Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, May 23, 2023

Federal Lawsuit Against the FDA to End Blood Testing Requirement To Provide Clozapine, for Severe Mental Illness

This lawsuit is against the FDA to end the requirement of blood testing before dispensing clozapine. Clozapine is a medicine to help people with severe mental illness that has not responded to other treatments. It is FDA approved to help people with schizophrenia and are suicidal. Many patients who need it refuse it due to the painful required testing. Interrupting treatment because of a lapse in blood testing often results in severe damaging consequences. 

It may be read here:

https://bit.ly/Behar-v-FDA




Wednesday, April 19, 2017

Hat Tip to Prof. Douglas Berman for information on this Hearing on Synthetic Drugs. Hat Tip to one of my Patients for the Insider Glimpse into this Massive Unexplored World of Synthetic Drugs.

The listing has links to submitted testimony. The hearing lost an opportunity to hear from the players in this world. That would have been far more edifying than the standard establishment cliches.

Difficult subject.

1) All substances and likely all remedies have a dose response curve. When diluted, the strongest poison on earth, botulinum toxin, has 753 medical benefits. When consumed too much, water causes seizures and death among dozens of healthy athletes. So, all claims of benefit or of harm should specify the dose, and provide a dose response curve. Judgment is therefore very difficult and requires data that is always missing.

2) Massive synthetic chemistry entrepreneurship is ongoing out there. Some of it has the potential to help people with medical problems, some normal people to enhance performance and to reduce risk, such as of car crashes from inattention or from sleepiness. It is not a simple utilitarian calculation.
3) Changing body functions is lucrative when reliable and effective, so could boost the economy, and tax revenues.

4) There is a massive grey and black market for these products, driven by consumer satisfaction with them. Chat rooms on alternative Internets, with lively intellectual discussions, ratings, and marketing of these synthetic products are really busy. The internet approach of ratings rather than prohibition or draconian regulation is likely far more effective. Compare nearly worthless contract law to disappointing an Ebay user and getting a low rating. The latter makes zero difference to our economy, the latter is devastating to a business. This grey territory is massive public self help alternative to the legal system, and 10 times more effective. It should be encouraged and brought out of shadows into the light. Doctors should get into it as a source of medical advances at nearly no cost. The legal system should get out of its way but tax it and promote consumer powers.

5) This do it yourself culture and territory is a threat to highly over regulated and very expensive pharmacology business. I would support shutting down the FDA, repealing all its enabling statutes. Let all out competition and ratings replace its worthless rent seeking with useful and safer methodology of drug regulation.

6) With all this synthetic chemistry talent in stir, Prison Industries should get into the drug making business, to make death penalty drugs which are a joke to make for these guys, following 19th Century recipes. Then instead of manufacturing prison clothes for $10, manufacture generic and synthetic drugs for $100 or $1000 a batch. Do it responsibly, and put the profits into improving the lives of the prisoners and into compensating their victims.

Did any of the speakers convey this level of complexity, and this great potential for both harm and benefit?


Tuesday, February 21, 2017

From The Volokh Conspiracy





There should be presumption of organ donation. Instead of checking off that one wants to be a donor, one should check off that one refuses to be a donor. Presumption of donation increases donations ten fold in comparable jurisdictions around the world.

The Kelo mentions only property, not real property. It therefore applies to chattel and corpses are chattel. The government should take corpses, and crush families that refuse to cooperate.  The idea of donating organs to feeding the worms or burning them in cremation is idiocy.

Because of their self dealt immunities, violence against legislators, regulatory officials,  and appellate judges has full justification in formal logic. These are not even human beings. They should be attacked but not killed. If they are killed they will be replaced by grateful competitors.  Included on the hit list should be religious leaders or ethicists, including doctors, opposing a market place for organ donations. They believe they know the interests of the donors better than they do. They are mostly elitist and stupid.