Antipsychotic Drugs in Kids Linked to Weight Gain

Children and teens who took antipsychotic medicines in a study gained weight and developed increased blood-fat levels, possibly harming their future health, researchers in New York State said.

The subjects, taking the antipsychotic drugs for the first time, gained from 9.7 to 18.7 pounds (4.4 to 8.5 kilograms) after about 11 weeks of treatment, depending on which medicine they were given, the scientists said today in the Journal of the American Medical Association. Fifteen patients who didn’t stick with drugs or who declined to participate in the research gained less than half a pound on average.

The study was the largest to show how antipsychotic medicines affect the bodies of children taking the drugs for the first time, the researchers wrote. Many past studies of the drugs involved patients who had also used other treatments -- methodology that may have masked the extent of weight gain, according to an editorial published with the study.

“We were able to show all of these agents can cause quite a bit of body weight changes and body composition changes that are not beneficial to the health,” said Christoph Correll, the study’s lead author, in a telephone interview on Oct. 23.

“What we need to figure out is what are the long-term consequences in the lives of children,” Correll, who is a medical director at Zucker Hillside Hospital in New York City’s Queens borough and an associate professor of psychiatry at Yeshiva University’s Albert Einstein College of Medicine in the Bronx.

Metabolic Syndrome

Gaining weight and changes in blood sugars and fats can be precursors to metabolic syndrome, a group of risk factors linked to heart disease and diabetes, according to the research article. Weight gain, obesity and increases in cholesterol in children are linked to their adult risk of cardiovascular problems and cancer.

Patients in the study had been diagnosed with mood disorders, schizophrenia and disruptive or aggressive behavior. Their doctors had prescribed Abilify, made by New York-based Bristol-Myers Squibb Co.; Zyprexa, made by Indianapolis-based Eli Lilly & Co.; Seroquel, made by London-based AstraZeneca Plc, or Risperdal made by New Brunswick, New Jersey-based Johnson & Johnson.

Risperdal and Abilify are the only two antipsychotics approved for pediatric use. A panel of outside advisers to the U.S. Food and Drug Administration recommended in June that Seroquel, Zyprexa and New York-based Pfizer Inc.’s Geodon be cleared for pediatric use.

Impact in Children

The medicines, so-called atypical antipsychotics, were introduced for adults in the mid-1990s and marketed as having fewer neurological side effects than older drugs. The FDA has grappled with pediatric use for years because of concerns that weight gain, sleepiness and movement disorders reported as side effects in adults may be more pronounced in children.

U.S. sales of antipsychotic drugs reached $14.6 billion last year, the most for any class of medicines, according to IMS Health Inc. in Norwalk, Connecticut. Use of antipsychotic medicines by people younger than 20 years old has more than doubled since 2001, according to data compiled by Medco Health Solutions Inc. of Franklin Lakes, New Jersey.

The study reported today was conducted to determine if weight gain and other changes to the body were related to the start of a psychiatric illness or hospital admission, or to the medicines.

Prescribed for Behavior

Researchers at Zucker Hillside, and at the Feinstein Institute for Medical Research in Manhasset, New York, studied 272 people ages 4 to 19 who were prescribed the antipsychotic medicines for behavioral, mood or psychosis-related problems. The patients were followed for the first 12 weeks.

At about 11 weeks, those taking Zyprexa gained 18.7 pounds on average, compared with 13.4 for Seroquel, 11.7 for Risperdal and 9.7 for Abilify, the study showed.

“The extent and the rate of weight gain is remarkable,” said Christopher Varley, a professor in the psychiatry and behavioral sciences department at the University of Washington in Seattle, in a telephone interview on Oct. 23. “Realistically the kids were exposed to 11 or 12 weeks of medication. Some of them gained over 20 pounds.” Varley co-wrote the editorial in the journal that was published with the study.

Ten percent to 36 percent of the patients in the study became overweight or obese within 11 weeks of starting the medicine, the researchers said.

Cholesterol Increases

Those on Zyprexa had larger increases in cholesterol and blood sugars, according to the study. Those on Risperdal had rises in their levels of triglyceride, a type of fat found in the blood, without affecting their blood sugar, the researchers wrote. Those on Seroquel also had an increase in total cholesterol and triglycerides, and patients on Abilify didn’t have any significant worsening in their blood fats or blood sugars, according to the scientists.

Correll recommended that parents monitor their children’s weight and make sure the kids are eating healthy food and exercising.

Doctors in some cases should consider counseling and behavior therapy, as well as parental training, before prescribing the drugs, Correll said. Once the medicines are given to children and adolescents, doctors need to frequently monitor the weight gain and the patients’ blood sugars and blood fats, he said.

In the editorial accompanying the study, Varley wrote, “Given the risk for weight gain and long-term risk for cardiovascular and metabolic problems, the widespread and increasing use of atypical antipsychotic medications in children and adolescents should be reconsidered.”

The study was funded partly by the U.S. National Institutes of Health, based in Bethesda, Maryland.

U.S. drug labels omit vital data

In a shocking revelation, two prominent doctors have revealed that most of the times key information telling about the extent of side-effects or the effectiveness of the medicines is excluded from the drug labels in the country.

Because of the omission of important information, the drug ultimately is presented in a way that makes it seem safer and more effective than it actually is. This was written by the doctors in a commentary in the New England Journal of Medicine.

Drs. Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, New Hampshire, wrote, “Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.”

The labels on various medicines are actually written by the manufacturers and the FDA finally gives a stamp of approval after discussing the wording.

However, some relevant information might be missing, said Woloshin. He questioned, “How can I decide if the potential harms of this drug are worth the risk if I don’t know how well the drug works, and vice versa?”

Examples of drug labels where key information was missing
Citing one of the numerous examples, the doctors quoted the case of Sepracor’s four-year-old sleep drug Lunesta that was promoted with an advertising campaign that cost a whopping $750,000 per day in 2007.

The company benefited very much and generated sales of $600 million last year. It even became a wholly-owned subsidiary of Dainippon Sumitomo Pharma Co Tuesday.

The label on the drug only said that Lunesta was superior to a placebo and nothing else was specified.

However, when the tests were conducted and the results were given to the FDA, it came to light that “Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvements in next-day alertness or functioning,” wrote Schwartz and Woloshin.

Another such case in point is that of Takeda Pharmaceutical Co’s insomnia drug Rozerem. The label on the drug did not mention that laboratory statistics have revealed that it still took 31 minutes for adults above 64 years of age, and 24 minutes for younger adults to fall asleep once they consumed the drug.

Not only this, when clinical trials were conducted, the volunteers reported “no subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep.” But all this information was not mentioned on the drug label, the researchers said.

Schwartz and Woloshin stressed in their commentary, “Sometimes what gets lost is data on harms.”

New system to make drug labels clearer in content
Woloshin believes that he and his colleagues have found a better system that can help in clarifying the extent of the dangers and benefits of the drugs to the consumers.

The FDA’s Risk Advisory Committee is also in favor of the new system and the matter will be further discussed next month.

As genetic medicine races ahead, docs are left behind

Genetic tests that can help predict and refine a patient's response to drug therapy may be the first big thing in personalized medicine. But the vast majority of physicians don't know how to use them, a new survey finds.

Individual genetic variations can affect how a patient will respond to many antidepressants, pain medications, cardiovascular medicines and certain drugs that treat cancers and gastrointestinal ailments. In all, roughly one in four American patients take medications whose effectiveness could be tweaked or predicted by a pharmacogenetic test. And purveyors of genomic testing services and devices are rushing to provide tests for them all.

A survey of more than 10,000 U.S. physicians undertaken by the American Medical Assn. and the pharmacy benefits manager Medco Healthcare Solutions Inc. found that just more than one in four had had any type of education in the use of genetic testing to guide medication decisions. And only 1 in 10 felt he or she had the necessary training and knowledge to put pharmacogenetic testing to good use in treating patients. Some 13% had ordered or recommended a genetic test for a patient in the last six months. But twice that many said they would do so in the next six months.

Genes that regulate liver enzymes can have a particularly powerful influence on a patient's response to a medication. Scientists believe that one such enzyme may be responsible for governing the way patients respond to some 30% of all drugs used today. In oncology, a test can help predict if breast cancer patients will respond to the drug tamoxifen. And cancer drugs in the development pipeline are expected overwhelmingly to be administered with the guidance of genetic tests. Genetic tests also can help reduce unwanted side effects; the blood thinner warfarin, for instance, can cause blood clots or serious bleeds in some patients with an identified genetic variance, and physicians are increasingly testing those on a blood-thinning regimen in an effort reduce such risks.

"It's clear there's wide acceptance" on physicians' part for the role that genetic testing can play in guiding medication decisions, said Dr. Robert Epstein, Medco's chief medical officer, who briefed physicians and researchers on the survey at the annual meeting of the American Society for Human Genetics on Thursday. But the AMA and other groups must step up efforts to educate physicians in the use of these tests, added Epstein. "With the number of new drugs coming to market with a companion diagnostic, it's paramount that this education takes place."

Promising Pre-Med Wins Nobel Prize in Medicine

The Nobel Prize Committee announced today that it is awarding the Prize in Medicine to Jimmy Duncan, a senior at Horace Greeley High School in Chappaqua, New York, for getting a 97 on his bio-chem final.

“The Committee felt that Master Duncan has shown great promise with his outstanding grades,” said Dr. Leif Quisling, chairperson of the Nobel Prize Committee. “It is our fervent hope that this award encourages him to do great things in the future, such as find a cure for cancer.”

The committee was first alerted to Jimmy Duncan when they came across a YouTube clip of Duncan’s class presentation on his career goals.

“We were particularly struck by his unbridled optimism,” said Dr. Quisling. “Duncan closed his passionate talk with these inspiring words: ’And we can end cancer in our lifetimes if we all work together really, really hard!’ It is exactly those kind of empty platitudes that impress this committee. Far more so than anything so gauche as actual achievement.”

Mr. Duncan was somewhat blase’ about the news. “I was lying in bed playing a little X-Box before heading off to school when my mom yelled, ‘Jimmy, you’ve got a phone call from Stockholm!’ It was pretty cool, yeah.”

Dr. Quisling acknowledged that the committee was inspired to award prizes prematurely after giving President Barack Obama a Nobel Peace Prize the year before, despite the fact that nominations had been closed only 11 days after he entered office.

“In Barack Obama’s case, we figured that if the American people were willing to hand over the U.S. presidency to someone who hasn’t accomplished much, why not give him the Nobel Peace Prize before he’s done anything, either?” Dr. Quisling said.

As for Jimmy Duncan, 17, he says he’s “psyched” about the Nobel Prize. “I should be a shoo-in now to get into Harvard,” he said.

“By the way, I’m not going pre-med anymore,” Duncan volunteered. ”Now that I’ve got the Nobel in Medicine, why bother? I’ll just invest my prize money in a diversified fund and I never have to work another day in my life. In fact, I may just skip Harvard and go to a party school. Arizona State, here I come!”

We contacted Dr. Quisling’s office for a comment on Duncan’s change in plans. Nobody returned our calls by press time.

Babies Born to Childhood Cancer Survivors Do Well

Cancer treatments can compromise fertility, but new research suggests that when survivors of childhood cancer are able to have children, their babies do not face an increased risk of birth defects.

Women who survived childhood cancer were more likely to have premature or low birth weight babies compared with women who had never had cancer, one study found. But the survivors’ newborns were no more likely to have malformations or die, nor were the mothers at greater risk for pregnancy complications over all.

A companion study of men who had survived childhood cancer found that their offspring were slightly more likely to be of low birth weight (less than five and a half pounds), but they were not at greater risk for birth defects or prematurity than children born to men who had not had cancer.

The two studies, done by researchers at the Fred Hutchinson Cancer Research Center in Seattle, were published in The Archives of Pediatrics and Adolescent Medicine.

The researchers used national cancer registry data from 1973 to 2000 in four regions — Seattle, Detroit, Salt Lake City and Atlanta — to identify boys and girls who had cancer before age 20. They then linked the data to birth records to identify the first children born to cancer survivors after their diagnosis.

They were able to compare the outcomes of babies born to 1,898 female cancer survivors with 14,278 controls, also identified from birth records, and to compare the outcomes of 470 babies of male survivors with 4,150 controls.

“The main take-home message is that most kids born to childhood cancer survivors did very well,” said Dr. Eric J. Chow, an author on both papers and a research associate at the cancer center.

The study was limited because it was only able to count birth defects that were obvious upon delivery, he said. Still, he added, “Most people can feel reassured.”

IBM using nanotech to read DNA

Scientists at IBM are using a combination of nanotechnology and microchips to map out personal genetic code -- a development that could significantly improve the process of diagnosing and treating diseases.

Merging biology with computer technology, researchers at IBM are working on a project that aims to make it easier to decode human DNA, and thus help scientists discover and test new medicines and medical techniques. And, IBM says, a faster and less expensive way to obtain genetic information would help doctors better understand their patients' predisposition to diseases.

The ultimate goal of IBM's project is to create process that could read, or sequence, a person's genome at a cost of $100 to $1,000. In comparison, the first sequencing ever done by the Human Genome Project cost $3 billion, according to IBM.

"The technologies that make reading DNA fast, cheap and widely available have the potential to revolutionize bio-medical research and herald an era of personalized medicine," said IBM research scientist Gustavo Stolovitzky, in a statement today. "Ultimately, it could improve the quality of medical care by identifying patients who will gain the greatest benefit from a particular medicine and those who are most at risk of adverse reaction."

IBM reported today that its researchers have drilled nano-sized holes, or nanopores, into microchips. When DNA strands are passed through the holes, the chips can sequence the genes.

Researchers said one of their challenges has been to figure out how to control the speed of the DNA strand's movement through the tiny nanopore. It needs to move slowly through the hole in order for sensors in the chip to be able to read the sequencing.

IBM reported that its scientists used a multi-layer nanostructure to surround the nanopore. The structure creates an electrical field inside the nanopore, which traps the DNA strand and should allow scientists to have minute control over the speed at which the strand moves through the hole.

Combining DNA with nanotechnology is an idea that's been getting some traction.

Just two months ago, IBM announced that it was using a combination of DNA molecules and nanotechnology to create tiny circuits that could form the basis of smaller, more powerful and energy-efficient computer chips that also are easier and cheaper to manufacture.

The DNA molecules would serve as scaffolding on which carbon nanotubes could assemble themselves into precise patterns. IBM said the process could help chip manufacturers move from 45-nanometer processor technology to 22nm or smaller.

And last winter, researchers at MIT found a way to use a combination of nanotechnology and DNA to fight cancerous tumors. The university announced that a group of scientists there had developed sensors made out of carbon nanotubes that were wrapped in DNA. The sensors then were placed inside living cells to determine whether chemotherapy drugs were reaching their targets or attacking healthy cells.

Alternative Medicine Use For Patients Suffering With Chronic Rhinosinusitis

A new study suggests that a growing segment of patients are turning to complementary and alternative medical therapies to help treat the symptoms of chronic rhinosinusitis (CRS).

In a paper presented at the 2009 American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting & OTO EXPO in San Diego, researchers sought to explore the pattern of complementary and alternative medicine (CAM) use in patients with a prior diagnosis of CRS at a rhinology outpatient clinic in Aberdeen, Scotland.

CRS is defined as a group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses of at least 12 weeks duration. The group of CRS disorders annually accounts for as many as 22 million office visits and more than 500,000 emergency department visits in the U.S., according to some estimates.

Questionnaires were provided to 75 patients over a two-month period. The questionnaire consisted of demographic information and whether they had ever used CAM from a list of 49 herbal and non-herbal alternative therapies (such as acupuncture, massage, aloe vera, and cod liver oil). Subjects were also asked why they used CAM, where they learned of CAM, whether they found it efficacious, and whether their general practitioner was aware they were using it.

Sixty-five percent of patients had used CAM. Thirty percent of patients used it for chronic rhinosinusitis. Women were significantly more likely to use CAM than men, according to the statistics. Patients who were employed, married, and had university degrees were also more likely to use CAM. Only 43 percent of CAM users had informed their doctor about the use of the therapy.

Researchers noted that patients were reticent about telling their physician about usage of CAM. Clinicians should enquire as to all the medications being taken by patients, and the dangers of non- compliance with conventional medications should be emphasized to CAM users by their treating physician.

Can Chinese herbal medicine combat endometriosis?

It may, according to a new review published by the Cochrane Collaboration, an international nonprofit that analyzes health care information.

The review, which looked at results of two randomized studies of Chinese herbal medicine involving 158 women, suggested that Chinese herbs may provide better relief of pelvic pain and other symptoms than one of the prescription drugs normally used in the West, Danazol.

Endometriosis occurs when tissue from inside the uterus escapes to other parts of the body. Outside the uterus, this tissue is seen as “foreign’’ by the immune system, which means that the body mounts an inflammatory response that can cause pain and scarring.

In the review, researchers at the University of Southampton in England found that Chinese herbs - which were not specified and which typically vary from patient to patient in Chinese medicine - were better at relieving menstrual pain than Danazol, a testosterone-derived drug, and were also better at shrinking endometrial masses. They did not prove better for other types of endometrial discomfort, such as rectal pain.

Dr. Aaron Styer, a reproductive endocrinologist at the Massachusetts General Hospital Fertility Center, noted that in the West, the first line of treatment for endometriosis is birth control and other hormonal drugs, which suppress secretion of estrogen by the ovaries. Although the Chinese herbal study is not conclusive, he said, “if a patient has not done well with traditional therapy or doesn’t want to proceed with it, she should investigate these approaches more completely, as long as there’s no potential health risk of taking these herbs.’’

Dr. Hope Riccotti, clinical director of obstetrics and gynecology at the Dimock Community Health Center, cautioned that “herbs are drugs and drug interactions can be dangerous,’’ which makes it important for women to tell their health care providers if they are taking these herbs.