[Marxism] International Socialist Review on Pharmaceutical corporate practice
sabocat59 at mac.com
sabocat59 at mac.com
Sun Apr 26 05:40:29 MDT 2009
Below is an older report from ISO on the political economy of the pharmaceutical companies, which is useful because it explores some of their common practices which continue to this day. The report also quotes the Null article which Costello and Bond have so much trouble with, as well as the more mainstream critique from JAMA which I posted subsequently.
The article demonstrates clearly how market forces dictate shaky science. Most of the trial group experiments are skewed to underreport or ignore negative effects on trial group participants. The issue of profit motive leading to BAD SCIENCE could not be more clear. And people wonder why there are so many deaths in hospitals. It is not due to malpractice in a large percentage of cases, but rather is the final outcome of a profit driven medical model.
I would urge developing countries to continue fighting for their own generic production of needed drugs which can be sold more cheaply. From my purview, the pharma corporations are beyond reform.
It really is a moot point anyway, since most pharma companies eschew research on drugs for poor populations. With no markets in developing countries for their expensive and dangerous (in many cases) drugs, instead we get 8 varieties of drugs dealing with penile erectile dysfunction, and tropical medicine is ignored for the most part because there is no $$ to be made.
And it is also quite clear that the issue of quackery is used to silence critics of this death mill.
Is this really the kind of pseudoscience you want to preserve from criticism?
Dangers of "standard" pharmaceutical drugs
The pharmaceutical industry already kills well over 100,000 people every year from correctly prescribed drugs in hospitals alone.9 This does not include deaths occurring outside the hospital or from incorrectly prescribed medications, or the millions of disabilities each year. To further put this in perspective, the death rate from illegal drugs is 20,000 per year; the initial death rate from the Union Carbide chemical disaster in Bhopal, India was 20,000; and 58,000 Americans died in the Vietnam War.
Contrary to what most people believe, drug companies, not the Food and Drug Administration (FDA) or independent researchers, finance and control virtually the entire process of testing and bringing new drugs to market. Because pharmaceutical companies finance the vast majority of all drug trials, they design and structure the studies, select and pay researchers, choose the patients, analyze the test results, closely oversee the writing and publication of the final studies and release the drugs through their massive sales network to the medical profession. No independent source confirms or oversees the research, analysis or final conclusions.10 The subjects of drug trials are generally young healthy men, even though the target market for the drug may be women, children or the elderly. Many of the paid subjects are "regulars" who supplement their income by hiding their participation in multiple drug trials when not enough time has passed for the previous drugs to fully leave their systems. The fraud begins at the onset of the drug trial, as drug companies will frequently drop large numbers of subjects who show what the industry classifies as a "sensitivity" or "bad reaction" to the drug. In other words, test subjects who experience exactly the kind of toxic reaction the trial is supposed to be tracking are dropped from the results simply because it occurs early in the trial. Drugs are frequently tested on much smaller numbers of people and for shorter periods than is generally thought. Psychiatric drug trials typically last only four to six weeks, and no psychiatric drug has ever been shown (i.e., tested) to be safe for long-term use. In many drug trials, only one or two dozen subjects actually finish the trial. Doctors who regularly prescribe Prozac believed that the drug had been tested on more than 10,000 patients before they prescribed it to their patients, a figure they had read in Eli Lilly marketing material. In fact, Dr. Peter Breggin went to great lengths to count the actual number of patients who had completed the trials and found the total number to be 286, a far cry from the thousands that the public had been led to believe.11 While most people believe that a drug that gains FDA approval has gone through many successful drug trials that have proven it to be substantially more effective than the placebo, in fact the entire drug trial system works on a simple "pass/fail" basis. When the company submits the trial results to the FDA and the FDA finds the drug insufficient or even harmful and rejects it, the company can simply drop and manipulate portions of data from the very same trial, submitting different permutations of the numbers over and over again until the FDA finally accepts the drug. It takes only two successful trials, even with small numbers of patients, and includes trials that had been previously rejected by the FDA but later passed with reworked numbers, for the FDA to approve a drug. And the drug does not have to show a substantial benefit over the placebo, only that it is "marginally" better than the placebo.12 Drug companies also systematically obscure adverse drug reactions and even deaths that occur during the trials by simply deleting or mislabeling them in the data submitted to the FDA. Suicides that occurred during the testing of Prozac were systematically mislabeled as "no drug effect" or "depression," so that when the FDA examined the drug data, patient suicides could not be found and counted.13 Suicide was one of the first major problems encountered when Prozac was released on the market, leading to multiple deaths and lawsuits. Most of the very symptoms fueling the current debate about the dangers of anti-depressant drugs were known and documented by the drug companies during the trials, but the drugs were released anyway. Manipulating research results Until 1991, 80 percent of drug testing was done by medical university research departments, giving the pharmaceutical companies "brand names" such as Harvard or Stanford Medical School to associate with their research data. Since the 1990s, however, the pharmaceutical companies are cutting costs by using commercial for-profit centers to perform the majority of all drug testing. It is well documented that if for-profit centers do not produce positive results for pharmaceutical companies, the drug companies take their lucrative contracts to another of the hundreds of competing centers. An analysis of 70 studies of specific cardiac drugs showed that 96 percent of authors with ties to the pharmaceutical company produced favorable results, while only 37 percent of independently funded studies of the same drugs showed favorable results.14 Additionally, many of these centers have been found to have financial stakes in the outcome of their own trials, standing to benefit financially from a drug’s approval and subsequent marketing. Many have been sued for deaths and injuries that occurred during fraudulently structured drug trials after producing poor quality data and using inadequately trained investigators to test drugs on subjects who were not informed of the drugs’ known dangers or told of the financial conflicts of interest.15 Drug companies retain the right to stop the publication of any study that does not show favorable results, including studies that show dangerous or deadly reactions. Should a company-funded study show negative results, drug companies have been known to delay the publication of the negative study, quickly fund a new study that produces a favorable response and then publish only the positive results.16 Dr. James O. Kahn conducted a study that concluded an AIDS vaccine didn’t work and had a multimillion dollar lawsuit initiated against him by the corporate funder of the study after it tried unsuccessfully to block publication of the data.17 And since both negative drug data studies and information on the frequency of these heavy-handed tactics are suppressed, we have no way of knowing how many drug studies with negative results have been censored by the very pharmaceutical companies that sponsored them in the first place, even if the drug’s release ends up causing multiple injuries and deaths. Adverse reaction reporting system designed to fail Most people don’t know that the release of a new drug is actually the final phase of the drug trial–Phase IV. After the drug has been approved by the FDA, thousands and even millions of patients taking the newly released drug are unknowingly participating in the largest, most poorly controlled medical experiment in the world.
The fraudulent and deceptive practices of the pharmaceuticals continue during Phase IV when adverse reactions of injury and death are supposed to be tracked and reported to determine if the drug should be pulled from the market. However, not only is the adverse reporting system entirely voluntary, but 90—99 percent of all adverse reactions are never reported, according to the head of the FDA for most of the 1990s, David Kessler.18 Imagine the true death rate if this fact were taken into account. Forty percent of all doctors don’t know that an adverse reporting system even exists. When a group of doctors was studied to determine how many adverse reactions they reported, it was found that only 6 percent of all reactions were reported–and these doctors knew that their rate of reporting adverse reactions was being monitored. And no program or oversight of any kind exists to ensure that reports made directly to the pharmaceutical companies are then reported to the FDA–the process is run entirely on the "honor system."
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