Category: Regulations

“The F.D.A. and the Drug Houses Were in Bed Together”

(p. A22) Dr. John S. Najarian, a groundbreaking transplant surgeon who made headlines for taking on difficult cases, and who weathered a different type of headline when he was accused, and then exonerated, of improprieties related to a drug he had developed, died on Aug. 31 in Stillwater, Minn., east of Minneapolis.

. . .

In November 1982, Dr. Najarian performed what may have been his highest-profile surgery. The patient was Jamie Fiske, who became the youngest successful liver transplant recipient when Dr. Najarian performed the operation a few weeks before her first birthday. Her parents had made a widely publicized appeal for a donor.

“They were told that she wouldn’t survive that kind of an operation,” Dr. Najarian said in an oral history recorded in 2011 for the University of Minnesota’s Academic Health Center. “I’m not the kind of guy that takes that lightly. So I told them, ‘If a liver becomes available, we’ll transplant it, and it will work’ — a pretty brash statement, but it did.”

Dr. Najarian’s success with transplants was aided by a drug he developed in 1970, a type of antilymphocyte globulin known as Minnesota ALG, which addressed the biggest problem with early transplants: the rejection of the new organ. He said the drug, which he began using around 1970, gave the Minnesota transplant teams notably better results than other surgical centers were getting with a product offered by a pharmaceutical company.

“Everybody thought we were lying,” Dr. Najarian said, “because we could take patients and we could transplant them, and 65 to 70 percent of them did extremely well, whereas they were lucky to have 50 percent with the commercially available product from Upjohn.”

Other transplant centers began asking for the product, and it turned into a multimillion-dollar business for the university. But in 1992, the Food and Drug Administration, which had approved ALG as an investigational drug but not for interstate sale, stopped the program, and the federal authorities began an investigation. The university turned on Dr. Najarian, pressuring him to resign, and in 1995 he was charged with violating drug safety laws and other crimes.

Dr. Najarian maintained that the case was an attempt by the pharmaceutical industry and its friends in the F.D.A. to squash a successful treatment that was costing drug companies money by besting their products.

“The F.D.A. and the drug houses were in bed together,” he said bluntly in the oral history.

His trial in federal court in St. Paul, Minn., in 1996 provided vindication. Judge Richard Kyle threw out six of the charges, and a jury acquitted him of the other 15. The judge then took the extraordinary step of blasting the F.D.A. and the prosecutors.

“I have some questions as to why we were here at all,” Judge Kyle said.

The F.D.A., he added, “was certainly aware of what was going on, and yet they came in here as a witness to testify that somehow they were hoodwinked by this defendant and his colleagues and other people at the university.”

“We had a program here in Minnesota,” the judge added, “which, for all its problems and shortcomings, was a good program, literally saved thousands of lives.”

For the full obituary, see:

Neil Genzlinger. “John Najarian, 92, Revered Transplant Surgeon Who Took Tough Cases, Dies.” The New York Times (Monday, September 29, 2020): A22.

(Note: ellipsis added.)

(Note: the online version of the obituary was updated Sept. 19, 2020, and has the title “John Najarian, Pioneering Transplant Surgeon, Dies at 92.”)

California Energy Shortage Partly Due to Government Mandated Price Ceiling on Energy Imported from Out-of-State

(p. B9) As California keeps facing electricity shortages, the discussion around its grid often veers to extremes.

. . .

Should California . . . have shut down less natural gas and nuclear power? That is definitely part of the issue, and future shutdowns might need to slow.

. . .

. . . at least some of the shortage is addressable through market rules.

For example, California has a hard import bid cap of $1,000 per megawatt hour. Christopher DaCosta, regional director of western power markets at Wood Mackenzie, says that surrounding areas have a softer cap and are able to pay more. During this summer, that meant power plants often rerouted electricity to higher bidders than California.

For the full commentary, see:

Jinjoo Lee. “To Keep Lights On, California Needs Power Play.” The Wall Street Journal (Thursday, September 17, 2020): B9.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sep. 16, 2020, and has the title “How to Keep the Lights On in California.”)

“You Can’t Wait for Somebody to Make a Giant Study”

(p. A6) In April [2020], researchers published an article in the Journal of the American Medical Association suggesting many Covid-19 patients with respiratory distress might require a different treatment approach than typically used for ARDS.

. . .

Maurizio Cereda, an anesthesiologist and head of the surgical ICU at the Hospital of the University of Pennsylvania, said doctors normally use standardized tables to match the level of oxygen in the blood with the amount of PEEP needed. Penn tends to use a table with lower PEEP values, he said, but even those lower levels seem to damage the lungs of some of his Covid-19 patients. As a result, he disregards the table entirely at times, he said, even though some in his institution disagree with his approach.

“You can’t wait for somebody to make a giant study,” Dr. Cereda said. “You are alone with your clinical observation. A lot of people don’t feel comfortable with that because they want to have big guidelines. People seem to be afraid they’re going to do something wrong.”

. . .

At Maimonides Medical Center in Brooklyn, critical-care and emergency-medicine doctor Cameron Kyle-Sidell said he was initially seeing much higher mortality rates from Covid19 patients on ventilators than he would have expected from classic ARDS, possibly because physicians were sticking to PEEP levels used to treat traditional ARDS.

“There are people who are treating this the way they would have treated any other ARDS,” he said. “Then there’re people on the flip side—and I am on that flip side—that think you should treat it as a different disease than we treated in the past.”

For the full story, see:

Sarah Toy and Mark Maremont. “Doctors Split on Best Way To Treat Coronavirus Cases.” The Wall Street Journal (Thursday, July 2, 2020): A6.

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

(Note: the online version of the story has the date July 1, 2020, and has the title “Months Into Coronavirus Pandemic, ICU Doctors Are Split on Best Treatment.” The online version quoted above includes a couple of added sentences quoting Dr. Cereda, beyond the single sentence quoted in the print version.)

California Government Allowed “Buildup” of “Fuel for Future Blazes”

(p. A1) California is one of America’s marvels. By moving vast quantities of water and suppressing wildfires for decades, the state has transformed its arid and mountainous landscape into the richest, most populous and bounteous place in the nation.

. . .

(p. A16) The intensity of the fires . . . reflects decades of policy decisions that altered those forests, according to Robert Bonnie, who oversaw the United States Forest Service under President Barack Obama. And the cost of those decisions is now coming due.

In an effort to protect homes and encourage new building, governments for decades focused on suppressing fires that occurred naturally, allowing the buildup of vegetation that would provide fuel for future blazes. Even after the drawbacks of that approach became clear, officials remained reluctant to reduce that vegetation through prescribed burns, wary of upsetting residents with smoke or starting a fire that might burn out of control.

That approach made California’s forests more comfortable for the estimated 11 million people who now live in and around them. But it has also made them more susceptible to catastrophic fires. “We’ve sort of built up this fire debt,” Mr. Bonnie said. “People are going to have to tolerate smoke and risk.”

For the full story, see:

Christopher Flavelle. “Mankind’s Feats Place California At Climate Risk.” The New York Times (Monday, September 21, 2020): A1 & A15.

(Note: ellipses added.)

(Note: the online version of the story has the date September 20, 2020, and has the title “How California Became Ground Zero for Climate Disasters.”)

“Operation Warp Speed, . . . , Is More Imaginative Than the Bureaucratic Norm”

(p. 11) . . . the blundering of the Trump administration, while real and deadly, may not be responsible for the bulk of America’s coronavirus fatalities.

. . .

. . . : the absence of challenge trials for vaccines (in which young, healthy participants agree to be vaccinated and then infected with the virus), the predictable expert resistance to at-home testing. But the most important one was the straightforward bureaucratic calamity at the C.D.C. that delayed effective testing for a fateful month.

An effective president might have addressed some of these problems. (Although Operation Warp Speed, the White House’s vaccine initiative, is more imaginative than the bureaucratic norm.) But overall they are problems with structures and habits rather than personalities — an institutional decadence that predated Trump and will persist when he is gone.

. . .

. . . the third thing you see when you look beyond Trump [is] the fact that so many countries in Western Europe, to say nothing of our neighbors in the Americas, have had death rates similar to ours.

This reality speaks not of exceptionalism but of convergence — and the possibility that the trends of the early 21st century have left us sharing more in common not only with France and Spain but also with Mexico and Brazil than most Americans might expect.

This, too, may matter long after Trump is gone. Where there are crises, in this dispensation, they are likely to be general rather than just American. Where there is decadence, it is the shared experience of late modernity. And if renewal comes to an exhausted West, it will not necessarily come through America alone.

For the full commentary, see:

Ross Douthat. “What Isn’t Trump’s Fault.” The New York Times, SundayReview Section (Sunday, September 13, 2020): 11.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sept. 12, 2020, and has the same title as the print version.)

“An Active Regulatory State Is a Playground for the Privileged Class”

(p. A17) . . . the poor would suffer most under Mr. Biden’s platform. Dividing U.S. households into five income groups, I have estimated the regulatory costs of each quintile and expressed them as a percentage of each quintile’s average income. The costs to the bottom group amount to 15.3% of its total income—representing a burden equal to all the taxes they currently pay. This group would experience part of the cost as lower wages, but the biggest bite would come in diminished purchasing power due to higher prices for energy, cars and other consumer goods.

The top quintile, by contrast, would suffer the least from regulatory restoration, with labor, energy and other consumer rules amounting to only a 2.2% implicit tax on the highest earners.

This estimate includes not only regulations Mr. Biden has explicitly said he would revive, but also many of those that would be necessary to meet the goals outlined in his platform.

. . .

An active regulatory state is a playground for the privileged class to indulge its own preferences at the expense of ordinary Americans.

For the full commentary, see:

Casey B. Mulligan. “The Real Cost of Biden’s Plans.” The Wall Street Journal (Thursday, September 17, 2020): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sep. 16, 2020, and has the same title as the print version.)

Former FDA Commissioners Urge Early “Emergency Use Authorization” for Covid-19 Vaccine

(p. A17) As former FDA commissioners, we are confident in the FDA’s career scientists to oversee vaccine development rigorously.

If a Covid vaccine clears this process, it could be made available initially to specific groups of people through an Emergency Use Authorization. This emergency authority enables the FDA to make products available before a full application is approved by the agency. Congress created the emergency-use pathway as part of the Project BioShield Act of 2004, which provided for the development of medical countermeasures against chemical, biological, radiological and nuclear threats. Following 9/11 and anthrax, lawmakers expected an urgent need for such defenses.

After the 2009 swine flu, Congress expanded this pathway in the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, a bipartisan measure aimed at preparing the country to weather a pandemic. The law streamlined the application process for emergency use, expanded the classes of drugs eligible, and broadened the testing the FDA could require.

. . .

This authority enables the staged entry of a vaccine. It’s unlikely that a Covid-19 vaccine will receive full approval and broad distribution right away. Instead, the FDA will probably authorize vaccines for use in targeted groups of people at high risk from Covid and most likely to benefit from the vaccine. For them, it may make sense to provide access to the vaccine before long-term follow-up studies that address very remote risks.

This might include health-care providers or first responders, who face greater exposure, or older people, who are more prone to severe complications if infected.

. . .

This process exists precisely to deal with public-health emergencies like Covid-19. It isn’t a lower standard for FDA approval. It’s a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a Covid-19 vaccine.

For the full commentary, see:

Mark McClellan, and Scott Gottlieb. “How ‘Emergency Use’ Can Help Roll Out a Covid Vaccine.” The Wall Street Journal (Monday, September 15, 2020): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sep. 13, 2020, and has the same title as the print version.)

Russia Approves Covid-19 Vaccine Before Completing Phase 3 Clinical Trial

(p. A6) MOSCOW — Russia has become the first country in the world to approve a vaccine for the coronavirus, President Vladimir V. Putin announced on Tuesday, though global health authorities say the vaccine has yet to complete critical, late-stage clinical trials to determine its safety and effectiveness.

Mr. Putin, who told a cabinet meeting on Tuesday [Aug. 11, 2020] morning that the vaccine “works effectively enough,” said that his own daughter had taken it. And in a congratulatory note to the nation, he thanked the scientists who developed the vaccine for “this first, very important step for our country, and generally for the whole world.”

. . .

If Russian scientists have taken an unorthodox route to the coronavirus vaccine, it would not be the first time. Back in the 1950s, a team of researchers tested a promising, and ultimately successful, polio vaccine on their own children.

For the full story, see:

Andrew E. Kramer. “Putin Says Russia Is First to Approve Vaccine, but Skepticism Abounds.” The New York Times (Wednesday, August 12, 2020): A6.

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

(Note: the online version of the story was updated Aug. 11, 2020, and has the title “Russia Approves Coronavirus Vaccine Before Completing Tests.”)

Shanghai Immunologist Says Phase 1 and Phase 2 Tests Show Chinese Vaccine Is Safe and “Highly Likely” to Protect Against Covid-19

(p. A8) The United Arab Emirates has become the first country outside China to approve emergency usage of a Chinese Covid-19 vaccine candidate, in a vote of confidence for a state-backed drugmaker racing global rivals to stop the spread of the coronavirus.

. . .

Tao Lina, a former immunologist with the Shanghai CDC, said in an interview that it makes sense for authorities to approve the usage of Chinese vaccines that have proved safe during the first two phases of clinical trials, given the scale of the Covid-19 crisis. Unlike medical drug treatments, vaccines work by triggering a person’s own immunity, he said. “I’m not at all worried about the safety of the vaccines,” Mr. Tao said.

While the level of efficacy of the Chinese vaccines being used including those of Sinopharm isn’t yet clear, Mr. Tao said the Chinese vaccines’ ability to induce the body to produce antibodies during previous clinical trials meant that they were highly likely to confer some degree of protection from the virus.

For the full story, see:

Chao Deng, and Rory Jones. “U.A.E. Approves Use of China-Made Covid-19 Vaccine.” The Wall Street Journal (Wednesday, September 16, 2020): A8.

(Note: ellipsis added.)

(Note: the online version of the story was updated Sep. 15, 2020, and has the title “In Global Covid-19 Vaccine Race, Chinese Shot Receives First Foreign Approval.”)

China’s “Emergency-Use” Rule Allows Vaccinating Hundreds of Thousands Against Covid-19

(p. A1) A Chinese pharmaceutical company has injected hundreds of thousands of people with experimental Covid-19 vaccines, as its Western counterparts warn against administering mass vaccinations before rigorous scientific studies are complete.

China National Biotec Group Co., a subsidiary of state-owned Sinopharm, has given two experimental vaccine candidates to hundreds of thousands of people under an emergency-use condition approved by Beijing in July [2020], the company said this week.

For the full story, see:

Chao Deng. “China Tests Vaccines on Hundreds of Thousands.” The Wall Street Journal (Saturday, September 12, 2020): A1 & A8.

(Note: bracketed year added.)

(Note: the online version of the story was updated September 12, 2020, and has the title “China Injects Hundreds of Thousands With Experimental Covid-19 Vaccines.”)

Asymptomatic Transmission of Covid-19 Reduces Value of Fever Checks

(p. A4) . . . while health officials have endorsed masks and social distancing as effective measures for curbing the spread of the coronavirus, some experts scoff at fever checks. Taking temperatures at entry points is nothing more than theater, they say, a gesture that is unlikely to screen out many infected individuals, and one that offers little more than the illusion of safety.

. . .

. . . a growing body of evidence suggests that many of those who are driving transmission are so-called silent carriers — people who have been infected but feel fine, and don’t have a fever or any other symptoms.

. . .

“We now have a better understanding of Covid-19 transmission that indicates symptom-based screening has limited effectiveness because people with Covid-19 may have no symptoms or fever at the time of screening, or only mild symptoms,” the C.D.C. said in a statement.

. . .

Evidence of asymptomatic spread dates back to early in the pandemic, but has been mounting ever since. A recent study from South Korea published in JAMA Internal Medicine in August offered even more proof, finding that infected individuals who don’t feel ill may carry just as much virus in their nose, throat and lungs as those with symptoms — and for almost as long.

. . .

A. David Paltiel, a professor of health policy and management at Yale School of Public Health, says these individuals are the “silent spreaders” who are driving transmission and sparking superspreading events.

“You are maximally infectious before you exhibit symptoms, if you exhibit any symptoms at all,” Dr. Paltiel said. “You can be exposed and incubating the virus, and be beginning to shed massive amounts of transmissible virus and be a superspreader, without actually exhibiting any symptoms like a fever.”

For the full story, see:

Roni Caryn Rabin. “Fever Checks Are on the Rise, but Are They Effective Gatekeepers?” The New York Times (Monday, September 14, 2020): A4.

(Note: ellipses added.)

(Note: the online version of the story was updated September 14, 2020, and has the title “Fever Checks Are No Safeguard Against Covid-19.”)

The paper in JAMA Internal Medicine discussed above is:

Lee, Seungjae, Tark Kim, Eunjung Lee, Cheolgu Lee, Hojung Kim, Heejeong Rhee, Se Yoon Park, Hyo-Ju Son, Shinae Yu, Jung Wan Park, Eun Ju Choo, Suyeon Park, Mark Loeb, and Tae Hyong Kim. “Clinical Course and Molecular Viral Shedding among Asymptomatic and Symptomatic Patients with Sars-Cov-2 Infection in a Community Treatment Center in the Republic of Korea.” JAMA Internal Medicine (published online in advance of print Aug. 6, 2020). Doi:10.1001/jamainternmed.2020.3862