Category: Regulations

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.)

Recycling Is Costly “Religious Ritual”

John Tierney penned another eye-opening commentary, this one as a cover-story for the SundayReview Section of The New York Times. A few of the best passages are quoted below.

(p. 1) In 1996, I wrote a long article for The New York Times Magazine arguing that the recycling process as we carried it out was wasteful.

. . .
So, what’s happened since then? While it’s true that the recycling message has reached more people than ever, when it comes to the bottom line, both economically and environmentally, not much has changed at all.
Despite decades of exhortations and man-(p. 4)dates, it’s still typically more expensive for municipalities to recycle household waste than to send it to a landfill. Prices for recyclable materials have plummeted because of lower oil prices and reduced demand for them overseas. The slump has forced some recycling companies to shut plants and cancel plans for new technologies.
. . .
One of the original goals of the recycling movement was to avert a supposed crisis because there was no room left in the nation’s landfills. But that media-inspired fear was never realistic in a country with so much open space. In reporting the 1996 article I found that all the trash generated by Americans for the next 1,000 years would fit on one-tenth of 1 percent of the land available for grazing. And that tiny amount of land wouldn’t be lost forever, because landfills are typically covered with grass and converted to parkland, like the Freshkills Park being created on Staten Island.
. . .
Last week the National Institutes of Health announced that it had prematurely ended a large national study of how best to treat people with high blood pressure because of its exceptional results.
In this trial of more than 9,000 people age 50 and older with high blood pressure, an aggressive treatment strategy to keep systolic blood pressure below 120 was compared with a conventional one aimed at keeping it below 140. The subjects all had a high risk of heart attacks, stroke and heart failure. The N.I.H. concluded, six years into a planned eight-year study, that for these patients, pushing blood pressure down far below currently recommended levels was very beneficial.
. . .
As a business, recycling is on the wrong side of two long-term global economic trends. For centuries, the real cost of labor has been increasing while the real cost of raw materials has been declining. That’s why we can afford to buy so much more stuff than our ancestors could. As a labor-intensive activity, recycling is an increasingly expensive way to produce materials that are less and less valuable.
Recyclers have tried to improve the economics by automating the sorting process, but they’ve been frustrated by politicians eager to increase recycling rates by adding new materials of little value. The more types of trash that are recycled, the more difficult it becomes to sort the valuable from the worthless.
In New York City, the net cost of recycling a ton of trash is now $300 more than it would cost to bury the trash instead. That adds up to millions of extra dollars per year — about half the budget of the parks department — that New Yorkers are spending for the privilege of recycling. That money could buy far more valuable benefits, including more significant reductions in greenhouse emissions.
So what is a socially conscious, sensible person to do?
It would be much simpler and more effective to impose the equivalent of a carbon tax on garbage, as Thomas C. Kinnaman has proposed after conducting what is probably the most thorough comparison of the social costs of recycling, landfilling and incineration. Dr. Kinnaman, an economist at Bucknell University, considered everything from environmental damage to the pleasure that some people take in recycling (the “warm glow” that makes them willing to pay extra to do it).
He concludes that the social good would be optimized by subsidizing the recycling of some metals, and by imposing a $15 tax on each ton of trash that goes to the landfill. That tax would offset the environmental costs, chiefly the greenhouse impact, and allow each municipality to make a guilt-free choice based on local economics and its citizens’ wishes. The result, Dr. Kinnaman predicts, would be a lot less recycling than there is today.
Then why do so many public officials keep vowing to do more of it? Special-interest politics is one reason — pressure from green groups — but it’s also because recycling intuitively appeals to many voters: It makes people feel virtuous, especially affluent people who feel guilty about their enormous environmental footprint. It is less an ethical activity than a religious ritual, like the ones performed by Catholics to obtain indulgences for their sins.
Religious rituals don’t need any practical justification for the believers who perform them voluntarily. But many recyclers want more than just the freedom to practice their religion. They want to make these rituals mandatory for everyone else, too, with stiff fines for sinners who don’t sort properly. Seattle has become so aggressive that the city is being sued by residents who maintain that the inspectors rooting through their trash are violating their constitutional right to privacy.

For the full commentary, see:
JOHN TIERNEY. “The Reign of Recycling.” The New York Times, SundayReview Section (Sun., OCT. 4, 2015): 1 & 4.
(Note: ellipses added.)
(Note: the online version of the commentary has the date OCT. 3, 2015.)

The Kinnaman paper mentioned above, is:
Kinnaman, Thomas C., Takayoshi Shinkuma, and Masashi Yamamoto. “The Socially Optimal Recycling Rate: Evidence from Japan.” Journal of Environmental Economics & Management 68, no. 1 (July 2014): 54-70.

“Strong-Willed Scientists Overstated the Significance of Their Studies”

The New York Times seems open to the idea that strong-willed scientists might overstate their results in science food studies. I wonder if The New York Times would be open to the same possibility in science climate studies?

(p. A19) For two generations, Americans ate fewer eggs and other animal products because policy makers told them that fat and cholesterol were bad for their health. Now both dogmas have been debunked in quick succession.
. . .
Epidemiological data can be used to suggest hypotheses but not to prove them.
Instead of accepting that this evidence was inadequate to give sound advice, strong-willed scientists overstated the significance of their studies.
Much of the epidemiological data underpinning the government’s dietary advice comes from studies run by Harvard’s school of public health. In 2011, directors of the National Institute of Statistical Sciences analyzed many of Harvard’s most important findings and found that they could not be reproduced in clinical trials.
It’s no surprise that longstanding nutritional guidelines are now being challenged.
In 2013, government advice to reduce salt intake (which remains in the current report) was contradicted by an authoritative Institute of Medicine study. And several recent meta-analyses have cast serious doubt on whether saturated fats are linked to heart disease, as the dietary guidelines continue to assert.
Uncertain science should no longer guide our nutrition policy. Indeed, cutting fat and cholesterol, as Americans have conscientiously done, may have even worsened our health.

For the full commentary, see:
NINA TEICHOLZ. “The Government’s Bad Diet Advice.” The New York Times (Sat., FEB. 21, 2015): A19.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date FEB. 20, 2015.)

FCC Gains Arbitrary Power Over Internet Innovation

(p. A11) Imagine if Steve Jobs, Larry Page or Mark Zuckerberg had been obliged to ask bureaucrats in Washington if it was OK to launch the iPhone, Gmail, or Facebook’s forthcoming Oculus virtual-reality service. Ridiculous, right? Not anymore.
A few days before the Independence Day holiday weekend, the Federal Communications Commission announced what amounts to a system of permission slips for the Internet.
. . .
As the FCC begins to issue guidance and enforcement actions, it’s becoming clearer that critics who feared there would be significant legal uncertainty were right. Under its new “transparency” rule, for example, the agency on June 17 conjured out of thin air an astonishing $100 million fine against AT&T, even though the firm explained its mobile-data plans on its websites and in numerous emails and texts to customers.
The FCC’s new “Internet Conduct Standard,” meanwhile, is no standard at all. It is an undefined catchall for any future behavior the agency doesn’t like.
. . .
From the beginning, Internet pioneers operated in an environment of “permissionless innovation.” FCC Chairman Tom Wheeler now insists that “it makes sense to have somebody watching over their shoulder and ready to jump in if necessary.” But the agency is jumping in to demand that innovators get permission before they offer new services to consumers. The result will be less innovation.

For the full commentary, see:
BRET SWANSON. “Permission Slips for Internet Innovation; The FCC’s new Web rules are already as onerous as feared and favor some business models over others.” The Wall Street Journal (Sat., Aug. 15, 2015): A11.
(Note: ellipses added.)
(Note: the online version of the commentary has the date Aug. 14, 2015.)

Feds Constrain Startups

(p. A15) Virtually every state has suffered a drop in startups, which suggests that this is a national, and not a regional or state, problem.
. . .
If history is any indication, many of today’s economic heavyweights will ultimately decline as new businesses take their place. Research by the Kaufman Foundation shows that only about half of the 1995 Fortune 500 firms remained on the list in 2010.
Startups also have declined in high technology. John Haltiwanger of the University of Maryland reports that there are fewer startups in high technology and information-processing since 2000, as well as fewer high-growth startups–annual employment growth of more than 25%–across all sectors. Even more troubling is that the smaller number of high-growth startups is not growing as quickly as in the past.
. . .
Surveys by John Dearie and Courtney Gerduldig, authors of “Where the Jobs Are: Entrepreneurship and the Soul of the American Economy” (2013), show that entrepreneurs report being hamstrung by difficulties in finding skilled workers, by a complex tax code that penalizes small business, by regulations that raise the costs of doing business, and by difficulties in obtaining financing that have worsened since 2008.

For the full story, see:
EDWARD C. PRESCOTT and LEE E. OHANIAN. “Behind the Productivity Plunge: Fewer Startups; New businesses were created at a 30% lower rate in 2012 than the annual average rate in the 1980s.” The Wall Street Journal (Thurs., June 26, 2014): A15.
(Note: ellipses added.)
(Note: the online version of the story has the date June 25, 2014.)

Belgian Government Mandates Mayo to Be No Less than 80% Fat

(p. A1) BRUSSELS–Mayonnaise here is a sauce celebre, so important that a 60-year-old royal decree governs what goes in it.
. . .
Belgian mayonnaise must contain at least 80% fat and 7.5% egg yolk. European rivals are permitted to sell mayo with a mere 70% fat and 5% egg yolk.

For the full story, see:
TOM FAIRLESS. “No Yolk, Belgian Food Producers Fed Up with Mayonnaise Rules; But effort to relax royal recipe doesn’t go down well with chefs; yellow peas.” The Wall Street Journal (Mon., Sept. 20, 2015): A1 & A10.
(Note: ellipsis added.)
(Note: the online version of the story has the date Sept. 20, 2015 and the title “In Belgium, Mayonnaise Makers Want a New Recipe; But effort to relax royal recipe doesn’t go down well with chefs; yell;ow peas.”)

Increasing Recalls of Organic Food Due to Bacterial Contamination

(p. B3) New data collected by Stericycle, a company that handles recalls for businesses, shows a sharp jump in the number of recalls of organic food products.
Organic food products accounted for 7 percent of all food units recalled so far this year, compared with 2 percent of those recalled last year, according to data from the Food and Drug Administration and the Department of Agriculture that Stericycle uses to compile its quarterly report on recalls.
In 2012 and 2013, only 1 percent of total units of food recalled were organic.
Kevin Pollack, a vice president at Stericycle, said the growing consumer and corporate demand for organic ingredients was at least partly responsible for the increase.
“What’s striking is that since 2012, all organic recalls have been driven by bacterial contamination, like salmonella, listeria and hepatitis A, rather than a problem with a label,” Mr. Pollack said. “This is a fairly serious and really important issue because a lot of consumers just aren’t aware of it.”

For the full story, see:
STEPHANIE STROM. “Private Analysis Shows a Sharp Increase in the Number of Organic Food Recalls.” The New York Times (Fri., Aug. 21, 2015): B3.
(Note: the online version of the story has the date AUG. 20, 2015, and has the title “Recalls of Organic Food on the Rise, Report Says.” The last paragraph quoted above differs in the print and online versions; the version quoted is the print version. The online version of the paragraph is: “According to Stericycle, 87 percent of organic recalls since 2012 were for bacterial contamination, like salmonella and listeria, rather than a problem with a label. “This is a fairly serious and really important issue because a lot of consumers just aren’t aware of it,” Mr. Pollack said.”)