The Drug$ Must be Approved before they can be Marketed
Big Pharma wants to get new medicines on the market as
quickly as possible. Time equals money
and the less time spent in pre-approval clinical trials, the better. They are not above “loading the deck” to suit
their agenda.
Simply put, financial deals influence NIH judgments about
grants, research priorities and the interpretation of research results. Some NIH scientists make hundreds of
thousands of dollars in consulting fees and more in stock options. This is on top of a nice six figure
salary. NIH does not require most senior
scientists to file public disclosures of their outside income. The pay scales were arranged to keep highly
paid scientists in a lower salary range category on paper so they would not have
to disclose conflicts of interest. Researchers with industry connections will
more likely favor company products. That
is the way of the world.
Spin Doctoring
Industry funded research clearly trumps studies funded by
nonprofit organizations. Bias is built
into placebo controlled clinical trials.
These studies, in reality, conclude that a new product is better than
nothing! A better test would be to find
out if a new product is better than what is already on the market. In many cases, it is not.
Another way to rig the results is to use young subjects in
trials even though the drugs will be used in older people. Younger people generally experience fewer
side effects and so the drugs look safer in trials than they would in actual
practice.
Another trick is to compare the new drug with an old drug
given at too low a dose. This trick is
used with many NSAIDS and even statins.
These trials may also administer the old drug incorrectly.
Trials can be too brief to be meaningful. Long term use would tell a more accurate
story but big pharma doesn’t want to uncover those kinds of facts. Furthermore, a drug can actually do a person
good for a short time but long-term use could be harmful.
It is not uncommon to present only part of the data – the data
that makes the drug look good – while ignoring the rest.
Pharmica did this with Celebrex. The rigged trials concluded that Celebrex
caused fewer side effects than two older arthritis drugs. All this research was published along with a
favorable editorial in JAMA. (The Journal of American Medical Association) The published article was based on the first
six months of a year long trial. After
the entire trial was analyzed, it was clear that there was no advantage to
Celebrex.
It is easy to suppress negative results in privately run
trials but can also be done at academic centers. Companies contract with researchers for large
investments of money and they expect favorable results. Some researchers blow the whistle on
unethical sponsors but many just go along.
Over the years, corporate contracts give companies the ultimate control
over such research.
How it Works: If at first you don't succeed.....
Though the original clinical trials on Remune (an
HIV/AIDS drug) proved that the vaccine was worthless, Big Pharma plans to test
it again on children!
Remune Studies Dropped - 2001
Effectiveness of Remune – University of California
Churdboonchart et al. paint an impressive picture of the effects of Remune on CD4 cell count in HIV-infected subjects. However, as individuals who were closely involved in the study, we believe that the paper presents a misleading account of the study results and a distorted view of the beneficial effects of Remune in this population.
In 1996, Immune Response Corporation contracted with Dr.
James O.Kahn – University of California at San Francisco and Dr. Stephen W.
Lagakos of the Harvard School of Public Health to conduct a multicenter trial
of its drug Remune. The drug was
supposed to slow the progression of AIDS by boosting the immune system. The company was seeking FDA approval to
market the drug as a vaccine. The trial
was carried out on 2500 HIV-infected patients at 77 medical centers. After three years, it was clear that Remune
was not effective. Immune Response
Corporation objected to these negative results and wanted to manipulate the
information to support their drug approval.
The researchers refused and stated that the company’s analysis was not
in accord with scientific standards.
How many times is this scenario repeated during the
course of obtaining approval for drugs that may or may not work? For drugs that have more harmful side effects
than health benefits? You cannot watch
American TV without seeing at least one drug commercial in 30 minutes or
less. The possible side effects are
plainly given to the viewer and anyone with just a bit of common sense would
conclude they’d rather be sick than risk those side effects! It has become a joke but it is not
funny. The public is so bombarded with
this type of information that they
become immune to it and no longer take it seriously. The result?
They buy the drugs anyway.
Corporate Disclosure
WA drug company is required to submit results from every
one of the clinical trials it has sponsored when it applies to the FDA for
approval of a new drug. IT IS NOT
REQUIRED TO PUBLISH THEM.
The FDA approves drugs on the basis of minimal
evidence. They require that the drug
work better than a placebo in two clinical trials. If it doesn’t work better in other trials –
those are simply suppressed and ignored.
Drug companies will publish only positive results and the
FDA has no control over such selective publishing.
For example, in the case of SSRI drugs – Zoloft, Paxil,
Prozac and Celexa et al, the clinical trials lasted just six weeks. It turns out that placebos were 80% effective
as the drugs. (IMO, maybe more so!)
There are a number of pdf papers at this site for more information.
SOP – Business as Usual
Even if Big Pharma was to stumble upon the miracle drug
of the century, how would we ever know?
They have little, if any, credibility and are like the boy who cried “wolf”
too often. They are unethical and use
every trick in the book, every legal loophole and every manipulation they can
think of to push their drugs onto trusting doctors and patients. Buyer Beware!!!!
Further Research and Reading
NIH Conflicts of Interest Policies
Reporting Allegations of Conflicts of Interest
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