“Creaky Regulations . . . Act as a Brake on Innovation”

“Paul Metzger, holding the Handler, an anti-microbial device that helps users avoid touching surfaces that might carry germs.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. C5) With so many people worried about getting sick — whether from the common cold and flu or exotic new strains of antibiotic-resistant bacteria — Paul and Jeffrey Metzger had every reason to hope that the germ-fighting key fob they invented would be a runaway hit.
Their device, known as the Handler, began selling last year online and in stores like Duane Reade pharmacies for about $11. It features a pop-out hook so germophobes can avoid touching A.T.M. keypads, door handles and other public surfaces where undesirable microbes may lurk. As added protection, the Handler’s rubber and plastic surfaces are impregnated with tiny particles of silver to kill germs that land on the device itself.
But those little silver particles have run Maker Enterprises, the Metzger brothers’ partnership in Los Angeles, into a big regulatory thicket. The Metzgers belatedly realized that the Environmental Protection Agency might decide that a 1947-era law that regulates pesticides would apply to antimicrobial products like theirs.
The agency ruled last fall that the law covered Samsung’s Silvercare washing machine. Samsung was told it would have to register the machine as a pesticide, a potentially costly and time-consuming process, because the company claims the silver ions generated by the washer kill bacteria in the laundry.
The Metzgers halted production of their key fob while they sought legal guidance on how to avoid a similar fate.
Their quandary highlights a challenge facing the growing number of entrepreneurs who have ventured into nanotechnology, a field that gets its name from its reliance on materials so small their dimensions are measured in nanometers, or billionths of a meter.
. . .
“They don’t really know how they want to register these particles,” said Tracy Heinzman, a lawyer in Washington who deals frequently with the E.P.A. “There’s no clear path forward.”
More broadly, the limbo into which the Handler has tumbled shows how the limited resources of agencies like the E.P.A. can combine with creaky regulations to act as a brake on innovation. “The marketplace is always ahead of the E.P.A.,” Ms. Heinzman said.

For the full story, see:
BARNABY J. FEDER. “Small Business; Fighting Germs and Regulators; Pesticide Rules May Apply to Tiny Particles That Kill Microbes.” The New York Times (Thurs., March 6, 2008): C5.
(Note: the title of the online version was “Small Business; New Device for Germophobes Runs Into Old Law.”)
(Note: ellipsis added.)

Handler.jpg

“Production of the Handler has ceased for the time being.” Source of caption and photo: online version of the NYT article quoted and cited above.

Resveratrol May Extend Life, Even at Lower Doses

(p. A1) Red wine may be much more potent than was thought in extending human lifespan, researchers say in a new report that is likely to give impetus to the rapidly growing search for longevity drugs.

The study is based on dosing mice with resveratrol, an ingredient of some red wines. Some scientists are already taking resveratrol in capsule form, but others believe it is far too early to take the drug, especially using wine as its source, until there is better data on its safety and effectiveness.
The report is part of a new wave of interest in drugs that may enhance longevity. On Monday, Sirtris, a startup founded in 2004 to develop drugs with the same effects as resveratrol, completed its sale to GlaxoSmithKline for $720 million.
. . .
(p. A16) Separately from Sirtris’s investigations, a research team led by Tomas A. Prolla and Richard Weindruch, of the University of Wisconsin, reports in the journal PLoS One on Wednesday that resveratrol may be effective in mice and people in much lower doses than previously thought necessary. In earlier studies, like Dr. Auwerx’s of mice on treadmills, the animals were fed such large amounts of resveratrol that to gain equivalent dosages people would have to drink more than 100 bottles of red wine a day.
The Wisconsin scientists used a dose on mice equivalent to just 35 bottles a day. But red wine contains many other resveratrol-like compounds that may also be beneficial. Taking these into account, as well as mice’s higher metabolic rate, a mere four, five-ounce glasses of wine “starts getting close” to the amount of resveratrol they found effective, Dr. Weindruch said.
Resveratrol can also be obtained in the form of capsules marketed by several companies. Those made by one company, Longevinex, include extracts of red wine and of a Chinese plant called giant knotweed. The Wisconsin researchers conclude that resveratrol can mimic many of the effects of a caloric-restricted diet “at doses that can readily be achieved in humans.”

For the full story, see:
NICHOLAS WADE. “New Hints Seen That Red Wine May Slow Aging.” The New York Times (Weds., June 4, 2008): A1 & A16.
(Note: ellipsis added.)

Prices of Education and Medical Care Increase Dramatically Over Decade

InflationGraphic.jpg

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

The most interesting part of a recent David Leonhardt column, was not what he wrote, but the graphs that were included with the article, especially the one at the top of this entry. Notice that the price of education and medical care have increased much more dramatically than other categories of consumer spending. (And remember how heavily government is involved in those two sectors, both directly through government run institutions, and indirectly through regulations and subsidies.)

For the full commentary, see:
DAVID LEONHARDT. “ECONOMIC SCENE; Seeing Inflation Only in the Prices That Go Up.” The New York Times (Weds., May 7, 2008): C1 and C11.

ConsumerSpendingGraphic.jpgSource of the graphic: online version of the NYT article cited above.

Freeing Medical Entrepreneurship Could Speed Cures

HaroldTomScyFIX.jpg

Medical entrepreneur Tom Harold.    Source of photo:   http://www.scyfix.org/management.php

(p. 1D) ScyFix, a Chanhassen, Minn., startup, has developed a device it claims treats diseases such as glaucoma and macular degeneration by shooting electric currents into the eye. The company, which is conducting clinical trials in India and the United States, hopes to sell the first device approved by the Food and Drug Administration designed to restore eyesight.
“To me, this is the pacemaker for the eye,” said Dr. Darrell DeMello, ScyFix president and a former executive at Boston Scientific Corp.
ScyFix hopes to eventually raise $60 million to $70 million to finish its clinical trials.
. . .
(p. 2D) Thomas Harold first came up with the idea for ScyFix in 2002. An Internet entrepreneur and a former executive at General Mills, Harold became interested in studies that showed electricity could restore sight. Drugs, however, could only slow the effects of some diseases.
. . .
Specifically, the studies showed electricity could stimulate the production of neurotrophins, a family of proteins that can instruct optic nerve, retinal neurons and photoreceptor cells not to die. In addition, neuromodulation can also repair cell membranes, allowing cells to absorb nutrients, release wastes, improve blood flow to the eye and rewire faulty nerve connections.
Working with doctors and engineers, Harold, who has no medical background, developed a device that releases low-intensity electric currents into the eyelids through electrodes. A complex mathematical equation programmed into the device controls the amount and frequency of the electricity. Patients can administer the treatment at home twice a day for 20 minutes.
Harold says he is encouraged by the results so far: Since 2002, the device has halted progression of diseases in 95 percent of the 1,000 patients tested in 29 countries, according to ScyFix.
“Everything stopped getting worse,” Harold said. “That was a win in itself.”
In addition, 80 percent of the patients reported vision improvement. There were no side effects, the company said.

For the full story, see:
Lee, Thomas (The Star Tribune). “‘Pacemaker’ for eyes shows initial promise.” Omaha World-Herald (Sunday, March 9, 2008): 1D & 2D.
(Note: ellipses added.)

Below I have pasted a couple of paragraphs from the ScyFIX web site. Note that Europeans are free to try the therapy, if they so desire. But citizens of the United States are not free to try the therapy, due to the regulations of the Food and Drug Admininstration (FDA) of the U.S. government.

Buy ScyFIX 600 and Accessories on-line!
Welcome to ScyFIX international web shop where you can order products, choose payment method, including a secure on-line credit card payment service (SSL), and check your delivery status on-line. Buying on-line is safe and easy and you will be guided all the way. All prices are in € (Euro). Place your order and your credit card company will convert the amount in € to your own currency. We accept Visa, Master Card, EuroCard and most bank cards connected to VISA or Master Card. Follow the instructions to take you through the pages, and then onto a secure site in which you will input your credit card and shipping details. When bank authorization has been attained, you will get a confirmation on-line, as well as a confirming e-mail. If at any stage you wish to change your order, just click the “Remove”-button.
Please note that ScyFIX can not ship devices to US addresses, until the ongoing FDA trials have resulted in an approval to market the product in the USA. US customers who mistakenly order and pay for a therapy kit over the web, will be contacted and refunded. However, ScyFIX will deduct 100€ (Euros) covering banking fees and handling costs. If you are a US resident and want to know more about our therapy, please send an inquiry by e-mail to our European office support@scyfix.org, or fill in your personal information in our Clinical Trial & Purchase Interest Form by clicking here www.scyfix.org/clinical_trial_form.htm.

The paragraphs were accessed on 3/9/08 from:
http://www.scyfix.org/shop/

Seniors Want Independence and to Live in Familiar Surroundings


StairsGeorgeAllen.jpg “Climbing stairs is a challenge for George Allen.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. A1) WASHINGTON — On a bluff overlooking the Potomac River, George and Anne Allen, both 82, struggle to remain in their beloved three-story house and neighborhood, despite the frailty, danger and isolation of old age.
Mr. Allen has been hobbled since he fractured his spine in a fall down the stairs, and he expects to lose his driver’s license when it comes up for renewal. Mrs. Allen recently broke four ribs getting out of bed. Neither can climb a ladder to change a light bulb or crouch under the kitchen sink to fix a leak. Stores and public transportation are an uncomfortable hike.
So the Allens have banded together with their neighbors, who are equally determined to avoid being forced from their homes by dependence. Along with more than 100 communities nationwide — a dozen of them planned here in Washington and its suburbs — their group is part of a movement to make neighborhoods comfortable places to grow old, both for elderly men and women in need of help and for baby boomers anticipating the future.
“We are totally dependent on ourselves,” Mr. Allen said. “But I want to live in a mixed community, not just with the elderly. And as long as we can do it here, that’s what we want.”
Their group has registered as a nonprofit corporation, is setting membership dues, and is lining up providers of transportation, home repair, companionship, security and other services to meet their needs at home for as long as possible.
Urban planners and senior housing experts say this movement, organized by residents rather than government agencies or social service providers, could make “aging in place” safe and affordable for a majority of elderly people. Almost 9 in 10 Americans over the age of 60, according to AARP polls, share the Allens’ wish to live out their lives in familiar surroundings.
. . .
(p. A18) The first village in the Washington area is expected to be on Capitol Hill. When it opens for business on Oct. 1, annual memberships will be $750 for a couple and $500 for an individual.
Among those eager to join are Marie Spiro, 74, and Georgine Reed, 78, who share a rambling house that they insist they will only leave “feet first.” Between them, Ms. Spiro, an emeritus professor of art history and archaeology, and Ms. Reed, a retired designer of museum exhibits, have already endured three knee replacements and an array of other ailments.
Ms. Spiro describes huffing and puffing while grocery shopping; Ms. Reed is increasingly reluctant to visit friends across town. Both women, who are childless, would already welcome help with meals, transportation and paperwork. If they need home care, Capitol Hill Village will be able to organize that.
“I’ve never had to rely on other people, and I never wanted to,” Ms. Spiro said. “But I’d rather pay a fee than have to ask favors.”

For the full story, see:
JANE GROSS “A Grass-Roots Effort to Grow Old at Home The New York Times (Tues., August 14, 2007): A1 & A18.

(Note: ellipses added; caption for the George Allen photo is the online caption, not the different one in the print version of the article.)
SpiroMarie.jpg “Georgine Reed, 78, right, and Marie Spiro, 74, share a Capitol Hill home and are joining a group that will help them stay there. “I’d rather pay a fee,” Ms. Spiro said, “than have to ask favors.”” Source of caption and photo: online version of the NYT article quoted and cited above.

Wal-Mart Designs Health Care Around the Needs of Consumers


LedlieAliciaWalMartHealth.jpg “Alicia Ledlie, senior director of health business development for Wal-Mart, said walk-in medical clinics would look like the mockup behind her, in a warehouse in Bentonville, Ark.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. C4) Moving to upgrade its walk-in medical clinic business, Wal-Mart is set to announce on Thursday plans for several hundred new clinics at its stores, using a standardized format and jointly branded with hospitals and medical groups.
. . .
Walk-in medical clinics are a growing industry, with numerous competitors that include big-box retailers, drugstores and even grocery chains around the country. Industry executives say 1,500 to 1,800 clinics will be open by the end of the year.
Propelled by the drugstore chains CVS and Walgreens, by far the biggest sponsors of the clinics to date, more than 700 clinics have opened in the last 15 months. But the business model is unproven so far.
Few, if any, clinics are profitable, according to industry analysts, and only a handful have broken even on daily operations. Most have been open a year or less, and executives say it takes up to three years for a clinic to become profitable enough to recover start-up costs.
Medical societies are inclined to be skeptical of the clinics. The American Academy of Pediatrics opposes them, saying they add to fragmentation in the health care system.
Dr. Edward Zissman, a pediatrician in central Florida, said he had qualms about hospitals that hook up with the clinics. “Putting their name on a product that I don’t think has the highest quality,” he said, “is going to cost them dearly with physicians.”
The American Academy of Family Physicians and the American Medical Association have set forth principles for clinics to observe, including sending patients’ medical record to their doctors and finding doctors for patients who do not already have them. Most states require varying degrees of physician supervision of the clinic nurses. Clinic operators say they are complying.
Many patients have said they like the convenience of the walk-in clinics’ weekend and evening hours, the short waiting times to see a nurse practitioner, and the posted price lists for a limited menu of care like tests and prescriptions for sore throats and ear infections and seasonal flu shots.
. . .
“The clinics are the latest big example of how you could think about consumers and what their needs are, rather than a health care system exclusively designed around the needs of providers,” said Margaret Laws, director of an innovations program at the California Health Care Foundation, an independent group that finances health policy research.



For the full story, see:
MILT FREUDENHEIM. “Wal-Mart Will Expand In-Store Medical Clinics.” The New York Times (Thurs., February 7, 2008): C4.
(Note: ellipses added.)



WalMartMedicalClinicDesign.jpg “The design of the Wal-Mart medical clinic is intended to look like a doctor’s office, complete with the usual medical hardware.” Source of caption and photo: online version of the NYT article quoted and cited above.

“Isn’t This a Teeny-Weeny Bit of Socialism?”


(p. 12) FROM the very beginning of the nation’s modern social welfare system — even before Michael Moore began to explore the issue — there was a tension in it: What should the government be expected to provide? What should be left to the individual? How much government is too much?
The questions were asked even in 1935, not exactly a time to instill confidence in the resilient power of private markets. Senator Thomas Pryor Gore, Democrat of Oklahoma, put it bluntly when Frances Perkins, the secretary of labor, testified on Capitol Hill that year about President Franklin D. Roosevelt’s plan for a new program called Social Security.
”Isn’t this socialism?” Senator Gore demanded. When Ms. Perkins denied it, he asked again: ”Isn’t this a teeny-weeny bit of socialism?” In recent days, on Capitol Hill and on the campaign trail, a new version of that debate has been flaring, this time around an issue that the New Dealers decided (perhaps wisely) to put off for a later date: health care.



For the full commentary, see:
Robin Toner. “IDEAS & TRENDS; Less, Less, Less! More, More, Moore!” The New York Times, Week in Review section (Sun., August 5, 2007): 12.

Ban on DDT is a Lethal Vestige of Colonialism


(p. A16) Environmental leaders must join the 21st century, acknowledge the mistakes Carson made, and balance the hypothetical risks of DDT with the real and devastating consequences of malaria. Uganda has demonstrated that, with the proper support, we can conduct model indoor spraying programs and ensure that money is spent wisely, chemicals are handled properly, our program responds promptly to changing conditions, and malaria is brought under control.
Africa is determined to rise above the contemporary colonialism that keeps us impoverished. We expect strong leadership in G-8 countries to stop paying lip service to African self-determination and start supporting solutions that are already working.



For the full commentary, see:
Sam Zaramba. “Give Us DDT.” Wall Street Journal (Tues., Jun 12, 2007): A16.

Much Health Spending “Does Nothing to Improve Our Health”


BrownleeShannon.jpg


Shannon Brownlee is the author of “Overtreated” which “diagnoses the big flaw in medical spending.” Source of caption and photo: online version of the NYT commentary quoted and cited below.


(p. C5) Fortunately — if that’s the right word — there is an obvious candidate for cost-cutting: all that care that brings no health benefit. It’s not hard to find examples. Scientific studies have shown that many treatments, including spinal fusion, routine episiotomies and neonatal intensive care, are overdone. These procedures often help specific subsets of patients. But for a lot of people, and “Overtreated” is full of stories, the treatments are a modern-day version of bloodletting.
“We spend between one fifth and one third of our health care dollars,” writes Ms. Brownlee, a senior fellow at the New America Foundation and former writer for U.S. News & World Report, “on care that does nothing to improve our health.”
Worst of all, overtreatment often causes harm, because even the safest procedures bring some risk. One study found that a group of Medicare patients admitted to high-spending hospitals were 2 to 6 percent more likely to die than a group admitted to more conservative hospitals.

For the rest of the commentary, see:
DAVID LEONHARDT. “ECONOMIC SCENE; No. 1 Book, And It Offers Solutions.” The New York Times (Weds., December 19, 2007): C1 & C5.

Non-Market Health Care Pricing Results in Health Care Shortages


(p. A22) When my Labrador retriever became acutely lame, we were able to locate a veterinary orthopedic expert in Atlanta within 48 hours who was able to repair a ruptured tendon within one week. But my prospects of identifying an endocrinologist who can care for my daughter’s diabetes when she turns 18 are much less promising.
The limited number of endocrine specialists is a not a consequence of limited demand — everyone is aware of the epidemic of diabetes we are facing. There are also shortages of generalists and other specialists, and the reason is the absence of market signals — i.e., market-based prices — for influencing the supply of physicians in various specialties.
The roots of this problem lay in the use of administrative pricing structures in medicine. The way prices are set in health care already distorts the appropriate allocation of efforts and resources in health care today. Unfortunately, many of the suggested reforms of our health care system — including the various plans for universal care, or universal insurance, or a single-payer system, that various policy makers and Democratic presidential candidates espouse — rest on the same unsound foundations, and will produce more of the same.
. . .
One important lesson of the 20th century is that, while markets are far from perfect, more choices are available when people are able to use free markets to interact with each other. Markets may not get the prices exactly correct all the time, but they are capable of self- correction, a capacity that has yet to be demonstrated by administrative pricing.
It tells you something when the supply of and demand for specialist veterinary care is so easily matched when the prices of these services are established on the market — while shortages and oversupplies are common for human medical care when the prices of these services are set by administrators in the public sector. Will health-care reformers — and American citizens — get the message?



For the full commentary, see:
Robert A. Swerlick. “Our Soviet Health System.” Wall Street Journal (Tues., Jun 5, 2007): A22.
(Note: ellipsis added.)

Entrepreneurial Medicine Hunter Seeks Cures in Ethnobotany


MacaDried.jpg Source of photo: screen capture from slide show on online version of the NYT article quoted and cited below.

(p. C1) Part David Attenborough, part Indiana Jones, Mr. Kilham, an ethnobotanist from Massachusetts who calls himself the Medicine Hunter, has scoured remote jungles and highlands for three decades for plants, oils and extracts that can heal. He has eaten bees and scorpions in China, fired blow guns with Amazonian natives, and learned traditional war dances from Pacific Islanders.
But behind the colorful tales lies the prospect of money, lots of money — for Western pharmaceutical companies, impoverished indigenous tribes and Mr. Kilham.
. . .
(p. C5) In Peru, Mr. Kilham is betting on maca, a small root vegetable that grows here in the central highlands — “a turnip that packs a punch,” he says, adding “it imparts energy, sex drive and stamina like nothing else.”
That view is supported by studies carried out at the International Potato Center, a Lima-based research center that is internationally financed and staffed. Studies there show maca improves stamina, reduces the risk of prostate cancer and increases the motility, volume and quality of sperm.
Some peer reviewed studies published in the journal Reproductive Biology and Endocrinology backed up those findings.
. . .
One product, Maca Stimulant, is sold in Wal-Mart under Mr. Kilham’s Medicine Hunter brand. Mr. Kilham earns a retainer from both Naturex and Enzymatic Therapy, in addition to royalties from another Medicine Hunter-branded product at Wal-Mart.
Mr. Kilham says he earns around $200,000 each year in retainers, and sales are so buoyant he expects to make “in the mid-six figures” in royalties next year.
Mr. Kilham insists he is not in the business simply for financial gain. His motivation comes from promoting herbal medicines and helping traditional communities, he said.
“I have financial security and don’t need to make money from this,” he said. “I believe trade is the best way to get good medicines to the public, to help the environment and to help indigenous people.”
He and Mr. Cam pay growers here in Ninacaca a premium of 6 soles (about $2) for a kilo of maca, almost twice the going rate of 3 to 3.40 soles a kilo. They have set up a computer room at the Chakarunas warehouse and a free dental clinic, the town’s first.
Mr. Kilham is clearly adored by the locals in these desolate, wind-swept villages. On a recent visit here, shamans, maca growers and their families flocked to him. Since only maca and potatoes grow at this altitude, they are thankful Mr. Kilham is helping them sell their produce.



For the full story, see:
ANDREW DOWNIE. “On a Remote Path to Cures.” The New York Times (Tues., January 1, 2008): C1 & C5.
(Note: ellipses added.)
MacaFlour.jpg Source of photo: screen capture from slide show on online version of the NYT article quoted and cited above.