[Marxism] International Socialist Review on Pharmaceutical corporate practice

[sabocat59@xxxxxxx]

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?

Greg McD


http://www.isreview.org/issues/33/druggingtodeath.shtml

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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