Category: Government

F.D.A. Chief Sets Low Bar for Cancer Progress–Three Months of Longer Life Is “A Major Therapeutic Advance”

F.D.A. regulations have slowed progress toward curing cancer. Rather than reduce regulations, the head of the F.D.A. redefines “progress” as occurring when a new drug increases average lifespan by a mere three months.

(p. D3) Was there a moment when you realized a new era had begun?

It was a gradual thing. I wish I could say I had an “a-ha” moment.

I remember though, one of our first approvals of a PD-1 drug (a drug that unleashes the immune system to fight cancer). A division director sent me an email with a survival curve for patients in a study. It was a Friday afternoon. I saw it and I nearly fell off my seat. It was such a positive study for these patients with squamous cell lung cancer. They lived an average of six months with standard chemotherapy. With the new drug they lived 9.2 months.

I called the division director and said, “What are we going to do to expedite this?”

We had to get a submission from the drug company and that can take several months. Sometimes it takes six months and sometimes up to a year because of the voluminous amount of material that must be provided.

We got the submission in a couple of months. Nivolumab was approved in March of 2015.

It was a major therapeutic advance. These were people who heretofore had few therapeutic options.

. . .

. . ., my regret? I won’t be here in 2049, my presumed 50th F.D.A. anniversary.

I would love to see what oncology looks like given the rapid changes in the past 25 years. Hang on tight. The velocity of innovation will only increase.

For the full interview see:

Gina Kolata, interviewer. “F.D.A.’s Cancer Chief Is Forward Focused.” The New York Times (Tuesday, November 19, 2024): D3.

(Note: ellipses added.)

(Note: the online version of the interview has the date Nov. 8, 2024, and has the title “He’s the F.D.A.’s Cancer Chief, Not a Fortune Teller.” The question is from the interviewer Gina Kolata. The rest of the words are quoted from the answers of Dr. Richard Pazdur.)

Peppermint at One Time Required a Prescription, While Strychnine Was Sold Over-the-Counter

I suspect I would not much like the Remaking the American Patient book–it seems to blame capitalism for all of the ills of the healthcare system. But it does include one compelling example of the limitations of government regulation of drugs: allowing strychnine while restricting peppermint.

(p. D3) Medical historians who focus on the conquest of dire diseases serve up narratives of progress and triumph. Not Ms. Tomes, a professor of history at Stony Brook University, who has chosen to examine instead the health care experience of average healthy citizens, the great silent majority whose lives are punctuated by a variety of minor ills and only the occasional major calamity.

. . .

Are you perplexed by our regulatory chaos, with layer upon layer of well-meaning but persistently ineffective efforts to guarantee the safety of medical services? It turns out we come from a long tradition of such inadequacy: Patient safety has been the holy grail for everyone, long sought, never achieved.

Drug regulatory efforts have been inconsistent and confusing. (At one point in the 1940s, peppermint drops were available by prescription, while strychnine could be freely purchased by anyone).

For the full review see:

Abigail Zuger, M.D. “When Patients Became Purchasers.” The New York Times (Tuesday, January 26, 2016 [sic]): D3.

(Note: ellipsis added.)

(Note: the online version of the review has the date Jan. 23, 2016 [sic], and has the title “Review: ‘Remaking the American Patient’.”)

The book under review above is:

Tomes, Nancy. Remaking the American Patient: How Madison Avenue and Modern Medicine Turned Patients into Consumers, Studies in Social Medicine. Chapel Hill: The University of North Carolina Press, 2016.

Democratic New York Department of Environmental Conservation Raids Home, Seizing and Killing P’Nut, Internet-Famous Orphan Pet Squirrel

(p. A15) . . . P’Nut was an internet-famous squirrel who was seized and euthanized by New York State wildlife agents last week . . .

. . .

. . . Elon Musk lionized the rodent as a Jedi martyr — more powerful in death than in life.

“RIP Peanut,” read a post on a Trump campaign’s official TikTok account on Sunday [Nov. 3, 2024]. “Needlessly murdered by Democrat bureaucrats in New York.”

. . .

P’Nut’s journey from cowboy-hat-wearing Instagram cutie to conservative lightning rod began on Oct. 30 [2024]. That was when New York State Department of Environmental Conservation officers, responding to what the agency said were anonymous complaints, arrived at the home of his owner, Mark Longo, in Pine City in Chemung County. In New York State, it is illegal to house animals considered wildlife without a special permit; Mr. Longo has said he was in the process of applying for one.

D.E.C. agents seized the squirrel, which Mr. Longo had cared for ever since its mother was hit by a car seven years ago. Agents also apprehended Fred the raccoon. At some point, the squirrel bit a person involved with the investigation, according to a statement put out by the agency, leading its officers to swiftly euthanize both animals to test for rabies.

In tearful online posts, Mr. Longo and his wife, Daniela, railed against tax dollars being spent to kill the animals they considered pets.

. . .

In Macon, Ga., Marjorie Taylor Greene, the Georgia congresswoman, spoke at a Trump rally and compared Peanut’s fate to that of Laken Riley, a local woman who was killed by a Venezuelan man who had once lived in New York. She blamed Democrats in New York City, which is 200 miles from Pine City, for euthanizing P’Nut.

“Democrats in New York City went in and raided a home to kill a squirrel,” Ms. Greene said. “Yet it was the same State of New York that let the criminal illegal alien go that came to Georgia that murdered our very own Laken Riley.”

. . .

. . . the animals’ owner, Mr. Longo, 34, considers himself apolitical. He is not registered with any political party and said he has never voted in his life.

. . .

He has spent the past days grieving, he said, and when he found a stray almond that Peanut had sneaked into his pocket, he burst into tears. He was just grateful, he said, “that somebody is giving P’Nut a voice.”

“I don’t care if it was the blue side or the red side,” he added. “Somebody on this planet is fighting for my animals.”

For the full story see:

Sarah Maslin Nir. “Death of a Pet Squirrel Is a G.O.P. Rallying Cry.” The New York Times (Wednesday, November 6, 2024): A15.

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

(Note: the online version of the story has the date Nov. 4, 2024, and has the title “How the Death of a Celebrity Squirrel Became a Republican Rallying Cry.”)

A Drug’s Lack of Randomized Clinical Trials Does Not Imply the Drug Lacks Efficacy

(p. D5) In 2013, the American College of Cardiology and the American Heart Association issued a series of statin recommendations for primary prevention, relevant to adults up to age 75 who have high cholesterol or diabetes, or who for other reasons face an estimated 7.5 percent risk or greater of developing heart disease within 10 years.

Last year, the United States Preventive Services Task Force similarly recommended statins for primary prevention in people aged 40 to 75 who had risk factors like high cholesterol, diabetes, high blood pressure or smoking, with a 10-year disease risk of 10 percent or greater.

But for people over age 75, both panels agreed, there was not sufficient evidence to reach a conclusion. As with many clinical trials, the major statin studies mostly haven’t included patients at advanced ages.

. . .

But Dr. Paul Ridker, a self-described “statin advocate” who directs the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, gets irked at the argument that we don’t know enough to give statins to older patients without heart disease.

“I don’t believe there’s any doubt that statin therapy is effective for primary prevention in older adults,” Dr. Ridker said. He cites a recent reanalysis of data from two major studies showing that patients over age 70 taking statins experienced the same reductions in cardiovascular events and mortality as younger ones.

Dr. Orkaby and her Harvard colleagues hoped to help resolve such questions with their recent study, published in the Journal of the American Geriatrics Society, comparing physicians over age 70 who took statins for primary prevention with those who didn’t.

The team matched each group for 30 variables and found that over an average of seven years, statin-takers had an 18 percent lower death rate, though not a statistically significant reduction in cardiovascular events.

In the same issue, though, an editorial co-authored by Dr. Rich called statin use for primary prevention in older patients “an unresolved conundrum.”

The physician study was observational, so can’t establish causes, he pointed out.

For the full story see:

Paula Span. “The New Old Age; If You’re Over 75 and Healthy, Are Statins for You?” The New York Times (Tuesday, January 9, 2018 [sic]): D5.

(Note: ellipsis added.)

(Note: the online version of the story has the date January 5, 2018 [sic], and has the title “The New Old Age; You’re Over 75, and You’re Healthy. Why Are You Taking a Statin?”)

The article on the effect of statins on older physicians, co-authored by Orkaby and mentioned above, is:

Orkaby, Ariela R., J. Michael Gaziano, Luc Djousse, and Jane A. Driver. “Statins for Primary Prevention of Cardiovascular Events and Mortality in Older Men.” Journal of the American Geriatrics Society 65, no. 11 (Nov. 2017): 2362-68.

Government Sugar Quotas Increase Demand for Harder-to-Metabolize Corn Syrup, Making Americans Fatter

For decades on the last day of every micro principles class I discussed the causes and effects of U.S. government sugar quotas. Government sugar quotas reduce the quantity of sugar that can be imported into the U.S., increasing the price of sugar. If the price of one substitute (sugar) rises, the demand for the other substitute (corn syrup) increases. As a result Americans consume more corn syrup which is harder to metabolize and easier to overconsume. Government sugar quota regulation thus increases obesity, and obesity-related diseases such as diabetes, heart disease, and cancer.

(p. D5) To clarify the effects of our high-sugar diet, I consulted an expert, Kimber L. Stanhope, a researcher in nutritional biology at the University of California, Davis, whose work is free of industry support and funded primarily by the National Institutes of Health. In a comprehensive 34-page review of research published in Critical Reviews in Clinical Laboratory Sciences in 2016, she linked consumption of added sugar to metabolic disease — cardiovascular disease, Type 2 diabetes and nonalcoholic fatty liver disease — as well as high blood levels of uric acid, a risk factor for kidney stones and gout.

In studies done in her lab among young adults consuming their normal diets, the risk for developing heart disease and kidney stones rose in direct proportion to the amount of high-fructose corn syrup they consumed.

. . .

“Fructose and glucose are not metabolized the same way in the human body,” which can account for the adverse effects of fructose, Dr. Stanhope said. Glucose is metabolized in cells throughout the body and used for energy. Fructose is metabolized in the liver, resulting in fat production and raising the risk of heart and fatty-liver disease. In addition, she explained, “fructose doesn’t stimulate the satiety-promoting substance leptin,” prompting some people to overconsume it, especially in soft drinks containing high-fructose corn syrup, and other tempting foods as well.

For the full story see:

Jane E. Brody. “The Sharp Bite of a Sweet Tooth.” The New York Times (Tuesday, July 23, 2019 [sic]): D5.

(Note: ellipsis added.)

(Note: the online version of the story has the date July 22, 2019 [sic], and has the title “The Downside of Having a Sweet Tooth.”)

The review article on the effect of sugar consumption on metabolism and obesity, mentioned above, is:

Stanhope, Kimber L. “Sugar Consumption, Metabolic Disease and Obesity: The State of the Controversy.” Critical Reviews in Clinical Laboratory Sciences 53, no. 1 (2016): 52-67.

Covid Loan Programs Passed by Congress Were “Comically Easy to Scam”

In a WSJ op-ed, I tell how a fraudster received a $42,200 Covid-19 Economic Injury Disaster Loan in my name for an alleged “Arthur M.D. Potato Farm.” As discussed in the NYT passages quoted below, there was also massive fraud in other related Congress-funded Small Business Administration Covid boondoggle programs. The NYT article blames the Trump Administration, but in my struggle to clear up the potato farm fraud case, a S.B.A. official told me that the Congress in 2020 put enormous pressure on the S.B.A. to get the money out the door as quickly as possible. The House of Representatives, which takes the lead in spending legislation, was controlled by the Democratic Party.

In the passages quoted below, “P.P.P.” means “Paycheck Protection Program” and “E.I.D.L.” means “Economic Injury Disaster Loan.”

(p. B4) An emergency relief program hastily rolled out in the early days of the pandemic had such poor fraud protections that it improperly doled out nearly $4.5 billion to self-employed people who said they had additional workers — even those who made wildly implausible claims, like having one million employees.

The $20 billion program, called the Economic Injury Disaster Loan Advance, offered small businesses immediate grants of up to $10,000 in the months after the pandemic shuttered much of the economy. But hundreds of thousands of the grants it made were inflated because there was no system to catch applications with “flawed or illogical information,” Hannibal Ware, the Small Business Administration’s inspector general, wrote in a report released on Thursday [Oct. 7, 2021].

. . .

. . . the S.B.A. skipped an obvious safeguard: It did not require sole proprietors claiming to have employees to enter their Employer Identification Number, instead allowing them to use their Social Security numbers.

. . .

Some of the claims were outright absurd. Hundreds of applicants received the maximum grants after saying that they employed more than 500 workers, a number that would generally make them ineligible for the small business program. Fifteen said they had one million employees — a figure that would put them in league with Amazon and Walmart.

The Small Business Administration “never requested additional information from these sole proprietors to verify the number of employees cited on their grant applications before approving and disbursing the grants,” Mr. Ware said in his report.

. . .

. . . a Bloomberg article last year described how almost comically easy it was to scam the system. It cited how-to videos that circulated on YouTube with titles like “$10k SBA Loans & GRANTS Got The STREETS Going CRAZY!”

. . .

The Justice Department has already prosecuted hundreds of cases involving fraudulent claims across the government’s $1 trillion small business pandemic relief programs, reclaiming more than $600 million.

But that is only a sliver of the amount lost to bogus claims. A March memo by the House Select Subcommittee on the Coronavirus Crisis identified an estimated $84 billion in suspected fraud in the P.P.P. and E.I.D.L. programs after the Trump administration “refused to implement basic controls.”

Mr. Ware told a House committee in April [2021] that his office had opened more than 400 cases involving the agency’s assorted relief programs.

“Fraud investigations will be a decades-long effort,” he said.

For the full story see:

Stacy Cowley. “S.B.A. Paid $4.5 Billion on Bogus Grant Claims.” The New York Times (Friday, October 8, 2021 [sic]): B4.

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

(Note: the online version of the story has the date Oct. 7, 2021 [sic], and has the title “S.B.A. Overpaid $4.5 Billion on ‘Illogical’ Small Business Grant Claims.”)

$700 Million Deployed for Harris by an “Elusive” Expert on Randomized Clinical-Trials

“The biggest super PAC in American politics” (p. 1) is spending $700 million on ads to elect Harris, more than the combined expenditures of both the official campaign of Harris and the official campaign of Trump (p. 1). “Leading the group” (p. 19) is an “elusive” PhD named Chauncy McLean, who has “ascended in the party by displaying encyclopedic knowledge of randomized controlled-trials” (p. 19). If Harris wins will that be more due to her overwhelming advantage in funding or more due to the methods used to spend the funds? (Or will the results depend more on how much Americans remember the record of Trump compared to how much they remember the record of Biden-Harris?)

For the full story see:

Theodore Schleifer and Shane Goldmacher. “Super PAC Places $700 Million Bet On Harris’s Bid.” The New York Times, First Section (Sunday, October 20, 2024): 1 & 19.

“Mass Deportation” Is Not in Trump’s Heart, but Is a Warning to Future Illegal Aliens

I am stressed by the image of the “mass deportation” of those who entered the U.S. illegally, but otherwise have been decent hard-working people. My plausible hope is that deep in his heart, Trump does not really mean it or plan it. Why “plausible”? Read the passage quoted below describing Trump’s visit with The Wall Street Journal editorial board.

At this year’s Republican National Convention, Mr. Trump vowed to undertake “the largest deportation operation in the history of our country.” Editorial board member Kyle Peterson asks how large—does Mr. Trump intend to deport aliens who are law-abiding except for their illegal presence in the country, even if they have American spouses and children? Maybe not, Mr. Trump says: “We have a lot of good people in this country, and we have to do something about it, and I’d like to see if we can do it.”

Pressed for specifics, he demurs: “Well, I don’t want to go too much into clarification, because the nicer I become, the more people that come over illegally.” When he was president, “I said, ‘We’re going to separate your family.’ . . . It doesn’t sound nice, but when a family hears they’re going to be separated, you know what they do? They stay where they are, because we couldn’t handle it. . . . But the interest from the heart, yeah, something’s going to be done. . . . I mean, there’s some human questions that get in the way of being perfect, and we have to have the heart, too. OK?”

The implication is that the optimal immigration policy is a happy medium between restriction and openness. That’s certainly true and perhaps a truism. Mr. Trump suggests that he, the bully with a heart of gold, is just the man to strike the balance.

For the full commentary/interview see:

James Taranto. “The Weekend Interview; Trump Tangles With the Journal’s Editors.” The Wall Street Journal (Saturday, October 18, 2024): A13.

(Note: ellipses in original.)

Europeans Tire of Costly and Ineffective Climate Transition Policies

(p. A15) The 2015 Paris Agreement aspired to “reduce the risks and impacts of climate change” by eliminating greenhouse-gas emissions in the latter half of this century. The centerpiece of the strategy was a global transition to low-emission energy systems.

. . .

U.S. and European governments are trying to induce an energy transition by building or expanding organizations and programs favoring particular “clean” technologies, including wind and solar generation, carbon capture, hydrogen production and vehicle electrification. Promoting technological innovation is a worthy endeavor, but such efforts face serious challenges as costs and disruptions grow without tangible progress in reducing local, let alone global, emissions. Retreats from aggressive goals are already under way in Europe, with clear signs of mandate fatigue. The climbdown will be slower in the U.S., where subsidies create constituencies that make it more difficult to reverse course.

. . . It means that today’s ineffective, inefficient, and ill-considered climate-mitigation strategies will be abandoned, making room for a more thoughtful and informed approach to responsibly providing for the world’s energy needs.

For the full commentary see:

Steven E. Koonin. “The ‘Climate Crisis’ Fades Out.” The Wall Street Journal (Tuesday, June 11, 2024): A15.

(Note: ellipses added.)

(Note: the online version of the commentary has the date June 10, 2024, and has the same title as the print version.)

Koonin’s commentary, quoted above, is related to his book:

Koonin, Steven E. Unsettled: What Climate Science Tells Us, What It Doesn’t, and Why It Matters. Dallas, TX: BenBella Books, 2021.

Charter School Founder Stood Up to “Education Bureaucrats”

The NYT ran an inspiring obituary for Joseph H. Reich last Tuesday. Reich and his wife were pioneers in the Charter School initiative. The obituary quotes them as saying that they were able to afford to send their own children to private school, but poor parents who want better for their children than what is on offer by the government public schools could not afford a similar option. They were quoted as saying “We recoil against this injustice.” They created one of the first charter schools and also donated $10 million for general support of charter schools. The obituary says that they stood up against “vigorous pushback from education bureaucrats.”

For the full obituary see:

Trip Gabriel. “Joseph H. Reich, 89, Pioneer of New York City’s Charter Schools, Dies.” The New York Times (Tuesday, October 15, 2024): A21.