Results for “fda” 391 found
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.
Operation Warp Speed showed that we can move much faster. FDA delay in approving rapid tests shows that we should move much faster. There is a window of opportunity for reform. The excellent Bart Madden and Siri Terjesen argue for the Promising Pathways Act.
One particularly exciting development is the Promising Pathway Act (PPA), recently introduced in Congress. PPA would reduce bureaucracy via legal changes and provide individuals with efficient early access to potential new drugs.
Under PPA, new drugs will receive provisional approval five to seven years earlier than the status quo via a two-year provisional approval. Drugs that demonstrate patient benefits could be renewed for a maximum of six years, and the FDA could grant full approval at any time based on real-world as opposed to clinical trial data documenting favorable treatments results.
The PPA allows patients, advised by their doctors, to choose early access to promising but not-yet-FDA -approved drugs. Patients and doctors would make informed decisions about using either approved or new medicines that demonstrate safety and initial effectiveness compared to approved drugs.
…Patients and doctors can log into an internet registry database for early access drugs that would contain treatment outcomes, side effects, genetic data, and biomarkers. Scientific researchers, as well as patients, will also benefit from the identification of subgroups of patients who do exceptionally well or fail to respond.
Data from the registry will open knowledge pathways to improve the biopharmaceutical industry’s research outlays to benefit future patients.
With radically lower regulatory costs plus heightened competition as more companies participate, expect substantially lower prescription drug prices for provisional approval drugs.
Here is the text of the PPA.
I wanted to reach out and provide some updates about new markets on the Exchange that may be of interest. We have a new market on whether the FDA will approve a vaccine for kids, in addition to a market on whether the CDC will identify a “variant of high consequence” (Delta is only a “variant of concern”). We also have markets about whether the Fed will taper at its next meeting, whether the U.S. will raise the debt ceiling before October 19, and whether or not Jerome Powell will be replaced….We also have markets on whether the capital gains and corporate tax will be raised, in case that’s of interest.
My first reaction upon hearing that boosters were rejected was to ask the same thing: would these same “experts” say that, because the vaccines are still effective without boosters, vaccinated persons don’t need to wear masks and can resume normal life? Of course not. They use the criterion “prevents hospitalization” for evaluating boosters (2a) but switch back to “prevents infection” when the question is masks and other restrictions. What about those that are willing to accept the tiny risk of side effects to prevent infection so that they can get back to fully normal life? The Science (TM) tells us that one can’t transmit the virus if one is never infected to begin with.
Also, one of the No votes on boosters said that he feared approval would effectively turn boosters into a mandate and change the definition of fully vaccinated. So, it appears that the overzealousness to demand vaccine mandates has actually contributed to fewer people getting access to (booster) vaccines, thus paradoxically contributing to spread. A vivid illustration of the problem with, “That which is not mandatory should be prohibited.”
The biggest problem with public health professionals continues to be (1) elevation of their own normative value judgements — namely that NPIs are no big deal no matter how long they last — which have nothing to do with scientific expertise, (2) leading them to “shade” their interpretation of data to promote their preferred behavioral outcome rather than answering positive (non-normative) questions with positive scientific statements, (3) thus undermining the credibility of public health institutions (FDA, CDC) and leading to things like vaccine hesitancy.
That is from BC.
The Biden administration says booster shots are coming, but the FDA hasn’t decided on the dose. Moderna wants a half-shot booster. Pfizer a full shot. But could the best dose for Americans and for the world be even less?
COVID-19 vaccines are the first successful use of mRNA vaccine technology, so a lot remains unknown. But identifying the smallest dose needed to provide effective boosting is critical to protect Americans from adverse effects, increase confidence in vaccines, and mitigate global vaccine inequity.
We’ve known since earlier this year that a half-dose of the Moderna vaccine produces antibody levels similar to the standard-dose and newer information suggests that even a quarter-dose vaccine may do the same. If a half or quarter dose is nearly as effective as a standard dose for first and second shots then a full dose booster may well be an overdose. The essential task of a booster is to “jog” the immune system’s memory of what it’s supposed to fight. Data from the world of hepatitis B suggest that the “reminder” need not be as intense as the initial “lesson.” And in the cases of tuberculosis, meningitis, and yellow fever vaccines, lower doses have been as good or better than the originals.
Lower doses could also reduce risks of adverse effects.
That’s myself and physicians Garth Strohbehn and William F. Parker on the Med Page Today. Strohbehn is an oncologist and specialist in optimizing doses for cancer drugs. William Parker is a pulmonologist and professor of medicine at the University of Chicago.
1. You can now buy a $475 NFT ticket to see Beeple’s $69 million NFT at an IRL party. The ticket also includes one drink.
7. Tensions between the CDC and Biden administration mount. Which one do you think is coming closer to trying to maximize expected value? It turns out even the FDA thinks the CDC is too slow.
Operation Warp Speed was by far the most successful government program against COVID. But as of yet there is very little discussion or history of the program. As just an indication I looked for references in a bunch of pandemic books to General Perna who co-led OWS with Moncef Slaoui. Michael Lewis in The Premonition never mentions Perna. Neither does Slavitt in Preventable. Nor does Wright in The Plague Year. Nor does Gottlieb in Uncontrolled Spread. Abutaleb and Paletta in Nightmare Scenario have just two index entries for Perna basically just stating his appointment and meeting with Trump.
Yet there are many questions to be asked about OWS. Who wrote the contracts? Who chose the vaccines? Who found the money? Who ran the day to day operation? Why was the state and local rollout so slow and uneven? How was the DPA used? Who lifted the regulations? How was the FDA convinced to go fast?
I don’t know the answer to these questions. I suspect when it is all written down, Richard Danzig will be seen as an important behind the scenes player in the early stages (I was involved with some meetings with him as part of the Kremer team). Grogan at the DPC seems under-recognized. Peter Marks at the FDA was likely extremely important in getting the FDA to run with the program. Marks brought people like Janet Woodcock from the FDA to OWS so you had a nominally independent group but one completely familiar with FDA policy and staff and that was probably critical. And of course Slaoui and Perna were important leaders and communicators with the private sector and the logistics group but they have yet to be seriously debriefed.
It’s also time for a revisionist account of President Trump’s Council of Economic Advisors. Michael Kremer and I spoke to the DPC and the CEA early on in the pandemic and argued for a program similar to what would later be called OWS. The CEA, however, was way ahead of the game. In Sept of 2019 (yes, 2019!) the CEA produced a report titled Mitigating the Impact of Pandemic Influenza through Vaccine Innovation. The report calculates the immense potential cost of a pandemic and how a private-public partnership could mitigate these costs–all of this before anyone had heard the term COVID. Nor did that happen by accident. Thomas Philipson, the CEA chair, had made his reputation in the field of economic epidemiology, incorporating incentives and behavioral analysis in epidemiological models to understand HIV and the spread of other infectious diseases. Eric Sun, another CEA economist, had also written with Philipson about the FDA and its problems. Casey Mulligan was another CEA chief economist who understand the danger of pandemics and was influenced by Sam Peltzman on the costs of FDA delay. So the CEA was well prepared for the pandemic and I suspect they gave Trump very good advice on starting Operation Warp Speed.
In short, someone deserves credit for a multi-trillion-dollar saving government program! More importantly, we know a lot about CDC and FDA failure but in order to know what we should build upon we also need to know what worked. OWS worked. We need a history of how and why.
“Add Dx of schizophrenia for use of Haldol,” read the doctor’s order, using the medical shorthand for “diagnosis.”
But there was no evidence that Mr. Blakeney actually had schizophrenia.
Antipsychotic drugs — which for decades have faced criticism as “chemical straitjackets” — are dangerous for older people with dementia, nearly doubling their chance of death from heart problems, infections, falls and other ailments. But understaffed nursing homes have often used the sedatives so they don’t have to hire more staff to handle residents…
The share of residents with a schizophrenia diagnosis has soared 70 percent since 2012, according to an analysis of Medicare data. That was the year the federal government, concerned with the overuse of antipsychotic drugs, began publicly disclosing such prescriptions by individual nursing homes.
Today, one in nine residents has received a schizophrenia diagnosis. In the general population, the disorder, which has strong genetic roots, afflicts roughly one in 150 people.
Schizophrenia, which often causes delusions, hallucinations and dampened emotions, is almost always diagnosed before the age of 40.
Here is more from the NYT, not unrelated to issues of guardianship of course. Furthermore, this tale does not exactly fit the usual “not enough medical care for the poor” narratives, and perhaps that is why the issue has not caught on more. The medical profession even appears to be slightly…suboptimal in its ethical procedures.
For the pointer I thank Michelle Dawson.
Australia is now one of the most authoritarian states in the world. Conor Friedersdorf writes:
Australia is undoubtedly a democracy, with multiple political parties, regular elections, and the peaceful transfer of power. But if a country indefinitely forbids its own citizens from leaving its borders, strands tens of thousands of its citizens abroad, puts strict rules on intrastate travel, prohibits citizens from leaving home without an excuse from an official government list, mandates masks even when people are outdoors and socially distanced, deploys the military to enforce those rules, bans protest, and arrests and fines dissenters, is that country still a liberal democracy?
As I noted earlier, Australia is in clear contravention of the UN Declaration of Human Rights, Article 13 of which states:
- Everyone has the right to freedom of movement and residence within the borders of each state.
- Everyone has the right to leave any country, including his own, and to return to his country.
To give Australia’s approach its due, temporary restrictions on liberty were far more defensible early in the pandemic…Had it behaved rationally and adequately valued liberty, a rich nation like Australia would have spent lavishly—before knowing which vaccines would turn out to be most effective—to secure an adequate supply of many options for its people. It could afford to eat the cost of any extra doses and donate them to poorer countries. Australia then could have marshaled its military and civil society to vaccinate the nation as quickly as possible, lifted restrictions more fully than Europe and the United States did, and argued that the combination of fewer deaths and the more rapid return to normalcy made their approach a net win.
Instead, Australia invested inadequately in vaccines and, once it acquired doses, was too slow to get them into arms. “Of the 16 million doses of the AstraZeneca vaccine that have been released to the government by manufacturer CSL, only about 8 million have gone into the arms of Australians,” The Age reported on August 21, citing concern about blood clots and a widespread preference for the Pfizer vaccine.
…Because of its geography, Australia is a neighbor and an observer of authoritarian countries as varied as China and Singapore. But its own fate, too, may turn on whether its people crave the feeling of safety and security that orders from the top confer, or whether they want to be free.
Australians largely support the restrictions but to me that makes them all the more disturbing.
Temporary restrictions on liberty can be justified in an emergency if the restrictions produce something else of great value but respecting the great value of liberty and individual rights means doing everything in one’s power to limit the scope of and lift such restrictions as quickly and completely as possible.
3. “A good start” — they should be working for us, not us for them. And yes I believe in following the science — the science of expected utility maximization. They are the ones who do not really believe in science, just their own status within their own branch of science.
We have vaccine abundance in the United States but not test abundance. Germany has test abundance. Tests are easily available at the supermarket or the corner store and they are cheap, five tests for 3.75 euro or less than a dollar each. Billiger! In Great Britain you can get a 14 pack for free. The Canadians are also distributing packs of tests to small businesses for free to test their employees.
In the United States, the FDA has approved less than a handful of true at-home tests and, partially as a result, they are expensive at $10 to $20 per test, i.e. more than ten times as expensive as in Germany. Germany has approved over 50 of these tests including tests from American firms not approved in the United States. The rapid tests are excellent for identifying infectiousness and they are an important weapon, alongside vaccines, for controlling viral spread and making gatherings safe but you can’t expect people to use them more than a handful of times at $10 per use.
We ought to have testing abundance in the US and not lag behind Germany, the UK and Canada. As usual, I say if it’s good enough for the Germans it’s good enough for me.
Addendum: The excellent Michael Mina continues to bang the drum.