Madden on the FDA

Here is the excellent Bartley Madden interviewed on the FDA and Free To Choose Medicine. See also Bart’s rejoinder to a critique of Free To Choose Medicine in Japan published in Science.


Evidently the FDA does an important job and reforming it is a bit of a conundrum, maybe even a Gordian Knot in more ways than one. However, in a time of renewed international tensions, reforms are inevitable and more to be welcome than to be avoide d. Beijing's fascist ruling clique has been unmasked. Its policies of aggression against its peaceful neighbours and territorial aggrandizemnt have been laid bare to be seen in plain sight by all. Its totalitarian leaders have been brought before the world's public opinion court and stronlgy convicted. Their orwellian totali- tarian regime is now known as what it is, a criminal enterprise. The peace-loving nations of the world have learned the hard and bitter lessons or Munich and will never allow those fascist jackals to prevail over their innocent, guileless, righteous neighbours.

Funny you have mentioned that. I have read recently about Chinese aggression against its peaceful neighbours!

Fortunately, China's righteous neighours have stood tall against Beijing's ruling cabal's aggression.

America, I think, has a moral duty to supply Vietnam, Myanmar, India, the Philippines, etc. uncondutional guarantees. Doing otherwise would repeating Munich's tragic farce.

That is a good point. Allowing Beijing's totalitarian regime to continue unabated its imperialist search for territorial aggrandizement would be criminal.

Thiago responding to thiago responding to Thiago responding to thiago.
4 Thaigos for the price of one!
MR is truly blessed.

Oh, no, I am Mr. Dillon, an independent voter.

And I'm the Sheikh of Araby!

I really do not know what you mean. I just think we can't look away while Beijing's ruling clique tries to enslave free nations. What do you suggest? Munich?!

James, when someone trolls you do not respond. You ignore them and they will look elsewhere for someone to play their silly game.

Great post. Thanks. Question for Alex -- tangentially related: why don't you get back into the (so to speak) "organ business," trying to resurrect something like LifeSharers?

Bartley J. Madden retired as a managing director of Credit Suisse Holt after a career in money management and invest­ment research that included the founding of Callard Madden & Associates. His early research was instrumental in the development of the cash-flow return on investment (CFROI) valuation framework that is used today by money management firms worldwide. He is now an independent researcher and his new book, Value Creation Principles, will be published by Wiley in May 2020.

Lots of people have excellent credentials; that does not mean they should be taken seriously on everything they write or do.

Defund the FDA?

Clearly the battle is between Defend vs Defund.

Abolish the FDA !

Madden's dismal solution is merely to tweak FDA policies in hopes of it granting slightly more drug consumer choice to critically ill citizens ... and perhaps streamling the government drug approval process.
He apparently favors a globalist approach to drug. regulation.

Maddden is a financial analyst and seems clueless about the basic issues of American government and law.
The origin and supposed legal authority of the FDA escape his understanding and interest.

Is there a problem with approaching a worldwide pandemic with a "free to choose" attitude?

"'We need to live with it': White House readies new message for the nation on coronavirus"

Like savages.


Off topic link and pointless “Boo outgroup” insults. Everyone knows how you feel about your political and tribal outgroups.

You idiot.

This is what you defend, because you think any criticism of it creates an "outgroup."

Beyond idiot at this point. Impossibly stupid.

But not deranged like you!

“They called me mad. They called me insane. They called me looney. They were right!”

Here's the challenge:

NBC is reporting that the government is going to go with "We need to live with it" as their best strategy for COVID-19.

If you think that's a great idea, lay out the logic, for why that is our best possible plan.

But don't play the game.

Don't say "well actually it's a bad plan, but we can't criticize it because that's partisan, and what with low public trust, and public choice, we can't expect anything better anyway."

This is a democracy, gosh darn it, and citizens should demand the best possible plans in all circumstance.

That just, ever so coincidentally, shifts the burdens and costs of determining the safety and efficacy of treatments onto those desperate enough to pay. To the benefit of us all, apparently.

I must confess that when I saw the thumbnail of this in my inbox, "Madden on the" I thought it was a Tyler post on John Madden's opinion about something football related.

I've always wondered what event lead to the persistent drooping of John Madden's left shoulder.

Unlkely that TC will talk about local football news, what with all that Fedex corporate canceling going on.

Why would any company be willing to have patients used an investigational drug when the company will get no data from the use. One of the policies that slowed the response to AIDS was letting so many AIDS victims use IND off protocol. It slowed the development process.

So build data generation into the modified protocol.

It is built in when the person agrees to be a party of the study. The refusal to be part of the study just means that the drug compnay cannot collect the data.

That is patently FALSE! I served on the Public Health Service Task Force that came up with the guidelines that allowed parallel track use. Use outside the trial could be stopped if it could be demonstrated that trials were slowed down. Even the AIDS activists on the Task Force were aware of this and supported the trials effort as it was the only way to cull out the drugs that were not working.

But creaing all of the AIDS exceptions created an expectation that people could get experimental drugs off-protocol. Now many drug studies are designed with "no off-protocol use" built in. That is what the finance types are bad about.

Look, I spent my working career doing reg affairs in the biopharma industry. What you are saying about the expectation is incorrect as well. Companies are not going to ramp up manufacturing for an investigational drug that they can only give away for those who want to try it. Companies can always use the 'Treatment IND' regulations to expand use should they so choose (you can count on one hand the number of times this provision has been used). Companies also incur a liability if they provide investigational drugs whose safety profile is not fully known. It's been almost 30 years, but I believe the AIDS experimental use program required informed consent.

The bottom line is companies produce enough drug for clinical trials and unless there is a real compelling public health need not much more. Even Gilead, who made remdesivir available for treating COVID-19, didn't have much for non-protocol use.

I have seen the no off protocol use more than five times in just one of the IRB's that I am on. Companies hate off protocol use of an IND because they will have to do MEDwatch reports for adverse effects but get no usable data from them.

I'm persuaded the problem with the FDA is that it it overweight risk in its cost benefit analysis of new drugs. Benefits to the consumer as represented by their choice is implicit in cost benefit analysis, but given information problems that consumers or even doctors have in evaluating costs and benefits, some centralizing of this analysis makes sense that "Free to Choose" does not capture.

I would take all these arguments semi-seriously if they addressed the pricing issue. Do the advocates of 'Free to Choose' support minimal pricing until the drug is somehow shown to be efficacious? One thing that insurers use FDA approval for is to pay for treatment. How do you think they would make this decision in the absence of approval? Would you pay $3K out of pocket per month for a treatment you did not know worked?

Or we could all move to Africa or India...

We all ready are doing this. It's called the placebo effect and I hear it on the radio every day.

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