New research suggests that young children and teenagers with type 1 diabetes could benefit by using an artificial pancreas device to lower the risk of dangerously low blood sugar levels during sleep and help them control their disease.

The findings, which appear in the Feb. 5 issue of The Lancet, examined use of an artificial pancreas by people aged 5 to 18 in a hospital setting.

The device, which combines blood sugar sensors and insulin pumps, give doses of insulin as needed to patients as they sleep.

Controlling blood sugar at night is a challenge for people with type 1 diabetes. If blood sugar levels drop to dangerously low levels, diabetics can suffer from seizures, coma and even death.

The researchers found that the study participants spent twice as much time during the night at targeted glucose levels when they used the artificial pancreas system compared to when they tried a “manual” approach.

“These studies show that automated systems not only can help people manage diabetes by maintaining good control, they will also improve quality of life for the people with type 1 diabetes and their families by lowering the risk for hypoglycemia,” principal investigator Roman Hovorka, of the Institute of Metabolic Science at the University of Cambridge in England, said in a news release from the journal. “These results suggest that closed-loop devices may be able to significantly lower the patient’s risk of developing complications later in life by reducing or even overcoming the burden of hypoglycemia.”

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People who buy prescription medications over the Internet, especially drugs purporting to treat erectile dysfunction, are playing Russian roulette with their lives, a new study contends.

At best the drugs won’t help you and at worst they could kill you, the review article said.

“You may be wasting your money or you may actually be hurting yourself,” said Dr. Margaret E. Wierman, professor of medicine at the University of Colorado at Denver and chief of endocrinology at the Denver VA Medical Center, who was not involved with the study.

Counterfeit Internet drugs are a mushrooming problem. Seizures of fake drugs in Europe quadrupled between 2005 and 2007. And the number of investigations undertaken by the U.S. Food and Drug Administration increased by a factor of eight between 2000 and 2006, according to the study, published in the International Journal of Clinical Practice.

The sale of counterfeit drugs has almost doubled in the last five years, and will hit $75 billion in 2010, according to one estimate, making it one of the more lucrative illicit drug markets.

As many as 2.5 million men in Europe may have taken counterfeit sildenafil (Viagra), the study authors stated.

“It’s a very significant problem and I think there are people who are being injured,” said Dr. Ira D. Sharlip, a spokesman for the American Urological Association and clinical professor of urology at the University of California, San Francisco. “The only way to avoid the problem is not to buy on the Internet.”

Viagra-like tablets bought on the Internet aren’t necessarily any cheaper than the real thing, but they do allow buyers to avoid the shame factor often associated with asking for this type of drug.

“The motivation is the anonymity of buying drugs on the Internet. It’s embarrassing to some men to go to a pharmacy and pick up his Viagra prescription, and it’s also embarrassing for some men to go to a doctor and say, ‘I have erectile dysfunction. I need some Viagra,’” Sharlip said.

The problem of fake drugs isn’t limited to impotence treatments. According to the study, two pregnant women died after they were given injections of a counterfeit iron preparation for anemia, and 51 children died in Bangladesh of kidney failure after taking paracetamol syrup that was contaminated with diethylene glycol, which is often used as antifreeze in cars.

So many things can go wrong with Internet purchases.

“The purity of the medication or the quality of the medication is under no sort of scrutiny or any type of oversight to determine if, first of all, it is the correct medication. And second, if it is correct is it in the correct dosage?” said Dr. Michael Chehval, chief of urology at St. Louis University.

Study author Dr. Graham Jackson, a cardiologist at London Bridge Hospital in the United Kingdom, said: “The first danger is people don’t know what’s in it. Some are just talcum powder or brick dust, while some have a bit of Viagra or Cialis and some chemicals that have nothing to do with it. One batch actually contained amphetamine, which is an addictive drug. Tablets are made shiny with road paint or shoe polish. The content of the medication could be anything.”

In 2008, four men in Singapore died after ingesting counterfeit impotence drugs that had been contaminated with a blood-sugar-lowering agent, the study reported.

And bypassing the involvement of a competent doctor means red flags could be missed.

“Erection problems can be an early warning sign of heart disease or diabetes,” Jackson said. “If you do have a problem and don’t see a doctor, diagnosis of those important conditions can be missed. Men with no symptoms at all who get an erection problem usually are an average of three to five years away from a heart attack. Instead of going to the Internet, they should be going to their doctors to find out if they are at risk and to do something about it.”

Problems also can occur when the impotence drugs actually do contain phosphodiesterase type 5 inhibitors (PDE5), the main ingredient in Viagra, as well as vardenafil (Levitra) and tadalafil (Cialis).

“People with underlying heart problems are at risk for cardiac events if they take this class of medication,” Chehval said.

According to the review article, about one-third of men reported sidestepping a health-care professional when buying erectile dysfunction drugs.

“This is a really serious issue. We can fix the erectile dysfunction and we can also fix the chances of getting a heart attack,” Jackson said.

Jackson is editor of the journal and reported multiple ties to pharmaceutical companies, including Pfizer, which makes Viagra. The review article covered more than fifty studies published between 1995 and 2009 and was conducted by British, Swedish and American researchers.

Technorati Tags: buy prescription medications, cialis, erectile dysfunction drugs, fake drugs risks, Levitra, Viagra

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Adding chemotherapy to standard cancer-suppressing tamoxifen (also manufactured under brand name Nolvadex) can boost survival in postmenopausal women with the most common type of breast cancer, known as estrogen receptor-positive, and it’s best given before the tamoxifen regimen starts, according to a new study.

“Chemotherapy with Adriamycin adds to your survival benefit over and above what tamoxifen would do if you are postmenopausal and have positive lymph nodes and estrogen receptor-positive cancer [the most common type],” explained Dr. Kathy Albain, the lead researcher and professor of medicine at Loyola University Chicago Stritch School of Medicine.

And in another study, Albain found that screening breast tumors with an available multi-gene test spots patients who may not need this form of chemotherapy, despite fitting the standard profile.

Both studies are published online Dec. 10, the first in the journal The Lancet and the second in The Lancet Oncology. Albain is also due to present her findings Thursday at the annual San Antonio Breast Cancer Symposium in San Antonio, Texas.

In estrogen receptor-positive cancer, tumor cells carry many receptors on their surfaces to which estrogen can attach, fueling tumor growth. Tamoxifen works by blocking the receptors.

Experts have long debated whether women with estrogen receptor-positive cancers — whose growth is fueled by circulating estrogen — would get more benefit from having a chemotherapy regimen on top of tamoxifen.

Albain led a research team from multiple centers that followed nearly 1,500 breast cancer patients for up to 13 years, with a median (half longer, half less) of nearly nine years. All were past menopause and had hormone receptor-positive cancer that had spread to at least one lymph node in the armpit area.

Albain’s team assigned 381 women to tamoxifen alone, 587 to chemotherapy alone and 590 to both, with some receiving tamoxifen and chemo together and some in a sequential manner.

Tamoxifen was taken daily for five years. The chemo regimen used is called CAF, for “cyclophosphamide, Adriamycin and 5-fluorouracil.”

In all, after accounting for study dropouts, 1,460 women received treatment.

The combined treatments of chemo plus tamoxifen increased the women’s disease-free survival by 24 percent, Albain found. When her team looked at which delivery protocol worked best — simultaneous tamoxifen and chemotherapy or chemo followed by tamoxifen — the sequential approach was found to be better, giving slightly better disease-free survival.

Ten-year disease-free survival estimates were 57 percent for the combination group and 48 percent for the tamoxifen-only group, the researchers found.

However, women receiving chemo were more likely to have drops in white blood cells, important for fighting infections, the team noted. And they were also more prone to blood clots, congestive heart failure and other complications.

In a second study, Albain’s team analyzed whether a gene test, called Oncotype DX, could predict which women would benefit from chemotherapy. Genomic Health, which makes the test, helped fund the study, along with the U.S. National Cancer Institute.

The test, which Albain said is already widely used, is done on the tumor itself. “This puts 21 genes together and comes up with a score,” she said. The score — low, intermediate, high — predicts the risk of recurrence over 10 years if a woman used tamoxifen alone.

When the researchers performed the test on 367 specimens, they found a low score identified those women who may not need the chemo, despite the fact that they have cancer that spread to lymph nodes.

“This is a positive study, there’s no question,” said Dr. Joanne Mortimer, vice chair of medical oncology for the City of Hope Cancer Center in Duarte, Calif., of the first study. “This study tells us [that] if you have positive lymph nodes [and are postmenopausal with estrogen receptor-positive cancer], you should have both chemo and tamoxifen, because the survival was better.”

But, she added, “when you give everyone [who has the estrogen receptor-positive, node-positive breast cancer] chemotherapy, probably there are some who don’t need it.”

According to Mortimer, that’s why the gene test looks promising — it may spare some women from having to have chemo while ensuring that those who will benefit from the treatment get it.

Technorati Tags: breast cancer, chemo and tamoxifen, chemotherapy, Nolvadex, tamoxifen

Drug giant GlaxoSmithKline says one of its swine flu vaccines has been certified by the World Health Organization, making it available for donors to buy for developing countries.

In a statement issued Tuesday, GlaxoSmithKline PLC said WHO had approved its Canadian vaccine after examining its quality and safety data. The vaccine contains an adjuvant, a chemical compound to boost the immune system.

Last month, Glaxo advised health authorities not to use one batch of its Canadian-manufactured swine flu vaccine in case it triggered life-threatening side effects like anaphylactic shock.

Several vaccine makers have promised WHO 156 million doses of swine flu vaccine, which it hopes to start shipping to 95 poor countries this month.

Technorati Tags: GlaxoSmithKline, swine flu vaccine, World Health Organization

WASHINGTON (AFP) – The risks of taking anti-inflammatory drug Vioxx could have been detected nearly four years before the drug was pulled from the market, according to analysis of nearly 30 clinical trials.

The findings, published in the Archives of Internal Medicine on Monday, analyzed 30 Vioxx trials involving around 20,000 individuals and fund evidence of the drug’s risks from as early as 2000.

The Merck-made drug was pulled in 2004 after it was linked with serious cardiovascular problems, including heart attacks.

Much of trial data used in the meta-study has only become available because of litigation against the firm.

The study’s authors, including Joseph Ross of the Mount Sinai School of Medicine in New York, said the results showed the need for the open publication of clinical trials.

“Physicians and the public deserve to be in a position to make informed choices about risk and benefits (of pharmaceutical products),” the authors said.

Merck voluntarily withdrew Vioxx from sale in September 2004 after a company internal study in 2001 showed the drug doubled the risks of heart attack in patients who took it for 18 months or longer.

The company has since faced a slew of lawsuits and was forced to pay billions of dollars in damages.

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THURSDAY, Nov. 19 (HealthDay News) — People’s genetic makeup has been shown to affect how they respond to asthma medications, but a new study finds that many people respond well to a particular combination treatment regardless of their genes.

However, the study did find a difference in response among blacks.

The drug combo in question combines the long-acting beta-agonist salmeterol (Serevent) and moderate doses of an inhaled corticosteroid. The genes in question relate to a receptor in the body that is crucial to the effectiveness of asthma bronchodilators.

Some research has suggested that a variation in these genes can affect how people respond to the drugs. The researchers tested that theory in 87 people who had two types of the genetic variation — B16 Arg/Arg or B16 Gly/Gly.

They found that lung function did not differ overall in the groups, although there was some difference in blacks. The results are reported online Nov. 19 in The Lancet.

“These findings provide reassurance that, in the general population, patients should continue to be treated with long-acting beta-agonists plus moderate-dose inhaled corticosteroids irrespective of B16 genotype,” the researchers wrote.

However, there are still questions to be answered, particularly involving blacks’ response to salmeterol, they said.

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Women with asthma may notice that their asthma symptoms get worse at certain times of the month. Now, a new study confirms that fluctuating female hormone levels appear to affect airway inflammation, but oral contraceptives might help ease those changes.

In women who were not using birth control pills, the study found that increased levels of estrogen were associated with decreased levels of exhaled nitric oxide — indicating decreased airway inflammation. In these same women, increased levels of progesterone were associated with increased levels of exhaled nitric oxide, indicating increased airway inflammation.

However, birth control pills lessen dramatic hormone fluctuations, and researchers didn’t find differences in asthma symptoms throughout the month for women who took them.

“This study is a first step in looking at the relationship between hormones and asthma,” said the study’s lead author, Dr. Piush Mandhane, an assistant professor of pediatric pulmonology at the University of Alberta in Canada. The findings might be of use in managing asthma among premenopausal women, the researchers said.

“Among women not on oral contraceptives, we did have changes in exhaled nitric oxide that were related to estrogen and progesterone levels. We didn’t have an association with estrogen and progesterone in women on oral contraceptives,” said Mandhane.

Results of the study are published in the November issue of the journal Chest.

Mandhane said that because many women report a change in asthma symptoms related to menstrual cycles, it’s often assumed that there is an association. But, he said, the relationship between hormonal fluctuations and asthma symptoms hasn’t been well-studied.

The current study included 17 women. Eight were on birth control pills that contained estrogen and progesterone. The average age of the women using oral contraceptives was 25.5, while the average age of the women not taking birth control pills was 37.5.

Three of the women in the group not on birth control reported experiencing menstrual-cycle related asthma prior to the study, while just one woman in the birth control group did.

The researchers gathered daily information about symptoms and conducted blood tests to measure estrogen and progesterone levels, performed spirometry (a lung function test) and took measurements of exhaled nitric oxide. They also conducted allergy tests, via skin pricks every other day.

They found that women who didn’t take birth control pills had an average exhaled nitric oxide level of 48.2 parts per billion (ppb), while those on oral contraceptives had an average level of 27 ppb. In women who weren’t taking oral contraceptives, each increase in estrogen levels was associated with a decrease in exhaled nitric oxide, while each increase in progesterone was associated with an increase in exhaled nitric oxide. That means when progesterone levels are elevated (before menstruation), asthma symptoms are likely to be worse.

Progesterone increases also aggravated allergy symptoms, with more severe allergic reactions evident on skin prick tests when progesterone levels were elevated.

The researchers didn’t find any statistically significant differences in allergic reactions during the month for women on birth control pills.

Mandhane said that “birth control works by flattening out the fluctuations in hormone levels,” and that’s likely why there weren’t many differences in asthma symptoms for women taking birth control pills.

“Hormones do play a role,” said Mandhane, “and women need to be aware that there’s a potential relationship between their asthma symptoms and their menstrual cycles.”

Dr. Jennifer Appleyard, chief of allergy and immunology at St. John Hospital and Medical Center in Detroit, said that this study “lends credence to the fact that asthma is affected by hormones. This is definitely not something women should just write off. It’s not just all in their minds.”

But she also pointed out that this was a small study, and that the women in each group were very different from each other. “There were a lot of older women in one group who took more asthma medication. It’s not really comparing apples to apples,” she said.

Because birth control pills can have some serious side effects, Appleyard said she would not advise someone to go on oral contraceptives just to help their asthma. However, if a woman notices a difference in her symptoms throughout her menstrual cycle, she may want to talk to her doctor about increasing her asthma medications during that particular time in her cycle, she said.

Technorati Tags: airway inflammation, asthma symptoms, birth control pills, menstrual cycles, oral contraceptives

LONDON (AFP) – British health professionals have called for a change in the treatment of dementia patients after an official report warned that wrongly prescribed anti-psychotic medicines are causing the deaths of an estimated 1,800 each year.

As many as 144,000 out of an estimated 180,000 people suffering from the disease are unnecessarily given powerful “chemical cosh” drugs, the Department of Health-ordered review revealed.

The report also linked a significant number of strokes among elderly patients due to over prescription of the medication.

“We need to be sure that only the people who benefit from these drugs get them, and they get them at the lowest possible dose for the shortest period of time,” Sube Banerjee, the report’s author and professor of mental health at King?s College London Institute of Psychiatry, said in the report.

“It is clear that these medications are being prescribed to deal with behaviour and psychological symptoms in dementia rather than just for psychosis,” he added.

Banerjee urged social care services to develop a “different mindset” in tackling the issue.

There are presently 700,000 people in the country with the condition, but the numbers are expected to rise to one million in the next decade because of an ageing population.

“We know there are situations where anti-psychotic drug use is necessary - we’re not calling for a ban, but we do want to see a significant reduction in use,” said care services minister Phil Hope.

Neil Hunt, chief executive of Britain’s Alzheimer’s Society, welcomed the review saying the recognition of the scale of the problem was long overdue.

“This goes beyond quality of care. It is a fundamental rights issue. Our members tell us of enormous worry and distress over what is happening to their loved ones,” he added.

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Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed.

According to the report, when a company-funded study’s primary finding wasn’t favorable, that result was usually buried and something else positive was highlighted, without disclosing the switch.

The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers. The lawyers, who are seeking class action status for the cases, claim Pfizer concealed evidence the epilepsy drug Neurontin didn’t work for those unapproved uses, including nerve pain, migraines and bipolar disorder.

One of the report’s authors is an expert witness for the plaintiffs; another has received fees from the lawyers.

Pfizer disputes the report’s conclusions, saying the company never “attempted to mislead the medical community about the effectiveness” of the drug for certain uses.

“We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research,” Pfizer said in a statement.

The report, by researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public Health, comes two months after Pfizer was fined a record $2.3 billion — including an unprecedented $1.2 billion criminal fine — for illegally marketing other blockbuster drugs.

The report appears in Thursday’s New England Journal of Medicine.

Dr. Sidney Wolfe, head of health research at consumer group Public Citizen, called it the first comprehensive look “at studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was.”

“In every instance, the published article made the drug look better than it would have,” said Wolfe, a member of the Food and Drug Administration’s drug safety advisory committee. “This results in harm.”

Neurontin was approved by the FDA a decade ago for treating seizures and later for pain caused by shingles — but not for other conditions. Its potential side effects include suicidal tendencies and depression.

While doctors can prescribe drugs for unapproved, or off-label uses, drug companies are legally barred from promoting their products for such uses. Drugmakers often test drugs for additional conditions and publicize the results. But they don’t always seek approval for those new uses, particularly if the new findings aren’t convincing.

Experts believe most Neurontin sales were for off-label uses — the ones in the reviewed studies. Sales peaked at $2.7 billion in 2004, when Pfizer paid $430 million in government fines to settle allegations it improperly marketed the epilepsy drug for unapproved uses. By last year, Neurontin sales fell to $387 million due to cheaper generic versions sold as gabapentin.

For the new review, the researchers examined 20 patient studies funded by New York-based Pfizer and its Parke-Davis unit on use of Neurontin for preventing migraines or treating nerve pain or bipolar disorder. The studies were published in medical journals or presented at conferences, mostly over the last decade.

In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn’t disclosed at all.

The authors cited some limitations to their review, including not knowing who made the changes.

“We cannot be certain that selective reporting was a decision made by employees of Pfizer and Parke-Davis, since the authors of the published reports included nonemployees,” the researchers wrote.

Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report “one of the most ethically disturbing papers I’ve read in some time” and “an indication that people have been playing fast and loose with studies,” particularly industry ones.

Caplan said the FDA should have the power to audit industry drug studies. Wolfe said there should be bigger fines and jail terms for manipulating study data, plus tougher rules for studies being published in journals.

Medical journals in recent years have required that studies be listed on a federal Web site, http://www.clinicaltrials.gov, to be eligible for publication. That move was made partly to make it harder for industry to hide studies on products that don’t pan out and only publish those with good results. The study descriptions also list their primary and secondary outcomes.

Pfizer said it now has 1,245 company-sponsored studies listed on the Web site.

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