Date: 2024-08-16 Page is: DBtxt003.php txt00005169
Health
Is regulation dysfunctional
Scores of unessential drugs - the main game ... some important questions about the purpose of oreganizations in the US health sector agenda
Burgess COMMENTARY
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
Gmail Peter Burgess
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
Donald W. Light
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I was also very disturbed (but not necessarily surprised) by these
findings. The key issues for consideration in medicines registration are
quality, safety and efficacy. This research shows that the US FDA is
apparently failing to deliver on 2 of these - safety and efficacy.
For the purposes of its Prequalification Programme, the FDA is recognised
by WHO as one of the Stringent Regulatory Authorities (SRAs) (see
http://apps.who.int/prequal/info_applicants/Guidelines/PQProcGenericSRA_July2011.pdf).
In order to improve medicines access, WHO, under the “accelerated
registration” pilot project - a new collaboration between medicines
regulators in developing countries and international experts working with
WHO’s Prequalification of Medicines programme - national regulatory
authorities are encouraged to fast track registration of medicines that
have already been assessed and approved by WHO’s stringent prequalification
procedure. The Global Fund also makes reference to SRAs in its Guide to the
Global Fund’s Policies on Procurement and Supply Management.
In the WHO Policy Perspectives on Medicines (December 2003): Effective
medicines regulation: ensuring safety, efficacy and quality, it states . .
. 'National Regulatory Authorities must be responsive to the needs of the
general public, and effective and efficient in discharging their duties.
Any deficiency or delay in decision-making may enable harmful medicines to
reach the market or lead to shortages of vital medicines, endangering
lives'.
SRAs have been rightly recognised as regulatory role models for countries
striving to improve medicines regulation. The behaviour and practices of
the FDA highlighted by this recent research may cast doubt on this
perception.
With the research conclusion that 'the FDA cannot be trusted to carry out
its historic mission to protect patients from harmful and ineffective
drugs', should the status of FDA as a reputable MRA and particularly as an
SRA now be questioned?
Chris Forshaw
Senior Pharmaceutical Advisor
Ministry of Health,
Kenya
Chris Forshaw
Donald W. Light Jr.
Sun, Jul 21, 2013 at 6:41 PM
Reply-To: Essential Drugs in English
To: Essential Drugs in English
E-DRUG: Scores of unessential drugs - the main game
Cell: 609-216-0071
Resident Fellow, Edmond J. Safra Center for Ethics, Harvard University
Professor, Rowan University-SOM
Visiting Researcher, Center for Migration & Development, Princeton University
'Donald W. Light Jr.'
_______________________________________________
E-Drug, an e-forum on essential drugs, is moderated by a team of international experts, and hosted by the FHI360-SATELLIFE Center for Health Information and Technology (www.healthnet.org).
Gmail Peter Burgess
Gmail Peter Burgess