Letter to the editor of the NYT sent on 17 November 2008
(never published - geez, I wonder why not?)
Now its esteemed majesty, the mighty New York Times, dissatisfied with just telling the world how it needs to be run, has decided to don itself with a medical diploma uber alles. Thank the Lord! The New York Times editorial staff, in all its wisdom, is handing out prescribing information for all of us poor idiots who might otherwise have to listen to some inferior species who just might have attended some medical institution. We know, of course, that physicians are all biased by the greedy pharmaceutical companies who give them pens and free lunches. Obviously, the fact that a study had a huge sample size and was performed at multiple sites, and was randomized, double-blind, and placebo controlled cannot negate the possible bias of the researcher who developed the assay and (God forbid!) might just develop some profit for his labors. Oh that he might swelter in the dungeons of hell for suffering such unethical motives. Thank you, oh mighty and wise New York Times. May your glory never cease to amaze us as you continue to shelter us within the charismatic cloak of your wondrous paranoia! Ronald J Innerfield, MD, FACE Austerlitz, NY-Ed (v.i.)
(Editorial Page, The New York Times, 17 November 2008)
The study, led by researchers at Brigham and Women’s Hospital in Boston, involved some 17,800 patients with normal or low levels of the bad form of cholesterol but high levels of C-reactive protein, or CRP, which is often a measure of inflammation in artery walls. Half were given the statin Crestor, made by AstraZeneca; the other half received a placebo.
The benefits of the statin were so striking that a monitoring board stopped the trial in midcourse so that the placebo group could get the medicine, too. Those who got the statin had 54 percent fewer heart attacks, 48 percent fewer strokes and 20 percent fewer deaths from all causes. The participants included men 50 and older and women 60 and older with no history of heart disease or high cholesterol. But they all had high levels of CRP, and many had such other risk factors as high blood pressure, obesity and smoking. Whether the statin helped because it reduced normal cholesterol to even lower levels or because it reduced CRP levels is not clear.
Some 16 million to 20 million Americans take statins to reduce bad cholesterol, but some experts believe the new study suggests several million more should probably take statins as well.
Before rushing ahead it will be crucial to establish who might really benefit. An editorial in The New England Journal of Medicine, where the study was published, stresses the importance of establishing the long-term safety of drastically lowering cholesterol levels before committing patients who have no clinical signs of disease to decades of drug treatment. Participants who took Crestor also had a worrisome increase in diabetes.
The results must also be evaluated in the light of two potential conflicts of interest. The lead investigator stands to benefit from a patent involving the use of CRP to evaluate the risk of cardiovascular disease, and AstraZeneca financed the study whose results it is now trumpeting as “dramatic.”
Given that half of all heart attacks and strokes occur in people whose cholesterol is not considered high, it seems likely that there is a group of people with normal cholesterol who could benefit by taking statins. The task ahead for the writers of medical guidelines is to define just who those people might be.
Another letter to the editor of the NYT sent on 10 December 2008 (never published - geez, once again I wonder why not?)
This is the second time I write to thank The Times for its lofty incursion into the complex arena of medical research and practice. The first time was heroically rejected but nevertheless may be found online at http://www.diabetes-mellitus.org/jupiter.htm. Nevermind that the well-intentioned road to hell paved by the initial generic move to limit the profitability of pharmaceutical research has resulted in a boon only for the pharmaceutical retailers and a huge bane (in future drug) costs for the consumers. Nevermind that any and all studies can and should be criticized by those with the relevant historical - as well as intellectual - credentials to do so. Ah, but the fundamental premises and hypotheses underlying modern liberal society must, of course and necessity, override any data or their interpretation thereof when, and if, those principles become jeopardized. Thank you once again Mister and Ms. Editors for looking out for us against the ignoble physicians and their wealthy co-conspirators. May new and better drugs cease to be developed forever. God condemn any who might profit thereby. Excelsior Ignorami! Ronald Jay Innerfield Ed
Health care reformers have high hopes that the relentless rise in prescription drug costs can be slowed by replacing brand-name medicines with cheaper generic versions. Unfortunately, so many physicians are so captive of the drug industry that it would take a huge effort to persuade more patients and doctors to use generics.
That discouraging lesson can be drawn from a recent report by Andrew Pollack in The Times. He reviewed how a big clinical study organized by the federal government found that a generic drug costing only pennies a day lowered high blood pressure more effectively than did newer, far costlier drugs.
While many experts expected that finding to set off a stampede to the cheaper option, it didn’t. The percentage of hypertension patients taking the cheaper drugs, known as diuretics, rose from 30 to 35 percent before the study to 40 percent afterward. Then it remained flat.
To blunt the study’s impact, pharmaceutical companies initiated heavy marketing campaigns and paid doctors to tout their costlier products. Newer drugs also came along that were not included in the original study, rendering its findings dated. The waters were further muddied when some specialists found fault with the design or interpretation of the study and a smaller Australian study reached a different conclusion.
This history sounds a caution to reformers who want to rely on “comparative effectiveness” studies to determine which drugs or treatments work best and which are worth paying for. That is no reason to abandon these studies, but it suggests the need for deep thought on how best to design them and implement the findings.
Another report, published recently in the Journal of the American Medical Association, compared the effectiveness of generic and brand-name drugs in treating cardiovascular disease and found no evidence that the brand-name drugs were clinically superior to their generic counterparts. Yet, discouragingly, most of the editorials written about these studies in medical journals took a negative view about substituting generics for the brand-name drugs.
The researchers speculate that the experts who wrote the editorials may have been influenced by anecdotal experience or by financial ties to the brand-name companies. Either way, it is disturbing that medical opinion leaders were so reluctant to accept the finding that generic drugs worked as well as their costlier competitors.
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