Wednesday, 14 June 2017

A Sociological assessment of the 'benefits' of pharmaceutical drugs and vaccines

An eminent American sociologist, Donald Light, has weighed in on the debate about pharmaceutical drugs. In fact, he did so in June 2013, four years ago, when his research was published in the Journal of Law, Medicine and Ethics was published (Vol 14, No 3: 590-610), entitled "Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs". This is what he said summarising his devastating findings:

               "Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board."

In the journal 'Footnotes' journal of the American Sociological Association, Light was described as the 2013 recipient of ASA’s Distinguished Career Award for the Practice of Sociology, and he said this in his article, 'The Epidemic of Sickness and Death from Prescription Drugs' he had more to say, and it is sufficient here to repeat his words in a series of hard-hitting statements:

               "At the intersection of medical and economic sociology sits prescription drugs. Economically, the strange, government-protected markets for drugs lead to prices largely unrelated to either value or cost, though companies claim they reflect one or the other, or both at the same time." 

               "Epidemiologically, appropriately prescribed, prescription drugs are the fourth leading cause of death, tied with stroke at about 2,460 deaths each week in the United States. About 330,000 patients die each year from prescription drugs in the United States and Europe. They cause an epidemic of about 20 times more hospitalizations, as well as falls, road accidents, and about 80 million medically minor problems such as pains, discomforts, and dysfunctions that hobble productivity or the ability to care for others. Deaths and adverse effects from overmedication, errors, and self-medication would increase these figures."

               "The Edmund J. Safra Center for Ethics at Harvard is devoted to researching “institutional corruption” in a range of domains, including Congress, the Environmental Protection Agency, and the Food and Drug Administration (FDA). Institutional corruption refers to legal ways in which an institution’s social mission and basic values get distorted, usually by big money. For example, the FDA, developed around a series of drug disasters to protect the public from unsafe and ineffective drugs, devotes only 10 percent of its budget to monitoring for harmful side effects. Further, evidence of serious risks is reviewed by the same committee that approved the drug in the first place as 'safe and effective'. This builds on another institutionally corrupt arrangement - companies testing their own products. They use well-documented techniques to produce evidence that new drugs appear safer and less harmful than they are in actual practice. These practices include randomly sampling from a preselected biased population, using substitute outcome measures, and using a high dose to hasten evidence of benefit while running trials too short to record the resulting adverse side effects.

Light states there hitherto there has been a lack of sociological research into the prevalence of mild and serious harms from prescription drugs.

               "Medical sociologists often concentrate their research on diabetes or Alzheimer’s disease rather than on prescription drugs as major cause of illness and death. Drugs as a major health risk, especially given that few new ones have offsetting advantages compared to their higher risks, unites the two sides of medical sociology because physicians prescribe them to help patients. It’s a field waiting for graduate students and faculty to explore."

The articles goes into detail about the operation of large pharmaceutical companies, which Light studied, and led his to realise that a far worse problem existed.... "the epidemic of harmful side effects from drugs that usually offer few or no new clinical advantages over existing drugs to offset their risks."

Light and his colleague went into many other medically related sociological issues, including evidence that new drugs were no better than old ones, questioning how much benefit drugs conferred, how inadequate testing regularly produced disasters such as those associated with Vioxx, that drug pricing was unjustified, and that American federal law required that Medicare payoff any FDA approved drug at the prices drug companies set. His conclusion was clear.

               "What, then, is going on? We concluded that companies charge unaffordable, impoverishing prices because legal protections in the United States encourage them. Further, we found in the large data set on prescription prices .... that companies keep raising these prices in subsequent years, doubling every five years. Thus the pricing of cancer, cardiovascular, and other specialty drugs can be characterized as 'market spiral pricing'.” 

The other factor spiralling out of control is the damage pharmaceutical drugs and vaccines are doing to patients throughout the world.