Category: Regulations

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.”)

Universally Applicable Egg Guidelines Are Impossible Because Some Are Hypo-Responders and Others Are Hyper-Responders to Dietary Cholesterol

(p. D5) “Intervention studies have shown that moderate egg consumption doesn’t appreciably raise cholesterol levels,” Dr. Hu [chairman of nutrition and epidemiology at the Harvard T.H. Chan School of Public Health] said. “Low to moderate consumption of three or four eggs a week doesn’t appear to have a major effect on blood cholesterol unless the person has high cholesterol or Type 2 diabetes.”

He added, “In most previous studies of healthy people, moderate egg consumption was not associated with a significant increase in cardiovascular risk.” However, among 21,275 participants in the Physicians’ Health Study who were followed for more than 20 years, those who ate one or more eggs a day were more likely to develop heart failure than those who ate eggs infrequently.

“Contradictory findings among different studies are not unusual — it’s part of the scientific process,” Dr. Hu said. “In forming guidelines, you have to look at the totality of evidence rather than overreact to a single new study.”

Zachary S. Clayton, author of a comprehensive review of research on egg consumption and heart health published in Nutrition in 2017, said in an interview that giving two eggs a day for 12 weeks to healthy people didn’t raise any of their cardiovascular risk factors and “actually decreased their triglyceride levels.”

But, Dr. Clayton, a postdoctoral fellow in nutrition at the University of Colorado, Boulder, said, “It’s important to distinguish between hypo-responders and hyper-responders to dietary cholesterol. If someone is a hyper-responder, eating two eggs a day would increase the risk of cardiovascular disease.”

For the full commentary see:

Jane E. Brody. “Cracking the Code on Eggs and Your Diet.” The New York Times (Tuesday, April 23, 2019 [sic]): D5.

(Note: bracketed words quoted from earlier in the commentary.)

(Note: the online version of the commentary has the date April 22, 2019 [sic], and has the title “Should You Be Eating Eggs?”)

Clayton’s co-authored academic review article on the effects of egg consumption, mentioned above, is:

Clayton, Zachary S., Elizabeth Fusco, and Mark Kern. “Egg Consumption and Heart Health: A Review.” Nutrition 37 (May 2017): 79-85.

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.

Constraints and Incentives Help Explain Useless Medical Procedures

(p. D4) Researchers surveyed 2,106 physicians in various specialties regarding their beliefs about unnecessary medical care. On average, the doctors believed that 20.6 percent of all medical care was unnecessary, including 22 percent of prescriptions, 24.9 percent of tests and 11.1 percent of procedures. The study is in PLOS One.

Nearly 85 percent said the reason for overtreatment was fear of malpractice suits, . . .

. . .

More than 70 percent of doctors conceded that physicians are more likely to perform unnecessary procedures when they profit from them, while only 9.2 percent said that their own financial security was a factor.

“This study is essentially the voice of physicians about the problem,” said the senior author, Dr. Martin A. Makary, a professor of surgery at Johns Hopkins. “We’re told that there are too many operations done for narrowed blood vessels in the legs. Spine surgeons say that a quarter of all spine surgery may not be necessary. Half of stents placed may be unnecessary. These are significant opportunities to improve quality and lower costs.”

For the full story see:

Nicholas Bakalar. “Doctors: Overtreatment Weighed.” The New York Times (Tuesday, September 12, 2017 [sic]): D4.

(Note: ellipses added.)

(Note: the online version of the story has the date Sept. 6, 2017 [sic], and has the same title “Overtreatment Is Common, Doctors Say.”)

The academic study in PLOS One mentioned above is:

Lyu, Heather, Tim Xu, Daniel Brotman, Brandan Mayer-Blackwell, Michol Cooper, Michael Daniel, Elizabeth C. Wick, Vikas Saini, Shannon Brownlee, and Martin A. Makary. “Overtreatment in the United States.” PLOS ONE 12, no. 9 (2017): e0181970.

After a Century an Important Serendipitous Health Hunch Is Pursued

All of us (you, me, dogs, and physicians) observe patterns all the time. Some of the patterns, if pursued, could make the world much better. When a physician observes a pattern, even one they cannot articulately describe or justify, they could change their practices, curing more patients, saving more lives. But they are constrained from deviating from mainstream protocols by government regulations, insurance company rules, hospital administrators, and potential lawsuits. How many serendipitous discoveries that would help us flourish are delayed a century, or even totally snuffed out?

(p. C2) . . . my eye was drawn to a new study in the New England Journal of Medicine finding that hysterosalpingography cured some cases of infertility. Hystero refers to the uterus. Salpingo, I knew, relates to the fallopian tubes that funnel eggs to the uterus. Ography relates to imaging—but how could taking a picture of reproductive organs cure anything?

Doctors use hysterosalpingography to see if there are blockages that could be causing fertility problems.

. . .

To look at blockages, technicians have to introduce a teaspoon or two of a dye that’s opaque to X-rays. How that material is introduced, it turns out, is the key to the procedure’s effect on childlessness.

. . .

Smaller studies had given the scientists an idea of what to do next. They randomly chose half of the women to get the X-ray-opaque dye dissolved in oil, while the other half got the dye in water.

. . .

In an average of three months, whether treated or not, about 40% of the women receiving the oil-based dye material became pregnant, while only 29% of the women who got the water-based dye material conceived.

Hysterosalpingography is exactly a century old this year. Luckily, some astute doctors guessed that the method of taking a picture was having an unintended fertility effect, and now research has backed this up. Such serendipity in medical progress is neatly captured by a saying of the great French biologist Louis Pasteur about the need to be ready to see the unexpected: “In the fields of observation, chance only favors the prepared mind.”

The realization that supposedly inert oil could help to fulfill some couples’ dreams has built slowly. No one knows exactly how it works.

For the full commentary see:

Melvin Konner. “Mind & Matter; Can Just Taking a Picture Help to Treat Infertility?” The Wall Street Journal (Saturday, July 29, 2017 [sic]): C2.

(Note: ellipses added.)

(Note: the online version of the commentary has the date July 26, 2017 [sic], and has the same title as the print version. The Latin words in the first quoted sentence appear in italics in the original version.)

The New England Journal of Medicine article discussed in the passages above is:

Dreyer, Kim, Joukje van Rijswijk, Velja Mijatovic, Mariëtte Goddijn, Harold R. Verhoeve, Ilse A.J. van Rooij, Annemieke Hoek, Petra Bourdrez, Annemiek W. Nap, Henrike G.M. Rijnsaardt-Lukassen, Catharina C.M. Timmerman, Mesrure Kaplan, Angelo B. Hooker, Anna P. Gijsen, Ron van Golde, Cathelijne F. van Heteren, Alexander V. Sluijmer, Jan-Peter de Bruin, Jesper M.J. Smeenk, Jacoba A.M. de Boer, Eduard Scheenjes, Annette E.J. Duijn, Alexander Mozes, Marie J. Pelinck, Maaike A.F. Traas, Machiel H.A. van Hooff, Gijsbertus A. van Unnik, Cornelia H. de Koning, Nan van Geloven, Jos W.R. Twisk, Peter G.A. Hompes, and Ben W.J. Mol. “Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women.” New England Journal of Medicine 376, no. 21 (May 25, 2017): 2043-52.

“Common Practice of Excluding Former Cancer Patients From Clinical Trials”

Phase 3 randomized double-blind clinical trials (RCTs) are very expensive and often fail. When they do the drug company loses their investment in the new drug. As a result they have a big incentive to design the RCT to maximize the chances of success. One way is to exclude weak patients who are less likely to survive the new drug, for example in the passages quoted below, by excluding patients who have a past history of cancer. But the result is that the RCT does not provide evidence about the efficacy of the new drug in helping one of the groups we would like to help.

(p. D5) In a recent report in JAMA Oncology by researchers at the University of Texas Southwestern Medical Center in Dallas, approximately 25 percent of Americans 65 and older and 11 percent of younger adults who were previously treated for cancer were subsequently found to have one or more new cancers in a different site. Depending on the type of original cancer and the person’s age, the risk of developing a second unrelated cancer ranged from 3.5 percent to 36.9 percent. The study covered 765,843 new cancer diagnoses made between 2009 and 2013 and recorded in a population-based national registry, the Surveillance, Epidemiology and End Results (SEER) program.

. . .

The Texas researchers, led by Caitlin C. Murphy, an epidemiologist, undertook the study of new cancers in cancer survivors in hopes of changing the common practice of excluding former cancer patients from clinical trials when they develop another cancer.

“This exclusion is not evidence-based,” Dr. Murphy said in an interview. “Patients with a prior cancer do not necessarily have a worse prognosis than those without a cancer history. They should be allowed to participate in clinical trials, which may be one of their only treatment options. If they’re excluded, a lot of patients are left out from what may be the best available treatment.”

For the full commentary see:

Jane E. Brody. “When Cancer Strikes Twice.” The New York Times (Tuesday, December 26, 2017 [sic]): D5.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date Dec. 25, 2017 [sic], and has the same title as the print version.)

The academic report mentioned above is:

Murphy, Caitlin C., David E. Gerber, and Sandi L. Pruitt. “Prevalence of Prior Cancer among Persons Newly Diagnosed with Cancer: An Initial Report from the Surveillance, Epidemiology, and End Results Program.” JAMA Oncology 4, no. 6 (June 2018): 832-36.ds

Allowing Entrepreneurial Physicians to Improvise Can Save Patient Lives, Especially for Rare Conditions

The article quoted below makes the case, by example, that drugs that would be rejected based on early randomized double-blind clinical trials, can be revived by clever trial-and-error adjustments. Such improvisations saved the life of Magglio Boscarino, whose body began to develop antibodies that attacked the medicine that had been successfully treating his rare Pompe disease. Emil Freireich used trial-and-error adjustments to develop the chemo cocktail that cured many of childhood leukemia. He mentored Vincent DeVita who used trial-and-error adjustments to develop the chemo cocktails that cured many of Hodgkin’s lymphoma. Another approach, advocated by Dr. Ridker in a passage below, is to learn which patients will be able to take the drug with developing resistance to it–a form of personalized medicine that does not seem easily compatible with the oft-claimed “gold standard” of randomized double blind clinical trials.

(p. D1) The miracle treatment that should have saved Becka Boscarino’s baby boy almost killed him.

Doctors diagnosed her newborn son, Magglio, with Pompe disease, a rare and deadly genetic disorder that leads to a buildup of glycogen in the body. Left untreated, the baby would probably die before his first birthday.

There is just one treatment: a series of infusions. But after the boy received his fifth dose, he turned blue, stopped breathing and slipped into anaphylactic shock.

The problem? Eventually doctors discovered that Magglio’s body was producing antibodies to the very drug saving his life.

. . .

In a paper published in March [2017] by The New England Journal of Medicine, Pfizer reported that in the final phase of testing a new drug to lower cholesterol, many of the 30,000 patients taking it had stopped re-(p. D6)sponding to it.

Their cholesterol levels, which had plunged when they began taking the drug, were rising again. As it turned out, the subjects had begun making antibodies to the drug.

Pfizer was forced to stop the trial and pull the drug after investing billions of dollars.

. . .

By the time Magglio was 6 months old, he was weak and lacked muscle tone. Then came the diagnosis of Pompe disease and the beginning of his treatments, infusions with an enzyme his body was failing to make.

At first, Magglio improved. Within a few months, he was learning to sit up and to use his arms. His enlarged heart was shrinking. But his fifth treatment was a disaster.

He fell into anaphylactic shock and stopped breathing.

. . .

Magglio was hardly alone: Most babies with Pompe disease who received the only available treatment soon produced antibodies that rendered it useless.

“We tried everything, but these babies did not make it,” said Dr. Priya Kishnani, a professor of pediatrics at Duke University.

Dr. Kishnani realized she had to find a way to trick the immune system so it would leave the infused protein alone. Her idea was to give the babies a chemotherapy drug, rituximab, that wipes out cells that develop into antibody producers.

Along with it, she tried giving the children methotrexate, which destroys many of the body’s white blood cells, and infusions of antibodies from pooled donors’ serum so the children would have a way to fight off infections.

And for babies like Magglio, who already were making antibodies that blocked the drug they need, she added another drug — bortezomib — to eliminate those antibody-producing cells.

As the children’s immune systems were brought under control, the treatments began to work again. “It was breathtaking,” Dr. Kishnani said. “We were able to rescue these babies.”

. . .

At Brigham and Women’s Hospital in Boston, cardiologist Dr. Paul Ridker, who directed the Pfizer study, is taking a different tack.

He wants to do a large genetic study to see if he can predict which patients will develop antibodies to the Pfizer drug and perhaps to other drugs that the immune system might see as foreign.

“We probably have the best opportunity ever afforded to understand the cause of these antibodies,” Dr. Ridker said. “That would be very valuable for the development of future drugs if you could say, ‘This one patient out of 20 should not take this drug.’”

It would mean, too, that drugs that might have been abandoned could be developed for the patients who can tolerate them.

For the full story see:

Gina Kolata. “When the Body Rejects the Treatment.” The New York Times (Tuesday, May 16, 2017 [sic]): D1 & D6.

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

(Note: the online version of the story has the date May 15, 2017 [sic], and has the title “When the Immune System Thwarts Lifesaving Drugs.”)

The 2017 paper reporting the failed Pfizer clinical trial and mentioned above is:

Ridker, Paul M, Jean-Claude Tardif, Pierre Amarenco, William Duggan, Robert J. Glynn, J. Wouter Jukema, John J.P. Kastelein, Albert M. Kim, Wolfgang Koenig, Steven Nissen, James Revkin, Lynda M. Rose, Raul D. Santos, Pamela F. Schwartz, Charles L. Shear, and Carla Yunis. “Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab.” New England Journal of Medicine 376, no. 16 (April 20, 2017): 1517-26.

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.”)