The NEJM of medicine recycles the old story that many of negative studies about antidepressants were not published. That doesn't affect whether the drugs work or not. It does add to the distortion of what a negative study is and why they are negative. Most of the time they are negative because they simply confirm the hypothesis. Other times they are poorly designed or small studies of little statistical power. They don't prove that the drugs fail. There is a difference. Taken together they can often help guide who responds to what medicines or why not...which again is why we need the Critical Path.
To suggest that the failure to publish negative studies is part of a coverup is wrong and leads to fearmongering once again. We have been down this road. And journalists are once again raising unfounded fears about the safety and efficacy of drugs...leading people to die because they stop taking medicines because of the fearmongering the media has engaged in regarding vaccines, SSRIs, Avandia, Vioxx and Vytorin. As for the public relations benefit of publishing negative studies...there is none. Just the opposite. I am afraid the willingness to confuse negative studies with "doesn't work" will lead to further congressional and media assaults on the scientific process. We will all be sicker and more imperiled for it.
To wit:
Lawmakers Have Vytorin Questions
By ANNA WILDE MATHEWS
January 16, 2008 5:08 p.m.
Congress is investigating advertising for the cholesterol-busting drug Vytorin in the wake of a study that suggested the pill may have no advantage over a generic cholesterol-lowering medicine.
In letters dated today and addressed to Schering-Plough Corp. and Merck & Co., which jointly sell Vytorin, and to the U.S. Food and Drug Administration, Reps. John Dingell and Bart Stupak, Michigan Democrats, raised questions about the ads for the medicine. The news was first reported in The Wall Street Journal' Health Blog.
In the letter to the companies, the congressmen wrote that the House of Representatives' Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are probing the "withholding of clinical trial data that may significantly affect the medical management of hypercholesterolemia, as well as the use of misleading statement in direct-to-consumer advertisements for prescription medicines."
Vytorin is in the news this week after the results of a long-awaited study, called Enhance, indicating that the drug may be no better than a generic statin at slowing the progression of heart disease.
http://online.wsj.com/article/SB120051737443695313.html?mod=googlenews_wsj
Or this...courtesy of Time magazine via fearmonger Steve Nissen:
Tuesday, Jan. 15, 2008
Is Vytorin a Failure?
By Alice Park
After nearly two years of waiting, the results came out on Monday on the long-awaited heart drug Vytorin — and the news wasn't good. Vytorin's manufacturers, Merck and Schering-Plough, announced that while the drug reduced levels of LDL, or bad cholesterol, in a group of 750 patients, the medication, which has been on the market since 2004, had little effect on the buildup of plaque in the arteries, a harbinger of heart attack and stroke.
To many experts, the results were both a surprise and a warning. "The fact that the trial showed a huge LDL" — or bad cholesterol — "reduction, and that things were still going the wrong way [as far as plaque buildup went] is stunning," says Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and an outspoken critic of the delay in the release of the study results. "This study shows that it matters how you lower cholesterol, not just how much you lower cholesterol."
Right. It pays to release negative studies. At least the researchers put their name on the study. The same thing can't be said about Nissen.
http://www.time.com/time/health/article/0,8599,1703827,00.html
To suggest that the failure to publish negative studies is part of a coverup is wrong and leads to fearmongering once again. We have been down this road. And journalists are once again raising unfounded fears about the safety and efficacy of drugs...leading people to die because they stop taking medicines because of the fearmongering the media has engaged in regarding vaccines, SSRIs, Avandia, Vioxx and Vytorin. As for the public relations benefit of publishing negative studies...there is none. Just the opposite. I am afraid the willingness to confuse negative studies with "doesn't work" will lead to further congressional and media assaults on the scientific process. We will all be sicker and more imperiled for it.
To wit:
Lawmakers Have Vytorin Questions
By ANNA WILDE MATHEWS
January 16, 2008 5:08 p.m.
Congress is investigating advertising for the cholesterol-busting drug Vytorin in the wake of a study that suggested the pill may have no advantage over a generic cholesterol-lowering medicine.
In letters dated today and addressed to Schering-Plough Corp. and Merck & Co., which jointly sell Vytorin, and to the U.S. Food and Drug Administration, Reps. John Dingell and Bart Stupak, Michigan Democrats, raised questions about the ads for the medicine. The news was first reported in The Wall Street Journal' Health Blog.
In the letter to the companies, the congressmen wrote that the House of Representatives' Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are probing the "withholding of clinical trial data that may significantly affect the medical management of hypercholesterolemia, as well as the use of misleading statement in direct-to-consumer advertisements for prescription medicines."
Vytorin is in the news this week after the results of a long-awaited study, called Enhance, indicating that the drug may be no better than a generic statin at slowing the progression of heart disease.
http://online.wsj.com/article/SB120051737443695313.html?mod=googlenews_wsj
Or this...courtesy of Time magazine via fearmonger Steve Nissen:
Tuesday, Jan. 15, 2008
Is Vytorin a Failure?
By Alice Park
After nearly two years of waiting, the results came out on Monday on the long-awaited heart drug Vytorin — and the news wasn't good. Vytorin's manufacturers, Merck and Schering-Plough, announced that while the drug reduced levels of LDL, or bad cholesterol, in a group of 750 patients, the medication, which has been on the market since 2004, had little effect on the buildup of plaque in the arteries, a harbinger of heart attack and stroke.
To many experts, the results were both a surprise and a warning. "The fact that the trial showed a huge LDL" — or bad cholesterol — "reduction, and that things were still going the wrong way [as far as plaque buildup went] is stunning," says Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and an outspoken critic of the delay in the release of the study results. "This study shows that it matters how you lower cholesterol, not just how much you lower cholesterol."
Right. It pays to release negative studies. At least the researchers put their name on the study. The same thing can't be said about Nissen.
http://www.time.com/time/health/article/0,8599,1703827,00.html
