Wednesday, March 18, 2009

Lose weight, quit smoking & take little green pills

I’m not sure exactly which commercial got me to thinking about it. Maybe it was one of those drugs designed to deal with “erectile dysfunction”. Or maybe it was the one for the drug which “extends” that most intimate part of the male anatomy, prompting a smile from an attractive young woman who proclaims: “Yeah. That could be fun.”

Then again, it might have been the one where a woman hikes her dress shocking a poor old man into a state of apoplexy while she steals his Nicorette gum to satisfy her “craving”..

But, the exact commercial isn’t really important. The point is that there are an ever-increasing number of these television ads promoting drugs as the solution to every ailment known to man, and a few, I’m sure, which haven’t been invented yet. Just take the little green pill folks, it’ll cure all your worries and have you grinning like a Cheshire cat. Don’t forget to ask your Doctor.

And, there’s probably a scientific study to support the claims of every single one of them. The question is: How reliable are the studies? And, apparently, in a growing number of cases, the answer is “not very”.

Sandy Szwarc wrote an article on Junkfood Science last week detailing what she calls “One of the biggest cases of academic fraud in medical history”.

Her article follows revelations in a medical journal, Anesthesiology News, which indicate that a leading medical researcher, Scott S. Reuben, M.D., of Baystate Medical Center in Springfield, Massachusetts, had fabricated much, if not all, of the data in his research. Dr. Reuben, apparently made up and falsified data in at least 21, and possibly more, studies published since 1996.

Much of Dr. Reuben’s research efforts centred on pain medication; evaluating drugs and conducting clinical trials for the pharmaceutical industry, most notably Pfizer, although it should be noted that Pfizer has not been accused of any wrondoing in relation to Dr. Reuben’s suspect research.

The allegations arose following a year long investigation by the Baystate Medial Centre. Dr. Hal Jenson, M.D, of Baystate, told media that in many cases “there was no clinical trial because there were no patients,” before noting, “the conclusions (of the investigation) are not in dispute.”

Now, many laymen will respond to this news with a shrug of the shoulders, and wonder why this is such a big deal. A researcher cheated, got caught and will likely suffer the consequences.

But, Dr. Reuben worked for a respected institution and he (and his work) is well-known among his colleagues who have trusted the results of his fabricated studies. His colleagues’ reliance on these studies may have, unwittingly, put their patients at risk.

But, perhaps the most troubling aspect of all is that for years his falsified studies went unquestioned. They passed the peer review process and were published in respectable journals as a matter of course.

As Szwarec says in her article: “[I]t is hard to imagine that not one of his medical colleagues ever noticed anything amiss in nearly two decades. Or, more troublingly, did they notice or suspect and decide to look the other way, not one professional willing to speak out?”

She’s makes a valid point; one that should be heeded by laymen and doctors alike. The public relies heavily on the advice of doctors as to what treatment is best for any medical condition which might present. If that advice is based on faulty studies or influenced by a financial association with drug companies, patients may not get the best treatment or advice. In addition, prescribing drugs manufactured by those companies with which they have an association could add an unnecessary financial burden to the health care system.

But, Dr. Reuben is not the only case in point.

US Senator Charles Grassley is also investigating what he perceives as a growing incidence of conflict of interest between the medical profession and the pharmaceutical industry, and the failure of some researchers and doctors to disclose those conflicts. An article by Alexandra Andrews in ProPublica suggests such conflict may be widespread.

And, Marcia Angell, a former editor for the New England Journal of Medicine, was also highly critical in an article published in The New York Times Book Review. The article, entitled “Drug Companies & Doctors: A Story of Corruption”, reviews several books on the subject, concluding: “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”

That’s a pretty damning indictment of the medical profession, researchers, and the pharmaceutical industry which offers the financial incentives that encourage this type of behaviour.

Szwarc concluded her piece saying: “Patients may have been needlessly put at risk and healthcare resources may have been wasted on unsound or potentially dangerous treatments. But the public has sadly lost even more. Whether or not it's warranted, this misconduct is another chip in their trust of the entire medical profession and in medical professionals to practice ethical and science-based medicine.”

And, once again, she’s right. Although the number of researchers submitting falsified or biased studies may be small, the entire medical and scientific establishment is likely to be tarred with the same brush and ridden out of town on the same rail. And, they can’t afford to ignore any impropriety on the part of their colleagues.

Is there anyone out there who doesn’t understand why I question the research studies conducted by, or on behalf of, the anti-smoker brigade and their partners in the pharmaceutical industry?

PS: Dr. Michael Siegel wrote an article on his blog yesterday about the smoking cessation drug Chantix. He claims a number of tobacco control researchers and authorities on an expert panel made recommendations for the treatment of nicotine dependence, “despite having significant financial conflicts of interest by virtue of their financial relationships with Big Pharma”. (Tobacco Analysis)



Michael J. McFadden said...

Soemthing I've always believed is that the amount of fraud in "tobacco control" research must be considerably higher than in other areas.

Why do I believe that? Simply because I believe *most* researchers are at least somewhat ethical. That sense of ethics keeps many of them from "tweaking" studies just to get the results pleasing to their "sponsors." They may *design* studies to give the desired results, but I think most of them draw the line when it comes to outright fraud.

So why is tobacco research different? Why do I believe it is likely to have more outright fraud involved? Simply because many of the researchers who take on studies that are going to directly impact such policies as smoking bans and taxes sincerely believe that they are, more or less, on a "mission from God." Yes, they want to get their check in the mail just as badly as the researcher studying a pain pill for a drug company, but not only do they have a strong direction clearly given to them as to "desired' results, they also often have a firm belief about what the correct results SHOULD show. So when the answers come back not quite right they can salve their conscience while doing the numbers juggling by saying "It's for the greater good." or "Look, I *know* this ban MUST be cutting heart attacks and my numbers are ALMOST statistically significant, so let me just add a couple more AMIs into the third column over here so it'll come out properly."

How much outright fraud has been committed? I don't think there's any way to know, but it's pretty clear that it's likely to be more than would generally be found in medical research.

Michael J. McFadden
Author of "Disseting Antismokers' Brains"

Mrs. Pelican said...

Old Rambler, bad research done by drug companies seems to be not only acceptable, but expected. Like the global warming crew and the antismokers, they identify the desired result, then work backwards to make the data fit. Money is the bottom line, and they don't give a rat's ass about the public, need I mention Chantix and Zyban? They work day and night to convince us that we need their crap, and people are so gullible they give antidepressants to their preschoolers and antianxiety medications to their DOGS!!! There's a good video on you tube called Aspartame, Brain Cancer And The FDA Approval Process that shows how they are able to push this stuff through. Like you, I am extremely of any claims made by the "health" industry, especially if statistics are involved.