Each case needs to be evaluated individually.

Pharma is under constant pressure from shareholders to deliver profits. Whether Industry Guy likes it or not, there is an inherent conflict of interest between profits and safety.

This is not to say that attorneys don’t go out of their way to feast on the fear surrounding drug safety data. Some safety issues are simply difficult to see ahead of time (even with a trial size of 4,000).

Here’s an interesting thought question. In the late ’90s, data began accumulating that indicated Baycol (a statin) was associated with muscle wasting (rhabdomyolysis) (see http://tinyurl.com/baycolrhabdo).
The drug was pulled from the US Market in mid-2001. When would you have pulled the drug (if at all)?

FDA preemption will be decided this Fall in the Supreme Court case of Wyeth v Levine.

Those opposed to this assault on our civil rights need to contact their U.S. representatives and senators as well as Senators Obama and McCain. Also, letters to newspapers and TV/radio might be useful.

It is now 25 years later. Nothing has changed.
******************************************
ARTHRITIS AT THE JUSTICE DEPARTMENT

Published: September 14, 1985

Oraflex is an arthritis drug that may have caused 26 deaths and 200 serious side effects in America. All that might have been prevented if earlier side effects in Britain had been promptly reported to the Food and Drug Administration. The Justice Department charges that Eli Lilly, the drug’s maker, failed to do so. Yet last month it let a single Lilly official plead no contest, and merely to a misdemeanor. Why?

No wonder Senator Howard Metzenbaum protests that ‘’something has gone awry” at Justice. The Senate Judiciary Committee plans to investigate its handling of cases against major corporations like Lilly, E.F. Hutton and General Dynamics.

In Lilly’s case, how could its top officials not have realized the significance of the deaths and liver and kidney failures in Britain? These were a red alert presaging the downfall of a potentially lucrative new drug. And if the significance was recognized, how could Lilly’s failure to report them, as American law requires, possibly have been unintentional? How can it merit only a single misdemeanor charge and a picayune $25,000 fine? The answers tell a sorry tale.
Side effects caused by a drug can be hard to distinguish from natural illnesses. Lilly says it didn’t recognize the significance of the liver and kidney damage associated with Oraflex in Britain until after April 1982, when the drug was approved for sale in America. The British drug regulatory agency didn’t either, says Lilly. The British banned the drug on Aug. 5, 1982, and Lilly withdrew it from sale in America the same day.

But the Justice Department’s investigators evidently didn’t believe the oversight was so innocent. They noted that from early 1981 Lilly was regularly informed of adverse reactions by its British affiliate. They assert that senior Lilly officials met often with the F.D.A. before the drug’s approval but ”did not tell F.D.A. of the foreign liver or kidney adverse reactions during any of these meetings.” A Justice Department fact sheet, as Lilly itself asserts in disputing it, ”is clearly designed to create the impression that Lilly consciously disregarded medically significant information . . . and withheld information from F.D.A.”

If that’s what Justice thought, then why didn’t the department bring the felony charges that its fact sheet implies were warranted? Why didn’t it charge all the top managers involved instead of a single individual, who, as it happens, has already returned to his native Britain? There’s an awkward discrepancy between the hard words of the Justice Department’s fact sheet and the soft actions it settled for.

Lilly claims the law is fuzzy as to whether foreign side effects have to be reported. So what? Wouldn’t a research company want to make the best scientific use of foreign data? And if its scientists had promptly recognized the side effects of Oraflex, there was nothing fuzzy about Lilly’s duty to report them.

Lilly also claims that its reporting practices on Oraflex ”compare favorably with that of any multinational pharmaceutical firm.” If so, Americans have reason to tremble. Certain drugs - like thalidomide, which caused children to be born without limbs - pass pre-approval screening tests and don’t manifest side effects until they reach the public at large. Without full and prompt reports of adverse reactions, the F.D.A. has no way of monitoring the drugs it has approved.

The prescriptions for avoiding more Oraflex scandals are obvious enough. Drug companies must diligently look for and report side effects, whether in foreigners or Americans. The F.D.A. must be tougher in insisting on getting the data it needs to protect the public. As for the Justice Department, its failure to prosecute the case its staff lawyers had built is a disservice to the drug industry, the F.D.A.’s reporting system and the public.

This is pretty standard in all business practice..
Just a shame that human life and loss is viewed as statistical by the pharmaceutical industry, surely human life should be valued above all else in the ” human health” industry..
It is practices like the Zyprexay and Paxil scandals which makes me question the validity of its claims to care about people and their well being..
It’s both ironic and disturbing…

The lawyers were nothing; the lawsuit and money just blood money which I could not deal with. Justice will only come with a criminal trial.

Even Bob Temple had a cow. (Interesting image.)

Even that sub-population could have been co-prescribed a PPI or (heaven forbid) a generic or OTC H-2 antagonist along with a NSAID instead of an expensive Cox-II.

Right now most NDAs are 2500 - 4000 people but only 500 for 6 months and 100 for 1 year. Since you need triple the number to detect even one case even with 4000 people and 100 for one year you would only see a single case if the rate was 3.3% or higher between 6 months and a year. If the normal background rate was even 0.3% one case would be a 10 fold increase but would always be explained away as due to chance.

Besides even if you see 15 or 20 cases of AEs they’re often explained away.
For example with Vioxx this is a long term cumulative toxicity and you may start with symptoms of pulmonary hypertension, (i.e. cough, fatigue, difficulty breathing, edema, heart failure) well before it’s picked up on that these are simply the beginning symptoms and heart attacks and strokes are coming later. Plus you’re most likely to see it in the most vulnerable population, e.g. the elderly, or in neonates whose mothers took it and they have trouble breathing (this will typically show up in the animal reproductive studies. Cardiac deaths will just be explained away as age related death. Plus these long term trials often don’t have placebo controls for comparison. (It’s unethical according to all those highly paid expert opinion leaders and medical societies.)

Best thing is to know the drug, predict what you’re likely to see and where and when you’ll see it and look very closely for it (a high index of suspicion). I’m not saying we shouldn’t study more people for truly unanticipated side effects but just doubling the numbers or even increasing them without consideration of the other factors Pharma uses to hides AEs will simply give you a false reassurance. REMEMBER VIOXX’S TOXICITY WAS NOT UNEXPECTED. Merck knew what to expect based on the animal data.

Remember the Medical Ethics program at Duke is funding with drug money and was instituted after Duke got caught with major clinical study ethics violations in the late 1990’s.