Monthly Archive for January, 2011

Personalized Medicine Regulation Needs More Than Band-Aids

Published on January 31, 2011 in News. 1 Comment

Dan Vorhaus January 28, 2011, Genomics Law Report

Editor’s Note: This post originally appeared as a guest column at Xconomy.]

Last week, New York State assemblyman J. Gary Pretlow introduced the descriptively named “act to amend the insurance law, in relation to requiring coverage for genetic testing in accident and health insurance polices.”

While not accompanied by a press release, or widely covered by media outlets, the bill merits close attention. While the substance of the bill is striking, its greater import lies in what it reveals about the United States’ current framework for personalized medicine regulation and in what the bill portends for the future of personalized medicine innovation and investment in this country.

The Basics and Breadth of the Pretlow Proposal. Despite its broadly worded title, New York bill #A02325 has a specific goal: to require insurance companies to “provide coverage for genetic testing” for any individual who, “in the opinion of an attending physician, [is at] significant risk of contracting cancer.”

Though not discussed in the text of the bill of itself, the bill’s accompanying memorandum clarifies an intent to specifically require insurance companies to reimburse the cost of genetic tests for individuals deemed to be at significant risk of developing breast cancer (more on this below). With the new legislation, at risk patients “will be able to seek genetic screening and counseling that will be paid for by insurance.”

Whether the bill would require coverage for genetic tests aimed at any type of cancer (as the bill’s text implies), or only for breast cancer (as the explanatory memorandum indicates), its scope is significant. In addition to requiring insurance companies to provide coverage for these genetic tests, it would also require insurers to cover “any subsequent treatment resulting from the results of such test” (emphasis added).

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Administration Says Health Law Will Lower Premiums, But Critics Disagree

Published on January 29, 2011 in News and Newsletter. 1 Comment

JULIE ROVNER, NPR, 28 January 2011

It’s been a rocky week for health overhaul.

House Republicans formally launched what promises to be a long series of hearings intended to turn the public against the the Patient Protection and Affordable Care Act, the official name for overhaul.

And President Obama even offered to make changes to the law, if warranted, both in Tuesday’s State of the Union address and again today in a speech before the pro-health law consumer group Families USA.

“As I said on Tuesday, I believe that anything can be improved,” he told the mostly adoring crowd. “As we work to implement it, there are going to be times where we say, you know what, this needs a tweak, this isn’t working exactly as intended, exactly the way we want.”

Now the administration is back with even more ammunition aimed at silencing critics. A new report attempts to quantify exactly how much individuals and businesses might save once the law is phased in starting in 2014.

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CDC Releases New Diabetes Estimates for U.S.

Published on January 28, 2011 in News. 1 Comment

Eryn Brown, Los Angeles Times, 27 January 2011

A total of 25.8 million people in the United States -- 8.3% of the U.S. population -- have diabetes. That's a 9% increase over the 2008 estimate. (Kirk McKoy/Los Angeles Times)

A factsheet released Wednesday by the Centers for Disease Control and Prevention reports that numbers of diabetes cases in the United States continued to grow in 2010.

Highlights from the factsheet:

  • 25.8 million people in the United States — 8.3% of the U.S. population — have diabetes. That’s a 9% increase over the 2008 estimate.
  • Most of those affected — somewhere between 90% and 95% — have Type 2 diabetes.
  • Among American residents 65 years and older, 10.9 million — 26.9% — had diabetes in 2010.
  • Seven million cases of the disease were undiagnosed.
  • The CDC estimated that more than a third of adults 20 years or older are prediabetic, which means their blood-sugar is higher than normal but not high enough to be classified as diabetes.  Those people have an increased risk of developing Type 2 diabetes, heart disease and stroke.
  • Diabetes is the seventh-leading cause of death in the United States. The risk for death among people with diabetes is about twice that of people of similar age but without diabetes, the CDC said.
  • Diabetes is the leading cause of new cases of blindness among adults aged 20–74 years.  It is also the leading cause of kidney failure. The CDC gathered the statistics from a variety of surveys and studies. The director of the center’s Division of Diabetes Translation, Ann Albright, said in a press release that the new figures “show how important it is to prevent Type 2 diabetes.”

See CDC factsheet…

Antibiotics Defeat Ear Infections In Young Kids, Studies Find

Published on January 14, 2011 in News. 1 Comment

RICHARD KNOX NPR, January 13, 2011

Two new studies add substantial weight to one side of a long-running controversy over whether to give antibiotics to young children suffering from ear infections.

The “wait and see” approach has been enshrined in current guidelines from the American Academy of Pediatrics. It’s based on a slew of studies over the past couple of decades indicating that most children with ear infections get better without antibiotics. Some researchers also worry that too many prescriptions are fueling resistance to the drugs.

But the new studies, from the United States and Finland, come down firmly on the side of early antibiotic therapy for kids under age 2 or 3. Both studies, which appear today in the New England Journal of Medicine, find these kids get over painful ear infections faster, and have less severe symptoms, if they get prompt treatment with Augmentin, an inexpensive antibiotic often used to treat respiratory infections.

But there’s a big “if.” Study authors and other experts say doctors should be sure the child really is suffering from an ear infection before writing that prescription.

Much of the confusion, experts say, has been caused by studies that weren’t careful enough about the diagnosis.  If many children in prior studies didn’t really have ear infections, then it’s not surprising the antibiotics didn’t work for them, says Dr. Jerome Klein of Boston University, who wrote an editorial that accompanies the new studies.

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Is Malaria Coming Home to Roost?

Published on January 13, 2011 in News and Newsletter. 1 Comment

Arthur Allen, Special to The Washington Post, January 11, 2011

The room where 10,000 Anopheles stephensi mosquitoes hatch each week is hot and humid and smells like the tropics – an appropriate surrogate for a warming world. The Johns Hopkins Malaria Research Institute in Baltimore, where the insects are raised, was created with a billionaire’s anonymous donation a decade ago, after a map printed in Scientific American suggested that by 2020 malaria could be breaking out in Baltimore, and across the eastern United States and Europe.

The idea that climate change will bring malaria and other tropical killers to our door turns out to be an extremely controversial one among ecologists, climatologists and biologists such as Marcelo Jacobs-Lorena, who runs the “insectary” at Johns Hopkins. “It’s a very complicated story,” says Jacobs-Lorena.

The malaria map accompanied a 2000 article, written by Harvard biologist Paul R. Epstein, that raised the alarm about the impact of global warming on the spread of infectious diseases. It helped influence a research agenda that last year resulted in more than 4,000 studies of climate change and disease.

Epstein believes that evidence of the disease risks of climate change have only grown in the past decade. “The earlier models did not take into account the dramatic increase in extreme weather that we’re seeing,” he said.

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EPA Encourages Regular Testing for Heavy Metal in Water

Published on January 13, 2011 in News. 1 Comment

Michael Hawthorne, Chicago Tribune, January 11, 2011

Cancer-causing hexavalent chromium, which attracted worldwide attention from the movie ‘Erin Brockovich,’ was found in tap water from Chicago and more than two dozen other cities.

Federal regulators on Tuesday urged nationwide testing for cancer-causing hexavalent chromium, the latest response to a study that found the heavy metal in tap water from Chicago and more than two dozen other cities.

In a memo to public water systems, a top official at the U.S. Environmental Protection Agency encouraged quarterly or semi-annual testing for the metal, also known as chromium-6, which attracted worldwide attention from the movie “Erin Brockovich.”

The advice isn’t binding but could be one of the first steps toward national limits intended to reduce the cancer risk from years of exposure to contaminated water.

The EPA now limits and requires water testing only for total chromium, a standard that includes another form of the metal, the essential nutrient chromium-3. Critics say federal rules need to be strengthened to reflect studies that link chromium-6 to stomach cancer.

“EPA believes that the enhanced monitoring will enable public water systems to better inform their customers about the levels of chromium-6 in their drinking water,” Peter Silva, the agency’s assistant administrator for water, wrote in the memo.

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11 Ways to Live Well in 2011

Published on January 13, 2011 in News and Newsletter. 1 Comment

Jennifer LaRue Huget and Lenny Bernstein, Washington Post, January 11, 2011

1. Check QR codes

You’ll be seeing more of these postage-stamp-shaped “quick response” graphics in and around the grocery store in the coming year as retailers and food manufacturers learn how to put this relatively new technology to work. Using your bar-code-reading smartphone, you take a picture of the QR code to access extra information about the product at hand. Look for food packages to feature QR codes that, when scanned, yield nutrition facts and recipes.

2. Try an ElliptiGO

Do you love your elliptical trainer but wish you didn’t have to be stuck in the gym when the weather turns warm? The makers of this “elliptical exercise cycle,” which costs about $2,500, promise the same low-impact workout that many people now do instead of running, coupled with the speed, handling and pleasure of a bike ride. For more information, visit www.elliptigo.com

3. Get with the guidelines

By the time you read this, new dietary guidelines, revised for the first time since 2005, should be released. The Dietary Guidelines for Americans shape U.S. food policy, governing everything from school lunches to military provisions, and they are online at www.dietaryguidelines.gov for you to read. You may not agree with the departments of Agriculture and Health and Human Services’ recommendations, but they’re a great springboard for eating more healthfully. Be one of those well-informed Americans who actually reads the document.

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