Health – Page 44 – artdiamondblog.com

Drug Innovation Funding Slashed in Economic Crisis

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

(p. B1) Big pharmaceutical companies have spent billions of dollars to buy other drug giants lately, leaving behind small biotech companies that can no longer find investors.

The biotech industry had thrived as a new-drug incubator for big pharma companies, which poured money into acquisitions and partnerships to build up their biotech-drug product line. Some of that is still happening, but most sources of investment funding have dried up in recent months.
Since November, 10 biotechs have declared bankruptcy, says Ellen Dadisman, a spokeswoman for the Biotechnology Industry Organization. Meanwhile, 120 of the 360 publicly traded biotechs have less than six months of cash left, compared with just 12 companies in that position a year ago, according to Burrill & Co., a venture-capital concern in San Francisco that follows the industry.

For the full story, see:

KEITH J. WINSTEIN. “Cash Dries Up for Biotech Drug Firms.” Wall Street Journal (Mon., MARCH 16, 2009): B1.

Government Regulators Again Suppress Entrepreneurial Innovation

Source of photo: http://images.quickblogcast.com/82086-71861/pedicurex_large.jpg

(p. A1) Until Mr. Ho brought his skin-eating fish here from China last year, no salon in the U.S. had been publicly known to employ a live animal in the exfoliation of feet. The novelty factor was such that Mr. Ho became a minor celebrity. On “Good Morning America” in July, Diane Sawyer placed her feet in a tank supplied by Mr. Ho and compared the fish nibbles to “tiny little delicate kisses.”

Since then, cosmetology regulators have taken a less flattering view, insisting fish pedicures are unsanitary. At least 14 states, including Texas and Florida, have outlawed them. Virginia doesn’t see a problem. Ohio permitted fish pedicures after a review, and other states haven’t yet made up their minds. The world of foot care, meanwhile, has been plunged into a piscine uproar. Salon owners who (p. A12) bought fish and tanks before the bans were imposed in their states are fuming.
The issue: cosmetology regulations generally mandate that tools need to be discarded or sanitized after each use. But epidermis-eating fish are too expensive to throw away. “And there’s no way to sanitize them unless you bake them for 20 minutes at 350 degrees,” says Lynda Elliott, an official with the New Hampshire Board of Barbering, Cosmetology and Esthetics. The board outlawed fish pedicures in November.
In Ohio, ophthalmologist Marilyn Huheey, who sits on the Ohio State Board of Cosmetology, decided to try it out for herself in a Columbus salon last fall. After watching the fish lazily munch on her skin, she recommended approval to the board. “It seemed to me it was very sanitary, not sterile of course,” Dr. Huheey says. “Sanitation is what we’ve got to live with in this world, not sterility.”
. . .
State bans have disrupted Mr. Ho’s plans to build a nationwide franchise network. Currently, he has four active franchises, in Virginia, Delaware, Maryland and Missouri. But others have terminated franchise agreements. In Calhoun, Ga., Tran Lam, owner of Sky Nails, says she paid Mr. Ho $17,500 in exchange for fish and custom-made pedicure tanks. A few weeks later, in October, the Georgia Board of Cosmetology deemed fish pedicures illegal. “I’m very mad,” says Ms. Lam. “I lost a lot of money and the economy is so bad.”

For the full story, see:
JOHN SCHWARTZ. “Ban on Feet-Nibbling Fish Leaves Nail Salons on the Hook; Mr. Ho’s Import From China Caught On, But Some State Pedicure Inspectors Object.” Wall Street Journal (Mon., MARCH 23, 2009): A1 & A12.
(Note: ellipsis added.)

Our “Patently Absurd” Patent System

(p. A15) The Founders might have used quill pens, but they would roll their eyes at how, in this supposedly technology-minded era, we’re undermining their intention to encourage innovation. The U.S. is stumbling in the transition from their Industrial Age to our Information Age, despite the charge in the Constitution that Congress “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”
. . .

Both sides may be right. New empirical research by Boston University law professors James Bessen and Michael Meurer, reported in their book, “Patent Failure,” found that the value of pharmaceutical patents outweighed the costs of pharmaceutical-patent litigation. But for all other industries combined, they estimate that since the mid-1990s, the cost of U.S. patent litigation to alleged infringers ($12 billion in legal and business costs in 1999) is greater than the global profits that companies earn from patents (less than $4 billion in 1999). Since the 1980s, patent litigation has tripled and the probability that a particular patent is litigated within four years has more than doubled. Small inventors feel the brunt of the uncertainty costs, since bigger companies only pay for rights they think the system will protect.
These are shocking findings, but they point to the solution. New drugs require great specificity to earn a patent, whereas patents are often granted to broad, thus vague, innovations in software, communications and other technologies. Ironically, the aggregate value of these technology patents is then wiped out through litigation costs.
Our patent system for most innovations has become patently absurd. It’s a disincentive at a time when we expect software and other technology companies to be the growth engine of the economy. Imagine how much more productive our information-driven economy would be if the patent system lived up to the intention of the Founders, by encouraging progress instead of suppressing it.

For the full commentary, see:
L. GORDON CROVITZ. “OPINION: INFORMATION AGE; Patent Gridlock Suppresses Innovation.” Wall Street Journal (Mon., JULY 14, 2008): A15.
(Note: ellipsis added.)

To Cure Fatal Diseases We Need More Financial Incentives and Fewer F.D.A. Restrictions

“JOSHUA THOMPSON with his sons, Wyatt and Jordan, after his diagnosis, top, and before, with his wife, Joy, and Wyatt.” Source of the photos and caption: online version of the NYT article quoted and cited below.

(p. 1) VIRGINIA BEACH — As Lou Gehrig’s disease sapped Joshua Thompson of his ability to move and speak last fall, he consistently summoned one question from within the prison of his own body. “Iplex,” he asked, in a whisper that pierced his mother’s heart. “When?”

Iplex had never been tested in people with amyotrophic lateral sclerosis, the formal name for the fatal disease that had struck Joshua, 34, in late 2006. Developed for a different condition and banished from the market by a patent dispute, it was not for sale to the public anywhere in the world.
But Kathy Thompson had vowed to get it for her son. On the Internet, she had found enthusiastic reviews from A.L.S. patients who had finagled a prescription for Iplex when it was available, along with speculation by leading researchers as to why it might slow the progressive paralysis that marks the disease. And for months, as she begged and bullied biotechnology companies, members of Congress, Italian doctors and federal drug regulators, she answered Joshua the same way:
“Soon,” she said. “Soon.”
At a time when terminally ill patients have more access to medical research than ever before, and perhaps a deeper conviction in its ability to cure them, many are campaigning for the chance to be treated with drugs whose safety and effectiveness is not yet known.
. . .
(p. 19) “Josh’s sadness is unbearable,” his mother wrote one night in her journal, nearly a year after her son’s diagnosis.
Unexpected encouragement came in a Mother’s Day note from her ex-husband. “You have given me some peace of mind that all potential options for Josh are being researched and acted upon,” Bruce wrote. “Thank you.”
Kathy’s boyfriend accompanied her to Insmed’s headquarters in Richmond, Va., offering to raise several million dollars to underwrite a compassionate use program for Iplex in the United States with A.L.S. patients. But the couple came away with a new understanding: F.D.A. regulations, they were told, prohibit any company from profiting on compassionate use. Even if Insmed could wriggle free of restrictions in the patent agreement, there was little financial incentive for it to invest in making the drug solely for compassionate use by A.L.S. patients.
. . .
On Jan. 16, when Dr. Werwath called to tell her the application had been rejected, she stood up in disbelief.
“How could that be?” she asked, dazed.
Kathy’s friend Mrs. Reimers had received a call with the same news.
“He said they had safety concerns,” Mrs. Reimers said. “This for a drug that was approved for children!”
“Safety,” Kathy repeated. “And what, exactly, is safe about A.L.S.?”

Appealing an F.D.A. Denial
Before the F.D.A.’s decision, Kathy had spared little thought for any broader meaning of her quest for Joshua. But when she met with Richard A. Samp, a lawyer with the Washington Legal Foundation a week later, her outrage went beyond her son, and beyond Iplex.
“The F.D.A. is supposed to protect American citizens,” Kathy fumed over an iced tea in Williamsburg, Va. “How does denying dying patients access to this drug serve the common good?”
Mr. Samp had handled a lawsuit by a patient advocacy group, the Abigail Alliance, that had sought to establish a constitutional right for terminally ill patients to use experimental drugs. In the case, which the group had lost on appeal in 2007, the F.D.A. claimed that it granted “nearly all” requests for compassionate use.
They would first make an administrative appeal, Mr. Samp told Kathy, asserting that the F.D.A. had violated its own guidelines. If that failed, they could pursue litigation that might allow them to raise the constitutional question again in a federal court in Virginia.
. . .
Kathy was pouring milk for her cereal on the morning of March 10 when Dr. Werwath’s number flashed on her phone. The F.D.A. had just reversed itself, he said.
Before she could take a breath, Senator Mark Warner’s office called. E-mail bleeped in as the news seeped out.
In the weeks after the appeal, Kathy learned, the F.D.A. had reached out to Insmed. The agency had persuaded the company to run a clinical trial for Iplex with several dozen A.L.S. patients, and permitted it to recoup the hefty costs directly from participants. In the trial, some of the participants would get a placebo. That way, the F.D.A. wrote on its Web site, the next wave of A.L.S. patients would learn whether the drug was in fact beneficial or harmful.
But for now, the agency had ruled, Joshua and 12 other patients would be given Iplex outside of the trial, on a compassionate use basis, if they agreed to read all the data about the risks.

For the full version of a very long story, see:
AMY HARMON. “Months to Live; Fighting for a Last Chance at Life; One Family’s Tenacious Campaign for Access to an Unproven Drug.” The New York Times, First Section (Sun., May 17, 2009): 1, 18-19.
(Note: ellipses added.)

“IN MARCH, Joshua Thompson received his first Iplex injection, from Dr. David L. Werwath. Thereafter Joshua’s wife, Joy, left, and mother, Kathy, took over the daily duties.” Source of the photo and caption: online version of the NYT article quoted and cited above.

“Don’t Kill the Goose”

(p. A11) I think there are two major but not fully formed or fully articulated fears among thinking Americans right now, and the deliberate obscurity of official language only intensifies those fears.

The first is that Mr. Obama’s government, in all its flurry of activism, may kill the goose that laid the golden egg. This is as dreadful and obvious a cliché as they come, but too bad, it’s what people fear. They see the spending plans and tax plans, the regulation and reform hunger, the energy proposals and health-care ambitions, and they–we–wonder if the men and women doing all this, working in their separate and discrete areas, are being overseen by anyone saying, “By the way, don’t kill the goose.”
The goose of course is the big, messy, spirited, inspiring, and sometimes in some respects damaging but on the whole brilliant and productive wealth-generator known as the free-market capitalist system. People do want things cleaned up and needed regulations instituted, and they don’t mind at all if the very wealthy are more heavily taxed, but they greatly fear a goose killing. Economic freedom in all its chaos and disorder has kept us rich for 200 years, and allowed us as a nation to be generous and strong at home and in the world. But the goose can be killed–by carelessness, hostility, incrementalism, paralysis, and by no one saying, “Don’t kill the goose.”

For the full commentary, see:
PEGGY NOONAN. “What’s Elevated, Health-Care Provider? Economy of language would be good for the economy.” Wall Street Journal (Sat., MAY 15, 2009): A11.

Medical Care is Much Advanced Since Victorian Era of Mid-1800s

In the final sentences quoted below, note the under-appreciated role of air conditioning, and electric light, in advancing medical education.

(p. W6) “Gray’s Anatomy” is one of the most famous medical books of all time, but if a picture is worth a thousand words, then the man most responsible for the success of the book was its long-forgotten illustrator, Henry Vandyke Carter. In “The Making of Mr. Gray’s Anatomy,” Ruth Richardson shows how Carter and Henry Gray came together to produce a classic that originally bore neither of their names — it was published as “Anatomy Descriptive and Surgical” — but she also affords us a remarkable glimpse of science in the 19th century.
. . .
Not much of a paper record exists regarding Henry Gray’s life. Ms. Richardson speculates that his possessions were burned in the “Victorian terror” stirred by smallpox, the disease that would kill him at age 34. Henry Carter kept a diary, but its contents are not exactly a trove of detail about his life and times. . . .
. . .
Describing their methods, Ms. Richardson reminds us of what we now take for granted in medicine by relating what wasn’t feasible back then. The “dissecting season” was the colder months, January-March, to make the most of the cadavers’ preservation. And the work day had to begin soon after dawn because sunlight was so much better for close observation than any other light source.

For the full review, see:
MARK F. TEAFORD. “Dissecting an Unheralded Alliance; A classic medical text bears one man’s name, but it was the product of a true collaboration.” Wall Street Journal (Fri., MARCH 27, 2009): W6.
(Note: ellipses added.)

The reference to the reviewed book is:
Richardson, Ruth. The Making of Mr. Gray’s Anatomy. Oxford, UK: Oxford University Press.

Source of book cover image: online version of the WSJ review quoted and cited above.

Greenmarket Rules Are “Cumbersome, Confusing and Contradictory”

“Dante Hesse, . . . , of Milk Thistle Farm, thinks Greenmarket rules are too hard on dairies.” Source of caption and photo: online version of the NYT article quoted and cited below. (Note: ellipsis in caption added.)

(p. D4) The basic aim of the producer-only rules is to ensure that all foods sold at market originate entirely or mostly on family farms within a half day’s drive from New York City. The 10-page document detailing these rules, however, is anything but clear.

“Cumbersome, confusing and contradictory,” was the assessment of Michael Hurwitz, the director of Greenmarket, which operates 45 markets in the five boroughs.
Pickle makers can sell preserved foods such as peppers in vinegar, but not processed foods such as hot sauce. Farmers, on the other hand, can sell processed hot sauce if it is made with their peppers. Dairies may purchase a higher percentage of their milk for cheese if the cheese is made from one type of milk rather than two milks, such as cow and sheep. Cider makers can buy 40 percent of the apples they press from local farmers, whereas wheatgrass juice sellers must grow all their wheatgrass.

For the full story, see:
INDRANI SEN. “Greenmarket Sellers Debate Maze of Producer-Only Rules.” The New York Times (Weds., August 6, 2008): D4.

Charles Wolf’s Main Cancer Regret: “I’m Not There for the Market Open”

“Charles Wolf with laptop and Archie, in his house near Denver last spring.” Source of the caption and the photo: online version of the WSJ article quoted and cited below.

(p. C5) He was irked when a cancer recurrence last year required him to resume morning radiation treatments, partly because that took him away from the market. “What kills me more than anything else is that I’m not there for the market open,” he said.

For the full obituary, see:
E.S. BROWNING. “Wolf Loses Battle With Cancer; Disease Didn’t Affect His Investing Success; Model Patient.” The Wall Street Journal (Thurs., JANUARY 29, 2009): C5.

Unintended Consequences in Medicine

“Jonas Salk, right, inoculates his son against polio as his wife, left, looks on.” Source of caption and photo: online version of the WSJ quoted and cited below.

(p. W9C) “The Polio Crusade” will stir many memories with its account of successful efforts to eradicate the disease whose fear factor, we’re told, was second only to that of the atom bomb. (Monday 9-10 p.m. ET on PBS’s “American Experience” series, but check local listings.) The documentary also tells less-familiar, and sometimes disturbing, stories about the birth of modern fund-raising techniques, and old testing techniques.
. . .
Since the virus is spread most effectively by mouth, or through contact with byproducts of the intestinal tract, the improved hygiene of the 20th century should have led to a decrease in polio infections. The opposite happened. First in Europe and then in America, a disease which had barely registered on the medical radar began to strike more and more people, culminating in a U.S. record of nearly 58,000 cases in 1952.
The explanation for this seemingly counterintuitive symbiosis between cleanliness and disease is astonishing, yet simple. In a germier age, newborns were likely to be exposed to the polio virus very early in life, when they still had immunity conferred by their mother in the womb. When improved hygiene pushed back the time of exposure to a later age, or even to adulthood, many people were by then defenseless.

For the full review, see:
NANCY DEWOLF SMITH. “TELEVISION; In a Time of Plague.” The Wall Street Journal (Tues., JANUARY 30, 2009): W9C.
(Note: ellipsis added.)

Experiments on Animal Genes Enthuses Longevity Researchers

“Charles Yogi, 89, a track & field athlete, is part of the Hawaii Lifespan Study.” Source of caption and photo: online version of the WSJ story quoted and cited below.

(p. A18) Based on animal experiments, gerontologists believe that one key to a healthy, longer lifespan may be found in a few master genes that affect cellular responses to famine, drought and other survival stresses. The more active these genes are, the longer an organism seems to survive — at least in the laboratory. Moreover, researchers are convinced that some genes may protect us against the risks of heart disease, diabetes, cancer and dementia.
. . .
Recent insights into the genetics of aging among simple organisms are stoking their enthusiasm. In January, for example, gerontologist Valter Longo at the University of Southern California reported that by altering two genes he made yeast that lived 10 times longer than normal. “We can really reprogram the lifespan of these organisms,” he said. In March, scientists at the University of Washington identified 15 genes regulating lifespan in yeast and worms that resemble genes found in humans. At least three companies are working independently on potential therapies based on the discovery that life span in mammals may be regulated partly by genetically controlled enzymes called sirtuins.

For the full story, see:
ROBERT LEE HOTZ. “Secrets of the ‘Wellderly’; Scientists Hope to Crack the Genetic Code of Those Who Live the Longest.” The Wall Street Journal (Fri., SEPTEMBER 19, 2008): A18.
(Note: ellipsis added.)