Not GE... Just an example from the world of BigPharma.
GE's time will come. And it *will* be a *nightmare*.
[...] An "independent" safety committee reviewed the Aleve study earlier this month and allowed the project to continue after deciding the drug did not present a clear risk. Researchers said Monday patients taking Aleve were 50 percent more likely to suffer heart attacks and strokes than patients not taking the drug. [Quoted "independent" added for sarcastic purposes.] [...]
Miami Herald: Posted on Wed, Dec. 22, 2004
MEDICINE Doctors: Too soon to worry about Aleve Some doctors are advising patients not to get nervous about a study that indicates the pain reliever Aleve could increase the risk of heart problems. By JACOB GOLDSTEIN AND FRED TASKER jgoldstein at herald.com
A day after researchers said the painkiller Aleve may increase the risk of heart attacks and strokes, some doctors questioned the validity of the findings and advised patients to stay calm.
''This result is out of left field, with no context in science or clinical experience,'' said Dr. Garret FitzGerald, chairman of pharmacology at the University of Pennsylvania. ``It's so premature it would be very unwise to conclude that it's a done deal in terms of any dangers.''
The news on Aleve came after recent announcements that two other painkillers -- Merck's Vioxx and Pfizer's Celebrex -- might also increase heart attacks and strokes.
But doctors warned that Vioxx and Celebrex, which belong to a class of drugs known as Cox-2 inhibitors, are different from Aleve, known generically as naproxen, which is more similar to Advil and aspirin.
''It's kind of like a snowball rolling down the mountain -- Vioxx, Celebrex and then naproxen gets included,'' said Dr. Robert Hoffman, chief of rheumatology at the University of Miami. ``I would argue that may be a mistake.''
On Monday, researchers said a recently halted study funded by the National Institutes of Health suggested Aleve might increase the risk of heart attack and stroke. In the study, doctors hoped to determine whether Aleve or Celebrex could prevent Alzheimer's disease.
SEPARATE STUDY The research was halted not because of possible risks of Aleve, but rather because a separate study, announced last week, found that Celebrex might increase the risk of heart attack or stroke.
An independent safety committee reviewed the Aleve study earlier this month and allowed the project to continue after deciding the drug did not present a clear risk. Researchers said Monday patients taking Aleve were 50 percent more likely to suffer heart attacks and strokes than patients not taking the drug. [...]
But in September, Vioxx was pulled from the market after a study of more than 2,000 patients found the drug nearly doubled the risk of heart attacks and strokes.
Since then, other data have suggested that Celebrex may have similar side effects. The drug is still on the market, but the Food and Drug Administration is reviewing the data.
An FDA official said this week she was unaware of any previous studies showing similar risks for Aleve, which has been on the market under various names since 1976. [...]
I must give "Honorable Mention" to: Dr. Garret FitzGerald...
News Flash: Researcher sell out own research [Too bad his research was correct.]
Article published Nov 13, 2004 Scientist Who Cited Drug's Risks Is Barred From F.D.A. Panel http://www.goupstate.com/apps/pbcs.dll/article?Date=20041113&Category=ZNYT04&ArtNo=411130392&SectionCat=NEWS01&Template=printart By GINA KOLATA New York Times
The Food and Drug Administration has told a researcher that he cannot be part of an advisory panel that will meet early next year to review the safety of a class of drugs, COX-2 inhibitors, used to treat arthritis and pain.
The reason, the agency said, is he publicly stated that he thought one of these drugs caused heart problems and that Pfizer, its maker, knew that and was covering it up.
The scientist, Dr. Curt D. Furberg, a professor of public health sciences at Wake Forest University School of Medicine in Winston-Salem, N.C., was not barred forever from the panel, an F.D.A. spokeswoman said. Instead, Dr. Furberg was asked not to participate when it took up an issue in which he was seen to have an intellectual conflict of interest."This is a routine procedure," said Victoria Kao, the spokeswoman. "They look at the members that will make up the committee, and they review them for each case to see whether they have a conflict of interest, financial or intellectual."
In September, Merck announced that it was withdrawing its COX-2 inhibitor, Vioxx, from the market after a clinical trial it was conducting showed an increased risk of heart attacks and strokes when patients took it for 18 months or longer.
That raised questions about similar drugs made by Pfizer, Celebrex and Bextra, and the F.D.A. panel was charged with reviewing what is known about them.The Vioxx findings were based on the strongest evidence - a clinical trial comparing the drug with a placebo. But no such evidence on heart attacks and strokes has been reported for Celebrex and Bextra.
There is, however, a scientifically weaker study, pooling data from 12 clinical trials, that Dr. Furberg and Dr. Garret A. FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania, completed recently. "Basically, we showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information,'' Dr. Furberg told The New York Times this week.Dr. Furberg said yesterday that he was surprised to be removed from the advisory committee."I had a call yesterday, out of the blue," from the F.D.A., "disinviting me," he said. [...]