22.3.2010
Står det til verdens største medicinalkoncern, amerikanske Pfizer, er en fremtid, hvor en stor del af markedsføringen foregår via sociale medier, lige om hjørnet. Vi skal være der, hvor patienterne og lægerne er, siger koncernens øverste medicinske direktør. Herhjemme har Lundbeck drevet debatforum på nettet i ni år, mens Novo Nordisk stadig er forbeholden.

Har du overvejet at være Facebook-ven med et medicinalselskab, deltage i en indsamling til behandling af sjældne sygdomme arrangeret af den danske medicinalkoncern Lundbeck på Twitter, eller se en video om hvor godt den nyeste astmamedicin virker på YouTube?

Eller hvad med at deltage i et socialt netværk på nettet, som skal bringe patienter og de læger, der lave medicinforsøg, tættere sammen, sponsoreret af verdens største medicinalkoncern Pfizer. (...)

What Do Physicians Think?
Psychiatr News 2010;45(6):5 (March 19) (American Psychiatric Association)
Psychiatric News March 19, 2010
The results of an online survey indicate physicians' strong disapproval of direct-to-consumer TV advertisement for psychotropic medications.

The survey was conducted and funded by HCD Research, a marketing research firm based in Flemington, N.J. The survey sample was drawn from the company's database of physicians across the United States, Vince McGourty, a company spokesperson, told Psychiatric News. A total of 612 physicians responded to the online survey, of whom 47 were psychiatrists. The survey was conducted in mid February via HCD Research's Web site. (...)

Dyrbar bluff om ”ny” medicin
dagensmedicin.se 16.3.2010
Under hösten 2009 lanserade Novartis läkemedlet Theracough (guaifenesin) som ska användas vid hosta med segt slem. I en reklamfilm för tv sägs bland annat: ”Om slemhosta får dig att gå miste om det roliga: Prova något nytt! Den nya hostmedicinen Theracough är den enda som innehåller guaifenesin som löser upp slem, lugnar och lindrar slemhosta”. Budskapet följs av en bild på läkemedelsförpackningen med ordet ”ny” i övre högra hörnet.

Problemet är bara att hostmedicinen godkändes 1974. Då hette det Resyl S, vilket var ett namn som bestod till i fjol då Novartis ansökte hos Läkemedelsverket om att få ändra namn på preparatet och utseende på förpackningen. (...)

A look at most-advertised prescription medicines
forbes.com 5.3.2010
Research by The Nielsen Co. shows that in 2009, drugmakers spent the most money on ads directly targeting consumers for these prescription medicines:

Drug/Condition Manufacturer Amount Spent

Lipitor/cholesterol problems Pfizer Inc. $244.2 million
Abilify/schizophrenia Bristol-Myers Squibb/Otsuka $202.2 million
Advair/astham GlaxoSmithKline PLC $182 million
Cymbalta/depression Eli Lilly & Co. $177.7 million
Cialis/erectile dysfunction Eli Lilly & Co. $166.8 million

Source: The Nielsen Co. (...)

FDA urged to probe digital marketing by drugmakers
pharmatimes.com 3.3.2010
The US Food and Drug Administration has been urged to conduct a thorough investigation into the use by pharmaceutical companies of digital marketing techniques.

The health and safety of US consumers must be protected from “inappropriate and potentially harmful use of digital marketing applications that have been embraced by pharmaceutical and health marketers,” and which have given the industry “unprecedented abilities to take advantage of consumers,” claims the non-profit Center for Digital Democracy (CDD). (...)

Legislators move to tighten rules for drug companies
kare11.com 1.2.2010
Saint Paul, MN -- Minnesota lawmakers are moving to tighten rules for drug company direct marketing to physicians and other health care providers. Among three bills offered up Monday at the State Capitol was a bill banning pharmaceuticals from collecting records of what individual doctors are prescribing.

"They actually know exactly what your doctor is prescribing, so if they can move to get your doctor to prescribe their brand," Pete Wyckoff, a longtime health care consumer advocate and drug industry watchdog told reporters.

"And so it's almost like a third person sitting in that examining room, influencing your doctor to prescribe more of what their company is doing or to switch to their brand," he asserted. (...)

FDA ad chief says drugmaker warnings double
reuters.com 29.1.2010
WASHINGTON (Reuters) - The number of U.S. Food and Drug Administration warnings to drugmakers and others for questionable drug promotion has nearly doubled since President Barack Obama took office a year ago, a top FDA official said on Friday.

The agency sent 41 enforcement letters in 2009 compared with 21 letters in 2008, Thomas Abrams, head of the FDA's Division of Drug Marketing, Advertising, and Communication, told Reuters.

It has sent nine letters in January -- a pace that is expected to continue in 2010, he said in an interview. (...)

If advertisements fail to list a drug's risks or overstate the benefits, the agency can issue a warning. Most of the time, FDA works with companies to resolve the problem, but it does have the authority to impose fines and other penalties. (...)

GlaxoSmithKline Fined $5.8 Million for Deceptive Marketing in Kentucky
drugs.com 29.1.2010
Jan. 29--Franklin Circuit Judge Roger Crittenden has awarded Kentucky more than $5.8 million in civil penalties in its case against GlaxoSmithKline for deceptive or false marketing of drugs including the anti-nausea drugs Kytril and Zofran .

The award was announced by state Attorney General Jack Conway and was the second in two days against a major pharmaceutical company. On Wednesday, Conway announced that Crittenden had awarded $5.3 million in civil penalties against AstraZeneca for violating Kentucky’s Consumer Protection Act. (...)

Legemiddelfirma må endre hjemmesidene
dagensmedisin.no 22.12.2009
Statens Legemiddelverk gir nå fire legemiddelfirma en kort frist for å rette opp hjemmesidene sine. De skiller ikke mellom sider for allmennhet og sider for helsepersonell.

Legemiddelverket har gått gjennom legemiddelfirmaenes hjemmesider, for å se om de oppfyller reglene om reklame.

- Legemiddelfirmaene skal skille mellom informasjon til helsepersonell og informasjon til pasienter. Vi ønsker ikke at pasientene skal få informasjonen som er beregnet for helsepersonell med én gang de går inn på firmaenes sider, sier Jerkø. (...)

Consumer ads pump up prescription drug costs
reuters.com 24.11.2009
NEW YORK (Reuters Health) - Medicaid pharmacy costs for the blood-thinning drug Plavix jumped at around the same time the drug's maker started advertising it to consumers -- even though the number of people prescribed the drug didn't change, new research shows.

In the current issue of the Archives of Internal Medicine, Dr. Michael R. Law of the University of British Columbia in Vancouver and colleagues note that spending by government insurers for prescription drugs rose about 15 percent each year between 1994 and 2004. There's been an assumption that advertising drugs to consumers helps drive up prescription drug costs but there's little evidence to back this up. (...)

PhRMA Proposes FDA-Approved Logo for Marketing in Social Media
adage.com 12.11.2009
NEW YORK (AdAge.com) -- PhRMA is advocating for a universal safety symbol -- either the FDA logo itself or an FDA-approved symbol -- to indicate that a Twitter or Facebook mention links to a page that contains the pharmaceutical company's FDA-mandated risk information. (...)

Drug industry presses FDA to allow more online ads
forbes.com 11.11.2009 (Associated Press)
WASHINGTON -- As federal regulators take their first tentative steps toward policing the wild west of medical information online, pharmaceutical companies are pressing their case to market drugs via Google, Twitter and other Web sites.
The Food and Drug Administration will convene a two-day meeting beginning Thursday to hear the drug industry's position on Internet marketing. The agency has agreed to consider developing rules for online advertising after companies complained that the current guidelines for traditional media - which require a detailed list of possible side effects - have left them hamstrung on the Web. (...)

Putin criticises drug companies for paying doctors to prescribe their drugs (Putin kritiserer legemiddelfirmaer for betale leger for å forskrive sine legemidler)
BMJ 2009;339:b4200 (16 October)
Russia’s prime minister, Vladimir Putin, has criticised drug companies for allegedly paying health professionals to prescribe their products, a practice that he describes as "impossible to tolerate."

He made his remarks at a meeting of drug manufacturers in Zelenograd, at which companies discussed the industry’s development strategy up to 2020. (...)

Prescription Drug Ads Drive Up U.S. Health Costs
kaiserhealthnews.org 13.10.2009
NPR reports on how prescription drug advertising drives up consumer demand, which drives up medical costs. The story, done in partnership with the public radio program, This American Life, is the third in a three-part series about why American health care costs are so high. "Prescription drug spending is the third most expensive cost in the U.S. health care system. The average American gets 12 prescriptions a year, and this number only seems to grow larger." (...)

As TV Drug Ads Increase, So Do Concerns
healthfinder.gov 4.10.2009
Experts question commercials' value to patients and health-care system overall. (...)

The amount of money spent by pharmaceutical companies on direct-to-consumer advertising more than tripled between 1997 and 2005, growing from $1.3 billion to $4.2 billion since restrictions governing drug ads were relaxed by the U.S. Food and Drug Administration, according to the California Public Interest Research Group, a public advocacy group nicknamed CalPIRG. (...)

FDA to Hold Public Hearings on Big Pharma's Social-Media Use
adage.com 23.9.2009
Drug Makers, Agencies Frustrated by Lack of New Guidelines for Web 2.0

NEW YORK (AdAge.com) -- The U.S. Food and Drug Administration will hold a two-day public hearing in November on how pharmaceutical companies use the web and social-media tools to market their products, the first step in a long overdue process that will finally establish guidelines for how drug makers proceed in a Web 2.0 world.

The industry is embracing the news, despite the newfound regulatory heavy hand the FDA has shown under the Obama administration. "It's about time," said an executive for one top-five pharmaceutical company who asked not to be identified. "Any guidance at all is better than having no guidance, which is what we have right now." (...)

EU vil tillade reklame for receptmedicin
kristeligt-dagblad.dk 8.9.2009
I Danmark er det forbudt at markedsføre receptpligtig medicin over for borgerne.

Men det vil et nyt EU-forslag lave om på. Sundhedsministeren kæmper imod forslaget (...)

Kampagner for penicillin, hjertepiller og anden lægeordineret medicin kan blive hverdag, hvis et forslag fra EU-Kommissionen bliver vedtaget. I dag er reklamer for receptpligtige lægemidler forbudt i Danmark, men Kommissionen har foreslået, at det skal være tilladt at føre informationskampagner direkte henvendt til forbrugerne – blandt andet på internettet. Forbrugerrådet vender sig kraftigt imod forslaget:

– Vi er bange for, at folk begynder at tage medicin, de slet ikke har brug for. Det skal ikke være sådan, at man som borger ser reklamer og tænker: Jeg skal bare have fire af de der piller, så bliver jeg rask, siger Sine Jensen, sundhedspolitisk medarbejder i Forbrugerrådet, der sammen med blandt andre Lægeforeningen og Danmarks Apotekerforening i foråret kraftigt advarede sundhedsministeren mod det nye forslag. De frygter, at en øget liberalisering vil føre til sygeliggørelse af borgerne, risiko for overforbrug af medicin og flere bivirkninger blandt forbrugerne. (...)

Campaigns to reduce antibiotic use in the US cannot compete with drug advertising, study says (Kampanjer for å redusere antibiotikabruk kan ifølge studie ikke konkurrere med legemiddelreklame)
BMJ 2009;339:b3785 (15 September)
Regional public education campaigns in the United States to promote more appropriate use of antibiotics among outpatients are underfunded and seldom evaluated for effectiveness, concludes a study presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco on 12-15 September.

"The main problems in the US are that the programmes are not adequately funded or evaluated," said the study’s lead author, Benedikt Huttner, from Geneva, Switzerland. Many operate on $100 000 (£60 000; $70 000) a year or less, which pays for little more than the salary of a programme administrator. "There is very little money left over for the interventions themselves," said Dr Huttner. (...)

Document Details Plan to Promote Costly Drug
nytimes.com 1.9.2009
The pharmaceutical industry has developed thousands of medicines that have saved millions of lives, but it has also used its marketing muscle to successfully peddle expensive pills that are no more effective than older drugs sold at a fraction of the cost.

No drug better demonstrates the industry’s salesmanship than Lexapro, an antidepressant sold by Forest Laboratories. And a document quietly made public recently by the Senate’s Special Committee on Aging demonstrates just how Forest managed to turn a medicinal afterthought into a best seller.

The document, “Lexapro Fiscal 2004 Marketing Plan,” is an outline of the many steps Forest used to make Lexapro a success. Because of concerns from Forest, the Senate committee released only 88 pages of the document, which may have originally run longer than 270 pages. “Confidential” is stamped on every page. (...)

Direct-to-consumer advertising under fire
Bull World Health Organ 2009;87:576–577 (August)
Pharmaceutical companies that market medicines directly to consumers in the United States of America (USA) are under increasing pressure to rein in their inventive urges, while attempts to establish a bridgehead in Europe look doomed to failure. Gary Humphreys reports. (...)

Ministerrådet siger nej til medicinreklamer i EU
forbrugerraadet.dk 24.6.2009
Direktivet om medicinreklamer er indtil videre bremset af stor modstand i Ministerrådet. Blandt modstanderne er den danske sundhedsminister Jakob Axel Nielsen (K). Forbrugerrådet glæder sig over, at reklamer for medicin er sat i bero. (...)

Direktivet om medicinreklamer møder modstand i Ministerrådet. Blandt modstanderne er den danske sundhedsminister Jakob Axel Nielsen (K). Forbrugerrådet glæder sig over, at reklamer for medicin er sat i bero.
Nu møder direktivet, der vil tillade reklamer for receptpligtig medicin i EU, massiv modstand fra sundhedsministrene i Europa. På et Ministerrådsmøde i forrige uge gav samtlige ministre udtryk for bekymring over de konsekvenser, det vil have, hvis medicinalindustrien får frit slag for at lave reklamer. Hele humlen er, at medicinalfirmaernes henvendelser til forbrugerne ikke kan betegnes som objektiv information – det er reklame og vil skabe uigennemsigtighed for forbrugeren. Det har i lang tid været det problem, som Forbrugerrådet og en række andre organisationer har peget på – og nu erklærer Ministerrådet sig enig. Den holdning bliver vel mødt i Forbrugerrådet. (...)

FDA Tells Drug and Device Makers to Give Balanced Picture of Risks in Ads, Labels
JAMA. 2009;301(24):2541. (June 24)
The US Food and Drug Administration (FDA) is advising the makers of medications and medical devices to avoid misleading consumers with marketing strategies that deemphasize the risks of these products.

Promotional materials that omit or minimize risk information are the most frequent reason the agency issues enforcement letters to companies, and the FDA says it has received requests from industry for clarification about what it considers a violation. In the new guidance (http://www.fda.gov/cder/guidance/7427dft.pdf), the agency emphasizes that simply including risk information is not enough to satisfy its requirements; rather, the agency weighs whether marketing materials leave consumers or clinicians with a balanced impression of a product's risks and benefits. (...)

Risker med läkemedel ska framgå i amerikansk reklam
lakemedelsvarlden.se 4.6.2009
Den amerikanske läkemedelsmyndigheten FDA har gett ut nya riktlinjer för läkemedelsreklam i tv och tidningar. När riskerna presenteras får det till exempel inte göras samtidigt med distraherande musik.

KONCENTRATION Det 27-sidiga dokumentet ”Guidance for industry presenting risk information in prescription drug and medical device promotion” har släppts från FDA i förra veckan. Innehållet ger tydliga instruktioner för hur risker och biverkningar ska presenteras i reklam så att det är tydligt för konsumenterna.

I tv-reklam bör filmerna inte innehålla snabba klipp och scenbyten samtidigt som riskerna presenteras. Det bör heller inte förekomma distraherande musik som avleder tittarens uppmärksamhet. Den speakerröst som talar om riskerna bör dessutom vara samma som tar upp fördelarna så att tittaren och lyssnaren inte uppfattar dem som mindre viktiga.

Riktlinjerna har tagits fram efter att kritik riktats mot att läkemedelsindustrin genom att använda vissa knep får riskerna inte framgår lika tydligt som fördelarna. Även om riktlinjerna inte är bindande hoppas myndigheten på att industrin ska förändra sitt beteende vid marknadsföringen. (...)

Kan viden være farlig?
Martin Barlebo, kommunikationsrådgiver, Holm Kommunikation A/S
Martin Barlebo rådgiver bl.a. lægemiddelvirksomheder om kommunikation – primært gennem håndtering af pressen.
dagensmedicin.dk 19.6.2009
Et nyt EU-forslag om lægemiddelvirksomheders adgang til at informere om receptpligtig medicin på internettet kan være med til at rette op på skævheden i information (...)

I dag er information om godkendte, receptpligtige lægemidler svær at finde. Det på trods af, at internettet bugner af information om sygdom og sundhed. (...)

Risker med läkemedel ska framgå i amerikansk reklam
lakemedelsvarlden.se 4.6.2009
Den amerikanske läkemedelsmyndigheten FDA har gett ut nya riktlinjer för läkemedelsreklam i tv och tidningar. När riskerna presenteras får det till exempel inte göras samtidigt med distraherande musik.

KONCENTRATION Det 27-sidiga dokumentet ”Guidance for industry presenting risk information in prescription drug and medical device promotion” har släppts från FDA i förra veckan. Innehållet ger tydliga instruktioner för hur risker och biverkningar ska presenteras i reklam så att det är tydligt för konsumenterna.

I tv-reklam bör filmerna inte innehålla snabba klipp och scenbyten samtidigt som riskerna presenteras. Det bör heller inte förekomma distraherande musik som avleder tittarens uppmärksamhet. Den speakerröst som talar om riskerna bör dessutom vara samma som tar upp fördelarna så att tittaren och lyssnaren inte uppfattar dem som mindre viktiga.

Riktlinjerna har tagits fram efter att kritik riktats mot att läkemedelsindustrin genom att använda vissa knep får riskerna inte framgår lika tydligt som fördelarna. Även om riktlinjerna inte är bindande hoppas myndigheten på att industrin ska förändra sitt beteende vid marknadsföringen. (...)

Reklamestop for Panodil og Pfizer
forbrugerraadet.dk 2.6.2009
Træk reklamerne tilbage. Sådan lyder kravet fra Lægemiddelstyrelsen til to store medicinproducenter Panodil og Pzifer. Det sker efter, at Forbrugerrådet har anmeldt begge producenter for at lave ulovlig reklame på deres hjemmesider.

”Vi er glade for, at reklamerne bliver fjernet fra begge hjemmesider. Det er jo et stort problem, at Panodil ikke skriver om bivirkningerne ved pillerne. Det skal de selvfølgelig. Hvad Pfizer angår, så må de slet ikke lave reklame, fordi de sælger receptpligtige midler. Pfizer er et glimrende eksempel på, hvad der kommer til at ske, hvis man med det forestående direktiv i EU beslutter, at give receptpligtige producenter frit løb. Konsekvensen bliver jo, at forbrugerne vil efterspørge og selvordinere en masse medicin, som de muligvis ikke har brug for. Og den opgave er altså lægernes bord – ikke dit og mit”, siger Sine Jensen, der er sundhedspolitisk medarbejder i Forbrugerrådet. (...)

FDA Issues Advertising Guidelines on Product Risk Information (FDA publiserer reklame-retningslinjer for informasjon om produktrisiko)
kaisernetwork.org 27.5.2009
FDA on Tuesday posted on its Web site advertising guidelines for drugmakers and medical device manufacturers, offering suggestions on how to present risk information to health care professionals and consumers, the Wall Street Journal reports. Agency officials said the industry had asked for guidance on how to comply with its rules, which require a balanced presentation of a product's risk and effectiveness. Exclusion or minimization of risk information is the most commonly cited violation each year in FDA-issued warnings or enforcement letters. The new guidelines include detailed information on how aspects such as font, types of contrast and white space in print materials can appropriately present risk information. According to the Journal, the 24-page document is not binding. FDA will accept public comments for 90 days prior to issuing final guidelines (Corbett Dooren, Wall Street Journal, 5/27). (...)

FDA Gives Advice on Divulging Risks
online.wsj.com 27.5.2009
The Food and Drug Administration issued proposed advertising guidelines for drug and medical-device makers, with suggestions on ways to present risk information to consumers and health-care professionals.

The draft guidelines, posted Tuesday on the agency's Web site, aren't binding, but they offer several ways that the industry can avoid running afoul of its rules. The FDA said the omission or minimization (...)

Reklamer om medicin direkte til forbrugerne på vej
Ugeskr Læger 2009;171(21):1735 (18.5.2009)
Trods stærk modstand fra interesseorganisationer over hele Europa, inklusive Lægeforeningen, vil EU-Kommissionen give medicinindustrien lov til at reklamere direkte over for forbrugerne og patienterne. Europa-Parlamentet skal tage stilling. (...)

EU-Kommissionen vil give medicinindustrien lov til at reklamere - eller informere, som det også kaldes her - for receptpligtig medicin direkte til forbrugerne.

Godt nok ikke på tv eller i radioen, men i såkaldte »sundhedsrelaterede publikationer« - det kan for eksempel være i et sundhedstillæg i en almindelig avis, websteder, web-tv, og direkte over for patienterne, hvis de selv beder om det. Informationen skal være objektiv og neutral og også omtale bivirkningerne. Den skal være evidensbaseret, forståelig og må ikke være misvisende. (...)

Media comment on medicines may constitute advertising, says EU Court (Mediakommentar på legemidler kan være reklame, ifølge EU-rett)
pharmatimes.com 12.5.2009
Information about medicines produced by third parties such as journalists may constitute advertising, even though they have no connection with the product’s manufacturer or marketer, says a landmark European Court of Justice (ECoJ) ruling.

Article 86 of European Union (EU) Directive 2001/83/EC, which defines the concept of medicines advertising, “does not rule out the possibility that a message originating from an independent third party may constitute advertising, nor does [it] require a message to be disseminated in the context of commercial or industrial activity in order for it to be held to be advertising,” said the Court.

Moreover, such “advertising…is liable to harm public health,” even when it is carried out by “an independent third party outside any commercial or industrial activity,” added the Court, in a shock ruling which is raising concerns for the future of media reporting of health care issues. (...)

Merck disguised "marketing publication" as medical journal to help promote Vioxx, court hears (I rettsforhandlinger opplyses at Merck maskerte "reklamepubliksajon" som tidsskrift for å promotere Vioxx)
BMJ 2009;338:b1714 (28 April)
The Federal Court in Australia has heard allegations that the drug company Merck produced an entire medical journal as part of its marketing campaign to allay safety fears about Vioxx (rofecoxib), its cyclo-oxygenase-2 inhibitor, which was withdrawn in 2004.

The allegations came during testimony from George Jelinek, an emergency doctor and journal editor. Dr Jelinek was called as an expert witness by lawyers acting for Graeme Peterson, who had a heart attack in 2003 after taking rofecoxib for several years and is lead plaintiff in a class action. (...)

US citizens are overwhelmed by the wrong kind of drug information (Amerikanske borgere er overlesset med feil type legemiddelinformasjon)
BMJ 2009;338:b1712 (28 April)
Ann Intern Med 2009;150:563-4[Full Text]
Ann Intern Med 2009;150:516-27[Abstract/Full Text]
American citizens are inundated with $5bn (£3.4bn; 3.8bn) of direct to consumer advertising each year. Most of it is top heavy with spin and light on essential facts, such as the risks and benefits of treatment. Summary information is required by law, but at least two experts describe it as a "user hostile welter of tiny print" that is verbose, dull, confusing, and inadequate. (...)

Drugmakers challenge FDA over Internet search ads
pharmatimes.com 21.4.2009
Including product risk information on Internet search ads, as required by warning letters sent this month by the US Food and Drug Administration (FDA) to 14 drug majors, has made the ads even more misleading, say the firms.

In early April, the FDA issued the warning letters after routine surveillance by its Division of Drug Marketing, Advertising & Communications (DDMAC) found that Internet company-sponsored links on search engines such as Google had “made representations and/or suggestions for the efficacy” of a total of 48 drugs without communicating any risk information about them, thus misleading patients. Among the medicines were 19 which carry “black box” warnings of serious side effects, and some of the ads included information on uses of the drugs which have not been approved by the FDA. (...)

Pharmaceutical Companies Concerned About FDA's Rules for Google Internet Search Ads
kaisernetwork.org 17.4.2009
Drug industry executives have raised concerns that FDA regulations on Internet search advertisements are unclear and that complying with the rules could make the ads confusing or misleading, the New York Times reports. Search advertisements are brief text ads that appear alongside search results on search engines such as Google (Clifford, New York Times, 4/17). (...)

Drug Companies Spent $2.9M in Vermont Last Year Marketing to Providers, AG Report Says
kaisernetwork.org 17.4.2009
Seventy-eight pharmaceutical companies spent more than $2.9 million on marketing their products and providing gifts to physicians, hospitals and universities in Vermont during the last fiscal year, according to a report released Wednesday by the state attorney general's office, the AP/Boston Globe reports.

Vermont's Pharmaceutical Marketing Disclosure Law, adopted in 2002, requires drugmakers to report annually their spending on consulting and speakers' fees, travel expenses, gifts, and other payments to physicians, hospitals, universities and others who prescribe medications. The companies contend that the spending goes toward education programs about the medications for physicians and patients, adding that they use feedback from prescribers and patients when developing their medications. (...)

ADVERTISING
F.D.A. Rules on Drug Ads Sow Confusion as Applied to Web
nytimes.com 16.4.2009
The F.D.A. says Web search ads for Celebrex and other popular drugs lack required precautions. (...)

Drugmakers Reduce Spending on Prescription Drug Advertising
kaisernetwork.org 16.4.2009
Drugmakers in 2008 reduced their spending on consumer advertising of prescription drugs by 8% to $4.4 billion, the first cutback since at least the late 1990s, the Wall Street Journal reports. Print advertising for pharmaceuticals declined by 18%, while television advertising declined by 4%, according to IMS Health.

Prescription drug advertisements "have surged" since 1997 when FDA relaxed restrictions on direct-to-consumer drug advertising, according to the Journal. Spending on such ads reached a high of $4.8 billion in 2007, compared with less than $1 billion in 1997, according to IMS data. (...)

EU: Det skal være lovligt at reklamere for receptmedicin
netdoktor.com 15.4.2009
Et nyt EU-forslag vil gøre det muligt for medicinalindustrien at reklamere for receptpligtig medicin. Det har fået Forbrugerrådet, Danske Patienter, Danmarks Apotekerforening, Danske Handicaporganisationer, Farmakonomforeningen og Lægeforeningen til skrive til sundheds- og forebyggelsesminister Jakob Axel Nielsen., for at kræve forslaget taget af bordet. (...)

Ifølge den nuværende lovgivning, er det kun de offentlige myndigheder, der må stå for oplysningskampagner om sundhed og sygdom. Medicinalindustrien må kun føre reklame- og sygdomskampagner, der omhandler håndkøbsmedicin. (...)

EU: Lovligt at reklamere for recept-medicin
politiken.dk 14.4.2009
Reklamer for receptpligtig medicin vil føre til overforbrug og unødige bivirkninger, advarer Forbrugerrådet.

Reklamer for receptpligtig medicin er i dag forbudt.

Men et nyt EU-forslag vil lempe reglerne og give industrien lov til at lave kampagner for medicin, som man kun kan få ordineret af lægen. (...)

FDA Demands Pharma Stops 'Misleading' Ads on Google, Yahoo
adage.com 6.4.2009
Letters to Major Marketers Say Advertised Drugs' Effectiveness Isn't Tied to Potential Risks in Search

NEW YORK (AdAge.com) -- The FDA's Division of Drug Marketing, Advertising and Communications has sent out letters to 14 leading drug companies requesting them to end what it's calling certain "misleading" and "misbranded" advertising on search engines such as Google and Yahoo. (...)

FDA Warns 14 Pharmaceutical Companies About Short Internet Ads That Do Not Contain Risk Information
kaisernetwork.org 6.4.2009
FDA has warned 14 major pharmaceutical firms about brief Internet advertisements that could have misled patients because they did not include information about health risks related to the drugs, according to letters posted to the agency's Web site Friday, the Wall Street Journal reports. The ads cited in the letters typically appeared as "sponsored links" when a user typed the name of a disease or drug into a search engine. The violations were identified during routine monitoring of Internet advertising conducted by the agency, spokesperson Rita Chappelle said. According to Chappelle, 19 of the 48 drugs cited by FDA carry "black box" warnings, the agency's strongest warning for side effects. In addition, some of the ads included information on uses beyond those approved by the agency. (...)

Sanofi-Aventis also received a letter citing ads for its anti-clotting drug Plavix, the world's second-leading drug in terms of sales. According to the letter, "The sponsored links misleadingly suggest Plavix is safer than has been demonstrated."

Other companies receiving letters include Johnson & Johnson, GlaxoSmithKline, Forest Laboratories, Cephalon, Bayer, Novartis, Merck, Eli Lilly, Roche Holding, Genentech and Boehringer-Ingelheim Pharmaceuticals, which recently was acquired by Roche. FDA has not contacted search engines where the ads appeared because its policy is not to contact third parties that carry drug ads, even if they violate agency rules, Chappelle said (Favole, Wall Street Journal, 4/4). (...)

Regeringen kritiska till informationsförslag
lakemedelsvarlden.se 30.3.2009
Den svenska regeringen ställer sig inte bakom EU-kommissionens förslag om läkemedelsinformation till patienter. Så som förslaget är utformat nu går det inte ihop med svensk grundlag konstaterar socialdepartementet i ett PM till riksdagen.

Den del av EU-kommissionens pharmapaket som handlar om information innehåller många kontroversiella delar och har redan stött på stort motstånd i olika EU-länder. Nu konstaterar även den svenska regeringen att de inte kan ställa sig bakom förslaget. (...)

GSK ads for Avodart are misleading, says FDA (GSK-annonser for Avodart villedende, ifølge FDA)
mmm-online.com 3.3.2009
Consumer ads in support of GlaxoSmithKline's prostate drug Avodart overstate its efficacy and present misleading claims, the FDA said in a letter to the company.

The specific ad in question—a 60-second TV spot titled Planetarium—depicts artists working on planetary models, with one artist having to leave for the bathroom. Afterward, the actor recounts a conversation with his doctor: "Avodart is different because, over time, it actually shrinks the prostate, so I go less often. Other medicines, they don't treat the cause, because they don't shrink the prostate.” (...)

Why we should know about the pill sweeteners (Hvorfor bør vi ha opplysninger om de som sukrer pillene)
scotsman.com 3.3.2009
ANY day now, UK drug companies might do what some American ones say they're going to, and tell us which doctors they're paying. Why is disclosure so important in medicine? And why should you care? If the act of revealing or uncovering didn't exist, there would be no office gossip, and journalists and researchers would be out of jobs.

I don't have a problem with people keeping their skeletons safely stored in their closets, as long as they aren't responsible for my wellbeing. Like doctors. (...)

Researchers To Ask FDA Panel To Require Rx Drug 'Fact Boxes' on Some Advertisements (Forskere vil be FDA-panel om å kreve "faktaboks" for noen annonser)
kaisernetwork.org 27.2.2009
Two researchers from the Dartmouth Institute for Health Policy and Clinical Practice on Friday plan to push an FDA advisory panel to adopt a "drug fact box" labeling system for print prescription drug advertisements that quantifies the benefits and risks of taking a drug, the New York Times reports. The fact boxes would be similar in concept to nutrition fact panels on food packaging. The advisory committee will be examining ways to best provide consumers with accurate data. (...)

Bayer to spend $20m to correct misleading advertising for oral contraceptive Yaz
BMJ 2009;338:b674 (17 February)
Bayer Healthcare Pharmaceuticals has agreed to spend $20m (£14m; 15.6m) to correct misleading direct to consumer advertising of its birth control pill Yaz (drospirenone and ethinylestradiol), the most popular birth control pill in the United States, with sales of about $616m last year.

The corrective advertisements began running last month and will continue through June, the US Food and Drug Administration (FDA) said. (...)

FDA to study TV drug ads' influence on U.S. consumers
ama-assn.org 2.2.2009 (American Medical Association)
Controversial since they debuted in 1997, DTC ads are thought by many to require more oversight.

Washington -- Are direct-to-consumer television ads the best way for consumers to absorb information? Maybe TV viewers don't even hear the laundry lists of potential side effects. Perhaps they are distracted by the accompanying scenes of happy people doing fun things or snoozing contentedly.

The Food and Drug Administration has outlined a novel study designed to measure participants' recall and comprehension of risk and benefit information in television ads. (...)

Kritiserer p-pillereklame
vg.no 26.1.2009
Legemiddelfirmaenes informasjon til legene om bivirkninger ved p-piller mangler ofte informasjon om alvorlige bivirkninger, mener Legemiddelverket.

- Vi vil skjerpe tilsynet med legemiddelfirmaenes markedsføring av p-piller, sier seniorrådgiver Bente Jerkø ved Legemiddelverket.

Den økte oppmerksomheten er knyttet til unge kvinners p-pillebruk og risiko for blodpropp. (...)

Proposal to allow drug companies to give information to public sparks outcry16 BMJ 2008;337:a3043 (December 2008)
Consumers’ groups and medical organisations have reacted angrily to moves by the European Commission to allow drug companies to provide information on prescription only drugs to the public.

The proposal to relax the existing restrictions is in a package of measures designed to make the drug industry more competitive, encourage research, clamp down on counterfeit products, and guarantee patients across Europe the same degree of information on drugs. (...)

Speaking on behalf of the Standing Committee of European Doctors, which represents all the European Union’s doctors, Daniel Mart said, "I just do not trust the pharmaceutical industry to give out unbiased information." He said that the proposal might be a way to circumvent the existing advertising ban "by the back door."

The European Consumers’ Organisation, BEUC, claimed that the initiative was "a disguised way of giving pharmaceutical companies greater flexibility to provide the information they want on prescription medicines" so as to boost their sales. (...)

US FDA urged to act on drug/device Internet ads
pharmatimes.com 5.12.2008
Pharmaceutical and medical device companies are illegally advertising their products on YouTube, according to an industry watchdog, which has filed a series of petitions asking the US Food and Drug Administration (FDA) to remove them.

Six videos should be removed immediately from the YouTube Internet supersite because they appear to have been posted by manufacturers but do not include the warning statements required by the FDA, says the Prescription Project group. It has launched six citizen petitions urging the FDA to remove the videos – four of which are posted by Abbott Laboratories for its XIENCE-V drug eluting stent, plus one for Medtronic’s Prestige Cervical Disc and one for Stryker’s Cormet Hip Resurfacing Technology. (...)

Vi köper mer receptfritt
sr.se 26.11.2008
De senaste två åren har läkemedelsföretag satsat drygt en halv miljard kronor på tv-reklam i Sverige. Samtidigt har konsumtionen av receptfria smärtstillande mediciner ökat mycket kraftigt. Det visar Radio Upplands granskning. Vad tycker du om det här? Tyck till här! (...)

Vilka är det som är storkonsumenter i dag av receptfria läkemedel?
– Det är faktiskt de yngre. Yngre använder mer än äldre, och kvinnor använder mer än män, som vanligt när det gäller alla läkemedel nästan, säger Chris Bingefors.

Radio Upplands undersökning visar att läkemedelsföretagen de två senaste åren köpt 700 timmar reklamtid hos olika TV-bolag för att vi hemma i soffan ska lockas att bland annat köpa receptfria smärtstillande läkemedel. Det motsvarar reklam - dygnet runt - i nästan en månad. Reklamen har varit mest massiv för Voltaren gel, Eeze, Alvedon och Ipren.

Sammanlagt köpte vi receptfria smärtstillande tabletter för drygt 28 miljoner förra året här i länet. Det är en ökning med 72 procent jämfört med för 7 år sedan. (...)

Justice Department Investigates Vytorin Marketing, More Lawsuits Face Merck, Schering
kaisernetwork.org 5.11.2008
Merck and partner Schering-Plough face an investigation by the U.S. Department of Justice and an increasing number of lawsuits over their marketing of cholesterol drug Vytorin, according to a filing to the Securities and Exchange Commission on Monday, the AP/Miami Herald reports. Merck and Schering, after being pressured by congressional investigators, in January released results of a "long-delayed" study that found Vytorin was no more effective than the generic cholesterol drug Zocor, which costs one-third as much. The findings resulted in investigations by the Senate Finance Committee and the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations regarding whether the companies deliberately delayed the results to maintain sales of Vytorin and Zetia. (...)

(Anm: Zetia (ezetimibe); markesføres i Norge under handelsnavnet Ezetrol (Zetia i i USA.)

(Anm: Vytorin (ezetimibe and simvastatin); Vytorin er en kombinasjon av Schering-Ploughs Zetia (ezetimibe; fornorsket ezetimib) og Mercks Zocor (simvastatin).)

Which Drug Web Sites Are Most Widely Viewed?
pharmalot.com 10.10.2008
Would you be surprised if the answer is AstraZeneca’s Nexium? The web site for the heartburn med, known as purplepill.com, generated the most site traffic in this year’s second quarter, with more than 1 million unique visitors, a 55 percent increase from a year earlier. Runners-up include sites for Takeda’s Actos diabetes drug and the Sanofi-Aventis Ambien CR sleeping pill. (...)

Expensive ads sell few prescription drugs: study
reuters.com 2.9.2008
WASHINGTON (Reuters) - Expensive advertising of prescription drugs directly to consumers may do little to encourage sales, U.S. and Canadian researchers reported on Monday.

They said that even though companies spent an estimated $3 billion in 2005 on such ads in the United States, they did not appear to result in more prescriptions. (...)

Drug ad rules are hazy, enforcement often slow, GAO reports
baltimoresun.com 28.7.2008
WASHINGTON - When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot.

When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem. During that time, a lot of prescriptions can be written.

The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as "off-label" prescribing. (...)

Direct-to-consumer advertising: end the compromise
CMAJ 2008;2008; 179 (2) (July 15)
Despite federal regulations forbidding direct-to-consumer advertising for drugs and medical devices, it has become commonplace in Canada. From the pages of People, Ladies' Home Journal, Redbook and other US-based publications, you can glean how to protect your young daughter from the ravages of HPV, protect yourself from a future myocardial infarction with Plavix or Crestor, or minimize joint destruction and pain from rheumatoid arthritis using new monoclonal antibodies — all while you wait to pay for groceries. You can also hear the pharmaceutical spin about new therapies while watching reruns of Friends or Law and Order on major American television channels that are widely shown in Canada by satellite or cable providers. (...)

Prescription Drugs Killed More Floridians Than Illicit Drugs In ’07
healthleadersmedia.com 26.6.2008
A report by the Florida Medical Examiners Commission found that the improper use of prescription drugs killed three times more Floridians in 2007 than did all illegal drugs combined.

The annual Drugs Identified in Deceased Persons report analyzed 168,900 autopsies performed in Florida in 2007 and found that 8,620 people died with one or more of the drugs specified in the report in their bodies.

Cocaine, heroin, and methamphetamine played a role in 989 deaths. Legal opioids like the painkillers Vicodin and OxyContin caused 2,328 deaths, and depressants like Xanax and Valium were involved in 743 deaths. (...)

US regulators should investigate television adverts for drug eluting stents
BMJ 2008;336:1156-1157 (24 May)
Short Cuts
N Engl J Med2008 online May 14; doi: 10.1056/NEJMp0801433
At the end of last year, direct to consumer advertising of drugs in the US entered new territory when the manufacturers of the Cypher serolimus eluting stent launched a television advertising campaign. At least one expert has called on the Food and Drug Administration (FDA) to investigate the content, which implies that a serolimus eluting stent can open up your life as well as your coronary arteries. Middle aged adults swim, fish, and jog, while a voice-over says "when your arteries narrow, so does your life" and "it’s time to open it."

Although the advert mentions a few potential complications of stent placement, such as heart attack or stroke, it doesn’t cover the full list, which includes coronary artery rupture, emergency coronary artery bypass, and death. (...)

Drug Company Executives Respond to Concerns About Ads at House Panel Hearing
kaisernetwork.org 9.5.2008
During a hearing of the House Energy and Commerce Committee Oversight Subcommittee on Thursday, executives from Johnson & Johnson, Pfizer and a joint-venture between Merck and Schering-Plough defended TV prescription drug advertisements that lawmakers have claimed potentially misled consumers, the AP/Houston Chronicle reports. Democratic members of Congress to date have been unsuccessful in passing legislation that would prohibit direct-to-consumer ads in the first three years after a drug is approved. They have "intensified their scrutiny of the drug industry, energized by a recent discovery" that Merck and Schering-Plough continued to advertise the cholesterol drug Vytorin after a study showed it is no more effective than a lower-cost generic drug, the AP/Chronicle reports. Lawmakers are expected to propose similar legislation later this year (Perrone, AP/Houston Chronicle, 5/8). (...)

Pharmaceutical Promotion to Physicians and First Amendment Rights
NEJM 358:1727-1732 (April 17)
In mid-February, the Food and Drug Administration (FDA) proposed a change in its rules governing pharmaceutical promotion that would widen the ability of drug manufacturers to distribute information on unapproved uses of their products.¹ This proposal has rekindled the debate over the rights of drug makers to promote their medications to physicians. (...)

Kraftige protester i EU mod medicinreklamer
pharmadanmark.dk 7.4.2008
En flodbølge Kraftige protester i EU mod medicinreklamer

En flodbølge af protester fra forbrugerorganisationer, farmaceuter, læger m.fl. har rejst sig, efter at EU-kommisær Günther Verheugen har foreslået at lempe reglerne for medicinalindustriens adgang til at reklamere over for EU's befolkninger. (...)

EC proposals fail to distinguish between information and advertising
BMJ 2008;336:792-793 (12 April)
Moves by the European Commission to allow drug companies to use the television, radio, and print media to provide information on prescription drugs to consumers throughout Europe are being strongly criticised by medical and consumer organisations. (...)

Analyzing the side effects of drug ads
usatoday.com 29.2.2008
A few times every week, patients ask Jim King about drugs they've seen advertised.

"They'll say, 'I saw this ad on TV, and I think I have this medical problem,' " says King, a family physician in Selmer, Tenn., who says he's not bothered by the requests. "It gives me an opportunity to talk with the patient. It's amazing how many don't have the problem" or need the drug they saw advertised.

Billy Tauzin, president of Pharmaceutical Research and Manufacturers of America, the industry's lobbying group, says the ads educate patients about diseases such as depression or diabetes and encourage them to see a doctor.
Doctors and health care analysts say those visits also prompt patients to seek the latest and often most expensive drug, helping to drive up spending on health care and raising questions about whether patients need those particular new medications. (...)

As drug ads surge, more get Rx's filled
usatoday.com 4.3.2008
Prescription-drug ads prompt nearly one-third of Americans to ask their doctors about an advertised medicine, and 82% of those who ask say their physicians recommended a prescription.

The findings in a national survey by USA TODAY, the Kaiser Family Foundation and the Harvard School of Public Health come as drug advertising hit a record $4.8 billion in 2006, up from $2.6 billion in 2002.

ANALYSIS: Public debates whose needs are being met with drug ads (...)

Prescription Drug Advertisements Prompt One-Third of U.S. Adults To Ask Their Physician About a Medication, Survey Finds
kaisernetwork.org 4.3.2008
Prescription drug advertisements prompt nearly one-third of U.S. adults to ask their physicians about an advertised medicine, and 82% of those who ask about drugs are given a prescription, according to a survey by USA Today, the Kaiser Family Foundation and the Harvard University School of Public Health, USA Today reports (Appleby [1], USA Today, 3/4). The telephone survey included responses from a nationally representative sample of 1,695 U.S. adults from Jan. 3 to Jan. 23 and has a sampling error of plus or minus three percentage points (USA Today/Kaiser Family Foundation/Harvard School of Public Health release, 3/4). (...)

Vurderer å forby medisin-lenking
helserevyen.no 25.2.2008
Legemiddelfirmaene bryter markedsføringsreglene når de lenker fra egne nettsider for forbrukere til firmaets hjemmeside, der reseptpliktige legemidler omtales. (...)

Mener legemiddelfirmaer kan ha ulovlige nettsider
vg.no 25.2.2008
(VG Nett) Statens legemiddelverk vil vurdere tiltak mot legemiddelfirmaer som legger ut omtale av reseptbelagte legemidler på sine nettsider. (...)

Legemiddelindustriforeningen (LMI) er åpne for dialog med Legemiddelverket.

- Vi har ikke hatt de store kontroversene omkring dette, men vi er veldig åpne for en dialog med Legemiddelverket. Og vi er selvfølgelig opptatt av at legemiddelfirmaene ikke skal henvende seg med produktrettet informasjon overfor forbruker - og generelt overholde regelverket, sier administrerende direktør Pål Christian Roland. (...)

Los Angeles Times Examines Problems With Pharmaceutical Industry Focus on 'Blockbuster' Medications
kaisernetwork.org 28.1.2008
The Los Angeles Times on Sunday examined how the business "strategy that has made the pharmaceutical industry one of the wealthiest and most powerful on Earth" might have begun to "betray it."

Pharmaceutical companies for 25 years have "imitated the basic business model of Hollywood" and have "focused on creating blockbusters," which they "hope will appeal to masses" and "promote like mad," according to the Times. Pharmaceutical companies must spend as much as $1 billion to promote new medications in their first two years on the market to make the products into a "mega-brand" with at least $1 billion in annual sales. (...)

A bitter pill for Big Pharma
latimes.com 27.1.2008
Overdependence on 'blockbuster' drugs is taking a toll on the industry.

The strategy that has made the pharmaceutical industry one of the wealthiest and most powerful on Earth is finally starting to betray it. (...)

Reklameforbud for legemiddelgigant
kampanje.com 7.12.2007
Statens legemiddelverk nekter legemiddelselskapet AstraZeneca å markedsføre sine produkter i et halvt år. (...)

Seniorrådgiver Bente Hjerkø i Statens legemiddelverk mener AstraZeneca med sin markedsføring har bidratt til å undergrave myndighetenes bestemmelser.

– En rekke leger har reagert og rapport til oss om brev og kampanjer de har fått, sier hun. (...)

36 motioner om läkemedel
lakemedelsvarlden.se 9.10.2007
Skärp kraven på läkemedelsreklam, starta en kommission för läkemedelssäkerhet och stäng av läkare som utreds av HSAN. Det är innehållet i några av de 36 motioner om läkemedel som kommit in under den allmänna motionstiden i riksdagen. Vaccinfrågor är dominerande i årets skörd, hela elva motioner handlar om vaccin, varav sju om vaccin mot livmoderhalscancer. (...)

The costly side effects of Nexium's ad blitz
msnbc.msn.com 14.8.2007
Heartburn pills may be safe enough, but their marketing is hazardous (...)

Doctoring the Evidence: GlaxoSmithKline Pushes Depression Drug
corpwatch.org 30.7.2007
A striking young woman with a talent for painting, Sharise Gatchell was - like many teenagers - painfully self-conscious. At 14, she moved with her family from South Africa to England where at first she found it hard to make friends. (...)

DRUG INDUSTRY'S MARKETING HAS BIG IMPACT
japantimes.co.jp 13.7.2007
Film explores antidepressant use in Japan

LOS ANGELES (Kyodo) Filmmaker Mike Mills used to think that Japan was a land where the social stigma associated with mental illness kept thousands of sufferers unseen, unheard and untreated. (...)

Drug, ad firms gird as House takes up FDA revamp
BOSTON.COM 12.6.2007
WASHINGTON -- Pharmaceutical and advertising industry lobbyists who thwarted attempts in the Senate to rein in drug advertising now turn their attention to the House of Representatives, which is scheduled to take up legislation to overhaul the Food and Drug Administration today. (...)

Exhibit A in the critics' case is Vioxx, a painkiller manufactured by Merck & Co. that was propelled to blockbuster status by ads featuring Olympic skater Dorothy Hamill , even as concerns about the drug's effect on cardiovascular health grew. Vioxx was blamed for tens of thousands of deaths before its manufacturer pulled it from the market. (...)

Drug ads spark doubts
muskogeephoenix.com 10.6.2007
— Slick advertisements touting the benefits of prescription drugs are common in television, print and Internet media.

In 2000, pharmaceutical companies spent $2.5 billion on advertising, according to Mike Fillon in “Ephedra: Fact or Fiction.” Dr. John Abramson, author of “Overdosed America,” says that number increased to more than $3 billion in 2003. (...)

Ønsker færre reklameregler
ba.no 4.6.2007
TV 2s påtroppende sjefredaktør Alf Hildrum ser ingen grunn til å beholde dagens regler for TV-reklame. (...)

Noen områder som rammer TV-reklamen, er forbudet mot reklame for medisiner og politisk reklame.

- Jeg kan ikke se noen begrunnelse for å beholde disse forbudene lenger, sier den nye TV 2-sjefen. (...)

Drug Risks and Free Speech — Can Congress Ban Consumer Drug Ads?
NEJM 2007;356:2236-2239 (May 31)
In 2004, the discovery that Vioxx (rofecoxib) was a risky drug put direct-to-consumer pharmaceutical advertising in the spotlight. The image of Dorothy Hamill lacing up her skates and gliding over the ice despite her osteoarthritis offered a disturbing contrast to the public realization that millions of patients who were lured by the ad into taking Vioxx were risking stroke or myocardial infarction. Now, 3 years later, legislation that — if it is not amended, as some legislators want — would allow the Food and Drug Administration (FDA) to block direct-to-consumer ad campaigns for new drugs has been introduced in Congress (see graph). (...)

Coming soon: the shopping channel run by drug firms
guardian.co.uk 21.5.2007
Four of the world's biggest pharmaceutical companies are proposing to launch a television station to tell the public about their drugs, amid strenuous lobbying across Europe by the industry for an end to restrictions aimed at protecting patients. (...)

Pfizer conducts survey of French patients on information provided by industry
BMJ 2007;334:1027 (19 May)
Pfizer's French headquarters is surveying groups of patients in France on whether legal restrictions in Europe on the types of information that drug companies can provide to patients should be lifted.

Some health experts see the survey as part of a push by the drug industry to allow direct advertising of drugs to European consumers. (...)

Given the choice, I'd have the miracle pill story
BMJ 2007;334:932 (5 May)
Complex problems have depressingly complex causes, and the solutions are often taxing and unsatisfactory (...)

Drug Risks and Free Speech — Can Congress Ban Consumer Drug Ads?
Published at www.nejm.org May 2, 2007 (10.1056/NEJMp078080)
In 2004, the discovery that Vioxx (rofecoxib) was a risky drug put direct-to-consumer pharmaceutical advertising in the spotlight. (...)

Reklam till allmänheten åter på tapeten
Läkemedelsvärlden 26.4.2007
Är förbudet mot marknadsföring av receptbelagda läkemedel till allmänheten på väg att luckras upp inom EU? Det hävdar kritiker. Industrin varnar för att informationen kan försämras. (...)

Minky Viagra? Pfizer Doesn’t Want You to Understand It, Just Buy It
nytimes.com 30.4.2007
How much sexual innuendo can an advertiser pack into 15 seconds? (...)

“In an ideal world, companies would have to sell drugs based on accurate and balanced information,” he said. “That doesn’t seem to work well enough, so instead of that they’re substituting gibberish.” (...)

States Cracking Down on Drug Marketing (Stater slår ned på markedsføring av legemidler)
forbes.com 12.4.2007
Pharmaceutical-company sales reps who visit doctors' offices to promote their products know a surprising amount about the physicians before they even walk through the door.

Maybe too much, some lawmakers around the country say.

Legislators are taking a hard look at data-mining companies that keep detailed records on exactly what drugs are prescribed by nearly every doctor in the U.S.
These databases, updated weekly, are stripped of patient names and then sold to drug companies, which use the information to identify doctors who might be particularly receptive to their sales pitches. (...)

Føler seg utestengt
nettavisen.no 23.3.2007
Norsk psykologiforening krever en lovendring slik at de kan delta på møter som arrangeres av legemiddelindustrien. (...)

LMI klager SLV inn for Sivilombudsmannen
lmi.no 6.2.2007
LMI er kritisk til Legemiddelverkets håndtering av reklamesaker, og har klaget etaten inn for Sivilombudsmannen. Han vil se nærmere på saken. (...)

Company Accused of Improprieties in Marketing Risperdal
psychiatryonline.org 2.2.2007
Psychiatr News 2007;42(3):30 (February 2)
© 2007 American Psychiatric Association
The Texas attorney general says TMAP was just one part of an elaborate marketing scheme to increase psychotropic drug sales.

The Texas state attorney general joined a whistleblower lawsuit this past December accusing the pharmaceutical and consumer goods giant Johnson and Johnson inc. of exaggerating the benefits and minimizing the known adverse effects associated with its second-generation antipsychotic Risperdal (risperidone), marketed by subsidiary Janssen L.P. (...)

Drug firm's tactics reprimanded
bbc.co.uk 2.10.2006
The Association of the British Pharmaceutical Industry represents over 75 firms
A major drugs firm has been named and shamed over "serious breaches" of the industry's code of conduct.

Merck Sharp & Dohme Ltd, the UK arm of Merck & Co Inc, has been suspended from the Association of the British Pharmaceutical Industry (ABPI).

Merck offered GPs help screening blood pressure patients, but the service was only available to doctors which used its blood pressure drug, Cozaar.
Merck said it regretted the situation and took the reprimand seriously.

"We are working hard to reaffirm our core values and standards, and restore confidence and pride in our business practices" - Chris Round, managing director of MSD. (...)

GSK boss predicts demise of most ‘big pharma’ rivals
timesonline.co.uk 24.8.2006
ONLY a “handful” of the world’s top 15 drug makers will survive the industry’s spiralling research and development costs, J. P. Garnier, the chief executive of GlaxoSmithKline, predicted yesterday.

In an interview with Germany’s Manager magazine, the head of the world’s second- largest drugs group said that a significant number of the leading pharmaceutical companies invested too heavily in advertising and marketing at the expense of R&D and production.

“From 15 pharmaceutical companies that are important today, only a handful will probably survive,” Dr Garnier said.

“Hardly any of the large companies are in a position right now to invest enough money into research. A medium-sized company will hardly be able to spend enough on R&D.”

Peter Cartwright, a Williams de Broë analyst, said: “Companies are unlikely to close but will probably end up merging.” (...)

Watchdog gives spoof awards for aggressive marketing of drugs
BMJ 2006;332:1050 (6 May) (...)