by Randy Hartnell
In recent days, we encountered two independent critiques of the profitable new diagnostic and treatment standards being created by a cozy alliance of medical professionals and their “big pharma” corporate sponsors
I read a startling series of articles in the Seattle Times, titled "Suddenly Sick: The Hidden Big Business Behind Your doctor's Diagnosis,” published during the week of June 26, 2005.
Coincidentally, Vital Choices producer and health writer/author Craig Weatherby heard an hour-long interview with Nortin Hadler, M.D., a Harvard-educated rheumatologist. Dr. Hadler is the author of a new book titled The Last Well Person: How to Stay Well Despite the Health-Care System.
Both the Seattle Times series and Dr. Hadler's book demonstrate, in persuasive fashion, that the routine use of certain commonly prescribed drugs, medical tests, and procedures—including heart bypass surgery—is not always justified by the evidence.
Dr. Hadler and many of the independent medical experts interviewed by the Seattle Times believe that the drive for drug profits is distorting the diagnostic and treatment criteria for some common diseases.
Note: Relatively few biomedical researchers receive no drug company funding. We suspect that the researchers who were critical of the current system in the Seattle Times series are either not reliant on funding from drug companies, or that they value the truth more highly than drug-company funding.
As a result, these expert insiders say, Americans don't receive unbiased, evidence-based advice concerning the relative value of the tests and drugs recommended by the panels and institutions that wield the greatest influence on health care procedures.
Doctors sound a drumbeat of growing dismay
The views expressed by Dr. Hadler and the researchers and experts interviewed by the Seattle Times reflects a growing unease within the medical community, and echo the criticisms voiced by other top insiders.
For example, Marcia Angell, M.D., former editor of “The New England Journal of Medicine,” blasted the drug industry and its influence over medical practice in last year's bestseller, The Truth About the Drug Companies: How They Deceive Us and What to Do About It. The Amazon.com page for Dr. Angell's book includes a laudatory five-star review by, of all people, Peter Rost, M.D., the current but likely-to-be-fired vice president of marketing for Pfizer, the world's largest drug company.
Dr. Rost had already expressed his agreement with other expert critics of drug company influence on medicine when he told CBS correspondent Bob Simon the naked truth about drug company practices and unhealthy influence during the June 5, 2005 edition of “60 Minutes.”
Dr. Rost's stunning interview was the most high-profile case of selfless career suicide since chemist Jeffrey Wigand, Ph.D. blew the whistle on his employer, the Brown & Williamson cigarette company, in a 1996 episode of “60 Minutes.” Dr. Rost's office phone and email at Pfizer have been shut off, but despite his highly public exposure of the system-corrupting practices of his employer and its fellow drug purveyors, Pfizer has not yet fired Dr. Rost … probably to avoid even more bad publicity.
The problem, in a nutshell
The Seattle Times' “Suddenly Sick” series focused on five health conditions: high blood pressure (hypertension), obesity, osteoporosis, deep-vein thrombosis, and female sexual dysfunction. In each case, they found that drug companies exert very strong influence on diagnostic and therapeutic guidelines.
To give you a taste of their findings, we will summarize their reports on two common concerns: hypertension and osteoporosis.
In both cases, the recommended diagnostic criteria and treatments have shifted substantially in recent years. And, as with all of the conditions that the Seattle Times' reporters examined, these shifts occurred not in response to compelling new evidence, but in response to the powerful influence that drug and medical device companies exert on members of the expert panels that physicians look to for diagnostic and therapeutic guidelines.
Thanks to the paucity of government funding, many biomedical researchers depend on drug-company funding to conduct research: work that results in exalted reputations, secure, cushy academic postings, and invitations to join the expert panels whose recommendations exert such strong influence on medical norms. The conflict of interest seems clear.
Pressuring blood-pressure panels
High blood pressure or hypertension was one of the cases the Seattle Times examined. As the paper reported, pharmaceutical companies that manufacture new and expensive hypertension drugs fund the members of expert panels from prestigious medical-research organizations such as the World Health Organization (WHO) and the federal National Institutes of Health (NIH), which have recommended lower treatment thresholds for blood pressure. Nine of the 11 authors of guidelines issued by an NIH panel that recommending broader use of hypertension drugs at lower blood pressures had ties to the new drugs' manufacturers.
Meanwhile, a group of hypertension experts whose research was funded solely by the federal government announced the results of the largest hypertension study ever conducted: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
The results of this landmark study proved that the newer blood-pressure drugs were less safe, generally no better, but far costlier than older, less glamorous drugs such as diuretics (pills that cause the body to eliminate water).
The study found that two of the costly new drugs—lisinopril and amlodipine—prevent death no more effectively than diuretics do.
Worse, lisinopril produced a 60 percent higher rate of strokes, while Amlodipine was found to cause to 38 percent more heart attacks and an increased risk of suicide and depression.
As Virginia Ashby Sharpe—the former director of the Integrity in Science Project of the Center for Science in the Public Interest—told the Seattle Times, "The more expensive drugs add $8 [billion] to $10 billion a year in health-care costs and provide no additional benefits."
Is a new bone “disease” real?
The Seattle Times series detailed another example of corrupting corporate influence. Creation by expert panels of a previously non-existent “condition” called osteopenia, or low bone density, has led thousands of middle-aged women to seek bone-density tests and take drugs like Fosomax.
By succeeding in their attempts to get expert panels to turn “low bone density”—itself a subjective description—into a “disease” called osteopenia, Merck and its fellow drug makers automatically expanded the target market for their drugs and devices.
This radical change happened despite little evidence of a link between bone density and bone fractures, or the kind of fractures that Fosomax has some small ability to help prevent, which is not even associated with the degree of bone-density picked up in tests.
The Seattle Times series quoted Dr. Steven Cummings of the University of California, a recognized expert on osteoporosis:
"The word 'prevention,' which has become so popular, has also created problems. Drug therapy for women with osteopenia does do some good because it reduces the risk of spine fractures, but women with osteopenia have a low risk of those fractures. So taking a drug for osteopenia probably does not improve the quality of life for women with osteopenia. It does generate huge sales."
In a characteristic move, the companies that make drugs designed to boost bone density bought up the companies that made bone density testing machines, thereby creating another way to influence the criteria by which “osteopenia” is diagnosed.
The drug makers also fund supposedly independent advocacy groups like the National Osteoporosis Foundation, which, helpfully, estimates that 10 million Americans have osteoporosis and that the disease is "a threat for an estimated 44 million Americans, or 55 percent of people 50 years of age and older."
The U.S. Food and Drug Administration has repeatedly warned Merck to stop running ads that suggest that all women develop osteoporosis at menopause, and told Merck that its Fosamax Web site "overstates the benefits while minimizing the risks associated with the drug."
But, as Dr. Cummings told the Seattle Times, patients “diagnosed” with osteopenia have measurements, not a disease.
Taking medical advice with a grain of salt
Our intention in this article is not to tar synthetic drugs with a broad negative brush, or discourage anyone from taking drugs recommended by their doctors. Instead, we want to alert you to the views of the respected physicians and industry insiders who believe that the medical guidelines upon which most doctors rely are generated in a corrupting, money-driven context.
If you are prescribed a drug—especially a new drug introduced to “replace” an older drug that's been proven effective and safe—you may want to ask your physician why he or she is convinced that it is better than, and at least as safe as, the older drugs prescribed for your condition.
Nutrition: the overlooked medical option
Because most of the research that comes across your doctor's desk is funded by drug companies or universities funded by them, little of it explores the often-dramatic benefits of foods and food- or herb-derived substances.
Obviously, we have an interest in communicating the health benefits of our products. Nonetheless, even at the risk of sounding like a drug company, that there is significant scientific evidence that nutrients such as the omega-3 fatty acids in fish can help to prevent and treat a wide range of conditions, including three addressed by the Seattle Times series: postmenopausal osteoporosis, hypertension, and weight control.
Clear evidence notwithstanding, we doubt that you will see many of the expert panels that strongly influence medical practice recommending nutritional approaches to disease prevention and amelioration, any time soon.
The reason for this deplorable deficit in nutritional recommendations is simple: Food and supplement companies do not fund research on their generally non-patentable products, or cushy medical conferences, at anywhere near the level that drug companies can easily afford.
By definition, pharmaceutical drug companies specialize in creating novel, synthetic substances that lend themselves to patent protection. The enormous net profits facilitated by patent protection and direct-to-consumer advertising of new drugs lets drug companies flood the medical community with cash.
These are the representative conclusions of articles published on Pub Med, the U.S. government's vast database of biomedical research.
Omega-3s and osteoporosis
Omega-3s may be the most overlooked nutritional support for bone health, while the overabundance of omega-6 EFAs in the standard American diet may be the most overlooked risk factor:
- “Preliminary data have suggested that a diet with a low n-6/n-3 ratio [i.e., less omega-6 fats, more omega-3 fats than in the standard American diet] may have beneficial effects on bone mineral density.… This may be useful particularly for the prevention of disease in the elderly, since a diet rich in n-3 PUFA has been shown to have additional benefit on the cardiovascular, central nervous system and joints.”
- “Sham and ovariectomized (OVX) mice were fed diets containing either 5% corn oil (CO) or 5% fish oil (FO).… In conclusion, inhibition of osteoclast [bone-degrading cells] generation and activation may be one of the mechanisms by which dietary n-3 fatty acids reduce bone loss in OVX mice.”
Omega-3s and hypertension-prevention
While we've received many comments to the contrary from physicians and consumers, controlled clinical trials of omega-3s have not proved them consistently effective at lowering blood pressure substantially in patients with hypertension. However, it seems clear that omega-3s can help prevent hypertension when people get enough of them in infancy:
“Perinatal [post-birth] supplementation of LCPUFAs [long-chain polyunsaturated fatty acids; i.e., omega-3 DHA and omega-6 arachidonic acid] decreases insulin resistance and prevents the development of hypertension in adult life, whereas deficiency of LCPUFAs in the perinatal period results in raised blood pressure later in life. Patients with essential hypertension have low concentrations of various LCPUFAs in their plasma phospholipid fraction.… Hence, it is proposed that availability of adequate amounts of LCPUFAs during the critical periods of growth prevents the development of hypertension in adulthood.”
Omega-3s and obesity
“Polyunsaturated fatty acids (PUFAs), specifically the n-3 series [i.e., omega-3s], have been implicated in the prevention of various human diseases, including obesity…”
As noted in this excerpt from a 2004 article by University of Wisconsin researchers—and as detailed in our June 27, 2005 issue (Exercise + Omega-3s = Perfect Weight Loss Pair)—omega-3s may be one of the most promising dietary allies in prevention of obesity.
- Fernandes G, Lawrence R, Sun D. Protective role of n-3 lipids and soy protein in osteoporosis. Prostaglandins Leukot Essent Fatty Acids. 2003 Jun;68(6):361-72. Review.
- Saldeen P, Saldeen T. Women and omega-3 Fatty acids. Obstet Gynecol Surv. 2004 Oct;59(10):722-30; quiz 745-6. Review.
- Albertazzi P, Coupland K. Polyunsaturated fatty acids. Is there a role in postmenopausal osteoporosis prevention? Maturitas. 2002 May 20;42(1):13-22. Review.
- Das UN. Long-chain polyunsaturated fatty acids interact with nitric oxide, superoxide anion, and transforming growth factor-beta to prevent human essential hypertension. Eur J Clin Nutr. 2004 Feb;58(2):195-203. Review.
- Sampath H, Ntambi JM. Polyunsaturated fatty acid regulation of gene expression. Nutr Rev. 2004 Sep;62(9):333-9. Review.
- Weatherby C. Exercise + Omega-3s = Perfect Weight Loss Pair. Vital Choices, June 27, 2005. Accessed online July 9, 2005 at http://www.imakenews.com/vitalchoiceseafood/e_article000419992.cfm?x=b57rb4R,b1pTrCB7,w.