Wednesday, August 20, 2008

What Line?

One of the excuses the pharmaceuticals give for the high price of new medications is that the companies have to recoup all the money spent for the research required to develop the drugs. Apparently that "research" includes marketing, at least it does for one of those large pharmaceutical companies, Merck, according to this piece published in the online version of the Los Angeles Times in their health blog section.

It was a clinical trial. At least it looked like one.

In fact, according to four physicians in the Aug. 19 issue of the Annals of Internal Medicine, Merck's clinical trial had a purpose very different from the goal of rigorously assessing the effectiveness and safety of Vioxx — the blockbuster painkiller drug that Merck withdrew from the market in September 2004 after it was linked to a possible doubling of a patient's risk of heart attack and stroke.

The clinical trial known as ADVANTAGE was a "seeding trial," write the four authors — all of whom have served as expert witnesses in court cases brought against Merck in connection with Vioxx. It was designed, they write, to speed and increase the rate at which doctors accepted and prescribed the new drug, to gather inspiring "patient stories" for future use by reporters and marketers, and to court the goodwill of front-line physicians with the promise of professional prestige, research funds and the chance to be among the first to try a vaunted new remedy for an age-old scourge.
[Emphasis added]

Now there's a creative approach to getting the word out to physicians: involve them in what looks like research and the prestige that term conjures. Here's how it worked:

Merck's ADVANTAGE trial had all the trappings of the real thing, Hill and his co-authors note. It was referred to by the kind of long acronym that gives many large-scale drug assays the appearance of scientific legitimacy (ADVANTAGE stood for Assessment of Differences Between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness). It had 5,557 subjects enrolled, and 600 primary-care physicians gathering and submitting data for analysis. In the end, it had a reputable physician — Dr. Jeffrey R. Lisse of the University of Arizon's Department of Rheumatology — to author the study and a berth in the esteemed Annals of Internal Medicine.

In fact, however, the article documents that Merck's marketing and sales force nominated the 600 primary-care physicians they thought could be most influenced — and influential — in their prescribing of Vioxx. After Vioxx was approved by the FDA, the Annals study found, Merck's marketers then monitored those doctors' prescribing practices to ascertain whether they were more likely to prescibe Vioxx than doctors who had not been chosen as trial investigators (begging the question — who WERE the subjects in this trial?). The marketing department handled all the collection, analysis and dissemination of the ADVANTAGE data, and wrote up the study on which Lisse became the principal author, the Annals article says.
[Emphasis added]

I wonder how those physicians feel after reading the journal article (which, by the way, is located here) detailing this deceptive process? Hopefully they're embarrassed, although I'm sure at least some of them were savvy enough to know what was going on right from the start.

What is especially troubling by this revelation, however, is that the drug in question had some nasty side effects, which apparently were never studied in this "trial," but, hey, that's research and what was going on here was just marketing.

Pretty slimy stuff, eh?



Blogger StatsGrandma's Office Hours said...

Diane, R + D is expensive, but most of it's done on the taxpayer's dime. Most research is conducted via NIH grants in academic and hospital settings.

And I hate direct marketing of prescription drugs to consumers. In fact, I had the whole notion of 'health care consumers'-- it commodifies us instead of humanizing us.

5:25 PM  
Blogger Diane said...

Sallyh, I am so glad you posted that comment, because most of us aren't aware of how that system works.

I have no objection for paying for real research, but I do have a whole lot of objections to paying for the kind of crap described in this article, especially since the end result meant the deaths of some poor souls.

And what really steams me is that PHARMA has so much yank in Congress that nobody is willing to take them on in such issues as comptetitive pricing for Medicare Part D.

5:52 PM  
Anonymous Anonymous said...

My name is Tina Harris and i would like to show you my personal experience with Vioxx.

I am 40 years old. Have been on Vioxx for 6 months now. I had quit taking Vioxx long before the recall because it was the only new med introduced into my regimen at the time the symptoms started. I was told that if I continued to take it, I would be let go from my job because of inability to perform simple tasks.

I have experienced some of these side effects -
vertigo, diarrhea, abdominal pain, respiratory problems and memory loss. I still have memory loss and have gaps in my thinking process where I can't even think of common words I am trying to say, even to this day.

I hope this information will be useful to others,
Tina Harris

1:57 PM  

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