Category: Regulations

Regulations Slow Eradication of Cancer

(p. D3) . . . the triumph of chemotherapy for Hodgkin’s and then for many other tumors opened an interlocking series of dilemmas. In the clinic and the hospital, the new protocols demanded that doctors muster the courage to make their patients very sick in order to make them well. But how sick was too sick? The risks and benefits of the powerful treatments now needed careful, deliberate assessment at every stage of the disease.
Similar questions dogged those who developed, evaluated and regulated the drugs. How poisonous could these agents safely be? How assiduously should desperate patients be saved by their government from pharmaceutical risk?
Dr. DeVita stands firmly among those affirming cancer patients’ right to aggressive treatment. One particular exchange summarizes his philosophy: “Do your patients speak to you after you do this to them?” one skeptic asked him early on. “The answer is yes,” he replied, “and for a lot longer.”
The regulatory caution of the Food and Drug Administration has been a thorn in his side for decades: “I’d like to be able to say that as cancer drugs have become increasingly more complex and sophisticated, the F.D.A. has as well. But it has not.” In fact, he writes, “the rate-limiting step in eradicating cancer today is not the science but the regulatory environment we work in.”

For the full review, see:
ABIGAIL ZUGER, M.D. “An Unbowed Warrior.” The New York Times (Tues., Dec.. 1, 2015): D3.
(Note: ellipsis added.)
(Note: the online version of the review has the date NOV. 30, 2015, and has the title “Review: Science and Politics Collide in ‘The Death of Cancer’.”)

The book under review, is:
DeVita, Vincent T., and Elizabeth DeVita-Raeburn. The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable–and How We Can Get There. New York: Sarah Crichton Books, 2015.

Anti-GMO Chipotle No Longer Wears Health Halo

(p. A13) . . . if you need an anecdote for how the year unfolded for the anti-GMO movement, look no further than Chipotle. Last spring the fast food company announced with great fanfare that it would take GMO ingredients off its menu. It was all downhill after that. As was quickly pointed out, Chipotle wasn’t being fully truthful, since its soft drinks and cheese contain genetically modified ingredients, and its meat comes from animals fed genetically modified grains. A lawsuit filed in California, which is pending, accused Chipotle of false advertising and deceptive marketing.
Then cases of food-borne illnesses hit Chipotle locations across the country. Supporters of traditional agriculture, who have felt maligned by the burrito company, started keeping a tally of the number of people sickened by Chipotle’s food (ongoing, but more than 300) versus the number sickened by GMOs (zero). As the year winds to a close, the company that once wore the restaurant industry’s health halo is apologizing, preparing for lawsuits, recentralizing its vegetable preparation and cutting locally sourced ingredients.

For the full commentary, see:
JULIE KELLY. “The March of Genetic Food Progress; ‘Farmaceuticals’ and other GM products are slowly being approved, despite political scare campaigns.” The Wall Street Journal (Weds., Dec. 30, 2015): A13.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date Dec. 29, 2015.)

Affirmative Action Reduces Number of Black Scientists

Malcolm Gladwell, in chapter three of David and Goliath, persuasively argues that science students who would thrive at a solid public university, may be at the bottom of their class at Harvard, and in discouragement switch to an easier non-science major. Gladwell’s argument has implications for affirmative action, as noted by Gail Heriot in the passages quoted below.

(p. A13) . . . , numerous studies–as I explain in a recent report for the Heritage Foundation–show that the supposed beneficiaries of affirmative action are less likely to go on to high-prestige careers than otherwise-identical students who attend schools where their entering academic credentials put them in the middle of the class or higher. In other words, encouraging black students to attend schools where their entering credentials place them near the bottom of the class has resulted in fewer black physicians, engineers, scientists, lawyers and professors than would otherwise be the case.

But university administrators don’t want to hear that their support for affirmative action has left many intended beneficiaries worse off, and they refuse to take the evidence seriously.
The mainstream media support them on this. The Washington Post, for instance, recently featured a story lamenting that black students are less likely to major in science and engineering than their Asian or white counterparts. Left unstated was why. As my report shows, while black students tend to be a little more interested in majoring in science and engineering than whites when they first enter college, they transfer into softer majors in much larger numbers and so end up with fewer science or engineering degrees.
This is not because they don’t have the right stuff. Many do–as demonstrated by the fact that students with identical entering academic credentials attending somewhat less competitive schools persevere in their quest for a science or engineering degree and ultimately succeed. Rather, for many, it is because they took on too much, too soon given their level of academic preparation.

For the full commentary, see:
GAIL HERIOT. “Why Aren’t There More Black Scientists? The evidence suggests that one reason is the perverse impact of university racial preferences.” The Wall Street Journal (Thurs., Oct. 22, 2015): A13.
(Note: ellipsis added.)
(Note: the online version of the commentary was updated on Oct. 21, 2015.)

Heriot’s report for the Heritage Foundation, is:
Heriot, Gail. “A “Dubious Expediency”: How Race-Preferential Admissions Policies on Campus Hurt Minority Students.” Heritage Foundation Special Report #167, Aug. 31, 2015.

Gladwell’s book, mentioned above, is:
Gladwell, Malcolm. David and Goliath: Underdogs, Misfits, and the Art of Battling Giants. New York, NY: Little, Brown and Company, 2013.

Hungry Suffer Due to G.M.O. Bans by Europe’s “Coalition of the Ignorant”

(p. 6) CALL it the “Coalition of the Ignorant.” By the first week of October [2015], 17 European countries — including Austria, Denmark, France, Germany, Greece, Hungary, Italy, the Netherlands and Poland — had used new European Union rules to announce bans on the cultivation of genetically modified crops.
. . .
I have spent time with malnourished children in Tanzania whose families were going hungry because cassava crops were wiped out by brown-streak disease. That was particularly painful because in neighboring Uganda I had recently visited trial plots of genetically modified cassava that demonstrated complete resistance to the virus. The faces of the hungry children come to mind every time I hear European politicians boast about their country’s G.M.O. ban and demand that the rest of the world follow suit — as Scotland’s minister did in August.
Thanks to Europe’s Coalition of the Ignorant, we are witnessing a historic injustice perpetrated by the well fed on the food insecure. Europe’s stance, if taken up internationally, risks marginalizing a critically important technology that we must surely employ if humanity is to feed itself sustainably in an increasingly difficult and challenging future. I can only hope that the Continent’s policy makers come to their senses before it is too late.

For the full commentary, see:
MARK LYNAS. “With G.M.O. Policies, Europe Turns Against Science.” The New York Times, SundayReview Section (Sun., OCT. 25, 2015): 6.
(Note: ellipsis, and bracketed year, added.)
(Note: the online version of the commentary was updated on OCT. 24, 2015, and has the title “With G.M.O. Policies, Europe Turns Against Science.”)

FDA Forces Child to Go to London to Get Drug to Fight His Cancer

(p. A15) How far would you go to get a drug that could save your child’s life? Across an ocean? That is exactly what the federal government is forcing some American families with dying children to do.
In 2012, when Diego Morris was 11 years old, he was diagnosed with a deadly cancer in his leg called osteosarcoma. Doctors at St. Jude Children’s Research Hospital in Memphis, Tenn., removed the tumor, but the prognosis was poor. There was a significant risk that even extensive chemotherapy after surgery would not prevent the cancer from returning.
Fortunately, a team of doctors at MD Anderson Cancer Center in Houston and Memorial Sloan Kettering Cancer Center in New York City had developed a revolutionary new drug, mifamurtide (MTP), that can prevent osteosarcoma from coming back. A study by Dr. Eugenie Kleinerman of MD Anderson and Dr. Paul Meyers of Sloan Kettering showed the drug resulted in a 30% reduction in the osteosarcoma mortality rate at eight years after diagnosis.
The drug was approved in 2009 by the European Medicines Agency and is currently the standard of care in Europe, Israel and many other countries. In 2012 it received the prestigious Prix Galien Award, the gold medal for pharmaceutical research and development in the United Kingdom.
MPT was exactly what Diego needed. But there was one problem: The drug was not available in America because the Food and Drug Administration had rejected it, demanding additional studies. That meant that Diego had to travel from Phoenix to London to get the drug he needed to save his life–a drug that was available in almost every industrialized nation and should have been available in the U.S.

For the full commentary, see:

DARCY OLSEN. “Winning the Right to Save Your Own Life; As the FDA dawdles, 24 states pass ‘right-to-try’ laws giving terminally ill patients access to drugs.” The Wall Street Journal (Fri., Nov. 27, 2015): A15.
(Note: the online version of the commentary has the date Nov. 26, 2015.)

Olsen’s commentary is related to her book:
Olsen, Darcy. The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need. New York: HarperCollins Publishers, 2015.

Cuomo Bans the Fracking that Could Revive New York’s Southern Tier

(p. A25) CONKLIN, N.Y. — The main grocery store here was replaced by a Family Dollar store, already faded. The historic front of the town hall, a castle no less, is crumbling, and donations are being solicited. The funds earmarked to strip off the lead paint from the castle’s exterior went instead to clear mold from the basement.
This town of roughly 5,500 residents looks alarmingly like dozens of other towns and cities in New York’s Southern Tier, a vast part of the state that runs parallel to Pennsylvania. Years ago, the region was a manufacturing powerhouse, a place where firms like General Electric and Westinghouse thrived. But over time companies have downsized, or left altogether, lured abroad or to states with lower taxes and fewer regulations.
. . .
In western New York, . . . , Gov. Andrew M. Cuomo, a Democrat, pledged $1 billion in 2012 to support economic development. Since then, he has poured hundreds of millions of dollars into numerous Buffalo-area projects.
The Southern Tier has proved to be a harder fix. It is predominantly rural and lacks a significant population core that typically attracts the private sector.
The region is resource rich, but landowners are angry the government will not let them capitalize on it. Some had pinned their hopes of an economic revival on the prospect of the state’s authorizing hydraulic fracturing, known as fracking; many of them can recite the payment formula gas companies were proposing: $500 a month per acre.
But the Cuomo administration, citing health risks, decided last year to ban the practice, leaving some farmers contemplating logging the timber on their land, a move that could destroy swaths of pristine forest.

For the full story, see:
SUSANNE CRAIG. “Former Hub of Manufacturing Ponders Next Act.” The New York Times (Weds., SEPT. 30, 2015): A20-A21.
(Note: ellipses added.)
(Note: the online version of the story has the date SEPT. 29, 2015, and has the title “New York’s Southern Tier, Once a Home for Big Business, Is Struggling.”)

FDA Has No Right to Stop the Terminally Ill from Seeking Cures

(p. C4) Ms. Olsen notes that “today, about 40 percent of cancer patients attempt to enroll in clinical trials, but only about 3 percent end up participating. That means that the vast majority don’t make the cut, whether because they fail to meet the strict criteria, or a trial is thousands of miles from their home.” Many of those who don’t get these experimental drugs are the sickest patients because they are deemed “too sick to be useful for the study.”
Ms. Olsen argues that terminally ill patients should be able to access such drugs–at their own risk and outside the context of FDA-required studies–if the companies are willing to provide them, and the book’s title alludes to her proposed remedy: the state-by-state campaign the Goldwater Institute is leading to pass “Right to Try” legislation. The bills would allow terminally ill patients who have “exhausted all conventional treatment options” to access an experimental treatment if their doctors believe it is “the best medical option to extend or save the patients’ life” and “the treatment has successfully completed basic safety testing and is part of the FDA’s ongoing evaluation and approval process.” Insurers, critically, would not be required to cover the treatment–a significant hurdle, largely unexplored here, since such costs could be significant.
The think tank’s campaign has been incredibly successful, with 24 states passing Right to Try laws to date. Still, Ms. Olsen doesn’t present such laws as a panacea. She doesn’t expect experimental treatments to always–or even often–work for terminally ill patients. But she believes that some chance is better than the alternative. “If you have the Right to Die, you have the Right to Try,” Ms. Olsen writes. “And you don’t have to wait on Washington to secure it.”
Yet therein lies the book’s main shortcoming. Washington, it turns out, has a fair bit of say here. Courts have found that the FDA’s powers to regulate drug development are extraordinarily broad. Many changes Ms. Olsen champions won’t be possible without congressional action to revamp the FDA’s drug development process and find new ways of paying for experimental drugs that would make widespread access sustainable for patients, companies and insurers. These issues, though touched on, are not grappled with in detail.

For the full review, see:
PAUL HOWARD. “BOOKSHELF; Hail Mary Medicine; Patients spend their last days pleading with reluctant drug companies and the FDA to get access to treatments that could save their lives.” The Wall Street Journal (Fri., Nov. 13, 2015): C4.
(Note: ellipses added.)
(Note: the online version of the review has the date Nov. 12, 2015.)

The book under review, is:
Olsen, Darcy. The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need. New York: HarperCollins Publishers, 2015.

Health Care Mandate “Freezes You at a Time When You Need to Be Moving Fast”

(p. B4) When LaRonda Hunter opened a Fantastic Sams hair salon 10 years ago in Saginaw, Tex., a suburb of Fort Worth, she envisioned it as the first of what would eventually be a small regional collection of salons. As her sales grew, so did her business, which now encompasses four locations — but her plans for a fifth salon are frozen, perhaps permanently.

Starting in January, the Affordable Care Act requires businesses with 50 or more full-time-equivalent employees to offer workers health insurance or face penalties that can exceed $2,000 per employee. Ms. Hunter, who has 45 employees, is determined not to cross that threshold. Paying for health insurance would wipe out her company’s profit and the five-figure salary she pays herself from it, she said.
“The margins are not big enough within our industry to support it,” she said. “It’s not that I don’t want to — I love my employees, and I want to do everything I can for them — but the numbers just don’t work.”
. . .
For some business owners on the edge of the cutoff, the mandate is forcing them to weigh very carefully the price of growing bigger.
“There’s kind of a deer-in-headlights moment for those who say, ‘I have this new potential client, but if I bring them on, I have to hire five additional people,'” said Philip P. Noftsinger, the payroll unit president at CBIZ, a financial services provider for businesses. “They’re really trying to assess how much the 50th employee is going to cost.”
. . .
For businesses that use many seasonal, variable-hour or temporary workers, like those in the hospitality industry, simply figuring out how many qualifying employees they have can be a challenge.
“I think companies are going to have to work with their payroll processor for the basic data, and then their accountant or attorney about what certain items mean,” Mr. Prince said.
The expense and distraction of all that paperwork is one of the biggest frustrations for one business owner, Joseph P. Sergio. His industrial cleaning company, Polar Clean, which is based in South Bend, Ind., but dispatches teams nationally, has just under 50 core employees. One of its business lines is disaster restoration, and after a flood or hurricane, its temporary staff balloons.
Mr. Sergio offers health insurance to his permanent staff, but the premiums have risen so quickly that he had to switch to a more restrictive plan, with a higher deductible. He is reluctant to go over the 50-employee line and incur all of the new rules that come with it. That makes bidding for new jobs an arduous and risky exercise.
“I’ve had to pull my controller and a couple of top people to sit and spend days going through this,” he said. “If you ramp up, and it pushes you over 50, there’s all these unknown costs and complicated rules. Are we really going to be able to benefit from going after that opportunity? It freezes you at a time when you need to be moving fast.”

For the full story, see:
STACY COWLEY. “ENTREPRENEURSHIP; Health Care Law Leads Business Owners to Rethink Plans for Growth.” The New York Times (Thurs., NOV. 19, 2015): B4.
(Note: ellipses added.)
(Note: the online version of the story has the date NOV. 18, 2015, and has the title “ENTREPRENEURSHIP; Health Care Law Forces Businesses to Consider Growth’s Costs.”)

How Democratic Operatives Fight Innovation-Crushing Regulations

(p. B1) SAN FRANCISCO — Over the last few years, so-called sharing companies like Airbnb and Uber — online platforms that allow strangers to pay one another for a room or a ride — have established footholds in thousands of communities well before local regulators have figured out how to deal with them.

. . .
Chris Lehane, a Washington political operative who now serves as Airbnb’s head of global policy and public affairs, framed Proposition F (p. B10) as a hotel-industry-led attack on the middle class.
In this city of about 840,000 people, roughly $8 million was raised by groups opposed to Proposition F — about eight times the amount raised by the proposition’s backers, according to records filed with the San Francisco Ethics Commission.
Much of that money was spent mobilizing Airbnb hosts and users, Mr. Lehane said. Still, he repeatedly homed in on one of the company’s most important talking points: Airbnb’s victory was a win for the middle class.
“Cities recognize where the world is going, right, they understand that you’re either going to go forward or you’re going to go backward,” he said. “They understand that in a time of economic inequality, this is a question of whose side are you on: Do you want to be on the side of the middle class, or do you want to be opposed to the middle class?”
. . .
Companies like Airbnb and Uber have become multibillion-dollar companies by employing a kind of guerrilla growth strategy in which they set up a modest team of workers in a city and immediately start providing their services to the public, whether local laws allow them to or not.
. . .
Mr. Lehane, a former political operative in the Clinton administration, was nicknamed the Master of Disaster for his no-holds-barred approach to winning political fights. David Plouffe, a former adviser to President Obama, is now a senior adviser to Uber and a member of its board.
Mr. Lehane and Mr. Plouffe have both tried to frame their companies as middle-class saviors in a moment of economic anxiety and income inequality — themes that are playing out in the presidential election as well. Jeb Bush and other Republicans have bragged about their Uber rides on the campaign trail, praising these companies as the future of self-sufficient employment.

For the full story, see:
CONOR DOUGHERTY and MIKE ISAAC. “Airbnb and Uber Mobilize Vast User Base to Sway Policy.” The New York Times (Thurs., NOV. 5, 2015): B1 & B10.
(Note: ellipses added.)
(Note: the online version of the story has the date NOV. 4, 2015.)

Bike Helmet Regulations Hurt Health

(p. D1) . . . many cycling advocates have taken a surprising position: They are pushing back against mandatory bike-helmet laws in the U.S. and elsewhere. They say mandatory helmet laws, particularly for adults, make cycling less convenient and seem less safe, thus hindering the larger public-health gains of more people riding bikes.
All-ages helmet laws might actually make cycling more dangerous, some cyclists say, by decreasing ridership. Research shows that the more cyclists there are on the road, the fewer crashes there are. Academics theorize that as drivers become used to seeing bikes on a street, they watch more closely for them.
. . .
Piet de Jong, a professor in the department of applied finance and actuarial studies at Sydney’s Macquarie University, actually calculated the trade-off of mandatory helmet laws. In a 2012 paper in the journal Risk Analysis, he weighed the reduction of head injuries against increased morbidity due to foregone exercise from reduced cycling.
Dr. de Jong concluded that mandatory bike-helmet laws “have a net negative health impact.” That is in part because many people cycle to work or for errands, experts say. People tend to replace that type of cycling not with another physical activity such as a trip to the gym, but with a ride in a car.

For the full story, see:
RACHEL BACHMAN. “The Helmet-Law Backlash.” The Wall Street Journal (Tues., Oct. 13, 2015): D1 & D4.
(Note: ellipses added.)
(Note: the online version of the article was dated Oct. 12, 2015, and has the title “Do Bike Helmet Laws Do More Harm Than Good?”)

FTC Retaliated Against, and Destroyed, Innocent Firm that Stood Up for Rule of Law

(p. A17) Sometimes winning is still losing. That is certainly true for companies that find themselves caught in the cross hairs of the federal government. Since 2013, my organization has defended one such company, the cancer-screening LabMD, against meritless allegations from the Federal Trade Commission. Last Friday, [November 13, 2015] the FTC’s chief administrative-law judge dismissed the agency’s complaint. But it was too late. The reputational damage and expense of a six-year federal investigation forced LabMD to close last year.
. . .
Unlike many other companies in similar situations, . . . , LabMD refused to cave and in 2012 went public with the ordeal. In what appeared to be retaliation, the FTC sued LabMD in 2013, alleging that the company engaged in “unreasonable” data-security practices that amounted to an “unfair” trade practice by not taking reasonable steps to protect patient information. FTC officials publicly attacked LabMD and imposed arduous demands on the doctors who used the company’s diagnostic services. In just one example, the FTC subpoenaed a Florida oncology lab to produce documents and appear for depositions before government lawyers–all at the doctors’ expense.
Yet after years of investigation and enforcement action, the FTC never produced a single patient or doctor who suffered or who alleged identity theft or harm because of LabMD’s data-security practices. The FTC never claimed that LabMD violated HIPAA regulations, and until 2014–four years after its investigation began–never offered any data-security standards with which LabMD failed to comply.
. . .
. . . , the FTC is likely to simply disregard the 92-page decision–which weighed witness credibility and the law–and side with commission staff. That’s the still greater injustice: The FTC is not bound by administrative-law judge rulings. In fact, the agency has disregarded every adverse ruling over the past two decades, according to a February analysis by former FTC Commissioner Joshua Wright. Defendants’ only recourse is appealing in federal court, a fresh burden in legal fees.
That’s what happens when a federal agency serves as its own detective, prosecutor, judge, jury and executioner. As Mr. Wright observed, the FTC’s record is “a strong sign of an unhealthy and biased institutional process.” And he puts it perhaps most powerfully: “Even bank robbery prosecutions have less predictable outcomes than administrative adjudication at the FTC.” Winning against the federal government should never require losing so much.

For the full commentary, see:
DAN EPSTEIN. “Hounded Out of Business by Regulators; The company LabMD finally won its six-year battle with the FTC, but vindication came too late.” The Wall Street Journal (Fri., Nov. 20, 2015): A17.
(Note: ellipses, and bracketed date, added.)
(Note: the online version of the commentary was updated on Nov. 19, 2015.)