Energy drinks' caffeine in line with coffee

Despite such speedy-sounding names as "Full Throttle," "Amp" and "Rush," energy drinks pack a punch that is generally no stronger than coffee, according to a report released on Monday. A comparison of 12 popular energy drinks, published in the September issue of Consumer Reports, found that the caffeine in 8 ounces of various brands ranged from 50-145 milligrams (mg), though most were in the 75- to 80-mg range.

Results were rounded to the nearest 5 mg. By comparison, the caffeine in an 8-oz cup of brewed coffee can range from 65-120 mg, with an average of 85 mg, according to the National Coffee Association. The least-caffeinated energy drink Consumer Reports tested was the fruit punch-flavored offering by Target Corp.'s private label Archer Farms, with 50 mg. At the high end was the lemon-lime flavored Celsius with 145 mg.

Market-leading Red Bull had 80 mg of caffeine. Sobe No Fear, owned by PepsiCo Inc., had 85 mg of caffeine. Amp had 75 mg of caffeine, while Rush and Coca-Cola Co.'s Full Throttle both had 80 mg.

Jamie Kopf Hirsh, associate editor at Consumer Reports and the report's author, said it was "good news" that energy drinks were not much more caffeinated than coffee, but said consumers should still be cautious.

Even though 8 ounces is the standard serving size for measuring, most containers have more than that, and most consumers drink more than that.

"You don't have to be alarmed by this, you just have to account for it in your daily caffeine intake," Hirsh said, adding that energy drinks, with their graphic video-game-like logos that appeal to young men, could be "coffee for the new generation."

source : news.yahoo.com

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Diabetes drug side effect reports triple

In the month after a surprising analysis revealed possible heart risks from the blockbuster diabetes drug Avandia, reports of side effects to federal regulators tripled.

The sudden spike is a sign that doctors probably were unaware of the drug's possible role in their patients' heart problems and therefore may not have reported many such cases in the past, several experts said.

It also shows the flaws of the safety tracking system and suggests that a better one might have detected a potential problem before the drug had been on the market for eight years.

Avandia is used to control blood sugar, helping more than 6 million people worldwide manage Type 2 diabetes, the kind that is linked to obesity. These people already are at higher risk for heart attacks, so news that the drug might raise this risk by 43 percent was especially disturbing.

In the 35 days after May 21, when the New England Journal of Medicine published the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped. The sharp rise in reports of heart problems appears in data obtained by The Associated Press through a Freedom of Information Act request to the federal Food and Drug Administration.

Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet.

Reporting a drug's side effects is voluntary, and only a crude indication rather than a scientific measure of how many problems patients are actually having. The FDA relies on this unenforced system once a drug is on the market. Critics say it leads to haphazard oversight in which problems can be missed because doctors don't connect the dots between a drug and symptoms they see in an individual patient.

With Avandia, the published analysis likely led to more cases being reported, said Vanderbilt University diabetes specialist Dr. Alvin C. Powers.

"Now, patients and their doctors are much more aware of the possible link between Avandia and cardiovascular disease. This is good — this is going to help us going forward to determine whether or not this drug is safe," he said.

The drug's manufacturer, British-based GlaxoSmithKline PLC, insists that the drug is safe and effective.

"This is a very well-known phenomenon," where news reports lead to increased reporting, said company spokeswoman Mary Anne Rhyne. "It's good that there's awareness of the reporting system, but drawing conclusions on such data is inappropriate."

The FDA plans hearings on safety concerns about the drug on July 30. In the meantime, diabetes experts have advised users of the medication to talk to their doctors and not to immediately discontinue it.

The side effects reported range from as minor as a blister to as serious as sudden cardiac death. Most of the reports the AP reviewed seemed to involve serious side effects, and rosiglitazone was listed by the FDA as the "primary suspect" rather than other medicines the patient may have been taking.

There was a total of only 50 adverse event reports in January and 73 in February. From April 16 to May 21, when the study was published, 121 events were reported, including 11 deaths. In the 35 days after the study, 357 events were reported, including 38 deaths.

"You really can't infer anything about incidence rates from that," because the spike in reports is likely due to the "publicity effect" of the study, said Dr. David Graham, an FDA drug safety expert.

Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital, agreed, saying it was "not conceivable" that only five people among the 1 million Americans taking Avandia had heart attacks in the month preceding the May 21 study, as the FDA reports suggest.

"It just heightens the concern about the poor reporting we have," said Nathan, who has received speaker fees from Glaxo and other drug companies. Powers and Graham have no financial ties to any diabetes drug makers.

The issue has roiled the medical community and sparked congressional probes into whether the FDA is properly investigating safety issues. The FDA issued a "safety alert" about the drug only after the May 21 study came out, even though Glaxo had informed the agency of its own analysis of heart risks nearly a year beforehand and possibly as early as 2005.

Avandia's label warns about possible heart failure and other heart problems when taken with insulin. The drug also raises LDL, or bad cholesterol, and can cause fluid retention and weight gain.

source : news.yahoo.com

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"Baby hatch" highlights Japan fears over adoption

When a newborn baby girl was left in Japan's controversial "baby hatch" last week, the child's life may have been saved, but her chances of finding new parents were slim due to a cultural aversion to adoption in Japan.

The baby is one of four tots -- one of them three-years-old -- so far left at the "stork's cradle" baby hatch at the Catholic-run Jikei Hospital in Kumamoto, southern Japan.

A small door in the outside wall of the hospital opens to reveal a tiny bed inside, allowing parents to leave their child safely and anonymously. Once they do, an alarm goes off to alert hospital staff to the new arrival.

Similar facilities exist in Germany, where babies are offered for adoption after an eight week period during which birth parents can change their minds.

But the many vocal critics of the first "baby hatch" in Japan are afraid it may encourage parents to opt out of their responsibilities. And legal barriers and prejudice against adoption in Japan may mean that children abandoned in the "baby hatch" will be raised in institutions rather than by adopted parents.

"There is a feeling that it is somehow natural for children who can't live with their parents to be in an institution," said Masaki Takakura, a journalist and author of a book on adoption.

"This is a hangover from the post-war years, when children whose parents had died were rounded up and sent to orphanages."

Local officials will not comment on specific cases, but if Japanese courts do not define the "baby hatch" children as officially "abandoned," they may be left in children's homes for years, theoretically awaiting the return of their birth parents.

The vast majority of the 30,000 children in Japan's children's homes -- which are struggling to cope with increasing numbers of abused youngsters -- will stay put until they are old enough to work.

Research shows growing up in an institution often leads to disadvantages in emotional development as well as education and employment, which is why many say attitudes towards adoption need to be changed in Japan.

"I used to have a very negative image of adoption and I think a lot of other people do too," explained 38-year-old housewife Tomoyo Suzuki, adding that her thinking changed after she went to a seminar about it. She and her husband went on to adopt two babies now aged three and one.

"I think a lot of people are concerned about blood ties."

Prime Minister Shinzo Abe -- who criticized the "baby hatch" for encouraging parents to opt out of their responsibilities -- and his wife, Akie, themselves rejected the idea of adopting.

CONFUCIAN ROOTS

Last year, Akie went public with her fertility problems and said her husband had suggested they adopt.

"I could not accept this and was not confident about bringing up an adoptee properly, so it did not happen," she told a Japanese magazine.

Those who do adopt often move house immediately afterwards to cover up their child's origins, said Kazuko Yokota of Motherly Network, a volunteer group that supports women coping with unexpected pregnancies and arranges adoptions.

Attitudes are shaped by everything from Confucian teachings to a detailed household registry system that can dog unwed mothers for their entire lives, even if they give their child up for adoption.

Confucianism, which spread to Japan from China and Korea more than a thousand years ago, emphasizes the importance of a child's relationship with its birth parents and reverence for ancestry.

"Children in need of adoption have been stigmatized by notions of pure and impure or good and bad blood," Peter Hayes of Britain's Sunderland University and Toshie Habu wrote in their book "Adoption in Japan."

EXTENDED FAMILY

For much of Japan's history, adoption has therefore remained within the extended family, with childless couples often taking in a nephew or other relative to carry on their family name or business, rather than because the child was in need of care.

"Special adoption," of needy non-relatives was not introduced until 1989 and only a few hundred cases are approved each year, compared with three to four thousand in the United Kingdom, which has around half Japan's population.

The difference lies not only in the shortage of willing parents, but also the small number of available babies, many say.

When women give birth they must enter the child's name on their family register, a powerful incentive for single women to end a pregnancy or even abandon a newborn rather than risk its being discovered by a potential employer or future husband.

"We have campaigned at least for minors to be able to leave this information off their registers, but we have been told it won't happen," said Yokota of Motherly Network.

Children's homes, which are subsidized by the government according to the number of children in their care, are partly to blame because they are reluctant to recommend candidates for adoption, says sociologist Roger Goodman of Oxford University.

"We need to spread the message that adoption is an important tool for helping children. How do we do this, given that there is no background of Christian values here?" said author Takakura.

Shocked by the fact that some adoption agencies charge huge fees to introduce Japanese babies to adoptive families abroad, he is working with sympathetic members of parliament to try to pass a law encouraging more Japanese to take in unwanted children.

source : news.yahoo.com

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FDA Seeks Strictest Warning for Diabetes Drugs

The U.S.Food and Drug Administration has asked that two controversial type 2 diabetes drugs carry a "black box" warning on the potentially heightened risk of congestive heart failure in some patients.

In prepared testimony before a Congressional committee that was convened Wednesday following a published report on the cardiac dangers of Avandia, FDA Commissioner Dr. Andrew von Eschenbach said the agency had asked that Avandia, made by GlaxoSmithKline, and Actos, made by Takeda Pharmaceuticals, carry the more prominent warning because "despite existing warnings, these drugs were being prescribed to patients with significant heart failure."

According to von Eschenbach's testimony, the request for the warning -- the strictest one possible -- was issued to both companies May 23, two days after publication of a study in the New England Journal of Medicine that found Avandia (rosiglitazone) increased the risk of heart attack by as much as 43 percent.

But the decision to request the heightened warning wasn't made public until von Eschenbach's appearance before the House Committee on Oversight and Government Reform, which is reviewing the FDA's role in the Avandia controversy.

The May 21 Avandia study was led by Dr. Steven Nissen, a Cleveland Clinic cardiologist who was among the first to warn about the heart risks posed by the now-banned arthritis drug Vioxx.

Following the release of the NEJM study on Avandia, the FDA issued a safety alert, but stopped short of asking for a stronger warning label, saying more analysis was needed.

"The Food and Drug Administration is aware of a potential safety issue related to rosiglitazone," Dr. Robert J. Meyer, director of FDA's Office of Drug Evaluation II, said during a May 21 teleconference. But, he added, "At this point, we have not reached a definitive conclusion on the data. We don't feel there is consistent enough data to make a decision from a regulatory standpoint. We are not ready to make an action."

On Tuesday, results of a British study, funded by GlaxoSmithKline, were released and showed no significant increased risk for heart attack or death from heart disease associated with Avandia.

The study, which was released early by the New England Journal of Medicine to coincide with the House hearing, also found no increased risk for cardiac events among diabetics taking Avandia and those not taking it.

"Overall, there was no significant difference between those on rosiglitazone and those not on rosiglitazone," study co-author Stuart J. Pocock, of the London School of Hygiene & Tropical Medicine, said Tuesday. "The concern about cardiovascular death, I think, we have clearly deflated. The concern on heart attack -- our data are modifying that concern, but it's still inconclusive."

But one expert pointed out Tuesday that the original goal of the new study was to show a benefit of rosiglitazone in preventing heart disease.

"When you get a finding that is against the hypothesis, it makes me sit up and take note," said Dr. David M. Nathan, of Massachusetts General Hospital, and author of an accompanying editorial in the journal. "None of the data is reassuring. You don't give the drug the benefit of the doubt -- you give safety the benefit of the doubt."

And another expert, Dr. Bruce M. Psaty, who wrote a second editorial in the journal, said Wednesday of the Avandia findings, "I combined the results from this study with the study by Nissen, and there was still a 33 percent increase in risk of a heart attack."

Psaty, of the University of Washington in Seattle, also testified at Wednesday's House hearing.

Afterwards, he said that the FDA needs to have a "black box" warning about heart attack risk, not just heart failure risk, which he said has been known for a long time.

"It sounds like the FDA has had this data on heart attack risk since 2005," he said. "In Europe, the label was revised back in September."

Psaty added that the FDA needs to mandate post-marketing studies to uncover safety problems.

"You need a drug safety system that is complementary to the rapid approval system that we have in place," Psaty said. "What we are seeing with Avandia and Vioxx is the fallout of the system where you sped up approval and did not do anything to test safety."

Meanwhile, the FDA announced Wednesday that an advisory panel will meet on July 30 to weigh the cardiovascular risks of the class of diabetes drugs that includes Avandia.

In response to that announcement, the Cleveland Clinic's Nissen said in a prepared statement: "We published our meta-analysis on the cardiovascular safety of Avandia because we felt it was our obligation to alert the medical and patient community to a potentially serious drug safety problem and urged comprehensive evaluations to clarify the risks."

He added, "We encourage a lively scientific debate about these issues and look forward to the results of the FDA advisory board hearings in July. During today's congressional hearings, we learned that meta-analyses conducted by the FDA and GlaxoSmithKline showed similar results to our findings. We would like to see those analyses published in peer-reviewed journals so that the totality of information on the cardiovascular safety of Avandia is available to doctors and patients."

Also Wednesday, Takeda Pharmaceuticals announced that it would add the boxed warning requested by the FDA to prescription labels for Actos (pioglitazone).

Dr. Robert Spanheimer, the company's senior medical director for diabetes and metabolism, said in a prepared statement, "Takeda remains confident in the safety and efficacy of Actos when used according to its label, and with this revision, we can heighten patient and physician awareness of an already known, but serious side effect."

On Tuesday, GlaxoSmithKline had issued a prepared statement saying that the British study should reassure type 2 diabetes patients that Avandia was safe.

"They [the findings] add to the weight of evidence, from both previously published long-term clinical trials and other studies, that the overall ischemic cardiovascular safety profile of Avandia is comparable to the traditional anti-diabetes treatments. Patients and physicians should find these data reassuring," said Moncef Slaoui, the company's chairman for research and development.

In response to the growing controversy over Avandia's safety profile, the American Diabetes Association on Wednesday issued an advisory statement.

"As a result of all of this information, the American Diabetes Association strongly encourages patients taking this medication to consult with their physician as to its benefits and risks," the statement read. "The Association also reminds patients, however, that they should not stop taking any prescribed medications without first discussing the issue with their health-care provider."

source : news.yahoo.com

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Nursing Homes Need Better Diabetes Care

Treatment of elderly patients with type 1 and type 2 diabetes in U.S. nursing homes often fails to meet American Diabetes Association standards, according to a new study.

Researchers at the Ohio University College of Osteopathic Medicine studied the quality of care received over a year by 108 diabetic residents living in 11 nursing homes in Ohio and West Virginia.

They found that only 38 percent of patients met blood glucose [sugar] goals, only 55 percent had satisfactory blood pressure levels, and only 31 percent had lipids (serum total cholesterol) checks yearly. Of those who had regular lipids checks, only 58 percent had acceptable levels.
The study authors noted that these three areas -- hypertension control, blood sugar and cardiovascular risk factors (such as cholesterol) -- have a major effect on the life expectancy of people with diabetes.

The findings, published Friday in the journal Diabetes Care, revealed that the nursing homes in the study lacked a systematic approach to diabetes care and that treatment guidelines for diabetic nursing home residents must be developed in order to provide optimal care.

The researchers are currently developing treatment protocols for diabetic patients in nursing homes. They plan to offer these protocols to the medical directors of those nursing homes included in the study.

A follow-up study will examine the effectiveness of these treatment protocols.

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TV linked with poor diabetes control

Diabetic children who spent the most time glued to the TV had a tougher time controlling their blood sugar, according to a Norwegian study that illustrates yet another downside of too much television.

The findings, based on a study of children with Type 1 diabetes, lend support to the American Academy of Pediatrics' advice that children watch no more than two hours of TV daily, said lead author Dr. Hanna Margeirsdottir of the University of Oslo.

Type 1 diabetes is the less common form of the disease and used to be called juvenile diabetes. It is not related to obesity and is caused when the body cannot make insulin, which converts sugar from food into energy. People with Type 1 must take insulin daily and regulate their blood-sugar levels.
Snacking and overeating can increase blood-sugar levels; physical activity can lower them. While TV-viewing is often accompanied by snacking, the researchers didn't examine diet or physical activity.

The study results "suggest that encouraging children with Type 1 diabetes to watch less television may be important for improved blood glucose control and better health outcomes," the study authors wrote.

Other experts said the study also might suggest something else. Diabetic children who already have consistently high blood-sugar levels could feel too sick to do much besides watch TV, said Jill Weissburg-Benchell, a psychologist and diabetes educator at Children's Memorial Hospital in Chicago.

"It's very clear that there is a relationship. Now the question is what underlies that relationship," she said.

Results of the Oslo research will appear in the June edition of the journal Diabetes Care.

The study involved 538 children with an average age of 13. In Norway, about 25,000 people have Type 1 diabetes. In the United States, there are 3 million with the condition and about 30 million worldwide.

The study evaluated results of a routine test that measured average blood-sugar control over three months. There was a continuous increase in the level of blood sugar with every hour of TV watched, rising to the highest level for those who watched at least four hours daily.

The results didn't surprise Chicago diabetes educator Monica Joyce, who founded a basketball camp for diabetic children.

Campers typically are asked how much TV they watch and are taught "they can get much better blood sugars if they're active," Joyce said.

If the researchers' theory is right, then turning off the TV could be added to a list of remedies "that are very low-cost to the health care system," said Dr. Francine Kaufman, head of a diabetes program at Children's Hospital in Los Angeles.

"This has got to be the social norm that it's just not acceptable for kids to be baby-sat by TV," she said.

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Diabetes complications frequently afflict elderly

People who develop diabetes late in life often suffer from a range of diabetes-related complications, and their life expectancy is shorter than that of nondiabetic individuals of the same age, a new study shows.

The investigators, Dr. Frank A. Sloan, of Duke University in Durham, North Carolina, and colleagues point out in the Archives of Internal Medicine that "little is known about the impact of diabetes mellitus in elderly populations."

The researchers examined illness and mortality rates in 33,772 Medicare beneficiaries with diabetes and in 25,563 similar people without diabetes ("controls") over a 14 year period.
The death rate was over 9 percentage points higher among the people with diabetes than the control patients. Being newly diagnosed as diabetic translated into a loss of life expectancy of just over 2 years.

Overall, 92 percent of the diabetes group experienced an adverse health event compared with 72 percent of the control group.

Disorders affecting the legs and complications associated with surgery were higher among patients with diabetes. Furthermore, 58 percent of those with diabetes were diagnosed with heart failure, compared with 34 percent of the control group. While kidney disease and retinal eye disorders were less common, both increased markedly in the diabetic group.

"Although the present data provide no insight into the cause of these patterns, the burden of diabetes mellitus complications on the individual and on the health care system is enormous," the researchers conclude.

SOURCE: Archives of Internal Medicine, May 14, 20077.

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Diabetes pill tied to heart risks

A widely used diabetes pill raises the risk of heart attacks and possibly death, according to a scientific analysis that reveals what some experts are calling another Vioxx-like example of the government failing to protect the public from an unsafe drug.

More than 6 million people worldwide have taken the drug, sold as Avandia and Avandamet, since it came on the market eight years ago to help control blood sugar in people with the most common form of diabetes. About 1 million Americans use it now.

Pooled results of dozens of studies on nearly 28,000 people revealed a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication, according to the analysis published online Monday. The study, published by the New England Journal of Medicine, also found a trend toward more heart-related deaths.
The findings are frightening because two-thirds of diabetics die of heart problems, so a drug that boosts this possibility is especially hazardous for them.

Still, the actual risks to any single patient appear small. Diabetics should talk to their doctors before stopping any medication, said a statement issued by the American Diabetes Association and two groups of heart doctors.

Avandia's maker, British-based GlaxoSmithKline PLC, disputed the results of the analysis but acknowledged that its own similar review found a 30 percent increased risk — information it gave last August and possibly even earlier to the U.S.Food and Drug Administration. But the company said that more rigorous studies did not confirm excess risk.

FDA officials issued a safety alert on Monday and said they likely would convene an advisory panel, but planned no immediate changes to the current side effect warnings on the drug's packaging.

Several members of Congress expressed alarm. Rep. Henry Waxman (news, bio, voting record), D-Calif., chairman of the House Committee on Oversight and Government Reform, announced a hearing for June 6 on FDA's role. On the Senate floor, Charles Grassley (news, bio, voting record), R-Iowa, criticized the agency for not acting more swiftly.

"Do we have another Vioxx on our hands with Avandia? I am not sure, but I intend to find out," he said, referring to the blockbuster arthritis drug withdrawn in 2004 because of safety problems. "Tens of millions of prescriptions have been written for Avandia, and Medicare and Medicaid have paid hundreds of millions of dollars for this drug."

Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity and afflicts 18 million Americans and 200 million people worldwide. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.

Avandia, or rosiglitazone, helps sensitize the body to insulin and was considered a breakthrough medication for blood-sugar control. It also is combined with metformin and sold as Avandamet. Only one other drug like it — pioglitazone, sold as Actos and Actoplus Met by Takeda Pharmaceuticals — is sold in the United States.

Avandia had total U.S. sales of $2.2 billion in 2006, slightly trailing $2.6 billion for Actos, according to IMS Health, a healthcare information company. About 13 million Avandia prescriptions were filled in the U.S. last year. A one-month supply of Avandia sells for between $90 and $170.

GlaxoSmithKline also has been testing Avandia to try to prevent diabetes in those at high risk of it, and, in separate studies, to prevent Alzheimer's disease.

However, the new analysis casts a pall on its prospects for prevention as well as treatment, many specialists said. The study was led by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic. Nissen accepts no personal fees for consulting for any drug makers.

While the analysis doesn't spell out the actual the rate of heart attacks among Avandia users, the 43 percent excess risk is in line with what a similar analysis found for lower doses of Vioxx use, Nissen said. Another context for that number: Heart attack risks are lowered about 25 percent by cholesterol-reducing statin drugs — ample reason to prescribe them.

The Avandia studies Nissen analyzed were not designed to look for heart risks and many of them were so short — some only 24 weeks — that risks may only appear over the longer term, he said.

Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital, agreed.

"This analysis is just scratching the surface of what may be there. It needs to be taken seriously," said Nathan, who reviewed the paper for the medical journal and has no financial ties to any diabetes drugmakers.

The situation "reflects very badly on the FDA and on Glaxo," Nathan said. "It's the FDA's responsibility to be monitoring this stuff."

The drug "represents a major failure of the drug-use and drug-approval processes in the United States," Drs. Bruce Psaty and Curt Furberg wrote in an editorial in the New England Journal. Psaty is with the University of Washington in Seattle and Furberg is with Wake Forest University.

When the drug was approved, evidence of its benefits were "at best mixed," wrote the two doctors. Both have been frequent critics of the FDA's failure to spot dangers in the drug approval process and its conduct involving Vioxx.

Avandia's label already warns about possible heart failure and other heart problems when taken with insulin. The drug also raises LDL or bad cholesterol, and can cause fluid retention and weight gain. Glaxo also has reported some patients suffered more bone fractures, swelling of the legs and feet, and rare reports of swelling in the eye that can cause vision problems.

However, in a conference call Monday, Dr. Lawson McCartney who leads Glaxo's diabetes drug development, said: "We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine."

Dr. Robert J. Meyer of the FDA's Center for Drug Evaluation and Research, also defended the agency's actions, saying information about risks is not clear-cut.

"We've tried to weigh the risks of going forward with an uncertain message ... with the level of uncertainty about the safety signal before us,"

Glaxo's shares trading in the United States closed down $4.53, or 7.9 percent, at $53.18.

Nissen used publicly available information from an earlier $2.5 million Glaxo settlement with the state of New York to do his study. He also led earlier research that derailed a similar diabetes drug, Pargluva, that seemed headed for FDA approval until safety issues emerged. A fourth drug in the same class, Rezulin, was withdrawn in 2000 after it was linked to liver problems.

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Diabetes drug use spikes in girls

The number of adolescent girls taking drugs for Type 2 diabetes nearly tripled in just five years, while use of chronic medicines for psychotic behavior and insomnia roughly doubled among boys and girls aged 10 to 19, a study shows.

Meanwhile, adolescents' use of drugs for depression and attention deficit hyperactivity disorder, or ADHD, leveled off or dropped in the last two years, after widespread new warnings about safety concerns.
The study, an analysis of prescription drug use from 2001 to 2006 among 370,000 insured children aged 10 to 19, was conducted by Medco Health Inc. of Franklin Lakes, N.J., the country's biggest prescription benefit manager, and released exclusively to The Associated Press.

Experts say the findings raise questions about physical and mental health problems in youth, the appropriateness of putting them on strong, long-term medicines mostly designed for adults, and whether it might be better to focus on other strategies, such as counseling, exercise and changes in diet, caffeine intake and bedtime routine.

"There's increasing use of medication in children the last 20 years, but does that mean we're treating them successfully or that we're overmedicating?" said Dr. Thomas Insel, director of the National Institute of Mental Health. Probably both, he said, but some children aren't getting needed help.

Dr. Wayne Snodgrass, chairman of the American Academy of Pediatrics' committee on drugs, said the levels of medication usage found in the study might be appropriate, but it's hard to know without details on why each prescription was written.

"It deserves watching," he said, particularly because adolescents' brains are still developing. Snodgrass said worried parents should question their child's doctor about their treatment or seek a second opinion.

The most striking trend was a 167 percent spike in girls 10 to 19 taking pills for type 2 diabetes, formerly called adult-onset diabetes. Medco found it jumped from 0.1 percent in 2001 to 0.27 percent in 2006; among boys, prevalence up 33 percent, to 0.08 percent.

Dr. John Buse, president-elect of the American Diabetes Association, said those figures are a bit higher than prior data but track U.S. increases in diabetes and obesity the past 15 years.

"It's really scary to think about people in their teens developing a disease that in the past only developed in the 40s, 50s and 60s," Buse said.

The big gap between the sexes, he said, likely is partly due to girls taking a generic diabetes drug, metformin, linked to weight loss and also prescribed for a hormonal condition that involves abnormal insulin function, causes male sex traits and increases cancer risk.

Also, hormone changes in puberty can trigger insulin resistance, or prediabetes. Puberty starts a couple years earlier in girls, so many more girls than boys in the study were in puberty.

Medco found prevalence of kids taking antipsychotic drugs, once called major tranquilizers, roughly doubled, with about 1.2 percent of boys and 0.75 percent of girls taking them in 2006.

Widely used antipsychotic drugs — including Risperdal, Zyprexa, Seroquel and Clozaril — are approved for treating schizophrenia and bipolar disorder in adults, but not children.

Insel said the drugs often are prescribed for kids for disruptive behavior and other unapproved uses, particularly to kids previously on antidepressants and ADHD drugs.

A federal survey of doctors' office practices estimated a sixfold jump from 1993 to 2002 in patients aged 20 or younger prescribed antipsychotic drugs, to 1.224 million. It found 38 percent of those prescriptions were for disruptive behavior such as ADHD, 32 percent were for mood disorders including depression, 17 percent were for developmental disorders such as mental retardation and autism, and 14 percent were for psychotic disorders such as schizophrenia.

Meanwhile, Medco found use of prescription sleeping pills nearly doubled, to about 0.3 percent of boys and 0.44 percent of girls.

"The fact that these kids have to get a prescription pill to go to sleep at night is amazing," said Dr. Robert Epstein, Medco's chief medical official, adding parents should try slowing kids down at night with curfews on caffeine and computer use, for example.

He said Medco's numbers reflect drug use among adolescents covered by private or government insurance, but in general kids in the Medicaid program use more prescription medications and those with no insurance take significantly less.

Use of ADHD drugs leveled off in girls in 2006 at 3.5 percent and dropped in boys to almost 8 percent, while antidepressant use dropped in both sexes in 2005 and 2006, to about 4 percent of girls and 3.2 percent of boys.

Insel said those trends make sense, given that after the drugs ago got stringent warnings about problems such as suicidal thoughts a couple years ago, many parents became concerned about side effects and pediatricians worried about their liability for prescribing the drugs.

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Dramatic Rise in U.S. Kids Hospitalized for Type 2 Diabetes

In another sign of the alarming childhood obesity epidemic in the United States, researchers report a 200 percent increase in the number of children hospitalized for type 2 diabetes.

Type 2 diabetes, which used to be called adult onset diabetes because it was rarely seen in children, is typically diagnosed in patients who are overweight. Left untreated, it can lead to such complications as heart disease, blindness, nerve damage and kidney damage.

The dramatic increase in pediatric type 2 diabetes occurred nationwide between 1997 and 2003, according to the study by researchers at New York University School of Medicine.
"The rapid rise in childhood obesity is now common knowledge," said Dr. David Katz, director of Yale University School of Medicine's Prevention Research Center, who was not involved in the study. "Increasingly, so is the concurrent rise in type 2 diabetes in children -- a generation ago, this condition did not exist. What is now called type 2 diabetes was called adult onset diabetes until quite recently."

"Epidemic childhood obesity has transformed a chronic disease of mid-life into a pediatric scourge," Katz added.

For the study, Dr. Rhonda Graves, a pediatrician, and her colleagues used data from nationwide hospital discharge records from 1997, 2000 and 2003. They compared the trends in hospitalization rates, length of stay and costs for children with type 2 diabetes and type 1 diabetes.

They found that rates of hospitalization for type 1 diabetes increased 15 percent between 1997 and 2003, while rates of hospitalizations for type 2 diabetes increased 200 percent.

"These findings, based on hospital records of a nationally representative sample of hospitals in the U.S.A., indicate that type 2 diabetes is increasingly becoming a pediatric illness that results in hospitalizations. It is associated with a very serious number of co-morbidities and complications which may have profound health implications both in childhood and in adulthood," Graves said in a prepared statement.

Graves' team also found that hospitalizations for type 2 diabetes were 1.3 times more likely for boys than girls. Children 9 to 12 years old had the highest rates of hospitalization.

The researchers also found that black, Hispanic and Native American children were at greatest risks of increasing hospitalizations.

The researchers also found that children hospitalized for type 2 diabetes were hospitalized longer than children with type 1 diabetes. Type 1 diabetes is a disease caused by the body's inability to produce insulin, and it's not related to obesity. Insulin is a hormone that converts blood sugar to energy for cells.

The findings were expected to be presented Saturday at the annual meeting of the Pediatric Academic Societies, in Toronto.

"The dramatic increase in hospitalizations for type 2 diabetes in children reported here confirms this trend and further demonstrates that it affects ethnic minorities disproportionately," Katz said.

The National Cholesterol Education Program considers diabetes such a potent risk factor for heart disease that, in adults, treatment guidelines essentially equate the two, Katz noted.

"There is no reason to think this will be any different in children. If 7- and 8-year-olds can get adult onset diabetes, 17- and 18-year-olds can start getting heart disease. I personally know of a 17-year-old boy, with early onset obesity and type 2 diabetes, who has already had a triple coronary bypass. If current trends persist, cases like his could become the rule rather than the rare and terrible exception," Katz said.

Graves thinks much more needs to be done prevent obesity in children.

"As pediatricians, we must learn to recognize the signs and symptoms of type 2 diabetes, and, in turn, educate the next generation of young physicians to be aware of this ever-growing epidemic and how best to prevent and treat it," she said. "Equally important is our duty to further explore the mechanisms causing health disparities in this new and profoundly serious child health problem."

One expert, however, thinks that this striking increase in hospitalization for children with type 2 diabetes needs to be viewed with some skepticism.

"There is a side of me that wonders if these children were diagnosed correctly," said Dr. Larry Deeb, the president for medicine and science at the American Diabetes Association. "Type 2 diabetes is rare in 9- to 12-year-olds. That's the age group that has the highest incidence of type 1 diabetes."

Deeb, a pediatric endocrinologist, noted that type 2 diabetes wasn't recognized until 1997. "The increase in type 2 diabetes seen here may be a function of more recognition rather than more of it," he said.

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'Rubber band' obesity surgery cuts diabetes risk

After having "lap band" surgery for weight loss, men and women show large increases in sensitivity to the blood-sugar-regulating hormone insulin -- even if they remain obese -- a new study shows.

"They don't have to reach their ideal weight in order to make some pretty significant health improvements," Dr. Joan F. Carroll of the University of North Texas Health Science Center in Fort Worth, one of the study's authors, told Reuters Health.

Carroll reported the findings this week at the American Physiological Society's annual meeting in Washington, DC.
In the operation Carroll and her team are investigating, known medically as laparoscopic gastric banding surgery, an elastic band is placed around the stomach, restricting the amount of food the stomach can comfortably hold. Another procedure, surgical gastric bypass, has been shown to help reduce the body's resistance to insulin -- often a prelude to full-blown diabetes -- before major weight loss has taken place, but less is known about how lap band surgery affects insulin resistance.

To investigate, Carroll and her team have been following 37 lap band patients for up to one year. Those followed for six months have lost 23 kilograms (51 pounds), on average, while average weight loss for those who have been followed for a year is 34 kg (75 pounds).

Their level of insulin resistance had fallen by 60 percent after six months, she told Reuters Health, even though the patients remained clinically obese.

Given that resistance to insulin greatly increases the risk of developing type 2 diabetes, which has a number of other health consequences including heart disease and even amputations, "over the long term it's really a benefit for all the body systems," Carroll said.

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New diabetes genetic risk factors found

Scientists have found clusters of new gene variants that raise the risk of Type 2 diabetes — and how the researchers did it is as important as what they found.

In one of the largest studies yet of human genetic variability, the scientists tested the DNA of more than 32,000 people in five countries to pin down spots that harbor genetic risk factors for this complicated killer.
This type of research — called a "genome-wide association" study — promises to usher in a new era of genetics. Most breakthroughs so far have come from finding a mutation in a single gene that causes illness. But some of the world's most common killers, such as heart disease and diabetes, are caused by complex interactions among numerous genes and modern lifestyles — and teasing out the genetic culprits until now has been almost impossible.

"We have been for all of the last decade or more looking under the lamppost to try to find those genes ... and lots of times the lamplight was not actually where we wanted it," said Dr. Francis Collins, genetics chief at the
National Institutes of Health, a co-author of the research unveiled Thursday.

This new approach "allows us to light up the whole street, and look what we find."

What? Four previously unknown gene variants that can increase people's risk of Type 2 diabetes, and confirmation that six other genes play a role, too.

The work, by three international research teams that shared their findings, was published online Thursday by the journal Science.

Also Thursday in the journal Nature Genetics, another team led by Iceland researchers reported separately finding one of those same new genes — and that, interestingly, it seems to increase the diabetes risk most in people who aren't obese.

Next, the researchers will have to figure out just what those genes do, in hopes they'll point toward new ways to treat or prevent a disease that affects more than 170 million people worldwide, and rising.

With Type 2 diabetes, the body gradually loses its ability to use insulin, a hormone key for turning blood sugar into insulin. It is a major cause of heart disease, as high blood sugar damages blood vessels, and leads to kidney failure, blindness and amputations.

Obesity and lack of exercise are chief risk factors. But heredity is involved, too: People with an affected parent or sibling are at 3.5 times greater risk of developing diabetes than people from diabetes-free families.

The new work scanned DNA to find patterns of small gene variations known as SNPs (pronounced "snips") more common in diabetics. SNPs can serve as signposts for tracing disease-promoting genes. To be certain the implicated SNPs were involved, the researchers then checked for them in still more volunteers, ultimately testing DNA from 32,500 people in Britain, Finland, Poland, Sweden and the U.S.

The highest-risk variants can increase by 20 percent someone's odds of developing Type 2 diabetes, the teams reported.

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