Regulations – Page 3 – artdiamondblog.com

“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.”)

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.

Trust Ventures Engages in “Trench Warfare” Against Regulations Binding the Firms It Finances

(p. A15) Another “Ghostbusters” movie is in theaters, but what we need are regulation busters. I spoke with Salen Churi and Brooke Fallon from Trust Ventures, a $500 million Texas-based venture-capital firm. It’s almost as if they are wearing plasma proton packs.

. . .

Trust Ventures came together, Mr. Churi said, because no one thinks “ ‘I hate innovation,’ except perhaps for incumbents. We have crises in the most human of industries—energy, healthcare, housing. Everyone thought I was nuts. They’re like, ‘Why would you invest in companies with regulatory problems?’ ” Good question.

Most venture capitalists invest and help startups with new strategies and hiring a team. Mr. Churi describes what he does as “trench warfare,” fighting with regulators and incumbents deal by deal.

. . .

Mr. Churi explains that “when you get a great new technology that’s fundamentally different, regulators just want to shove you in the old box, right? Our challenge is to say, ‘Well, actually, this needs a new box.’ Otherwise, it’s going to sit on the shelf.”

Eye exams are a great example of an old box. The American Optometric Association is powerful, and many states banned online vision tests. “Regulators don’t care about all those single mothers who have to pay three times as much or that people in Central Illinois have to drive three hours,” Mr. Churi says.

The pandemic loosened telehealth rules, providing an opening to test your eyes with your own smartphone. As lockdowns ended, Trust Ventures worked with the startup Visibly in several states to legalize online eye exams permanently. They got help from their investors network—some of their limited partners “are great American families,” Mr. Churi says. Visibly’s Food and Drug Administration-approved online eye tests, now in 36 states, cost as little as $35 instead of three times as much at LensCrafters or box-store-located optometrists.

For the full commentary see:

Andy Kessler. “Inside View; America’s New Regulation Busters.” The Wall Street Journal (Monday, April 15, 2024): A15.

(Note: ellipses added.)

(Note: the online version of the commentary has the date April 14, 2024, and has the same title as the print version.)

People Thinking about the Rules They Have to Obey, Are Not Thinking about the Problems They Have to Solve

(p. A18) . . . I looked into the growing bureaucratization of American life. It’s not only that growing bureaucracies cost a lot of money; they also enervate American society. They redistribute power from workers to rule makers, and in so doing sap initiative, discretion, creativity and drive.

Once you start poking around, the statistics are staggering. Over a third of all health care costs go to administration. As the health care expert David Himmelstein put it in 2020, “The average American is paying more than $2,000 a year for useless bureaucracy.” All of us who have been entangled in the medical system know why administrators are there: to wrangle over coverage for the treatments doctors think patients need.

. . .

In every organization I’ve interacted with, the administrators genuinely want to serve the mission of the organization, but the nature of their jobs is to enforce compliance with this or that rule.

Their power is similar to what Annie Lowrey of The Atlantic has called the “time tax.” If you’ve ever fought a health care, corporate or university bureaucracy, you quickly realize you don’t have the time for it, so you give up. I don’t know about you, but my health insurer sometimes denies my family coverage for things that seem like obvious necessities, but I let it go unless it’s a major expense. I calculate that my time is more valuable.

As Philip K. Howard has been arguing for years, good organizations give people discretion to do what is right. But the trend in public and private sector organizations has been to write rules that rob people of the power of discretion. These are two different mentalities. As Howard writes, “Studies of cognitive overload suggest that the real problem is that people who are thinking about rules actually have diminished capacity to think about solving problems.”

. . .

. . ., Mark Edmundson teaches literature at the University of Virginia. The annual self-evaluations he had to submit used to be one page. Now he has to fill out about 15 electronic pages of bureaucratese that include demonstrating how his work advances D.E.I., to make sure his every waking moment conforms to the reigning ideology.

In a recent essay in Liberties Journal, he illustrates how administrators control campus life . . .

. . .

Organizations are trying to protect themselves from lawsuits, but the whole administrative apparatus comes with an implied view of human nature. People are weak, fragile, vulnerable and kind of stupid. They need administrators to run their lives. They have to be trained never to take initiative, lest they wander off into activities that are deemed by the authorities to be out of bounds.

The result is the soft despotism that Tocqueville warned us about centuries ago, a power that “is absolute, minute, regular, provident and mild.” In his Liberties essay, Edmundson writes that this kind of power is now centerless. Presidents and executives don’t run companies, universities or nations. Power is now held by everyone who issues work surveys and annual reports, the people who create H.R. trainings and collect data. He concludes: “They are using the terms of liberation to bring more and more free people closer to mental serfdom. Some day they will awaken in a cage of their own devising, so harshly confining that even they, drunk on their own virtue, will have to notice how their lives are the lives of snails tucked in their shells.”

Trumpian populism is about many things, but one of them is this: working-class people rebelling against administrators. It is about people who want to lead lives of freedom, creativity and vitality, who find themselves working at jobs, sending their kids to schools and visiting hospitals, where they confront “an immense and tutelary power” (Tocqueville’s words) that is out to diminish them.

For the full commentary see:

David Brooks. “Death by a Thousand Paper Cuts.” The New York Times (Friday, January 18, 2024): A18.

(Note: ellipses added.)

(Note: the online version of the commentary has the date January 19, 2024, and has the title “Lessons of the Trump Assassination Attempt.”)

The article by Lowrey mentioned above is:

Lowrey, Annie. “The Time Tax; Why Is So Much American Bureaucracy Left to Average Citizens?” The Atlantic, July 27, 2021. Available at: https://www.theatlantic.com/politics/archive/2021/07/how-government-learned-waste-your-time-tax/619568/

The academic paper co-authored by Himmelstein that underlies the Reuters article cited by Brooks above is:

Himmelstein, David, Terry Campbell, and Steffie Woolhandler. “Health Care Administrative Costs in the United States and Canada, 2017.” Annals of Internal Medicine (2020) doi:10.7326/M19-2818.

The article by Howard mentioned above is:

Howard, Philip K. “Bureaucracy Vs. Democracy.” The American Interest (Jan. 31, 2019) Available at: https://www.nytimes.com/2024/01/18/opinion/american-life-bureaucracy.html?searchResultPosition=1.

The article by Edmundson mentioned above is:

Edmundson, Mark. “Good People: The New Discipline.” Liberties Journal 3, no. 4 (2023) Available at: https://libertiesjournal.com/articles/good-people-the-new-discipline/.

The two Tocqueville quotes are from Book 4, Chapter 6 of:

Tocqueville, Alexis de. Democracy in America. Chicago: University of Chicago Press, 2000 (1st ed. 1835).

Dual-Class Stock Allows Firm Founders to Retain Control

(p. B10) . . . Britain is changing the rules to attract more would-be corporate dictators. Its financial regulator this month [July 2024] is ditching shareholder protections in an effort to attract IPOs back to the venerable London Stock Exchange.

The hope is that owners of companies will like London more if they can maintain control, while management will like London more if they don’t forever have to ask pesky shareholders for permission for things.

. . .

Investors in the U.S. have been all too happy to buy companies where the founders have kept control, or act as if they did. Benign dictators are in fashion.

. . .

The history of corporate success fits this model perfectly. Founders who manage to create, expand and list a company are usually pretty good. It isn’t surprising that shareholders like to give successful founders a free rein, avoiding all the usual corporate-governance restraints designed to prevent flights of fancy by a runaway CEO.

Founders also have skin in the game, in the form of a large part of their fortunes tied up in the stock, unlike the hired help who fill the C-suite at most big companies. Their flights of fancy might not always work out—Alphabet’s “moonshot” ventures have mostly lost money—but are part of the point of investing with a founder promising growth.

. . .

In companies that give extra votes to the founder, it becomes hard or impossible to change the board, let alone kick out the CEO.

. . .

London’s outright ban on dual-class stock has been tested by market forces and failed because companies simply listed elsewhere, usually on the Nasdaq. Britain will now have a corporate-governance regime that puts more onus on shareholders to protect themselves.

For the full commentary see:

James Mackintosh. “Streetwise; There Is a Time for Corporate Despots.” The Wall Street Journal (Saturday, July 20, 2024): B10.

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

(Note: the online version of the commentary was updated July 19, 2024, and has the title “Streetwise; There Is a Time for Corporate Despots—but It Isn’t Forever.”)

Hayflick Said Lifespans Are Limited by Maximum Times Cells Can Divide (the “Hayflick Limit”)

Hayflick thought the “Hayflick limit” was a permanently binding constraint on the maximum lifespans that humans could achieve. But cancer cells provide a proof-of-concept that some cells are able to escape the limit. The challenge is to engineer cells that escape the limit without otherwise killing us. (Hayflick himself died of cancer.)

(p. A20) Leonard Hayflick, a biomedical researcher who discovered that normal cells can divide only a certain number of times — setting a limit on the human life span and frustrating would-be-immortalists everywhere — died on Aug. 1 [2024] at his home in Sea Ranch, Calif. He was 96.

His son, Joel Hayflick, said the cause was pancreatic cancer.

Like many great scientific findings, Dr. Hayflick’s came somewhat by accident. As a young scientist in the early 1960s at the Wistar Institute, a research organization at the University of Pennsylvania, he was trying to develop healthy embryonic cell lines in order to study whether viruses can cause certain types of cancer.

He and a colleague, Paul Moorhead, soon noticed that somatic — that is, nonreproductive — cells went through a phase of division, splitting between 40 and 60 times, before lapsing into what he called senescence.

. . .

This finding, which the Nobel-winning virologist Macfarlane Burnet later called the Hayflick limit, ran counter to everything scientists believed about cells and aging — especially the thesis that cells themselves are immortal, and that aging is a result of external causes, like disease, diet and solar radiation.

. . .

Dr. Hayflick made other important contributions to science. He developed a particularly vibrant cell line, WI-38, which has been used for decades to make vaccines.

. . .

The National Institutes of Health had funded the research on his WI-38 cell line but declined to fund its distribution, even as other researchers clamored for samples. Dr. Hayflick established a company to process orders, charged a minimal fee for shipping and set the proceeds aside until ownership was clarified.

But in a private report that was released to the news media, the N.I.H. accused Dr. Hayflick of theft. He sued the institute, charging invasion of privacy and reputational damage, including a forced resignation from his position at Stanford. The litigation took six years and ended in a settlement that allowed him to keep some of the money and cell samples.

During those six years, Congress passed the Bayh-Dole Act, which allows scientists to profit off government-funded research. The law, which would have made Dr. Hayflick’s earlier actions unquestionably legal, helped catalyze the biotech industry.

For the full obituary see:

Clay Risen. “Leonard Hayflick, 96, Explorer of Cells Who Showed Why No One Lives Forever.” The New York Times (Tuesday, August 20, 2024): A20.

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

(Note: the online version of the obituary was updated Aug. 19, 2024, and has the title “Leonard Hayflick, Who Discovered Why No One Lives Forever, Dies at 96.”)

Otherwise Innovative Retailers Exit Healthcare Due to “the Layers of Government”

(p. B3) Walmart, the world’s largest retailer, said Tuesday [April 30, 2024] that it was shutting down its health care centers, a network that only last year it said it planned to expand.

The retailer said in a blog post that its 51 health centers across five states would close.

. . .

Offering health care is more difficult than selling consumer goods like laundry detergent and car parts, said David Silverman, a retail analyst at Fitch Ratings, noting the layers of government and insurance providers involved.

“The attempts to enter these spaces and some of the failures of doing so really underscore the challenges and complexities of operating in the U.S. health care space,” Mr. Silverman said.

. . .

In 2021, Amazon, Berkshire Hathaway and JPMorgan Chase ended their high-profile joint health care venture, which sought to explore new ways to deliver health care to their employees. In March, Walgreens said it had closed 140 of its VillageMD clinics and planned to close 20 more.

For the full story see:

Jordyn Holman. “Walmart Is Shutting Down Health Centers in 5 States.” The New York Times (Wednesday, May 1, 2024): B3.

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

(Note: the online version of the story has the date April 30, 2024, and has the title “Walmart Is Shutting Health Centers After Plan to Expand.”)

Growth-Impeding Red Tape Especially Hurts Small and Midsize Firms

(p. B1) When Markus Wingens created the position of “energy manager” for the metal heat-treatment company he runs in southwestern Germany, his idea was to increase energy efficiency and attract customers interested in sustainability.

But the job has become as much a task of filling out paperwork and studying seemingly ever-changing laws as it is ensuring that the firm, Technotherm Heat Treatment Group, is meeting energy requirements.

Last year, four new laws and 14 amendments to existing ones governing energy use took effect, each bringing fresh demands for data to be reported and forms to be submitted — in many cases to prove the same standards that the company has already been certified as reaching since 2012, Mr. Wingens said.

“We have the Renewable Energy Act, we have the Energy Efficiency Act, we have the Energy Financing Act, and each comes with an administrative burden,” he said. “It’s madness.”

Freedom from red tape has been a rallying cry for farmers from Poland to Portugal at recent protests against European Union laws and policies. Indeed, the burden of bureaucracy is a general complaint of corporate executives across the globe.

But nowhere is the issue more pressing than in Germany, Europe’s largest economy, which is facing anemic growth of no more than 0.2 percent this year. In a report last month, the International Monetary Fund called “too much red tape” one of the major impediments to reviving the German economy.

For example, it takes 120 days to obtain a business license in Germany — more than double the average in other Western economies. Germany also lags behind the rest of the European Union in the digitization of government services, still requiring written forms for certain tax refunds and building permits.

. . .

(p. B2) German companies spend 64 million hours every year filling out forms to feed the country’s 375 official databases, according to industry estimates. When the Stuttgart chamber of commerce asked its 175,000 members to name their biggest challenges, red tape topped the list.

. . .

The red tape drain on time and resources is felt especially by small and midsize firms — those with fewer than 500 employees and annual revenue below €50 million (about $54 million) — that are the backbone of the German economy.

These businesses often lack in-house legal departments dedicated to filing audits, recording statistics and deciphering which information is wanted by which authorities — the European, federal, state and local governments.

. . .

“In Germany, we have regulations about handing over business cards at business meetings and whether it’s still allowed,” [Andreas Kiontke, a lawyer who works with the Stuttgart chamber of commerce] said.