This is the mission statement of the US Food and Drug Administration:
“FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”
Unfortunately, the FDA consistently fails in fulfilling its crucial safety mission. Most egregiously, it has unaccountably been asleep at the wheel for almost twenty years despite shocking accumulating evidence that prescription opioids are the most dangerous of drugs, directly responsible for almost twenty thousand deaths a year and indirectly responsible for many more.
The FDA has seemed more intent on protecting the pharmaceutical companies making the opioid drugs, than in protecting the public victimized by them. It has privileged the efficacy of the drugs in relieving pain above the lethality of the drugs in causing death. It has legitimized a drug industry that has become a bigger killer and threat to public safety than the drug cartels.
FDA Belatedly Takes Action
Thankfully, the FDA has recently taken a decisive step in meeting its responsibility for reducing the tragic safety risks of prescription opioid drugs – but it is a step taken far too late and what it will accomplish is far too little. It has requested that Endo Pharmaceuticals voluntarily withdraw its prescription opioid Opana ER (oxymorphone hydrochloride) from the US market, citing concerns that its benefits in managing pain do not justify its risks in causing addictions and overdoses.
Opana ER was first approved by FDA in 2006 and reformulated by Endo in 2012 in a new preparation that supposedly would render it less likely to promote addictions via snorting or injecting. The FDA stated that “data did not show that the reformulation could be expected to meaningfully reduce abuse.”
The FDA threatened that if Endo fails to voluntarily remove the drug, it will revoke its approval.
The Drug Company Responds
This is taken from Endo’s statement in response to the FDA action:
“Despite the FDA’s request to withdraw OPANA® ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that OPANA® ER has a favorable risk-benefit profile when used as intended in appropriate patients.”
It is the depths of Pharma cynicism to claim a good risk/benefit ratio under proper use of a drug, while simultaneously doing everything possible through marketing to promote its improper misuse.
The risk/benefit ratio of a drug in a carefully monitored clinical trial, conducted with highly selected patients, often does not generalize its risk/benefit ratio very well once it is marketed under poorly monitored conditions to the general public.
In carefully selected populations, the prescription opioid may be remarkably effective and relatively safe. In the real world where appropriate controls are almost totally lacking and where Pharma marketing amounts to aggressive drug pushing, the same opioid drugs have proven to be totally devastating because they are so often carelessly misused, rather than used cautiously and appropriately.
Drugs get FDA approval based on very limited research performed under very exotic conditions in very few subjects by the very drug companies that stand to profit if the research is positive and the drug appears to be safe. Safety issues are inherently hard to determine on small sample sizes and are further minimized due to Pharma’s enormous conflict of interest.
The FDA should have a powerful surveillance arm to determine how well drugs perform in real world situations after they come to market. Instead, post surveillance is terribly underfunded and ranges from nil to minimal.
The FDA should also be anticipating possible harmful unintended consequences of marketing new drugs – especially addictive ones that can cause massive epidemics of deadly overdoses. Instead it is an all too porous filter that legitimizes bad drugs instead of protecting the public from them.
Congress and the FDA
Up until now, Congress has been a terrible influence on the FDA. It recently passed the euphemistically named “The 21st Century Cures Act” which more properly could have been named the “Give Pharma Complete Control of FDA Act.”
For the last several years, the FDA has caved under Pharma pressure approving almost all drugs under review, even some real losers. Now Congress has made it official that the FDA is almost toothless- it’d new role is to speed new drugs to market even faster. This is a great boon to Pharma profits, but a great risk to patient safety.
Congress has also confirmed as director someone whose sympathies, loyalties, experiences, and conflicts of interest are totally on the side of giving Pharma a free hand over the agency he is meant to run.
The opioid epidemic is shocking proof how dangerous for public health and product safety is a weak FDA that is constantly looking over its shoulder trying to please its Pharma masters.
Unless the FDA is strengthened, made independent and rescued from its current state of regulatory capture by Pharma, there is no doubt whatsoever that we will continue to have repeated drug safety catastrophes.
I hold no hope for reform under the current badly corrupted Congress and Executive Branch. The only hope is the future election of more responsible leadership in the elections of 2018 and 2020.
A Congress more responsive to the people than to the drug companies would conduct a thorough-going investigation of the opioid epidemic as a classic case of terrible FDA failure and would reconstitute the mission, funding, organizational structure, and hiring practice of the FDA so that public safety, not Pharma profits, are its first and most urgent priority.
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