Category: Health

Those Who Suffer from a Problem, Can Invent to Solve It

(p. 1) Is it possible to extract blood from people without causing pain? For decades, this problem has stumped the medical industry. In an effort to replace the old-fashioned needle, companies are trying to deploy laser beams and tiny vacuums to draw blood.
In 2014, an engineer at Harvard named Ridhi Tariyal hit on a far simpler workaround. “I was trying to develop a way for women to monitor their own fertility at home,” she told me, and “those kinds of diagnostic tests require a lot of blood. So I was thinking about women and blood. When you put those words together, it becomes obvious. We have an opportunity every single month to collect blood from women, without needles.”
Together with her business partner, Stephen Gire, she has patented a method for capturing menstrual flow and transforming it into medical samples. “There’s lots of information in there,” Ms. Tariyal said, “but right now, it’s all going in the trash.”
Why did Ms. Tariyal see a possibility that had eluded so many engineers before her? You might say she has an unfair advantage: her gender.
. . .
(p. 4) Eric von Hippel, a scholar of innovation at M.I.T., has spent decades studying what seems like a truism: People who suffer from a problem are uniquely equipped to solve it. “What we find is that functionally novel innovations — those for which a market is not yet defined — tend to come from users,” he said. He pointed out that young Californians pioneered skateboards so that they could “surf” the streets. And surgeons built the first heart-and-lung machines to keep patients alive during long operations. “The reason users are so inventive is twofold. One is that they know the needs firsthand,” he said. The other is that they have skin in the game.

For the full commentary, see:
PAGAN KENNEDY. “The Tampon of the Future.” The New York Times, SundayReview Section (Sun., APRIL 3, 2016): 1 & 4-5.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date APRIL 1, 2016.)

Pagan Kennedy’s book, that is related to her commentary quoted above, is:
Kennedy, Pagan. Inventology: How We Dream up Things That Change the World. New York: Houghton Mifflin Harcourt Publishing Co., 2016.

How Health Insurance Slows Medical Innovation

(p. A8) A recent study led by Wendell Evans at the University of Sydney supports growing evidence that early tooth decay, before a cavity forms, can often be arrested and reversed with simple treatments that restore minerals in the teeth, rather than the more typical drill-and-fill approach.
The randomized, controlled trial followed 19 dental practices in Australia for three years, then researchers checked up on the patients again four years later. The result: After seven years, patients receiving remineralization treatment needed on average 30% fewer fillings.
. . .
There is a substantial body of research supporting remineralization as a treatment for early tooth decay, and little opposition in the dental profession, says Margherita Fontana, a professor of cariology at the University of Michigan School of Dentistry. Tradition, however, has been an obstacle to widespread use of the treatment. “For older generations [of dentists], it just feels wrong to leave decay and not remove it,” Dr. Fontana says. “That’s how they were trained.”
Reimbursement is another obstacle. Insurance typically covers application of fluoride varnish in children, but not adults. The cost ranges from $25 to $55, according to the American Dental Association’s Health Policy Institute. Other preventive treatments also generally aren’t covered.

For the full story, see:
DANA WECHSLER LINDEN. “Simple Dental Treatments Can Help Reverse Decay.” The Wall Street Journal (Tues., APRIL 12, 2016): D3.
(Note: ellipsis added.)
(Note: the online version of the story has the date April 11, 2016, and has the title “Simple Dental Treatments May Reverse Decay.”)

Government Regulations Protect Health-Care Incumbents Against Innovation

(p. A15) As people age, the main valve controlling the flow of blood out of the heart can narrow, causing heart failure, and sometimes death. In the past the only way to repair the damage was risky open-heart surgery. But an ingenious medical device now allows the heart to be repaired using a catheter that introduces a replacement valve through a main artery in the leg–another miracle of modern medicine.
In 2011, more than four years after they hit the European market, the Food and Drug Administration finally approved aortic heart valves for use in the U.S. The total cost of the new procedure is about the same as open-heart surgery. But government bureaucrats feared that the new replacement valve’s lower risks and easier administration would mean that many more elderly patients would seek to fix their failing heart valves, pushing up Medicare’s total spending. To limit their use, regulators created coverage rules based on a set of strained medical criteria. It was a budget prerogative masquerading as clinical reasoning.
This episode is a vivid example of the government’s increasing practice to regulate medicine and ration care. A series of landmark studies published earlier this month in the Lancet and the New England Journal of Medicine, and presented at the annual meeting of the American College of Cardiology in Chicago, makes clear how contrived the original Medicare guidelines were.
For a patient to be qualified for the aortic valve device, Medicare required two cardiac surgeons to certify first that a patient wasn’t a candidate for the open-heart repair. Also mandated was the presence of a cardiothoracic surgeon and an interventional cardiologist in the operating room during the procedure.

For the full commentary, see:
SCOTT GOTTLIEB. “Warning: Medicare May Be Bad for Your Heart; Aortic valve replacements are superior to open-heart surgery and less risky. So why are they hard to get?” The Wall Street Journal (Tues., April 12, 2016): A15.
(Note: the online version of the commentary has the date April 11, 2016.)

The Lancet article mentioned above, is:
Thourani, Vinod H., Susheel Kodali, Raj R. Makkar, Howard C. Herrmann, Mathew Williams, Vasilis Babaliaros, Richard Smalling, Scott Lim, S. Chris Malaisrie, Samir Kapadia, Wilson Y. Szeto, Kevin L. Greason, Dean Kereiakes, Gorav Ailawadi, Brian K. Whisenant, Chandan Devireddy, Jonathon Leipsic, Rebecca T. Hahn, Philippe Pibarot, Neil J. Weissman, Wael A. Jaber, David J. Cohen, Rakesh Suri, E. Murat Tuzcu, Lars G. Svensson, John G. Webb, Jeffrey W. Moses, Michael J. Mack, D. Craig Miller, Craig R. Smith, Maria C. Alu, Rupa Parvataneni, Ralph B. D’Agostino, Jr., and Martin B. Leon. “Transcatheter Aortic Valve Replacement Versus Surgical Valve Replacement in Intermediate-Risk Patients: A Propensity Score Analysis.” The Lancet (April 3, 2016), DOI: 10.1016/S0140-6736(16)30073-3.

The New England Journal of Medicine article mentioned above, is:
Leon, Martin B., Craig R. Smith, Michael J. Mack, Raj R. Makkar, Lars G. Svensson, Susheel K. Kodali, Vinod H. Thourani, E. Murat Tuzcu, D. Craig Miller, Howard C. Herrmann, Darshan Doshi, David J. Cohen, Augusto D. Pichard, Samir Kapadia, Todd Dewey, Vasilis Babaliaros, Wilson Y. Szeto, Mathew R. Williams, Dean Kereiakes, Alan Zajarias, Kevin L. Greason, Brian K. Whisenant, Robert W. Hodson, Jeffrey W. Moses, Alfredo Trento, David L. Brown, William F. Fearon, Philippe Pibarot, Rebecca T. Hahn, Wael A. Jaber, William N. Anderson, Maria C. Alu, and John G. Webb. “Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients.” New England Journal of Medicine (April 2, 2016), DOI: 10.1056/NEJMoa1514616.

Government Limits Hospital Competition

(p. A9) When the 124-bed StoneSprings Hospital Center opened in December, it became the first new hospital in Loudoun County, Va., in more than a century. That’s more remarkable than it might at first seem: In the past two decades, Loudoun County, which abuts the Potomac River and includes growing Washington suburbs, has tripled in population. Yet not a single new hospital had opened. Why? One big reason is that StoneSprings had to fight through years of regulatory reviews and court challenges before laying the first brick.
County officials and the Hospital Corporation of America, or HCA, began talking about building a new hospital in 2001. But Virginia is one of the 36 states with a “certificate of need” law, which requires health-care providers to obtain a state license before opening a new facility. Getting a license is supposed to take about nine months, according to the state Health Department. HCA first submitted an application in July 2002 but didn’t win approval for a new facility until early 2004.
Then the plan faced a series of legal challenges from the Inova Health System, an entrenched, multibillion-dollar competitor. Over decades Inova has become the dominant player in the Virginia suburbs.
. . .
It’s not hard to understand why Inova might fight so hard to keep out challengers: There’s a direct correlation between prices and competition. In a paper released in December, economists with Yale, Carnegie Mellon and the London School of Economics evaluated claims data from Aetna, Humana and UnitedHealth. They found that rates were 15.3% higher, on average, in areas with one hospital, compared with those serviced by four or more. In markets with a two-hospital duopoly, prices were 6.4% higher. Where only three hospitals compete they were 4.8% higher.
Research by Chris Koopman of the free-market Mercatus Center suggests that Virginia could have 10,000 more hospital beds and 40 more hospitals offering MRIs if the certificate of need restrictions did not exist. “In many instances, they create a quasi-monopoly,” he says. “In essence, it’s a government guarantee that no one will compete with you, until you get notice and an opportunity to challenge that person’s entry into that market.”

For the full commentary, see:
ERIC BOEHM. “CROSS COUNTRY; For Hospital Chains, Competition Is a Bitter Pill; Building a new medical center in Virginia can take a decade, because state laws favor entrenched players.” The Wall Street Journal (Sat., Jan. 30, 2016): A9.
(Note: ellipsis added.)
(Note: the online version of the commentary has the date Jan. 29, 2016.)

The academic paper mentioned above that relates hospital charges to the number of hospitals in the area, is:
Cooper, Zack, Stuart V. Craig, Martin Gaynor, and John Van Reenen. “The Price Ain’t Right? Hospital Prices and Health Spending on the Privately Insured.” NBER Working Paper # 21815. National Bureau of Economic Research, Inc., 2015.

Chris Koopman’s research, mentioned above, can be found in:
Koopman, Christopher, and Thomas Stratmann. “Certificate-of-Need Laws: Implications for Virginia.” In Mercatus on Policy: Mercatus Center, George Mason University, 2015.

After Wife’s Cancer, F.D.A. Regulator Cuts Decision Time from Six to Five Months (Beyond Years Spent Testing)

(p. 1) BETHESDA, Md. — Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators.
So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr. Richard Pazdur, has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.
He was also Mary’s husband.
In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and passion to fight the disease that patient advocates thought he lacked.
. . .
(p. 13) Certainly there has been a change at the powerful agency. Since Ms. Pazdur learned she had ovarian cancer in 2012, approvals for drugs have been faster than at any time in the F.D.A.’s modern history. Although companies go through a yearslong discovery and testing process with new drugs before filing a formal application with the F.D.A., the average decision time on drugs by Dr. Pazdur’s oncology group has come down to five months from six months. That is a major acceleration in a pharmaceutical industry where every month’s delay can mean thousands of lives lost and sometimes hundreds of millions of dollars in sales that, given limited patent times, can never be recovered.
When asked specifically how his wife’s illness had changed his work at the F.D.A., Dr. Pazdur said he was intent on making decisions more quickly.
“I have a much greater sense of urgency these days,” Dr. Pazdur, 63, said in an interview. “I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate.”

For the full story, see:
GARDINER HARRIS. “A Wife’s Cancer Prods the F.D.A.” The New York Times, First Section (Sun., JAN. 3, 2016): 1 & 13.
(Note: ellipsis added.)
(Note: the online version of the story has the date JAN. 2, 2016, and has the title “F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval.”)

The Value of Longer Life

(p. C6) With the seeker’s restlessness that seems not to have left him until his last breath, . . . [Dr. Paul Kalanthi accrued] two B.A.s and an M.A. in literature at Stanford, then a Master of Philosophy at Cambridge, before graduating cum laude from the Yale School of Medicine. He returned to Stanford for a residency in neurological surgery and a postdoctoral fellowship in neuroscience. His training was almost complete when the bad diagnosis hit.
. . .
And then everything changes. In a single moment of recognition, everything Dr. Kalanithi has imagined for himself and his wife evaporates, and a new future has to be imagined.
. . . A job at Stanford for which he was the prime candidate? Not happening. Another good job that would require the Kalanithis to move to Wisconsin? Too far from his oncologist. Long-term plans of any kind? Well, what does long-term mean now? Does he have a day, a month, a year, six years, what? He’s heard the advice about living one day at a time, but what’s he supposed to do with that day when he doesn’t know how many others remain?

For the full review, see:
JANET MASLIN. “Books of The Times; Singularly Striving Until Life Steps In.”The New York Times (Tues., July 7, 2015): C1 & C6.
(Note: ellipses, and bracketed words, added.)
(Note: the online version of the review has the date July 6, 2015, and has the title “Books of The Times; Review: In ‘When Breath Becomes Air,’ Dr. Paul Kalanithi Confronts an Early Death.”)

The book under review, is:
Kalanithi, Paul. When Breath Becomes Air. New York: Random House, 2016.

Ugly, Invasive, Depressing Federal LEDs Disrupt Sleep and Increase Risk of Breast Cancer

(p. B1) In my repellently contented middle age, I don’t seek blue light. Like most sane people, I spurn restaurants whose lighting glares. I recoil from mirrors under fluorescent tubes. I switch on an overhead only to track down a water bug while wielding a flip-flop. Yet each evening from March onward, in the Brooklyn neighborhood where I live part of the year, it seems as if the overhead is always on.
Along with other parts of South Brooklyn, Windsor Terrace is an early recipient of the Department of Transportation’s new light-emitting diode streetlights. New Yorkers who have not yet been introduced to these lights: We are living in your future.
Our new street “lamps” — too cozy a word for the icy arrays now screaming through our windows — are meant to be installed across all five boroughs by 2017. Indeed, any resident of an American municipality that has money problems (and what city doesn’t?) should take heed.
In interviews with the media, my fellow experimental subjects have compared the nighttime environment under the new streetlights to a film set, a prison yard, “a strip mall in outer space” and “the mother ship coming in for a landing” in “Close Encounters of the Third Kind.” Although going half-blind at 58, I can read by the beam that the new lamp blasts into our front room without tapping our own Con Ed service. Once the LEDs went in, our next-door neighbor began walking her dog at night in sunglasses.
Medical research has firmly established that blue-spectrum LED light can disrupt sleep patterns. This is the same illumination that radiates in far smaller doses from smartphone and computer screens, to which we’re advised to avoid exposure for at least an hour before bed, because it can suppress the production of melatonin. . . .
While the same light has also been associated with increased risk of breast cancer and mood disorders, in all honesty my biggest beef with LEDs has nothing to do with health issues. These lights are ugly. They’re invasive. They’re depressing. New York deserves better.
. . .
Even fiscally and environmentally conscientious California has compromised on this point. Berkeley, Oakland and San Francisco have all opted for yellow-rich LEDs. These cities have willingly made the modest 10-15 percent sacrifice in efficiency for an ambience that more closely embodies what Germans call Gemütlichkeit and Danes call hygge: an atmosphere of hospitality, homeyness, intimacy and well-being.
. . .
As currently conceived, the D.O.T.’s streetlight plan amounts to mass civic vandalism. If my focus on aesthetics makes this issue sound trivial, the sensory experience of daily life is not a frivolous matter. Even in junior high school, I understood that lighting isn’t only about what you see, but how you feel.

For the full commentary, see:
LIONEL SHRIVER. “Ruining That Moody Urban Glow.” The New York Times, SundayReview Section (Sun., OCT. 18, 2015): 5.
(Note: ellipses added.)
(Note: the online version of the commentary has the date OCT. 17, 2015.)

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.