HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, August 2, 2008

Proposed Bill Would Finalize Sunscreen Labeling Rules

The New York Times reports on the Sunscreen Labeling Protection Act of 2008 proposed Friday [August 1, 2008], which would compel the FDA to make final comprehensive rules on sunscreen.  The new sunscreen rules would require manufacturers to test the efficacy of the products against the sun’s longer-wavelength ultraviolet A rays, which also can damage skin. Sunscreen labels would be required to display both the familiar SPF number and a new rating for UVA protection.  Natasha Singer writes,

SunscreenTwo United States senators on Friday introduced a bill that would compel the Food and Drug Administration to make final comprehensive rules on sunscreen.

Last summer, the agency proposed updated rules that would standardize the labeling on sunscreens, giving consumers more detailed information about their efficacy. But the agency has not made the regulations final, which must happen before they can be implemented.

Senator Christopher J. Dodd, Democrat of Connecticut, said the agency appeared to be moving at a deliberately slow pace for the benefit of sunscreen manufacturers. “The delay is happening for economic reasons,” Senator Dodd said. “The F.D.A. knows better.

“It sounds like an industry reluctant to have a standard set because that may open the doors to insisting upon more accurate labels on certain other products as well.”

The proposed Sunscreen Labeling Protection Act of 2008, sponsored by Senator Dodd and Senator Jack Reed, Democrat of Rhode Island, would give the F.D.A. 180 days to make its own rules final. If the agency fails to do so within 180 days of enactment of the bill, the proposed rules would take effect.

“We hope the mere introduction of the bill will have the desired effect,” Senator Dodd said.

Rita Chappelle, a spokeswoman for the F.D.A., said, “As a federal agency, F.D.A. will continue to work to finalize the sunscreen rule as soon as possible for the American public.”

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August 2, 2008 | Permalink | Comments (0) | TrackBack (0)

L.A. Law May Keep Homeless in Hospitals

The Wall Street Journal reports on a Los Angeles city ordinance that will cut down on the number of hospitals dropping homeless patients onto skid row by making it a misdemeanor for health facilities to transport patients to places other than their residences without written consent.  Rhonda L. Rundle writes,

AmbulanceHospitals here have been shamed in recent years by reports some of them dumped homeless patients onto downtown's skid row before they were well enough to care for themselves. Now, hospitals caught in the act will be charged with a crime.

A new city ordinance, believed to be the first of its kind in the nation, makes it a misdemeanor for health facilities to transport a patient to a place other than his or her residence without written consent.

Hospital administrators fear that a conviction could trigger an automatic exclusion from government health programs, a financial blow few hospitals could survive. They also worry about the cost of keeping patients who are healthy enough to be discharged but have no place to go.

Homeless patients have at times received poor treatment by hospitals in other U.S. cities, but the issue has been particularly visible in Los Angeles because of documented reports of patients being dropped off at shelters. The issue achieved national attention after last year's Michael Moore film "Sicko" included video of an elderly woman apparently being dropped off by a taxi on the street while wearing little more than a hospital gown.

"The most important thing is to get culture change in the way that hospitals discharge patients," says a spokesman for Los Angeles City Attorney Rockard J. Delgadillo, whose office is investigating about 50 suspected dumping cases from before June 30, when the law took effect.

The Hospital Association of Southern California says it has asked an attorney to investigate whether the measure violates state law. The association is also seeking clarity from the federal agency that oversees Medicare on the consequences of a conviction.

Several hospitals have admitted failings in their procedures for homeless patients and say they have made changes. They say it has become increasingly difficult to discharge these patients because many refuse to leave.

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August 2, 2008 | Permalink | Comments (0) | TrackBack (0)

AIDS Infection Rate in U.S. Higher Than Previously Estimated

The Washington Post reports that the CDC has concluded that there are about 56,300 new HIV infections a year, not the 40,000 figure that has been used for over a decade.  These new numbers do not imply that the epidemic is increasing in the US, but rather showcase more accurate testing methods.  David Brown writes,

Red_ribbonUpdated federal estimates of the annual number of new HIV infections in the United States, released today, reveal that while the AIDS epidemic here is worse than previously thought, prevention efforts appear to be having some effect.

Even though the number of Americans living with HIV has risen by more than a quarter million people since 1998 -- largely the result of life-extending antiretroviral drugs -- the number of new cases each year has declined slightly over that period. That suggests that a person's likelihood of transmitting the virus to someone else is substantially lower now than it was a decade ago.

The new, if indirect, evidence that prevention programs are paying off was one of the few encouraging findings in an update on the American AIDS epidemic released today by the Centers for Disease Control and Prevention on the eve of the 17th International AIDS Conference, in Mexico City.

"Over 95 percent of people living with HIV are not transmitting to someone else in a given year," said David R. Holtgrave, an expert on AIDS prevention at the Bloomberg School of Public Health at Johns Hopkins University. "What that says is the transmission rate has been kept very low by prevention efforts."

Those include targeting public health messages to high-risk groups, promoting widespread AIDS testing, and getting quick medical care for newly diagnosed cases, which in most cases lowers the person's infectiousness.

The CDC spends about $750 million a year on AIDS prevention. The main finding of its report is that HIV incidence in 2006 -- the latest year for which data are available -- was 56,300 new cases of infection. That is 40 percent higher than the previous government estimate of 40,000, but statistical back calculation suggests that HIV incidence has been unchanged since about 2000.

The more accurate estimate was possible for two reasons. A new testing method lets researchers detect infections that are less than six months old more quickly than before. New federal regulations also are pushing states to collect data on new HIV infections and not just new AIDS diagnoses.

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August 2, 2008 | Permalink | Comments (0) | TrackBack (0)

Friday, August 1, 2008

Mexican Farm Tied to Salmonella Outbreak

The Washington Post reports that the salmonella outbreak initially link to raw tomatoes has been traced to a jalapeño and serrano pepper farm in Mexico.  Lawmakers yesterday began the first of two hearings on what went wrong in the investigation.  Annys Shin writes,

JalapenoA three-month-old salmonella outbreak initially linked to raw tomatoes has been traced to a jalapeño and serrano pepper farm in Mexico.

Investigators discovered the Salmonella saintpaul strain in irrigation water and in serrano pepper samples from the farm, which is in the northeastern state of Nuevo Leon partially bordering Texas. The Food and Drug Administration is now warning consumers not to eat raw serrano peppers, in addition to raw jalapeños.

"We have a smoking gun, it appears," Lonnie King, a director at the Centers for Disease Control, said yesterday.

The discovery of the outbreak strain on a farm does not answer all of the questions confronting investigators. But it will improve their chances of stopping the outbreak, which has sickened more than 1,300 people since April. It also gets them closer to a full explanation of an outbreak that stumped the nation's most experienced disease detectives and drew criticism from tomato growers and Congress about the FDA and CDC's handling of the case.

Lawmakers yesterday began the first of two hearings on what went wrong in the investigation, which was initially focused on tomatoes, and later expanded to include jalapeño and serrano peppers. They had summoned top FDA and CDC officials to testify.

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August 1, 2008 | Permalink | Comments (0) | TrackBack (0)

Amgen Told to Reword Drug Label

The New York Times reports that the FDA has ordered Amgen to change the labels for its anemia drugs, which could further restrict their use in treating patients with cancer.  This is the first time the FDA has invoked authority under a 2007 law that empowered it to order changes in a drug's prescribing information.  Andrew Pollack writes,

Amgen_suit_articleThe Food and Drug Administration has ordered Amgen to change the labels for its flagship anemia drugs in a way that could further restrict their use in treating patients with cancer.

The move, which the F.D.A. announced on Wednesday, represents the first time the agency has invoked authority under a 2007 law that empowered it to order changes in a drug’s prescribing information. Previously, the F.D.A. could only negotiate with a drug’s manufacturer to change the label.

Sales of the drugs, Aranesp and Procrit, have already plummeted in the last year because of studies suggesting that their use to treat the anemia caused by chemotherapy could actually make cancer worse or shorten lives. Procrit is manufactured by Amgen but sold under license by Johnson & Johnson.

Sales of Aranesp, generally considered Amgen’s flagship product, fell 13 percent in the second quarter from a year earlier, to $825 million, the company announced Monday in posting its quarterly results. In the United States alone, sales plunged 26 percent, to $427 million.

Yaron Werber, a biotechnology analyst at Citi Investment Research, estimated that the new label could reduce the use of Aranesp for cancer patients in this country — the drug is also used by people with kidney disease — by an additional 40 percent, further cutting annual sales by about $264 million.

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August 1, 2008 | Permalink | Comments (0) | TrackBack (0)

Scientists Create First Personalized Stem Cells in ALS Patients

The Los Angeles Times reports that researchers for the first time are able to reprogram cells from sick patients.  Though hurdles remain, such cells could be used to help screen drugs to treat the crippling disease.  Karen Kaplan writes,

Stem_cells2Scientists have created the first personalized stem cells for patients with a genetic disease by rewinding their skin cells to an embryonic state, according to a study published Thursday in the online edition of Science.

The researchers then converted some of those stem cells into the two kinds of brain cells that cause their crippling disease, amyotrophic lateral sclerosis, commonly known as Lou Gehrig's disease.

Stem cell experts said they were delighted -- though not surprised -- to see proof that the reprogramming technique worked on human cells from sick patients.

Previously, human versions of the so-called induced pluripotent stem cells had only been made from skin samples provided by healthy subjects.

"It is quite amazing and an important step that should allow the development of experimental and therapeutic interventions for this disease," said Kathrin Plath, a researcher at the Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, who was not involved in the study.

The new cells were derived from 3-millimeter patches of skin removed from the arm of an 82-year-old woman and her 89-year-old sister, who share a rare genetic mutation that causes about 2% of ALS cases.

The scientists from Harvard University and Columbia University focused on the rare form of ALS in part to test whether cells from elderly patients could be reprogrammed, said biologist Kevin Eggan of the Harvard Stem Cell Institute.

"This opens the door to being able to make patient-specific stem cell lines from diseases which affect people very late in life, like Parkinson's disease or Alzheimer's disease," said Eggan, the study's senior author.

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August 1, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, July 31, 2008

House Votes to Regulate Tobacco as a Drug

The New York Times reports that the House of Representatives has approved legislation giving the FDA power to regulate tobacco products.  Stephanie Saul writes,

CigaretteDecades after the surgeon general first warned that cigarettes were a health hazard, the House of Representatives overwhelmingly approved legislation on Wednesday that would for the first time give the Food and Drug Administration the power to regulate tobacco products.

Citing the long history of warnings about the dangers of smoking, Representative John D. Dingell, chairman of the Energy and Commerce Committee, said that it was hard to believe that the federal government had not yet regulated the tobacco industry.

“With this legislation, we change this,” said Mr. Dingell, a Michigan Democrat.

The White House has signaled its opposition to the bill. And while the legislation has strong support in the Senate, which could take up the measure this fall, it is not clear whether the bill has a veto-proof majority there.

The show of support in the House, which passed the bill by a vote of 326 to 102, illustrated not only the strength of antismoking sentiment in the country but the benefit of enlisting a powerful ally. The legislation was partly the result of negotiations with Philip Morris USA, the nation’s largest cigarette company, which split with other companies by endorsing it.

Most large public health groups supported the measure — and its passage was applauded by groups including the American Lung Association and the American Heart Association — but some antismoking advocates said the bargain struck with Philip Morris gave too many concessions to the industry.

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July 31, 2008 | Permalink | Comments (0) | TrackBack (0)

Judge's Ruling Throws Southern California Power Plant Plans into Disarray

The Los Angeles Times reports that a Los Angeles County Superior Court judge ruled Tuesday [July 29, 2008] that thirteen proposed electricity-generating power plants cannot be built without the necessary environmental and health analyses.  Margot Roosevelt writes,

Electric_power_plant2Does Southern California need a dozen or so new gas-fired power plants -- and if it does, can it build them? No one seems to know for sure.

The region's long-term plans to generate electricity to serve a growing population and to replace decades-old dirty plants were thrown into disarray this week, when a Los Angeles County Superior Court judge ruled Tuesday that local authorities had failed to do the necessary environmental and health analyses.

Officials from the South Coast Air Quality Management District, which encompasses Orange County and large swaths of Los Angeles, San Bernardino and Riverside counties, warned of likely "blackouts and brownouts" if the plants are not built.

Many of the plants, such as a 914-megawatt generator sponsored by the small industrial city of Vernon, would be in low-income, crowded areas that have high rates of asthma and other pollution-related diseases. Though they would be outfitted with the latest in pollution-control technology, the gas-fired generators would emit thousands of tons of fine soot particles, which are linked to cancer, heart disease and other illnesses.

The court decision is "a victory for the health of our children," said Lucy Ramos, a Boyle Heights middle-school aide and president of Mothers of East L.A., a group that has been fighting the Vernon plant. "Our community is not a dumping ground."

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July 31, 2008 | Permalink | Comments (0) | TrackBack (0)

Grassley, Dingell Lead Calls for Overhauling FDA

The Wall Street Journal reports that several of this year's crises like the salmonella outbreak have led some members of Congress to scrutinize the FDA and propose giving it broader powers. Alicia Mundy writes,

Fda1Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising.

Leading the drive are Rep. John Dingell (D., Mich.) and his longtime friend in Congress, Sen. Chuck Grassley (R., Iowa). A series of crises during the past year, including deaths linked to tainted Chinese-made blood thinners and cases of salmonella linked to jalapeño peppers, have given ammunition to the lawmakers, both longtime critics of the FDA.

A House subcommittee led by Mr. Dingell plans a Thursday hearing on the FDA's response to the salmonella outbreak. Mr. Dingell called it a "disaster." Among those hurt were tomato growers, who lost millions of dollars during the month that their products were thought to be the culprit.

Congress isn't likely to enact major changes to the agency this  year because it has only a brief fall session before the November elections, but 2009 may bring the most significant overhaul at the FDA in a generation if Messrs. Dingell and Grassley get their way.

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July 31, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, July 30, 2008

Efforts Against AIDS Among African Americans Criticized

The Washington Post reports that the Black AIDS Institute criticized the federal government yesterday [July 29, 2008] of doing too little to fight AIDS among African Americans in the US.  Bush is scheduled to sign a bill today that will extend the program and authorize the spending of $48 billion for the next five years to twelve countries in Africa, Guyana, Haiti, and Vietnam.  David Brown writes,

Red_ribbonA prominent AIDS organization accused the federal government yesterday of doing too little to fight AIDS among black Americans, in whom the size and scope of the epidemic resembles that seen in many African nations.

In a 55-page report, the Black AIDS Institute argued that the disease should be viewed as a threat to the entire black population, and not just specific high-risk groups. Unlike in white Americans -- and in the citizens of most industrialized nations -- HIV in American blacks is increasingly transmitted heterosexually through "networks" where men especially have many sex partners at the same time, the report noted.

The report's authors asserted that the black AIDS epidemic here is being overlooked as the United States is allocating unprecedented resources to fighting the disease in sub-Saharan Africa.

African Americans with HIV -- at least 500,000 -- are more numerous than in seven of the 15 "target countries" in the Bush administration's global AIDS initiative, which has spent about $19 billion overseas in the past five years.

President Bush is scheduled to sign a bill today that will extend the program and authorize the spending of $48 billion for the next five years. The target countries consist of 12 in Africa and three others: Guyana, Haiti and Vietnam.

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July 30, 2008 | Permalink | Comments (0) | TrackBack (0)

New Arthritis Drug Gets Approval Recommendation

The Washington Post reports on the recently approved drug Actemra, a new treatment for rheumatoid arthritis.  Ricardo Alonso-Zaldivar writes,

Hand_xrayA government advisory panel Tuesday recommended approval of the drug Actemra, promoted as a new type of treatment for rheumatoid arthritis, a painful and disabling swelling of the joints generally kept in check with medication.

The Hoffmann-La Roche, Inc. drug is already being used in Japan, and the Food and Drug Administration must now decide whether to give its approval for patients in the United States. Actemra's effectiveness was not in dispute, but some of its side effects raised questions. Nonetheless, the vote was 10-1 in favor of approval, and the agency generally follows the recommendations of its advisors.

While the most common form of arthritis comes from wear and tear on the joints as people age, rheumatoid arthritis is an immune system disorder in which the body turns on itself, attacking the joints. Known as "RA," it affects about 2.5 million Americans and usually strikes in early adulthood or middle age. Women are much more likely to suffer from the condition, which can lead to disability and an early death if untreated.

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July 30, 2008 | Permalink | Comments (0) | TrackBack (0)

EPA Says Clean-Air Ruling Threatens Health

The Wall Street Journal reports that on Tuesday [July, 29, 2008], the US Court of Appeals for the District of Columbia Circuit struck down the Clean Air Interstate Rule, which sought to reduce smog-forming and soot-producing emissions that contribute to respiratory illnesses by allowing companies that exceed their emissions caps to buy allowances from companies that do not. The EPA had predicted that the rule would prevent about 17,000 premature deaths a year.  Stephen Power and Mark Peters write,

Car_fumesA federal court's decision to strike down the Bush administration's signature clean-air program threatens public health by encouraging companies to slow their pollution-control efforts, a top Environmental Protection Agency official told Congress.

Prospects for a legislative fix are clouded by a dispute between Democrats and Republicans over whether new pollution legislation should cover carbon dioxide, the main global-warming gas.

Separately Tuesday, four Democratic senators asked the Justice Department to investigate whether the EPA's administrator, Stephen Johnson, made false statements to Congress when he testified earlier this year that his 2007 decision to block California from regulating automobile greenhouse-gas emissions was his alone and not directed by the White House.

A White House spokesman accused Democrats of "throwing stones." A spokesman for Mr. Johnson defended the administrator's comments to Congress as being truthful and said Mr. Johnson's overall record was one that promoted "aggressive, health-protective environmental standards."

The matter occupying more senators' attention Tuesday was a decision earlier this month by the U.S. Court of Appeals for the District of Columbia Circuit that struck down the Clean Air Interstate Rule. The regulation, announced in 2005 and covering more than two dozen, mostly Eastern, states, sought to bring about major reductions in smog-forming and soot-producing emissions that contribute to respiratory illnesses by instituting a "cap and trade" system in which companies that exceed their emissions caps can buy allowances from companies that do not. The EPA had predicted that the rule would prevent about 17,000 premature deaths a year.

In response to a court challenge brought by some power companies, the court invalidated the regulation, saying the agency had overstepped its authority.

July 30, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, July 29, 2008

A Call for a Warning System on Artificial Joints

The New York Times reports that because the US lacks a national database tracking artificial joints, the risk in the US that a patient will need a replacement procedure because of a flawed product or technique can be double the risk of countries with databases.  Barry Meier writes,

Artificial_jointsDr. Lawrence Dorr, a nationally known orthopedic surgeon in Los Angeles, realized last year that something was very wrong with some of his patients.

Months after routine hip replacements, patients who had expected to live without pain were in agony. “The pain was grabbing me around the back,” said Stephen Csengeri, who is 54, and a lawyer from Torrance, Calif.

Dr. Dorr found he had implanted the same metal hip socket in each patient. Several needed surgery again — a replacement for their replacement.

The doctor first told the device’s manufacturer, Zimmer Holdings, last year about his concerns but nothing happened. Then in April, Dr. Dorr, who was a highly paid consultant for Zimmer, sounded an alarm to colleagues in a professional association and soon heard back from doctors with similar experiences.

“I saw one of Zimmer’s engineers at a meeting, and I told her that you should pull this cup because you are crippling patients,” Dr. Dorr said.

Last week, Zimmer announced it was suspending sales of the device, known as the Durom cup, until it trained doctors how best to implant it. The company said a “low” percentage of the 13,000 patients who got the socket would need replacements, but some doctors fear the number could reach into the hundreds.

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July 29, 2008 | Permalink | Comments (0) | TrackBack (0)

Doctor and Patient, Now at Odds

The New York Times reports on an alarming study from Johns Hopkins finding that one out of four patients are skeptical of their physicians.  This distrust seems to stem from a system based on impersonal care and declining reimbursements. Tara Parker-Pope writes,

DoctorpatientA growing chorus of discontent suggests that the once-revered doctor-patient relationship is on the rocks.

The relationship is the cornerstone of the medical system — nobody can be helped if doctors and patients aren’t getting along. But increasingly, research and anecdotal reports suggest that many patients don’t trust doctors.

About one in four patients feel that their physicians sometimes expose them to unnecessary risk, according to data from a Johns Hopkins study published this year in the journal Medicine. And two recent studies show that whether patients trust a doctor strongly influences whether they take their medication.

The distrust and animosity between doctors and patients has shown up in a variety of places. In bookstores, there is now a genre of “what your doctor won’t tell you” books promising previously withheld information on everything from weight loss to heart disease.

The Internet is bristling with frustrated comments from patients. On The New York Times’s Well blog recently, a reader named Tom echoed the concerns of many about doctors. “I, as patient, say stop acting like you know everything,” he wrote. “Admit it, and we patients may stop distrusting your quick off-the-line, glib diagnosis.”

Doctors say they are not surprised. “It’s been striking to me since I went into practice how unhappy patients are and, frankly, how mistreated patients are,” said Dr. Sandeep Jauhar, director of the heart failure program at Long Island Jewish Medical Center and an occasional contributor to Science Times.

He recounted a conversation he had last week with a patient who had been transferred to his hospital. “I said, ‘So why are you here?’ He said: ‘I have no idea. They just transferred me.’

“Nobody is talking to the patients,” Dr. Jauhar went on. “Everyone is so rushed. I don’t think the doctors are bad people — they are just working in a broken system.”

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July 29, 2008 | Permalink | Comments (0) | TrackBack (0)

Rapid Rise Seen in Fatal Medication Errors at Home

The Washington Post reports on a study that documents the rise in deaths from abuse of prescription drugs and inattentiveness to taking medications at home such as overdosing, mixing alcohol with medications, and sharing medications.  However, this dramatic increase in deaths may be partly due to better coding location on death certificates. Carla K. Johnson writes,

Deaths_from_medication_mistakesDeaths from medication mistakes at home, like actor Heath Ledger's accidental overdose, rose dramatically during the past two decades, an analysis of U.S. death certificates finds.

The authors blame soaring home use of prescription painkillers and other potent drugs, which 25 years ago were given mainly inside hospitals.

"The amount of medical supervision is going down and the amount of responsibility put on the patient's shoulders is going up," said lead author David P. Phillips of the University of California, San Diego.

The findings, based on nearly 50 million U.S. death certificates, are published in Monday's Archives of Internal Medicine. Of those, more than 224,000 involved fatal medication errors, including overdoses and mixing prescription drugs with alcohol or street drugs.

Deaths from medication mistakes at home increased from 1,132 deaths in 1983 to 12,426 in 2004. Adjusted for population growth, that amounts to an increase of more than 700 percent during that time.

In contrast, there was only a 5 percent increase in fatal medication errors away from home, including hospitals, and not involving alcohol or street drugs.

Abuse of prescription drugs plays a role, but it's unclear how much. Valid prescriptions taken in error, especially narcotics such as methadone and oxycodone, account for a growing number of deaths, said experts who reviewed the study.

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July 29, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, July 28, 2008

Should Genetic Tests Be Regulated?

Time magazine reports that although a federal advisory committee in April recommended increasing federal regulation of genetic testing and creating a mandatory online registry of all laboratory genetic tests performed, no action has been taken yet.  Sarah Lynch questions whether genetic tests should be regulated in this booming industry.  Lynch writes,

Genetic_testing6When the human genome was decoded and the achievement breathlessly announced in 2003, a new race was launched: Who would be the first to make this trove of genetic information practically useful — and profitable?

So far, at least 30 direct-to-consumer testing companies have answered the call, analyzing genetic information for curious consumers at anywhere from several hundred to several thousand dollars a pop. (One company charges $350,000 for whole-genome sequencing.) The services range from paternity and ancestry tests to risk assessments for specific diseases, such as breast cancer and Type 2 diabetes. Some tests look for single genes associated with disorders (baldness, in the case of HairDX); others, like 23andMe, one of the industry leaders, use a DNA chip to scan the entire genome in search of single nucleotide polymorphisms, or SNPs — genetic variants that help determine risk for disease or likely traits such as eye color.

Currently this booming direct-to-consumer industry operates with little federal oversight and few industry guidelines. But the popularity of the genetic tests has snared the attention of state and federal regulators. A report released by a federal advisory committee in April recommended increasing federal regulation of the tests and creating a mandatory online registry of all laboratory genetic tests performed, but no action has yet been taken.

Meanwhile, representatives of leading companies, including 23andMe, Navigenics, deCODE Genetics and DNA Direct, have stepped into the void, launching discussions this month in Washington to devise their own voluntary standards, which they expect will promote integrity among their competitors. The companies said they will collaborate with the Personalized Medicine Coalition (PMC), an educational nonprofit, to create the guidelines. They plan to present a draft of the new rules at a PMC conference in December, says Edward Abrahams, PMC's executive director.

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July 28, 2008 | Permalink | Comments (0) | TrackBack (0)

What Can Genetic Tests Tell You?

Time magazine interviews Linda Avey, co-founder of a genetic-testing company, about some of the misconceptions with the industry and how helpful genetic testing can be for a person. writes,

Linda_aveyIf you'd like to know your lifetime risk of Type 2 diabetes or whence your forebears came, there's probably a Web-based genetic-testing company out there that can tell you. Most of them require just a visit to the website, a credit-card number and your spit sample sent in the mail. But the question is, How helpful is the information you receive? How accurate? The science behind these tests is still so new that some health regulators and medical professionals are questioning their validity and their practical utility.'s Sarah N. Lynch recently sat down with Linda Avey, co-founder of one of the industry's leaders, 23andMe, based in Mountain View, Calif.

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July 28, 2008 | Permalink | Comments (0) | TrackBack (0)

Fitter Alzheimer's Patients Had Less Brain Damage

The Washington Post reports on a study that showed less shrinkage in the hippocampus region of Alzheimer's patients' brains with higher fitness scores.  Exercise and physical fitness have been shown to slow age-related brain cell death in healthy older adults.  The Washington Post writes,

AlzheimersPatients in the early stages of Alzheimer's disease who performed better on a treadmill test had less atrophy in the areas of the brain that control memory, according to a study released Sunday.

Magnetic resonance imaging (MRI) showed less shrinkage in the hippocampus region of patients' brains in the Alzheimer's patients with higher fitness scores. In Alzheimer's the hippocampus is one of the first parts of the brain to suffer damage.

Exercise and physical fitness have been shown to slow age-related brain cell death in healthy older adults.

The new study was released at the International Conference on Alzheimer's Disease in Chicago. Researchers at the University of Kansas Medical Center in Kansas City, Kan., studied the connection between cardiorespiratory fitness and regional brain volume in more than 100 people over 60. About half were healthy older adults and half were in the early stages of Alzheimer's.

In a statement, lead researcher Robyn A. Honea said the study suggests "that maintaining cardiorespiratory fitness may positively modify Alzheimer's-related brain atrophy."

But it isn't clear whether exercise helped avoid brain damage or if brain-damaged people had less ability to exercise.

The study was funded by the National Institute on Aging and National Institute on Neurological Disorders and Stroke

July 28, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunday, July 27, 2008

Weight Drives the Young to Adult Pills, Data Says

The New York Times reports on the alarming increase of children experiencing problems such as Type 2 diabetes, high blood pressure, high cholesterol, and acid reflux that were unheard of in children two decades ago.  Doctors continue to debate on whether to keep prescribing adult medications to children as a quick fix to lack of exercise and improper diet or because of society and environment.  Stephanie Saul writes,

Pills3A growing number of American children are taking drugs for a wide range of chronic conditions related to childhood obesity, according to prescription data from three large organizations.

The numbers, from pharmacy plans Medco Health Solutions, Express Scripts and the marketing data collection company Verispan, indicate that hundreds of thousands of children are taking medication to treat Type 2 diabetes, high blood pressure, high cholesterol and acid reflux — all problems linked to obesity that were practically unheard-of in children two decades ago.

The data, disclosed publicly in recent months or provided at the request of The New York Times, shows that concerns that children will be taking adult medications — heightened recently by a controversial recommendation by a national pediatricians group — are already a reality.

This month, the American Academy of Pediatrics said that more children, as young as 8, should be given cholesterol-lowering drugs. The recommendation was quickly attacked by some experts as a license to put children on grown-up drugs.

While the drugs do help treat the conditions, some doctors fear they are simply a shortcut fix for a problem better addressed by exercise and diet. Even so, some pharmaceutical companies are developing new versions, including flavored ones, of adult medications for children.

While some of the percentage increases in the three analyses are significant, doctors emphasize that prescriptions of these drugs to children still represent less than 1 percent of their sales.

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July 27, 2008 | Permalink | Comments (0) | TrackBack (0)

CDC: ADHD Increasing in Older Kids

Time magazine reports that a government study released July 23, 2008 concludes that the percentage of older children diagnosed with ADHD has been rising by 4% each year. However, these results may not indicate a growing problem with adult concentration, but rather the misuse of ADHD medications as study aides and recreational stimulants.  Mike Stobbe writes,

RitalinMore older children are being diagnosed with attention deficit hyperactivity disorder while the rate is holding steady for children under 12, according to a government report released Wednesday.

Some experts called the finding surprising, noting that most childhood diagnoses traditionally occur by age 11.

The study didn't investigate why the increase in one age group was so much higher than the other. It found the%age of older children diagnosed with ADHD has been rising by 4% each year.

Some experts say the increase may reflect that doctors are increasingly considering the possibility of ADHD in older kids who have concentration problems — a trend that coincides with the marketing of ADHD medications to teens and adults.

The finding may also reflect the misuse of Ritalin and other ADHD medications in that age group as study aides and recreational stimulants, some experts speculated.

"There are people out there being treated for ADHD that probably don't meet the diagnostic criteria," said Scott Kollins, director of Duke University Medical Center's ADHD Program.

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July 27, 2008 | Permalink | Comments (0) | TrackBack (0)