Bring Back the FDA’s Parallel Track

In 1992, the AIDS/HIV “parallel track” was approved as a regulatory change for FDA to allow patients exclusive access to AIDS/HIV drugs that had passed safety tests but had not yet passed all efficacy tests. Other drugs did not have access to this approval option. As a result of parallel track, the highly effective anti-viral drug stavudine was approved, saving thousands of lives.

…In the years that followed, FDA and Congress created several paths to speed approval and open access to promising medications, including accelerated approval, priority review, fast track, breakthrough therapy, right to try, and expanded access, or “compassionate use.” Unfortunately, these approaches are often confusing, and it is difficult for drug developers to determine which approach to pursue. None of these reforms have matched the openness and simplicity of the parallel track…

Ed Hudgins in How Extending the AIDS Drug Access Model to Other Diseases Would Save Lives.

Comments

Well, when you have a disease with a 100% fatality rate, what one could call paying for efficacy test results makes sense - particularly if the process is handled in such a way to ensure that profiteering is not the main goal of the people selling the latest version of laetrile - oops, amygdalin.

Profiteering is good because capitalism is better than socialism. We have iPhones and Android and many other products because people were trying to profit.

Why did "they" discriminate in favour of AIDS/HIV patients i.e. against some comparably doomed sufferers of other diseases?

'against some comparably doomed sufferers of other diseases'

Mainly desperation, particularly on the part of those with AIDS. AIDS was a nightmare spreadable disease in the U.S., showing the limits of medicine in a way that cancer, strokes, or heart disease didn't.

And although Prof. Tabarrok is perhaps too polite to point it out, that there was a group of people willing to use others and a group willing to be test subjects played a role too - the fear of AIDS spreading was profound throughout the 80s, and there is no question that many people scared of AIDS had no problem in allowing those infected with AIDS to be test subjects.

However, that laetrile example is intentional - cancer is a disease where large amounts of money can be earned from those desperate for a cure, and even after decades showing laetrile has no efficacy, there are still desperate people willing to use it.

There is no descrimination if there is no drug that _might_ treat the disease.

A treatment, even cure, for Sickle Cell using HIV seems to exist, but its not a drug.

Not clear the FDA can approve anything. The method is more like the State regulated compounding labs which in a few "mass market" cases caused death and disability in hundreds of patients by introducing fungus into treatment infusions.

Ie, a lab takes the patient blood/DNA and HIV and does Crisper to create infusion for after patient bone marrow is destroyed by chemo.

"matched the openness and simplicity of the …"

-

Free & voluntary markets are the gold standard of of openness, simplicity, and efficiency.

Federal FDA commissars are the opposite.
Abolish the FDA (it' s flagrantly non-constitutional anyway)

It's frequency unconstitutional because they mainly regulate speech such as the inserts in drug packages.

Whenever there has been a disease with the mortality , and the speed of that mortality (or severe morbidity) the FDA has sped things up. Look at Ebola. The FDA already has a program that works very well for people with end stage diseases who want to try experimental diseases. (The author in the cited piece is making up claims about difficulties and elides over the difficulties with right to try when you have to deal directly with the drug company, which is probably worse.)

While I read Alex and Tyler and appreciate what they do, this is total BS on their part and I find it disgusting what they are doing here. Note that they never, and I do mean never, look at what happens if drugs are released too early. We get a never-ending series of stories from them about only the goos things that would happen if drugs were released early, and never an assessment of the harms, just like you see in this cited article.

If one actually cared about this topic, and the people affected, I can see taking the approach that we will release earlier, but we will increase post-release surveillance. You can make a general argument that this would work better for many drugs, especially those in a broad class that has already been released.

Overall, it is very telling that they chose to compare this to AIDS, which as noted above had a 100% mortality rate. You arent really going to worry about the safety of the drug that will kill you in 5 years if the disease is going to kill you in one year.

Steve

"Note that they never, and I do mean never, look at what happens if drugs are released too early."

Well do tell. Given that the FDA kept Beta blockers out of America while they were working fine over in Europe I'm inclined to think the body pile on the 'drugs too late' side of the ledger is far bigger than the pile on the other side.

Impossible!

Only the USA has for profit drug companies that invent every cure. Europe never invented beta blockers before the US drug companies invented and sold them at high profits.

;)

Diagnosed with essential hypertension in the 70s by a European trained immigrant doctor, I'm familiar with all the drugs, and the problem is US pharma not the FDA, and all the efforts to remove the FDA "obstacles" has only given pharma the power to get Congress to grant bigger rent seeking power to US pharma.

Prices on hypertensive drugs have been going up as every patent expires for drugs approved in the 90s because FDA certified factories have been bought and closed. The supposed obstacle is that it costs $25 million for FDA approval of a new billion dollar "clean room" "robot" factory using semiconductor factory design. FDA approval is no costlier than ISO 9000 certification required for any product that goes into a government procurement. ISO specifies documentation of processes and quality control of any production system.

The solution is simple: pay workers.

But conservatives say requiring workers be paid kills jobs. Repeal the 13th amendment so drugs come to market faster by enslaving white professionals with science technology and law degrees so it costs nothing to fill out paperwork which opens factories and creates so much excess supply, every drug company goes bankrupt because they earn just a billion dollars more profit than Amazon and Tesla, a $100 billion cut in profits.

+1

In the case of early antiretrovirals, it was clear that the benefit warranted expedited access.

In the case of me-too antihypertensive #7848, this is not the case, so why should the standard be relaxed?

Most recent cancer drug approvals didn't even have to demonstrate efficacy! See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5695531/

I served on the Public Health Service Work Group that came up with the Parallel Track approach for experimental HIV medicines. This was the result of careful deliberation over some months so that we could assure expanded access during the clinical trial process, yet not compromise the trials themselves. The activists arguing for expanded access realized that the only way to get reliable efficacy and safety data was through well controlled clinical trials.

The Free to Choose movement ignore the fact that there are already a number of mechanisms to expand the use of experimental drugs. They also ignore the fact that the chief road block is the limited amount of clinical trial material from the pharmaceutical company. Hudgins paper cited by Alex is just a rehash of arguments that I heard back when then Senator Brownback of Kansas was the chief proponent of this approach (I think it was 2008 and I met with his staff at the time to give the industry perspective on this point. ).

Alex might better focus his energies on the Anti-Vaccine movement who pose a real threat to public health.

"Free to chose" drug laws are pharma free lunch policies and lobbying opportuunities to prevent destruction of their rent seeking profits on generic drug sales.

Ie, you are free to pay a million dollars for a drug that might work, but only if the drug company is sure annyone able to pay a million dollars for a drug can't afford a hundred thousand to sue for fraud, etc, after the patient dies. If the drug company has excess test batches of drugs they can give it away with zero commercial liability, but no way will they take money to manufacture a drug until FDA approval eliminates a product fitness test for a commercial transaction.

If you propose allowing the sale of medication before efficacy is proven in a controlled trial, an important question to ask is, "what are the odds that some unproven medicine ends up working in this disease?" For anti-infectives, where clinical success rate is somewhere around 20%, this is a reasonable approach, particularly for life-threatening illnesses. For anti-cancer agents (where around 5% of new medicines show efficacy) or alzheimer's disease medicines (current efficacy rate of very close to zero), it's probably best to wait for proof of effectiveness, rather than dumping a massive pile of placebos onto consumers, particularly if proposed changes to the regulatory scheme end up slowing down the data collection necessary to prove efficacy of a given drug.

The other significant issue is how safety and even potential efficacy data will be collected and reported if we permit widespread use of experimental medicines. Most community physicians don't understand this and would they even be interested in following up with their patients if an adverse drug event occurred.

Great comment. Based on this and others, Alex's posts is not looking so great. I think the problem Alex has is that he shares TC's interest in pontificating on things he's under-qualified and under-educated to comment on (but hey, economists know everything, right?) but lacks TC's subtlety to avoid saying obviously silly things (what else are Straussian readings for?)

although some services offer genetic testing it is difficult to see what benefit this would give an individual. Even if someone has a genetic resistance to most HIV infections, they can still be infected by other strains. i-Base doesn’t provide links to commercial sites unless there is a therapeutic need for HIV positive people.

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