Prominent Transplant Surgeon Endorses Market for Kidneys

 

KidneyTransplantWaitingListGraph.gif   Source of graphic:  online version of the WSJ article quoted and cited below.

 

(p. A1)  Amid a severe kidney-donor shortage, an idea long considered anathema in the medical community is gaining new currency: payments for people willing to give up a kidney. 

One of the most outspoken voices on the topic isn’t a free-market libertarian, but a prominent transplant surgeon named Arthur Matas.

Dr. Matas, 59 years old, is a Canadian-born physician best known for his research at the University of Minnesota. Lately, he’s been traveling the country trying to make the case that barring kidney sales is tantamount to sentencing some patients to death.

"There’s one clear argument for sales," Dr. Matas told a gathering of surgeons earlier this year. The practice, currently illegal in the U.S., "would increase the supply of kidneys, save lives and improve the quality of life for those with end-stage renal disease."

The doctor supports a regulated market only for kidneys, since live donors can give one up and survive without excessive health risks. (Transplants of other organs, such as livers and lungs, pose greater complications to a living donor.) And Dr. Matas doesn’t rule out financial incentives for the families of deceased donors.

 

For the full story, see:

LAURA MECKLER.  "Kidney Shortage Inspires A Radical Idea: Organ Sales As Waiting List Grows, Some Seek to Lift Ban; Exploiting the Poor?"  The Wall Street Journal  (Tues., November 13, 2007):  A1 & A22.

 

MatasArthurTransplantSurgeon.jpg  Source of image:  online version of the WSJ article quoted and cited above.

 

Unwashed Hospital Worker Hands Often Spread Disease

 

   "A special light reveals deadly bacteria."  Source of caption and photo:  online version of the NYT article quoted and cited below.

 

If health care in the U.S. were a free market, with unregulated entry, and real consumer choice, it is hard to believe that some Wal-Mart-of-health-care wouldn’t come along that would gain huge market share and profits by providing its employees incentives to wash their hands.

 

(p. A1)  PITTSBURGH — At a veterans’ hospital here, nurses swab the nasal passages of every arriving patient to test them for drug-resistant bacteria. Those found positive are housed in isolation rooms behind red painted lines that warn workers not to approach without wearing gowns and gloves.

Every room and corridor is equipped with dispensers of foamy hand sanitizer. Blood pressure cuffs are discarded after use, and each room is assigned its own stethoscope to prevent the transfer of microorganisms. Using these and other relatively inexpensive measures, the hospital has significantly reduced the number of patients who develop deadly drug-resistant infections, long an unaddressed problem in American hospitals.

The federal Centers for Disease Control and Prevention projected this year that one of every 22 patients would get an infection while hospitalized — 1.7 million cases a year — and that 99,000 would die, often from what began as a routine procedure. The cost of treating the infections amounts to tens of billions of dollars, experts say.

But in the past two years, a few hospitals have demonstrated that simple screening and isolation of patients, along with a relentless focus on hygiene, can reduce the number of dangerous infections. By doing so, they have fueled a national debate about whether hospitals are doing all they can to protect patients from infections, which are now linked to more deaths than diabetes or Alzheimer’s disease.

. . .

(p. A16)  Dr. Richard P. Shannon, who championed a program to reduce catheter infections at Allegheny General Hospital in Pittsburgh, was able to show administrators that the average infection cost the hospital $27,000. He demonstrated that reimbursement payments for weeks of extended treatment were not keeping pace with actual costs. “I think it was assumed that hospitals didn’t mind treating these infections because they were getting paid for it,” Dr. Shannon said.

A major emphasis at the Pittsburgh hospitals has been hand hygiene. Studies have consistently shown that busy hospital workers disregard basic standards more than half the time. At the veterans hospital, where nurses have taken to pushing elevator buttons with their knuckles, annual spending on hand cleaner has doubled.

 

For the full story, see:

KEVIN SACK.  "Swabs in Hand, Hospital Cuts Deadly Infections."  The New York Times   (Fri., July 27, 2007):   A1 & A16.

(Note:  ellipsis added.)

 

 InfectionsDropGraph.jpg CunninghamBillNurse.jpg  In the photo on the right, Pittsburgh nurse Bill Cunningham, "puts on a gown and gloves before approaching patients with infections."  Source of graph, caption, and photo:  online version of the NYT article quoted and cited above.

 

Entrepreneur Bets His Wealth on a Risky, Important Project

 

  "Alfred E. Mann, at his home in Beverly Hills, Calif., has put nearly $1 billion of his own money into developing an insulin that can be inhaled."  Source of caption and photo:  online version of the NYT article quoted and cited below.

 

(p. C1)  LOS ANGELES, Nov. 15 — Pfizer, the world’s biggest drug company, flopped miserably with a seemingly can’t-miss idea. But Alfred E. Mann is so certain he can succeed that he is betting nearly $1 billion of his own money on the effort.

Pfizer’s failure was a form of insulin that people with diabetes could inhale rather than inject. But last month, after selling only $12 million worth of inhaled insulin in the first nine months of the year, Pfizer said it would take a $2.8 billion charge and abandon the product.

Mr. Mann, the 82-year-old chief executive and controlling shareholder of the MannKind Corporation, is not deterred. He says his company’s inhalable insulin is not just a way to avoid needles but is medically superior to Pfizer’s product and to injected insulin.

If he is right, he could help change the way diabetes is treated.

“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 said at his 23,000-square-foot mansion overlooking the San Fernando Valley. The interview took place on a Saturday evening, which Mr. Mann said was the only opening in his seven-day work schedule.

Despite Mr. Mann’s remarkable entrepreneurial career — he has founded more than a dozen aerospace and medical device companies — there are people who wonder whether he has so much invested in this latest effort, both financially and emotionally, that he cannot see any odds against him.

“I don’t know of an individual who has spent as much of a personal fortune on a long shot,” said Andrew Forman, an analyst with WR Hambrecht & Company. Mr. Forman said MannKind faced numerous regulatory and patent challenges, as well as possible competition from the leaders in injected insulin, Eli Lilly and Novo Nordisk, which are also developing inhalable products.

 

For the full story, see:

ANDREW POLLACK. "Betting an Estate on Inhaled Insulin." The New York Times  (Fri., November 16, 2007):  C1 & C5.

 

  "The inhaled insulin device, about the size of a cellphone."  Source of caption and photo:  online version of the NYT article quoted and cited above.

 

Cuba’s Best Doctors Not Blind to Incentives Offered by “Communist” Government

 

   "Patients at the Ramón Pando Ferrer eye hospital in Havana."  Source of caption and photo:  online version of the NYT article quoted and cited below.

 

(p. A4)  Cuban doctors abroad receive much better pay than in Cuba, along with other benefits from the state, like the right to buy a car and get a relatively luxurious house when they return. As a result, many of the finest physicians have taken posts abroad.

The doctors and nurses left in Cuba are stretched thin and overworked, resulting in a decline in the quality of care for Cubans, some doctors and patients said.

 

For the full story, see:   

JAMES C. McKINLEY Jr.  "Havana Journal;  A Health System’s ‘Miracles’ Come With Hidden Costs."  The New York Times   (Tues., November 20, 2007):  A4. 

 

Von Hippel Promotes User-Driven Innovation

 

     "Eric von Hippel of M.I.T., left, and Dr. Nathaniel Sims, with hospital devices Dr. Sims has modified. Mr. von Hippel says users can improve on products."  Source of caption and photo:  online version of the NYT article cited below.

 

Some innovation is done by the devoted for free.  But in his books, and in the article excerpted below, I think von Hippel puts too little emphasis on the entrepreneur and the entrepreneur’s profit motive, as drivers of innovation. 

One example is the Moveable Type free program that underlies this, and many other blogs.  It is often described as one of the best blog platforms, but it is hard to use for a non-techie, kludgey, and very limited in some obvious ways.  For example, there apparently is no way that I can make comments to the most recent 10 entries visible on the main blog page.  And there is only limited backup capabilities.  And the spell-checker does not have "blog" in its dictionary, and asks me if I really meant to type "bog."

You can bet that if Moveable Type was produced for profit, they would have provided users these obvious capabilities.  And I would rather pay for a more capable program, rather than get a less capable program for free.

 

(p. 5) DR. NATHANIEL SIMS, an anesthesiologist at Massachusetts General Hospital, has figured out a few ways to help save patients’ lives. 

In doing so, he also represents a significant untapped vein of innovation for companies.

Dr. Sims has picked up more than 10 patents for medical devices over his career. He ginned up a way to more easily shuttle around the dozen or more monitors and drug-delivery devices attached to any cardiac patient after surgery, with a device known around the hospital as the “Nat Rack.”

. . .

What Dr. Sims did is called user-driven innovation by Eric von Hippel, a professor at the Massachusetts Institute of Technology’s Sloan School of Management. Mr. von Hippel is the leading advocate of the value of letting users of products modify them or improve them, because they may come up with changes that manufacturers never considered. He thinks that this could help companies develop products more quickly and inexpensively than with their internal design teams.

“It could drive manufacturers out of the design space,” Mr. von Hippel says.

It is a difficult idea for research and development departments to accept, but one of his studies found that 82 percent of new capabilities for scientific instruments like electron microscopes were developed by users.

. . .

One problem with the user-innovation model is that it can run into intellectual property rights protections.  . . .

. . .

. . . , Mr. von Hippel’s ideas are up against more conventional forms of user-aided design, such as sending anthropologists to study how people use products in their daily lives. Companies then translate their research into new designs.

Even some of Mr. von Hippel’s acolytes remain cautious. “A lot of this is still in the category of, ‘You could imagine this working out really well,’ ” says Saul T. Griffith, who as an M.I.T. engineering student was part of a group of kite-surfers who developed products for their sport that have since become commercialized. Mr. von Hippel wrote about Mr. Griffith in his 2005 book, “Democratizing Innovation.

 

For the full story, see:

MICHAEL FITZGERALD.  "Prototype How to Improve It? Ask Those Who Use It."  The New York Times, Section 3  (Sun., March 25, 2007):  5.

(Note:  ellipses added.) 

 

von Hippel has two main books in which he defends his user-driven innovation ideas:

von Hippel, Eric. The Sources of Innovation. New York:  Oxford University Press, 1988.

von Hippel, Eric. Democratizing Innovation. Cambridge, MA:  MIT Press, 2005.

 

Accepting an 80% Pay Cut for a Chance to Defy Death

 

   David Sinclair (left) and Christoph Westphal (right).  Source of photo:  online version of the NYT article cited below.

 

Humans are often risk-averse, but are also often willing to accept greater risk, in the pursuit of a really important goal. 

 

SIRTRIS PHARMACEUTICALS wants to sell you the elixir of youth. Yet the company’s founders are neither cranks nor quacks, but include a well-regarded Harvard scientist and a serial entrepreneur. 

Imagine a pill, derived from a compound found in something as benign as red wine, that treated the most feared and debilitating diseases of aging: illnesses like diabetes, neurodegenerative conditions like Alzheimer’s and Parkinson’s, and many forms of cancer. Imagine, furthermore, that this pill had no injurious side effects. Imagine, finally, that the pill’s only side effect conferred what human beings have always wanted: an increase in life span. That’s what Sirtris wants to create.

. . .

Mr. Sinclair, who at the relatively youthful age of 37 is already renowned for his investigations into how we grow old, discovered in 2003 that a molecular compound called resveratrol, found in red wine and other plant products, extends the life span of mice by as much as 24 percent and the life span of other animals, such as flies and fish, by as much as 59 percent.

Dr. Westphal, a self-described “geek” who relaxes by reading papers in academic journals like Nature and Science, was stunned by Mr. Sinclair’s discovery, and visited him in his lab to discuss the implications for drug development. The two soon decided to start a company.

“I figured if there’s going to be one chance that I’d take an 80 percent pay cut to be the C.E.O. of a company rather than general partner in a venture firm, then this was it,” Dr. Westphal, 39, told me when I visited Sirtris’s offices in Cambridge, Mass. “If we’re right on this one, everyone’s going to want to take these drugs and they’re going to treat many of the major diseases of Western society.”

. . .

“Nobody knows why we age,” Mr. Sinclair explained to me. “We’re working on genes that increase fitness and defenses against diseases. The body mounts those defenses when it’s under adversity. Caloric restriction is one of those triggers and the molecules we’re developing are also one of those triggers.”

Dr. Westphal and Mr. Sinclair stress that they are not working to “cure” aging, a condition that, so far at least, is common to all humanity and that most physicians do not consider a disease. “Curing aging is not an endpoint the federal drug agency would recognize,” Dr. Westphal says dryly. Instead, both men say, they are working to ameliorate the diseases of aging.

While Mr. Sinclair has bragged that resveratrol is as “close to a miraculous molecule as you get,” much uncertainty surrounds his research and the commercialization of his discovery faces many challenges.

. . .

Sirtris hopes to have its first drugs in commercial production by 2012 or 2013. While that may seem far off, it’s wonderfully fast for the biopharmaceutical industry, where development is onerously slow, difficult and uncertain.

This speed of research and development owes much to Dr. Westphal’s energy and Mr. Sinclair’s ambition.

“For as long as I can remember, I’ve wanted to develop drugs that combat diseases of aging,” Mr. Sinclair says. “As soon as I realized I was mortal, I started to worry. I set a goal to see if we could make drugs that would target the diseases of aging in my lifetime. I didn’t know it would be possible at all — and I didn’t know it would happen so quickly.”

 

For the full story, see: 

JASON PONTIN.  "SLIPSTREAM; An Age-Defying Quest (Red Wine Included)."  The New York Times, Section 3  (Sun., July 8, 2007):  3.

(Note:  ellipses added.)

 

FDA Hurts Consumers with New Burdens on Small Firms Making Proven Drugs

 

  "Larry Blansett, chief executive of the Blansett Pharmacal Company, sells a wide range of what he calls legacy drugs."  Source of caption and photo:  online version of the NYT article cited below.

 

(p. C1)  In the 1970s, Larry Blansett was producing a wide array of prescription cough syrups, antihistamine tablets and pain killers at the company he co-founded, UAD Laboratories. But the Food and Drug Administration was not keeping a close watch.

Mr. Blansett continues to sell the same range of products at his latest venture, the Blansett Pharmacal Company, which employs about 90 people in North Little Rock, Ark. “We grew gradually at first, but are now a national company,” he said.

Now, however, the F.D.A. has begun to crack down on the thousands of drugs that have never had to go through the agency’s stringent approval process, many of them made by small companies like Blansett Pharmacal. And those companies are crying foul.

. . .

Perry Cole, executive director of the Branded Pharmaceutical Association, . . .  said these drugs — the makers call them legacy drugs and define them as (p. C5) drugs that have been prescribed for at least 25 years and have gained a history for safety and efficacy — were far safer than many prescription drugs of recent vintage, like Viagra, which he said had been associated with hundreds of premature deaths.

. . .

The agency began its campaign against the makers of unapproved drugs in June 2006, and immediately began ordering companies that made products that it deemed potentially hazardous to file new drug applications or take them off the market.

In December, for example, it told firms to stop making unapproved products containing quinine, which has been used since the 1600s to treat malaria. The one company that made an approved quinine product, Qualaquin, was the Mutual Pharmaceutical Company of Philadelphia, and the F.D.A’s action, in effect, granted Mutual a temporary monopoly.

 

For the full story, see:

BRENT BOWERS. "Small Business; A Headache for Small Drug Makers."  The New York Times (Thurs., October 18, 2007): C1 & C5.

(Note:  ellipses added.)

 

Doctors Seek New Business Models to Avoid Paperwork and Insurance Regulation

 

   "Dr. Steven Meed works for Sickday Medical House Calls, a service in Manhattan."  Source of caption and photo:  online version of the NYT article quoted and cited below.

 

“We have that perfect storm. The current system doesn’t work well for patients or physicians,” said Dr. Rick Kellerman, a doctor who works in Wichita, Kan., and is president of the American Academy of Family Physicians. "More doctors are coming up with new home business practice models. They’re exasperated with paperwork and insurance regulation.”

The demand for primary care physicians outweighs the supply in many cities, so patients can wait weeks, and even months, for appointments, and hospital emergency rooms are becoming overloaded with nonemergency cases. Health insurance premiums, meanwhile, have continued to rise.

Some doctors are doing things like taking only house-call appointments or operating “micropractices” in which they work without front-office staff and nurses and see their patients in a smaller one-room office, Dr. Kellerman said.

When making house calls, “you get paid,” said Dr. Steven Meed, one of eight New York physicians working for Sickday Medical House Calls, which started last year and serves patients in Manhattan. “The paperwork overhead is kept at a minimum, the fee is fixed and it’s not going to be reduced.”

 

For the full story, see:

JENNIFER ALSEVER. "SPENDING; Retro Medicine: Doctors Making House Calls (for a Price)."  The New York Times, SundayBusiness Section  (Sun., September 23, 2007):  6.

 

MeedStevenHouseCalls2.jpg  "He took the subway, top, to travel to the apartment of a patient, Kayla McDermott, who had a sore throat."  Source of caption and photos:  online version of the NYT article cited above.

 

Incentives for Organ Donations Would Save Lives

 

SatelSally.jpg    Sally Satel is a medical doctor and a resident scholar at the Amerrican Enterprise Institute.  Source of photo:  http://www.aei.org/publications/filter.all,pubID.25785/pub_detail.asp

 

(p. A12)  At the annual meeting of The American Society of Transplant Surgeons this winter a straw poll revealed that 80 to 85% were in favor of studying incentives for living donors, according to society president Arthur Matas. In 2003, the American Medical Association testified on behalf of legislation that would have permitted pilot studies of incentives for deceased organs.

The public seems receptive as well, according to a new Gallup poll on attitudes toward donation of organs after death. The most striking results were among 18 to 34 year olds wherein an impressive 34% said that incentives would make them "more likely" to donate while 6% said less likely.  . . .

. . .

The idea of combining organ donation with material gain can make people queasy. Yet the mix of financial and humanitarian motives is commonplace. No one objects, for example, to a tax credit for charitable contributions–a financial incentive to complement the "pure" motive of giving to others. The great teachers who enlighten us and the doctors who heal us inspire no less gratitude because they are paid. An increase in the supply of kidneys will ameliorate suffering and prevent needless death. This is more important than whether an organ has been given freely or for material gain.  . . .

 

For the full commentary, see: 

Satel, Sally.  "Doing Well By Doing Good."  The Wall Street Journal  (Fri, March 16 2007):  A12.

(Note:  ellipses added.)

 

Unintended Consequences of Health Privacy Law

 

HealthPrivacyLawGraphic.gif   Source of graphic:  online version of the NYT article cited below.

 

(p. A1)  An emergency room nurse in Palos Heights, Ill., told Gerard Nussbaum he could not stay with his father-in-law while the elderly man was being treated after a stroke. Another nurse threatened Mr. Nussbaum with arrest for scanning his relative’s medical chart to prove to her that she was about to administer a dangerous second round of sedatives.

The nurses who threatened him with eviction and arrest both made the same claim, Mr. Nussbaum said: that access to his father-in-law and his medical information were prohibited under the Health Insurance Portability and Accountability Act, or Hipaa, as the federal law is known.

Mr. Nussbaum, a health care and Hipaa consultant, knew better and stood his ground. Nothing in the law prevented his involvement. But the confrontation drove home the way Hipaa is misunderstood by medical professionals, as well as the frustration — and even peril — that comes in its wake.

Government studies released in the last few months show the frustration is widespread, an unintended consequence of the 1996 law.

. . .

(p. A12)   

Most common are seat-of-the-pants decisions made by employees who feel safer saying “no” than “yes” in the face of ambiguity.

. . .

Ms. McAndrew said there was no way to know how often information was withheld. Of the 27,778 privacy complaints filed since 2003, the only cases investigated, she said, were complaints filed by patients who were denied access to their own information, the one unambiguous violation of the law.

Complaints not investigated include the plights of adult children looking after their parents from afar. Experts say family members frequently hear, “I can’t tell you that because of Hipaa,” when they call to check on the patient’s condition.

That is what happened to Nancy Banks, who drove from Bartlesville, Okla., to her mother’s bedside at Town and Country Hospital in Tampa, Fla., last week because Ms. Banks could not find out what she needed to know over the telephone.

Her 82-year-old mother had had a stroke. When Ms. Banks called her room she heard her mother “screaming and yelling and crying,” but conversation was impossible. So Ms. Banks tried the nursing station.

Whoever answered the phone was not helpful, so Ms. Banks hit the road. Twenty-two hours later, she arrived at the hospital.

But more of the same awaited her. She said her mother’s nurse told her that “because of the Hipaa laws I can get in trouble if I tell you anything.”

In the morning, she could speak to the doctor, she was told.

The next day, Ms. Banks was finally informed that her mother had had heart failure and that her kidneys were shutting down.

“I understand privacy laws, but this has gone too far,” Ms. Banks said. “I’m her daughter. This isn’t right.”

A hospital spokeswoman, Elena Mesa, was asked if nurses were following Hipaa protocol when they denied adult children information about their parents.

She could not answer the question, Ms. Mesa said, because Hipaa prevented her from such discussions with the press.

 

For the full story, see: 

JANE GROSS.  "Keeping Patients’ Details Private, Even From Kin."  The New York Times  (Tues., July 3, 2007):  A1 & A12.

(Note:  ellipses added.)

 

   After nurses refused to tell her what was wrong over the phone, Nancy Banks (left) drove 22 hours to find out that her mother Lourene Trusler (right) had had a stroke.  Source of photo:  online version of the NYT article cited above.

 

Texas Shows Tort Reform Works

 

   "Dr. Donald W. Patrick, executive director of the Texas Medical Board, with applications for medical licenses sent to it."  Source of caption and photo:  online version of the NYT article quoted, and cited, below. 

 

HOUSTON, Oct. 4 — In Texas, it can be a long wait for a doctor: up to six months.

That is not for an appointment. That is the time it can take the Texas Medical Board to process applications to practice.

Four years after Texas voters approved a constitutional amendment limiting awards in medical malpractice lawsuits, doctors are responding as supporters predicted, arriving from all parts of the country to swell the ranks of specialists at Texas hospitals and bring professional health care to some long-underserved rural areas.

The influx, raising the state’s abysmally low ranking in physicians per capita, has flooded the medical board’s offices in Austin with applications for licenses, close to 2,500 at last count.

“It was hard to believe at first; we thought it was a spike,” said Dr. Donald W. Patrick, executive director of the medical board and a neurosurgeon and lawyer. But Dr. Patrick said the trend — licenses up 18 percent since 2003, when the damage caps were enacted — has held, with an even sharper jump of 30 percent in the last fiscal year, compared with the year before.

“Doctors are coming to Texas because they sense a friendlier malpractice climate,” he said.

 

For the full story, see: 

RALPH BLUMENTHAL.  "After Texas Caps Malpractice Awards, Doctors Rush to Practice There."  The New York Times  (Fri., October 5, 2007):  A21.