Findings Are Bogus'
"The findings are bogus,'' said plaintiff's attorney Mark Lanier, who won a $253 million verdict against Merck in a Vioxx case last year. "This was clearly orchestrated for the stock analysts. It's bought and paid for. The firm that did it, which is a notorious anti-plaintiffs' firm, claims to be independent.'' (bloomberg.com 6.9.2006)
Orchestrated for the stock analysts? Shares of Merck rose 23 cents, or a half percent, to $41.40 in New York Stock Exchange composite trading. (bloomberg.com 6.9.2006)
Granskning til salgs Hemmelig: Jens Ulltveit Moe ble frikjent av sitt eget granskningsutvalg, men vil ikke frigi dokumentasjonen som de la til grunn. (morgenbladet.no 15.9.2006)
Throughout those weeks, Dr. Abuzzahab recorded Ms. Endersbe’s adverse effects as “0,” but nurses documented a steady decline. (nytimes.com 3.6.2007)
...Cannot possibly be surprising
"The conclusion of Merck's own counsel cannot possibly be surprising," said Jay Gould, a partner at Pillsbury Winthrop Shaw Pittman. "I don't know of any firm that wouldn't do what [Debevoise & Plimpton] did. That's our job. We're not paid to be impartial." (latimes.com 7.9.2006)
Some seek to lift veil on research funding Full disclosure urged on money sources (boston.com 8.8.2006)
Pengers innflytelse på medisinsk forskning
The Influence of Money on Medical Science (Pengers innflytelse på medisinsk forskning)
Leder
Catherine D. DeAngelis, MD, MPH
JAMA 2006;296
While on vacation recently, I had the opportunity to contemplate the sometimes unethical influence of money on medical science, a very serious issue, which has become more evident over the past year or so. It seemed ironic that this wonderful time of contemplation was aided by the soothing, normal flow of the Delaware River in Pennsylvania, which just a week before had deluged roaring destructive flood waters well beyond its normal banks. Such is the nature of Nature, which very much mimics the pattern of my thoughts over the past few weeks as I experienced what happened as a result of trying to address a serious problem. (...)
(Anm: Uredelighet og fusk i medisinsk forskning. (mintankesmie.no/).)
Some seek to lift veil on research funding
Some seek to lift veil on research funding
boston.com 8.8.2006
Full disclosure urged on money sources
Three weeks ago, the editor of the prestigious Journal of the American Medical Association called Dr. Joseph B. Martin, dean of Harvard Medical School, and said, as she describes it, ``Joe, do something with your kids!"
Dr. Catherine D. DeAngelis, the editor, told the dean that in violation of the journal's policies, Harvard authors of three recent articles had failed to disclose relevant financial ties with drug companies.
Responding to DeAngelis' s concerns, Martin told her that he plans to send a letter laying out the conflict-of-interest disclosure requirements for JAMA and another top medical journal to all 8,000 members of the medical school's faculty, which encompasses most doctors practicing at more than a dozen Boston hospitals and research centers.
The Harvard cases and others like them are fueling mounting concern about potential conflicts of interest in medical research. (...)
Merck-Funded Vioxx Review Says Firm 'Acted With Integrity'
Merck-Funded Vioxx Review Says Firm 'Acted With Integrity'
latimes.com 7.9.2006
A review commissioned by the drug maker finds that its top managers `acted with integrity' and did not knowingly put patients at risk. (...)
A report commissioned by Merck & Co.'s board said Wednesday that the drug maker's top executives did not knowingly put patients at risk in developing and marketing Vioxx, the popular arthritis drug withdrawn after a study showed that it increased heart risks.
The 20-month review of the drug company's conduct concluded that Merck management "acted with integrity" in the development and marketing of Vioxx, said former Manhattan federal judge John Martin, who led the probe.
The report, on which Merck spent about $21 million, criticized certain Merck promotional activity but generally absolved top management.
"Critics contend that senior officials at Merck knowingly put patients at risk of cardiovascular events rather than jeopardize the profits that Merck generated from the sale of Vioxx," the report said. "After an exhaustive investigation, we have concluded that there is no basis for such a claim."
Martin, along with other lawyers and paralegals at Debevoise & Plimpton, spent more than 53,000 hours on the 179-page report, which also included about 1,500 pages of appendixes. They interviewed 115 people, including top company executives, and drew upon testimony in civil and governmental proceedings.
One securities lawyer who isn't involved in litigation affecting Merck questioned the objectivity of the Merck-sponsored report.
"The conclusion of Merck's own counsel cannot possibly be surprising," said Jay Gould, a partner at Pillsbury Winthrop Shaw Pittman. "I don't know of any firm that wouldn't do what [Debevoise & Plimpton] did. That's our job. We're not paid to be impartial." (...)
(Anm: Det at legemiddelfirmaet Merck betaler en såkalt privat gransker 21 milloner dollar (omtrent 134 millioner kroner), for å granske seg selv, er i utgangspunktet absurd. I praksis innebærer dette Merck bruker samme taktikk, som da de forsket på legemidlert Vioxx, dvs. kjøper de ønskede resultater (dvs. hvitvasker informasjonen før den publiseres.)
Merck benekter hvitvask
Merck Handled Vioxx `With Integrity,' Study Concludes (Update2)
bloomberg.com 6.9.2006
-- Merck & Co.'s special investigation on the 2004 withdrawal of its Vioxx painkiller concluded that company scientists and managers ``acted with integrity'' in studying the drug's potential heart risks.
Former U.S. Judge John Martin Jr. released a 1,700-page report saying Whitehouse Station, New Jersey-based Merck adequately studied red flags before the drug's launch in May 1999. Martin's report also said Merck didn't mislead regulators about a 2000 study showing Vioxx caused five times more heart attacks than another painkiller, naproxen. (...)
'Findings Are Bogus'
"The findings are bogus,'' said plaintiff's attorney Mark Lanier, who won a $253 million verdict against Merck in a Vioxx case last year. "This was clearly orchestrated for the stock analysts. It's bought and paid for. The firm that did it, which is a notorious anti-plaintiffs' firm, claims to be independent.''
The report "wasn't designed for the litigation,'' said Merck attorney Ted Mayer of Hughes Hubbard & Reed in New York.
"It's really speculative to what extent anybody will use it in the litigation,'' Mayer said. "If you look deeply in the report at any issue, you find a consistent finding that Merck acted with integrity and with a deep belief that Vioxx was a safe drug.''
Shares of Merck rose 23 cents, or a half percent, to $41.40 in New York Stock Exchange composite trading. The stock has gained 26 percent this year, outperforming a 9 percent rise in the 14-member Standard & Poor's 500 Pharmaceutical Index.
Martin's report weighed many of the same aspects of the drug's development, marketing and labeling that have gone before federal and state juries with mixed success for Merck.
The company has won five verdicts and lost four since July 2005. On Aug. 30, Merck won a post-trial victory when a federal judge ruled that a $51 million verdict against the company was "grossly excessive.'' (...)
Whitewash Denied
He also found that a card used by sales representatives to help brief doctors on the Vigor trial did not, "standing alone, provide all of the available cardiovascular data.''
In an interview, Martin denied suggestions that the report was written to help Merck. "
I understand that cynics are going to say this is a whitewash,'' Martin said.
"That's why we put out a 1,400-page appendix which details all of the actions that were taken. Any fair-minded people who look at that report, look at those appendices and read them carefully will come to the same conclusions we did.'' (...)
(Anm: Vioxx - informasjon vs kunnskap og visdom - hvem visste hva? (mintankesmie.no).)
Plaintiffs' Steering Committee for Vioxx Cases Charges Merck with 'Sophisticated Jury Tampering'
Plaintiffs' Steering Committee for Vioxx Cases Charges Merck with 'Sophisticated Jury
Tampering'
yahoo.com 7.9.2006
-- As the fourth federal Vioxx case gets set to go to court, the Plaintiffs' Steering Committee (PSC) is calling for Merck to stop its attempts to sway the jury pool. Merck has blanketed the area that is covered by the Federal Courts Eastern District of Louisiana jurisdiction with an extensive television ad campaign designed to create favorable impressions of the company during the ongoing several months prior to and during trials in the Federal Eastern District of Louisiana. (...)
Pasienter avviser Vioxx-rapport
Patients dismiss Vioxx report (Pasienter avviser Vioxx-rapport)
timesonline.co.uk 8.9.2006 (The Times)
Merck & Co’s management was largely absolved of wrongdoing in relation to the withdrawn painkiller Vioxx, in an investigation dismissed by the attorney for Vioxx patients who are suing Merck as a whitewashing exercise.
Christopher Seegar said that the investigation, which had been commissioned by the board of the US company, read as “a legal brief on behalf of the company”.
The report found that the management of Merck did not mislead the public, and “acted with integrity” in developing and selling Vioxx.
However, the 20-month investigation also questioned Merck’s position that the heart risks from Vioxx, the reason for the drug’s withdrawal, occurred only after 18 months of use.
Additionally, the investigation raised questions about Merck’s communications with the public, its aggressive marketing techniques, and errors in data analysis.
Merck faces more than 14,200 lawsuits alleging that Vioxx caused heart attacks and strokes. So far, the company has won four cases that have gone to trial and lost four. (...)
Merck says probe clears management on Vioxx (Merck sier granskning godkjenner behandling av Vioxx)
marketwatch.com 6.9.2006
- Merck & Co. said Wednesday that an investigative team hired by its board of directors determined that senior management didn't do anything wrong in the development and marketing of its now-recalled drug Vioxx.
"We concluded that senior management at Merck acted with integrity in regard to Vioxx," said the committee's lead investigator, John Martin, a former federal judge, during a press conference held in New York Wednesday afternoon to discuss the report.
Martin now practices with the law firm Debevoise & Plimpton, which was commissioned by Merck (MRK: Merck & Co., Inc. MRK41.23, +0.59, +1.5%) to help conduct the investigation. The firm worked under the auspices of a special committee convened in December 2004 by Merck's board to look into management handling of Vioxx. (...)
Merck Inquiry Backs Conduct Over Vioxx
Merck Inquiry Backs Conduct Over Vioxx
nytimes.com 7.9.2006
After 20 months and $21 million, the investigator that Merck’s board hired to examine the company’s conduct regarding Vioxx has rendered his verdict: The company behaved more or less perfectly.
So said a former federal judge, John S. Martin Jr., after an inquiry into whether the senior management at Merck hid the risks of Vioxx, its former best-selling pain drug.
“The report is essentially a very positive report, because that’s the conclusion I reached,” Mr. Martin said at a news conference yesterday to discuss his findings. The investigation by his law firm, Debevoise & Plimpton, was entirely independent, Mr. Martin said. (...)
Dommer ber Merck opplyse om saksomkostninger
Judge Orders Merck to Reveal Trial Cost (Dommer ber Merck opplyse om saksomkostninger)
chron.com 17.10.2006
NEW YORK — A N.J. judge ordered Merck & Co. on Tuesday to release records on how much it spent on a trial involving its Vioxx painkiller.
The information would provide a window into how much Merck spends on its trials, and what its legal defense costs could be in the future. More than 21,000 suits have been filed against Merck, which has vowed to try each case over Vioxx.
So far, Merck has reserved $970 million for legal costs and spent $285 million of that last year. (...)
Granskning til salgs
Granskning til salgs
morgenbladet.no 15.9.2006
Hemmelig: Jens Ulltveit Moe ble frikjent av sitt eget granskningsutvalg, men vil ikke frigi dokumentasjonen som de la til grunn.
Granskningsutvalg klinger godt. Men en ny dom i Oslo tingrett tyder på at det bare er en avansert form for kommunikasjonsstrategi.
Granskningsutvalg klinger godt. Men en ny dom i Oslo tingrett tyder på at det bare er en avansert form for kommunikasjonsstrategi.
Å sette ned et granskningsutvalg er ment å skulle vekke tillit. Etter en dom i Oslo tingrett tirsdag har ikke fenomenet "granskningsutvalg" lenger samme klang. Utvalget har ikke "hatt tilstrekkelig årvåkenhet mot bevis som går i en annen retning enn det oppdragsgiveren ønsket", konkluderer dommer Christofer Heffermehl.
Oppdragsgiveren var Jens Ulltveit Moe. Utvalget som så i den retning Ulltveit Moe ønsket, besto av professor i statsvitenskap Janne Haaland Matlary, konsernsjef i Scana Industrier Frode Alhaug, og advokat Jan-Fredrik Wilhelmsen, som nå er partner i advokatfirmaet BA-HR. Sistnevnte er ikke minst interessant i denne sammenheng, ettersom han også er forfatter av læreboka Juristetikk.
– Jeg vil ikke kommentere denne saken, sier Jan-Fredrik Wilhelmsen først. Men så sier han litt etter hvert likevel. (...)
Granskning som forretning. Sitatet fra dommen kan også leses som at utvalgets konklusjoner var kjøpt og betalt. Det gjør spørsmålet om honorarets størrelse interessant. (...)
Strider mot straffeprosessen.
Inntil den dag kommer når en parts eget granskningsutvalg har konkluderert mer kritisk enn det offentlige utvalget som gjerne arbeider parallelt, vil troverdigheten imidlertid forbli på nivå med kommunikasjonsbyråenes. Et hovedpoeng i dommen som falt denne uken er nemlig at ingen andre enn det iranske selskapet og UMOEs egne granskere har fått se dokumentasjonen som lå til grunn for granskningsutvalgets "frifinnelse". Retten finner dermed at den ikke kan forholde seg til utvalgets beviser, og kommer med en refs: "Å unndra motparten adgang til å se de primære bevisene (…) synes å være i strid med straffeprosessloven og Den europeiske menneskerettighetskonvensjon." Ville det ikke, etter dette, være naturlig for Wilhelmsen å fremlegge dokumentasjonen nå, dersom han har den, for å styrke sin ære som gransker?
– Å offentliggjøre dokumentene er ikke noe jeg kan gjøre. Det må UMOE og IOEC i så fall bestemme seg for, svarer Wilhelmsen. (...)
Diverse artikler
Federal Court Grants Public Access to Evidence that Drug Company
'Ghostwrote' Medical Articles About Deadly Hormone Therapy Drug
publicjustice.net 24.9.2009 (News release)
(...) The evidence has been under seal in an ongoing federal lawsuit filed on behalf of victims of Prempro. Public Justice, a national public interest law firm headquartered in Washington D.C., sought access to the evidence on behalf of PLoS Medicine, a medical journal published by the nonprofit Public Library of Science (PLOS). Along with the New York Times, PLOS had moved to
interevene in the case to unseal the ghostwriting documents because the public has powerful interest in knowing the truth about the drug companies' conduct and the safety of their drugs.
"We are thrilled by the Court’s decision to stop Wyeth’s attempt to hide evidence of its ghostwriting,” said Amy Radon, Public Justice's lead attorney for PLoS Medicine. "Public health and safety is put at serious risk when a drug company fails to reveal its role in authoring a medical journal article touting its own product." (...)
Medical Papers by Ghostwriters Pushed Therapy (Medisinske artikler og studier forfattet av spøkelsesforfattere pushet terapi)
nytimes.com 4.8.2009
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.
The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.
But the seeming consensus fell apart in 2002 when a huge federal study on hormone therapy was stopped after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. A later study found that hormones increased the risk of dementia in older patients. (...)
The documents on ghostwriting were uncovered by lawyers suing Wyeth and were made public after a request in court from PLoS Medicine, a medical journal from the Public Library of Science, and The New York Times. (...)
Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company. (...)
After Sanctions, Doctors Get Drug Company Pay
nytimes.com 3.6.2007
A decade ago the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a “reckless, if not willful, disregard” for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that. (...)
A Battle With Depression and Suicidal Tendencies
nytimes.com 3.6.2007
Susan Endersbe, a schizophrenic who lived in Minneapolis, battled depression all her life. When her illness worsened, she usually checked into a hospital, which she did for the last time on May 7, 1994. On that occasion, doctors gave her an antidepressant, and three weeks later she said she felt ready to leave soon, according to nurses’ notes.
The next day, she was referred to Dr. Faruk Abuzzahab and agreed to participate in a drug study he was being paid to conduct, although her suicidal tendencies should have excluded her. Dr. Abuzzahab stopped giving her the antidepressant, and she was forced to wait nearly two weeks before receiving either an experimental drug or a placebo.
Throughout those weeks, Dr. Abuzzahab recorded Ms. Endersbe’s adverse effects as “0,” but nurses documented a steady decline. Ms. Endersbe expressed reservations about being part of a study. “I guess I didn’t understand that I would be going off all my other medications,” she told a hospital worker, according to records.
She spoke repeatedly of killing herself, even telling a nurse in a late-night talk on June 8 that she planned to jump off the Franklin Avenue Bridge, “but says she is safe in the hospital,” a hospital worker wrote.
On June 10, Dr. Abuzzahab wrote in her chart that Ms. Endersbe was “medically improving.” He gave her permission to visit her apartment alone, although leaving the hospital violated the study’s rules and she had spoken of suicide only the night before. (...)
Mr. Endersbe said he was stunned to learn years later from The New York Times that Dr. Abuzzahab was still overseeing clinical trials. (...)
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