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Is Tom Cruise Anywhere Near Right… Even for the Wrong Reasons?
7/11/2005
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Actor’s recent “Today” show rant held grains of truth about drug prescriptions and approvals

by Craig Weatherby


Our last issue featured an article—titled “Diseased by Definition”—about medical insiders’ dismay over the distorting effect that drug companies exert on guidelines for diagnosis and treatment of disease.  In some cases, this influence appears to have created new “diseases” of dubious reality or significance.


We received many complimentary comments, but we also received a rather angry missive from two physicians, who protested that no doctor would commit knowing errors in diagnosis or treatment. While we didn’t say or even suggest that, we felt that our readers’ strong positive and negative responses warranted a follow-up.


We have no doubt that virtually every physician tries to do the right thing for their patients.  But the evidence indicates that physicians are subject to the very human desire to please their patients, as well as to overt pressure from patients and the clever, seemingly “scientific” marketing campaigns mounted by drug makers.


There are several stages at which drug makers can influence patients’ questions to and demands on doctors, and doctors’ reactions to those questions and demands.


Who decides what gets researched and recommended?

Attempts to influence doctors’ prescription behavior begin with the sources of funding for research.  Much of the funding for biomedical research comes from profit-making drug companies: a situation that inevitably skews the focus of research toward studies designed to discover potential drugs or uncover the characteristics of potential drugs under development.   And, research indicates that the biases inherent in a for-profit source of funding often affect research outcomes.   Who should be surprised by this?


The physician-insiders we quoted in our last issue—who included the former editor of the New England Journal of Medicine and the current (but likely-to-be-fired) vice president of marketing for the world’s largest and most successful drug maker (Pfizer)—were not alleging bribery or conscious bias. Instead, they expressed their dismay at the far subtler but still substantial influence that corporate funding exerts.


Then, the distorting effect of research bias gets magnified through the dominance of expert panels by scientists whose primary research programs are substantially dependent on drug-company funding.


These panels—established by such seemingly unbiased groups as the World Health Organization and the National Institutes of Health—issue diagnosis and treatment guidelines that heavily influence the decisions of physicians on the front lines of medicine.


Most practicing clinicians simply lack the time and/or special expertise to examine all of the relevant research in depth, and, must, for all practical purposes, accept the advice of expert panels at face value.


Publication bias: another hidden corrupter

Another way in which doctors’ prescribing behavior can be shifted is through the well-documented phenomenon known as “publication bias,” which affects the drug-approval process at the very start.


Publication bias is the tendency, on average, to produce drug-trial results which, in aggregate, appear significantly positive because negative or near-neutral results of drug trials are almost never published.


A case study of bias: Prozac and company on trial

During a testy exchange with host Matt Lauer on a recent episode of NBC TV’s “Today” show, movie actor and Scientology™ advocate Tom Cruise denounced the psychiatric establishment’s heavy reliance on pharmaceutical solutions.


Despite the arguably vapid vantage from which he made it, he made a valid point.  And the reason that Cruise was at least partially right has everything to do with drug company influence on the directions of biomedical research, and the publication or burial of research findings.


Two years ago, the well-respected British Medical Journal (BMJ) published a damning analysis titled “Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications.” The authors used Sweden’s approval of the Prozac-type drugs known as selective serotonin reuptake inhibitors (SSRIs) as a test case.


They found that the information set upon which the Swedish government’s approval to prescribe SSRIs was based was plagued by “…duplicate publication, selective publication, and selective reporting” of research data, and that, “Studies showing significant differences between efficacy of drug and placebo were three times more likely to appear as stand alone publications than were studies with non-significant results.”



As the authors of the BMJ study concluded, “… for anyone who relies on published data alone to choose a specific drug, our results should be a cause for concern. Without access to all studies (positive as well as negative, published as well as unpublished) and without access to alternative analyses (intention to treat as well as per protocol), any attempt to recommend a specific drug is likely to be based on biased evidence.”



In 2004 Britain’s National Institute for Health and Clinical Excellence (NICE) conducted a “meta-analysis” (analysis of all prior studies) of the efficacy of selective serotonin reuptake inhibitors (SSRIs) such as Prozac and Zoloft: the most widely prescribed class of anti-depression drugs.  As a result, the NICE recommended that doctors prescribe SSRIs as the first line treatment for moderate-to-severe depression.



Yet, as a recent study in the British Medical Journal points out, the NICE’s own data contradict the agency’s advice:  “The NICE review data suggest that selective serotonin reuptake inhibitors do not have a clinically meaningful advantage over placebo, which is consistent with other recent meta-analyses.  In addition, methodological artifacts may account for the small effect seen. Evidence that antidepressants are more effective in more severe conditions is not strong, and data on long term outcome of depression and suicide do not provide convincing evidence of benefit.”




Drug ads seen driving prescription patterns


Most of the studies conducted in recent years find—as one might expect—that doctors’ prescription practices are significantly influenced by patients’ requests for specific drugs, and that the drugs advertised most frequently are among those most requested.  (Interestingly, the only contrary findings we uncovered were from a methodologically weak study conducted by an openly pro-business, anti-regulation think tank.)



While researchers have not found dramatically strong correlations between the prescriptions given to patients who bring up specific drugs, and the prescriptions to those who do not, the correlations are not insignificant.  And, when projected over the entire doctor-visiting population, these differences can make the difference between financial success or failure for a new drug.



As the authors of one of these studies concluded, “Our results suggest that more advertising leads to more requests for advertised medicines, and more prescriptions [for the advertised drug].  If DTCA [direct-to-consumer advertising] opens a conversation between patients and physicians, that conversation is highly likely to end with a prescription, often despite physician ambivalence about treatment choice.”



We’ve listed our research sources below.  For links to more studies that document the influence of marketing on prescription behavior, go to the physician-run Web site No Free Lunch, located at http://nofreelunch.org/requiredinfluence.htm.



Trust, but verify


Ronald Reagan’s willing but wary stance vis a vis the reformist Soviet leaders of the late 1980’s also constitutes good advice for medical consumers.



Before even asking your doctor’s advice about a drug for a condition with which you have been diagnosed, it’s smart to do a little research on the pros and cons of the drugs most commonly prescribed for it: especially any new drugs approved within the past several years.



There are a few medical-consumer-protection organizations whose Web sites are authored by credible people, including physicians.  Their information on FDA-approved drugs is generally worth knowing.





  • Consumer Reports MedicalGuide.org (http://www.consumerreports.org/main/health/home.jsp).  This is the new, subscription -based medical consumer site from the highly respected products-testing non-profit group.  In recent years, Consumer Reports has become one of the fiercest and most credible critics and watchdogs over the pharmaceutical and medical industries.

  • The Health Research Group (http://www.citizen.org/hrg/) promotes, as their site says, “research-based, system-wide changes in health care policy and provides oversight concerning drugs, medical devices, doctors and hospitals and occupational health. “  Director Sidney Wolfe, M.D., is one of the most high-profile critics of the cozy relationship between drug makers and expert panels.  The HRG also identifies what it calls the “Worst Pills and Best Pills” at http://www.worstpills.org/, and offers links to dozens of governmental and other health-information sites, at http://www.citizen.org/hrg/links/index.cfm

  • No Free Lunch (www.nofreelunch.org) is an organization of health care providers (e.g., physicians, pharmacists, nurses, dentists) who, as their site says, “believe that pharmaceutical promotion should not guide clinical practice, and that over-zealous promotional practices can lead to bad patient care. The organization's goal is to encourage health care practitioners to provide high quality care based on unbiased evidence rather than on biased pharmaceutical promotion.”


We should note that the stances on dietary supplements taken by consumer-protection organization like these often appear unreasonably negative.  However, their sometimes-harsh stances stem not from any evidence of particular risk, but from the paucity of sound research on many supplements (versus the claims made for them), the obnoxious hype used to sell some supplements, and the loosely regulated nature of this health product category.




Supplements rank as safe or safer than drugs

FDA-approved drugs injure and kill vastly more people than do supplements, whose safety record remains remarkably clean by comparison, with very few injuries and even fewer fatalities clearly traceable to their use or misuse.  Even in the case of recently banned, widely used diet ingredient ephedrine, only a handful of deaths bore a possible link to its use, and in most cases, the cause was unclear.



In contrast, the authors of a landmark 1998 study, published in the Journal of the American Medical Association, estimated that, “… in 1994 overall 2,216,000 … hospitalized patients had serious ADRs [adverse drug reactions] and 106,000 … had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.”



As the authors of a more recent review of the same data noted, data limitations make these estimates less than reliable, but few knowledgeable observers dispute the contention that adverse reactions to “properly” prescribed drugs are a major cause of death.



The JAMA study’s authors were open about its shortcomings, noting that their findings should “be viewed with circumspection,” but the scale of risk they suggest are supported by a smaller, more detailed study in Britain.  In fact, the death rate from adverse reactions to all medical and drug treatments rose from 1.07 per 100,000 in 1994 to 1.23 per 100,000 Americans in 1997.



Take prescribed drugs when you need them: just be sure you do


When someone is suffering, or is told they are at risk from a non-symptomatic condition, it is hard to resist the impulse to do whatever is recommended by a health professional.



We only wish to point out that evidence of bias in the establishment of diagnostic and treatment guidelines seems very solid, and that the drug testing and approval process is, as recent studies and Congressional testimony indicate, also rife with biases.



So, do your homework before blindly acceding to being a “good patient” who takes drugs without researching for yourself, and asking tough questions.



By the way, this advice also applies to our reports concerning research on fish, berries, and omega-3s.  While we strive for balance in our presentations of new science, we can’t credibly claim to be the only profit-making company on the planet with no unconscious biases in favor of our products.  That’s why we always provide the sources upon which we relied to write an article.  We urge you to read them for yourself!



Sources




  • Mintzes B, Barer ML, Kravitz RL, Kazanjian A, Bassett K, Lexchin J, Evans RG, Pan R, Marion SA. Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: two site cross sectional survey. BMJ. 2002 Feb 2;324(7332):278-9. No abstract available. Erratum in: BMJ 2002 May 11;324(7346):1131.

  • Mintzes B, Barer ML, Kravitz RL, Bassett K, Lexchin J, Kazanjian A, Evans RG, Pan R, Marion SA. How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. CMAJ. 2003 Sep 2;169(5):405-12.

  • Weissman JS, Blumenthal D, Silk AJ, Zapert K, Newman M, Leitman R. Consumers' reports on the health effects of direct-to-consumer drug advertising. Health Aff (Millwood). 2003 Jan-Jun;Suppl Web Exclusives:W3-82-95.

  • Zachry WM 3rd, Shepherd MD, Hinich MJ, Wilson JP, Brown CM, Lawson KA. Relationship between direct-to-consumer advertising and physician diagnosing and prescribing. Am J Health Syst Pharm. 2002 Jan 1;59(1):42-9.

  • IMS Health. US leading products by DTC spend. January 2000-December 2000. Fairfield, CT: IMS Health, 2001. www.imshealth.com/public/structure/dispcontent/1,2779,1203-1203-143221,00.html (accessed 19 December 2001).

  • Watson R. EC moves towards "direct to consumer" advertising. BMJ 2001; 323: 184

  • Therapeutic Products Programme. Direct-to-consumer advertising of prescription drugs. Discussion document. Ottawa: Health Canada, 1999.

  • Findlay S. Prescription drugs and mass media marketing. Research brief. Washington, DC: National Institute of Health Care Management, 2000. www.nihcm.org (accessed 15 March 2001).

  • Silversides A. Direct-to-consumer prescription drug ads getting bolder. Can Med Assoc J 2001; 165: 462.

  • Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5.

  • Kvasz M, Allen IE, Gordon MJ, Ro EY, Estok R, Olkin I, Ross SD. Adverse drug reactions in hospitalized patients: A critique of a meta-analysis. MedGenMed. 2000 Apr 27;2(2):E3.

  • Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K, Park BK, Breckenridge AM. drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004 Jul 3;329(7456):15-9.

  • U.S. Injury Mortality Statistics, Centers for Disease Control and Prevention, Adverse-Event-Related (Medical Care and Drugs) Deaths and Rates Per 100,000. Accessed online July 16, 2005 at http://www.guncite.com/CDCStats/us9794_Ae.htm.


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