Oleg I. Reznik, M.D.   Board Certified Family Physician

Assistant Professor at OHSU  Department of Family Medicine

Interesting Medico-Political Facts

[Posted 7/12/06] Elder Care.

Are we living longer or are we adding more years of misery to our lives. While more than 80% of Americans wish to die at home, most die at a hospital. In the long term, technological developments have not increased active life expectancy, they have increased dependent live expectancy. In the short term, the industrial interest promotes increasing the intensity of care during the last six months of life.^1,2 This has actually been shown to shorten life slightly.³ Cartoon to the right (by Peter Brandt) demonstrates precisely what is happening with today’s Elder Care.

[Posted 7/12/06] Does Anyone Suffer From Our Spending Billions on the Most Expensive Medical Treatments?

As a result of enormous cost of today’s allopathic medicine, the social support for the poor is dwindling. Whenever we spend millions of dollars on unproven or minimally effective but maximally expensive practices (cancer care, interventional cardiology, advanced imaging, ICU care for the elderly) we are taking the money away from the people who lack basic, inexpensive and proven health measures. Thousands of such people are dying here, in the US, every year, without a voice to speak on their behalf. Click here to read my brief case report of one of my patients who recently passed away due to inconsistent Medicaid coverage, and inability to obtain some of the basic medications.

[Posted 3/09/06] ‘Ghost Writing’— Another Trick From the Pharmaceutical Industry to Promote Its Financial Agenda.

This one academic physician and reviewer for a medical journal revealed how she was approached by a an industry-funded medical education  company to "author" an already completed research manuscript that was designed to promote one of the new drugs. She was honest enough to decline but later encountered the same, but slightly revised manuscript, submitted under another academic physician’s name.¹¹ This is one of many tricks that the pharmaceutical industry uses for promoting their agenda under the guise of legitimacy. The company designs the trials that give favorable results, then finds an academician for money or prestige would agree to publishing it under an independently appearing name. How do the pharmaceuticals get the results that they want in their clinical trials? See my summary of another article below.

[Posted 3/09/06] Medical Journals Have Become an Extension of the Marketing Arm of the Pharmaceutical Industry

Here is what an editor of 25 years of the British Medical Journal wrote in his recent essay.¹⁰ “The evidence is strong that companies are getting the results they want, and this is especially worrisome because between two-thirds and three-quarters of the trials published in the major journals—Annals of Internal Medicine, JAMA, Lancet, and New England Journal of Medicine—are funded by the industry… The companies seem to get the results they want not by fiddling the results, which would be far too crude and possibly detectable by peer review, but rather by asking the “right” questions—and there are many ways to do this…” Here is a list of the specific techniques used by the industry to get the results that favor their drug or treatment:

· Conduct a trial of your drug against a treatment known to be inferior.

· Trial your drugs against too low a dose of a competitor drug.

· Conduct a trial of your drug against too high a dose of a competitor drug (making your drug seem less toxic).

· Conduct trials that are too small to show differences from competitor drugs.

· Use multiple endpoints in the trial and select for publication those that give favourable results.

· Do multicentre trials and select for publication results from centres that are favourable.

· Conduct subgroup analyses and select for publication those that are favourable.

· Present results that are most likely to impress—for example, reduction in relative rather than absolute risk.

Once the “right” results are obtained the industry used a variety of publishing strategies to ensure maximum exposure of the results of their studies. They suppress unfavorable results and publish favorable results more than once, often in supplements to journals, which are highly profitable to the publishers. Companies conduct multicenter trials, and publish different results from different centers at different times in different journals. They also combine the results from different centers in multiple combinations.

Editors of the journals are becoming increasingly biased in favor of publishing such studies in their journals since the journal gets substantial kick backs from the pharmaceuticals from publishing reprints. The author adds: “...editors are increasingly responsible for the budgets of their journals and for producing a profit for the owners. Many owners—including academic societies—depend on profits from their journals. An editor may thus face a frighteningly stark conflict of interest: publish a trial that will bring $100,000 of profit or meet the end-of-year budget by firing an editor.” All this is another reason to have a healthy skepticism toward an ever more stringent guidelines for the treatment of a variety of illness. The journals are used by the pharmaceutical industry as a platform for the creation of new guidelines, which are then enforced by the legal system. All of this comes under the guise of providing better care. In fact, this movement drives the cost of health care up creating deficits in basic care and education. As a result, many voiceless victims (usually people living in the underserved areas, where basic social structure is lacking) die from the very treatable conditions.

[Posted July 2006] More recently an editor of the British medical journal wrote the following. “But the stand-off between journal and drug company is just one symptom of a wider disease: an overpowerful, under-regulated drug industry and a research establishment and publishing industry in its thrall...”

“The pressures on journals to publish drug industry trials include the need for newsworthy content and revenues from reprint sales. These pressures are intensifying, and recent examples of selective reporting and data manipulation have made clear that peer review in its current form is unequal to the task...”

“Drug companies should not be allowed to evaluate their own products. To get their products licensed they would contribute to a central pot for independent, publicly funded clinical trials.”

The destructive influence of the industry is becoming more widely recognized. Changing things is not going to be easy because medical industry has acquired inordinate political power, and is exerting a constant brainwashing campaign on general public.¹²

[Posted in 2005] Do Those Advances in Health Care and High-Tech Medical Treatments Really Work?

Several recent articles seem to suggest that they don’t^5,6. In fact, while we spend 2.1 times what Canada, France, Germany, Italy, Japan, and UK spend per capita on health care, our outcomes are worse. In spite of the fact that people in those countries smoke more than we do (I’m not endorsing smoking) and get half the money that we spend on health care per capita, they live seven to ten years longer than we in the good old US of A. Longevity is the true bottom line of health. By the way, their quality of life isn’t worse than ours either. Think about that when you are asked to give more money for health research, or offered a new and expensive drug or treatment.

You might also find it interesting that the total Healthcare Expenditures in the US is now 3.6 times the spending on defense, and 2.0 times the spending on education. It is projected to rise from 13.2% of GDP in 2000 to 15.5% of GDP in  2005.⁵

In 2004, the US spent 14.6% of GDP on healthcare, compared with Germany's 10.9%, Canada's 9.6%, Australia's 9.1%, New Zealand's 8.5%, and the United Kingdom's 7.7%.⁷ Again, this greater spending did not translate into better health, better longevity, or better quality of life.

[Posted in 2005] How Much do we Spend on Prescription Drugs?

You might find it interesting to know that 216.4 billion was spent in 2004. This number is steadily growing. In 2005 an increase of 10-12% is anticipated in prescription drug expenditure in the outpatient setting, 12-15% in clinics, 6-9% in hospitals. Ask yourself whether these staggering sums of money have brought a significant relief of suffering into your world.⁴

[Posted in 2005] FDA is Financially Dependent on the Pharmaceutical Industry

I have recently learned that the FDA (which is the organization that decides whether a certain drug will be approved for treatment of a certain condition, or taken off the market) is now financially dependent on the pharmaceutical companies. This is a result of the law that went into effect in 2002. If you go to the official government web site, you can see the following for yourself (http://www.fda.gov/oc/pdufa/overview.html) “In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). This was reauthorized by the Food and Drug Modernization Act of 1997 and again by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. PDUFA authorized FDA to collect fees from companies that produce certain human drug and biological products. Any time a company wants the FDA to approve a new drug or biologic prior to marketing, it must submit an application along with a fee to support the review process. In addition, companies pay annual fees for each manufacturing establishment and for each prescription drug product marketed. Previously, taxpayers alone paid for product reviews through budgets provided by Congress. In the new program, industry provides the funding in exchange for FDA agreement to meet drug-review performance goals, which emphasize timeliness.”

Instead of getting its revenue from the tax money, FDA is now financially wed to the pharmaceutical industry.

One result of this marriage between the FDA and the pharmaceuticals is an ‘accelerated approval’ for the new drugs. Read more on the recent approval and subsequent quick withdrawal from the market of a drug called natalizumab, in the Conventional Medicine section of this web site. It provides a concrete example of the consequences of the formation of this industrio-medical conglomerate.

[Posted in 2005] Who Pays the People that Make the Guidelines

Not too surprisingly, the groups of experts that create guidelines are also on the payroll of the industry. The recent, more stringent cholesterol guidelines, for example, were created by the group of people whose disclosures (except for one member who, quite admirably, had nothing to disclose) speak for themselves:

Dr. Grundy has received honoraria from Merck, Pfizer, Sankyo, Bayer, Merck/Schering-Plough, Kos, Abbott, Bristol-Myers Squibb, and AstraZeneca; he has received research grants from Merck, Abbott, and Glaxo Smith Kline.

Dr. Cleeman has no financial relationships to disclose.

Dr. Bairey Merz has received lecture honoraria from Pfizer, Merck, and Kos; she has served as a consultant for Pfizer, Bayer, and EHC (Merck); she has received unrestricted institutional grants for Continuing Medical Education from Pfizer, Procter & Gamble, Novartis, Wyeth, AstraZeneca, and Bristol-Myers Squibb Medical Imaging; she has received a research grant from Merck; she has stock in Boston Scientific, IVAX, Eli Lilly, Medtronic, Johnson & Johnson, SCIPIE Insurance, ATS Medical, and Biosite.

Dr. Brewer has received honoraria from AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Esperion, and Novartis; he has served as a consultant for AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Sankyo, and Novartis.

Dr. Clark has received honoraria for educational presentations from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; he has received grant/research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer.

Dr. Hunninghake has received honoraria for consulting and speakers bureau from AstraZeneca, Merck, Merck/Schering-Plough, and Pfizer, and for consulting from Kos; he has received research grants from AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, and Pfizer.

Dr. Pasternak has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/Schering-Plough, Sanofi, Pfizer Health Solutions, Johnson & Johnson-Merck, and AstraZeneca.

Dr. Smith has received institutional research support from Merck; he has stock in Medtronic and Johnson & Johnson.

Dr. Stone has received honoraria for educational lectures from Abbott, AstraZeneca, Bristol-Myers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, Pfizer, Reliant, and Sankyo; he has served as a consultant for Abbott, Merck, Merck/Schering-Plough, Pfizer, and Reliant.”

All of this can be found on the National Institute of Health web site at: http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04_disclose.htm.

The new guidelines guarantee that more people will be placed on cholesterol lowering medications, that the dosages of the medications will be higher, and that people will be on the medications longer. The validity of the need for this change is debated by many individuals and organizations, including Center for Science in the Public Interest. While cholesterol lowering drugs have their place in medicine, extremes are likely to be harmful.

[Posted in 2005] A Greater Side-Effect of the Dominance of Pharmaceutical Industry

Privately funded clinical trials of childhood cancer treatments use known weak drugs to exaggerate the effect of the new drugs they promote. When a desperate parents enrol their child with cancer into a clinical trial they hope that the child will get the best treatment available. This certainly did not turn out to be the case when the researchers analysed the privately funded trials and compared them to the publicly funded ones (i.e. those funded by the National Institute of Health).  “...A systematic review published in the BMJ (BMJ 2003;326: 1167-70[Abstract/Free Full Text]) found that industry funded trials are more likely to favor the company's drug. The two most likely explanations seem to be selective reporting of good outcomes, or violation of the uncertainty principle by, for example, choosing a comparator that is known to be inferior.”⁸ So if your child ends up receiving a control drug in the privately funded study, he may be getting a treatment that is known not to work. The authors of this article give an unusually mild word of caution. “So should you encourage parents to enroll their children into randomized trials? If the trials are publicly funded, this paper says that you should. For industry funded studies the answer is probably also yes, but look hard at the control treatment and at the outcome measures.”

Another article by the former editor of the British Medical Journal is revealing some of the extent of the influence of pharmaceutical industry on the practice of medicine today. It describes how the industry uses financial incentives and a variety of other tricks to get published in the major medical journals. Journal articles are, of course, used as evidence for the guiding agencies for determination and updating of the new guidelines. The tricks used by the industry to achieve favorable results in randomized clinical trials include: asking the “right” questions, using inappropriate comparators, using multiple endpoints and subgroup analysis (with publication of only the most favorable results), separately publishing results from selected centers in a multi-center trial (as if they were independent trials), and reporting results in the most favorable terms (e.g. relative, rather than absolute risk reduction).¹⁰ For all of those reasons current medical guidelines are a suspect, especially when they lead to more people getting more medications.

 

References:

1. Pritchard RS, Fisher ES, Teno JM, Sharp SM, Reding DJ, Knaus WA, Wennberg JE, Lynn J. Influence of patient preferences and local health system characteristics on the place of death. J Am Geriatr Soc. 1998;46:1242-1250.

2. Wennberg, John E et al. Use of hospitals, physician visits, and hospice care during last six months of life among cohorts loyal to highly respected hospitals in the United States. BMJ  2004; 328:607 (13 March), doi:10.1136/bmj.328.7440.607

3. The Dartmouth Atlas of Health Care 1999.  Center for the Evaluative Clinical Sciences at Dartmouth Medical School. www.dartmouthatlas.org/about.php. 1999. Overuse and Underuse of End of Life Care. Chapter 7, The Quality of Medical Care in the United States. Section Thirteen.

4. Hoffman, J et al, Projecting future drug expenditures—2005. Am J Health-Syst Pharm. Vol 62, Jan 15, 2005.

 

5. Bukata, W.R. Healthcare expenditures—Time for hard choices. Primary Care Medical Abstract Essey. 14 No 2, Feb. 2005, abstracted in Action Advisor for Primary Care. PC Press. Vol. 7, No. 8.

 

6. Tenzer, P. Quality in Residency Education. Ann. of Fam. Med. Vol. 3, No. 5, Sept/Oct 2005.

7. Schoen et al, "Taking The Pulse of Health Care Systems: Experiences Of Patients With Health Problems in Six Countries," Health Affairs, Sept/Oct 2005; published online. Abstracted in Medpage Today, New York, Nov.4, 2005.

8. Godlee, Fiona, Editor’s Choice. BMJ  2005;331 (3 December), doi:10.1136/bmj.331.7528.

10. Smith, R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med. 2005 May;2(5):e138. Epub 2005 May 17. Abstracted in The Family Practice Newsletter. Colin P. Kopes-Kerr. Vol. 21, No. 24, December 15, 2005.

11. Fugh-Berman A. The Corporate Coauthor. J Gen Intern Med 2005; 20: 546; abstracted in Emerg Med Abstracts 2005; 10/05: #33, abstracted in Action Advisor for Primary Care Vol. 8 No. 1 January 2006.

12. Godlee, F. Editor’s choice: Can we tame the monster? BMJ  2006;333 (8 July), doi:10.1136/bmj.333.7558.0-f

 

Illustration: Margaret Shear, Public Library of Science) From: Smith R (2005) Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med 2(5): e138