Health – Page 81 – artdiamondblog.com

AquaBounty Has Waited More than 17 Years for FDA Approval

“The Enviropig Scientists at the University of Guelph, in Canada, developed these pigs to produce more environmentally friendly waste than conventional pigs. But the pigs were killed because the scientists could not get approval to sell them as food.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. 4) If patience is a virtue, then AquaBounty, a Massachusetts biotech company, might be the most virtuous entity on the planet.

In 1993, the company approached the Food and Drug Administration about selling a genetically modified salmon that grew faster than normal fish. In 1995, AquaBounty formally applied for approval. Last month, more than 17 years later, the public comment period, one of the last steps in the approval process, was finally supposed to conclude. But the F.D.A. has extended the deadline — members of the public now have until late April to submit their thoughts on the AquAdvantage salmon. It’s just one more delay in a process that’s dragged on far too long.
The AquAdvantage fish is an Atlantic salmon that carries two foreign bits of DNA: a growth hormone gene from the Chinook salmon that is under the control of a genetic “switch” from the ocean pout, an eel-like fish that lives in the chilly deep. Normally, Atlantic salmon produce growth hormone only in the warm summer months, but these genetic adjustments let the fish churn it out year round. As a result, the AquAdvantage salmon typically reach their adult size in a year and a half, rather than three years.
. . .
We should all be rooting for the agency to do the right thing and approve the AquAdvantage salmon. It’s a healthy and relatively cheap food source that, as global demand for fish increases, can take some pressure off our wild fish stocks. But most important, a rejection will have a chilling effect on biotechnological innovation in this country.
. . .
Then there’s the Enviropig, a swine that has been genetically modified to excrete less phosphorus. Phosphorus in animal waste is a major cause of water pollution, and as the world’s appetite for meat increases, it’s becoming a more urgent problem. The first Enviropig, created by scientists at the University of Guelph, in Canada, was born in 1999, and researchers applied to both the F.D.A. and Health Canada for permission to sell the pigs as food.
But last spring, while the applications were still pending, the scientists lost their funding from Ontario Pork, an association of Canadian hog farmers, and couldn’t find another industry partner. (It’s hard to blame investors for their reluctance, given the public sentiment in Canada and the United States, as well as the uncertain regulatory landscape.) The pigs were euthanized in May.
The F.D.A. must make sure that other promising genetically modified animals don’t come to the same end. Of course every application needs to be painstakingly evaluated, and not every modified animal should be approved. But in cases like AquaBounty’s, where all the available evidence indicates that the animals are safe, we shouldn’t let political calculations or unfounded fears keep these products off the market. If we do that, we’ll be closing the door on innovations that could help us face the public health and environmental threats of the future, saving countless animals — and perhaps ourselves.

For the full commentary, see:
EMILY ANTHES. “Don’t Be Afraid of Genetic Modification.” The New York Times, SundayReview Section (Sun., March 10, 2013): 4.
(Note: ellipses added.)
(Note: the online version of the commentary has the date March 9, 2013.)

Emily Anths, who is quoted above, has written a related book:
Anthes, Emily. Frankenstein’s Cat: Cuddling up to Biotech’s Brave New Beasts. New York: Scientific American / Farrar, Straus and Giroux, 2013.

Patent Allows Mechanic to Profit from Invention to Ease Births

“With Jorge Odón’s device, a plastic bag inflated around a baby’s head is used to pull it out of the birth canal.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. A1) The idea came to Jorge Odón as he slept. Somehow, he said, his unconscious made the leap from a YouTube video he had just seen on extracting a lost cork from a wine bottle to the realization that the same parlor trick could save a baby stuck in the birth canal.

Mr. Odón, 59, an Argentine car mechanic, built his first prototype in his kitchen, using a glass jar for a womb, his daughter’s doll for the trapped baby, and a fabric bag and sleeve sewn by his wife as his lifesaving device.
. . .
(p. A4) In a telephone interview from Argentina, Mr. Odón described the origins of his idea.
He tinkers at his garage, but his previous inventions were car parts. Seven years ago, he said, employees were imitating a video showing that a cork pushed into an empty bottle can be retrieved by inserting a plastic grocery bag, blowing until it surrounds the cork, and drawing it out.
. . .
With the help of a cousin, Mr. Odón met the chief of obstetrics at a major hospital in Buenos Aires. The chief had a friend at the W.H.O., who knew Dr. Merialdi, who, at a 2008 medical conference in Argentina, granted Mr. Odón 10 minutes during a coffee break.
The meeting instead lasted two hours. At the end, Dr. Merialdi declared the idea “fantastic” and arranged for testing at the Des Moines University simulation lab, which has mannequins more true-to-life than a doll and a jar.
Since then, Mr. Odón has continued to refine the device, patenting each change so he will eventually earn royalties on it.
. . .
Dr. Merialdi said he endorsed a modest profit motive because he had seen other lifesaving ideas languish for lack of it. He cited magnesium sulfate injections, which can prevent fatal eclampsia, and corticosteroids, which speed lung development in premature infants.
“But first, this problem needed someone like Jorge,” he said. “An obstetrician would have tried to improve the forceps or the vacuum extractor, but obstructed labor needed a mechanic. And 10 years ago, this would not have been possible. Without YouTube, he never would have seen the video.”

For the full story, see:
DONALD G. McNEIL Jr. “Promising Tool in Difficult Births: A Plastic Bag.” The New York Times (Thurs., November 14, 2013): A1 & A4. [National Edition]
(Note: ellipses added.)
(Note: the online version of the story has the date November 13, 2013, and has the title “Car Mechanic Dreams Up a Tool to Ease Births.”)

“Pretty Cool” Cochlear Implant: “It Helps Me Hear”

“The cochlear implant.” Source of caption and photo: online version of the WSJ commentary quoted and cited below.

(p. A15) . . . , three pioneering researchers– Graeme Clark, Ingeborg Hochmair and Blake Wilson –shared the prestigious Lasker-DeBakey Award for Clinical Medical Research for their work in developing the [cochlear] implant. . . . The award citation says the devices have “for the first time, substantially restored a human sense with medical intervention” and directly transformed the lives of hundreds of thousands.
I’ve seen this up close. My 10-year-old son, Alex, is one of the 320,000 people with a cochlear implant.
, , ,
“What’s that thing on your head?” I heard a new friend ask Alex recently.
“It helps me hear,” he replied, then added: “I think it’s pretty cool.”
“If you took it off, would you hear me?” she asked.
“Nope,” he said. “I’m deaf.”
“Cool,” she agreed. Then they talked about something else.
Moments like that make me deeply grateful for the technology that allows Alex to have such a conversation, but also for the hard-won aplomb that lets him do it so matter-of-factly.

For the full commentary, see:
Denworth, Lydia. “OPINION; What Cochlear Implants Did for My Son; Researchers who were just awarded the ‘American Nobel’ have opened up the world of sound to the deaf.” The Wall Street Journal (Fri., Sept. 20, 2013): A15.
(Note: ellipses, and bracketed word, added.)
(Note: the online version of the article has the date Sept. 19, 2013.)

Regulators Harass Saucy and Irreverent Buckyball Entrepreneur

“Craig Zucker, former head of Maxfield & Oberton, which made Buckyballs, sells Liberty Balls to raise a legal-defense fund against an unusual action by federal regulators.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. B1) Over the last three weeks, more than 2,200 people have placed orders for $10-to-$40 sets of magnetic stacking balls, rising to the call of a saucy and irreverent social media campaign against a government regulatory agency.
. . .
It involves an effort by the federal Consumer Product Safety Commission to recall Buckyballs, sets of tiny, powerfully magnetic stacking balls that the magazines Rolling Stone and People once ranked on their hot products lists.
Last year, the commission declared the balls a swallowing hazard to young children and filed an administrative action against the company that made the product, demanding it recall all Buckyballs, and a related product called Buckycubes, and refund consumers their money. The company, Maxfield & Oberton Holdings, challenged the action, saying labels on the packaging clearly warned that the product was unsafe for children.
But the fuss now has less to do with safety. After Maxfield & Oberton went out of business last December, citing the financial toll of the recall battle, lawyers for the product safety agency took the highly unusual step of adding the chief executive of the dissolved firm, Craig Zucker, as a respondent in the recall action, arguing that he con-
(p. B6)trolled the company’s activities. Mr. Zucker and his lawyers say the move could ultimately make him personally responsible for the estimated recall costs of $57 million.
While the “responsible corporate officer” doctrine (also known as the Park doctrine) has been used frequently in criminal cases, allowing for prosecutions of individual company officers in cases asserting corporate wrongdoing, experts say its use is virtually unheard-of in an administrative action where no violations of law or regulations are claimed.
. . .
Three well-known business organizations — the National Association of Manufacturers, the National Retail Federation and the Retail Industry Leaders Association — banded together this summer to file a brief urging the administrative law judge reviewing the recall case to drop Mr. Zucker as a respondent.
The groups argue that holding an individual responsible for a widespread, expensive recall sets a disturbing example and runs counter to the business desire for limited liability. They contend that such risk would have a detrimental effect on entrepreneurism and openness in dealing with regulatory bodies.
. . .
Conservative legal groups like Cause of Action, a nonprofit that targets what it considers governmental overreach, have been watching the proceedings with interest and weighing taking some action.
“This really punishes entrepreneurship and establishes a bad precedent for businesses working to create products for consumers,” said Daniel Z. Epstein, the group’s executive director. “It undermines the business community’s ability to rely upon the corporate form.”

For the full story, see:
HILARY STOUT. “In Regulators’ Sights; Magnetic-Toy Recall Gives Rise to Wider Legal Campaign.” The New York Times (Fri., November 1, 2013): B1 & B6.
(Note: ellipses added.)
(Note: the online version of the article has the date October 31, 2013, and has the title “Buckyball Recall Stirs a Wider Legal Campaign.”)

Buffett’s Berkshire Buys More of Dubious DaVita

A case has been made on CNN that DaVita has committed Medicare fraud costing taxpayers many millions of dollars. DaVita has been discussed in previous blog entries on November 30, 2012, May 18, 2013, and June 11, 2013.

(p. 3D) Omaha investor Warren Buffett’s company bought nearly 3.7 million more shares of DaVita Inc. after the dialysis provider reported its earnings . . . [in the first week of November 2013].

Berkshire Hathaway Inc. said in documents filed with the Securities and Exchange Commission on Friday that it owns 35.1 million shares of DaVita.

For the full story, see:
THE ASSOCIATED PRESS. “Berkshire buys 3.7 million more shares of DaVita after report.” Omaha World-Herald (Mon., November 11, 2013): 3D.
(Note: ellipsis and bracketed words added.)

Stem Cells Used to Create Tiny, Simple Human Livers

“Researchers from Japan used human stem cells to create “liver buds,” rudimentary livers that, when transplanted into mice, grew and functioned.” Source of caption and photo: online version of the NYT article quoted and cited below.

(p. A3) Researchers in Japan have used human stem cells to create tiny human livers like those that arise early in fetal life. When the scientists transplanted the rudimentary livers into mice, the little organs grew, made human liver proteins, and metabolized drugs as human livers do.

They and others caution that these are early days and this is still very much basic research. The liver buds, as they are called, did not turn into complete livers, and the method would have to be scaled up enormously to make enough replacement liver buds to treat a patient. Even then, the investigators say, they expect to replace only 30 percent of a patient’s liver. What they are making is more like a patch than a full liver.
But the promise, in a field that has seen a great deal of dashed hopes, is immense, medical experts said.
“This is a major breakthrough of monumental significance,” said Dr. Hillel Tobias, director of transplantation at the New York University School of Medicine. Dr. Tobias is chairman of the American Liver Foundation’s national medical advisory committee.

For the full story, see:
GINA KOLATA. “Scientists Fabricate Rudimentary Human Livers.” The New York Times (Thurs., July 4, 2013): A3.
(Note: the online version of the story has the date July 3, 2013.)

The research article is:
Takebe, Takanori, Keisuke Sekine, Masahiro Enomura, Hiroyuki Koike, Masaki Kimura, Takunori Ogaeri, Ran-Ran Zhang, Yasuharu Ueno, Yun-Wen Zheng, Naoto Koike, Shinsuke Aoyama, Yasuhisa Adachi, and Hideki Taniguchi. “Vascularized and Functional Human Liver from an iPSC-Derived Organ Bud Transplant.” Nature (July 3, 2013) DOI: 10.1038/nature12271.

Paper Towels Are Better than Air Dryers at Removing Bacteria

Green environmentalists have forced hot air hand dryers on us in many public restrooms. They are slow and noisy and frustrating, and many of us leave the restroom with still-wet hands. But did you also know that by taking away our paper towels, the environmentalists are helping to spread disease? Read the article abstract below:

(p. 791) The transmission of bacteria is more likely to occur from wet skin than from dry skin; therefore, the proper drying of hands after washing should be an integral part of the hand hygiene process in health care. This article systematically reviews the research on the hygienic efficacy of different hand-drying methods. A literature search was conducted in April 2011 using the electronic databases PubMed, Scopus, and Web of Science. Search terms used were hand dryer and hand drying. The search was limited to articles published in English from January 1970 through March 2011. Twelve studies were included in the review. Hand-drying effectiveness includes the speed of drying, degree of dryness, effective removal of bacteria, and prevention of cross-contamination. This review found little agreement regarding the relative effectiveness of electric air dryers. However, most studies suggest that paper towels can dry hands efficiently, remove bacteria effectively, and cause less contamination of the washroom environment. From a hygiene viewpoint, paper towels are superior to electric air dryers. Paper towels should be recommended in locations where hygiene is paramount, such as hospitals and clinics.

Source:
Cunrui, Huang, Ma Wenjun, and Susan Stack. “The Hygienic Efficacy of Different Hand-Drying Methods: A Review of the Evidence.” Mayo Clinic Proceedings 87, no. 8 (Aug. 2012): 791-98.

Beer Was Safer than Water

(p. C24) . . . what would beer be without water? . . . New York City, at least until the opening of the Croton Aqueduct in 1842, had no clean, reliable source. In fact, since hops have a preservative quality, and brewing requires boiling, “beer was once considered safer to drink than water.”

For the full review, see:
EDWARD ROTHSTEIN. “EXHIBITION REVIEW; A Tipple or Two? It Was Safer Than Water.” The New York Times (Fri., May 25, 2012): C19 & C24.
(Note: ellipses added.)
(Note: the online version of the review has the date May 24, 2012.)

Foreign Aid Frees Despots from Having to Seek the Consent of the Governed

Source of book image: online version of the NYT review quoted and cited below.

(p. 4) IN his new book, Angus Deaton, an expert’s expert on global poverty and foreign aid, puts his considerable reputation on the line and declares that foreign aid does more harm than good. It corrupts governments and rarely reaches the poor, he argues, and it is high time for the paternalistic West to step away and allow the developing world to solve its own problems.

It is a provocative and cogently argued claim. The only odd part is how it is made. It is tacked on as the concluding section of “The Great Escape: Health, Wealth, and the Origins of Inequality” (Princeton University Press, 360 pages), an illuminating and inspiring history of how mankind’s longevity and prosperity have soared to breathtaking heights in modern times.
. . .
THE author has found no credible evidence that foreign aid promotes economic growth; indeed, he says, signs show that the relationship is negative. Regretfully, he identifies a “central dilemma”: When the conditions for development are present, aid is not required. When they do not exist, aid is not useful and probably damaging.
Professor Deaton makes the case that foreign aid is antidemocratic because it frees local leaders from having to obtain the consent of the governed. “Western-led population control, often with the assistance of nondemocratic or well-rewarded recipient governments, is the most egregious example of antidemocratic and oppressive aid,” he writes. In its day, it seemed like a no-brainer. Yet the global population grew by four billion in half a century, and the vast majority of the seven billion people now on the planet live longer and more prosperous lives than their parents did.

For the full review, see:
FRED ANDREWS. “OFF THE SHELF; A Surprising Case Against Foreign Aid.” The New York Times, SundayBusiness Section (Sun., October 13, 2013): 4.
(Note: ellipsis added.)
(Note: the online version of the review has the date October 12, 2013.)

The book reviewed is:
Deaton, Angus. The Great Escape: Health, Wealth, and the Origins of Inequality. Princeton, N.J.: Princeton University Press, 2013.

Gene-Altered Mice Live 20% Longer

“NIH researchers found that lowering the expression of a single gene helped extend the life of mice by about 20%. A mouse with a manipulated gene on the right and an unchanged mouse on the left.” Source of caption and photo: online version of the WSJ article quoted and cited below.

(p. A3) By reducing the activity of one type of gene, scientists said they increased the average life span of mice by about 20%, a feat that in human terms is akin to extending life by about 15 years.

Moreover, the researchers at the National Institutes of Health found that memory, cognition and some other important traits were better preserved in the mice as they aged, compared with a control group of mice that had normal levels of a protein put out by the gene.
The findings, published Thursday [August 29, 2013] in the journal Cell Reports, strengthen the case that the gene, called mTOR, is a major regulator of the aging process.
. . .
The results . . . build on a growing body of research challenging the belief that aging is an intractable biological process, prompting scientists to think of slowing aging as a possible way to prevent disease.
“What we need right now is for scientists and the public to wake up to the concept that you can slow aging,” said Brian Kennedy, president of the Buck Institute for Aging Research in Novato, Calif., who wasn’t involved in the new study. “If you do, you prevent many of the diseases that we’re so scared of and that are associated with aging.” They include cardiovascular disease, cancer and Alzheimer’s disease.

For the full story, see:
RON WINSLOW. “Altered Gene Points Toward Longer Life Spans; Successful Experiment With Mice May One Day Play Role in Slowing Human Aging; Side Effects Could Be Problematic.” The Wall Street Journal (Fri, August 30, 2013): A3.
(Note: ellipsis, and bracketed date, added.)
(Note: the online version of the story has the date August 29, 2013, and has the title “Genetic Manipulation Extends Life of Mice 20%; But Translating Findings to Humans Faces Many Hurdles.”)

The scientific article being discussed above, is:
Wu, J. Julie, Jie Liu, Edmund B Chen, Jennifer J Wang, Liu Cao, Nisha Narayan, Marie M Fergusson, Ilsa I Rovira, Michele Allen, Danielle A Springer, Cory U Lago, Shuling Zhang, Wendy DuBois, Theresa Ward, Rafael deCabo, Oksana Gavrilova, Beverly Mock, and Toren Finkel. “Increased Mammalian Lifespan and a Segmental and Tissue-Specific Slowing of Aging after Genetic Reduction of mTor Expression.” Cell Reports 4, no. 5 (Aug. 29, 2013): 913-20.

Salt May NOT Be Bad for Our Health, After All

(p. A7) An influential government panel said there is no evidence that very low-salt diets prevent heart disease, calling into question current national dietary guidelines on sodium intake.
The Institute of Medicine, in a report released Tuesday [May 14, 2013], said there isn’t sufficient evidence that cutting sodium intake below 2,300 milligrams per day cuts the risk of heart disease. The group of medical experts also said there is no evidence that people who already have heart disease or diabetes should cut their sodium intake even lower.

For the full story, see:
JENNIFER CORBETT DOOREN. “U.S. NEWS; Low-Salt Benefits Questioned.” The Wall Street Journal (Weds., May 15, 2013): A7.
(Note: bracketed date added.)
(Note: the online version of the story has the date May 14, 2013.)

For a summary of the Institute of Medicine report, see:
Institute of Medicine of the National Academies. “Sodium Intake in Populations: Assessment of Evidence.” Report Brief. Washington, D.C.: National Academy of Sciences, 2013.