Category: Health

“Endless” Trial-and-Error Experiments Led to Creation of Islet Cells to Cure Type 1 Diabetes

(p. 1) Brian Shelton’s life was ruled by Type 1 diabetes.

. . .

His ex-wife, Cindy Shelton, took him into her home in Elyria, Ohio. “I was afraid to leave him alone all day,” she said.

Early this year, she spotted a call for people with Type 1 diabetes to participate in a clinical trial by Vertex Pharmaceuticals. The company was testing a treatment developed over decades by a scientist who vowed to find a cure after his baby son and then his teenage daughter got the devastating disease.

Mr. Shelton was the first patient. On June 29, [2021] he got an infusion of cells, grown from stem cells but just like the insulin-producing pancreas cells his body lacked.

Now his body automatically controls its insulin and blood sugar levels.

Mr. Shelton, now 64, may be the first person cured of the disease with a new treatment that has experts daring to hope that help may (p. 18) be coming for many of the 1.5 million Americans suffering from Type 1 diabetes.

“It’s a whole new life,” Mr. Shelton said. “It’s like a miracle.”

. . .

One problem was the source of the cells — they came from unused fertilized eggs from a fertility clinic. But in August 2001, President George W. Bush barred using federal money for research with human embryos. Dr. Melton had to sever his stem cell lab from everything else at Harvard. He got private funding from the Howard Hughes Medical Institute, Harvard and philanthropists to set up a completely separate lab with an accountant who kept all its expenses separate, down to the light bulbs.

Over the 20 years it took the lab of 15 or so people to successfully convert stem cells into islet cells, Dr. Melton estimates the project cost about $50 million.

The challenge was to figure out what sequence of chemical messages would turn stem cells into insulin-secreting islet cells. The work involved unraveling normal pancreatic development, figuring out how islets are made in the pancreas and conducting endless experiments to steer embryonic stem cells to becoming islets. It was slow going.

. . .

The next step for Dr. Melton, knowing he’d need more resources to make a drug that could get to market, was starting a company.

. . .

His company Semma was founded in 2014, a mix of Sam and Emma’s names.

One challenge was to figure out how to grow islet cells in large quantities with a method others could repeat. That took five years.

The company, led by Bastiano Sanna, a cell and gene therapy expert, tested its cells in mice and rats, showing they functioned well and cured diabetes in rodents.

At that point, the next step — a clinical trial in patients — needed a large, well financed and experienced company with hundreds of employees. Everything had to be done to the exacting standards of the Food and Drug Administration — thousands of pages of documents prepared, and clinical trials planned.

Chance intervened. In April 2019, at a meeting at Massachusetts General Hospital, Dr. Melton ran into a former colleague, Dr. David Altshuler, who had been a professor of genetics and medicine at Harvard and the deputy director of the Broad Institute. Over lunch, Dr. Altshuler, who had become the chief scientific officer at Vertex Pharmaceuticals, asked Dr. Melton what was new.

Dr. Melton took out a small glass vial with a bright purple pellet at the bottom.

“These are islet cells that we made at Semma,” he told Dr. Altshuler.

Vertex focuses on human diseases whose biology is understood. “I think there might be an opportunity,” Dr. Altshuler told him.

Meetings followed and eight weeks later, Vertex acquired Semma for $950 million. With the acquisition, Dr. Sanna became an executive vice president at Vertex.

. . .

Less than two years after Semma was acquired, the F.D.A. allowed Vertex to begin a clinical trial with Mr. Shelton as its initial patient.

For the full story, see:

Gina Kolata. “A Cure for Severe Diabetes? For an Ohio Patient, It Worked.” The New York Times, First Section (Sunday, November 28, 2021): 1 & 18.

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

(Note: the online version of the story has the date Nov. 27, 2021, and has the title “A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked.”)

Wisconsin Hospitals Increasingly Sue Patients

(p. A8) Hospitals in Wisconsin have sued patients over medical debt at a rate that amounts to one out of every 1,000 residents a year, especially people in low-income areas and who are Black, a new study found.

The study, published Monday [Dec. 6, 2021] in the health-policy journal Health Affairs, found some hospitals were more likely than others to take patients to court and low-income and Black patients were disproportionately sued.

The findings highlight how the financial and legal jeopardy that patients face depends on which hospital they go to. The findings also add to mounting research on the consequences of medical debt, a problem that research shows is more acute among people who are uninsured.

Medical-bill lawsuits “are not a fait accompli,” said Zack Cooper, an economist with the Yale University School of Public Health and an author of the new lawsuit analysis. “This is very much a choice that these hospitals are making.”

. . .

Hospitals were suing people more for unpaid bills, the study also found. The rate increased to 1.53 lawsuits for every 1,000 residents in 2018, up from 1.12 lawsuits per 1,000 residents in 2001.

. . .

Dr. Cooper called for more data to better understand potential factors driving the disproportionate number of lawsuits among Black patients.

“First, Black patients could have a higher burden of unpaid medical bills, which leads them to get sued more on a per-capita basis,” he said. “Second, Black patients could have a similar amount of debt, but were more likely targeted by hospitals.”

For the full story, see:

Melanie Evans and Tom McGinty. “Hospital Debt-Collection Practices Vary.” The Wall Street Journal (Tuesday, Dec. 07, 2021): A8.

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

(Note: the online version of the story was updated December 6, 2021, and has the title “Hospitals in Wisconsin Pursued Medical Debt Collection Widely but Unevenly, Study Finds.” The online version says that the title of the New York print version is “Hospitals Faulted on Medical-Debt Suits.” The title of my National edition of the print version is “Hospital Debt-Collection Practices Vary.”)

The article co-authored by Cooper, and discussed above, is:

Cooper, Zack, James Han, and Neale Mahoney. “Hospital Lawsuits over Unpaid Bills Increased by 37 Percent in Wisconsin from 2001 to 2018.” Health Affairs 40, no. 12 (Dec. 2021): 1830-35.

Immuno-Suppressed Patients Take Longer to Clear Covid-19, Allowing Time for More Mutations and New Variants

(p. 14) When people with H.I.V. are prescribed an effective antiretroviral and take it consistently, their bodies almost completely suppress the virus. But if people with H.I.V. aren’t diagnosed, haven’t been prescribed treatment, or don’t, or can’t, take their medicines consistently each day, H.I.V. weakens their immune systems. And then, if they catch the coronavirus, it can take weeks or months before the new virus is cleared from their bodies.

When the coronavirus lives that long in their systems, it has the chance to mutate and mutate and mutate again. And, if they pass the mutated virus on, a new variant is in circulation.

“We have reasons to believe that some of the variants that are emerging in South Africa could potentially be associated directly with H.I.V.,” said Tulio de Oliveira, the principal investigator of the national genetic monitoring network.

In the first days of the pandemic, South Africa’s health authorities were braced for soaring death rates of people with H.I.V. “We were basically creating horror scenarios that Africa was going to be decimated,” said Salim Abdool Karim, an epidemiologist who heads the AIDS institute where KRISP is housed. “But none of that played out.” The main reason is that H.I.V. is most common among young people, while the coronavirus has hit older people hardest.

An H.I.V. infection makes a person about 1.7 times as likely to die of Covid — an elevated risk, but one that pales in comparison with the risk for people with diabetes, who are 30 times more likely to die. “Once we realized that this was the situation, we then began to understand that our real problems with H.I.V. in the midst of Covid was the prospect that severely immunocompromised people would lead to new variants,” Dr. Abdool Karim said.

. . .

. . . a single variant can rattle the world, as Omicron has.

The origin of this variant is still unknown. People with H.I.V. are not the only ones whose systems can inadvertently give the coronavirus the chance to mutate: It can happen in anyone who is immunosuppressed, such as transplant patients and those undergoing cancer treatments.

By the time the KRISP team identified the second case of a person with H.I.V. producing coronavirus variants, there were more than a dozen reports of the same phenomenon in medical literature from other parts of the world.

Viruses mutate in people with healthy immune systems, too. The difference for people with H.I.V., or another immunosuppressing condition, is that because the virus stays in their systems so much longer, the natural selection process has more time to favor mutations that evade immunity. The typical replication period in a healthy person would be just a couple of weeks, instead of many months; fewer replications mean less opportunities for new mutations.

. . .

. . ., South Africa’s efforts to tackle the variant issue, and be transparent about it, have come at a steep price, in the form of flight bans and global isolation.

“As scientists, especially in the kind of forefront, we debate playing down the H.I.V. problem,” Dr. de Oliveira mused in his lab last week. “If we are very vocal, we also risk, again, big discrimination and closing borders and economic measures. But, if you are not very vocal, we have unnecessary deaths.”

For the full story, see:

Stephanie Nolen. “A Variant Hunt on Dirt Roads and in the Lab.” The New York Times, First Section (Sunday, December 5, 2021): 1 & 14.

(Note: ellipses added.)

(Note: the online version of the story was updated Dec. 6, 2021, and has the title “The Variant Hunters: Inside South Africa’s Effort to Stanch Dangerous Mutations.” The online version says that the New York edition of the print version had the title “A Variant Hunt From the Labs To Dirt Roads.” The title of my National edition of the print version was “A Variant Hunt on Dirt Roads and in the Lab.”)

Ross Douthat’s Self-Doctoring Was “Intensely Empirical”

(p. 12) The early chapters of “The Deep Places” unfold like the first act of a horror movie. Feeling the pull of home and burned out by life on Capitol Hill, Ross Douthat (a New York Times columnist) and his wife buy a 1790s farmhouse on three acres of Connecticut pasture.

. . .

Something is lurking in those woods. Back in D.C., Douthat has a swollen lymph node, a stiff neck and strange vibrations in his head and mouth. The urgent care doctor he sees first diagnoses him with a harmless boil. A few weeks later, he is in an emergency room at dawn with an alarming full-body shutdown, “as if someone had twisted dials randomly in all my systems.” The E.R. doctor suggests stress as the culprit — as do, in subsequent visits, an internist, neurologist, rheumatologist and gastroenterologist. A psychiatrist, his 11th doctor in 10 weeks, disagrees.

Only after Douthat completes his move north to Connecticut, namesake of Lyme disease, does it seem obvious to local doctors that he is suffering from something tick-borne.

. . .

He makes his case that tick-borne disease needs more research and its sufferers deserve more respect.

The trouble is that Douthat also wants to present his reckless journey as a road map. His revelation: “Given a stockpile of antibiotics, the array of over-the-counter medications available on Amazon and crowdsourced data from hundreds and thousands of Lyme sufferers sharing their experiences online, I could effectively become my own doctor, mixing and matching to gauge my body’s reaction to different combinations, like a Lyme researcher working on a study with a sample size, an ‘N,’ of only 1.”

This self-doctoring, he adds, “was in its own way intensely empirical and materially grounded — the most empirical work, in fact, that I have ever attempted in my life.” (Comparing this approach to Khakpour’s introspective memoir, I kept thinking of the couples-therapy trope that women prefer to talk through their problems while men leap to solve them.)

. . .

A subsequent bout of undiagnosed Covid-19, and scientists’ stumbles as they’ve worked to understand the new virus, have only hardened Douthat’s distrust of institutions like the Centers for Disease Control and Prevention and the Food and Drug Administration. “From the beginning of the pandemic to its still unfinished end,” he writes, “there were weirdos on the internet who were more reliable guides to what was happening, what was possible, and what should actually be done than Anthony Fauci or any other official information source.”

For the full review, see:

Sara Austin. “Darkness Invisible.” The New York Times Book Review (Sunday, November 28, 2021): 12.

(Note: ellipses, added; italics, in original.)

(Note: the online version of the review has the Updated Oct. 30, 2021, and has the title “A Transporting and Cozy Biography of a Pottery Pioneer.”)

The book under review is:

Douthat, Ross. The Deep Places: A Memoir of Illness and Discovery. New York: Convergent Books, 2021.

When Sri Lanka Government Banned Chemical Fertilizers, Yields Tanked and Prices “Shot Up”

(p. A4) RATNAPURA, Sri Lanka — This year’s crop worries M.D. Somadasa. For four decades, he has sold carrots, beans and tomatoes grown by local farmers using foreign-made chemical fertilizers and pesticides, which helped them reap bigger and richer crops from the verdant hills that ring his hometown.

Then came Sri Lanka’s sudden, and disastrous, turn toward organic farming. The government campaign, ostensibly driven by health concerns, lasted only seven months. But farmers and agriculture experts blame the policy for a sharp drop in crop yields and spiraling prices that are worsening the country’s growing economic woes and leading to fears of food shortages.

Prices for some foodstuffs, like rice, have risen by nearly one-third compared with a year ago, according to Sri Lanka’s central bank. The prices of vegetables like tomatoes and carrots have risen to five times their year-ago levels.

“I haven’t seen times that were as bad as these,” said Mr. Somadasa, a 63-year-old father of two who sells vegetables in the small town of Horana, just outside the island nation’s capital, Colombo. “We can’t find enough vegetables. And with the price hikes, people find it hard to buy the vegetables.”

. . .

President Gotabaya Rajapaksa cited health concerns when his government banned the importation of chemical fertilizers in April [2021], a pledge he had initially made during his 2019 election campaign.

. . .

The push for organic farming didn’t start with Mr. Rajapaksa’s current government, nor when another brother, Mahinda Rajapaksa, currently the prime minister, was president from 2005 to 2015. Some farmers and agriculture industry officials say they are warming to the idea of reducing dependence on chemicals in farming. But the shift was too sudden for farmers who didn’t know how to work organically, said Nishan de Mel, director of Verité Research, a Colombo-based analysis firm.

Verité found in a July [2021] survey that three-quarters of Sri Lanka’s farmers relied heavily on chemical fertilizers, while just about 10 percent cultivated without them. Almost all major crops grown in the country depend on the chemicals. For crops crucial to the economy like rice, rubber and tea, the dependence reaches 90 percent or more.

The April ban went into effect just before what is known as the Yala planting season, which lasts from May to August, and was felt almost immediately. The Verité survey showed that 85 percent of farmers expected a reduction in their harvest because of the fertilizer ban. Half of them feared that their crop yield could fall by as much as 40 percent.

Food prices shot up in September [2021], . . .

For the full story, see:

Aanya Wipulasena and Mujib Mashal. “A Plunge Into Organic Farming Brings Disaster to Sri Lanka.” The New York Times (Wednesday, December 8, 2021): A4.

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

(Note: the online version of the story has the date Dec. 7, 2021, and has the title “Sri Lanka’s Plunge Into Organic Farming Brings Disaster.”)

“Unanticipated Tragedies Are Unpreventable, No Matter How Many Regulations”

(p. A15) Dr. Offit acknowledges the limits of regulatory fixes, noting that, while regulatory guidelines are important, “unanticipated tragedies are unpreventable, no matter how many regulations, training programs, fines, and penalties are put in place.” He contrasts the tragic death in 1999 of 18-year-old Jesse Gelsinger in an early gene-therapy study—aimed at remediating a rare enzyme deficiency—with the triumphant experience of Emily Whitehead, a girl with leukemia treated 11 years later at the same university with genetically manipulated T-cells. Gelsinger’s death has been ascribed to protocol deficiencies, conflicts of interest and inadequate regulation, but “a closer look,” Dr. Offit writes, “shows that the only difference between the outcomes of Emily Whitehead and Jesse Gelsinger were luck and timing.” The specific supportive approach used by Whitehead’s doctors to address a life-threatening complication of her T-cell infusion stemmed directly from the lessons learned during Gelsinger’s ordeal. We recognize successes, Dr. Offit laments, but “never the failures that made those successes possible.”

One anxiety suffusing every page of “You Bet Your Life” is what to make of the Covid-19 vaccines. Dr. Offit, a member of the FDA’s vaccine advisory committee, has been described in The Wall Street Journal as “an outspoken advocate of the science and value of vaccinations,” including the Covid-19 vaccine. He has described its clinical-trial data as “enormously reassuring” and has seen little evidence of “a very rare, serious side effect that would be something that would cause a long term problem.” Yet his review of the history of vaccination and of its complexities evokes surprising empathy for the vaccine-hesitant. He recounts the early days of the Salk polio vaccine, which saved lives yet also tragically transmitted the disease to some patients when the product was inadequately prepared by one of its manufacturers. He notes that “the first vaccines aren’t always the best, safest, and last” and regrets the “disturbing show of hubris” by the Covid vaccine developers.

Ultimately, Dr. Offit emphasizes, we need to come to terms with the fact that all medical technologies carry risk—as does the decision not to avail oneself of them. “A choice not to get a vaccine is not a risk-free choice,” Dr. Offit notes. Either way, he says, “you’re gambling”—so “choose the lesser risk.”

For the full review, see:

David A. Shaywitz. “BOOKSHELF; The Dangers Of Finding a Cure.” The Wall Street Journal (Tuesday, Nov. 09, 2021): A15.

(Note: the online version of the review has the date November 8, 2021, and has the title “BOOKSHELF; ‘You Bet Your Life’ Review: The Dangers of Finding a Cure.”)

The book under review is:

Offit, Paul A. You Bet Your Life: From Blood Transfusions to Mass Vaccination, the Long and Risky History of Medical Innovation. New York: Basic Books, 2021.

Covid-19 Raised Our Blood Pressure

(p. A12) On Monday [Dec. 6, 2021], scientists reported that blood pressure measurements of nearly a half-million adults showed a significant rise last year, compared with the previous year.

These measurements describe the pressure of blood against the walls of the arteries. Over time, increased pressure can damage the heart, the brain, blood vessels, kidneys and eyes. Sexual function can also be affected.

“These are very important data that are not surprising, but are shocking,” said Dr. Donald M. Lloyd-Jones, president of the American Heart Association, who was not involved in the study.

“Even small changes in average blood pressure in the population,” he added, “can have a huge impact on the number of strokes, heart failure events and heart attacks that we’re likely to be seeing in the coming months.”

The study, published as a research letter in the journal Circulation, is a stark reminder that even in the midst of a pandemic that has claimed more than 785,000 American lives and disrupted access to health care, chronic health conditions must still be managed.

. . .

“We observed that people weren’t exercising as much during the pandemic, weren’t getting regular care, were drinking more and sleeping less,” said Dr. Luke Laffin, the lead author, a preventive cardiologist who is co-director of the Center for Blood Pressure Disorders at the Cleveland Clinic. “We wanted to know, was their blood pressure changing during the pandemic?”

The researchers found that blood pressure readings changed little from 2019 to the first three months of 2020, but increased significantly from April 2020 through December 2020, compared with the same period in 2019.

. . .

The new study found that the average monthly change from April 2020 to December 2020, compared with the previous year, was 1.10 mm Hg to 2.50 mm Hg for systolic blood pressure, and 0.14 to 0.53 for diastolic blood pressure.

The increases held true for both men and women, and in all age groups. Larger increases in both systolic and diastolic blood pressure were seen in women.

The average age of the study participants was just over 45, and slightly more than half were women.

. . .

The causes of an overall increase in blood pressure are not clear, Dr. Laffin and his colleagues said. The reasons may include an increase in alcohol consumption, a decline in exercise, rising stress, a drop in doctors’ visits and less adherence to a medication regimen.

The researchers dismissed a possible effect of weight gain, known to raise blood pressure, saying that the men in the study had lost weight and that the women had not gained more weight than usual.

For the full story, see:

Roni Caryn Rabin. “Does the Pandemic Have Your Blood Pressure Rising? You’re Not Alone.” The New York Times (Tuesday, December 7, 2021): A12.

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

(Note: the online version of the story has the date Dec. 6, 2021, and has the title “The Pandemic Has Your Blood Pressure Rising? You’re Not Alone.”)

The study summarized above is:

Laffin, Luke J., Harvey W. Kaufman, Zhen Chen, Justin K. Niles, Andre R. Arellano, Lance A. Bare, and Stanley L. Hazen. “Rise in Blood Pressure Observed among Us Adults During the Covid-19 Pandemic.” Circulation (2021) Published online: https://doi.org/10.1161/CIRCULATIONAHA.121.057075.

New Nuclear Designs Are “Cheap, Efficient, Extremely Reliable”, “Nearly Carbon-Free” and Much Safer

(p. A17) Jacopo Buongiorno, a nuclear-engineering professor at the Massachusetts Institute of Technology, has calculated that over the life cycle of power plants, which includes construction, mining, transport, operation, decommissioning and disposal of waste, the greenhouse-gas emissions for nuclear power are 1/700th those of coal, 1/400th of gas, and one-fourth of solar. Nuclear also requires 1/2,000th as much land as wind and around 1/400th as much as solar. For any given power output, the amount of raw material used to build a nuclear plant is a small fraction of an equivalent solar or wind farm. Although nuclear waste is obviously more difficult to dispose of, its volume is 1/10,000th that of solar and 1/500th of wind. This includes abandoned infrastructure and all the toxic substances that end up in landfills. One person’s lifetime use of nuclear power would produce about a half-ounce of waste. Even including the Chernobyl disaster, human mortality from coal is 2,000 to 3,000 times that of nuclear, while oil claims 400 times as many lives.

Although the federal government tends to resist nuclear power, many nuclear technologies are being investigated and funded by private capital including molten-salt reactors, liquid-metal reactors, advanced small modular reactors, microreactors and much more. More than 70 development projects are under way in the U.S., with many designs intended to create assembly-line construction facilities to simplify and standardize testing, licensing and installations. One appealing approach is to replace large-scale facilities with many smaller but safer, cheaper and more-manageable ones. The $10 billion 10-year planning and implementation cycle for a large nuclear plant can be cut in half with a small modular reactor and another half with a microreactor.

. . .

Nuclear power is cheap, efficient, extremely reliable and nearly carbon-free. New designs, including smaller reactors, drastically reduce the risk of large-scale radioactive contamination.

. . .

Sacrifice isn’t always the path to progress.

For the full commentary, see:

Andrew I. Fillat and Henry I. Miller. “Nuclear Power Is the Best Climate-Change Solution by Far.” The Wall Street Journal (Friday, Nov. 5, 2021): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date November 4, 2021, and has the same title as the print version.)

“Precautionary Principle Would Have Vastly Slowed” Anesthesia, Antibiotics, Chemotherapy and Other Medical Innovations

(p. 15) In his new book, “You Bet Your Life,” Paul A. Offit wants to understand the failures and tragedies that help pave the way to medical innovation. For most of human history, anesthesia did not exist. Patients had to be forcibly restrained while their limbs were amputated and their cancers were removed, typically amid piercing screams and unbearable agony. Things did not start to change until the 1840s, when a carnival barker named Gardner Colton charged people 25 cents to sniff “laughing gas,” also known as nitrous oxide, which made them fall down in hysterics and then go to sleep for a few minutes. On Dec. 10, 1844, a dentist named Horace Wells attended Colton’s show. Soon after inhaling the gas (and making a fool of himself), he told a friend that a person could probably “have a tooth extracted or a limb amputated and not feel any pain.”

Wells sought out Colton immediately after the show, and the very next day, he became the first person to use nitrous oxide as an anesthetic: He asked a fellow dentist to extract one of his own teeth. The procedure was painless. Over the following weeks, Wells used nitrous oxide on 15 of his patients. It worked every time. In January 1845, he asked if he could demonstrate his method to specialists in a large amphitheater at the Massachusetts General Hospital. The demonstration failed. Wells gave too little of the anesthetic to his patient, who woke up during the extraction, in intense pain and screaming. Members of the audience shouted out, “Humbug!” Wells was disgraced.

. . .

Offit is a good storyteller, and he has some terrific stories to tell. He also draws important lessons. In the domain of medical innovation, tragedies cannot be prevented, no matter how many regulations we put in place. Science moves forward in fits and starts, with blunders, failures and losses along the way. New discoveries are rarely immediate; we inevitably learn more over time. Ours is not a risk-free world, which means that we need to choose the lesser risk. New technologies are always a gamble.

All of those claims are true, but I think that Offit also pulls out an even deeper and more provocative moral from this history. In life and in public policy, many people in Europe and the United States are drawn to the “precautionary principle,” which essentially calls for a high degree of risk aversion: Whenever an innovation threatens to cause harm, we should be exceedingly cautious before we allow it. Offit’s examples, and the history of medical advances, demonstrate that in its most extreme forms, the precautionary principle is self-defeating. Simply put, precautions kill. Whether we are speaking of anesthesia, heart transplants, antibiotics, chemotherapy or blood transfusions, the precautionary principle would have vastly slowed down innovations that, yes, carried serious risk and led to real harm, but were ultimately a great boon to humanity.

For the full review, see:

Cass R. Sunstein. “Side Effects.” The New York Times Book Review (Sunday, October 17, 2021): 15.

(Note: ellipsis added.)

(Note: the online version of the review was updated Oct. 25, 2021, and has the title “A History of Medical Innovation That Doesn’t Ignore the Side Effects.”)

The book under review is:

Offit, Paul A. You Bet Your Life: From Blood Transfusions to Mass Vaccination, the Long and Risky History of Medical Innovation. New York: Basic Books, 2021.

N.I.H. Funded EcoHealth Wuhan Research to Make Coronaviruses More Infective and Virulent

(p. A21) EcoHealth Alliance has come under scrutiny because of its collaboration on coronavirus research with researchers at the Wuhan Institute of Virology, which is situated in the city where the pandemic began.

. . .

Last month, The Intercept, an online publication, posted 900 pages of materials related to the N.I.H. grants to EcoHealth Alliance for the research. The materials provided details about experiments designed to provide new insights into the risk that bat coronaviruses have for sparking new pandemics.

In some of their experiments, the researchers isolated genes from bat coronaviruses that encode a surface protein, called spike. Coronaviruses use the spike protein to bind to host cells, the first step to an infection. The spike protein latches onto a cell-surface protein called ACE2.

According to the materials published, the researchers then engineered another bat virus, called WIV1, to carry spike proteins from other bat coronaviruses. They then conducted experiments to see if the engineered WIV1 viruses became better at attaching to ACE2 on cells.

. . .

Dr. Lawrence Tabak, the principal deputy director of the N.I.H., wrote in the letter to Representative Comer that the agency determined that the research proposed by EcoHealth Alliance did not meet the criteria for additional review . . .

. . .

Dr. Tabak noted that in one line of research, the researchers had produced mice genetically engineered to produce the human version of the ACE2 protein on their cells. Infecting these animals with coronaviruses could potentially provide a more realistic sense of the risk that the viruses have of infecting humans than just using dishes of cells.

The N.I.H. required that EcoHealth Alliance notify the agency if the engineered viruses turned out to grow 10 times faster or more than WIV1 would without their new spike proteins.

In some experiments, it turns out, that viruses did grow quickly.

“EcoHealth failed to report this finding right away, as required by the terms of the grant,” Dr. Tabak wrote.

The N.I.H. also sent Representative Comer a final progress report that EcoHealth Alliance submitted to the agency in August [2021].

In the report, the researchers describe finding that WIV1 coronaviruses engineered to carry spike proteins were more virulent. They killed infected mice at higher rates than did the WIV1 virus without spikes from the other coronaviruses.

The filing had been submitted late, the N.I.H. said, nearly two years beyond the grant-specified deadline of 120 days from completion of the work. “Delayed reporting is a violation of the terms and condition of N.I.H. grant award,” Renate Myles, a spokeswoman for the agency, said.

Jesse Bloom, a virologist at the Fred Hutchinson Cancer Center who has called for more research into the origins of the pandemic, said the revelations raised serious questions about the risks of investigating viruses originating from animals, known as zoonotic viruses.

For the full story, see:

Carl Zimmer and Benjamin Mueller. “N.I.H. Says Bat Studies Were Not Submitted Promptly.” The New York Times (Friday, October 22, 2021): A21.

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

(Note: the online version of the story was updated October 28, 2021, and has the title “Bat Research Group Failed to Submit Virus Studies Promptly, N.I.H. Says.”)

CDC Intentionally Overestimated Risk of Heterosexual Spread of AIDS

(p. A17) ‘Follow the science,” we’ve been told throughout the Covid-19 pandemic. But if we had paid attention to history, we would have known that once a disease becomes newsworthy, science gets distorted by researchers, journalists, activists and politicians eager for attention and power—and determined to silence those who challenge their fear-mongering.

When AIDS spread among gay men and intravenous drug users four decades ago, it became conventional wisdom that the plague would soon devastate the rest of the American population.

. . .

In reality, researchers discovered early on that transmission through vaginal intercourse was rare, and that those who claimed to have been infected that way were typically concealing intravenous drug use or homosexual activity. One major study estimated the risk of contracting AIDS during intercourse with someone outside the known risk groups was 1 in 5 million. But the CDC nonetheless started a publicity campaign warning that everyone was in danger. It mailed brochures to more than 100 million households and aired dozens of public-service announcements, like a television ad with a man proclaiming, “If I can get AIDS, anyone can.”

The CDC’s own epidemiologists objected to this message, arguing that resources should be focused on those at risk, as the Journal reported in 1996. But they were overruled by superiors who decided, on the advice of marketing consultants, that presenting AIDS as a universal threat was the best way to win attention and funding. By those measures, the campaign succeeded. Polls showed that Americans became terrified of being infected, and funding for AIDS prevention surged—much of it squandered on measures to protect heterosexuals.

Scientists and public officials sustained the panic by wildly overestimating the prevalence of AIDS. Challenging those numbers was a risky career move, as New York City’s health commissioner, Stephen C. Joseph, discovered in 1988 when he reduced the estimated number of AIDS cases in the city by half. He had good reasons for the reduction—the correct number turned out to be much lower still—but he soon needed police protection. Activists occupied his office, disrupted his speeches, and picketed and spray-painted his home.

Another victim of 1980s-style cancel culture was Michael Fumento, who meticulously debunked the scare in his 1990 book, “The Myth of Heterosexual AIDS.” It received good reviews and extensive publicity, but it was unavailable in much of the country because local bookstores and national chains succumbed to pressure not to sell it. Mr. Fumento’s own publisher refused to keep it in print, and he was forced out of two jobs—one as an AIDS analyst in the federal government.

The AIDS fear-mongers suffered few consequences for their mistakes.

For the full commentary, see:

John Tierney. “Unlearned AIDS Lessons for Covid.” The Wall Street Journal (Monday, October 4, 2021): A17.

(Note: ellipsis added.)

(Note: the online version of the commentary was updated October 3, 2021, and has the same title as the print version.)