To FDA, Death is Not a Disease, So FDA Won’t Approve Drugs to Lengthen Life

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

 

(p. A1)  Can you have your cake and eat it?  Is there a free lunch after all, red wine included?  Researchers at the Harvard Medical School and the National Institute on Aging report that a natural substance found in red wine, known as resveratrol, offsets the bad effects of a high-calorie diet in mice and significantly extends their lifespan.

Their report, published electronically yesterday in Nature, implies that very large daily doses of resveratrol could offset the unhealthy, high-calorie diet thought to underlie the rising toll of obesity in the United States and elsewhere, if people respond to the drug as mice do.

Resveratrol is found in the skin of grapes and in red wine and is conjectured to be a partial explanation for the French paradox, the puzzling fact that people in France enjoy a high-fat diet yet suffer less heart disease than Americans.

The researchers fed one group of mice a diet in which 60 percent of calories came from fat.  The diet started when the mice, all males, were a year old, which is middle-aged in mouse terms.  As expected, the mice soon developed signs of impending diabetes, with grossly enlarged livers, and started to die much sooner than mice fed a standard diet.

Another group of mice was fed the identical high-fat diet but with a (p. A18) large daily dose of resveratrol (far larger than a human could get from drinking wine).  The resveratrol did not stop them from putting on weight and growing as tubby as the other fat-eating mice.  But it averted the high levels of glucose and insulin in the bloodstream, which are warning signs of diabetes, and it kept the mice’s livers at normal size.

Even more striking, the substance sharply extended the mice’s lifetimes.  Those fed resveratrol along with the high-fat diet died many months later than the mice on high fat alone, and at the same rate as mice on a standard healthy diet.  They had all the pleasures of gluttony but paid none of the price.

. . .

For the Food and Drug Administration, if for no one else, aging is not a disease and death is not an end-point.  The F.D.A. will approve only drugs that treat diseases in measurable ways, so Dr. Westphal hopes to show that his sirtuin activators will improve the indicators of specific diseases, starting with diabetes.

“We think that if we can harness the benefits of caloric restriction, we wouldn’t simply have ways of making people live longer, but an entirely new therapeutic strategy to address the diseases of aging,” Dr. Guarente said.

 

For the full story, see: 

NICHOLAS WADE.   ‘Yes, Red Wine Holds Answer.  Check Dosage."  The New York Times  (Thurs., November 2, 2006):  A1 & A18.

(Note:  ellipsis added.)

 

Here is a link to an abstract of the research report in Nature (which, by the way, is usually considered one of the top journals in science):

http://www.nature.com/nature/journal/vaop/ncurrent/abs/nature05354.html

 

Pill Mimicking Calorie Restriction Would Be Highly Cost-Effective

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

 

(p. D1)  Recent tests show that the animals on restricted diets, including Canto and Eeyore, two other rhesus monkeys at the primate research center, are in indis-(p. D4)putably better health as they near old age than Matthias and other normally fed lab mates like Owen and Johann.  The average lifespan for laboratory monkeys is 27.

The findings cast doubt on long-held scientific and cultural beliefs regarding the inevitability of the body’s decline.  They also suggest that other interventions, which include new drugs, may retard aging even if the diet itself should prove ineffective in humans.  One leading candidate, a newly synthesized form of resveratrol — an antioxidant present in large amounts in red wine — is already being tested in patients.  It may eventually be the first of a new class of anti-aging drugs.  Extrapolating from recent animal findings, Dr. Richard A. Miller, a pathologist at the University of Michigan, estimated that a pill mimicking the effects of calorie restriction might increase human life span to about 112 healthy years, with the occasional senior living until 140, though some experts view that projection as overly optimistic.

According to a report by the Rand Corporation, such a drug would be among the most cost-effective breakthroughs possible in medicine, providing Americans more healthy years at less expense (an estimated $8,800 a year) than new cancer vaccines or stroke treatments.

“The effects are global, so calorie restriction has the potential to help us identify anti-aging mechanisms throughout the body,” said Richard Weindruch, a gerontologist at the University of Wisconsin who directs research on the monkeys.

. . .

While an anti-aging pill may be the next big blockbuster, some ethicists believe that the all-out determination to extend life span is veined with arrogance.  As appointments with death are postponed, says Dr. Leon R. Kass, former chairman of the President’s Council on Bioethics, human lives may become less engaging, less meaningful, even less beautiful.

“Mortality makes life matter,” Dr. Kass recently wrote.  “Immortality is a kind of oblivion — like death itself.”

That man’s time on this planet is limited, and rightfully so,  is a cultural belief deeply held by many.  But whether an increasing life span affords greater opportunity to find meaning or distracts from the pursuit, the prospect has become too great a temptation to ignore — least of all, for scientists. 

“It’s a just big waste of talent and wisdom to have people die in their 60s and 70s,” said Dr. Sinclair of Harvard.

 

For the full story, see:

MICHAEL MASON.  "One for the Ages:  A Prescription That May Extend Life."  The New York Times  (Tues., October 31, 2006):  D1 & D4. 

(Note:  ellipsis added.)

  Mike Linksvayer is eating a calorie restricted diet.  Source of photo:  online version of the NYT article cited above.

 

Medical Cures Going First to the Dogs

Bazell_melanoma_dog.jpg  One of the dogs cured of melanoma by a new vaccine.  Source of photo:  screen capture from NBC news report.

 

Melanoma has taken many human lives, including my father’s on April 15, 2000.  Government licensing and regulations reduce competition in medicine and slow the pace of medical innovation.  Animal health care is less regulated.  Is it an accident that dogs are being cured for melanoma before humans?  

 

Vet Philip Bergman remembers the first time he tried the vaccine in a dog.

"That was a dog that thankfully underwent complete disappearance of his tumor," says Bergman.  "It was remarkable, obviously, to us."

Since then, more than 100 dogs have been treated, including Lawana Hart’s Lucky, who last June appeared to have only a few months to live.

 

For the full report, see:

Robert Bazell.  "Treatment for canines with cancer raises hopes; Researchers encouraged by melanoma vaccine’s success on dogs."  NBC Evening News Report; online print version updated: 6:36 p.m. CT Oct 26, 2006.

 

For the video version, go to:

http://video.msn.com/v/us/msnbc.htm?g=d7f603e0-86bb-44db-bad0-524ec79b02c8&f=00&fg=copy

300,000,000 Strong, and Free

LifeExpectancyGraph.gif  Source of graph:  online version of the WSJ article cited below.

 

The Census Bureau tells us that some time in the weeks ahead the U.S. population will reach 300 million.  . . .

This demographic milestone is not cause for alarm — as some prophets of doom would have it.  Rather, it is cause for celebration.  We 300 million Americans are on balance healthier and wealthier and freer than any population ever:  We breathe cleaner air, drink cleaner water, earn higher incomes, have more leisure time, and live in less crowded housing.  Every natural resource we depend on — water, food, copper and, yes, even oil — is far more abundant today measured by affordability than when our population was 100 million or even 30 million.

Thanks to the rapid pace of technological progress, there’s every reason to believe these resources will be still more abundant when our population reaches 400 million — which should happen about 40 years from now.  As the late economist Julian Simon reminded us, thanks to our free market capitalist system, the history of America is one of leaving the storehouse for every successive generation more endowed with wealth, knowledge and natural resources.

 

For the full commentary, see:

STEPHEN MOORE.  "Supply Side; 300,000,000."  Wall Street Journal  (Tues., October 3, 2006):  A26.

(Note:  ellipsis added.)

The Missing Pillow: A Lack of Incentives Leaves an Obvious ‘Job’ Undone


In late July, I had an appointment for a treadmill stress-test at Omaha’s Methodist Hospital.  They told me the process would be over in an hour, but it took about two hours, due to another patient having some sort of crisis during their stress-test. 

They had me put on a gown, they stuck an I-V "dye" drip in back of my hand, and they pasted about six electrodes to my chest, after shaving and applying something like sand paper to the parts of the chest where the electrodes were attached.  Then they had me lie on my side on a hard table, to wait.  It was very uncomfortable.  The first nurse said that there was supposed to be a pillow on the table, but did nothing to obtain one.  Every several minutes some technician or nurse would stop in to ask if I was ready for them.  (I was always ready.)  But it turned out that someone needed to do something to me first, and that person was, I guess, taking care of the crisis next door.  At least one of these visitors also mentioned that I was supposed to have a pillow, but did nothing to acquire one.  If memory serves, the first nurse came back in, and again mentioned that I was supposed to have a pillow, but again did nothing to obtain one.

These people were all pleasant and friendly.  For example, they had a lot of friendly chats amongst themselves, that I could not help but over-hear.  (One of them was pregnant with twins, but did not know the genders of the babes-to-be, and so had not yet spent the time to come up with names.)

But two hours later, when the whole process was over, I still did not have a pillow.

A week or two after the test, I received a several page survey from Methodist Hospital asking a bunch of questions about how I thought they had done during the test.  You see they really "care" about my opinion.  (They also run frequent, slick TV ads about how much they "care.")

Marketers, and management gurus, say that organizations need to invest in surveys and the like to figure out what the customer wants and needs.  And Clayton Christensen advocates spending resources to figure out what "job" the customer needs to have done.  And maybe, sometimes, it does take surveys and research.

But sometimes it is obvious that the customer needs a pillow.

What is missing is not a survey, or statistical analysis.

What is missing is the incentive for someone to go get the pillow. 

 

P.S.  You may wonder, then, if it is simply a mistake for the hospital to send out the survey?  I suspect that those who send out the survey are not making a mistake, but are trying to get a different job done than the one that appears to be intended.  It appears that they are trying to find out what customers want and need.  But maybe they already know that.  Maybe they are mainly sending out the survey so that if anyone asks if they are "customer-oriented" they can whip out the survey to prove that yes-indeed, they sure are.  In other words, the point of the survey is not to learn about customers; it is to cover rear-ends.


United States Cardiologists Fail to Prescribe Fish Oil, Despite Low Cost, Safety, and Evidence of Efficacy


  Source of graphic:  online verison of the NYT article quoted and cited below.


United States cardiologists are reluctant to prescribe fish oil, wanting more definitive data on efficacy.  But a lack of definitive data on efficacy doesn’t stop them from performing costly and risky procedures such as the application of stents.  Possibly relevant:  installing stents is much more lucrative for cardiologists, than prescribing fish oil.  Doctors are not bad people, but like most of us, they respond to financial incentives.


(p. D5) ROME — Every patient in the cardiac care unit at the San Filippo Neri Hospital who survives a heart attack goes home with a prescription for purified fish oil, or omega-3 fatty acids.

“It is clearly recommended in international guidelines,” said Dr. Massimo Santini, the hospital’s chief of cardiology, who added that it would be considered tantamount to malpractice in Italy to omit the drug.

In a large number of studies, prescription fish oil has been shown to improve survival after heart attacks and to reduce fatal heart rhythms.  The American College of Cardiology recently strengthened its position on the medical benefit of fish oil, although some critics say that studies have not defined the magnitude of the effect.

But in the United States, heart attack victims are not generally given omega-3 fatty acids, even as they are routinely offered more expensive and invasive treatments, like pills to lower cholesterol or implantable defibrillators.  Prescription fish oil, sold under the brand name Omacor, is not even approved by the Food and Drug Administration for use in heart patients.

“Most cardiologists here are not giving omega-3’s even though the data supports it — there’s a real disconnect,” said Dr. Terry Jacobson, a preventive cardiologist at Emory University in Atlanta.  “They have been very slow to incorporate the therapy.”


For the full story, see:

ELISABETH ROSENTHAL  "In Europe It’ s Fish Oil After Heart Attacks, but Not in U.S."  The New York Times  (Tues., October 3, 2006):  D5.


Technology Liberates the Paralyzed

  Paralyzed from a stabbing, Matthew Nagle can move computer cursor by means of a sensor implanted in his brain.  Source of image:  online version of NYT article cited below.

 

(p. A1)  A paralyzed man with a small sensor implanted in his brain was able to control a computer, a television set and a robot using only his thoughts, scientists reported yesterday.

Those results offer hope that in the future, people with spinal cord injuries, Lou Gehrig’s disease or other conditions that impair movement may be able to communicate or better control their world.

“If your brain can do it, we can tap into it,” said John P. Donoghue, a professor of neuroscience at Brown University who has led development of the system and was the senior author of a report on it being published in today’s issue of the journal Nature.

 

For the full story, see: 

ANDREW POLLACK. "Paralyzed Man Uses Thoughts to Move a Cursor." The New York Times  (Thurs., July 13, 2006):  A1 & A21.

Sulfa: First Antibiotic Was Pursued for Profit

  Source of the book image:  http://ec1.images-amazon.com/images/P/1400082137.01._SS500_SCLZZZZZZZ_V52133117_.jpg

 

Economists have debated whether patents mainly provide incentives, or obstacles, to innovation.  In the story of the development of sulfa, the first powerful antibiotic, the desire for profit, through patents, was one motive that drove an important part of the development process; this, even though, in the end, sulfa turned out not to be patentable:

(p. P9) Mr. Hager follows a group of doctors into postwar German industry — specifically into the dye conglomerate IG Farben.  These men, having witnessed horrible deaths by infection on the battlefield, picked up on Ehrlich’s hypothesis by trying to synthesize a dye that specifically stained and killed bacteria.  Led by the physician-scientist Gerhard Domagk, they brought German know-how, regimentation and industry to the enterprise.

Year after year the team infected mice with streptococci, the bacteria responsible for so many deadly infections in humans.  The researchers then treated the mice with various dyes but had to watch as thousands upon thousands of them died despite such treatment.  Nothing seemed to work.  The 1920s turned into the ’30s, and still Domagk and his team held to Ehrlich’s idea.  There was simply no better idea around.

Then one of the old hands at IG Farben mentioned that he could get dyes to stick to wool and to fade less by attaching molecular side-chains containing sulfur to them.  Maybe what worked for wool would work for bacteria by making the dye adhere to the bacteria long enough to kill it.

. . .

The IG Farben conglomerate expected huge profits from Prontosil.  But then French scientists at the Pasteur Institute in Paris dashed these dreams.  The German scientists — all of them Ehrlich disciples — thought that the power to cure infection rested in the dye, with the sulfa side-chain merely holding the killer dye to the bacteria.  The scientists at the Pasteur Institute, though, showed that the sulfa side-chain alone worked against infection just as well as the Prontosil compound.  In fact, the dye fraction of the compound was useless.  You could have Ehrlich’s magic bullet without Ehrlich’s big idea!  This bombshell rendered the German patents worthless.  The life-saver "drug" turned out to be a simple, unpatentable chemical available in bulk everywhere.

 

For the full review, see: 

PAUL MCHUGH.  "BOOKS; Medicine’s First Miracle Drug."  The Wall Street Journal  (Sat., September 30, 2006):  P9.

(Note: ellipsis added.)

 

The reference for the book is: 

Thomas Hager.  The Demon Under The Microscope.  Harmony, 340 pages, $24.95

Intel Chairman Says Health Care Inefficient

 

WASHINGTON (AP) – Intel Corp. Chairman Craig Barrett said Tuesday that U.S. jobs will continue to move offshore at a rapid pace unless corporate America forces the health care industry to adopt systems that will cut costs and improve efficiency.

"Every job that can be moved out of the United States will be moved out . . . because of health care costs," which averaged more than $6,000 per person in 2004, Barrett said at a conference sponsored by eHealth Initiative, a nonprofit coalition of health information technology interest groups.

. . .

Barrett was joined on-stage by Wal-Mart Stores Inc. Executive VP Linda Dillman.  Barrett said the health care industry could learn from the efficiency of the retail giant, which tracks every item in inventory.

 

For the full story, see: 

"Health care waste costs jobs, says Intel chief."  Omaha World-Herald  (Wednesday,  September 27, 2006):  3D. 

(Note:  ellipsis in the Barrett quote, in original; ellipsis between paragraphs, added.)

 

Health Care Costs Continue to Increase

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

 

(p. C1)  The cost of living keeps going up, but the cost of healthy living is going up even faster.

A widely followed national survey reported yesterday that the cost of employee health care coverage rose 7.7 percent this year, more than double the overall inflation rate and well ahead of the increase in the incomes of workers.

The 7.7 percent increase was the lowest since 1999.  But the average cost to employees continued an upward trend, reaching $2,973 annually for family coverage out of a total cost of $11,481.

Since 2000, the cost of family coverage has risen 87 percent while consumer prices are up 18 percent and the pay of workers has increased 20 percent, the survey noted.  That is without counting the cost of deductibles and other out-of-pocket payments, which have also been rising.

 

For the full story, see: 

MILT FREUDENHEIM.  "Health Care Costs Rise Twice as Much as Inflation."  The New York Times (Weds., September 27, 2006):  C1 & C7.

 

  Source of graphic:  online version of the NYT article cited above.

“An Image Was Worth a 1,000 Statistical Tables”


HandWithGerms.jpg  Artistic vision of germ-laden hand.  (This is not the photographic image mentioned below, and used as a hospital screen-saver.)  Source of image:  online version of the NYT article cited below.

 

(p. 22)  Leon Bender noticed something interesting: passengers who went ashore weren’t allowed to reboard the ship until they had some Purell squirted on their hands.  The crew even dispensed Purell to passengers lined up at the buffet tables.  Was it possible, Bender wondered, that a cruise ship was more diligent about killing germs than his own hospital?

Cedars-Sinai Medical Center, where Bender has been practicing for 37 years, is in fact an excellent hospital.  But even excellent hospitals often pass along bacterial infections, thereby sickening or even killing the very people they aim to heal.  In its 2000 report “To Err Is Human,” the Institute of Medicine estimated that anywhere from 44,000 to 98,000 Americans die each year because of hospital errors — more deaths than from either motor-vehicle crashes or breast cancer — and that one of the leading errors was the spread of bacterial infections.

. . .

. . . the hospital needed to devise some kind of incentive scheme that would increase compliance without alienating its doctors.  In the beginning, the administrators gently cajoled the doctors with e-mail, (p. 23) faxes and posters.  But none of that seemed to work.  (The hospital had enlisted a crew of nurses to surreptitiously report on the staff’s hand-washing.)  “Then we started a campaign that really took the word to the physicians where they live, which is on the wards,” Silka recalls.  “And, most importantly, in the physicians’ parking lot, which in L.A. is a big deal.”

For the next six weeks, Silka and roughly a dozen other senior personnel manned the parking-lot entrance, handing out bottles of Purell to the arriving doctors.  They started a Hand Hygiene Safety Posse that roamed the wards and let it be known that this posse preferred using carrots to sticks:  rather than searching for doctors who weren’t compliant, they’d try to “catch” a doctor who was washing up, giving him a $10 Starbucks card as reward.  You might think that the highest earners in a hospital wouldn’t much care about a $10 incentive — “but none of them turned down the card,” Silka says.

When the nurse spies reported back the latest data, it was clear that the hospital’s efforts were working — but not nearly enough.  Compliance had risen to about 80 percent from 65 percent, but the Joint Commission required 90 percent compliance.

These results were delivered to the hospital’s leadership by Rekha Murthy, the hospital’s epidemiologist, during a meeting of the Chief of Staff Advisory Committee.  The committee’s roughly 20 members, mostly top doctors, were openly discouraged by Murthy’s report.  Then, after they finished their lunch, Murthy handed each of them an agar plate — a sterile petri dish loaded with a spongy layer of agar.  “I would love to culture your hand,” she told them.

They pressed their palms into the plates, and Murthy sent them to the lab to be cultured and photographed.  The resulting images, Silka says, “were disgusting and striking, with gobs of colonies of bacteria.”

The administration then decided to harness the power of such a disgusting image.  One photograph was made into a screen saver that haunted every computer in Cedars-Sinai.  Whatever reasons the doctors may have had for not complying in the past, they vanished in the face of such vivid evidence.  “With people who have been in practice 25 or 30 or 40 years, it’s hard to change their behavior,” Leon Bender says.  “But when you present them with good data, they change their behavior very rapidly.”  Some forms of data, of course, are more compelling than others, and in this case an image was worth 1,000 statistical tables.  Hand-hygiene compliance shot up to nearly 100 percent and, according to the hospital, it has pretty much remained there ever since.

 

For the full commentary, see:

STEPHEN J. DUBNER and STEVEN D. LEVITT.  "FREAKONOMICS; Selling Soap."  The New York Times Magazine (Section 6)  (Sunday, September 24, 2006):  22-23.

(Note:  ellipses added.)

 

      The screen-saver at Cedars Sinai Hospital.  Source of image:  http://freakonomics.com/pdf/CedarsSinaiScreenSaver.jpg