WASHINGTON — President-elect Donald Trump is weighing naming as Food and Drug Administration commissioner a staunch libertarian who has called for eliminating the agency’s mandate to determine whether new medicines are effective before approving them for sale.
“Let people start using them, at their own risk,” the candidate, Jim O’Neill, said in a 2014 speech to a biotech group.
O’Neill has also called for paying organ donors and setting up libertarian societies at sea — and has said he was surprised to discover that FDA regulators actually enjoy science and like working to fight disease.
Whoever is chosen to lead the FDA Americans can only pray that new leadership will be open minded as to ecigarettes. We hope that new leadership will at least recognize research and allow smokers who need to have options in order to quit to have access to this new technology. Thousands of small businesses have had to close as a result of the FDA’s journalistic embargo meant to demonize ecig. They have been successful and most Americans believe them to be more dangerous than inhaling burning tobacco. Common sense certainly would deny that idea. Research also. The American people deserve better sense than this!
You idiots. This would be a great pick. This is what people on the left should want. But you are too blinded by Trump hate to see it.
This guy is a pro marijuana activist. It substantially raises the chances of getting a federal weed bill started.
And the FDA needs a dramatic shrinking. It seems maybe most of you have never had a health issue? This is the same FDA that wanted to ban vitamin C at one point. Trust me they are not out for your best interests. Why do you think they allow spinal stims on the market? Or pain shots? All things that not only dont work but can in many cases make the person worse off. They allow these becauses its a cash cow and they have their hands in it.
I nearly choked on my sandwich as I read the opening sentence. I have worked in this regulated industry for 45 years and I have heard every complaint out there about the FDA. Frankly, l seriously doubt that any respectable physician would prescribe a drug without an FDA approval for safety and efficacy.
Removing the efficacy requirement would generate a need for an independent body to perform the same work that the FDA now does. Physicians do not have the time to review thousands of pages of efficacy data for each new drug that might have some applicability to their practice. This is what the FDA provides – a way for physicians to be confident that the new drug they prescribe actually has passed some form of independent review to verify the proposed claims. Now, let’s see…how much might this approach cost compared to what industry pays under PDUFA today?
The biggest problems at the FDA are with the Center for Devices, which keeps getting ignored by every Administration and Congress since first proposed by JFK and passed 14 years later. It is the stepchild of the FDA.
I suggest O’Neil require all originally grandfathered and substantially similar medical and dental devices prove safety before they can continue to be sold. Patient labels, right of written informed consent, and entry into one’s EMR (not just dental record for those devices) must be required – along with mandatory pre-screening to determine if device materials are “right for you” before anything is installed on a non-emergency basis.
Physicians and dentists should be mandatory reporters of device illness and injury, as proposed in the Medical Device Guardians Bill. The PreMarket Approval protection from liability should be removed, as proposed in Ariel Grace’s Bill. The Adverse Event Report Form 3500 must clearly state that it covers dental as well as medical devices, and give examples such as dental amalgam and other fillings. Device illness patients harmed by Essure, Mesh, implants, amalgam, and more are uniting and identifying gaps and solutions.
O’Neill should also release the FDA 2012 draft Patient Safety Communication on Dental Amalgam, and return the 2006 and 2010 Transcripts of Public Hearings on Dental Amalgam to FDA’s website from the archives. Both expert Dental Products Panels raised significant safety concerns about amalgam’s impact on vulnerable subpopulations, and the public should be able to read it.
Maybe we can get a new Thalidomide on the market!
Seriously, I’d rather the FDA erred on the side of caution. Even now they allow the drug manufacturers to do the testing and report the results, a practice that has allowed some questionable drugs to be released…….because the profit motive outweighs safety concerns.
Erring on the side if caution is lethal. It reduces drug innovation, blocking access to life-saving drugs. It has drastically reduced competition, creating Big Pharma. The government has no legitimate authority to prevent Americans from gaining access to the drugs they want and need. Pop over the border to Mexico to see how desperate Americans are for drugs. There are rows of drug stores, thanks to FDA and DEA, and mostly to congress.
Nicolas Martin, you make some good points, but you need to study the device side of FDA. Safety and biocompatibility with the individual patient’s own allergies and immune system is essential. Otherwise an inflammatory cascade begins that fuels all kinds of chronic disease. One cannot simply “stop” taking a device when it harms you as you can a pill. It requires costly surgery, often removal of the device itself, removal of organs, removal of fillings and teeth. The FDA’s PreMarket Approval system gives a liability exemption to the manufacturer. Health insurance has rising co-pays and deductibles and often requires lengthy appeals and stepwise treatment before approval. Dental insurance is a pathetic product with high co-pays, low annual gaps, ridiculous rules, and no medical necessity as it is only subject to contracts law.
FDA approval basically gives a license to harm with devices without consequence. Patients have no recourse. They are ill from a device that was not “right for them.” Doctors and dentists are not responsible because it was FDA approved. Insurers deny appeals to cover replacement with safer materials because it is FDA approved. Manufacturers are not responsible because it ws FDA approved. Patients are responsible. They have to fix themselves.
Safety and Effectiveness…what about informed choice. Drug manufacturers and sellers should be required to describe all safety and effectiveness aspects , and all ingredients, of the product honestly, accurately and completely. There should be 2 descriptions, one in techie and one in 6th grade English.
Then the patient (and family of the patient) should make the decision with their chosen doctors and experts giving advice. Nobody should be forced to take a drug. Nobody should be forced to not take a drug. (OK, children of stupid parents is a separate issue under any and all situations.)
Drug disclosure info, simple and complex, is available at many web sites.
Wow the suggestion of approving drugs based on safety alone shows an astounding misunderstanding of the purpose and use of drugs. Safety is relative and must be balanced against the expected benefits of a drug. We don’t expect for example chemotherapy drugs, which can cause cancer themselves, to be as safe as a decongestant or a drug to treat a fever in kids. This would set us back to the pre-60s . . . before the Kefauver Harris amendment. So not only is a little science ed in order, but also some history.
You offered nothing to discredit safety as an approval criterion. You mention nothing about lives lost due to FDA approval delays. Do you think effectiveness is not even more subjective than safety?
Nicolas – Of course safety is a requirement. Susan does not say it should not be a criteria, just that it should not be the only criteria.
And both safety and efficacy are tested in the current system. There clinical trials are done with a known scientific method that determines how safe and effective a drug is. It is not subjective.
Yes, lives can we lost when a drug is undergoing clinical trials. And that is unfortunate. But, on the flip side, lives can be lost by putting out a drug that is not effective – see my example below.
Safety alone is not enough for drug approval. Otherwise we will be swamped with drugs that do not work.
Yea and I bet you recommend benzos and pain shots you scum bad. So many FDA approved nonsense things out there that you peddle that do far more harm then good for people. The FDA is not looking out for safety they are looking out for the pockets of those in charge. So scum bag doctors like you can get your kick backs from benzos and heartburn meds.
Nicholas Martin, we already have provisions that fast-track drug approval for illnesses like cancer and AIDS, and provisions that allow drug companies to pay for expedited approval. Why then do we need to eliminate the requirement for effectiveness across the board for things like nasal spray?
STAT has picked up the “libertarian” identification from left-wing critics, as has been applied to Thiel. But I know of no actual libertarians who embrace these men, and many libertarians loathe Thiel. Jim O’Neill may have some libertarian beliefs, but so does Jill Stein, for that matter. The left is using “libertarian” to denigrate where would formerly used “conservative,” as a term on derision.
Sheila Kaplan has impeccable leftist cred, having even worked with Bill Moyer’s. That’s fine, but don’t pretend STAT provides a politically neutral view.
A bio for Ms. Kaplan:
http://ethics.harvard.edu/people/sheila-kaplan
https://www.cato-unbound.org/2009/04/13/peter-thiel/education-libertarian
Mr. O’Neill calls himself a libertarian. We did not pick that up from a third-party. Thank you for reading!
Medical innovators say FDA regulations are the #1 thing holding them back. I’m not a big Trump fan, but Jim’s position that safety should be sufficient for approval seems pretty reasonable to me.
Consider the following : I “develop” a drug which is nothing more than a sugar and salt combination. I do my safety testing and the FDA approves it. I price is at $30,000 a year compared to the standard treatment which is $100,000 a year. The insurance company decides that patients must go on the new “drug” for at least a month because it is cheaper. In that month the pill does nothing and your condition worsens to the point that the standard treatment will no longer work. You die.
Approving drugs for use without any indication of efficacy is a very bad idea.
This approach authorizes and legitimizes snake oil salesmen. Slaves to the profit motive are going to derive great harm.
Tom a free market would kill your ridiculous drug before it had a chance. Have any of you ever even read about the FDA and all the unreal stuff they have pulled? My god. They are not there to benefit you. They are there to limit you from access to all options. In many cases cheaper options. Ask AIDs patients.
Chad, yes, free market will kill it but it will not before the “sugar and salt” drug has made millions. When it is know that it is not effective, I can make a new drug with honey and salt and make millions again.
The biggest impediment to innovation in healthcare by far is the fact that the people who use the products (patients) are not the same people who pay for them.
Video of Jim O’Neill’s 2014 SENS Rejuvenation Biotechnology conference speech:
https://www.youtube.com/watch?v=9Y7oazjaSyE