Monday, March 31, 2008

Have A Heart, Somebody

The Associated Press reports this morning that Vytorin, a cholesterol-reducing drug made and marketed jointly by Merck and Schering-Plough, has little effect in improving heart disease. According to the article, the "study was watched closely because Zetia and Vytorin have racked up $5 billion in sales despite limited proof of benefit. [Italics mine.] Two congressional panels launched inquiries into why it took drugmakers nearly two years after the study's completion to release results." The article also reports that the "New England Journal of Medicine also published a report showing that Vytorin and Zetia's use soared in the United States amid a $200 million marketing blitz. In Canada, where advertising drugs to consumers is not allowed, sales were four times lower."

This last point raises more questions than it answers. As Canada's population is one-tenth that of ours, one might well ask why sales there were so relatively high. Clearly, something stealthy and insidious is going on, something that merits a full-fledged journalistic inquiry from somewhere. Among the questions that need answering:
  • What conditions allow $5 billion dollars of sales of a drug with limited proof of benefit?
  • What is the full extent of the Merck/Schering-Plough marketing strategy?
  • How are doctors complicit?
  • To what extent to state and federal regulations permit this? (Too often, the real scandal is what's legal.)
  • How could the government have legally interposed itself and why didn't it, or why didn't whatever efforts it took have more impact?
  • What other Vytorins and Zetias are out there?
Heart disease is the leading cause of death in the United States, killing over 1,200 Americans every day. Think of it this way: Every 2.5 days, heart disease kills as many of us as died in the World Trade Center on 9/11. This is a serious matter deserving of a sturdier inquiry than "Gee, how did they get away with dragging their feet on releasing the results of the study." Don't get me wrong: That's a great question, but it's only the first of what should be many. This is a great example of where the press must assume some public responsibility, because you can bet that no one else will...

One sad day, 87-year old Helen Thomas will no longer be with us. Until then, may she write many more columns as good as this one, which wonders why the people of the United States have no say in whether we continue the blundering in Iraq...

David Horsey, Pulitzer Prize-winning cartoonist of the Seattle Post-Intelligencer, writes a nuanced and thoughtful blog entry about Bruce Springsteen and Friday night's show here. A whole bunch of stupid comments follow, as well as at least one nuanced and thoughtful defense...

Remember the back page fold-ins in MAD magazine? Then you won't want to miss this opportunity to revisit them. Enjoy!

5 comments:

Scrumpy's Baker said...

Too many docs now are just allowing patients to come in and basically ask for a specific script. I don't know what the answer is, but all of this advertising needs to stop in my opinion. I suppose it might help if HMO docs weren't so busy that they have about five minutes to examine you and decide what you might need.

K. said...

Maybe it's that simple, although I still wonder about the numbers in Canada. (Of course, it's more than possible that the reporter misrepresented them.) In any case, you're right about the advertising. It takes unhealthy advantage of the situation HMO and clinic docs are in, where they are under a lot of pressure to see a certain number of patients per hour. Without excusing the practice, it has to be pretty easy for many of them to give the patient was he or she wants and move on to the next one.

rgg said...

I'm reminded of the movie "The Fugitive":
Dr. Richard Kimble: [turns to banquet crowd] He falsified his research. He switched the samples so that RDU-90 could be approved and Devlin McGregor could give you... Provasic!

K. said...

The first year of the TV show is out on DVD. "And in that darkness, Fate moves its huge hand..." Dah-DAAHH-da-daahhh!

purplemd said...

Good thoughts. Ever since seeing this film I have had a discomfort with the drug companies
Points:
In the film Kimble has many other attributes of an honest MD
1-Will not drink while on-call
2-Will not attend a drug company sponsored golf outing.
3-Diagnosis a ruptured spleen while posing as an orderly, and saves the life of one of the guards when his bus to jail is taken over by the prisoners and explodes. Not too mention he uses his brains when he realizes that patients are bleeding and his powers of observation lead to the discovery of the liver biopy/"ies" that show that it is only one slide. By all accounts, this is a model example of a model doctor and a vascular surgeon at that. So who is a similar MD who is essentially mired in the midst of the way over blown Enhance study, JP Kastelein, who recuses himself from the minutes of the meeting to discuss the findings, and is in the midst of a battle started by Merck (maker of Vioxx) and Schoering_Plow) who calls one of the Merck spokesman a Prick.So who is the victim here? Patients. They are suspicious of trials that are poorly done and thus have essentially just sparked a question that should lead to better studies to clarify. It was done once with Estrogen Tx. Lot's of healthy nurses where looked at and it was discovered that they seemed to benefit from estrogen. So did many other interesting though "not definitive" studies in fact, one such study actually showed that estrogen lowered the progression thickening of the artery, just the opposite of what Zetia does!
So it turns out that the necessary trial of estrogen vs< placebo showed absolutely no benefit, and in another trial showed that they may actually in the first year of treatment.
So Vioxx, Vytorin, Celebrex, Avandia, really never had there due chance, thanks to the drug companies who delayed the risks data. So my patients are stopping Zetia, as well as statins based on what they read in the media and what patients and even doctors are missing. I hope this will change, That the FDA gets more money with little influence from the Pharm giants, that Drs, stop using drugs with no clinically sound data. As in the Fugitive we are not sure who to trust? How prescient?By all accounts, this is a model example of a model doctor and a vascular surgeon at that. So who is a similar MD who is essentially mired in the midst of the way over blown Enhance study, JP Kastelein, who recuses himself from the minutes of the meeting to discuss the findings, and is in the midst of a battle started by Merck (maker of Vioxx) and Schoering_Plow) who calls one of the Merck spokesman a Prick.So who is the victim here? Patients. They are suspicious of trials that are poorly done and thus have essentially just sparked a question that should lead to better studies to clarify. It was done once with Estrogen Tx. Lot's of healthy nurses where looked at and it was discovered that they seemed to benefit from estrogen. So did many other interesting though "not definitive" studies in fact, one such study actually showed that estrogen lowered the progression thickening of the artery, just the opposite of what Zetia does!
So it turns out that the necessary trial of estrogen vs< placebo showed absolutely no benefit, and in another trial showed that they may actually in the first year of treatment.So Vioxx, Vytorin, Celebrex, Avandia, really never had there due chance, thanks to the drug companies who delayed the risks data. So my patients are stopping Zetia, as well as statins based on what they read in the media and what patients and even doctors are missing. I hope this will change, That the FDA gets more money with little influence from the Pharm giants, that Drs, stop using drugs with no clinically sound data. As in the Fugitive we are not sure who to trust? How prescient?