Results for “fda” 402 found
Cousin Alex says the FDA is paternalistic. Yah, it is paternalistic. Paternalism is good.
You know what would happen without vater FDA? Herr Trudeau sells 1.5 million copies of Natural Cures "They" Don’t Want You to Know About, that’s what happens. When left to their own thinking die volk swarms to an ex-con who has been banned from the airwaves by the FTC for marketing "Japanese" marine coral with claims that it can cure cancer, heart disease, high blood pressure, lupus, and other illness. If it were up to me this guy would be jailed. But the FTC can’t stop him from selling his book. Silly first amendment. Don’t you Americans know the truth is more important than free speech?
Libertarians say how can you trust people to make decisions about toothpaste but not about their own health? Zat is an easy one. No one buys toothpaste out of fear. But sick people don’t think rationally they are emotional they hold out hope, even the kind of hope that "they" don’t want them to know about. Father FDA must protect them.
I will be speaking this Wednesday (March 29) at 6 pm in the back ballroom of Student Union II at GMU on the subject, Is the FDA Safe and Effective?
Pizza and refreshments as well as intellectual wonderment will be served.
Writing in the WSJ (Oct. 3), whose editors ought to know better, Cynthia Crossen says:
Only 70 years ago, American companies could legally sell poison in a
Obviously, no drug maker would knowingly kill its customers — the
free market would punish that kind of bad business. But a company
that inadvertently sold a drug resulting in multiple deaths faced no
In 1937, however, the consequences of Americans’ unfettered right to
buy and sell medicine became disastrously clear. An antibacterial
syrup called Elixir Sulfanilamide killed at least 75 people, some of
them young children who had been suffering from nothing more serious
than a sore throat.
What a load of rot. Here is a letter I sent to the WSJ:
Crossen get the bizarre idea that poisoining was not illegal 70 years ago? It’s true that there was no federal law
against drug fraud but there was no federal law against rape either –
this did not mean that only 70 years ago rape was legal. In fact,
Massengil, the company that sold Elixir Sulfanilamide, was successfully
sued and punished under the common law of tort.
Dramatic, easy to see, tragedies like those caused by Elixir
Sulfanilamide and Thalidomide encouraged the naive to demand an
expansion of the FDA’s powers. The less easily seen tragedy has been drug delay, fewer new drugs, and higher prices. Careful observers
– see FDAReview.org for some evidence – estimate that the costs of the latter tragedy
far exceed the former. The FDA has put the nail in the coffin of more
than just the "pain and beauty boys."
If aspirin were invented today it might not be approved by the FDA. Keep this in mind when thinking about Vioxx, Bextra and other pain-relief drugs that have recently been taken off the market. This is not to say that the new pharmaceuticals are "safe," but rather that all pharmaceuticals involve tradeoffs.
Bottom line: The public thinks the FDA is great. Regular economists think it’s pretty good. And economists who specialize in the FDA think it’s pretty bad.
That is Bryan Caplan, read more here.
Addendum: I’ll grant that those who specialize in studying a particular agency may tend to be the critics. That being said, the "man in the street" simply has not, in most cases, considered the economic criticisms of the FDA.
At this point, we all face a dilemma. For instance Paul Krugman cites the predominance of academic Democrats as an argument against the Republican party. Must he then accept this evidence on the FDA? Must Caplan become a Democrat? When is citing professional consensus opinion most persuasive? What is the professional consensus on this question?
This week’s Forbes (the Nov. 1 issue) has a feature story on Alex’s work to make drug regulation more sensible.
Alex notes that off-label drug uses are largely unregulated. No proof of efficacy is required, and off-label drug prescriptions bring a net health gain; see this paper. Yet to get a new drug approved it must go through, in addition to Phase I trials,
…Phase II and Phase III trials, which typically take years and focus on efficacy as well as safety. The long wait can cost lives and runs up new-drug costs–to an estimated $900 million per successful drug.
Tabarrok says this system makes little sense; the FDA demands costly, time-consuming efficacy tests for some uses and no tests for others. And while the FDA allows off-label prescribing by docs, it strictly limits the drugmakers’ promotion of such uses to doctors and permits none at all to patients.
Alex argues that FDA regulation ought to be reduced, making the regulation of new and old drugs more consistent. But that is not all:
Tabarrok and [Dan] Klein also offer some alternative proposals at FDAReview.org. One is to make all FDA testing optional. Drugs that didn’t go through the process would be labeled “Not FDA Approved.” Under this approach, they say, “the FDA would become a genuinely voluntary institution, much like Underwriters Laboratories.” Another idea is for the FDA to award letter grades, A to D, to claims made by drugmakers, much as it is considering doing for health claims for foods and dietary supplements. The FDA could still have its say, but wouldn’t be able to impose long delays, since a new drug could be marketed at first as “unrated.”
At the least, Tabarrok argues, the FDA should permit drug companies to sell any drug that has been approved by other sophisticated drug regulators, such as those in Canada, Australia or the European Union. Under such a system U.S. patients would get speedier access to new medicines without losing out on safety protection.
Kudos to Alex, the only sorrow is that the on-line version does not reproduce the excellent photo of him in the magazine. But you can see that at your local Borders.
In the latest Milken Institute Review, Nobel laureaute Gary Becker argues (sign up required) that the FDA should permit drugs to be sold once they have passed a safety standard, i.e. a return to the pre-1962 system. He writes:
…a return to a safety standard alone would lower costs and raise the number of therapeutic compounds available. In particular, this would include more drugs from small biotech firms that do not have the deep pockets to invest in extended efficacy trials. And the resulting increase in competition would mean lower prices – without the bureaucratic burden of price controls…
Elimination of the efficacy requirement would give patients, rather than the FDA, the ultimate responsibility of deciding which drugs to try…To be sure, some sick individuals would try ineffective treatments that would otherwise have been prevented from reaching market under present FDA regulations. But the quantity of reliable health information now available with only a little initiative is many times greater than when the efficacy standard was introduced four decades ago.
Dan Klein and I have written extensively on this issue at our web site, FDAReview.org, and in our latest paper Do Off Label Drug Practices Argue Against FDA Efficacy Requirements?
Have you ever heard of Chagas disease? It is rare in the United States but common in Latin America, where 18 million people are infected and 50,000 die of it every year. Some little thingie crawls down your mouth and sucks your blood when you are sleeping (lovely), beware the thatched hut, and next thing you know, maybe about ten or thirty years later, your weakened heart or organs explode. There is no known vaccine, cure, or treatment.
Chagas is now making its way into the United States blood supply. Ideally, all donated blood should be screened for Chagas. But, can you believe this, the FDA needs to approve all blood tests of this kind. They haven’t approved any test for Chagas, nor have they shown much urgency in this regard, here is the full story.
About 30 tests are currently in use in Latin America, but none would appear to meet the FDA’s accuracy guidelines. In the meantime it appears someone would prefer that we have no test at all.
The New York Times put it as follows:
The failure of the blood industry and its regulators to develop a test since it was endorsed by a Blood Products Advisory Committee in 1989 seems to be a combination of bureaucratic inertia and divided responsibility for such a decision. Blood banks cannot use a test that the F.D.A. has not approved. The agency usually defers to its advisory committees, which have many experts from blood banks as members.
“It’s a political process that is not always fully engaged,” said Dr. Stuart J. Kahn of the Infectious Disease Research Institute, a Seattle group hunting cures for tropical diseases.
Whatever you think of the FDA as a regulator of drugs, this kind of bureaucratic control is hard to understand. Now it is longer enough for you to beware the thatched hut, you have to worry about the blood supply as well.
This was emailed to me, but I am not doing a double indent…in any case I fear the person might be right…
“The prevailing sentiment is that the COVID pandemic is close to over. The vaccines are of course miraculous but we are not currently on a good trajectory.
- It is increasingly clear that two shots plus a booster of our current vaccines are the least one needs to have effective medium-term protection. Almost nowhere (least of all the US) is on track to reach this kind of coverage. The messaging in the US remains mistaken, where the CDC to this day recommends boosters only for those aged 50 and older. More broadly, the institutional confusion around boosters shows that the adults are not yet in charge.
- Even though Delta arose in the spring, we are still vaccinating (and boosting) people with the original Wuhan strain. This is insane, and probably meaningfully less effective, and yet nobody is up in arms about it.
- Severe outbreaks are manifestly possible even in exceptionally vaccinated populations, especially when booster uptake is low. See: Singapore, Gibraltar, Ireland. One should assume that almost every part of the US will see significant waves before COVID “ends”, whatever that turns out to mean. Note that just 60% of the US population is vaccinated today with two doses.
- There is early suggestive evidence from Israel that boosters may wane.
- Waning aside, it’s clear that breakthrough infections in boosted individuals are not uncommon. While the vast majority of those infections are not severe, this does mean that there will still be plenty of mutagenesis.
- It’s unclear that longitudinal cross-immunity is strong. Getting COVID is not enough to confer long-term protection. We probably can’t just “get this over with”, even if we are willing to tolerate a large number of one-time deaths.
- The currently-breaking news about the South African Nu strain shows that arguments about how the spike protein is running out of mutation search space are almost certainly wrong.
- While the fog of war is thick right now, the early data on Nu suggests that it may be a big deal. Even if it’s not, however, it has been obvious since we got the vaccines that vaccine escape is a concern. You can debate whether the probability of a vaccine escaping variant is 20% or 80%, but in any case we need effective contingency plans in place. If we fail to respond effectively to Nu, that will be a considerably greater institutional failure than anything that happened at the outset of the pandemic. We’ve had almost two years since the first COVID case and one year from the vaccine approvals to prepare. So I ask: what is the plan for the vaccine-escaping variant?
On current trends, it looks like we will probably need one of two things to effectively end the pandemic: (1) very effective COVID therapeutics (paxlovid, molnupiravir, and fluvoxamine all being candidates but my guess is that none is a silver bullet) or (2) pan-coronavirus vaccines (with broader protection than what is currently available).
It isn’t over yet.
P.S. Has any U.S. health body recommended the clinical use of fluvoxamine (an already-approved drug), or has the FDA given any guidance as to when it might approve paxlovid? If not, can they outline their reasoning? 1,600 Americans died of COVID on Nov 24.”
That is the topic of my latest Bloomberg column, here is one excerpt of some super-simple (but neglected) arguments:
Education is another area where Friedman’s ideas seem newly relevant. Friedman was a strong supporter of school choice, but over time the movement stalled, as a variety of studies showed scholastic gains from school-voucher programs that were either modest, zero or negative. Advocates for school choice then moved on to the argument that vouchers allow parents to choose the kind of education they want for their children, whether or not test scores go up. That argument, too, went nowhere.
Then came the pandemic, when millions of American parents encountered a public school system that didn’t seem to care too much about educating their children. Schools stayed closed or offered inferior remote instruction, and generally followed their own bureaucratic imperatives. All of a sudden, home schooling, charter schools, private schools, micro-schools — in short, an entire host of “school choice” alternatives — rose in popularity. It remains to be seen how much those trends will stick, but Friedman may yet win this intellectual battle, at least partially.
And it’s not just the bureaucracy, it’s what’s taught in the classroom. Consider critical race theory and other instructional practices affiliated with wokeism. Whatever your views on this movement, it seems clear that it provokes strong and perhaps irresolvable differences among parents, teachers and administrators. Within a single public school district, those matters will probably never be settled to everyone’s satisfaction. Rather than pursuing a polarizing “fight to the death,” perhaps all sides can see that the case for school choice is stronger and more compelling than they had thought.
There are periodic attempts to knock Milton Friedman off his pedestal. For the most part, however, his legacy remains strong.
And who was the guy who predicted the recent problems with the FDA?
3. Questions that are rarely asked: “Does It Matter if I Eat the Stickers on Fruits and Vegetables?” (NYT) And does it matter for FDA regulatory issues?
5. David Kedrosky on the greatest paper in economic history of all time (by Peter Temin…in his opinion).
7. David Brooks on the national conservatives (Atlantic).
Zvi at LessWrong rounds up the COVID news including this excellent bit on Pfizer’s anti-Covid pill Paxlovid which looks to be very effective but is not yet FDA approved.
The trial was stopped due to ‘ethical considerations’ for being too effective. You see, we live in a world in which:
- It is illegal to give this drug to any patients, because it hasn’t been proven safe and effective.
- It is illegal to continue a trial to study the drug, because it has been proven so safe and effective that it isn’t ethical to not give the drug to half the patients.
- Who, if they weren’t in the study, couldn’t get the drug at all, because it is illegal due to not being proven safe and effective yet.
- So now no one gets added to the trial so those who would have been definitely don’t get Paxlovid, and are several times more likely to die.
- But our treatment of them is now ‘ethical.’
- For the rest of time we will now hear about how it was only seven deaths and we can’t be sure Paxlovid works or how well it works, and I expect to spend hours arguing over exactly how much it works.
- For the rest of time people will argue the study wasn’t big enough so we don’t know the Paxlovid is safe.
- Those arguments will then be used both by people arguing to not take Paxlovid, and people who want to require other interventions because of these concerns.
- FDA Delenda Est.
The U.S. Food and Drug Administration (FDA) has authorized the SalivaDirect PCR COVID-19 test created by the Yale School of Public Health for use with pooled saliva samples.
Pooled testing allows labs to combine saliva samples from multiple individuals into a single tube and process the batch as a single test. This approach maintains the clinical sensitivity associated with the real-time reverse transcription polymerase chain reaction tests — the gold standard for detecting SARS-CoV-2, the virus that causes COVID-19 — and gives labs the ability to process the tests far more quickly. The FDA authorizes Yale-designated laboratories to use the SalivaDirect test to pool as many as five samples at a time for SARS-CoV-2 testing.
Better to have nothing in the meantime I guess! In the meantime, only a handful of pooled spit tests have been approved.
Here is the full piece, via DR.
1. Stephen Crane, The Red Badge of Courage. I read this as a kid, and was surprised how well my reread held up. To the point, subtle, and with an economy of means. I hope the new Paul Auster biography of Crane (which I will read soon) will revive interest in this classic.
2. Frank Herbert, Dune Messiah. #2 in the Dune series, I disliked this one as a tot, but currently am marveling at its political sophistication. Somewhat uneven, but better than its reputation. The Wikipedia page for the book also indicates that Villeneuve is likely to do a Dune 3 based on this story.
3. Elisabeth Anderson (not the philosopher), Agents of Reform: Child Labor and the Origins of the Welfare State. Considers the political economy of child labor reform Germany, France, the United States, and the failed case of Belgium. Pathbreaking, a major advance on the extant literature. The explanations are messy rather than monocausal, but often focus on the success or failure of individual policy entrepreneurs.
4. Gordon Teskey, Spenserian Moments. No one seems to care about poor old Edmund Spenser, yet there seem to be quite a few good books about him.
5. Patrick McGilligan, Alfred Hitchcock: A Life in Darkness and Light. The best book on Hitchcock, John Nye recommended it to me eight years ago.
There is Howard Husock, The Poor Side of Town, And Why We Need It.
And Mary Roach, Fuzz: When Nature Breaks the Law.
Richard A. Williams, Fixing Food: An FDA Insider Unravels the Myths and Their Solutions, covers the food regulatory side of the FDA, and:
Markus K. Brunnermeier, The Resilient Society.
In July of 2020 in Frequent, Fast and Cheap is Better than Sensitive, I wrote:
A number of firms have developed cheap, paper-strip tests for coronavirus that report results at-home in about 15 minutes but they have yet to be approved for use by the FDA because the FDA appears to be demanding that all tests reach accuracy levels similar to the PCR test. This is another deadly FDA mistake.
It’s depressing that we are still moving so slowly on these issues but the media has finally gotten on board. Earlier I mentioned David Leonhardt’s article. Here is Margaret Hartmann in the New York Magazine.
In many Asian and European countries, at-home COVID-19 tests are cheap and easy to find in stores. CBS News reported this month that home antigen tests are now used routinely in the U.K., where they are free and “readily available at pretty much every pharmacy in the country.”
The situation is drastically different here because U.S. health officials focused on getting people vaccinated against COVID-19 and never leaned into asymptomatic testing as a strategy to fight the pandemic. While some foreign governments moved quickly to encourage screening and subsidize the cost of at-home tests, the Food and Drug Administration’s approval process moved much more slowly.
….The FDA said it needed to ensure that the tests were accurate, but many scientists countered that the agency was letting the perfect be the enemy of the good.
Note also that this is a way of saying that the politicians have now also had it with the FDA:
In addition to ramping up production of tests already on the market, the government is also working to speed up the approval process. On October 4, the FDA authorized Flowflex, an at-home antigen test produced by ACON Laboratories that is expected to retail for around $10 per test. And on October 25, the Department of Health and Human Services announced that the FDA will streamline its authorization process, and the National Institutes of Health will spend $70 million on a new program to “establish an accelerated pathway” to aid test makers seeking approval for their products.