Science in the Profit Interest

Another black eye for the so-called “ethical pharmaceutical” business. In what is being called “the biggest research fraud in medical history,” a member of Pfizer’s “speaker bureau” has pled guilty to fabricating dozens of drug studies. Dr. Scott Reuben, working on a $75,000 grant from Pfizer produced a research study on their drug Celebrex. Naturally, the drug was found to be remarkably effective against pain. Well, except there were no patients in the study. It was completely fabricated.

This isn’t a first for the good (for business) doctor. The peer-reviewed (and shame on the reviewers) journal Anesthesia and Analesia had to retract 10 papers authored by Reuben. Another 21 Reuben articles were apparently also fabricated according to London’s The Day. Reuben received nearly a half million from Pfizer, which I guess he has to give back, and possibly pay a $250,000 fine on top of that. Maybe even jail time.

But for Pfizer and the other companies that got rave reviews from “ethical research,” nothing. Bextra and Vioxx were also beneficiaries of Reuben’s fairy tale “research.” But these drug companies are not treated as conspirators. They’re “victims” of this fraud. Coverage in The Day fills in the details.

Reuben’s studies, five of which were funded by Pfizer, had bolstered claims about the post-surgery effectiveness of such painkillers as Pfizer’s Celebrex and Merck’s Vioxx.

Reuben’s attorneys said a bipolar disorder with “alternating periods of mania and depression fueled his misconduct.”

Oh poor guy. I’m sure we can all understand how depression could make someone want to fake dozens of scientific articles. No, we can’t. That’s a BS defense.

Meanwhile, these bogus “research studies” have been used to bolster claims of effectiveness for Celebrex and other drugs, as the public is fed the fiction that we have the best research in the world and the safest and most effective drugs. Yes, we have the best research results money can buy, and the best “approving for dollars” system too.

This corporate medical/scientific corruption hurts us all, and the media is only too happy to trot out the results of these “studies” while lapping up billions in pharma advertising.

And it’s not like this is new. Before this “biggest drug research fraud case in history,” there was the former biggest in 1989 when NJ physician Robert Fogari pled guilty to taking $2 million from drug companies for investigational new drug research that he never conducted. Fogari “investigated” new drugs for nine drug companies including Ciba-Geigy, Johnson & Johnson, Warner-Lambert, Pfizer, Upjohn, Syntex, and Merck, Sharp & Dohme. Fogari had his employees list persons who were not in the study and make up patients. He failed to do the urine, stool and blood tests and forged signatures of radiologists and others. The doctor also failed to report the deaths of two
patients in the “study” in order to “maintain a favorable impression” with the drug companies who hired him. At least the deaths were presumably not caused by the drugs they didn’t take as a part of the study they weren’t in that never took place.

Fogari admits he did not conduct any legitimate research during the whole eight year period.

A year earlier, Constantine Kostas admitted that of the 85 subjects in his clinical trial of Cipro, only 15 had actually been given Cipro. I suppose it hardly matters, since Kostas also faked the results of lab tests and examinations that never took place.

All of this is especially irksome to those of us who have endured Big Pharma’s war on herbs and supplements. How many of the so-called “research studies” on herbs funded by big pharma are also bogus? It’s easy to find such “studies” in which the patients chosen were inappropriate, or the protocol designed in ways that appear destined to fail. Indeed, “failure” of an alternative medicine is exactly what the drug companies want to see.

et tu Prince Charles? “Herbal medicine must be regulated”

In a recent BBC article (hat tip to Ed Smith of Herb Pharm for noting this) Prince Charles is quoted as saying “herbal medicine must be regulated.” Here in the United States, we often hear legislators and especially FDA officials calling for stricter regulation of herbal products and other dietary supplements. So my first reaction to the BBC article was “oh, no! The orthodox medical establishment has gotten to Prince Charles.” I even wondered if his opinion was colored by the fact that he is now in the herbal medicine business with his own herbal product line.

Prince Charles has been a consistent supporter of alternative medicine, and made a special appearance by video at the Columbia medical school course on botanical medicine. The Prince has been a consistent supporter of homeopathy and traditional herbal remedies. So this seemed like a bit of a betrayal of his former position.

On further thought, though, I had to reflect on the drama surrounding regulation of herbal products and nutritional products by the European Union. The “drama” featured a clash of different regulatory approaches employed by Great Britain and Germany. In Germany, nutritional and herbal products are regulated as drugs, and the German position has been adamantly in support of the entire world treating these products as such. Read more

Adverse Event Reporting

Industry experts are proclaiming victory in getting a law passed that requires dietary supplement (and OTC drug) manufacturers to report all serious “adverse events” to their products to the FDA, which will, of course, make those reports public. The idea is that this will be seen as a “responsible” act by industry and help stem the tide of negative publicity about supplements. Oh really? With the obvious bias in the media against supplements, each reported (but not proven) “reaction” will likely be used to hammer dietary supplements. Does anyone think that reports of OTC “adverse events” will get the same exposure? Face it, another aspirin overdose or a liver destroyed by Tylenol is simply not news. Especially to media outlets heavily sponsored by drug companies.

Besides, a supplement manufacturer has no right to ask for a customer’s medical records, to see if she already had a health condition or risk factor that might explain the apparent reaction to a supplement. Marketers of supplements simply can’t fully investigate complaints, which may or may not be related in any way to the supplement. I’m reminded of the infamous case of a fatality attributed by the Texas Health Department to an ephedra supplement. Yes, the ephedra supplement user died, but the coroner blamed the knife wound. In another “ephedra fatality” it was probably the extreme blood alcohol coupled with the head on auto collision. Chaparral was said to be so dangerous it had caused a rash of liver failures. There have been none before or since. Same with kava. And scullcap, that turned out to be germander, itself probably innocent. Again, no problems before or since.

Maury Silverman, a literature researcher and staunch supporter of supplements argued unsuccessfully to have the language of the new law require the disclosure of simultaneous drug use, which may better explain the “adverse event”. For example, if someone takes an herbal supplement and a Tylenol, seriously, which one is more likely to have caused that liver toxicity?

Who Are These Guys?