unexpected but welcome

by russell

Leaving the flaming hulk of the Trump administration aside for a moment, I thought this piece from Reuters to be of interest.  Unexpected, but welcome.

tl;dr - big pharma is not all that interested in a massive rollback of FDA regulation.  

The primary reason seems to be that drugs that actually make it through the regulatory hoops have demonstrated value and safety, and thus can command a premium price.  But patient safety also pops up on the radar, which is... a good thing.  Nobody wants people to be harmed by pharmaceuticals released to market with insufficient vetting - glad to hear it!

In any case, worth a read IMO.

Comments

[Snarki, child of Loki]

That's "big pharma" though.

Not "predatory/parasitical pharma", frex Shkreli.

[Frank Shannon]

I have this weird sense that Trump might be right here. I hate it when that happens. If big pharma likes the bottleneck provided by the FDA and thinks it enhances their monopoly profits then deregulation might do some good.

Somebody tell me I'm wrong please.

[Ugh]

Big pharma also likes their barriers to entry, perhaps justified in this case.

I'm curious though, what happens with things like the epi-pen and Shkreli's insanity in Europe? Are they being gouged too?

[CharlesWT]

When the FDA announces that they've approved a drug that can save thousands of lives a year, they're also saying that thousands of people a year died while they took their time approving the drug.

[hairshirthedonist]

When the FDA announces that they've approved a drug that can save thousands of lives a year, they're also saying that thousands of people a year died while they took their time approving the drug.

What does it say when they decide not to approve a drug at all?

If there were a way to approve drugs after a scientifically thorough review for safety and effectiveness, but that could happen significantly faster, I'd be all for it. But an after-the-fact accounting of deaths not prevented during the approval process for life-saving drugs ultimately approved, in and of itself, means what?

Some number of people are potentially going to die during an approval process of any significant duration. How much time is too much time to make sure a drug is safe? What number of people should be allowed to die to make sure a drug doesn't kill even more people once it's put into use?

Again, a speedier but still competent review sounds great. Bring it on. But that particular argument - that people have died during approval, something you can say once you have the hindsight of approval - is both obvious and circular.

Risk management is hard.

[Countme-In]

"they're also saying that thousands of people a year died while they took their time approving the drug."

What will they be saying when they are forced to recall a drug that they didn't "take their time approving?

Whoops? Which is Libertarian pig-Latin for freedom.

http://www.raps.org/Regulatory-Focus/News/2016/03/29/24664/FDA-Review-Times-Steadily-Decreasing-Report-Finds/

As with the lower taxes go over time, the faster drugs are approved, the unhappier the full-of-shit caucus becomes.

[wj]

If big pharma likes the bottleneck provided by the FDA and thinks it enhances their monopoly profits then deregulation might do some good.

Except that what mostly provides the monopoly profits is the monopoly granted by the patent system. Which Trump isn't (that I know of) talking about changing.

I mean, does the EpiPen include some wonderful new drug? Or just a new and more convenient way to deliver an old one? A way which is patented.

[Countme-In]

Just so with numbers of illegal immigrants deported:

http://fusion.net/story/252637/obama-has-deported-more-immigrants-than-any-other-president-now-hes-running-up-the-score/

Just so with military spending:

http://www.huffingtonpost.com/nicolas-j-s-davies/the-record-us-military-bu_b_8227820.html

The more things go conservatives' way, the more like losers they feel.

You poor, dear victims.

[Nigel]

I'm really unconvinced that any radical change to the regulatory regime would make a huge difference to the cost of developing drugs. Companies are still going to need to show efficacy and safety in much the same way they do now; the idea that there is a whole host of effective treatments that could be brought to the market were it not for regulation is plain wrong.

There are some rules which are ludicrous, though:
https://www.wsj.com/articles/marathon-pharmaceuticals-to-charge-89-000-for-muscular-dystrophy-drug-1486738267

[Countme-In]

http://www.lawyersgunsmoneyblog.com/2017/02/the-question-of-the-moment

It's all relevant but this fits the thread:

"Those uncomfortable silences accompany chatter about Trump’s state of mind, which is abetted by talk from a leaky White House and even from a Trump doctor, Harold Bornstein, who may have crossed a doctor-patient confidentiality line when he told the Times that Trump has been taking the drug finasteride, to preserve his unique haircut. Writing in the Washington Post, Daniel Marchalik, a urologist at the MedStar Washington Hospital Center, discussed what he called “potentially life-changing and irreversible side effects that may be associated with these medications,” and which may include sexual, physical, and psychological changes, pretty much none of them good. It’s hard to dismiss all of this."

Without FDA-mandated warning labels on this approved drug, we might lack one explanation for the dangerous lalaland drug trump is massaging America's scalp with.

As haircuts go, trump's could be the most dangerous one, or at least the one most fraught with side effects since Dr. Joseph Ignace Guillotine lobbied France for the eponymous tonsorial buzz cut he made popular.

It would be not funny if the FDA took too long to add this warning label to finasteride: "May cause paranoia spikes in chronic users and the initiation of sudden nuclear exchanges between the world's superpowers which could incinerate areas of the world roughly the size of Texas."

My understanding is that all regulatory labeling intrusions by the federal government will be repealed by trump as well, so the first warning you will get is that flash of light on the horizon we learned about in the first grade in 1957.

I voted for the combover and all I got was this lousy mushroom cloud.

[jrudkis]

The government should just underwrite the disadvantages of drugs that are ineffective or dangerous, sort of like we do for private nuclear power. Make a profit, and if something goes wrong, the government will pay for harms. That would make some useful drugs available faster, and compensate for the harm created by failures.

[Countme-In]

"That would make some useful drugs available faster, and compensate for the harm created by failures."

So I get a choice of a placebo OR my relatives hitting the jackpot?

[jrudkis]

Count, exactly. Every harm can be compensated by dollars, so we get some better medicine faster, and the bad stuff just gets compensated. The key though is that like nuclear power, the profits go to investors, the costs go to tax payers.

[hairshirthedonist]

So we have a vote for moral hazard.

[jrudkis]

Maybe you can hope I was tongue in cheek. I do not think pharmaceuticals should be able to profit, while the government takes risk for failure, as in the nuclear industry.

[hairshirthedonist]

I suspected.

[Ugh]

Hey! Only Wall Street gets keep the profits private and force the public to bear the costs!

[Countme-In]

Given the way American business schools have brainwashed their students with the iron laws of incentives/disincentives and carrots/sticks, I suspect this conversation would be repeated throughout pharmaceutical company boardrooms should only government be on the hook for the, uh, failures:

Young Wharton graduate, now Vice President of the Brashness Division of What'sittoya Pharmaceuticals: "My proposal, Board members, is to throw any bunch of low-overhead crap in a test tube, run it through the centrifuge for appearances' sake and call it a cure. Charge an arm and a leg per dose and if the patients turn green and keel over with black bile flowing from their orifices, well, Uncle Sam will pick up the tab ...."

Corporate PR spokesperson: Yes, but how .....

The Brash One: .... "let me finish! Not only will shareholders dance the Calypso barefoot with wanton cupidity, but, wait for it, we could get rid of the entire legal department and all of that annoying small print."

CEO, raising an index finger: "So, you are saying that failure would never flow to our bottom line? Is that your pitch?"

Brash One: "Not only that, but we wouldn't have to spend money on successful products, especially if we get our lackeys in Congress to add language to the legislation also giving us 100% tax writeoffs for the failures in addition to footing the bill for our unfortunate dead customers, AND invoking a gag rule on all government and fourth estate elitist tattletales via libel law rule changes, and thus increasing shareholder payouts and .. AND ... corporate officers' options accounts.

CEO: But wait a second, what happens if we run out of customers through no fault ... ha ha, no fault, did you get that ... of our own?

Brash one (fending off the question with one raised outfacing palm) "Very droll, sir, I must say. But my research tells me that the 2020 Census has totaled up all the data on the U.S. population and its consumer base and concludes as the only bullet point on its executive summary that a sucker has been born every minute since the last Census a full decade ago. People, we are selling to an inexhaustible resource!"

CEO" "By Jove, young man, where have they been hiding you? Never has failure been made to sound so successful! Draw up your proposal in writing, one page maximum, in blue crayon please, and join me in the penthouse for lunch so we can toast this breakthrough in pharmaceutical research. You know when I was your age, we could only dream of a new day in America when everyone and everything could be so full of shit!"

;)

[bobbyp]

When the FDA announces that they've approved a drug that can save thousands of lives a year, they're also saying that thousands of people a year died while they took their time approving the drug.

Thalidomide.

I rest my case.

[bobbyp]

It would be not funny if the FDA took too long to add this warning label to finasteride: "May cause paranoia spikes in chronic users and the initiation of sudden nuclear exchanges between the world's superpowers which could incinerate areas of the world roughly the size of Texas."

My doctor prescribed it for swollen prostate, and I take a dose daily. I guess it shows.

[bobbyp]

Obviously the drug companies should be broken up into an infinite number of small (40 acres or less)firms, none with any market power---since they have to be price takers, not makers, to have a free competitive market that will allocate our scarce resources to achieve the greatest amount of social welfare consistent with true Liberty.

Thus spake a real glibertarian.

/sarcasm.

As usual, Dean Baker to the rescue.

[CaseyL]

I'm not inclined to make it easier to bring new drugs to market, because I don't know how they can speed up the process without eliminating crucial phases in development. Even if animal testing could be replaced with computer simulations, you still need the human studies and that still takes a long time.

And now there's growing evidence the "next gen" of drugs will be genetically tailored to individual patients. Messing around with genetics has all kinds of new ways to go pear-shaped, since we have only the most elementary understanding of how genes interact with one another, what makes them switch on and off. Genetically tailored therapies are exciting, fascinating, potentially game changing... but, like the early generations of new tech, full of bugs you don't know about.

IOW, it seems to me the proposal to speed up FDA approval is coming at a very bad time.

[Snarki, child of Loki]

" it seems to me the proposal to speed up FDA approval is coming at a very bad time."

Or a very good time.

Skip all that exhaustive testing stuff. Just load The Donald up with a few LD50's of the proposed pharmaceutical, and if survives for a month, ship it to market.

WIN-WIN, I tell you!

[CharlesWT]

Thalidomide.

I rest my case.

My case: Beta-blockers.

[...]
Deaths owing to drug lag have been numbered in the hundreds of thousands. Wardell estimated that practolol, a drug in the beta-blocking family, could save ten thousand lives a year if allowed in the United States. Although the FDA allowed a first beta-blocker, propranolol, in 1968, three years after that drug had been available in Europe, it waited until 1978 to allow the use of propranolol for the treatment of hypertension and angina pectoris, its most important indications. Despite clinical evidence as early as 1974, only in 1981 did the FDA allow a second beta-blocker, timolol, for prevention of a second heart attack. The agency’s withholding of beta-blockers was alone responsible for probably tens of thousands of deaths.
[...]
Theory, Evidence and Examples of FDA Harm

A risk adverse FDA would rather block or slow-walk a drug that could save thousands of, largely invisible, lives than to approve a drug that could have a very visible adverse side-effect like birth defects.

People, being informed of the risks, should be allowed to use drugs that don't have FDA approval.

Also, the FDA should fast-track drugs that have been approved in other countries that have reliable drug approval regimes.

[Frank Shannon]

I'm late responding to wj but my understanding is that there is a generic version of the epi-pen and it isn't covered by patent. But any device manufactured has to be approved by the FDA. I could be wrong.

[Ugh]

A risk adverse FDA would rather block or slow-walk a drug that could save thousands of, largely invisible, lives than to approve a drug that could have a very visible adverse side-effect like birth defects.

This is likely correct as a general matter, along the lines of "no one ever got fired for hiring IBM." OTOH, hard to account for desperate people being victimized by unscrupulous drug salesman, warned or not.

But as with many things, it involves tradeoffs and difficult choices about where to strike the balance.

[dr ngo]

FWIW, the excellent British TV series "Call the Midwife" (shown on PBS here) had some episodes situated in the 1950s-60s which involved the prescription in good faith of thalidomide and the devastating results - a salient reminder (at least to me, who had forgotten most of it) of how tragic an insufficiently tested drug can be.