[e-drug] Scores of unessential drugs - the main game

e-drug
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E-DRUG: Scores of unessential drugs - the main game
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Dear Colleagues,

During this year as a Fellow at the E J Safra Center for Ethics at Harvard University, I have been part of a team on "institutional corruption" in how prescription drugs are tested, approved, and marketed. Our research shows that the FDA cannot be trusted to carry out its historic mission to protect patients from harmful and ineffective drugs.

For years, the FDA has allocated less than 10 percent of its budget to monitoring prescription drugs for harmful side effects, and 90 percent to approving new drugs. However, independent expert teams of physicians and pharmacists have found that most new drugs and little better for patients than previously approved new drugs. They may be technically innovative and better than a placebo, but not better clinically for patients.

The small percent of clinically superior new drugs help patients and add to the large medicine chest of effective drugs.

The Harvard Center has just posted a blog about this research. It centers on how FDA officers are proposing to approve new drugs for "early stage Alzheimer's disease" when no such disease exists and they admit there are not biomarkers or clinical symptoms that differ from people misplacing something or saying "I've forgotten what I was going to say... " See the text and links:
http://www.ethics.harvard.edu/lab/blog/312-risky-drugs. In effect, the FDA is acting as a market-maker to legitimate drugs for a non-disease fear of incipient Alzheimer's disease, using even less evidence that the drugs are safe or effective than they use now.

The FDA has played this role before, legitimating a widespread non-disease and approving drugs for them. "Osteopenia" as a constructed disease is a good example, designed to expand sales.

While most new drugs approved by the FDA are slightly better than a placebo or substitute measure, they may be worse (or better) than drugs approved in previous years for the same condition. But all of them are under-tested for harmful side effects.

Prescription drugs are the 4th leading cause of death, on a par with stroke. One in every five new drugs is likely to cause serious harm. There is an epidemic of harmful side effects from prescription drugs, about 80 million a year in the United States alone. (See the linked article) http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2282014

The FDA's new array of post-market surveillance measures to detect harmful side effects, we find, is not yet doing that job. It may, after years of pilots and ramp-up; but for now there are about 2460 deaths and 53,000 hospitalizations every week of the year from serious adverse reactions.

Simple reforms could make new drugs safer and more effective than they are now. But the FDA is going the other way, by lowering criteria for approval, less is known about whether new drugs are better or safer, leaving it to drug sales reps to tell us that they are, based on no solid evidence. Are we returning to the era of hucksterism of the 1890s?

Don Light

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E-DRUG: Scores of unessential drugs - the main game(2)
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This report is very discouraging to those of us in developing countries who have in the past relied on the FDA as a stringent drug regulatory authority where we do not have the resources to evaluate the new chemical entities that have been approved. This makes me feel that when companies with FDA approval come to market their products in our countries we are in a sense being used as guinea pigs.

I trust that the FDA authorities have received this report and are committed to rectifying the anomalies addressed in the report. Can anyone confirm this. If not then we in the developing countries must demand that they style up

Dr. Elizabeth Ominde-Ogaja
Executive Secretary for Health
Kisumu County
Kenya
lizogaja@gmail.com

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E-DRUG: Scores of unessential drugs - the main game (4)
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Dear Colleagues

Thank you.
I am not at all surprised by the information supplied by Don Light in his
post to this list, and I think it is important to take note of the
situation being reported.

The US medical establishment has some amazing strengths and some very
worrisome weaknesses. In my view these are not monitored in any meaningful
way, so there is more reporting based on ideology than reporting based on
meaningful quantified data. I am happy to see the information supplied by
Don Light.

The US financial establishment has a singular focus on profit performance,
and so called Big Pharma and research are driven by profit performance and
stock price behavior. The distortions that arise because of this in the
allocation of resources to solving important health problems is
preposterous ... but this is bound to be as long as the primary driver of
the performance of these drug companies is based on the financial metrics.

I have argued for a long time that the purpose of the medical establishment
is to improve the state of health ... and I believe it is fair to say that
the vast majority of health researchers embrace that idea. Medical
researchers might advise on decisions about allocation of R&D resources,
but the actual decisions get made with a heavy weighting from the financial
community where profit trumps health impact. The 'orphan drug' problem
needs to be talked about a lot more.

As regards the regulatory bodies such as the FDA, their performance can be
understood in the context of the career path of the staff, and potential
for profit associated with regulatory decisions and the influence that can
be brought to bear through all sorts of 'interesting' channels. Science and
data is somewhere in the mix ... but whether or not good science gets to
dominate the decisions is less than obvious.

While I believe that the US business model of 'profit above all else' is
broken and unsuited to the 21st century I think it is still fair to say
that medical science is at an amazing place, and even more amazing progress
is possible. I argue that the framework for decision making about
allocation of resources should be based on something bigger than profit ...
specifically the impact of people, place and planet. So what is the value
of saving the life of a child growing up in poverty in a poor place
relative to selling a drug at high profit to a rich person in a rich place?
So ... how should fund flows into activities that save lives in poor places
be incentivized and rewarded? How do we move from where we are to where we
want to be? How do we make the best use of the human resources that we have
... including the unemployed and underemployed educated youth? How do we
make brain-power the limiting factor in progress rather than a shortage of
R&D funding?

All sorts of things are possible ... the challenge is to make them happen.
A singular focus on money profit for an organization is a huge constraint.
Somehow we need to quantify the value of doing the right thing so that
people's health improves.

Peter Burgess
TrueValueMetrics
Peter Burgess <peterbnyc@gmail.com>

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E-DRUG: Scores of unessential drugs - the main game (6)
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Dear all,
I do agree with Peter Burgess' opinion. The worrying matter here is if the regulators are fabricating the facts to fit profitability. Clearly such practice would be a criminal offense under any law.

The quest to have a 'people- or public health- centred' basis for research, etc, suggests that private sector must change its nature, from profit- driven to public health- driven. The question is whether such a thing, such a wholesale change from what is the fundamental (profit) basis of the make up of nations, is possible.

Regards,
Bonnie

Dr Bonface Fundafunda
Dir line: +260211254183
Mobile: +260979252900
Email: bcfunda@hotmail.com