Health Care Thoughts: Counterproductive Regulations?
by Tom aka Rusty Rustbelt
Health Care Thoughts: Counterproductive Regulations?
Depakote (divalproex sodium) is an anti-seizure medication approved by the FDA to treat epilepsy, migraines. and bipolar mania.
Many physicians and long-term care nurses (including my favorite nurse) are absolutely convinced Depakote is effective in mitigating the impacts of agitated dementia. Depakote has also proved useful in treating other conditions.
Depakote is important in long-term care because many other effective psych medications are routinely denied to nursing home patients by another set of counterproductive regulations (a topic for another column).
Abbott Labs is now paying $1.6B in settlement of criminal and civil charges by the feds. The states will also get a small cut of the loot.
Abbott’s crime? Telling physicians what they already k new, Depakote was a very valuable medication for “off-label” (unapproved uses).
In the irony department, prescribing and administering Depakote for off-label uses is legal, and may be considered best practices in certain instances.
The feds are thumping their chests (via press releases) about protecting patients and consumers, which is clearly not true. Abbott is going to bail out of the legacy drug business.
There has to be a better way.
Note; Both the government officials and the media has mentioned that Depakote was marketed to nursing homes. Nursing homes can only administer medications ordered by physicians, so marketing to nursing homes would be a complete waste of time?.Abbott actually plead guilty to this crime, which they very likely did not commit, just to get this case settled. Weird.
(Rdan…off label prescription of drugs is less common now but still widespread. It is also an issue worth thinking about in relation to government policy, and also to examine physician expertise and competence in such matters either ‘on label’ or ‘off label’ in the aggregate, as well as the issue of trade regulations under the heading of health and medicine. There is also the question of how to handle ‘best practice’ and ‘evidence based’ treatment, often full of the politics of medicine in addition to government regulation. My thoughts can be found in comments.)
Of course we liberals are for good regulation, not for just any old regulation. Any thoughts leading to better regulation are welcome.
Requiring companies to prove that a drug is safe and effective for a given use before it can be marketed for that use makes sense. Allowing companies to market a drug for off-label uses creates a gaping hole in that regulation. For example, if they want to market a drug for a common but not-too-serious condition but can’t prove that it is appropriate for that, all they need to do is to find any other use for the drug, such as for a rare and serious condition (for which the safety standards are laxer) and get it approved, and then market the drug for the common condition.
Reg-Abbott labs off-label promotion of Depakote.
I took Depakote for 6 years was ineffective for my condition PTSD,the doctor kept telling me to take it.
The saga of the schizophrenia drugs is one of incredible profit.Eli Lilly made $65 BILLION on Zyprexa franchise. Described as *the most successful drug in the history of neuroscience*.There is a whole underclass block of our society,including children in foster care that are the market for these drugs,but have little voice of protest if harmed by them.
–Daniel Haszard *tell the truth don’t be afraid* FMI Google-Haszard Zyprexa
I think the distinction is that particular physicians are allowed to prescribe for “off use” and to recommend it to each other but drug companies are not allowed to market on that basis unless and until they get FDA approval. I think that makes sense to avoid allowing drug companies to do end runs around FDA requirements while allowing physicians to practice medicine as they feel it is professionally appropriate to do so and taking the professional risk of adverse consequences down the road.