Leger diktet opp resultater (forbes.com 12.2.2008)

Godkjenning av antibiotika bekymrer statsansatte som arbeider med sikkerhet “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned,” Dr. Graham wrote. (...)

Dr. Graham concluded that the agency should recommend the drug’s “immediate withdrawal.” (nytimes.com 18.7.2006)

FDA Says Aventis Failed To Act on Ketek Drug Fears (wsj.com 25.10.2007)

FDA Cites Fakes Results in Sanofi Study (forbes.com 25.10.2007)

Vi tror nytteverdi oppveier risikoer.

“We continue to believe that the benefits of Ketek outweigh the risks when it is used as directed for its approved indications,” Ms. Feltmann said. (nytimes.com 18.7.2006)

- Leger diktet opp resultater

FDA Staff: Sanofi Ignored Ketek Problems (FDA stab: Sanofi ignorerte Ketek-problemer)
forbes.com 12.2.2008
WASHINGTON - En statlig gransker opplyste at Sanofi-Aventis satt på bevis om at deres sikkerhetsstudie på antibiotika inneholdt forfalskede data, men innsendte dem allikevel til Food and Drug Administration. (WASHINGTON - A government investigator said Sanofi-Aventis had evidence that its safety study of its antibiotic contained fake data, but submitted it to the Food and Drug Administration anyway.)

"Katastrofal svikt" var beskrivelsen FDA-gransker Douglas Loveland ga i høringen på tirsdag om firmaets behandling av studien. (...) ("Catastrophic failure" was how FDA investigator Douglas Loveland described the company's handling of the study in a hearing on Tuesday.)

Ketek, som ble godkjent i 2004, fikk FDAs alvorligste advarsel februar sist år etter rapporter om leversvikt. FDA gikk senere tilbake og og fant at flere leger hyret av Aventis forfalsket data i 2002-studien. En lege soner en fireårig dom etter å ha erklært seg skyldig i å ha dikte opp resultater. (...) (Ketek, approved in 2004, received FDA's most serious warning last February after reports of liver failure appeared. FDA later went back and found that several physicians hired by Aventis falsified data in the 2002 study. One is now serving a four-year sentence after pleading guilty to making up results.)

(Anm: Ketek (telithromycin) (mintankesmie.no).

Drug's chilling path to market
sptimes.com 27.5.2007
How a broken FDA approved a cold antibiotic despite a wide trail of alarms. (...)

FDA Restricts Use of Antibiotic
washingtonpost.com 12.2.2007
-- The government on Monday restricted an antibiotic linked to rare reports of severe liver problems including several deaths, saying the drug should be used only to treat pneumonia and not less serious illnesses.

The Food and Drug Administration said the antibiotic, Ketek, would remain on the market but that its label will bear a new, stern warning. The agency said it and manufacturer Sanofi-Aventis SA also created a guide for patients outlining the drug's risks and its safe use. (...)

FDA, Lawmaker Clash Over Antibiotic
washingtonpost.com 30.11.2006
WASHINGTON -- President Bush's choice to head the Food and Drug Administration is refusing to give Congress all the information it seeks about a controversial antibiotic, setting up further confrontations with a Republican senator blocking his nomination.

The agency's acting chief, Dr. Andrew von Eschenbach, said full disclosure of the information about Ketek could have a chilling effect on the FDA's ability to be an independent and objective evaluator of drug safety and other issues.

The statement came in a written response to questions by Sen. Charles Grassley, R-Iowa. Grassley is blocking Senate confirmation of von Eschenbach while he investigates the FDA's handling of Ketek, which has been linked to severe liver problems and several deaths. (...)

Approval of Antibiotic Worried Safety Officials
nytimes.com 18.7.2006
WASHINGTON, July 18 — In an internal review, a federal drug safety official concluded that a controversial antibiotic made by a French drug company should be withdrawn, according to e-mail messages exchanged among top agency officials.

The official, Dr. David Graham, part of the Food and Drug Administration’s drug safety office, wrote in a message dated June 16 that the agency’s approval of Ketek, an antibiotic made by Sanofi-Aventis that is also known as telithromycin, was a mistake.

“It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned,” Dr. Graham wrote.

Referring to reports of negative, or adverse, drug reactions voluntarily submitted to the agency, he continued, “We don’t really know if the drug works; no one is claiming it works better than other, safer drugs; and we’re flying blind as far as safety goes, except for our own A.D.R. data that suggests telithromycin is uniquely more toxic than most other drugs.”

Dr. Graham concluded that the agency should recommend the drug’s “immediate withdrawal.”

Melissa Feltmann, a spokeswoman for Sanofi-Aventis, said the company had already changed the drug’s label.

“We continue to believe that the benefits of Ketek outweigh the risks when it is used as directed for its approved indications,” Ms. Feltmann said. (...)

- FDA sier Aventis ikke formidlet frykt relatert til Ketek

FDA Says Aventis Failed To Act on Ketek Drug Fears (FDA sier Aventis ikke formidlet frykt relatert til Ketek)
wsj.com 25.10.2007
The Food and Drug Administration said drug maker Aventis failed to act on reports of serious problems with a safety study on its antibiotic Ketek and didn't properly oversee the trial's conduct.

The FDA detailed its concerns in a letter posted yesterday on its Web site and sent to Sanofi-Aventis SA, the successor company after a merger. Ketek, which has been linked to a risk of liver damage, was approved by the FDA in 2004, though the agency has said it didn't rely on the questionable safety study in approving the drug. (...)

- FDA Cites Fakes Results in Sanofi Study

FDA Cites Fakes Results in Sanofi Study
forbes.com 25.10.2007
WASHINGTON - Government investigators say drug maker Sanofi-Aventis ignored misconduct by doctors who helped test an antibiotic that was later linked to several deaths.

The Food and Drug Administration sent a letter to Sanofi this week outlining numerous problems with its 2002 patient study of Ketek. A series of Congressional hearings were held last year after several users of the drug developed serious liver problems and died.

FDA said even after Sanofi identified problems with multiple physicians in the study, "violations persisted."

The government said one physician who worked on the Sanofi patient study fabricated data and in one case fabricated a patient's existence. Even after raising concerns about the researcher with Sanofi, government investigators said the company did not discipline or fire the physician. (...)

- FDA, Lawmaker Clash Over Antibiotic

FDA, Lawmaker Clash Over Antibiotic
forbes.com 30.11.2006
President Bush's choice to head the Food and Drug Administration is refusing to give Congress all the information it seeks about a controversial antibiotic, setting up further confrontations with a Republican senator blocking his nomination.

The agency's acting chief, Dr. Andrew von Eschenbach, said full disclosure of the information about Ketek could have a chilling effect on the FDA's ability to be an independent and objective evaluator of drug safety and other issues.

The statement came in a written response to questions by Sen. Charles Grassley, R-Iowa. Grassley is blocking Senate confirmation of von Eschenbach while he investigates the FDA's handling of Ketek, which has been linked to severe liver problems and several deaths.

"Selectively providing documents and access to executive agency officials pursuant to a congressional subpoena cannot constitute compliance," Grassley wrote Health and Human Services Secretary Mike Leavitt on Wednesday.
The letter was released Thursday; the FDA is part of HHS.

An FDA spokeswoman had no immediate comment.

Von Eschenbach wrote that "the disclosure of information that might relate to any open investigation in response to congressional inquiries poses an inherent threat to the integrity of the executive branch's enforcement and litigation functions."

Grassley said he would continue to block von Eschenbach's confirmation due to "resistance from the FDA and the Department of Health and Human Services to congressional oversight."

"The actions and words of this nominee display a misunderstanding of congressional oversight of the executive branch of government," Grassley said.
Ketek is made by the French pharmaceutical company Sanofi-Aventis (nyse: SNY - news - people) SA. (...)

Two Senators block von Eschenbach
fiercebiotech.com 15.9.2006
Fresh from giving the green light on Plan B in order to satisfy two Democrats holding up the nomination of Andrew von Eschenbach to head the FDA, two Republican Senators now say they have demands of their own that will have to be met prior to his elevation to the post. Senator David Vitter is demanding that the government provides a compromise agreement on importing drugs from Canada and Senator Jim DeMent is demanding that the abortion drug RU-486 is taken off the market, according to a report in The New York Times. Neither action is likely anytime soon and Vitter is predicting that Eschenbach's nomination will remain in limbo until next year. Only yesterday, though, analysts were predicting clear sailing for his nomination in a vote scheduled for next week.
- check out the UPI's report on the demands (...)

Senator makes dramatic demand in Ketek probe
fiercebiotech.com 15.6.2006
Senator Chuck Grassley (R-IA) says he suspects the FDA is involved in a cover-up of its activities involving the controversial antibiotic Ketek, citing the agency's refusal to make one of its investigators available for questioning. Grassley showed up at the Department of Health and Human Services to make his demands known and quickly filled in reporters after he left with nothing. HHS says that they aren't involved in a cover-up, claiming that they've already turned over more than 400 boxes of information on Ketek and wouldn't offer up the investigator in the middle of an agency inquiry. One point of contention is the use of data from a clinical trial for Ketek that was riddled with fraud. Safety data from that trial was presented to an FDA committee, which wasn't told about the problems that surrounded the study.

- read the article from The Washington Post on Ketek (...)

Halt Is Urged for Trials of Antibiotic in Children
nytimes.com 8.6.2006
A Food and Drug Administration official called in May for a drug company to halt clinical trials of an antibiotic in children because the drug could be deadly, according to internal memorandums sent to other F.D.A. officials. (...)

- Vioxx whistle-blower weighs in on demoted antibiotic Ketek

Vioxx whistle-blower weighs in on demoted antibiotic Ketek
usatoday.com 13.2.2007
More than two years after David Graham told a Senate panel that the Food and Drug Administration was "incapable of protecting America against another Vioxx," the FDA scientist was back on Capitol Hill on Tuesday to tell a House panel that "nothing has really changed." (...)

- Panel urges limits on antibiotic linked to liver risks

Panel urges limits on antibiotic linked to liver risks
latimes.com 16.12.2006
Common uses for Ketek should stop, it says in a new blow to the FDA.

WASHINGTON — In another setback for the Food and Drug Administration's drug safety program, government medical advisors recommended Friday that sharp restrictions be placed on the use of a once-promising antibiotic that helps patients with respiratory infections but has also been linked to cases of sudden liver failure. (...)

Advisers Suggest Restricting Antibiotic
forbes.com 15.12.2006
Benefits of an antibiotic linked to rare reports of severe liver problems, including several deaths, outweigh its risks in treating pneumonia but not less serious bacterial infections like bronchitis and sinusitis, federal health advisers said Friday. (...)

- Kongressrepresentanter lanserer granskning av populær antibiotika (Ketek)

Reps. Launch Investigation of Popular Antibiotic, Ketek (Representanter ber om granskning av populær antibiotika, Ketek)
medadnews.com 1.5.2006
WASHINGTON, May 1, 2006– Representanten Edward J. Markey (D-MA) og representanten Henry A. Waxman (D-CA), seniordemokrater i House Energy and Commerce Committee, sendte i dag et brev til Food and Drug Administration (FDA) som ber om tiltak angående godkjenningen av antibiotikaet telithromycin (Ketek). Ketek er et antibiotika som er godkjent for behandling av visse bakterielle lunge- og bihuleinfeksjoner hos mennesker fra og med 18 år. Selv om FDA hele tiden har forsikret publikum om Keteks sikkerhet og effektivitet, indikerer mottatte offentlige dokumenter som representantene Markey og Waxmans stab har fått tilgang på og undersøkt at godkjennelsesprosessen for legemidler er alvorlig forfeilet. (– Representative Edward J. Markey (D-MA) and Representative Henry A. Waxman (D-CA), senior Democrats on the House Energy and Commerce Committee, sent a letter today to the Food and Drug Administration (FDA) questioning actions surrounding its approval of the antibiotic telithromycin (Ketek). Ketek is an antibiotic that is approved for treatment of certain bacterial lung and sinus infections in people 18 years and older. Although the FDA has consistently assured the public of Ketek’s safety and efficacy, public documents obtained and examined by Reps. Markey and Waxman’s staff indicate that the approval process for this drug was seriously flawed.)

Representanten Markey uttalte, “Jeg er svært bekymret over at FDA godkjente Ketek til tross for at det verken er trygt eller effektivt, og at FDA har tillatt sponsorene å gi dette legemidlet til barn i kliniske forsøk. Vi trenger å se nærmere på Ketek-saken for å avgjøre hvorvidt denne godkjennelse skyldes feil, og vi trenger å vurdere hvorvidt godkjennelsesprosessen for Ketek reflekterer mer omfattende problemer som gjelder hele systemet innen FDA. Vi kan ikke tillate at denne vaktbikkje for livsviktig samfunnsmedisin blir en skjødehund for legemiddelindustrien.” (Rep. Markey said, “I am very concerned that the FDA approved Ketek even though it may be neither safe nor effective, and that FDA has allowed the sponsor to give this drug to children in clinical trials. We need to look more closely at the Ketek case to determine whether this approval was made in error, and we need to assess whether the Ketek approval process reflects broader systemic problems within the FDA. We cannot allow this critical public health watch dog agency to become a lapdog for the pharmaceutical industry.”)

“Ketek-saken viser det presserende behov for reform hos FDA og i den farmasøytiske industri,” sa representanten Waxman. “Vi vet at legemiddelfirmaer manipulerer publiserte studier på legemidler, skjuler negativ informasjon for leger. Her gikk Aventis til og med lenger, unnlot å offentliggjøre overfor FDA graverende feil i en nøkkelstudie som gikk på sikkerhet. FDA godkjente legemidlet på grunnlag av spinkle data uten finne en løsning på sikkerhetsspørsmål, og de unnlot å ilegge Aventis straff. Amerikanere fortjener mer årvåkenhet fra FDA og fra firmaer som produserer livsviktige medisinske behandlinger.” (...) (“The Ketek case demonstrates the urgent need for reform at the FDA and in the pharmaceutical industry,” said Rep. Waxman. “We know drug companies manipulate published studies on their drugs, hiding negative information from physicians. Here, Aventis went even further, failing to disclose to FDA grave flaws in a key safety study. FDA approved the drug on flimsy data without resolving the safety issues, and it failed to penalize Aventis. Americans deserve more vigilance from FDA and from the companies that make critical medical treatments.”)

Representanten Markey sa, “GAO fant nylig at FDA ikke har et godt nok system på plass for å beskytte publikum mot legemidler straks de er kommet på markedet. Imidlertid viser Ketek-saken dessuten også at FDA kanskje ikke gjør en god nok jobb når de avgjør hvilket legemiddel som overhode skal eller ikke skal godkjennes.” (Rep. Markey said, “Recently the GAO found that the FDA does not have a good enough system in place to protect the public from drugs once they are on the market. However, the Ketek case shows that the FDA may also not be doing a good enough job deciding which drugs should or should not be approved in the first place.”)

(Anm: Brev til FDA: FDALetter_5-1-06.pdf.)

(Anm: What is Sinusitis (Sinus Infection)? (webmd.com 3.5.2016).)

(Anm: Sinus Attack! Pain in the forehead or between the eyes? Upper teeth ache? Face feeling full, nose stuffy and congested? You may have a common complaint that sends many people to a doctor's office: sinus trouble. (webmd.com 5.5.2017).)

Diverse artikler

The Leading Cause Of Drug-Induced Liver Damage Is Use Of Antibiotics Such As Ketek
drug-injury.com 2.1.2009
Two December 2008 Medical Journal Articles Examine Prescription Drug Hepatotoxicity And Reports Of Liver Damage Associated With Ketek
(Posted by Tom Lamb at DrugInjuryWatch.com)

Antibiotics cause drug-induced liver injury (DILI) more often than other prescription drugs according to a recent medical journal article, "Causes, Clinical Features, and Outcomes From a Prospective Study of Drug-Induced Liver Injury in the United States", which appeared in the December 2008 edition of Gastroenterology. (...)

Congress Presses FDA on Investigations
online.wsj.com
WASHINGTON -- The criminal-investigations wing of the Food and Drug Administration is in hot water with Democrats and Republicans in both the Senate and the House.

The Office of Criminal Investigations, or OCI, has operated largely autonomously in recent years, emphasizing a crackdown on illegal abuse of drugs such as Oxycontin. Its budget doubled to $42.8 million from fiscal 2000 to fiscal 2009, even as FDA officials were conceding that funds for assuring the quality of imported drugs weren't adequate. Monday, the Bush administration announced it would ask Congress for an extra $275 million to beef up FDA inspections. (...)

Sen. Grassley's request follows questions raised by Democrats on the House Energy and Commerce Committee in February during a hearing on Ketek, the antibiotic made by Sanofi-Aventis SA. OCI agents testified about their unsuccessful efforts to initiate a task force on Ketek that would have looked at whether Sanofi's executives knew that an outside contractor had used fraudulent data in a clinical trial of the drug. Rep. Bart Stupak (D., Mich.), who leads the Ketek investigation in the House, wrote in a release that "OCI management did not follow through on the line agents' work, and recommendations to expand fraud investigations were ignored." (...)

“Ketek Almost Killed Me”
lawyersandsettlements.com 22.9.2007
Iowapark, TX: Two years ago, Teresa Virgin was prescribed Ketek for a simple sinus infection. It was almost her death sentence. "I went through 65 days of hell, including three hospital visits and my teenage kids thought they were losing their Mom," says Teresa.

"Within two days of taking Ketek, I got so sick," says Teresa "My whole body felt drained and I had no energy. I couldn't sleep because I had trouble breathing then it got so bad that my husband took me to ER. I also had severe diarrhea. (...)

The FDA and the Case of Ketek
NEJM 2007;356:1601-1604 (April 19)
Three years ago, the Food and Drug Administration (FDA) approved the drug Ketek (telithromycin), lauding it as the first of a new class of antimicrobial agents that circumvent antibiotic resistance. Since then, Ketek has been linked to dozens of cases of severe liver injury, been the subject of a series of increasingly urgent safety warnings, and sparked two Congressional investigations of the FDA's acceptance of fraudulent safety data and inappropriate trial methods when it reviewed the drug for approval. As a former FDA physician who was involved in the Ketek review, I believe there are lessons to be learned from an examination of the events surrounding the approval of this product. (...)

FDA Hounded Over Ketek Scandal
By Evelyn Pringle digg Del.icio.us
lawyersandsettlements.com 19.3.2007
Washington, DC: The new drug application for the antibiotic, Ketek, was rejected twice, in 2001 and 2003, before FDA management approved the drug on April 1, 2004, based on fraudulent studies, and over the objections of the agency's own scientists.

The approval of Ketek, marketed by Sanofi-Aventis, follows a pattern that has emerged since the Big Pharma friendly Bush administration took control of the FDA where the agency has overruled the findings of its own reviewers.

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