The Threat To Science From The Judiciary
By
Leonard Zwelling
Despite what you may have heard from libertarians, there are people who know more about some things than you do. Some of those people work for the federal government and we should be glad that they do. Many smart people work at the Pentagon. Many more work at the CIA and FBI. And, despite my long-held concern about the manner in which it makes decisions (e.g., ignoring advisory panel’s advice) the FDA has a lot of smart people who work there, too. I actually know some of them well.
Don’t misunderstand me. I think the FDA’s accelerated approvals of the anti-Alzheimer’s drugs were probably too precipitous. And, on the other hand, there have been many instances when I thought the agency moved too slowly or not at all as they did in not approving the BW’s liposomal-encapsulated MTP to treat the lung metastases from osteosarcoma. The definitive trial was good enough for the European Medicines Agency and approval processes all around the world from Israel, to Taiwan, to Kazakhstan, but not for the approving agency in the USA. Thus, I am not a fan of the FDA for a lot of reasons, but they do try and they did protect some MD Anderson patients back in 1995 using a Warning Letter against a faculty member who was misusing a drug he had developed.
That being said, the latest chapter in the on-going saga of who is in the best position to protect Americans from faulty drugs and speed the approval of life-saving ones, seems to suggest that it is Texas judge, Matthew Kacsmaryk of the Northern District of Texas who is best positioned to determine what is safe and effective. He ruled that the federal government has seven days to file motions that would stop his order to overturn the FDA’s authority to approve mifepristone, one of the ingredients in the oral abortion regimen.
I understand that this case makes conservatives salivate because in one fell swoop it is both anti-abortion and anti-federal regulatory bodies, but goodness, this is just stupid. This drug has been used by over 5 million women with under 30 deaths reported. That one judge can outlaw one drug means any judge can outlaw any drug on a whim. The entire scientific community backs mifepristone’s continued use and even big pharma is against the judge’s ruling. What’s the next therapy a judge will deem harmful?
Society is organized in such a fashion that we are all dependent on others for knowledge that we ourselves may not possess. We need the police to solve crimes and district attorneys to convict the criminals. We need firefighters to protect property and all sorts of public servants from traffic cops to the military to keep society going. The ideas of one man should not be able to undo the proper consideration of the utility and safety of a medicine. This is just nuts.
What’s worse is that another judge in Washington state has ruled in the other direction. That means that the question will undoubtedly be brought before the Supreme Court and we know that those guys and gals consider themselves above the law and I don’t mean just the conservative justices either. That any of the justices would tolerate the nonsense of Justice Thomas claiming to be an RV guy and then flying off to Indonesia on a private plane is shameful. They are clearly unable to police themselves. Congress must step in and impose guidelines on the Court.
Finally, as a footnote. I know some of you out there really like Justice Thomas and his rulings. I don’t, but no matter. It should have been obvious at his initial hearings that he is an undisciplined person when it comes to his own behavior and he married a nut who thought it was just swell to overthrow the government on January 6. Of course, who you marry is not a punishable offense by the courts–sort of.
The Court is out of control and not doing what is best for most Americans. The Dobbs decision may well rid many rural places of the few obstetricians left there because they fear the consequences of providing good pre-natal and associated care to women whose lives are at risk during pregnancy in red states.
Like so much in our society today, the leaders of the judiciary are lackluster ordinary people who cannot get over their own prejudices.
We must trust the fiduciaries we put in place to protect us. The FDA is one of those agencies and on the whole tries its best to do the right thing. No federal judge should be able to override the expertise of scientists.
The judge in Texas is as out of control as conservatives think the FDA is. This is no way to solve the on-going matter of abortion rights. That is in the hands of the various states and it is their legislatures that need to rule in this regard. At least the legislature has been elected and presumably represents the will of the people although on this question, oral abortion drugs, I think most Americans think that these drugs should remain easily available. Most Americans are smarter than some judges.
Dr. Zwelling’s new novel, Conflict of Interest: Money Drives Medicine and People Die is available at:
barnesandnoble.com,
on amazon if you search using the title and subtitle, and
directly from the publisher Dorrance at: https://bookstore.dorrancepublishing.com/conflict-of-interest-money-drives-medicine-and-people-die-pb/
2 thoughts on “The Threat To Science From The Judiciary”
You so eloquently describe how our judicial system is overstepping its trust and wisdom when it comes to drugs that the FDA has approved and help so many women. What’s next? Can you imagine if they took Viagra or Cialis off the market? There would be a lot of old Republican congressmen and senators in an uproar. Trump would likely have another conniption!
And, Judge Thomas needs to either resign or be impeached for his taking of “bribes.” His wife is another mess, but that is his problem and not ours.
She’s our problem too but it’s a different subject. As a couple, they take the cake!