General Cautions About Drug Trials
It is important for people with MS to keep an open mind, perhaps even a skeptical one, about the supposed benefits of many of the drugs that are widely prescribed in MS. It is unfortunate, but MS is big business. When natalizumab was fast-tracked onto the market by the Food and Drug Administration (FDA) in the US, it stood to make around US3 billion dollars in its first year.
Virtually all of the randomized controlled trials for these drugs are sponsored by the drug companies who make them because of the expense of the drugs and of conducting such large trials. We know that the results of drug company sponsored research are less reliable than those of independently conducted research, and that therapeutic claims tend to be exaggerated. For instance, it has been shown that drug company-sponsored research is four times as likely to be favourable to a company’s product than independently conducted research1; authors of company-sponsored research are more than five times as likely to recommend the company drug as independent authors, regardless of results2; and researchers with industry connections are far more likely to favour company products. In one study of calcium channel blocking drugs used in heart disease, 96% of authors of papers favourable to the drug had financial ties to the company making it versus 37% of those critical of the drug.3
Virtually all of the randomized controlled trials for these drugs are sponsored by the drug companies who make them because of the expense of the drugs and of conducting such large trials. We know that the results of drug company sponsored research are less reliable than those of independently conducted research, and that therapeutic claims tend to be exaggerated. For instance, it has been shown that drug company-sponsored research is four times as likely to be favourable to a company’s product than independently conducted research1; authors of company-sponsored research are more than five times as likely to recommend the company drug as independent authors, regardless of results2; and researchers with industry connections are far more likely to favour company products. In one study of calcium channel blocking drugs used in heart disease, 96% of authors of papers favourable to the drug had financial ties to the company making it versus 37% of those critical of the drug.3
These research findings may surprise some people. A 2007 study published in the New England Journal of Medicine confirmed these strong financial links between medicine and the pharmaceutical industry.4 In that US national survey, 94% of physicians reported financial links with drug companies. Of these over one third received financial reimbursements for travel, etc, and 28% received direct payment for lecturing or acting as consultants on behalf of the companies. Further, there was clear evidence that the drug industry focused on opinion leaders in the medical community, as they were the ones with the most influence on prescribing patterns of their peers.
A neurologist I know suggested to me that the best place to go to find the latest on new drugs is the Financial Times, not the medical journals. This is because the drug companies’ share prices are directly affected by such things as the reporting of unexpected side effects, and drug companies must disclose these things urgently to the Stock Exchange or risk serious financial consequences. For instance, the day the medical community found out about the unexpected deaths from natalizumab, the two sponsoring drug companies’ share prices fell dramatically and it was front page news in the financial papers.
To read more about the real problems ordinary consumers of health care face because of the insidious influence of drug companies, I recommend The Truth About the Drug Companies by Dr Marcia Angell, former Editor in Chief of the New England Journal of Medicine.5 Here she states, no doubt to the grave concern of many ordinary consumers of healthcare, ‘In many drug-intensive medical specialties it is virtually impossible to find an expert who is not receiving payments from one or more drug companies’. Useful websites to visit with information about the problems caused by conflict of interest between doctors and the drug companies are www.nofreelunch.org and www.healthyskepticism.org. A good recent summary of the influence of the pharmaceutical industry in medicine has been published in the Journal of Law and Medicine6.
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A neurologist I know suggested to me that the best place to go to find the latest on new drugs is the Financial Times, not the medical journals. This is because the drug companies’ share prices are directly affected by such things as the reporting of unexpected side effects, and drug companies must disclose these things urgently to the Stock Exchange or risk serious financial consequences. For instance, the day the medical community found out about the unexpected deaths from natalizumab, the two sponsoring drug companies’ share prices fell dramatically and it was front page news in the financial papers.
To read more about the real problems ordinary consumers of health care face because of the insidious influence of drug companies, I recommend The Truth About the Drug Companies by Dr Marcia Angell, former Editor in Chief of the New England Journal of Medicine.5 Here she states, no doubt to the grave concern of many ordinary consumers of healthcare, ‘In many drug-intensive medical specialties it is virtually impossible to find an expert who is not receiving payments from one or more drug companies’. Useful websites to visit with information about the problems caused by conflict of interest between doctors and the drug companies are www.nofreelunch.org and www.healthyskepticism.org. A good recent summary of the influence of the pharmaceutical industry in medicine has been published in the Journal of Law and Medicine6.
- Bodenheimer T. Uneasy alliance—clinical investigators and the pharmaceutical industry. N Engl J Med 2000; 342:1539-1544
- Als-Nielsen B, Chen W, Gluud C, et al. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? Jama 2003; 290:921-928
- Stelfox HT, Chua G, O’Rourke K, et al. Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 1998; 338:101-106
- Campbell EG, Gruen RL, Mountford J, et al. A national survey of physician-industry relationships. N Engl J Med 2007; 356:1742-1750
- Angell M. The truth about the drug companies. How they deceive us and what to do about it. Carlton North: Scribe Publications, 2005
- Jelinek GA, Neate SL. The influence of the pharmaceutical industry in medicine. J Law Med 2009;17:216-23
- Bodenheimer T. Uneasy alliance—clinical investigators and the pharmaceutical industry. N Engl J Med 2000; 342:1539-1544
- Als-Nielsen B, Chen W, Gluud C, et al. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? Jama 2003; 290:921-928
- Stelfox HT, Chua G, O’Rourke K, et al. Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 1998; 338:101-106
- Campbell EG, Gruen RL, Mountford J, et al. A national survey of physician-industry relationships. N Engl J Med 2007; 356:1742-1750
- Angell M. The truth about the drug companies. How they deceive us and what to do about it. Carlton North: Scribe Publications, 2005
- Jelinek GA, Neate SL. The influence of the pharmaceutical industry in medicine. J Law Med 2009;17:216-23