Category: Regulations

Ramaswamy Avowed That the F.D.A. “Erects Unnecessary Barriers to Innovation”

The New York Times article quoted below worried that if Vivek Ramaswamy succeeded in “slashing regulation” of drugs, his own drug development firm would have benefitted. Maybe so, but that misses the main point–all the rest of us also would have benefitted by medical entrepreneurs being allowed to create more and quicker cures. Presumably The New York Times was relieved when Ramaswamy resigned from DOGE, but I was discouraged.

I was in favor of Elon Musk’s push to reduce the number of federal employees. But I was even more in favor of Vivek Ramaswamy’s push to deregulate innovative entrepreneurs.

[By the way, isn’t it predictable that The New York Times delights in highlighting Roivant’s one failure, but gives only passing scant mention to its six successes?]

(p. A10) Vivek Ramaswamy is the less famous and less wealthy half of the duo of billionaires that President-elect Donald J. Trump has designated to slash government costs.

. . .

At 39, he is one of the world’s youngest billionaires, having made his fortune in the pharmaceutical industry.  . . .

Mr. Ramaswamy, who owns a stake currently valued at nearly $600 million in a biotechnology company he started, has called for changes at the Food and Drug Administration that would speed up drug approvals.

. . .

Since being named to jointly lead DOGE, Mr. Ramaswamy had until recently been posting on Mr. Musk’s social media site X, hinting about where he may look to make changes in the government.

He called for slashing regulation, not just cutting government spending. He pointed to federal workers focused on diversity as potential targets for “mass firings.”

And he has been taking aim at the F.D.A. “My #1 issue with FDA is that it erects unnecessary barriers to innovation,” he wrote on X. He criticized the agency’s general requirement that drugmakers conduct two successful major studies to win approval rather than one.

Mr. Ramaswamy founded his biotechnology company, Roivant Sciences, in 2014, betting that he could find hidden gems whose potential had been overlooked by large drugmakers. The idea was to hunt for experimental medications languishing within large pharmaceutical companies, buy them for cheap and spin out a web of subsidiaries to bring them to market.

The venture is best known for a spectacular failure.

In 2015, Mr. Ramaswamy whipped up hype and investment around one of his finds, a potential treatment for Alzheimer’s disease being developed by one of his subsidiaries, Axovant. Two years later, a clinical trial showed that it did not work, erasing more than $1.3 billion in Axovant’s stock value in a single day.

Mr. Ramaswamy personally lost money on paper on the failure, but thanks to the savvy way he had structured his web of companies he and Roivant weathered the storm. Six products have won F.D.A. approval, and today Roivant has a market valuation of $8 billion.

Mr. Ramaswamy sold some of his Roivant stock to take a large payout in 2020, reporting nearly $175 million in capital gains on his tax return that year. But he is still one of the company’s largest shareholders.

If Mr. Ramaswamy recommends changes that speed up drug approvals through DOGE, that could be good news for Roivant, which is developing drugs that might come up for approval during Mr. Trump’s second term. The faster it can get medicines onto the market, the more valuable the company — and Mr. Ramaswamy’s stake in it — stands to become.

For the full story see:

Rebecca Robbins, Maureen Farrell and Jonathan Weisman. “From Ramaswamy’s High-Profile Perch, a Web of Potential Conflicts.” The New York Times (Thursday, January 16, 2025): A10.

(Note: ellipses added.)

(Note: the online version of the story has the date Jan. 15, 2025, and has the title “Ramaswamy Has a High-Profile Perch and a Raft of Potential Conflicts.” At one point this entry was posted on March 30. I had not noted that another entry had been posted for March 30, so for consistency I moved this entry to April 23.)

If Risks Are Low and Alternatives Few, Let Patients Try Therapies That Lack Proof of Efficacy

I like Dr. Shirvalkar’s decision process quoted below. He says that a patient should be allowed to take a therapy without proof of efficacy, if the costs and risks are low.

This decision process is consistent with my suggestion that the F.D.A. should stop mandating efficacy, and limit itself to only mandating safety, thus greatly reducing the costs of drug development.

(p. D7) Acetaminophen. Acupuncture. Massage. Muscle relaxants. Cannabinoids. Opioids. The list of available treatments for low back pain goes on and on. But there’s not good evidence that these treatments actually reduce the pain, according to a new study that summarized the results of hundreds of randomized trials.

. . .

Aidan Cashin, the paper’s first author and deputy director of the research group Center for Pain IMPACT at Neuroscience Research Australia, said the aim of the study was to identify which first-line treatments for low back pain had any specific effects beyond a placebo, which might merit further study and which may not be worth pursuing.

. . .

One limitation of the type of analysis that Dr. Cashin conducted was that it aggregated data from different studies and different populations in order to emulate one large trial. But in the process, a strong signal from one study that a treatment worked could be diluted amid noise from other studies that may not have been designed as well, he said.

. . .

The evidence for something like heat might be inconclusive, doctors said, but they would still recommend that patients try it. “It’s cheap, it’s accessible, it almost causes no harm,” Dr. Shirvalkar said.

For the full story see:

Nina Agrawal. “Low Back Pain Relief Is Stubbornly Elusive.” The New York Times (Tuesday, March 25, 2025): D7.

(Note: ellipses added.)

(Note: the online version of the story was updated March 24, 2025, and has the title “What Works for Low Back Pain? Not Much, a New Study Says.” Where the versions differ, in the passages quoted above, I follow the online version.)

Alternatives to Government F.D.A.: Private “High-Quality Third-Party Seals of Approval”

The many label inaccuracies found in the “2022 study” (Crawford et al. 2022) mentioned below would seem to bode ill for the supplement consumer. But if you look at the “new study” you will find that NONE of the 30 supplements they examined had “a third-party certification seal.” This leaves open the plausible possibility that prudent consumers could do well for themselves by limiting their supplement purchases to those with a private third-party certification seal. It would be very useful if someone does another study–this one to confirm or refute my hypothesis that supplements with third-party certification seals had many fewer label inaccuracies. Confirmation would be evidence that the consumer could do well without the F.D.A.’s governmental regulatory mandates.

The relevant quotation from the “2022 study” (Crawford et al. 2022) is:

“No product had a third-party certification seal (ie, naming the third-party company), such as BSCG (Banned Substances Control Group), NSF (National Sanitation Foundation)International, Informed Sport, or USP (US Pharmacopeia), presented on the label” (Crawford et al. 2022, pp. 3 & 5 [all of p. 4 was a table]).”

(p. D7) Supplements claiming to support immunity often contain vitamins and minerals necessary for the immune system. So it isn’t unreasonable to believe that these products could help you sidestep common viral infections or lessen symptoms once you’ve become sick.

In fact, some nutrients such as vitamins A, C, D and zinc are needed to protect against germs, and deficiencies in them raise your risk of becoming sick, said Dr. Mahtab Jafari, a professor of pharmaceutical sciences at the University of California, Irvine.

. . .

It’s hard to firmly state the benefits of immune system supplements because there are few high-quality randomized clinical trials, the gold standard of medical research, assessing their effectiveness, said Dr. Pieter Cohen, an associate professor at Harvard Medical School who studies dietary supplement safety.

And dietary supplements aren’t approved by the Food and Drug Administration before hitting the market.

This means companies can sell products containing ingredients that haven’t been rigorously tested to offer benefits, Dr. Cohen said, and they generally don’t have to prove to the F.D.A. that their products contain what they claim.

A 2022 study analyzing 30 supplements marketed to support the immune system found that more than half had inaccurate labels, 13 were misbranded and nine contained ingredients not listed on the label.

. . .

“You need to have a really healthy dose of skepticism when you’re pulling something off the shelf,” Dr. Ben-Aderet said.

But if you want to give supplements a try, check for high-quality third-party seals of approval from organizations such as U.S. Pharmacopeia or NSF, which test the quality of dietary supplements, Dr. Jafari said.

For the full story see:

Katie Mogg. “Supplements and Claims of Improved Immunity.” The New York Times (Tuesday, February 25, 2025): D7.

(Note: ellipses added.)

(Note: the online version of the story was updated March 3, 2025, and has the title “Can Vitamin C and Zinc Actually Boost Your Immune System?”)

The “2022 study” mentioned above is:

Crawford, Cindy, Bharathi Avula, Andrea T. Lindsey, Abraham Walter, Kumar Katragunta, Ikhlas A. Khan, and Patricia A. Deuster. “Analysis of Select Dietary Supplement Products Marketed to Support or Boost the Immune System.” JAMA Network Open 5, no. 8 (2022): e2226040-e40.

New York Times Says Trump “Has Waged a Multipronged Assault at Regulations” on Environment

The passages quoted below are further evidence apropos my dialogue with my libertarian friends who argue that the Trump administration’s efforts to deregulate and downsize have failed.

(p. 1) With a flurry of actions that have stretched the limits of presidential power, Mr. Trump has gutted federal climate efforts, rolled back regulations aimed at limiting pollution and given a major boost to the fossil fuel industry.

. . .

To achieve such a wholesale overhaul of the country’s climate policies in such a short time, the Trump administration has reneged on federal grants, fired workers en masse and attacked longstanding environmental regulations.

. . .

(p. 31) [Trump] has waged a multipronged assault at regulations designed to curb pollution, immediately sweeping some rules to the side and circumventing the normally lengthy rule-making processes. At the same time, Mr. Trump has declared an energy emergency, giving himself the authority to fast-track the construction of oil and gas projects as he works to stoke supply as well as demand for fossil fuels.

. . .

The administration and Republicans in Congress plan to use a legislative maneuver to quickly erase California’s authority to ban the sale of new gasoline-powered cars in the state by 2035. That authority has never before been challenged in this way, and critics say the maneuver is illegal. But it would be much faster than trying to overturn the California ban through the standard process that requires months of public notice and comment.

“They’re doing all the things I thought they would do, and they’re doing other things that I only dreamed they might do,” said Myron Ebell, a conservative activist who led the E.P.A. transition team during Mr. Trump’s first term.

. . .

And in a move that could have far-reaching implications for government efforts to regulate industry, Lee Zeldin, the administrator of the E.P.A., has recommended that the agency reverse its 2009 finding that greenhouse gas emissions endanger human health and welfare, according to three people familiar with the decision. That would eliminate the legal basis for the government’s climate laws, such as limits on pollution from automobiles and power plants.

“We’re talking about undoing 50 years of environmental regulation and accelerating the extinction crisis and risking the health of the American people,” said Ben Jealous, the executive director of the Sierra Club. “There’s so much shocking news every day. People are struggling to process all of it.”

. . .

Much of the damage to the country’s environmental regulatory apparatus may be long-lasting.

. . .

On Wednesday [Feb. 26, 2025] Trump said he believed Mr. Zeldin, the E.P.A. administrator, would be cutting about 65 percent of the agency’s more than 17,000 jobs. Mr. Zeldin later said that he thought the E.PA. could cut at least 65 percent of its budget and make cuts to its work force.

For the full story see:

David Gelles, Lisa Friedman and Brad Plumer. “Undoing Years of Climate Policy in a Few Weeks.” The New York Times, First Section (Sunday, March 2, 2025): 1 & 31.

(Note: ellipses, and bracketed name and date, added.)

(Note: the online version of the story has the date March 2, 2025, and has the title “‘Full on Fight Club’: How Trump Is Crushing U.S. Climate Policy.”)

Breakthrough Innovations Often Reach Success Through Incremental Improvements

After 130 days, the patient with the longest (so far) transplant of a pig kidney decided to have the transplant “explanted” and return to dialysis. Her surgeon explained that this should not be viewed as a failure of the basic innovation. The patient had the option to continue improvisations to keep the pig kidney alive, but decided that for her the risks had become too high.

The surgeon, Dr. Robert Montgomery said:

“All this takes time,” he said. “This game is going to be won by incremental improvements, singles and doubles, not trying to swing for the fences and get a home run.” (p. A24)

The pig kidney transplants follow the pattern of many other medical innovations, where on-the-fly adjustments, when the protocol allows them, lead to longer duration successes with fewer side effects. Emil Freireich found this with his chemo cocktails for childhood leukemia. Early human heart transplants also followed this pattern.

We should not allow early setbacks to push us to overregulate the incremental progress that can eventually leads to success.

My source is:

Roni Caryn Rabin. “Pig Kidney Is Removed From an Alabama Woman After Organ Is Rejected.” The New York Times (Sat., April 12, 2025): A24.

(Note: the online version of the article has the date April 11, 2025, and has the title “Pig Kidney Removed From Alabama Woman After Organ Rejection.”)

Trump Deregulates Biden’s Logging and Mining Bans on Public Lands

Trump’s agriculture secretary announced the deregulation of logging on 113 million acres of public lands–logging is now allowed on those lands. The Agriculture Department also announced the deregulation of mining on 264,000 acres of public lands, in order to “boost production of critical minerals” (p. A19).

Source:

Lisa Friedman. “White House Reverses Biden Limits on Drilling and Mining on Public Lands.” The New York Times (Thurs., April 10, 2025): A19.

(Note: the online version of the article has the date April 8, 2025, and has the title “Trump Administration Opens More Public Land to Drilling and Mining.”)

Trump Orders That Regulations Include “Sunset” Provisions

Several of my free market or libertarian friends are extremely upset about Trump’s tariff policies. I am confused and discouraged about them too. But I have said to my friends that while we criticize the tariff policies we should also find time to praise the Trump policies reducing regulations and downsizing government.

The response from several libertarians has been that nothing significant has been achieved on deregulation and downsizing. So I have resolved that at least for the next few weeks I will be alert to evidence on this issue, and occasionally run a post when I find some.

For instance, the NYT reported on Saturday that last week Trump instructed 10 federal agencies to add “sunset” clauses to most of their regulations saying that they will expire by October 2026. If the agency decides a regulation should be kept, they are to add a clause that the regulation will expire in five years unless reapproved. Trump also told all of his cabinet secretaries that within 60 days they are to have plans on which of the regulations in their areas should be repealed.

Trump also ordered the specific repeal of regulations limiting water flow in shower heads. (I like this one. Let’s Make America Clean Again (MACA) or at least let’s let people be free to choose to be clean.)

My source is:

Brad Plumer and Lisa Friedman. “Trump Deploys Shortcuts As He Moves to Eliminate Many Federal Regulations.” The New York Times (Sat., April 12, 2025): A15.

(Note: the online version of the article has the date April 11, 2025, and has the title “Trump’s New Way to Kill Regulations: Because I Say So.”)

Healthcare Under ObamaCare’s “Affordable” Care Act Is Neither Popular Nor Affordable

In my Openness book, I argue that government regulations bind entrepreneurs and reduce innovation. As part of an antidote, I suggest that “sunset laws,” where regulations automatically expire, if not renewed. Later, at a small conference on Adam Thierer’s latest book, I was discouraged to hear a couple of participants grant the plausibility of the “antidote,” but report that in actual practice it does not work because almost all old regulations get renewed. Some hope returned when I read a report from James Broughel of a successful sunset review process:

(p. A17) Well, well. Progressives are at last acknowledging that ObamaCare is a failure. They aren’t doing so explicitly, of course, but their social-media screeds against insurers, triggered by last week’s murder of UnitedHealthcare CEO Brian Thompson, suggest as much. “We’ve gotten to a point where healthcare is so inaccessible and unaffordable, people are justified in their frustrations,” CBS News medical contributor Céline Gounder said during a Friday segment on the roasting of health insurers.

A Gallup survey released Friday [Dec. 6, 2024] affirms the sentiment, finding that only 44% of Americans rate U.S. healthcare good or excellent, down from 62% when Democrats passed ObamaCare in 2010. A mere 28% rate the country’s insurance coverage highly, an 11-point decline. ObamaCare may rank as the biggest political bait-and-switch in history.

Remember Barack Obama’s promise that if you like your health plan and doctor, you could keep them? Sorry. How about his claim that people with pre-existing conditions would be protected? Also not true. The biggest howler, however, was that healthcare would become more affordable.

Grant Democrats this: The law has advanced their political goal of expanding government control over insurers, in return for lavishing Americans with subsidies to buy overpriced, lousy products.

. . .

At the same time, ObamaCare’s perverse effects are fueling public rage against insurers and support for a single-payer system that would eliminate them. Mr. Obama and Peter Orszag, the law’s chief architect, must be smiling. Mr. Orszag, now CEO of the financial-services firm Lazard, has dined out on advising health insurers on mergers he says were spurred by the law’s regulations. How convenient.

. . .

If the goal were to help Americans with costly health conditions, it would have been far simpler and less expensive to boost subsidies for state high-risk pools. But that wouldn’t have accomplished Democrats’ actual goal, which is to turn insurers into de facto public utilities and jerry-rig a halfway house to single-payer healthcare. What a con.

For the full commentary see:

Allysia Finley. “Life Science; UnitedHealthcare and the ObamaCare Con.” The Wall Street Journal (Mon., Dec. 9, 2024): A17.

(Note: ellipses, and bracketed date, added.)

(Note: the online version of the commentary has the date December 8, 2024, and has the same title as the print version.)

The Gallup poll results mentioned above can be viewed at:

Brenan, Megan. “View of U.S. Healthcare Quality Declines to 24-Year Low.” Gallup, Inc., Dec. 6, 2024 [cited March 27, 2025]. Available from https://news.gallup.com/poll/654044/view-healthcare-quality-declines-year-low.aspx.

Doctors Burnout from Spending Less Time with Patients and More Time Arguing with Insurance Firms

Government policies have increased the paperwork that physicians must process and the time they must spend arguing with insurance companies on behalf of their patients. The policies have increased the need for back-office staff to handle the regulations, and so increased the overhead of private practice. So more and more physicians have given up private practice and become employees. They find their work less fulfilling and face burnout. Patients suffer when more of their physicians are bitter and burned-out.

(p. A1) There’s a question dividing the medical practice right now: Is being a doctor a job, or a calling?

. . .

(p. A2) Physicians work an average of 59 hours a week, according to the American Medical Association, and while the profession is well-compensated—the average physician makes $350,000, a recent National Bureau of Economic Research analysis found—it comes with high pressure and emotional strain.

. . .

Among physicians under age 45, only 32% own practices, down from 44% in 2012. By comparison, 51% of those ages 45 to 55 are owners.

Owners have more autonomy, but also increasing overhead costs. Vaughan, who sold his private practice in 2011, saw his malpractice insurance premiums increase to $65,000 a year.

Dr. Joseph Comfort, 80, sold his anesthesiology practice in 2003, frustrated by rising billing tussles with insurance companies. He now works part time as an internal medicine doctor at a small concierge clinic in Sanford, Fla.

“We’ve been ripped down off our pedestals,” he says.

For generations, Comfort says, doctors accepted being at the mercy of their pager and working long hours as the cost of doing business. “We took it because we considered ourselves to be masters of our own fate,” he says. “Now, everything’s changed. Doctors are like any other employee, and that’s how the new generation is behaving.”

They also spend far more time doing administrative tasks. One 2022 study found residents spent just 13% of their time in patient rooms, a factor many correlate with burnout.

. . .

In San Francisco, Dr. Christopher Domanski—a first-year resident who had his first child earlier this year—says he’s interested in pursuing a four-day workweek once he’s completed his training.

“I’m very happy to provide exceptional care for my patients and be there for them, but medicine has become more corporatized,” says Domanski, 29. Though he’s early in his medical career, he’s heard plenty of physicians complain about needing to argue with insurance companies to get their patients the treatments they need.

“It’s disheartening,” he says.

For the full story see:

Te-Ping Chen. “Younger Doctors Balk at Medicine’s Workaholic Culture.” The Wall Street Journal (Monday, Nov 04, 2024 [sic]): A1-A2.

(Note: ellipses added.)

(Note: the online version of the story has the date November 3, 2024 [sic], and has the title “Young Doctors Want Work-Life Balance. Older Doctors Say That’s Not the Job.”)

Public Health “Experts” Rebuffed Renegades Who Saw Covid Spread in Aerosols

Steven Johnson’s The Ghost Map shows how rigid adherence to the miasma theory of disease shut out alternatives. And an alternative was indeed needed to explain the spread of cholera. But the defeat of the miasma theory for cholera may have been too complete, prejudicing scientists to oppose theories of disease-spread through the air, which turn out to be important for some diseases, such as Covid-19.

(p. C9) In early 2020, as word spread of a frightening new respiratory outbreak in China, the World Health Organization and the Centers for Disease Control and Prevention were pressed for advice. Both initially counseled social distancing, guided by the assumption that the disease was spread by large, boggy droplets that fell rapidly to the ground after being expelled by coughing or sneezing.

By avoiding such projectiles and keeping surfaces clean, the reasoning went, infection could be avoided. Yet this advice ignored—with tragic consequences—nearly a century of science suggesting that many respiratory diseases can spread via microdrops that are exhaled during normal breathing and can remain suspended in the air for hours.

In “Air-Borne,” the New York Times science writer Carl Zimmer seeks to explain how public-health officials could have overlooked such an important mechanism of the Covid-19 contagion. He begins his meticulous history with the ancient Greek physician Hippocrates, who taught that illness could be caused by “an invisible corruption of the air,” which he termed a “miasma.”

. . .

While the field of aerobiology may have entered the new millennium stuck on a “stagnant plateau,” as one journal article lamented, hope was starting to emerge. Advances in technology led to a more complete characterization of the aerobiome. A range of scientists from around the world, meanwhile, re-examined the possibility of airborne transmission and discovered the evidence against it wanting.

Following the emergence of Covid-19, many of these researchers were appalled by the seemingly reflexive—“mind-boggling,” in the words of one scientist—rejection of airborne transmission by public-health agencies. At first, these renegades individually struggled to have their work published but were largely rebuffed.

After an early Covid-19 outbreak among a choir in Washington state was initially attributed to large-droplet spread, a more detailed analysis by a unified group of skeptical researchers suggested that airborne transmission was far more likely. On Dec. 23, 2021—nearly 21 months after tweeting “FACT: #COVID19 is NOT airborne”—the WHO “finally issued a clear public statement that the virus was airborne,” Mr. Zimmer writes. A triumph for persistent scientists, perhaps, but also a pointed reminder of the complexity, fragility and deeply human dependencies of evolving science.

For the full review see:

David A. Shaywitz. “Microbes in the Mist.” The Wall Street Journal (Saturday, March 15, 2025): C9.

(Note: ellipsis added.)

(Note: the online version of the review has the date March 14, 2025, and has the title “‘Air-Borne’: The Microbes in the Mist.”)

The book under review is:

Zimmer, Carl. Air-Borne: The Hidden History of the Life We Breathe. New York: Dutton, 2025.

Idaho Cut or Simplified 95% of Regulations by a “Sunset” Review

In my Openness book, I argue that government regulations bind entrepreneurs and reduce innovation. As part of an antidote, I suggest that “sunset laws,” where regulations automatically expire, if not renewed. Later, at a small conference on Adam Thierer’s latest book, I was discouraged to hear a couple of participants grant the plausibility of the “antidote,” but report that in actual practice it does not work because almost all old regulations get renewed. Some hope returned when I read a report from James Broughel of a successful sunset review process:

Idaho has proved deregulation is possible. The state repealed and revised its administrative rules code through a sunset review process in 2019. The results were dramatic. Since then, 95% of state regulations have been eliminated or simplified. The sky didn’t fall. Most regulations, when subject to genuine scrutiny, fail to justify their existence.

I will keep my eyes open on this issue, looking for more evidence.

James Broughel’s commentary is:

James Broughel. “Recipe for a Regulatory Spring Cleaning.” The Wall Street Journal (Tues., Nov. 26, 2024): A13.

(Note: the online version of the commentary has the date November 25, 2024, and has the same title as the print version.)

My book mentioned above is:

Diamond, Arthur M., Jr. Openness to Creative Destruction: Sustaining Innovative Dynamism. New York: Oxford University Press, 2019.

Adam Thierer’s book mentioned above is:

Thierer, Adam. Evasive Entrepreneurs and the Future of Governance: How Innovation Improves Economies and Governments. Washington, D.C.: Cato Institute, 2020.