Health’s Blog

Middle-aged men, many women and the elderly are routinely put on the powerful drugs to lower high cholesterol. Now the nation’s leading pediatric group says that certain high-risk children as young as 8 may also be put on statin therapy, just like Mom, Dad and Grandpa.

The new guidelines from the American Academy of Pediatrics have been sharply criticized by many pediatricians and parents. They worry about the long-term health consequences of the drugs and have raised questions about financial ties between the academy and drug companies. There is also concern that the guidelines could lead to more widespread use of the drugs among children. An estimated 13 percent of children have total cholesterol above 200 milligrams per deciliter, the threshold used in adults to determine high cholesterol.

But the doctors who wrote the guidelines say they have been largely misunderstood. They say that far from leading to widespread use of statin drugs by children, the guidelines target the small percentage of children with genetic cholesterol problems or those with several worrisome risk factors, like obesity, high blood pressure and diabetes.

“I don’t see this as a major groundswell for the indiscriminate use of lipid-lowering drugs,” said Dr. Stephen Daniels, a member of the A.A.P.’s nutrition committee and chairman of the department of pediatrics at the University of Colorado Denver School of Medicine. “That’s exactly why we need these guidelines, to say where the limits of that usage should be.”

It’s not clear how many children will be affected. About 1 in 500 have genetic cholesterol disorders, and doctors estimate that currently, about 30 percent to 60 percent of those children haven’t had a diagnosis. Over all, only about 5 percent of children have levels of LDL, or “bad” cholesterol, above 130. Drug therapy would be suggested for children with bad cholesterol of 130 only if they have diabetes. Otherwise, drugs would be recommended for those with bad cholesterol of 160 and a family history of heart disease or two other risk factors, or when bad cholesterol hits 190.

Already five statin drugs — Bristol-Myers Squibb’s Pravachol, Pfizer’s Lipitor, Merck’s Zocor and Mevacor, and Novartis’s Lescol — have been approved for use in children with genetic cholesterol disorders. But there is little data on long-term use.

“People should realize that these drugs have only been studied in children with a genetic defect that causes very high cholesterol levels,” said Dr. Dianne Murphy, director of the Food and Drug Administration’s office of pediatric therapeutics, who noted that those children were followed for only two years.

Some doctors say the short-term data on statin use in children is reassuring and mirrors long-term safety data in adults. “The concept is that prevention should start early,” said Dr. Daniels. “You already have children who have risk factor levels that would be a concern for an adult.”

But the lack of long-term data has caused concern among many pediatricians, who say children often metabolize drugs differently than adults.

Dr. Darshak Sanghavi, a pediatric cardiologist at the University of Massachusetts Medical School, said statin drugs may affect a child’s endocrine system, which regulates growth and development, among other things. “I, for one, feel unsafe simply saying children are little adults in this case,” he said.

The medical literature is filled with examples of mistakes made when medical experts extrapolated data from one group to another. For years, doctors assumed that since menopause hormones appeared to protect the hearts of middle-aged women, then older women would benefit even more. But when the issue was studied in the large Women’s Health Initiative trial, older women on hormones turned out to have a far higher risk for heart attack and stroke.

The new guidelines have raised questions about the pharmaceutical industry’s ties to both the A.A.P. and the members of the group’s nutrition committee that made the recommendations. But the A.A.P. asserted last week that “there is no involvement by any commercial entity in the development of any statement or report” it issues.

Reports filed with the Internal Revenue Service and provided by the A.A.P. show that the academy has received contributions from several companies with ties to statins, including $433,000 from Merck, $835,250 from Abbott Laboratories’ Ross Product Division and $216,000 from the Bristol-Myers Squibb company Mead Johnson Nutritionals. The biggest statin maker, Pfizer, is not listed as a contributor. The A.A.P. reported a total of $81 million in revenue in 2007.

Three committee members have disclosed industry ties. Dr. Daniels was a one-time consultant for Merck and has also worked for Abbott Laboratories, although not on cholesterol drugs. Dr. Nicolas Stettler of the Children’s Hospital of Philadelphia took part in clinical trials for Merck’s Mevacor and a failed Pfizer cholesterol drug. Dr. Jatinder Bhatia, chief of neonatology at the Medical College of Georgia in Augusta, couldn’t be reached for comment, but in earlier disclosure statements he listed financial relationships with Bristol-Myers Squibb’s Mead Johnson unit, Abbott’s Ross Products and Dey Laboratories, which is affiliated with Merck.

Two committee members — Dr. Frank Greer, the committee chairman and a neonatologist at the University of Wisconsin, Madison; and Dr. Marcie Schneider, a pediatrician in Norwich, Conn. — said they had no financial relationships with the drug industry. Two others could not be reached for comment.

But the notion that the A.A.P. recommendations will turn into a bonanza for the drug industry — at least in the short term — is unlikely. Because five statins have already been approved for pediatric use, and most of the drugs have already gone off patent or are nearing the end of their patents, additional growth opportunities for the existing branded drugs are limited.

Regardless, many in the pediatrics community appear ready to resist the notion of putting children on statin therapy. Dr. Barney Softness, associate professor of pediatric endocrinology at Columbia University’s College of Physicians and Surgeons, who regularly treats diabetic children, said he would be reluctant to prescribe a statin to a child. He notes that he himself stopped taking the statin Lipitor because of muscle aches.

“There’s no data yet on long-term safety and efficacy studies in children,” Dr. Softness said. “I just don’t think the drug is benign enough to take the chance on some long-term side effects.”

NICOLA Sturgeon must think that Christmas has come early. Having seen her counterparts in England given a rough ride from the medical professions, she could not have imagined that she would have received such a welcome from doctors at the British Medical Association conference in Edinburgh earlier this week: two standing ovations and enthusiastic rounds of applause.
It is just as well for her that doctors are so opposed to private sector involvement in the NHS – almost as much as the Scottish National Party is.

Doctors continued praising the Scottish health secretary long after she had left the building. “She was on top of her subject, she showed she had a sense of humour and she said what doctors wanted to hear,” one medic said. Another added: “I thought she was extremely positive. She realises that the privatisation issue is a worry for GPs and has made it clear that she does not want that here.”

And another Christmas present seems to have arrived for the SNP’s deputy leader. Some thought it strange that Tuesday’s question and answer session with Ms Sturgeon did not hear any questions about the much-hated extended hours policy to increase access to GPs in the evenings and at weekends.

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“The ACL is one of the ligaments in the center part of the knee that stops the shin bone from sliding forward,” explained Dr. Derek K. Lichota, an assistant professor of surgery at Texas A & M Health Science Center College of Medicine and a sports medicine physician at Scott & White. “When you rupture it, the majority of patients’ knees become unstable so, routinely, especially for young, active people, we recommend reconstruction.”

The choices for reconstruction include a ligament from the patellar-tendon bone, the hamstring tendons or a ligament from a cadaver.

For this study, 64 patients aged 40 or older who had undergone ACL reconstruction with a replacement ligament from a cadaver were followed for at least two years.

Almost one-quarter (23.4 percent) of the reconstructions failed, meaning the patient had to undergo a second reconstruction because of additional injury, graft failure or low scores on a test of function.

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WASHINGTON, DC, July 8, 2008 (ENS) - Officials in the White House and Vice President Dick Cheney’s office pressured federal health and environmental officials to edit congressional testimony to downplay the public health impacts of climate change, according to a former senior official with the U.S. Environmental Protection Agency.

Senior Senate Democrats contend the allegations of Jason Burnett, the EPA’s former top climate advisor, add to evidence of a concerted effort by the Bush administration to mislead the public about the risks of climate change and to prevent the EPA from regulating greenhouse gases.

“This cover-up is being directed from the White House and the Office of the Vice President,” said Senator Barbara Boxer, a California Democrat who chairs the Senate Environment and Public Works Committee. “History will judge this Bush administration harshly for recklessly covering up a real threat to the people they are supposed to protect.”

Boxer held a press briefing today to release a July 6 letter from Burnett, an economist who initially worked at the EPA from 2004 through 2006 before resigning due to disagreements over an air pollution rule.

A rare Democrat within the Bush administration, Burnett agreed in 2007 to return to the agency as a climate advisor.

Burnett resigned last month in protest over the EPA’s decision to block California from setting limits on greenhouse gas emissions from automobiles. Under the Clean Air Act, California has the unique power to enact stricter clean air laws than the federal government, but only if the EPA issues a waiver of federal standards. Once California has its waiver, other states can adopt the stricter standard. EPA Administrator Stephen Johnson has declined to issue the waiver, and California has sued seeking to secure it from the federal agency.

After his resignation, Burnett announced his intention to campaign for Democratic presidential candidate Senator Barack Obama of Illinois.

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The work by Harvard University, published in the journal Cell, boosts the prospect of similar treatments for people with the condition one day.

There is no cure for the disease, which is inherited and causes rapid and progressive weakening of muscle tissue.

About 1 in every 20,000 births in the UK are affected by muscular dystrophy.

The idea behind stem cell therapy is to find a way to boost the body’s ability to replace or produce new tissues.

Stem cells can have the ability to form a wide variety of tissue types, and the Harvard team focused on adult muscle stem cells, which specialise in generating new muscle cells in response to growth or injury.

They bred mice which have a faulty dystrophin gene, the same problem which causes Duchenne MD in humans.

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July 11, 2008 — If you are staring down a serious disease, where would you go for the best medical treatment and care?

U.S. News & World Report is out with its “best hospitals” list, and Johns Hopkins in Baltimore has the highest ranking.

An independent research firm looked at data on 5,453 medical centers to come up with this year’s specialty rankings. Only 170 hospitals were ranked in one or more specialties and just 19 of those reached “honor roll” status.

Some hospitals received the same rank; they are listed together.

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Sperm DNA quality is known to be tied to decreased embryo quality, low embryo implantation rates, higher miscarriage rates and some serious childhood diseases, including cancers.

“We found a class of compounds known as advanced glycation end products (AGEs) in the male reproductive tract. These are formed as the result of glycation (the addition of sugar),” Mallidis said, “and accumulate during normal aging. They are dependent on lifestyle, diet, smoking, etc., and in many diabetic complications are centrally implicated in DNA damage. We believe that they play a similar role in the male reproductive system.”

The researchers plan to now determine how AGEs cause and contribute to DNA damage.

Obesity, which often plays a factor in diabetes, and being too thin, was also found to cause problems with sperm. In a separate study, scientists found that men with a higher body mass index (BMI, a ratio of weight to height) had less seminal fluid and more abnormal sperm.

The findings showed that men with an optimal BMI of 20 to 25 had higher levels of normal sperm than those who were either overweight or underweight. They also had higher semen volume.

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THE Surtees Arms owes its name to the widespread County Durham family, the most notable of which is Robert Smith Surtees, who became Lord High Sheriff of Durham in 1856.

Originally from Hamsterley Hall, near Burnopfield, he created the character Jorrocks, the sporting cockney grocer, firstly in the New Sporting Magazine (1831) and developed further in rollicking novels about country life and foxhunting which have drawn comparison with Dickens.

He was a friend and admirer of Ralph Lambton, whose great interest was hunting around Sedgefield. Further information at www.r.s.surteessociety.org

THE PUB on the street has a yard at the back. The yard at the back has a micro-brewery in an outhouse. The micro-brewery in the outhouse serves the pub over the yard. Let’s call it the Yard of Ale Brewery.

Simple reasoning, nice pub, super micro, fantastic beer, lovely people. The Surtees Arms in Ferryhill, County Durham, was bought in February 2007 by Alan and Susan Hogg with a note in their business plan that in-house brewing would be up and running within two years.

Even allowing for delays in planning permission, observing rules and following regulations, they have achieved their goal with time to spare. Yard of Ale is brewing once a week and can spare enough to sell to eager customers across the county.

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A leading U.S. trailer manufacturer failed to disclose to Hurricane Katrina evacuees or the government its internal findings that formaldehyde in some units exceeded a federal health standard by as much as 45 times in 2006, its chairman acknowledged to Congress yesterday.

Jim Shea, chairman of Gulf Stream Coach, which built 50,000 trailers for the Federal Emergency Management Agency for $520 million, said his company decided that its results were “irrelevant information” because FEMA already knew about high formaldehyde levels. The agency and the company were working together to improve ventilation, he said, and FEMA later turned down company offers to conduct more tests.

In hindsight Gulf Stream should have shared information from its sampling, Shea said. “Anything that would have been helpful to public health in any kind of way with this in retrospect, we would have loved to have been able to shed more light on it,” he said.

The testimony came as Democrats and Republicans on the House Committee on Oversight and Government Reform clashed over builders’ responsibility for the housing debacle that unfolded after the August 2005 storm, raising both public health alarms along the Gulf Coast and doubts about how the government will house Americans in future emergencies.

The U.S. Centers for Disease Control and Prevention recommended this winter that all Katrina trailer residents be moved to safer housing after finding elevated formaldehyde levels in 42 percent of trailers. Four companies — Gulf Stream, Forest River, Keystone and Pilgrim International — were identified as having significant problems.

Appearing under oath, executives of those companies each acknowledged CDC findings that some of their products contained unsafe levels of formaldehyde, a common industrial chemical used in glues to make particle board and plywood. It has been linked to cancer and higher rates of respiratory illness.

But company officials and some GOP lawmakers blamed the federal government for failing to set any binding indoor air-quality standards for formaldehyde in trailers or any other U.S. housing. Republicans from Indiana, where the recreational vehicle industry is based, defended builders’ records and integrity.

“The problem was and remains confusion among federal agencies, not some conspiracy among trailermakers,” said ranking committee Republican Rep. Tom Davis (Va.).

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Monogram Biosciences Inc. said it will make its HERmark breast cancer assay available to doctors throughout the United States starting July 15.

The announcement by South San Francisco’s Monogram (NASDAQ:MGRM) came as the Food and Drug Administration approved a genetic test to determine which breast cancer patients are good candidates for treatment with Genentech Inc.’s drug Herceptin.

That test, SPOT-Light, is made by Invitrogen Corp. (NASDAQ:IVGN) of Carlsbad and could go head-to-head against Monogram’s test.

A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells to tell them when to grow, divide and make repairs. Patients with breast cancer may have more copies of the HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide too quickly.

Monogram’s test, which costs $3,350, quantifies HER2 total protein levels. It would replace other diagnostic tests that look at gene amplification.

Invitrogen’s test measures the number of copies of the HER2 gene.

The various tests are used to determine if breast cancer patients should be treated with Herceptin, which targets HER2 protein production, chemotherapy or a combination of Herceptin and chemotherapy.

The company said that as many as 15 percent to 20 percent of patients determined by conventional technologies to be HER2-negative would be reclassified by HERmark.

HERmark, according to Monogram, has been validated by the Clinical Laboratories Improvement Act, or CLIA, which establishes quality standards for all laboratory testing. CLIA is administered by the Centers for Medicare & Medicaid Services.