Tuesday, August 19, 2008

"Drugmonkey" I Can Hear Some Of You Say, "You Haven't Written About Big Pharma Pud Sucking In Awhile Now. Might Big Pharma Have Stopped Sucking Pud?"

To which I would say, "Oh you silly naive waif. The pud sucking of Big Pharma is eternal. It can be counted on as the tides are counted on to rise and fall, it can be counted on as the sun is counted on to rise and set." Let yourself forget never my dear reader, that the primary interest of the pharmaceutical corporation, as in any corporation, is the accumulation of many dollars as it can possibly accumulate. Sometimes the best way for a pharmaceutical corporation to accumulate dollars is to develop a medicine that will alleviate disease and suffering. Other times the best way for a pharmaceutical corporation to accumulate dollars is to pretend a marketing campaign is a scientific study:

A 1999 Merck & Co. study of its since-withdrawn painkiller Vioxx, touted to participating doctors and patients as meant to show whether Vioxx caused fewer stomach problems than another drug, was primarily a stealth marketing strategy, researchers report.

The true purpose was to get lots of doctors and patients in the habit of using Vioxx just in time for its launch, according to doctors who uncovered internal Merck memos discussing the strategy behind the study, called ADVANTAGE.


OK, wait, on second thought, I was probably wrong. About what I said about Pharmaceutical company's primary interest being the accumulation of dollars. These days they'd probably be more interested in Euros. Because Euros are worth more.

Dr. Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, said Monday "the ADVANTAGE study was primarily a scientific study" designed and executed by the company's clinical research unit

But Dr. Kevin P. Hill said he and colleagues, while working as paid consultants for lawyers representing plaintiffs who claimed Vioxx caused heart attacks or other harm, stumbled on documents indicating Merck's marketing division designed ADVANTAGE and handled the data collection and analysis.

Using funding from the Robert Wood Johnson Foundation's clinical scholars program, they searched further, uncovering items such as a memo from two top Merck executives nominating the study for an internal marketing award.

"The objectives were to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class," the memo states.


Now I'm not calling Dr. Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, a liar, but it would seem that he said one thing while the facts indicate the exact opposite to be true. Notice how Merck told its own people the objective of the ADVANTAGE study was to "provide product trial among a key physician group to accelerate uptake of Vioxx." That doesn't sound very scientific, and it doesn't have much at all to do with comparing the GI tolerability of Vioxx and naproxen, which is what Merck was telling the rest of the world the ADVANTAGE study was for. I bet having your pants on fire makes it really hard to poop. Not to mention the bad things that could happen should the fire spread to your genital region. Not that Dr. Jonathan Edelman would know anything about that.

Your government is on the case though. You know what a deep respect this administration has for science:

The director of the Food and Drug Administration's Office of Medical Policy, Dr. Robert Temple, said that if a study follows a research protocol, asks a legitimate question and "uses garden-variety physicians" instead of academic experts but has a marketing purpose, "I'm not sure that's a sin."


I'll translate that for you. "We at the Bush administration don't give a rat's ass if you signed up for a Vioxx trial thinking you were helping advance the state of scientific knowledge, had a heart attack you otherwise wouldn't have had taking naproxen, and were really just part of a big Vioxx commercial."

"It's a serious violation of research ethics" and prevents patients from figuring out the risks and benefits of participating in the study, said Arthur Caplan, who heads University of Pennsylvania's medical ethics department.


So the scientists get it, and Bush Administration doesn't. Yet again. Like you needed another reason to do the right thing in November.

I wonder how long a liar's pants stay on fire? Do they ever get to poop again? I think I may have found the origin this night of the expression "full of shit"

Maybe I'll have Merck do a study to prove my thesis.

4 comments:

DrugMonkey, Master of Pharmacy said...

PS- Make your own joke about something called " The Robert Wood Johnson Foundation's clinical scholars program"

Wood....Johnson....huh huh....huh huh....

Cracked Pestle said...

Merck-y ethics. (That's not original, by the way, but I like it so much I'm going to use it regularly.)
Remember the VIGOR trial? VIoxx Gastrointestinal Outcomes Research, the study Merck had to run to make the FDA all warm and fuzzy about the claims Merck was making about the GI safety of rofecoxib. Kind of makes ADVANTAGE redundant, unless ADVANTAGE had a different purpose, ie. marketing and promotion. Another Merck internal memo quote that's notable:
Third, execution of the trial ... [involved] integration of the field, marketing, and CDP [Clinical Development Program].

And another:
Finally, the results of the trial are being carefully tracked. An analysis performed at 6 months post launch demonstrated a significantly higher level of prescribing for VIOXX among primary care ADVANTAGE investigators compared to a control group of VIOXX 99 prescribers....

Putting basically uninformed study participants at risk of cardiovascular events and death. Ugh.

I feel like I need a shower.

Who makes up these study title acronyms? TORCH - TOward a Revolution in COPD Health. ONTARGET - ONgoing Telmisartan ALone and in combination with Ramipril Global Endpoint Trial. How can I get that job?

And this just out from Boston University, an astute institution of learning. Feeding your kids calcium containing dairy products while they are growing makes their bones stronger when they're teenagers. Funded by, you guessed it, the National Dairy Council. That gem of research no doubt counts toward the authors' tenure.

Anonymous said...

at least schering-plough was let off the hook this time. >whew<

hee hee

Anonymous said...

I'm so glad you bring these issues into the spotlight (and dumb it down for the lazy, like me)

And by the way, I also have your "old" site bookmarked. Yes, it's an extra click to get here, but I'm a sucker for nostalgia.