If drugs are to be effective and safe to use, it is axiomatic that the regulatory process has the power, resources and competence to be capable of validating all the information which has to assessed before official approval can be granted. Genuine doubts have frequently been expressed which indicate that the regulation of drugs is seriously flawed. A recent book (1) on Crony Capitalism devotes one chapter to the pharmaceutical industry, which is very revealing. Here are some of the points covered (2):
- In order to obtain approval for a new drug in the USA, a drug company needs to have the right people involved. Essentially this means that the companies have to employ staff, with experience of working for the Food and Drugs Administration (FDA). In addition they need to use consultants with specialised expertise. Very often these are the same people who serve on the advisory committees of the FDA. The companies also have to make direct payments to support the FDA budget. As a consequence there is a close working relationship between those who are employed by the companies and regulators.
- The strategies applied by the drug companies have been described in an article in The Economist, which explains that it is common practice to bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a company’s drug. It goes on to describe how the regulators, who do get access to some of the hidden results, often guard them jealously, even from academic researchers, seeming to serve the interests of the firms whose products they are supposed to police. The French journal Prescrire applied to Europe’s drug regulator for information on the diet drug rimonabant. The regulator sent back 68 pages in which virtually every sentence was blacked out.
- The scientific journals also come in for criticism because they frequently fail to perform basic checks on the papers they print, so all sorts of sharp practice remain uncorrected. Many published studies are not written by the academics whose names they bear, but by commercial ghostwriters paid by drug firms. Doctors are bombarded with advertising encouraging them to prescribe certain drugs.
- Within the financial world, since 2008, 75 people have been charged with trying to profit from inside information about drug approvals or company mergers related to patentable drugs. One of them, an FDA chemist named Cheng Yi Liang with access to the Agency’s approval database, pleaded guilty to insider trading on 25 companies for a total gain of $3.78 million over five years.
- Although the costs of drug approval keep growing, along with the related corruption, the financial payoff for those ultimately winning approval can be astronomical, because approval also brings with it a government-protected monopoly. Only FDA-approved drugs can be prescribed within government programs such as Medicare. Doctors may prescribe unapproved substances, but by doing so risk losing their license to practice. Some approved drugs may be priced as high as $500,000 per year per patient.
- The FDA will also discourage, and often ban, substances that might compete with approved drugs. When anti-depression drugs (based on extending the life of a hormone, serotonin, inside the body) were approved, the Agency promptly banned a natural substance, L-Tryptophan, that increased serotonin, even though the natural substance was much cheaper and had long been available. Many years later, after the anti-depression drugs were well established, Tryptophan was finally allowed back, but under restrictions that made it more expensive.
- In general, the FDA maintains a resolutely hostile stance toward supplements. It will not allow any treatment claims to be made for them, no matter how much science there is to support it, unless they are brought through the FDA approval process and thus become drugs. The Agency understands that this is a classic “Catch-22.” Who can afford to spend up to a billion dollars to win FDA approval of a non-patented substance? The answer is obvious: no one. So the real FDA intent is simply to eliminate any competition for patented drugs, since these drugs pay the Agency’s bills. There are many examples of centres, which have been closed down by the authorities on the grounds that the treatments have not been “approved”, even though a large number of people have testified that they have been totally cured. In some cases the doctors have been charged with criminal offences and if found guilty sent to prison.
- Drug companies and the FDA are not alone in wishing to suppress supplement alternatives to hyper-expensive patented prescription drugs. They have allies among both politicians and doctors. For example, the Archives of Internal Medicine, run by the American Medical Association, and supported financially by drug companies, often publishes flimsy studies attacking supplements, and generally ignores the considerable scientific evidence in their favor. One such study, published October 10, 2011, by University of Michigan researchers, purported to show that taking supplements could shorten your life. It caused a media feeding frenzy, with headlines everywhere. The problem was that this study, like its predecessors, was junk science. The women in the study were asked every six years what they had taken. They were supposed to remember what they had taken for the six-year period. The reports did not have to be specific: the word “multivitamin” could mean anything. Who knows what was taken or even it if was taken? It could also be synthetic or natural. Those who reported taking “multivitamins” were found over time to be healthier on average than others and to live longer. But the authors of the study, who clearly had an anti-supplement agenda, made numerous “adjustments” attributing the good health to other factors. Once these arbitrary “adjustments” were made, they then concluded that supplements actually made these healthier than average and longer living people unhealthier. Even after the “adjustment,” the statistical evidence was weak to nonexistent, but that did not prevent media from all over the world reporting that supplements may hasten your death.
- Hunter Lewis (2013) “Crony Capitalism in America” AC2 Books ISBN: 978-0-9887267-2-7