Category: Regulations

Airline Startups Stall in Bureaucratic Regulatory Headwinds

(p. B4) Mr. Vallas owns California Pacific Airlines, known as CP Air, his latest venture in a peripatetic business career that has included stints in areas as varied as land development and other aviation-related ventures.
CP Air has sat on a metaphorical runway for years — engines idling, ready for takeoff — while awaiting certification by the Federal Aviation Administration.
Mr. Vallas’s patience is wearing thin. After all, he is 95, and he regards the airline as a legacy, an exclamation point to a colorful life.
. . .
. . . then there was that matter with the F.A.A. The agency has repeatedly denied applications. A letter from 2013, one of several from the agency, advised him that the application’s contents were “incomplete, inaccurate and do not appear to have been reviewed for quality.”
. . .
The government shutdown in 2013 and the F.A.A.’s staff reduction did not help matters, the agency acknowledges.
. . .
The process of greenlighting a new airline has become more complicated since Mr. Vallas sold a previous venture, a charter service called Air Resorts, in 1997.
He acknowledges the vast increase in paperwork since that era but contends that the conditions for acceptance have been met.
Mr. Vallas’s airline is not the only one that has encountered bureaucratic headwinds. Other proposed airlines are in limbo for various reasons, including Baltia Airlines, created in 1989 to fly between New York City and Russia, which still lacks the authorities’ blessing.

For the full story, see:
MIKE TIERNEY. “ITINERARIES; A Start-Up Airline Idles on a California Runway.” The New York Times (Tues., APRIL 26, 2016): B4.
(Note: ellipses added.)
(Note: the online version of the story has the date APRIL 25, 2016, and has the title “ITINERARIES; Start-Up Airline Idles on a California Runway, Stymied by Bureaucracy.”)

FDA Blocking Stem-Cell Therapies from Those With No Other Hope

(p. D2) Research is exploding into ways stem cells might be harnessed to cure diseases, mend damaged tissue, even grow replacement organs.
. . .
Jeffrey Weiss, a retinal surgeon in Margate, Fla., has treated about 570 patients with retinal and optic nerve diseases with stem cells taken from patients’ bone marrow as part of a study, and says that about 60% have had meaningful improvement. Patients pay $19,000 to $21,000 to receive the injections.
Shawn Rockafellow, a 31-year old truck dispatcher in Chandler, Ariz., started rapidly losing his vision in 2014 to a genetic disease and says he was told to accept that he was going blind. His mother read about Dr. Weiss’s work. Mr. Rockafellow raised the $20,000 fee on GoFundMe, a personal charity website, and had the treatment in both eyes in January.
After three months, the vision in his right eye went from roughly 20/1,000 to 20/400. After six months, it was 20/300. His left eye hasn’t improved as much, so he wants to try the treatment again. His regular ophthalmologist, Scott Markham, says “the fact that he’s not worsening is fantastic.”
. . .
Mark Berman, a Beverly Hills, Calif., cosmetic surgeon who co-founded a network of stem-cell clinics, says “fundamentally, all we are doing is a simple, surgical procedure. This is not witch-doctor stuff. We are repairing cell damage with people’s own stem cells.” He says the member clinics in 25 states have treated about 5,000 patients to date, with no significant adverse events.
SammyJo Wilkinson, a former dot-com executive, developed multiple sclerosis in 1995 and was confined to a wheelchair by 2011. She says her symptoms started to improve almost immediately after receiving a high-dose stem cell treatment at a Houston clinic in 2012. When the FDA blocked access to that form of therapy, Ms. Wilkinson went to Cancún, Mexico, for follow-ups. After a total of five treatments for $90,000, she says she has far less pain, can exercise and walk short distances with the help of a walker.
At the FDA hearing, Ms. Wilkinson, who founded a patient group called Patients for Stem Cells, plans to appeal for a faster approval process for stem-cell therapies and a registry to monitor patient outcomes. “Patients will never get these treatments if they have to go the traditional double-blind placebo-controlled trial route. That takes 10 years and $1 billion,” she says. “There’s got to be a middle ground, where you don’t shut off treatment, you just keep track of it.”

For the full story, see:
Beck, Melinda. “Stem-Cell Treatments Become More Available, and Face More Scrutiny.” The Wall Street Journal (Tues., Aug. 30, 2016): D2.
(Note: ellipses added.)
(Note: the online version of the story has the date Aug. 29, 2016, and has the title “Stem-Cell Treatments Become More Available, and Face More Scrutiny.” There are minor differences in wording between the online and print versions. The sentences quoted above, follow the online version.)

Precautionary Principle Slows Cloning Innovation

(p. A8) Dolly the Sheep started her life in a test tube in 1996 and died just six years later. When she was only a year old, there was evidence that she might have been physically older. At five, she was diagnosed with osteoarthritis. And at six, a CT scan revealed tumors growing in her lungs, likely the result of an incurable infectious disease. Rather than let Dolly suffer, the vets put her to rest.
Poor Dolly never stood a chance. Or did she?
Meet Daisy, Diana, Debbie and Denise. “They’re old ladies. They’re very healthy for their age,” said Kevin Sinclair, a developmental biologist who, with his colleagues at the University of Nottingham in Britain, has answered a longstanding question about whether cloned animals like Dolly age prematurely.
In a study published Tuesday in Nature Communications, the scientists tested these four sheep, created from the same cell line as Dolly, and nine other cloned sheep, finding that, contrary to popular belief, cloned animals appear to age normally.
. . .
Not only did many countries, including Canada and Australia, ban reproductive cloning in animals, but the United Nations banned all kinds of cloning in humans in 2005. Last year the European Union made importing food from cloned animals or their offspring illegal.
. . .
Now, based on results of this new study, researchers have confirmed what most scientists believed years ago: Cloning does not lead to premature aging.
. . .
Many scientists hope that changes in perception will lead to advances in reproductive technology that will enable us to provide food for a growing global population, save endangered species and develop advanced therapies.

For the full story, see:
JOANNA KLEIN. “Dolly’s Fellow Clones, Enjoying the Golden Years.” The New York Times (Weds., JULY 27, 2016): A8.
(Note: ellipses added.)
(Note: the online version of the commentary has the date JULY 26, 2016, and has the title “Dolly the Sheep’s Fellow Clones, Enjoying Their Golden Years.”)

American Indians Suffer from Lack of Property Rights

(p. A15) There are almost no private businesses or entrepreneurs on Indian reservations because there are no property rights. Reservation land is held in trust by the federal government and most is also owned communally by the tribe. It’s almost impossible for tribe members to get a mortgage, let alone borrow against their property to start a business. The Bureau of Indian Affairs regulates just about every aspect of commerce on reservations.
Instead of giving Indians more control over their own land–allowing them to develop natural resources or use land as collateral to start businesses–the federal government has offered them what you might call a loophole economy. Washington carves out a sector of the economy, giving tribes a regulatory or tax advantage over non-Indians. But within a few years the government takes it away, in many cases leaving Indian tribes as impoverished and more disheartened than they were before.
. . .
What American Indians need first is less regulation. There is a reason that Native Americans say BIA, the initials for the Bureau of Indian Affairs, really stands for “Bossing Indians Around.”

For the full commentary, see:
NAOMI SCHAEFER RILEY. “The Loophole Economy Is No Jackpot for Indians; Running casinos or selling tax-free cigarettes can’t substitute for what tribes truly need: property rights.” The Wall Street Journal (Thurs., July 28, 2016): A15.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date July 27, 2016.)

The above commentary by Riley is related to her book, which is:
Riley, Naomi Schaefer. The New Trail of Tears: How Washington Is Destroying American Indians. New York: Encounter Books, 2016.

Fragmented Health Care Causes Polypharmacy Harms

(p. D5) Dr. Caleb Alexander knows how easily older people can fall into so-called polypharmacy. Perhaps a patient, like most seniors, sees several specialists who write or renew prescriptions.
“A cardiologist puts someone on good, evidence-based medications for his heart,” said Dr. Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. “An endocrinologist does the same for his bones.”
. . .
“Pretty soon, you have an 82-year-old man who’s on 14 medications,” Dr. Alexander said, barely exaggerating.
Geriatricians and researchers have warned for years about the potential hazards of polypharmacy, usually defined as taking five or more drugs concurrently. Yet it continues to rise in all age groups, reaching disturbingly high levels among older adults.
. . .
Ultimately, the best way to reduce polypharmacy is to overhaul our fragmented approach to health care. “The system is not geared to look at a person as a whole, to see how the patterns fit together,” Dr. Steinman said.

For the full commentary, see:
Span, Paula. “THE NEW OLD AGE; An Ever-Mounting Pile of Pills.” The New York Times (Tues., APRIL 26, 2016): D5.
(Note: ellipses added.)
(Note: the online version of the commentary has the date APRIL 22, 2016, and has the title “THE NEW OLD AGE; The Dangers of ‘Polypharmacy,’ the Ever-Mounting Pile of Pills.”)

“To Understand Zoning, You Have to Have a Law Degree”

(p. 27) Not all buildings are worth keeping. In Midtown East, many nonconforming structures have low ceilings and columns that make them unappealing to new businesses. Some developers have gone so far as to demolish all but the bottom quarter of their buildings, and then build up from there, allowing them to retain the old zoning for their plots so as not to sacrifice a single square foot. The city is currently reconsidering a proposal that would allow these buildings to be rebuilt to their original size and possibly even larger.
It does not have to be this complicated. In honor of the code’s 100th anniversary, the Municipal Art Society of New York has called on City Hall to consider overhauling the code in a way that would make it intelligible to all.
“To understand zoning, you have to have a law degree, it’s so convoluted and so dense,” Mike Ernst, director of planning at the civic group, said. “The whole process of how buildings get built these days is so confusing and opaque to people. There really should be more transparency, so people can have an understanding of what the future holds for their city.”

For the full story, see:
“Reviled, Revered, and Still Challenging Russia to Evolve.” The New York Times, First Section (Sun., MAY 22, 2016): 27.
(Note: the online version of the story has the date MAY 20, 2016, and has the title “40 Percent of the Buildings in Manhattan Could Not Be Built Today.” It is substantially longer than the print version and includes three authors, while no authors were listed for the print version. The authors listed for the online version were: QUOCTRUNG BUI, MATT A.V. CHABAN and JEREMY WHITE.)

“Doctors Often Do Not ‘Know’ What They Are Doing”

(p. A11) Into the “swift currents and roiling waters of modern medicine” plunges Dr. Steven Hatch, whose informative “Snowball in a Blizzard” adds an important perspective. Dr. Hatch believes that our health-care system can “champion patient autonomy” and facilitate “more humane treatment, less anxiety, and better care” by revealing to patients the “great unspoken secret of medicine.” What’s the secret? Simply stated, “doctors often do not ‘know’ what they are doing.” In Dr. Hatch’s view, despite spectacular advances in biomedical science, modern “doctors simply cannot provide the kind of confident predictions that are often expected of them.”
. . .
He begins where Donald Rumsfeld ended: There will always be “known knowns, known unknowns, and unknown unknowns” in medicine. Dr. Hatch illustrates this spectrum of uncertainty with engaging exposés of popular screening tests like mammograms (attempting to detect breast cancer is like “finding a snowball in a blizzard”); common drug treatments, like those used to lower serum cholesterol or blood-pressure levels (about which expert national guidelines seem to change almost yearly); and health-care coverage in the lay media (whose “breaking news” too often ignores the uncertainty of the news being broken). Throughout his book, Dr. Hatch’s message is “caveat emptor,” warning his readers to beware not only the pseudoscientists, flim-flammers, anti-vacciners and celebrity doctors but also the all-too-certain pronouncements of the medical establishment.

For the full review, see:
BRENDAN REILLY. “BOOKSHELF; Give It To Me Straight, Doc; Doctors can’t really be certain if any treatment will help a particular person. But patients are looking for prescriptions, not probabilities.” The Wall Street Journal (Tues., March 15, 2016): A11.
(Note: the ellipsis between paragraphs, and the first two in the final quoted paragraph, are added; the third ellipsis in the final paragraph is in the original.)
(Note: ellipsis added.)
(Note: the online version of the review has the date March 14, 2016.)

The book under review, is:
Hatch, Steven. Snowball in a Blizzard: A Physician’s Notes on Uncertainty in Medicine. New York: Basic Books, 2016.

“Draconian” Regulations Reduce Consumer Choice

(p. B1) The Consumer Financial Protection Bureau, the watchdog agency set up after the last financial crisis, is poised to adopt strict new national rules that will curtail payday lending.
. . .
(p. B6) A sweeping study of bans on payday lending, scheduled to be published soon in The Journal of Law and Economics, found similar patterns in other states. When short-term loans disappear, the need that drives demand for them does not; many customers simply shift to other expensive forms of credit like pawn shops, or pay late fees on overdue bills, the study’s authors concluded.
Mr. Munn, who works as a site geologist on oil wells, first borrowed from Advance America eight months ago when his car broke down. He had some money saved, but he needed a few hundred more to pay the $1,200 repair bill. Then his employer, reacting to falling oil prices, cut wages 30 percent. Mr. Munn became a regular at the loan shop.
He likes the store’s neighborhood vibe and friendly staff, and he views payday loans as a way to avoid debt traps he considers more insidious.
“I don’t like credit cards,” said Mr. Munn, who is wary of the high balances that they make it too easy to run up. “I could borrow from my I.R.A., but the penalties are huge.”
At Advance America, he said, “I come in here, pay back what I’ve taken, and get a little bit more for rent and bills. I keep the funds to an extent that I can pay back with the next check. I don’t want to get into more trouble or debt.”
. . .
The rules would radically reshape, and in some places eliminate, payday borrowing in the 36 states where lenders still operate, according to Richard P. Hackett, a former assistant director at the Consumer Financial Protection Bureau.
. . .
“It’s a draconian scenario,” said Jamie Fulmer, an Advance America spokesman.

For the full story, see:
STACY COWLEY. “To Curb Abuse, Loan Rules May Cut a Lifeline.” The New York Times (Sat., JULY 23, 2016): B1 & B6.
(Note: ellipses added.)
(Note: the online version of the story has the date JULY 22, 2016, and has the title “Payday Loan Limits May Cut Abuse but Leave Some Borrowers Looking.”)

Certificate-of-Need Regulations Protect Incumbents and Hurt Consumers

(p. A11) An important but overlooked debate is unfolding in several states: When governments restrict market forces in health care, who benefits? Legislative majorities in 36 states believe that consumers benefit, because restrictions help control health-care costs. But new research confirms what should be common sense: Preventing qualified health-care providers from freely plying their trade results in less access to care.
Most states enforce market restrictions through certificate-of-need programs, which mandate a lengthy, expensive application process before a health-care provider can open or expand a facility. The story goes: If hospitals or physicians could choose what services to provide, competition for patients would force providers to overinvest in equipment such as MRI machines–and the cost could be passed on to patients through higher medical bills.
. . .
These restrictions have largely failed to reduce costs, but they certainly reduce services. A 2011 study in the Journal of Health Care Finance found that certificate-of-need laws resulted in 48% fewer hospitals and 12% fewer hospital beds.

For the full commentary, see:
THOMAS STRATMANN and MATTHEW BAKER. “Certifiably Needless Health-Care Meddling.” The Wall Street Journal (Tues., Jan. 12, 2016): A11.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date Jan. 11, 2016.)

The “new research” mentioned by Stratman in the passage quoted above, is:
Stratmann, Thomas, and Matthew C. Baker. “Are Certificate-of-Need Laws Barriers to Entry?: How They Affect Access to MRI, CT, and Pet Scans.” Mercatus Working Paper, Jan. 2016.

Denmark Drones Saving Lives

(p. B1) Mr. McLinden is a member of a group of middle-aged emergency workers taking part in a trial to jump-start the use of unmanned aircraft by Europe’s emergency services. The goal is to give the region a head start over the United States and elsewhere in using drones to tackle real-world emergencies.
The “drone school” builds on Europe’s worldwide lead in giving public groups and companies relatively free rein to experiment with unmanned aircraft. If everything goes as planned, the project’s backers hope government agencies in Europe and farther afield can piggyback on the experiences, helping to transform drones from recreational toys to lifesaving tools.
“For us, this technology is a game-changer,” said Mr. McLinden, who traveled to Copenhagen (p. B4) for a three-day training course with two colleagues from the Mid and West Wales Fire and Rescue Service. They will start offering 24/7 drone support — allowing colleagues, for example, to monitor accidents from 300 feet above — across central Wales later this month.
“Drones aren’t going to replace what we do,” Mr. McLinden added. “But anything that we can do to give our crews an advantage, that’s great.”
. . .
In a somewhat stuffy classroom at a disused fire station in Copenhagen, Thomas Sylvest gave advice to Mr. McLinden and others from his two years of flying. As Denmark’s first, and so far only, emergency service drone pilot, Mr. Sylvest has responded to things as varied as missing person cases and fires, often receiving calls late at night.
Mr. Sylvest, a fast-talking 50-year-old, offered tips on how best to share videos streamed directly from drones to commanders on the ground. During a recent fire in downtown Copenhagen, Mr. Sylvest said, he was able to beam high-definition images from high above, allowing his bosses to judge if a building’s walls would collapse (they did not). And when the police called him out last year after a man was reported missing, he flew his drone along a stretch of train tracks to guide colleagues on where best to look. (The man was found.)

For the full story, see:
MARK SCOTT. “Emergency Workers Turn to Drones to Save Lives.” The New York Times (Mon., JUNE 20, 2016): B1 & B4.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date JUNE 19, 2016, and has the title “Europe’s Emergency Workers Turn to Drones to Save Lives.”)

Crony Credentialism Is Regulatory Barrier to Telemedicine

(p. A11) Telemedicine has made exciting advances in recent years. Remote access to experts lets patients in stroke, neonatal and intensive-care units get better treatment at a lower cost than ever before. In rural communities, the technology improves timely access to care and reduces expensive medevac trips. Remote-monitoring technology lets patients with chronic conditions live at home rather than in an assisted-living facility.
Yet while telemedicine can connect a patient in rural Idaho with top specialists in New York, it often runs into a brick wall at state lines. Instead of welcoming the benefits of telemedicine, state governments and entrenched interests use licensing laws to make it difficult for out-of-state experts to offer remote care.
. . .
Using its power under the Commerce Clause of the Constitution, Congress could pass legislation to define where a physician practices medicine to be the location of the physician, rather than the location of the patient, as states currently do. Physicians would need only one license, that of their home state, and would work under its particular rules and regulations.
This would allow licensed physicians to treat patients in all 50 states. It would greatly expand access to quality medical care by freeing millions of patients to seek services from specialists around the country without the immense travel costs involved.

For the full commentary, see:

SHIRLEY SVORNY. “Telemedicine Runs Into Crony Doctoring; State medical-licensing barriers protect local MDs and deny patients access to remote-care physicians.” The Wall Street Journal (Sat., July 23, 2016): A11.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date JUNE 22, 2016.)