Statin guidelines we love to hate – and the docs who write them

Here at Ethical Nag World Headquarters, it’s been quite the week ever since the American Heart Association and the American College of Cardiology released their new cardiovascular disease treatment guidelines, which I have taken the liberty of sub-titling:

“If you have a detectable pulse, you need to be taking statins!”

For more specifics on the guidelines – including the list of four newly-identified  groups of people whose heart health will benefit from taking cholesterol-lowering medicationoops, I mean statins only – every day for the rest of their natural lives, read yesterday’s Ethical Nag post, Can Statins Prevent My Head From Exploding?

What happens next? Your doctor will now review all 284 pages of the new guidelines, and then, in a bonding moment of shared decision-making, the two of you will soon sit down together to decide upon just the right course of action – oops, I mean drug prescription – based on what the guideline authors have recommended, in turn based on an (allegedly) flawed risk calculator that’s predicted to significantly increase the very large pool of daily statin-using drug takers, even among healthy individuals formerly considered low-risk for future cardiovascular disease.

But first, let’s set off for a behind-the-scenes visit to the people who actually write these treatment guidelines.  Continue reading

How drug companies get the clinical trial results they want

Every prescription drug (or over-the-counter medication) in your bathroom cabinet is there because it’s been evaluated in research called a clinical trial. For a basic introduction to clinical trials, let’s turn to former editor-in-chief of the prestigious New England Journal of Medicine, Dr. Marcia Angell, who wrote the following in her frightening landmark piece called “Drug Companies & Doctors: A Story of Corruption” (New York Review of Books, 1/15/2009):

“Before a new drug can enter the market, its manufacturer must sponsor clinical trials to show the Food and Drug Administration that the drug is safe and effective, usually as compared with a placebo or dummy pill.

“The results of all the trials (there may be many) are submitted to the FDA, and if one or two trials are positive – that is, they show effectiveness without serious risk – the drug is usually approved, even if all the other trials are negative.” 

Continue reading

Stealth marketing: how Big Pharma tries to shape medical news

Although Jeanne Lenzer’s article about stealth marketing in Reporting On Health is actually meant for other journalists, it reminds me that we consumers should all be more savvy when it comes to evaluating medical news. Before my own heart attack, for example, I pretty well swallowed any medical miracle breakthrough news without question.

But because I now take a fistful of powerful cardiac medications everyday, I have become gradually both aware of and alarmed by Big Pharma marketing, and especially about what Dr. Marcia Angell herself (for over 20 years the Editor-in-Chief at the prestigious New England Journal of Medicine) calls “… its pervasive conflicts of interest that corrupt the medical profession.”

In fact, I have absolutely no way of knowing which of my cardiac meds were prescribed for me based on flawed research or tainted medical journal articles that were funded and ghostwritten by the very drug companies who stand to gain by paying for positive outcomes.  And, worse, neither do my doctors. This is allowed to happen in part because of what we now know as stealth marketing“.

Continue reading

Does the medical profession need to wean itself from its “pervasive dependence” on Big Pharma money?

Judges do not hear cases in which they have a financial interest. Reporters do not write stories about companies in which they have a financial interest. By the same token, doctors should not have a financial interest in treatments they are evaluating, or accept gifts from the makers of drugs they prescribe.” 

That’s what Dr. Marcia Angell says, and she ought to know.  She spent over 20 years as editor of the prestigious New England Journal of Medicine. She wrote these words last January in a letter to Dr. Nada Stotland, president of the American Psychiatric Association in response to Stotland’s criticisms of her essay in the New York Review of Books.

Back then, the editorial board at the New York Times had decreed:

“The medical profession needs to wean itself almost entirely from its pervasive dependence on industry money.”

Dr. Angell agreed with the Times, adding:

“Pervasive conflicts of interest corrupt the medical profession, not in a criminal sense, but in the sense of undermining the impartiality that is essential both to medical research and clinical practice.” 

Dr. Angell disagreed strongly with psychiatrist Dr. Stotland’s assertion that very few drugs of any kind have been tested on children. Not so, claims Dr. Angell.  Continue reading