Healing the Health Care System - Part 2

Last issue we began the discussion of how our health care system has lost its way. Doctors are losing the "Art of Medicine," and the so called "Science of Medicine" has been hijacked by drug company money. Let's look at this issue a bit closer, as it is a critical piece of the problem.

By way of background, I've been a physician (board-certified internist) and researcher for almost 30 years. As a patient advocate, I do not take money from any pharmaceutical or natural products companies, and 100% of the royalties for my products go to charity.

In the 1970s when I was in medical school things were very different. Medications were relatively inexpensive and it was unusual for a research study to only be sponsored by a drug company.¹ By the 1980's things had changed. As a 1982 article in science noted, "Scientists who 10 years ago would have snubbed their academic noses at investor money now eagerly legally seek it out."² A 2005 report notes that approximately 75% of clinical trials published in the Lancet, New England Journal of Medicine, and JAMA are industry funded,³ with approximately two thirds of the studies being done at for-profit research companies instead of universities.⁴ This gives the drug companies enormous control over study design and data analysis. In fact, the majority of researchers to not even have access to the results from their own studies.^5,6 In fact, a researcher who complained publicly about not being able to get access to the data in his study was fired by his university—certainly a chilling commentary for most researchers.

This problem has progressed to where a 2003 study in JAMA found that studies funded by drug companies were approximately far more likely to report a recommendation to use the drug than studies funded by nonprofit groups despite the data supporting use of the drug being no stronger (16% vs. 51%; odds ratio 5.3; p<.001—see abstract below). Their conclusion was that "conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of test results. Readers should carefully evaluate whether conclusions and randomized trials are supported by data."⁷ This is difficult when access to the data is often not even available to the study authors, let alone the peer reviewer's.

Having the study be randomized or placebo controlled offers approximately a 30% increase in validity. Who pays for the study however affects the validity by as much as 500%. Nonetheless, this blind spot is ignored in our current financial climate. I am less concerned by the financial implications, although they are devastating to our health care system, than I am by the safety implications. To give a current example, the recent study using natural remedies for arthritis versus Celebrex actually showed the natural remedies to be as or more effective.⁸ The data actually showed:

For moderate to severe arthritis:

• Placebo: 54% improved and average pain score decreased 123 points.
• Glucosamine/Chondroitin (Natural): 79% improved and average pain score decreased 177 points.
• Celebrex: 69% improved and average pain score decreased 153 points.

Overall-all patients:

• Placebo: 62% improved and average pain score decreased 86 points.
• Chondroitin: 66.5% improved and average pain score decreased 100.5 points.
• Celebrex/COX2: 70% improved and average pain score decreased 100.2 points.

Nonetheless, the study conclusions recommended not using the natural remedies and only using medications. This is not surprising, as 11 of the study authors are on the payroll of pharmaceutical companies making pain medications. Equally dismaying but not surprising was that the Journal chose somebody on the payroll of the company making Celebrex to write the accompanying editorial. Given this enormously misleading bias, it was not surprising to see the New York Times headline note, "No effect was found for glucosamine, chondroitin, or a combination of both." The AP story says, "The drug Celebrex did reduce pain — 70% improved — affirming the study's validity." What makes this misinformation so devastating is that it results in over 16,500 unnecessary American deaths each year from NSAIDs like Motrin,⁹ with Celebrex being 11% more likely to cause serious side effects than NSAIDs.¹⁰ Celebrex family medications have also been estimated to cause ~ 139,000 heart attacks and strokes. Meanwhile, this kind of medical misinformation also unnecessarily drains over $8 billion from our health care system yearly.

Of course flaws can be found in even the best studies. Unfortunately, the recent string of studies on natural remedies suggests that the study authors (many of whom are on the payroll of the drug companies involved) chose study designs guaranteed to fail. Even research done by the NIH—seemingly forced to study complementary medicine against their will by Congress—shows this severe bias. CAM medicine was the only department in the NIH led by somebody who boasted that they had absolutely no experience in the field. Having previously been assigned to head the chronic fatigue syndrome research, he sadly has a long experience of creating studies guaranteed to fail. My letter in JAMA noted the fatal flaws in one of his studies designs when he was in charge of Chronic Fatigue Syndrome research. This may change as, sadly, he died of a brain tumor and a new director will be in charge of further studies.

As we discussed, other examples of this bias are the use of therapy groups for the St. John's Wort and Saw Palmetto studies that clinical committee members familiar with the therapies and research noted were pretty much guaranteed to fail, instead of using therapy groups that were appropriate based on clinical experience and previous research.

As a physician and researcher using both prescription and natural therapies, and as a patient advocate who does not take money from either side, I will be happy to offer some thoughts on how to fix these problems

For more information, see:

• Healing the Health Care System—Part 3
• Healing the Health Care System—Part 1

References

1. Andreoli TE. The undermining of academic medicine. Academe 1999; 6: 32-37.

2. Culliton BJ. The academic-industrial complex. Science 1982; 216: 960-2.

3. The House of Commons Health Committee, The Influence of the Pharmaceutical Industry, Volume 1. April 5, 2005, p. 55. Available from: http://www.parliament.the-stationery-office.co.uk /pa/cm200405/cmselect/cmhealth/42/42.pdf

4. Petersen M. Madison Ave. has growing role in the business of drug research. New York Times, November 22, 2002.

5. Bodenheimer T. Uneasy alliance—clinical investigators and the pharmaceutical industry. N Engl J Med 2000; 342: 1539-44.

6. Schulman KA, Seils DM, Timbie JW, et al. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med 2002; 347: 1335-41.

7. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA 2003; 290: 921-8

8. Daniel O. Clegg, M.D., Domenic J. Reda, Ph.D., Crystal L. Harris, Pharm.D., et al. Glucosamine, Chondroitin Sulfate, and the Two in Combination for Painful Knee Osteoarthritis. N Engl J Med. 2006 Feb 23;354(8):795-808

9. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal Toxicity of NSAIDs-Review article. NEJM. June17,1999.P1888-99.

10. FDA Medical Officer's Gastroenterology Advisory Committee Briefing Document, February7,2001. http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_05_gi.doc

11. http://www.medscape.com/viewarticle/524994 ;Hosted by George Lundberg-former editor of JAMA: Medscape General Medicine. 2006;8(1):74. References for his statements include:

1. Kassirer JP. On the Take: How Medicine's Complicity With Big Business Can Endanger Your Health. New York: Oxford University Press; 2004.

2. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373-380.

3. Blumenthal D. Doctors and drug companies. N Engl J Med. 2004;351:934-935.