Category: Health

   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.)

  "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.)

   "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.

  "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.

   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.