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pharmaceutical company Merck had not only obscured measure the effect of a single factor, often a drug or critical data on the drug's toxicity but had also givena technology, on a symptom or disease. While this biased presentation of its research and had used approach can provide essential data, often multiple ghostwriters to write papers on it. He went on to state _ factors are involved in causing illness and many aspects hat "its [Merck's] behavior may not be any different of our physiology must be addressed in providing an rom that of others in the pharmaceutical or effective treatment. For this reason, a new clinical biotechnology industry"."° Vioxx®, as you may _ research model has emerged, called an outcome study. remember, was withdrawn from the market in 2004 after In these studies, many treatment modalities are massive litigation and a media uproar resulted when — simultaneously varied and the cumulative effect of his drug, used as a painkiller worldwide, was linked to different sets of variables is measured over time. For many thousands of heart attacks and cardiac deaths and _ example, an integrative physician treating a patient with strokes. cancer might seek simultaneously to strengthen the Dozens of other cases are almost as blatant. In 2001, patient's immunity with supplements and herbs, or example, TAP Pharmaceuticals pleaded guilty and __alkalinise his pH, support the ability of his gut to digest, agreed to pay $875 million to settle criminal and civil absorb and detoxify what is eaten, add high-dose charges brought under the False Claims Act over its antioxidants and start him on a regimen of exercise and raudulent marketing of Lupron, a drug used for the yoga. If in controlled clinical trials the patients on this reatment of cancer." protocol improved, we'd know the outcome but not the To get a sense of proportion, roles of each of the factors in contrast this with evidence for modifying the course of the he use of vitamin D as a cancer This kind of ethical illness. deterrent. Almost 90 scientific . : studies over many decades misconduct is often related Ethics issues for research ave shown that vitamin D is . . scientists and the FDA he cancer-protective factor to conflicts of Interest Next up is the issue of generated from direct contact involving financial gain, professional. ethics among with sunlight, reducing cancer some medical researc risk by up to 50 per cent. A career advancement and scientists. In a July 3, 2006 definitive, carefully controlled personal fame. article titled "Stop study published in 2007 on the Misbehaving!", Ushma S. Neill, effect of 1,000 IU/day of vitamin executive editor of the D (with calcium) on cancer prestigious Journal of Clinical incidence showed, after four years, that the cancer risk Investigation, wrote: "Scientists are usually thought to be was 60 per cent lower than with a placebo and 77 per _ beyond reproach, but with the recent spate of high- cent lower when corrected for participants who had __ profile ethical transgressions by scientists, the public's already had cancers present.'’? Other studies have _ trust in science and scientists is deteriorating. The shown equally significant associations of vitamin D with numerous cases of scientific misconduct that have the reduction of diabetes, number of falls by the elderly, | crossed my desk in the last year leave me disenchanted, MS and other maladies. Yet, as with the case of the disappointed, and disillusioned."” simple technology of photonic stimulation, how much Of course, most scientists are honest and operate have you heard about this astounding scientific with the highest integrity. Yet, every year, a surprising evidence? number of scientific medical articles are published tha A few more crucial points... Randomised, double- are later found to have been falsified. This kind o blind, placebo-controlled trials are not the only way to ethical misconduct is often related to conflicts o validate treatments for clinical practice. Traditional interest involving financial gain, career advancemen systems such as those in Chinese, Tibetan and Native — and personal fame. American medicine are all time tested and have strong Pharmaceutical companies are in business to further empirical value, whether they are tested "scientifically" he interests of their investors, but doctors and medica or not; they have endured for hundreds or even _ schools have no such excuse: Their only responsibility thousands of years for a reason. Nonetheless, asinthe is to patients. "The mission of medical schools and case of acupuncture, strict scientific study has eaching hospitals—and what justifies their tax-exemp' progressed greatly in recent years, even as experts status—is to educate the next generation of physicians, debate the proper research methodology to be used to carry out scientifically important research, and care for correct for disparities in the skill of a given practitioner he sickest members of society," wrote former New and for related variables. England Journal of Medicine editor-in-chief Marcia Angell in Finally, it should be noted that the scientific method — The New York Review of Books on January 15, 2009. "It is not as conventionally applied in medical research strives to o enter into lucrative commercial alliances with the pharmaceutical company Merck had not only obscured critical data on the drug's toxicity but had also given a biased presentation of its research and had used ghostwriters to write papers on it. He went on to state that "its [Merck's] behavior may not be any different from that of others in the pharmaceutical or biotechnology industry".'° Vioxx®, as you may remember, was withdrawn from the market in 2004 after massive litigation and a media uproar resulted when this drug, used as a painkiller worldwide, was linked to many thousands of heart attacks and cardiac deaths and strokes. involving financial gain, career advancement and 30 * NEXUS This kind of ethical misconduct is often related to conflicts of interest personal fame. DECEMBER 2009 - JANUARY 2010 www.nexusmagazine.com