Category: Health

Regulatory Costs Slow Development of Lifesaving Antibiotics

(p. A13) In the 1980s, 29 new antibiotics were approved; another 23 were approved during the 1990s. But only nine new drugs made it to market from 2000-10, and a study by the Pew Charitable Trusts shows few drugs in development for the most serious microbial threats such as multidrug resistant Acinetobacter and Pseudomonas aeruginosa.
. . .
To revitalize the search for lifesaving antibiotics, the Food and Drug Administration needs a new way to approve them. Legislation proposed in both the House and the Senate would create a new regulatory pathway that would enable the FDA to approve drugs specifically for patients whose serious infections can’t be treated with existing drugs, and for whom there are few or no other treatment options.
For these patients, the FDA would be empowered to approve new drugs based on fewer or smaller clinical studies than for antibiotics intended for broader use. The goal is to reduce the cost of development and accelerate the availability of new drugs for a targeted public health need.

For the full commentary, see:
JONATHAN LEFF And ALLAN COUKELL. “How to End the Regulatory Slowdown for New Antibiotics; With the threat from lethal drug-resistant bacteria growing, the FDA needs to speed up its approval process.” The Wall Street Journal (Fri., July 3, 2015): A13.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date July 2, 2015.)

More Evidence for Stigler’s Capture Theory

(p. A15) WASHINGTON — Marilyn B. Tavenner, the former Obama administration official in charge of the rollout of HealthCare.gov, was chosen on Wednesday to be the top lobbyist for the nation’s health insurance industry.
Ms. Tavenner, who stepped down from her federal job in February, will become president and chief executive of America’s Health Insurance Plans, the trade group whose members include Aetna, Anthem, Humana, Kaiser Permanente and many Blue Cross and Blue Shield companies.
As the new voice for insurers, Ms. Tavenner will lead the industry in a time of tumultuous changes and challenges, including delicate negotiations with Congress over the future of the Affordable Care Act.
. . .
The board of America’s Health Insurance Plans unanimously elected Ms. Tavenner at a meeting here on Wednesday, according to Mark B. Ganz, the board chairman, who is also the chief executive of Cambia Health Solutions, based in Portland, Ore.
. . .
Mr. Ganz said that Ms. Tavenner had “the trust and respect of members of Congress from both sides of the aisle.”
Senator John Barrasso, Republican of Wyoming, described the selection in more negative terms. “While millions of Americans are still being hurt by Obamacare’s soaring costs and fewer choices,” he said, “Ms. Tavenner’s appointment shows how the law has created a cozy and profitable relationship for some.”

For the full story, see:
ROBERT PEAR. “Head of Obama’s Health Care Rollout to Lobby for Insurers.” The New York Times (Thurs., JULY 16, 2015): A15.
(Note: ellipses added.)
(Note: the online version of the story has the date JULY 15, 2015.)

Feds’ Dietary Policy Is “an Obstacle to Sensible Change”

(p. A25) BOSTON — SINCE the publication of the federal government’s 1980 Dietary Guidelines, dietary policy has focused on reducing total fat in the American diet — specifically, to no more than 30 percent of a person’s daily calories. This fear of fat has had far-reaching impacts, from consumer preferences to the billions of dollars spent by the military, government-run hospitals and school districts on food. As we argue in a recently published article in The Journal of the American Medical Association, 35 years after that policy shift, it’s long past time for us to exonerate dietary fat.
. . .
Recent research has established the futility of focusing on low-fat foods. Confirming many other observations, large randomized trials in 2006 and 2013 showed that a low-fat diet had no significant benefits for heart disease, stroke, diabetes or cancer risks, while a high-fat, Mediterranean-style diet rich in nuts or extra-virgin olive oil — exceeding 40 percent of calories in total fat — significantly reduced cardiovascular disease, diabetes and long-term weight gain. Other studies have shown that high-fat diets are similar to, or better than, low-fat diets for short-term weight loss, and that types of foods, rather than fat content, relate to long-term weight gain.
. . .
The limit on total fat is an outdated concept, an obstacle to sensible change that promotes harmful low-fat foods, undermines efforts to limit refined grains and added sugars, and discourages the food industry from developing products higher in healthy fats.

For the full commentary, see:
DARIUSH MOZAFFARIAN and DAVID S. LUDWIG. “Stop Fearing Fat.” The New York Times (Thurs., JULY 9, 2015): A25.
(Note: ellipses added.)
(Note: the online version of the commentary has the title “Why Is the Federal Government Afraid of Fat?”)

The Wealth of Project Entrepreneurs Is Fragile

The stories of Alfred E. Mann (below) as well as that of Malcom McLean, the entrepreneur behind standardized shipping containers, support George Gilder’s point that innovative project entrepreneurs have most of their wealth tied up in their projects. Their wealth only stays large as long as the projects continue to go well.

(p. A20) Alfred E. Mann, who started medical device companies that pioneered in the development of pacemakers for erratic hearts, insulin pumps for diabetics, cochlear implants for the deaf and retinal implants for the blind, died on Thursday [February 25, 2016] in Las Vegas. He was 90.
. . .
Mr. Mann, who spent most of his career in the Los Angeles area, became a billionaire from his entrepreneurial activities. His biggest success was MiniMed, which became the leader in insulin pumps, wearable devices that deliver insulin throughout the day, allowing people with diabetes to more precisely control their blood sugar levels.
. . .
In all, Mr. Mann started and largely financed 14 companies, nine of which were acquired for a total of almost $8 billion, according to MannKind.
. . .
In 1979, while running Pacesetter, Mr. Mann was visiting a cardiac ward and was challenged by a doctor there to work on diabetes, which caused many of the heart problems in patients. That led to the creation of MiniMed and later to MannKind, which developed a form of insulin that is inhaled instead of injected.
MannKind, Mr. Mann’s last big venture, may also have been his Waterloo, eating up much of his fortune.
The pharmaceutical giant Pfizer suffered a costly marketing flop with an inhaled form of insulin in 2007. After that, other big insulin manufacturers dropped their own plans for similar products.
But Mr. Mann, who was chief executive of MannKind for many years, would not give up. He insisted MannKind’s inhaler was better than Pfizer’s and that its insulin had desirable medical characteristics beyond being inhalable. He put about $1 billion of his own money into the company he had named for himself, keeping it afloat through years of setbacks.
“I believe this is one of the most valuable products in history in the drug industry, and I’m willing to back it up with my estate,” Mr. Mann told The New York Times in 2007.
The inhaled insulin, called Afrezza, was finally approved by the Food and Drug Administration in 2014, but sales have been dismal. In January, Sanofi, the big French drug company, pulled out of an agreement to market the product. MannKind is now in danger of going out of business, though it is vowing to survive.
“Our resolve is now stronger than ever to continue Al’s legacy of medical innovation, as a tribute to this remarkable man, who did so much to help mankind,” Matthew Pfeffer, chief executive of MannKind, said in a statement Friday.
Mr. Mann, who worked seven days a week even when he was in his 80s, was divorced three times.

For the full story, see:
ANDREW POLLACK. “Alfred E. Mann, 90, Pioneer in Medical Devices, Is Dead.” The New York Times (Sat., FEB. 27, 2016): A20.
(Note: ellipses, and bracketed date, added.)
(Note: the online version of the story has the date FEB. 26, 2016, and has the title “Alfred E. Mann, Pioneer in Medical Devices, Dies at 90.”)

Gilder defends entrepreneurial wealth in:
Gilder, George. “The Enigma of Entrepreneurial Wealth.” Inc. 14, no. 10 (Oct. 1992): 161-64, 66 & 68.

Technology Extends Capabilities of Older Japanese

(p. A1) TOKYO–At an office-building construction site in the center of Japan’s capital, 67-year-old Kenichi Saito effortlessly stacks 44-pound boards with the ease of a man half his age.
His secret: a bendable exoskeleton hugging his waist and thighs, with sensors attached to his skin. The sensors detect when Mr. Saito’s muscles start to move and direct the machine to support his motion, cutting his load’s effective weight by 18 pounds.
“I can carry as much as I did 10 years ago,” says the hard-hatted Mr. Saito.
Mr. Saito is part of an experiment by Obayashi Corp. , the construction giant handling the building project, to confront one of the biggest problems facing the company and the country: a chronic labor shortage resulting from a rapidly aging population. The exoskeleton has allowed Mr. Saito to extend his working life–and Obayashi to keep building.
. . .
(p. A14) The Fujisawa Aikoen nursing home about an hour outside Tokyo started leasing the “hybrid assistive limb,” or HAL, exoskeletons from maker Cyberdyne Inc. in June.
In Hokkaido, 60-year-old potato-pickers use rubber “smart suits” making it easier to bend over. Baggage handlers at Tokyo’s Haneda airport employ similar assistance.
In cases where older people simply can’t do the job or aren’t available, Japanese manufacturers are turning to robots, which help them keep costs down and continue growing.
Bank of Tokyo Mitsubishi UFJ, Japan’s largest bank, employs a small robot speaking 19 languages to greet customers, while a Nagasaki hotel staffed mainly by robots opened in July. Komatsu Ltd. is developing self-driving vehicles for construction sites, while industrial robot maker Fanuc Corp. is designing machines that repair each other.
Toyota Motor Corp. is testing in homes its “human support robot,” a videophone/remote-controlled android that allows family and friends to perform tasks for distant elderly people as if they were in the same home. In one demonstration, a young man uses a tablet to look around a bed-bound older man’s room, then directs the robot to open the curtains and bring the older man a drink.
SoftBank Group Corp. earlier this year drew global attention when it put on sale in Japan an automaton called Pepper, which it called the world’s first robot capable of understanding emotions. One of the earliest uses for the 4-foot-tall white humanoid is as a nursing helper.
In a Kanagawa Prefecture test, Pepper entertained a room of 30 80- to 90-year-olds for 40 minutes. He led them in light exercises and tested their ability to recognize colors and letters. Women patted his head like a grandchild.
Showing a video of Pepper with a dementia patient on another occasion, Shunji Iyama, one of the developers, says the robot may sometimes work better than people. “That man keeps repeating himself over and over again,” Mr. Iyama said. “If Pepper were human, he’d get fed up, but he just repeats the same reaction and doesn’t get tired.”

For the full story, see:
Jacob M. Schlesinger and Alexander Martin. “Graying Japan Tries to Embrace the Golden Years.” The Wall Street Journal (Mon., Nov. 30, 2015): A1 & A14.
(Note: ellipsis added.)
(Note: the online version of the story has the date Nov. 29, 2015, and has the title “Graying Japan Tries to Embrace the Golden Years.”)

Serendipitous Fix for Colorblindness

(p. 3) The eyeglass lenses that Don McPherson invented were meant for surgeons. But through serendipity he found an entirely different use for them: as a possible treatment for colorblindness.
Mr. McPherson is a glass scientist and an avid Ultimate Frisbee player. He discovered that the lenses he had invented, which protect surgeons’ eyes from lasers and help them differentiate human tissue, caused the world at large to look candy-colored — including the Frisbee field.
At a tournament in Santa Cruz, Calif., in 2002, while standing on a grassy field dotted with orange goal-line cones, he lent a pair of glasses with the lenses to a friend who happened to be colorblind. “He said something to the effect of, ‘Dude, these are amazing,’ ” Mr. McPherson says. “He’s like, ‘I see orange cones. I’ve never seen them before.’ ”
Mr. McPherson was intrigued. He said he did not know the first thing about colorblindness, but felt compelled to figure out why the lenses were having this effect. Mr. McPherson had been inserting the lenses into glasses that he bought at stores, then selling them through Bay Glass Research, his company at the time.
Mr. McPherson went on to study colorblindness, fine-tune the lens technology and start a company called EnChroma that now sells glasses for people who are colorblind. His is among a range of companies that have brought inadvertent or accidental inventions to market. Such inventions have included products as varied as Play-Doh, which started as a wallpaper cleaner, and the pacemaker, discovered through a study of hypothermia.
. . .
EnChroma was still struggling to solve its marketing conundrum when another serendipitous event occurred: A paint company wanted to finance an ad campaign featuring the glasses. The idea was to introduce color to the colorblind. To that end, videos were made of EnChroma users wearing the glasses for the first time while looking at things like sunsets, colorful artwork and, of course, paint samples.
The ad campaign increased EnChroma’s sales and spurred a trend: New EnChroma customers began filming and sharing their experiences online. The company placed inserts in its eyeglass boxes encouraging customers to participate.
Prompted by the insert, Bob Balcom, a 60-year-old retired high school science teacher and labor relations specialist in Chatham, N.Y., uploaded his first YouTube video in March. Shot by his wife, it shows Mr. Balcom putting the glasses over his own eyeglasses and staring up at the sky quietly for several seconds. “The blue sky is deeper than I’ve ever seen,” he says. “It reminds me of Colorado. And the pine trees, they’re just so green.” Tears stream down his cheeks and into his gray beard.

For the full story, see:
CLAIRE MARTIN. “Finding a Niche for the Accidental Spectacles.” The New York Times, SundayBusiness Section (Sun., AUG. 16, 2015): 3.
(Note: ellipsis, and bracketed dates, added.)
(Note: the online version of the story has the date AUG. 15, 2015, and has the title “EnChroma’s Accidental Spectacles Find Niche Among the Colorblind.” )

Communist Chinese One Child Laws Violated Basic Human Rights

On Sat., Jan. 17, 2016 I caught the re-broadcast of an interview with Mei Fong that C-SPAN’s web site suggests was first broadcast on Jan. 11, 2016. The interview focused on Fong’s book on the history, causes and effects of China’s one child laws. Fong is understated in her style, but it is clear that the Chinese communist government violated the rights of many Chinese citizens by forcing them to have unwanted abortions, and to undergo unwanted sterilizations. In many cases, when their “one child” died in a disaster, or of natural causes, parents desperately rushed to try to have the forced sterilization reversed.

Fong’s book, that she discussed on C-SPAN, is:
Fong, Mei. One Child: The Story of China’s Most Radical Experiment. Boston, MA: Houghton Mifflin Harcourt, 2016.

Health Spending Rises Faster

HealthCostGrowthGraphs2016-01-21.jpgSource of graph: online version of the WSJ article quoted and cited below.

(p. A3) WASHINGTON–Growth in U.S. health-care spending is accelerating after reaching historic lows, a pickup largely attributed to the millions of Americans who have gotten health coverage under the Affordable Care Act.

Spending on all health care increased 5.3% in 2014, according to a report Wednesday [Dec. 2, 2015] from actuaries at the Centers for Medicare and Medicaid Services. That compares with the 2.9% growth in 2013, which marked the lowest rate since the government began tracking the gains 55 years ago.
The return to more robust growth after a slowdown in spending had been anticipated by economists. Still, it is likely to add to criticism that the 2010 health law isn’t doing enough to rein in costs. The report, based on 2014 government numbers and published in the journal Health Affairs, follows five consecutive years where average spending growth was less than 4% annually.

For the full story, see:
STEPHANIE ARMOUR. “Health Spending Picks Up.” The Wall Street Journal (Thurs., Dec. 3, 2015): A3.
(Note: bracketed date added.)
(Note: the online version of the article has the date Dec. 2, 2015, and has the title “Growth in U.S. Health-Care Spending Picks Up.”)

Medical Establishment Relies on “Accepted Dogma”

(p. A3) The Food and Drug Administration and leading cardiologists are warning that aortic heart valves from animal tissue–implanted surgically in thousands of patients world-wide–can develop tiny blood clots, causing the valves to function improperly.
The findings hit the field of cardiology as something of a shock, as these valves from pig and cow tissue have been used for three decades in patients with malfunctioning valves. In addition, the tissue valves have been regarded as less likely to produce blood clots than mechanical valves made of synthetic materials.
. . .
Cardiologist Eric Topol, chief academic officer at Scripps Health in San Diego, called it “remarkable” that such a finding could emerge after three decades of use of the animal-tissue valves. The idea that they lead to less clotting, he said, was “accepted dogma that wasn’t looked at.”

For the full story, see:
THOMAS M. BURTON. “Clot Risk Is Seen in Some Heart Valves.” The Wall Street Journal (Tues., Oct. 6, 2015): A3.
(Note: ellipsis added.)
(Note: the online version of the article has the date Oct. 5, 2015, and has the title “Clot Risk Is Seen in Some Heart Valves.” Where there were minor differences between the print and online versions, the passages quoted above follow the online version.)

Eric Topol, quoted above, has written persuasively for more medical innovation, in his:
Topol, Eric. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care. New York: Basic Books, 2012.

Unusual Array of Groups Strongly Push Breast-Feeding

C-SPAN on Sat., Jan. 17, 2016 broadcast a thought-provoking presentation by Courtney Jung on her book Lactivism. Jung argues that an unusual array of groups strongly advocate breast-feeding for reasons that are independent of the fairly modest health benefits, for baby and mother, that result from breast-feeding.

Jung’s book, that she discussed on C-SPAN, is:
Jung, Courtney. Lactivism: How Feminists and Fundamentalists, Hippies and Yuppies, and Physicians and Politicians Made Breastfeeding Big Business and Bad Policy. New York: Basic Books, 2015.

Gene Therapy Again Showing Promise

(p. B2) Biotechnology startup Spark Therapeutics Inc. said its experimental gene therapy improved vision among patients with hereditary vision impairment in a clinical trial, without the serious safety problems that have dogged the emerging field of gene therapy in the past.
. . .
Spark said it plans to seek U.S. Food and Drug Administration approval to market its treatment next year, which could make it the first gene therapy to reach the U.S. market if regulators approve it for sale. . . .
Gene therapy involves the injection of genetic material into a person’s cells to treat or prevent a disease. The research stalled after some study participants died or developed cancer after receiving gene therapies in the late 1990s and 2000s.
But gene therapy is gaining ground again. In 2012, the European Commission approved the Western world’s first gene therapy, UniQure NV’s Glybera, for the treatment of patients with a rare enzyme deficiency. The therapy hasn’t been approved for sale in the U.S.

For the full story, see:
PETER LOFTUS. “Eye Gene Therapy Shows Promise.” The Wall Street Journal (Tues., Oct. 6, 2015): B2.
(Note: ellipses added.)
(Note: the online version of the article has the date Oct. 5, 2015, and has the title “Gene Therapy for Visually Impaired Shows Promise.” Where there were minor differences between the print and online versions, the passages quoted above follow the online version.)