DHEA hormone may help women through menopause - study

LONDON (Reuters) - A hormone called DHEA and mostly secreted by the adrenal glands may be able to help women who are going through menopause and could also give them better sex lives, a study found on Tuesday.

Italian researchers writing in the journal of the International Menopause Society, Climacteric, said they had found the first robust evidence that low doses of DHEA can help sexual function and menopausal symptoms, suggesting it may one day become an alternative to hormone replacement therapy (HRT).

But they stressed that the trial was small, so far larger studies are needed to confirm the results.

"We must bear in mind that this is a pilot study with a small sample," Anna Fenton, co-editor of Climacteric, said in commentary on the work. "We can't yet say that this study means that DHEA is a viable alternative to HRT, but ... we should be looking to do larger studies to confirm these initial results."

DHEA, or dehydroepiandrosterone, is a natural steroid hormone mostly made in the adrenal glands and has a variety of therapeutic uses.

HRT, which is a combination of the hormones oestrogen and progesterone, is an approved treatment for women going through the menopause, who often experience unpleasant symptoms such as hot flushes, night sweats, loss of sex drive and mood swings.

But sales of HRT drugs have fallen sharply since a large study in 2002 found higher rates of ovarian cancer, breast cancer and strokes in women who took the pills, and the search has since been on for alternatives.

American researchers said in January that the antidepressant Lexapro, made by drugmaker Forest Laboratories, significantly cut the number and severity of hot flushes in menopausal women, and other antidepressants including GlaxoSmithKline's Paxil and the Pfizer drugs Prozac and Effexor also have been found to be effective.

For this trial, a team of researchers led by Andrea Genazzani of the University of Pisa followed a group of 48 post-menopausal women with troubling symptoms.

Over a year, 12 women took vitamin D and calcium, 12 took DHEA, 12 took standard HRT and 12 took a synthetic steroid called tibolone which is used to alleviate menopausal symptoms.

The women's menopausal symptoms, sexual interest and activity were measured using a standard questionnaire that explores factors such as satisfaction with frequency of sex, vaginal lubrication, orgasm, and sexual partner.

After 12 months, all the women on hormone replacements had improvements in menopausal symptoms, but those taking vitamin D and calcium did not show any significant improvement.

At the start of the trial, all groups had similar sexual activity, but after the year, those taking calcium and vitamin D scored an average of 34.9 on the questionnaire scale, while those taking DHEA had a score of 48.6, showing that those on DHEA had more sexual interest and activity.

The results for the HRT group were similar, and both the HRT DHEA groups showed a higher level of sexual intercourse in comparison to the control group, the researchers said.

Genazzani said the results showed DHEA has potential, especially for those women who may have problems in taking more conventional HRT. "But this is a small study, a proof of concept. What we need to do now is to look at a larger study, to confirm that these initial results are valid," she added.

(Reporting by Kate Kelland; Editing by Jon Loades-Carter)

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Amgen,Watson to collaborate on cancer biosimilars

DEC 19 - Amgen Inc, the world's largest biotechnology company, and generic drugmaker Watson Pharmaceuticals Inc, said on Monday they will work together to develop and sell biosimilar versions of several biotech cancer drugs.

The companies, which plan to sell biosimilar products under a joint Amgen/Watson label, did not identify which drugs they are planning to develop cheaper versions of, but said they will not be current Amgen products.

Amgen, which is already facing competition in Europe from biosimilars of some of its products, signaled in April that it hoped to utilize its biotech manufacturing expertise to get into the business of biosimilars.

Under terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing and initially commercializing the biosimilar cancer drugs, the companies said. Watson will contribute up to $400 million in co-development costs and take advantage of its expertise in the sale and marketing of specialty and generic drugs. Watson will initially receive royalties and sales milestones from product revenue.

The Food and Drug Administration is expected soon to shed more light on a process for the production and approval of less expensive copies of biotech medicines in the United States in an effort to save billions of dollars in health care costs. However, because biologic drugs are far more complex to produce than chemical pills, biosimilars are not expected to be anywhere near as cheap as traditional generic drugs.

"Biosimilars provide an exciting long-term growth opportunity for Amgen. We have a dedicated team to leverage existing capabilities and capacity and drive the success of the collaboration," Amgen Chief Operating Officer Robert Bradaway, who will become CEO next year, said in a statement.

The deal will also allow Watson to gain a major foothold in the field of biosimilars without having to first develop the complex capability of biologic manufacturing.

(Reporting by Bill Berkrot)

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DHEA hormone may help women through menopause: study

LONDON (Reuters) - A hormone called DHEA and mostly secreted by the adrenal glands may be able to help women who are going through menopause and could also give them better sex lives, a study found on Tuesday.

Italian researchers writing in the journal of the International Menopause Society, Climacteric, said they had found the first robust evidence that low doses of DHEA can help sexual function and menopausal symptoms, suggesting it may one day become an alternative to hormone replacement therapy (HRT).

But they stressed that the trial was small, so far larger studies are needed to confirm the results.

"We must bear in mind that this is a pilot study with a small sample," Anna Fenton, co-editor of Climacteric, said in commentary on the work. "We can't yet say that this study means that DHEA is a viable alternative to HRT, but ... we should be looking to do larger studies to confirm these initial results."

DHEA, or dehydroepiandrosterone, is a natural steroid hormone mostly made in the adrenal glands and has a variety of therapeutic uses.

HRT, which is a combination of the hormones oestrogen and progesterone, is an approved treatment for women going through the menopause, who often experience unpleasant symptoms such as hot flushes, night sweats, loss of sex drive and mood swings.

But sales of HRT drugs have fallen sharply since a large study in 2002 found higher rates of ovarian cancer, breast cancer and strokes in women who took the pills, and the search has since been on for alternatives.

American researchers said in January that the antidepressant Lexapro, made by drugmaker Forest Laboratories, significantly cut the number and severity of hot flushes in menopausal women, and other antidepressants including GlaxoSmithKline's Paxil and the Pfizer drugs Prozac and Effexor also have been found to be effective.

For this trial, a team of researchers led by Andrea Genazzani of the University of Pisa followed a group of 48 post-menopausal women with troubling symptoms.

Over a year, 12 women took vitamin D and calcium, 12 took DHEA, 12 took standard HRT and 12 took a synthetic steroid called tibolone which is used to alleviate menopausal symptoms.

The women's menopausal symptoms, sexual interest and activity were measured using a standard questionnaire that explores factors such as satisfaction with frequency of sex, vaginal lubrication, orgasm, and sexual partner.

After 12 months, all the women on hormone replacements had improvements in menopausal symptoms, but those taking vitamin D and calcium did not show any significant improvement.

At the start of the trial, all groups had similar sexual activity, but after the year, those taking calcium and vitamin D scored an average of 34.9 on the questionnaire scale, while those taking DHEA had a score of 48.6, showing that those on DHEA had more sexual interest and activity.

The results for the HRT group were similar, and both the HRT DHEA groups showed a higher level of sexual intercourse in comparison to the control group, the researchers said.

Genazzani said the results showed DHEA has potential, especially for those women who may have problems in taking more conventional HRT. "But this is a small study, a proof of concept. What we need to do now is to look at a larger study, to confirm that these initial results are valid," she added.

(Reporting by Kate Kelland; Editing by Jon Loades-Carter)

View the original article here

Amgen, Watson to collaborate on cancer biosimilars

DEC 19 - Amgen Inc, the world's largest biotechnology company, and generic drugmaker Watson Pharmaceuticals Inc, said on Monday they will work together to develop and sell biosimilar versions of several biotech cancer drugs.

The companies, which plan to sell biosimilar products under a joint Amgen/Watson label, did not identify which drugs they are planning to develop cheaper versions of, but said they will not be current Amgen products.

Scott Foraker, head of Amgen's biosimilar division, said the company was fully committed to the effort and expects to see Amgen/Watson biosimilar products on the market in "the second half of this decade."

"Clearly, we're all in," Foraker told Reuters in a telephone interview. "We know exactly which products we're going after. We have detailed product plans and it's fair to say that there has been some work done on some of those products, so we're not starting from scratch."

Amgen, which is already facing competition in Europe from biosimilars of some of its own products, signaled in April that it hoped to utilize its biotech manufacturing expertise to get into the business of biosimilars.

Under terms of the agreement, Amgen will assume primary responsibility for developing, manufacturing and initially commercializing the biosimilar cancer drugs, the companies said. Watson will contribute up to $400 million in co-development costs and take advantage of its expertise in the sale and marketing of specialty and generic drugs. Watson will initially receive royalties and sales milestones from product revenue.

Amgen's biosimilar efforts, however, will not be limited to the collaboration with Watson.

"Each company has the ability to pursue biosimilars outside of the products we're collaborating on, and I will tell you that you can expect to see biosimilars from Amgen outside the oncology space in other therapeutic areas," Foraker said, declining to identify which other areas.

The U.S. Food and Drug Administration is expected soon to shed more light on a process for the production and approval of less expensive copies of biotech medicines in the United States in an effort to save billions of dollars in health care costs. However, because biologic drugs are far more complex to produce than chemical pills, biosimilars are not expected to be anywhere near as cheap as traditional generic drugs.

"Although the detailed guidance that the FDA is working on has not come out we have a pretty good idea of what their expectations are with respect to product development for biosimilars and they align well with our expectations," Foraker said.

Because medicines produced from living proteins cannot be exactly replicated the way chemical pills can, the products are commonly referred to as biosimilars rather than biogenerics and will require separate FDA guidelines for gaining approval than traditional generic drugs.

"Biosimilars provide an exciting long-term growth opportunity for Amgen. We have a dedicated team to leverage existing capabilities and capacity and drive the success of the collaboration," Amgen Chief Operating Officer Robert Bradaway, who will become CEO next year, said in a statement.

The deal will also allow Watson to gain a major foothold in the field of biosimilars without having to first develop the complex capability of biologic manufacturing.

Several other companies have expressed in interest in getting into the business of biosimilars, including Biogen Idec, Merck & Co, Teva Pharmaceuticals Industries Ltd and Sandoz, the generic unit of Swiss drugmaker Novartis.

(Reporting by Bill Berkrot)

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Strict diet could save brain from aging: study

Eating less may keep the mind young, according to Italian scientists who reported Monday they have discovered the molecular process by which a strict diet may save the brain from the ravages of age.

The research, published in the US journal the Proceedings of the National Academy of Sciences, is based on a study of mice that were fed a diet of about 70 percent of the food they normally consumed.

Scientists found the calorie-restricted diet triggered a protein molecule, CREB1, that activates a host of genes linked to longevity and good brain function.

"Our hope is to find a way to activate CREB1, for example through new drugs, so to keep the brain young without the need of a strict diet," said lead author Giovambattista Pani, researcher at the Institute of General Pathology, Faculty of Medicine at the Catholic University of Sacred Heart in Rome.

Researchers have previously discovered that mice on diets showed better cognitive abilities and memory, less aggression, and tended to avoid or delay Alzheimer's disease. But they have not known exactly why.

"CREB1 is known to regulate important brain functions as memory, learning and anxiety control, and its activity is reduced or physiologically compromised by aging," said the study.

Mice that were genetically altered to lack CREB1 showed none of the same memory benefits if they were on a low-calorie diet as mice that had the molecule, and showed the same brain disabilities as mice that were overfed.

"Thus, our findings identify for the first time an important mediator of the effects of diet on the brain," Pani said.

"This discovery has important implications to develop future therapies to keep our brain young and prevent brain degeneration and the aging process."

According to Marc Gordon, chief of neurology at Zucker Hillside Hospital in Glen Oaks, New York, the findings could shed new light on why some people who are obese in middle age encounter cognitive problems later in life.

"Mid-life obesity has been associated with late-life dementia. However, the physiological basis for this association remains unclear," said Gordon, who was not part of the study.

"These investigators have studied the effects of limiting caloric intake in mice, and have identified a biochemical pathway that may mediate at least some of the brain's responses to dietary restriction."

View the original article here

US breakthrough in live cancer cells

US researchers said Monday they have discovered how to keep tumor cells alive in the lab, generating buzz in the scientific community about a potential breakthrough that could transform cancer treatment.

Until now, scientists have been unable to make cancer cells thrive for very long in the laboratory in a condition that resembles the way they look and act in the body. Doctors have largely relied on biopsied tissue that is frozen or set in wax to diagnose and recommend treatment.

The advance has sparked new hope that someday doctors may be able to test a host of cancer-killing drugs on a person's own tumor cells in the lab, before returning to the patient with a therapy that is likely to be a good match.

"This would really be the ultimate in personalized medicine," said lead author Richard Schlegel, chairman of the department of pathology at Georgetown University's Lombardi Comprehensive Cancer Center.

"The therapies would be exactly from their tissues. We would get normal tissue and tumor tissue from a particular patient and specifically match up their therapies," Schlegel told AFP.

"We are really excited about the possibilities of testing what we can do with this."

The method, described in the online edition of the American Journal of Pathology, borrows on a simple method used in stem cell research, experts said.

Lung, breast, prostate and colon cancers were kept alive for up to two years using the technique, which combines fibroblast feeder cells to keep cells alive and a Rho kinase (ROCK) inhibitor that allows them to reproduce.

When treated with the duo, both cancer and normal cells reverted to a "stem-like state," Schlegel said, allowing researchers to compare the living cells directly for the first time.

The two elements have previously been used separately in stem cell research, according to Yale University pathology professor David Rimm, who wrote a commentary that accompanies the article.

"No individual technique was new, as far as I know. It was in some sense a very clever combination that led to this success," Rimm told AFP.

Rimm cautioned that more labs need to show they can do it too, and that attempts to try different therapies to kill the cancer cells are just "speculation" now, but described the initial results as "pretty compelling."

"One of my senior scientists went down to Georgetown for a week and she got it to work. She got pancreatic cells to work, which is impossible. Even they were having trouble with that one," he said.

"So that just further served to stoke my enthusiasm, rather than generate skepticism."

If other scientists can replicate the technique -- and three university labs in the United States are already working on it -- the advance could herald a long-awaited transformation in the way cancer cells are studied.

The study was published after two years of research in collaboration with National Institutes of Health scientists and was funded by the NIH, the Department of Defense, Georgetown University and the National Cancer Institute.

"A tumor from one patient is different from a cancer from another patient, even though they appear to be the same under a pathologist's microscope, and really that is one important reason why so many clinical trials fail," said Marc Symons, investigator at the Center for Oncology and Cell Biology at The Feinstein Institute for Medical Research in Manhasset, New York.

"I think it is fair to say this may revolutionize the way we think of cancer treatment," added Symons, who was not involved in the study.

Cancer is the leading cause of death in the world, killing 7.6 million people in 2008 according to the latest data from the World Health Organization.

Mark Friedman, who works in the department of pathology at St. Luke's Roosevelt Hospital, said the real gain for patients could be reducing the harmful effects of chemotherapy that may not be suited for various tumors.

"This would be a tremendous benefit for the patient because you would be minimizing toxicity while maximizing the benefit of the treatment," said Friedman, who was not part of the study.

Karen Anderson, of the Biodesign Institute at Arizona State University, was one of the scientists who recently completed training in the method at Georgetown. She said the process took three days to learn.

"It is actually surprisingly straightforward... I am optimistic about it but we have to confirm whether or not the cells that are growing are really going to be the things we want to be able to study," she said.

"But I think it is pretty exciting."

ksh/oh

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Canadian doctor to star athletes gets fine, no prison

BUFFALO, New York (Reuters) - A Canadian sports doctor who treated top athletes and admitted bringing illegal performance-enhancing drugs into the United States was sentenced on Friday to probation for his role in transporting drugs across the border.

Dr. Anthony Galea of Toronto pleaded guilty in July to introducing misbranded drugs into the United States in a plea agreement under which stiffer charges he faced were dismissed.

Prosecutors alleged Galea and a former assistant lied to border agents during more than 100 cross-border trips between 2007 and 2009.

Galea was accused of smuggling such substances as human growth hormone used to aid in muscular and joint recovery time, energy-boosting ATP used in training, and performance drug actovegin. Human growth hormones are banned by professional sports, and actovegin is not approved for use in the United States.

U.S. District Judge Richard Arcara sentenced Galea to one-year supervised release and a $270,000 penalty.

"There is no question he's paying a huge price for his misdeeds," Arcara said, citing heavy media exposure and a negative impact on Galea's career.

The judge noted Galea has been ejected from some medical associations and risks losing his medical license in Canada. He was never licensed to practice medicine in the United States.

At least 20 professional athletes were among Galea's patients, but prosecutors said they were not accusing them of using illegal drugs.

The athletes included champion pro golfer Tiger Woods, baseball player Alex Rodriguez and professional football players Jamal Lewis and Takeo Spikes.

Letters from more than 130 former patients and others were read in court, including one from former National Hockey League player Tie Domi, who also attended the sentencing.

The case came to light when Galea's assistant, Mary Anne Catalano, was arrested in 2009 carrying drugs as she crossed the Peace Bridge into Buffalo from Ontario. She pleaded guilty to making a false statement and was sentenced to one year probation.

Galea addressed the court, choking up when he described his remorse and apologizing to his former assistant "for the strife that I caused her."

"I blew it and I'll never forgive myself for that," he said.

Galea originally faced five charges, including a smuggling charge that carried a potential penalty of 20 years in prison.

(Editing by Ellen Wulfhorst and Greg McCune)

View the original article here

Alexza to explore strategic options

Vietnam says an outbreak of hand, foot and mouth disease has killed 156 people, mostly children, and sickened more than 96,000 through late November.

View the original article here

Roche melanoma drug wins European green light

LONDON (Reuters) - European regulators have recommended approval of a targeted melanoma drug from Swiss group Roche Holding AG, opening the way to a new treatment option for patients with the deadliest form of skin cancer.

The green light for Zelboraf from the European Medicines Agency -- which Roche said on Friday it expected to be formally endorsed by the European Commission in February -- follows U.S. approval in August.

The new drug is given as a twice-daily pill and is designed to be used alongside a companion diagnostic test, also from Roche, that identifies which patients have a specific genetic mutation that means they will benefit from the treatment.

The London-based agency said the benefits of Zelboraf, particularly the improvements seen in terms of patients going longer before their disease progressed and overall survival, outweighed its potential risks.

Side effects from Zelboraf can include secondary growths, rash, slight hair loss, extreme photosensitivity and joint pain.

Zelboraf was developed in partnership with Daiichi Sankyo and became the second drug to be approved for melanoma in the United States this year, after Yervoy from Bristol-Myers Squibb.

Roche said in August that Zelboraf would cost just over $56,000 for a six-month course of treatment in the United States. It has yet to announce a price in Europe.

Analysts tracked by Thomson Reuters Pharma, on average, forecast annual sales of $930 million for the medicine by 2016, making it a useful addition to Roche's market-leading portfolio of cancer therapies.

Zelboraf, known clinically as vemurafenib, is targeted for patients with tumors that have a mutation in a gene known as BRAF that allows melanoma cells to grow. About half of all melanomas have the genetic aberration the drug targets.

The European drugs watchdog said it backed Zelboraf for treating patients with the BRAF mutation who suffered from metastatic or unresectable melanoma, meaning it cannot be removed by surgery.

Melanoma globally afflicts nearly 160,000 new people each year. It can spread quickly to internal organs and average survival is six to nine months.

(Reporting by Ben Hirschler)

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Asthma Drugs in Pregnancy Might Pose Risk for Kids

FRIDAY, Dec. 16 (HealthDay News) -- Infants born to mothers who use inhaled glucocorticoids -- a class of steroids -- to treat asthma during pregnancy may be at risk for endocrine and metabolic disorders, a new study indicates.

Researchers looked at more than 65,000 mother-child pairs from the Danish National Birth Cohort who were followed from early pregnancy into childhood.

Of the women in the study, about 61,000 (94 percent) had no asthma during pregnancy while almost 4,100 (6 percent) did have asthma during pregnancy. At the end of follow-up, the median age for the children was about 6, with an age range of about 3.5 to 9.

For mothers who used the asthma inhalers, budesonide (Pulmicort) was the most common glucocorticoid.

The use of inhaled glucocorticoids during pregnancy was not associated with an increased risk of most diseases in children, with the exception of endocrine and metabolic disorders.

"Our data are mostly reassuring and support the use of inhaled glucocorticoids during pregnancy," wrote first author Marion Tegethoff, an associate faculty member in clinical psychology and psychiatry at the University of Basel, Switzerland, and colleagues.

The study appears online ahead of print in the American Journal of Respiratory and Critical Care Medicine.

Asthma is common in pregnant women and glucocorticoids are the recommended treatment, the researchers noted.

"This is the first comprehensive study of potential effects of glucocorticoid inhalation during pregnancy on the health of offspring, covering a wide spectrum of pediatric diseases," study co-author author Gunther Meinlschmidt, an associate faculty member in clinical psychology and epidemiology, said in a journal news release. "While our results support the use of these widely used asthma treatments during pregnancy, their effect on endocrine and metabolic disturbances during childhood merits further study."

Although the study found an association between inhaler use and certain disorders, it did not show cause and effect.

More information

The Canadian Lung Association has more about asthma and pregnancy.

View the original article here

Canadian doctor to star athletes gets fine, no prison

BUFFALO, New York (Reuters) - A Canadian sports doctor who treated top athletes and admitted bringing illegal performance-enhancing drugs into the United States was sentenced on Friday to probation for his role in transporting drugs across the border.

Dr. Anthony Galea of Toronto pleaded guilty in July to introducing misbranded drugs into the United States in a plea agreement under which stiffer charges he faced were dismissed.

Prosecutors alleged Galea and a former assistant lied to border agents during more than 100 cross-border trips between 2007 and 2009.

Galea was accused of smuggling such substances as human growth hormone used to aid in muscular and joint recovery time, energy-boosting ATP used in training, and performance drug actovegin. Human growth hormones are banned by professional sports, and actovegin is not approved for use in the United States.

U.S. District Judge Richard Arcara sentenced Galea to one-year supervised release and a $270,000 penalty.

"There is no question he's paying a huge price for his misdeeds," Arcara said, citing heavy media exposure and a negative impact on Galea's career.

The judge noted Galea has been ejected from some medical associations and risks losing his medical license in Canada. He was never licensed to practice medicine in the United States.

At least 20 professional athletes were among Galea's patients, but prosecutors said they were not accusing them of using illegal drugs.

The athletes included champion pro golfer Tiger Woods, baseball player Alex Rodriguez and professional football players Jamal Lewis and Takeo Spikes.

Letters from more than 130 former patients and others were read in court, including one from former National Hockey League player Tie Domi, who also attended the sentencing.

The case came to light when Galea's assistant, Mary Anne Catalano, was arrested in 2009 carrying drugs as she crossed the Peace Bridge into Buffalo from Ontario. She pleaded guilty to making a false statement and was sentenced to one year probation.

Galea addressed the court, choking up when he described his remorse and apologizing to his former assistant "for the strife that I caused her."

"I blew it and I'll never forgive myself for that," he said.

Galea originally faced five charges, including a smuggling charge that carried a potential penalty of 20 years in prison.

(Editing by Ellen Wulfhorst and Greg McCune)

View the original article here

Drug helps prevent mountain sickness, herbs don't

NEW YORK (Reuters Health) -- Acetazolamide, a drug commonly used to prevent acute mountain sickness, may reduce symptoms for some people who use it, a review of studies indicates.

However, herbal supplements were not effective treatments for the condition, found the researchers from Indiana University School of Medicine.

Acute mountain sickness, also called altitude sickness, "feels exactly like a hangover but can last a day or two," Dr. Peter Hackett, director of the Institute for Altitude Medicine in Telluride, Colorado told Reuters Health.

According to Hackett, upon arriving to Colorado mountain ski resorts, as many as 40 percent of tourists experience symptoms of headache, nausea and fatigue.

"Our aim was to determine which medications or supplements most effectively prevented acute mountain sickness with the fewest side effects in adults traveling to high elevations," lead author Dr. Rawle Seupaul told Reuters Health.

Seupaul and his team reviewed seven studies that compared several drugs and supplements for treating the symptoms of acute mountain sickness, and published the review this month in the Annals of Emergency Medicine.

Three trials studied acetazolamide, marketed as Diamox and approved by the Food and Drug Administration to prevent acute mountain sickness.

Acetazolamide speeds up the body's natural acclimation to altitude by stimulating breathing, which in turn increases the amount of oxygen in the blood.

The other studies looked at the effects of gabapentin (marketed as Neurontin), used to treat seizures and chronic pain, sumatriptan (Imitrex), used to treat migraine headaches, antioxidants, magnesium and Ginkgo biloba.

All trials were published after 2000 and had at least 50 participants.

Acetazolamide, which costs about $6 per 500 milligram pill, prevented symptoms in as many as one of every three people taking the drug, at doses ranging from 125 milligrams twice per day to 750 milligrams once a day.

Lower doses, though slightly less effective, were also associated with fewer side effects. The most common side effects reported by people using acetazolamide included numbness and tingling, or a "pins-and-needles" sensation, frequent urination and an alteration in the way things taste.

Though gabapentin and sumatriptan are not commonly prescribed for acute mountain sickness, they each showed benefit in a single trial for one of every six people treated with gabapentin and one of every four people using sumatriptan.

People using antioxidants, magnesium and Ginkgo biloba experienced acute mountain sickness at similar rates as those given a placebo.

"There's a lot of enthusiasm for antioxidants and herbals, but no evidence to back it up," said Seupaul.

The review did not include trials studying the use of dexamethasone, a medication given to treat severe cases of altitude sickness, but rarely prescribed preventatively, according to Hackett.

Acute mountain sickness occurs most frequently in people who travel rapidly to elevations above 8,000 feet. Anyone can get acute mountain sickness, although some people appear more genetically prone to it.

A slow ascent to altitude is considered the best way to prevent acute mountain sickness, but often isn't an option for people flying directly from sea level to a mountain resort.

It's helpful to stay overnight at an intermediate altitude if possible, suggested Hackett, for example staying a night in Denver before traveling to your resort.

It's also a good idea to avoid alcohol the first night you arrive and take care not to overexert yourself the first day, he said.

While acute mountain sickness can leave you feeling crummy, it usually clears up within a day or two on its own. Ibuprofen, rest and drinking plenty of water can help said Dr. Hackett, but do seek medical care if you are short of breath, you feel dizzy or your headache worsens.

SOURCE: http://bit.ly/u59kUp Annals of Emergency Medicine, online December 9, 2011.

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German body questions InterMune drug, shares drop

(Reuters) - Shares of InterMune Inc fell as much as 30 percent on Thursday, after a German advisory body raised questions on the clinical benefits of its lung drug Esbriet, raising concerns about reimbursement for the drug.

The Institute for Quality and Efficiency in Health Care (IQWiG), an independent scientific institute that provides recommendations to the Germany's reimbursement authority, said treatment with Esbriet, also known as pirfenidone, showed no "additional benefit" or effect on the mortality rate or quality of life.

InterMune, in a press statement, said it had a number of important concerns with the methodology applied by the committee, and plans to vigorously challenge the IQWiG assessment during the 90-day review period that has now begun.

Esbriet, which has a so-called "orphan drug" status in Europe, was approved by the European regulatory authorities in March, as a treatment for idiopathic pulmonary fibrosis -- the scarring or thickening of the lungs without a known cause. The company launched the drug in Germany in September.

Orphan drugs are those approved for the treatment of rare medical conditions. Under German law, such drugs are deemed as having an additional benefit, leading IQWiG to assess the Esbriet additional benefit as given "but not quantifiable," the company said.

"As a next step, we will now carefully analyze the IQWiG report and provide a detailed response by January 5, 2012," Markus Leyck Dieken, InterMune's senior vice president and general manager for Germany, said in a statement.

However, the company's shares had already lost a third of their value earlier in the day on media reports about the committee decision. At least three brokerages cut their price targets on the stock saying that the final report, which is expected next year, will likely have an effect on the reimbursement of Esbriet.

"We wonder if other EU countries would wait to price/reimburse the drug until IQWiG's final assessment/potential re-pricing in Germany," Jefferies analyst Eun Yang said in a note to clients. Yang predicts the final decision will not be significantly different from this preliminary one.

Accordingly, the analyst lowered his 2013 Europe Esbriet sales estimates to $51 million from $92 million, while cutting his price target on the stock to $10 from $18.

Brisbane, California-based InterMune is studying the drug in a late-stage trial for approval in the United States, after the country's health regulators asked for a new efficacy data on it.

Brean Murray Carret analyst Brian Skorney, who has a price target of $42 on the stock, said the FDA's decision on U.S. approval would not be influenced by the German body's assessment.

Earlier on Thursday, Goldman Sachs cut its sales expectations for Esbriet on an analysis of the drug's launch, calling the European launch "staggered." The brokerage reduced its price target on the stock to $22 from $29.

InterMune shares closed down more than 30 percent at $12.74 on Nasdaq, after touching a 52-week low of $12.60 earlier on Thursday.

(Reporting by Vidya L Nathan in Bangalore; Editing by Sriraj Kalluvila and Richard Chang)

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Health Highlights: Dec. 15, 2011

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Drug Shortages Caused by Production Problems: GAO

Production problems and factory shutdowns are the main reason for the shortages of important drugs in the United States, according to a report released Thursday by the federal Government Accountability Office.

The GAO said the number shortages of crucial drugs, including cancer drugs and nutritional products, has more than tripled since 2006, the Wall Street Journal reported.

"Manufacturing problems were the primary cause of most shortages," the GAO concluded in its analysis of the situation.

The GAO said the solution includes giving the Food and Drug Administration the authority to force manufacturers to give immediate notice when they experience problems that will halt production, and to require manufacturers to "take certain actions to prevent, alleviate or resolve shortages," the WSJ reported.

------

Asthma, Bronchitis Among Top Kids' Medical Conditions: Report

Acute bronchitis, asthma, trauma-related disorders, middle-ear infections and mental disorders were the five most commonly treated medical conditions among U.S. children in 2008, a federal government report says.

More than 40 percent of the nation's children age 17 and younger were treated for at least one of those conditions that year, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

About 12 million children were treated for acute bronchitis, making it one of the most common ailments. However, bronchitis had the lowest treatment cost, an average of $226 per child.

Mental disorders were the fifth most commonly treated condition (5 million children) and had the highest treatment cost, an average of $2,483 per child.

Medicare paid the largest share of treatment costs for asthma (51 percent) and mental disorders (46 percent), while private insurance paid the largest share for the treatment of middle-ear infections (64 percent), trauma (62 percent) and bronchitis (55 percent).

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New Bill Would Boost Monitoring of Medical Implants

Legislation introduced in the U.S. Senate Wednesday would require makers of artificial hips and other medical implants to monitor the performance of their products after they receive Food and Drug Administration approval.

Recently, there have been a number of problems with artificial hips and other medical implants and the bill is meant to address longstanding complaints by patients advocates and others about the FDA's approval system for certain types of implants, The New York Times reported.

Under what's known as the 510(k) process, the manufacturer need only show that a new product is "substantially similar" to a product already on the market. Thousands of all-metal hips approved under this process are now failing prematurely in patients.

The new bill would not require pre-approval testing of such medical implants but would give the FDA the power to force companies to gather data on the performance of the products. The bill would also boost federal scrutiny of product recalls, The Times reported.

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U.S. Must Protect Research Participants: Panel

Greater transparency, easy-to-understand warnings for patients about the potential dangers of participating in studies, and high ethical standards should be required in research funded by the U.S. government, says a report released Thursday by the President' Bioethics Commission.

The commission also said federal officials should consider compensating victims who are harmed in future research financed by U.S. government dollars, Agence France-Presse reported.

The panel was convened by President Barack Obama last year after it was revealed that 1,300 people in Guatemala were exposed to venereal disease as part of U.S.-led research in the 1940s. The research resulted in 83 deaths.

Last year, the U.S. was involved in 55,000 human research projects worldwide, most of them for health and medical purposes, AFP reported.

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View the original article here

Health Highlights: Dec. 16, 2011

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Recalled Defibrillator Leads Could Injure Patients: Report

Riata defibrillator leads have been recalled by the U.S. Food and Drug Administration because they can potentially injure or kill patients, device maker St. Jude Medical said Thursday.

The devices are used to connect defibrillators to the heart. The company said about 79,000 patients have the Riata leads, Bloomberg News reported.

Wires inside some leads can penetrate the insulation and compromise the device's integrity, St. Jude said. The devices may inappropriately deliver a shock to a patient's heart or fail to deliver a needed shock. The company stopped selling the Riata leads last year.

"At this time, no blanket statement can be made about clinical recommendations," Anne Curtis, chairwoman of medicine at the University at Buffalo in New York and a member of St. Jude's medical advisory board, said in a news release, Bloomberg reported.

"Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads," Curtis advised.

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Drug Shortages Caused by Production Problems: GAO

Production problems and factory shutdowns are the main reason for the shortages of important drugs in the United States, according to a report released Thursday by the federal Government Accountability Office.

The GAO said the number of shortages of crucial drugs, including cancer drugs and nutritional products, has more than tripled since 2006, the Wall Street Journal reported.

"Manufacturing problems were the primary cause of most shortages," the GAO concluded in its analysis of the situation.

The GAO said the solution includes giving the Food and Drug Administration the authority to force manufacturers to give immediate notice when they experience problems that will halt production, and to require manufacturers to "take certain actions to prevent, alleviate or resolve shortages," the WSJ reported.

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Asthma, Bronchitis Among Top Kids' Medical Conditions: Report

Acute bronchitis, asthma, trauma-related disorders, middle-ear infections and mental disorders were the five most commonly treated medical conditions among U.S. children in 2008, a federal government report says.

More than 40 percent of the nation's children age 17 and younger were treated for at least one of those conditions that year, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

About 12 million children were treated for acute bronchitis, making it one of the most common ailments. However, bronchitis had the lowest treatment cost, an average of $226 per child.

Mental disorders were the fifth most commonly treated condition (5 million children) and had the highest treatment cost, an average of $2,483 per child.

Medicare paid the largest share of treatment costs for asthma (51 percent) and mental disorders (46 percent), while private insurance paid the largest share for the treatment of middle-ear infections (64 percent), trauma (62 percent) and bronchitis (55 percent).

View the original article here

States to weigh in on basic health coverage

(Reuters) - U.S. health officials will allow states to select the basic set of medical benefits that must be offered by insurance plans participating in new exchanges mandated by the federal healthcare overhaul, the U.S. government said on Friday.

The Department of Health and Human Services announcement relates to the so-called essential health benefits for millions of Americans expected to qualify for coverage sold through state-based insurance exchanges beginning in 2014.

The proposed approach reflects the federal government's commitment to give states flexibility as they set up the exchanges, HHS Secretary Kathleen Sebelius said on Friday.

"The coverage that works in Florida may not work in Nebraska," Sebelius told reporters on a conference call.

Under the approach announced on Friday, states can select an existing health plan to set the benchmark for services included in the essential health benefits package.

As benchmarks, states would be able to choose either: One of the three largest small employer plans in the state; one of the three largest state employee health plans; one of the three largest federal employee health plan options; or the largest health maintenance organization plan offered in the state's commercial market.

As set out in the law, states must ensure the essential benefits package covers services in at least ten categories of care, among them preventive care, emergency services, maternity care and prescription drugs.

Ron Pollack, executive director of healthcare advocacy group Families USA, said that HHS needed to provide "strong oversight and enforcement" of the benefit standards as they are implemented in the states.

"It will be important to ensure that adequate coverage across all ten required benefit categories is provided - marking an improvement over many plans offered today," Pollack said.

HHS said it would take comments on the proposal until January 31. The announcement on Friday addressed only the services and items covered by a health plan, not cost sharing, such as deductibles, co-payments, and co-insurance. HHS plans to address cost in a future announcement.

The essential benefits are perhaps the most anticipated piece of information still awaited by states, employers, health providers and especially insurers under President Barack Obama's landmark healthcare overhaul.

The exchanges are designed to create easy access to an open marketplace of insurance plans and to allow uninsured people and small businesses to band together to negotiate cheaper rates for healthcare coverage, as well as automatically be considered for government subsidies.

HHS has been subject to intense lobbying over the rule as virtually the entire U.S. healthcare system, including insurers such as Aetna Inc and WellPoint Inc, could be affected by it.

The Institute of Medicine, an advisory group to U.S. policymakers, recommended in October that essential benefits stay in line with the cost of insurance in a typical small employer plan, in step with inflation and medical advances.

The healthcare overhaul is designed to extend coverage to an estimated 32 million Americans who are now uninsured.

(Reporting by Lewis Krauskopf; Additional reporting by Anna Yukhananov in Washington; Editing by Lisa Von Ahn, Gunna Dickson, Gary Hill)

View the original article here

U.S. states to weigh in on basic health coverage

(Reuters) - U.S. health officials will allow states to select the basic set of medical benefits that must be offered by insurance plans participating in new exchanges mandated by the federal healthcare overhaul, the U.S. government said on Friday.

The Department of Health and Human Services announcement relates to the so-called essential health benefits for millions of Americans expected to qualify for coverage sold through state-based insurance exchanges beginning in 2014.

The proposed approach reflects the federal government's commitment to give states flexibility as they set up the exchanges, HHS Secretary Kathleen Sebelius said on Friday.

"The coverage that works in Florida may not work in Nebraska," Sebelius told reporters on a conference call.

Under the approach announced on Friday, states can select an existing health plan to set the benchmark for services included in the essential health benefits package.

As benchmarks, states would be able to choose either: One of the three largest small employer plans in the state; one of the three largest state employee health plans; one of the three largest federal employee health plan options; or the largest health maintenance organization plan offered in the state's commercial market.

As set out in the law, states must ensure the essential benefits package covers services in at least ten categories of care, among them preventive care, emergency services, maternity care and prescription drugs.

Ron Pollack, executive directore of healthcare advocacy group Families USA, said that HHS needed to provide "strong oversight and enforcement" of the benefit standards as they are implemented in the states.

"It will be important to ensure that adequate coverage across all ten required benefit categories is provided - marking an improvement over many plans offered today," Pollack said.

HHS said it would take comments on the proposal until January 31. The announcement on Friday addressed only the services and items covered by a health plan, not cost sharing, such as deductibles, co-payments, and co-insurance. HHS plans to address cost in a future announcement.

The essential benefits are perhaps the most anticipated piece of information still awaited by states, employers, health providers and especially insurers under President Barack Obama's landmark healthcare overhaul.

The exchanges are designed to create easy access to an open marketplace of insurance plans and to allow uninsured people and small businesses to band together to negotiate cheaper rates for healthcare coverage, as well as automatically be considered for government subsidies.

HHS has been subject to intense lobbying over the rule as virtually the entire U.S. healthcare system, including insurers such as Aetna Inc and WellPoint Inc, could be affected by it.

The Institute of Medicine, an advisory group to U.S. policymakers, recommended in October that essential benefits stay in line with the cost of insurance in a typical small employer plan, in step with inflation and medical advances.

The healthcare overhaul is designed to extend coverage to an estimated 32 million Americans who are now uninsured.

View the original article here

Fewer veterans with PTSD using anti-anxiety drugs

NEW YORK (Reuters Health) - Use of a class of anti-anxiety drugs fell during the past decade among veterans with posttraumatic stress disorder, a large U.S. study shows.

The trend is encouraging, researchers say, because current guidelines recommend against using the drugs, benzodiazepines, to treat symptoms associated with posttraumatic stress disorder (PTSD).

"One of our concerns is that it's very, very difficult to get patients off benzodiazepines," said Dr. Matthew Friedman, executive director of the National Center for PTSD and a professor of psychiatry at Dartmouth, who co-authored the study.

Benzodiazepines include the medications alprazolam (Xanax), diazepam (Valium) and clonazepam (Klonopin). They are used to manage conditions such as anxiety and insomnia, which are often linked to PTSD. Long-term use of the drugs can lead to high tolerance and addiction.

The study, which looked at data from more than 498,000 patients in the Veterans Affairs health care system between 1999 and 2009, found decreases in the frequency, duration and doses of benzodiazepines given to veterans with PTSD.

Treating veterans with PTSD will become even more important in coming years, the team notes, due to recent and ongoing U.S. military conflicts. The number of veterans with PTSD treated in the Veterans Affairs health care system rose nearly 200 percent between 1999 and 2009.

The percentage of PTSD patients given benzodiazepines fell from about 37 percent in 1999 to about 31 percent in 2009. Of patients taking the drugs, the proportion of long-term (more than 90 days) users dropped from about 69 percent in 2000 to about 64 percent in 2009. Daily doses fell 14 percent on average, according to findings published in the Journal of Clinical Psychiatry.

Veterans with PTSD have an increased risk for harm because they often also suffer from substance abuse disorders, the researchers note. Estimates place the co-occurrence of alcohol abuse and PTSD around 25 percent, or higher, nationally.

Emerging evidence also suggests benzodiazepines may interfere with prolonged exposure therapy, which has been one of the most effective treatments for PTSD, Friedman said.

Guidelines issued by the departments of Defense and Veterans Affairs earlier this year recommend against using the drugs to treat veterans with PTSD. Instead, experts generally recommend psychotherapy to treat core symptoms such as hypervigilance, avoidance and flashbacks. The guidelines also recommend using antidepressant medications to treat PTSD symptoms.

"We believe a lot of benzodiazepines are being prescribed for problems with sleep, which is also a symptom of depression," Friedman told Reuters Health. "If we treat the depression, perhaps the insomnia will also go away."

The study found that new PTSD patients -- those who were diagnosed and began treatment at a Veterans Affairs medical center -- in 2009 were prescribed benzodiazepines at the lowest rate, about 21 percent. Newly diagnosed patients are often the first to benefit from updated treatment guidelines.

TRADING ONE RISK FOR ANOTHER?

But the possibility that benzodiazepines are simply being swapped out for other risky drugs concerns some experts.

Substituting more modern medications such as zolpidem (Ambien) or quetiapine (an antipsychotic) is not the answer, said Dr. Alexander Neumeister, a professor of psychiatry and radiology at New York University.

"Unfortunately, when you look into databases like the VA's, it is pretty evident that there is a lot of off-label use of medications like quetiapine to treat sleep issues," Neumeister told Reuters Health, referring to the ability of doctors to prescribe drugs approved for conditions other than PTSD.

"Even if you avoid the abuse problem, you're nevertheless treating a patient with a medication that really should not be used for that indication. Not at all."

The study authors also recognized that possibility.

"We are trying to characterize these diagnoses to get a better handle on who's prescribing what, who's getting what, and for what reasons," said Friedman. "Based on that information, we can develop our educational approaches to inform clinicians who may not be as familiar with clinical practice guidelines."

SOURCE: http://bit.ly/rAcuOG Journal of Clinical Psychiatry, online November 29, 2011.

View the original article here

Dutch pot sales to foreigners go up in smoke

AMSTERDAM (Reuters) - The reputation of the Netherlands as the go-to country for a legal joint will begin to vanish like a puff of smoke next year as sales to foreigners of cannabis and hashish in coffee shops are banned.

The Dutch government has been clamping down on the sale of soft drugs since 2007 because of gang-related crime and concern about the risk to health, particularly as stronger forms of cannabis have been introduced.

"The Dutch drugs policy's appeal to foreign users has to be reduced," Dutch Security and Justice Minister Ivo Opstelten said in a letter to parliament.

"Drug use by minors will be strongly discouraged and in particular, vulnerable young people will be protected against drug use," the minister added.

The new rules, which will first take effect in the south and gradually be extended countrywide, limit sales of cannabis to residents of the Netherlands who must enroll as members of a coffee shop, the minister said.

The rules will come into effect from January 1, 2012, but will not be enforced until May 1, starting in the three southern provinces where drug tourism is most common and regarded as a problem by many local residents.

The rest of the country, including Amsterdam, whose drugs scene is a tourist magnet, will enforce the new rules from January 1, 2013.

From that year onwards, a coffee shop can have a maximum of 2,000 members.

The Dutch government, whose push for a stricter drugs policy is led by the Christian Democrats party, will forbid any coffee shops within 350 m (yards) of a school, with effect from 2014.

The government in October launched a plan to ban what it considered to be highly potent forms of cannabis -- known as "skunk" -- placing these in the same category as hard drugs such as heroin or cocaine.

(Reporting by Gilbert Kreijger)

View the original article here

Drug Users With HIV at Much Higher Overdose Risk

FRIDAY, Dec. 16 (HealthDay News) -- HIV-infected drug users are 74 percent more likely to have an overdose than those without HIV, a new evidence review finds.

Behavioral and biological factors may be among the reasons for this increased risk, according to the Rhode Island Hospital researchers. Drug overdose is a frequent cause of non-AIDS death among people with HIV.

The link between HIV infection and drug use is well documented, but the association between HIV and overdose has received less attention and was the focus of this study, which involved a review of 24 previous studies.

"Over the past 30 years, we have made impressive strides in caring for and prolonging the lives of people with HIV. Our study found that premature death by overdose is an issue that affects people with HIV disproportionately," study leader Traci Green, a researcher with Rhode Island Hospital and the Lifespan/Tufts/Brown Center for AIDS Research, said in a hospital news release.

"It is not entirely clear why the risk is greater, and few studies have endeavored to figure out why this might be happening," she added.

Biological factors may include clinical status, weakened immune systems, opportunistic infections and poorer physical health among HIV-infected drug users. Some research has suggested that hepatitis C infection and other conditions that affect metabolic ability may also increase the risk of overdose, according to the release.

Behavioral factors -- such as high-risk lifestyles and an increased rate of psychiatric conditions -- may also contribute to the higher risk of overdose among HIV-infected drug users, Green said.

Other possible factors could include homelessness and poverty, and poor access to medications and therapy used to treat opioid dependence, she suggested. Many HIV patients take opioid painkiller drugs as part of their treatment, while others use illegal opioids.

The study appears online in advance of print in the journal AIDS.

"Bringing overdose awareness and prevention into the HIV care setting is critical to reducing overdose deaths," Green said.

"Health care providers who treat HIV-infected patients with a history of substance abuse or who are taking opioid medications should consider counseling patients on how to reduce their risk of overdose. They may also consider prescribing naloxone (Narcan) to patients, or offering a referral to MAT (medication-assisted therapy) to reduce the risk of overdose," she advised.

Naloxone is a prescription medication that reverses an opioid overdose and has no abuse potential.

More information

The New Mexico AIDS Education and Training Center has more about recreational drugs and HIV.

View the original article here

U.S. agrees to limit medical research on chimpanzees

CHICAGO (Reuters) - The U.S. National Institutes of Health (NIH) will sharply curtail medical research studies using chimpanzees, humans' closest relative in the animal kingdom, after an expert panel said such studies are rarely warranted.

NIH Director Dr. Francis Collins said on Thursday his agency will adopt new recommendations from the Institute of Medicine (IOM), part of the National Academies of Sciences, that will limit research funded by the agency involving chimpanzees.

"After very serious and careful consideration, I have decided to accept the IOM committee recommendations," Collins told reporters on a telephone briefing.

He said effective immediately, the NIH will stop accepting any applications for research grants using chimpanzees until the agency can get rules in place that will allow it to adhere to the new guidelines.

The NIH in 2010 asked the IOM to reassess the use of chimpanzees in medical research in light of new technologies that provide for other testing methods.

In its report, issued on Thursday, the IOM panel of experts said use of chimpanzees in government-funded medical research should be reserved only for studies where no suitable alternative is available or where testing in people would be unethical, and only for life-threatening or debilitating conditions.

"Research use of animals that are so closely related to humans should not proceed unless it offers insights not possible with other animal models and unless it is of sufficient scientific or health value to offset the moral costs," Jeffrey Kahn of Johns Hopkins Berman Institute of Bioethics in Baltimore, who chaired the committee.

"We found very few cases that satisfy these criteria," Kahn said in a statement.

MINIMIZING PAIN AND DISTRESS

The report was initially requested by the U.S. Congress, which has been considering legislation that would ban research on chimpanzees and other great apes, which use tools and have complex social structures.

Congress became interested after animal rights groups protested NIH's decision to transfer chimpanzees housed at Alamogordo, a primate reserve facility that does not have an active chimpanzee research primate facility.

The chimps were set to be transferred to the Southwest National Primate Research Center, a setting where active research was allowed. Animals rights groups, including the Humane Society of the United States, instead wanted the chimps to be permanently retired.

The controversy prompted members of the Senate to call for an assessment of how chimpanzees are used in biomedical research.

The European Union banned research on use of all great apes in 2010. The EU ban also includes a provision using these animals in cases where no other suitable alternative could be found.

In its report, the panel of IOM experts said the NIH should limit the use of chimpanzees in behavioral research to studies that provide insights into behavior, mental health, emotion, or cognition that could not be obtained otherwise.

It also said current research on monoclonal antibodies, drugs that use molecules engineered to help the immune system, could continue. Such research is a major area for biotechnology companies and has led to the development of live-saving medicines worth billions of dollars.

The report said NIH should require these studies to be performed only on animals that do not resist participating, using techniques that are minimally invasive and reduce potential pain and distress.

Researchers who conduct studies with chimpanzees must house them in appropriate physical and social environments, or in natural habitats.

Collins said NIH has more than 600 chimpanzees in its research facilities, and it will soon start figuring out what to do with them, including assessing how many are needed for research in the event of a global disease pandemic.

He estimates that NIH currently is funding about 27 grants involving chimpanzee research outside of the agency, and there are about 10 studies going on within NIH.

"We would guess that something like 50 percent of those may no longer fit the principles and criteria" laid out in the IOM report, Collins said.

The IOM did not address use of chimpanzees in research done by industry, but Kahn, writing in the journal Science, urged companies to take up the same standard.

The group was split on whether chimpanzees should be used in research for a hepatitis C vaccine, a disease that affects 3.2 million Americans and can cause liver disease and cancer.

Chimpanzees and humans are the only two species that are susceptible to HCV infection, and no other suitable animal models currently exist to test a vaccine.

(Editing by Michele Gershberg and Sandra Maler)

View the original article here

Dutch pot sales to foreigners go up in smoke

AMSTERDAM (Reuters) - The reputation of the Netherlands as the go-to country for a legal joint will begin to vanish like a puff of smoke next year as sales to foreigners of cannabis and hashish in coffee shops are banned.

The Dutch government has been clamping down on the sale of soft drugs since 2007 because of gang-related crime and concern about the risk to health, particularly as stronger forms of cannabis have been introduced.

"The Dutch drugs policy's appeal to foreign users has to be reduced," Dutch Security and Justice Minister Ivo Opstelten said in a letter to parliament.

"Drug use by minors will be strongly discouraged and in particular, vulnerable young people will be protected against drug use," the minister added.

The new rules, which will first take effect in the south and gradually be extended countrywide, limit sales of cannabis to residents of the Netherlands who must enroll as members of a coffee shop, the minister said.

The rules will come into effect from January 1, 2012, but will not be enforced until May 1, starting in the three southern provinces where drug tourism is most common and regarded as a problem by many local residents.

The rest of the country, including Amsterdam, whose drugs scene is a tourist magnet, will enforce the new rules from January 1, 2013.

From that year onwards, a coffee shop can have a maximum of 2,000 members.

The Dutch government, whose push for a stricter drugs policy is led by the Christian Democrats party, will forbid any coffee shops within 350 m (yards) of a school, with effect from 2014.

The government in October launched a plan to ban what it considered to be highly potent forms of cannabis -- known as "skunk" -- placing these in the same category as hard drugs such as heroin or cocaine.

(Reporting by Gilbert Kreijger)

View the original article here

Dutch pot sales to foreigners go up in smoke

AMSTERDAM (Reuters) - The reputation of the Netherlands as the go-to country for a legal joint will begin to vanish like a puff of smoke next year as sales to foreigners of cannabis and hashish in coffee shops are banned.

The Dutch government has been clamping down on the sale of soft drugs since 2007 because of gang-related crime and concern about the risk to health, particularly as stronger forms of cannabis have been introduced.

"The Dutch drugs policy's appeal to foreign users has to be reduced," Dutch Security and Justice Minister Ivo Opstelten said in a letter to parliament.

"Drug use by minors will be strongly discouraged and in particular, vulnerable young people will be protected against drug use," the minister added.

The new rules, which will first take effect in the south and gradually be extended countrywide, limit sales of cannabis to residents of the Netherlands who must enroll as members of a coffee shop, the minister said.

The rules will come into effect from January 1, 2012, but will not be enforced until May 1, starting in the three southern provinces where drug tourism is most common and regarded as a problem by many local residents.

The rest of the country, including Amsterdam, whose drugs scene is a tourist magnet, will enforce the new rules from January 1, 2013.

From that year onwards, a coffee shop can have a maximum of 2,000 members.

The Dutch government, whose push for a stricter drugs policy is led by the Christian Democrats party, will forbid any coffee shops within 350 m (yards) of a school, with effect from 2014.

The government in October launched a plan to ban what it considered to be highly potent forms of cannabis -- known as "skunk" -- placing these in the same category as hard drugs such as heroin or cocaine.

(Reporting by Gilbert Kreijger)

View the original article here

Alcohol Use Down, Pot Use Up Among U.S. Teens

WEDNESDAY, Dec. 14 (HealthDay News) -- Alcohol use by American teens has dropped to historic lows, but more of them are using marijuana and don't believe it's a dangerous drug, according to an annual national survey conducted by the U.S. National Institute on Drug Abuse and the University of Michigan.

The nationally representative survey of 47,000 students in grades eight, 10 and 12 at 400 public and private schools found a continuing trend of lower alcohol consumption that stretches back to the 1980s.

Forty percent of 12th graders reported drinking within the previous 30 days in the new survey, compared to 54 percent in 1991. And rates declined from 43 percent to 27 percent among 10th graders, and from 25 percent to 13 percent among eighth graders.

The 2011 Monitoring the Future survey also found evidence of declines in teens' use of illicit drugs such as cocaine, crack cocaine and inhalants, as well as illegal use of the narcotic drug Vicodin, the stimulant drug Adderall, sedatives, tranquilizers, and cough and cold medicines.

But, marijuana use among teens rose in 2011 for the fourth straight year, after a large decline in the preceding decade.

The number of teens in all three grades who said they had used marijuana in the past year increased from 21.4 percent in 2007 to 25 percent in 2011. Rates of daily or near daily marijuana use have also increased in all three grades and this year were 1.3 percent in grade eight, 3.6 percent in grade 10, and 6.6 percent in grade 12.

"Put another way, one in every 15 high school seniors today is smoking pot on a daily or near daily basis," principal investigator Lloyd Johnston said in a University of Michigan news release. "And that's the highest rate that we have seen over the past 30 years -- since 1981."

The increasing use of marijuana may be due to the fact that fewer teens believe the drug is dangerous, even with regular use, the researchers said. This "perceived risk" among teens has fallen sharply over the past five years and continued to decline this year, the survey found.

In addition, teens' disapproval of marijuana use has declined over the past three or four years, which suggests there is less peer pressure to discourage use of the drug.

More information

The U.S. National Institute on Drug Abuse offers marijuana facts for teens.

View the original article here

Drugmakers get more time to record gifts to doctors

WASHINGTON (Reuters) - U.S. drugmakers and device companies got an extension on the deadline to record all payments and gifts to doctors because of a delay in a proposed rule from health officials.

The Physician Payment Sunshine Act, part of President Barack Obama's healthcare overhaul last year, requires manufacturers to report all payments to doctors above $10 and pay penalties if they fail to do so.

The Centers for Medicare and Medicaid Services (CMS) on Wednesday posted draft regulations that outline procedures for companies to report the information and share it with the public.

The rules were supposed to be finished by October 1 and would have required companies such as pharmaceutical giant Pfizer and devicemaker Medtronic to start collecting information on payments from January 1.

But CMS said because the rules were late, manufacturers now have until the final rule is published sometime in 2012 before they must start recording payments to doctors.

CMS said it needed extra time to draft the proposed rule in order to determine the most efficient and cost-effective way to implement the provision, and also make sure its Office of Information Systems had enough resources to make it work.

The new requirements are meant to shine light on the industry's ties to physicians, which can include pricey dinners,

golf vacations, and consulting and speaking fees.

Critics of such gifts say the perks may skew doctors' decision-making when prescribing treatments.

CMS said it would post the payment information on a public website that would be easily searchable and aggregated - a key issue for consumer groups that fought for the rule's passage.

"When people are faced with the difficult task of choosing the right doctor, they need all the information they can gather," said Dr. Peter Budetti, CMS deputy administrator for Program Integrity.

"If your doctor is taking money from manufacturers of prescription drugs, suppliers of wheelchairs or other devices, you deserve to know about it," he said in a statement.

The proposed rule would fine manufacturers $150,000 for failing to report such payments, and $1 million for knowingly failing to report them.

Companies, as well as group purchasing organizations (GPOs), would also have to report any ownership or investment stakes held by doctors. GPOs negotiate lower drug prices from manufacturers in return for guaranteed contracts from a range of hospitals and pharmacies in their system.

The rules came one day before a planned hearing in the Senate Special Committee on Aging, chaired by Wisconsin Democrat Herb Kohl, to discuss the delay in the regulations. The hearing has now been postponed.

The gifts-reporting measure was originally proposed in 2009 by Kohl and Iowa Republican Charles Grassley, and then became part of President Obama's healthcare law in 2010 as a way of reducing healthcare costs through greater transparency.

Both senators have sent several letters to CMS in past months, urging it to act on the rule.

"The completion of the guidance is good news," Grassley said in a statement. "It came after a lot of follow-up from Sen. Kohl and me to find out the status and to press for results from CMS.

"It shows Congress has a responsibility not just to make laws but also to see that they're carried out as intended."

(Reporting By Anna Yukhananov; Editing by Gary Hill)

View the original article here

Analysis: Big Pharma gets a driving lesson from carmakers

LONDON (Reuters) - Big drugmakers, under pressure to streamline operations in the face of rising costs and slowing sales, are looking to the automotive industry for tips on tuning up their profit engines.

Cars and medicines may seem to have little in common but executives are starting to join the dots between the sectors, applying the lessons of "lean" car production systems and fragmented value chains to the world of pharmaceuticals.

It shows a new openness to outside ideas by Big Pharma.

GlaxoSmithKline, for example, teamed with McLaren in September to get innovation and process know-how from its Formula One engineers, mirroring a 2009 move by AstraZeneca to tap manufacturing expertise from Jaguar Land Rover, part of India's Tata Motors.

The 250-strong consulting arm of German sports carmaker Porsche, for its part, has targeted pharmaceuticals as a sector ripe for advice.

That may raise eyebrows because profitability in the drugs industry, with a 10 percent pretax return on invested assets, is roughly double that in the global auto sector.

But as drugmakers face healthcare cuts, a record wave of patent expiries and increased regulatory hurdles for new drugs, they may need to take a page from carmakers' playbook when it comes to ruthless streamlining and cost cutting.

Vivian Hunt, European pharma head at consultancy McKinsey, sees clear parallels between the way autos have "disaggregated" and what is starting to happen in pharmaceuticals.

"The auto industry has been through a huge number of structural changes yet is still a hugely innovative sector, and is a growth industry in many countries and for many players," Hunt said, adding that this offered lessons to others.

RETREATING TO THE CORE

Once upon a time, the auto sector was vertically integrated and dominated by large, mainly Western companies. Today, some 70 percent of a car's value is attributable to suppliers, according to market researcher SupplierBusiness.

Major carmakers have retreated to a few core operations such as brand marketing, design, and final assembly of key modules such as engines and chassis.

They now orchestrate an army of contractors who supply brakes, transmissions and sometimes even bodywork, along with thousands of other parts needed to build a car.

A similar trend may be emerging in pharmaceuticals as research budgets are cut, more drugs are licensed in from biotech companies and certain operations, including parts of the clinical trials process, are farmed out.

As of now, drug firms still rely heavily on creating value in-house, suggesting there is a way to go yet and moving down a similar track could potentially yield big rewards.

According to Porsche, the average product development time in the auto industry has fallen by 28 percent in recent years, while in pharmaceuticals it has risen by 31 percent.

In a report last week, McKinsey warned that drug majors need to change their ways since "the good old days of the pharmaceutical industry are gone forever" as profit margins head substantially lower.

In addition to pressures from medical insurers and regulators, large drug companies are also finding more upstart competitors moving in on their patch. The world's top 10 firms may still control nearly half the market but Big Pharma has a growing bunch of more focused rivals, from biotech to generics.

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Margins in pharma vs autos http://link.reuters.com/car55s

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PERFECT STORM

"We are in a perfect storm," the head of Swiss cancer drug maker Roche, Severin Schwan, told an industry conference last week.

He sees the drugs industry becoming polarized, with only companies that are truly innovative or extremely efficient makers of generic medicines being able to survive.

As times get tougher, returns on pharma research have fallen nearly 30 percent in the past year, according to a recent study by Deloitte and Thomson Reuters. That has pushed the sector into territory familiar to carmakers.

"The auto industry in Europe has not always been able to recoup the costs of capital, to put it mildly," said Reto Hess, who coordinates analysis of global car makers at Credit Suisse Private Banking.

"But in terms of production costs, the auto industry may be a model for other industries. The amount of high tech that is offered at affordable prices in today's cars is remarkable."

Simon Hammett, Deloitte's head of European pharma, sees some parallels with autos but is wary of pushing the analogy too far, given the unusual and serendipitous nature of drug discovery.

"Different parts of the pharma value chain have different analogies. There are some lessons from the automotive industry but there are also some really interesting analogues in the creation of productive talent in the media industry," he said.

Drug companies, while keen to reduce inventories, also need to be careful before embracing the auto industry's "just-in-time" supply lines, given the imperative to avoid supply disruptions in life-saving medicines.

The case of Boeing's 787 Dreamliner shows how emulating carmakers' radical approach to outsourcing can go wrong. The U.S. plane maker's decision to rely on a complex supply chain of about 50 partners put the project nearly three years behind schedule.

(Editing by Jane Merriman)

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Teen smoking at historic lows but marijuana use high: survey

(Reuters) - Cigarette and alcohol use among teens is at the lowest level in decades, but marijuana use is on the rise, according to a survey released on Wednesday.

Just under 19 percent of high school seniors said they smoked cigarettes in the past month compared to a peak rate of 36.5 percent in the mid-1990s, results from the National Institutes of Health Monitoring the Future survey showed.

Rates of cigarette smoking among all teens surveyed decreased compared to last year's results.

Researchers said 100 percent smoke-free locations and higher cigarette prices helped drive down the number of teen smokers.

Although alcohol remains popular among teens, rates of underage and binge drinking showed significant declines, researchers said.

Overall, cigarette and alcohol usages by teens are at the lowest points since the first survey was taken in 1975.

Marijuana use among teens rose in 2011 for the fourth straight year -- a sharp contrast to a dramatic decline that occurred in the preceding decade.

Daily marijuana use is at a 30-year peak level among high school seniors, the survey found.

Monitoring the Future is an annual survey of eighth, 10th and 12th graders conducted by researchers at the University of Michigan with funding from the National Institute on Drug Abuse.

Nearly 47,000 students from 400 public and private schools were polled in classrooms earlier this year.

Among 12th graders, 36.4 percent said they smoked marijuana in the past year and 6.6 percent reported daily use, it found.

The 2011 survey for the first time included questions about use of synthetic marijuana, a blend of herbs and spices laced with chemicals and commonly branded Spice or K2.

More than 11 percent of high school seniors reported using the synthetic substance in the past year, it found.

Until recently, K2 and Spice were sold legally online, in gas stations and other shops. Earlier this year federal regulators banned some of the synthetic chemicals.

Next year researchers said they expect to ask questions about bath salts, an increasingly popular street drug that mimics the effects of drugs like LSD or cocaine.

Monitoring the Future is one of three major surveys used by federal health officials to monitor data on youth substance abuse.

(Reporting by Lauren Keiper; Editing by Ellen Wulfhorst and Greg McCune)

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Could Statins Help Those Hospitalized With Flu?

WEDNESDAY, Dec. 14 (HealthDay News) -- Statins, the drugs that can dramatically lower cholesterol levels, may one day also prove useful in combating serious cases of the flu.

A preliminary study in the Journal of Infectious Diseases finds that patients hospitalized with influenza were less likely to die if they were taking a statin, compared with their peers who weren't taking one of the drugs. The effect held even after adjusting for heart disease.

But it's far too soon to consider adding statins to the existing anti-flu armamentarium, the authors stated.

"At this point, statins should not become the standard of care for people hospitalized with the flu," cautioned study co-author Dr. Ann Thomas, a public health physician with the Oregon Public Health Division in Portland. "We would like to see more studies, [and] I think it would be worthwhile to do these studies."

Right now, preventive vaccinations and antiviral medications are the best weapons against this wily foe, but both stop far short of perfection.

Statins have piqued the interest of virologists and others because they may have anti-inflammatory properties that might mitigate the damage from the influenza virus.

"There have been a couple of studies that have found an apparent association between statins and improved mortality in patients who've had sepsis [blood infections], who've had community-acquired pneumonia," said Dr. Bruce Hirsch, an attending physician in infectious diseases at North Shore University Hospital in Manhasset, NY.

This is the first observational study to investigate a possible relationship between statins and deaths from the flu.

The authors reviewed chart records on more than 3,000 patients hospitalized with laboratory-confirmed influenza in 10 states during the 2007-2008 flu season.

Patients on statins were 41 percent less likely to die, the study found, even after adjusting for age, the presence of heart, lung and/or kidney disease, whether or not they had had a flu shot, or whether or not they had received antiviral medications such as Tamiflu (oseltamivir).

But the study also suffers from several limitations, as the authors themselves acknowledged.

Perhaps most importantly, the authors do not know if patients taking statins were already healthier than people not taking statins.

"The big question at baseline was were the people on statins healthier than those not on statins and did that account for why they were less likely to die?" Thomas said. "That's difficult to answer."

"There's no question that these observations are striking in terms of death from influenza but they can't say why," said Dr. Len Horovitz, a pulmonary specialist with Lenox Hill Hospital in New York City. "Why did these people start statins? Were they cardiac patients? Did they think it was a good idea because their cholesterol looked lousy?"

A randomized controlled trial could provide some of these answers but only two have been registered, one of which is terminated and the other of which is no longer recruiting.

This study was sponsored by the U.S. Centers for Disease Control and Prevention's Emerging Infections Program, which usually only does observational studies, Thomas said.

More information

The U.S. Centers for Disease Control and Prevention has more on the seasonal flu.

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Helicopter not always better for stroke patients

NEW YORK (Reuters Health) - The conventional wisdom that helicopters are the best way to transport all stroke patients treated with clot-busting drugs may not be correct, a small study at one medical center suggests.

People suffering a stroke caused by a blood clot -- which most strokes are -- can be treated with a medication called tissue plasminogen activator (tPA). As long as the drug is given within three hours of the first stroke symptoms, it can break up the blood clot and help limit brain damage from the stroke.

Often, patients are treated with tPA at their local ER, then transferred to a larger medical center for admission. And the standard thinking has been that a helicopter, rather than a ground ambulance, is the better way to do that.

That is true in some cases, according to Dr. Alejandro Rabinstein of the Mayo Clinic in Rochester, Minnesota, one of the researchers on the new study.

But the assumption that helicopters are better for all patients has not actually been put to the test -- which, given the expense, is an important gap.

"It's been presumed that getting to the stroke center from your local center faster (by helicopter) is going to improve outcomes," Rabinstein told Reuters Health. "But the reality is that no one has examined that."

So Rabinstein and his colleagues looked at records for 122 stroke patients who'd been transferred to their center from a "spoke" hospital -- mostly rural hospitals within a 120-mile radius of the Mayo Clinic.

Of those patients, 94 were transported by helicopter and 28 by ground -- usually because a helicopter was requested, but not available.

Overall, the study found, helicopters were faster, taking an average of 54 minutes, versus 69 minutes by ambulance.

But there was no difference in patient complications, like bleeding from the tPA treatment, en route to the stroke center. And there were no clear differences in how patients fared longer-term -- including their length of stay in the hospital, and their risk of dying within 30 days.

One-quarter of patients transported by ambulance died, compared with 17 percent of helicopter-transported patients -- a statistically insignificant difference.

Still, Rabinstein said, there are some tPA-treated patients who should be transferred by helicopter -- namely, those who need an additional, "endovascular rescue therapy" to treat the clot (if the tPA doesn't work, for instance).

For those patients, "minutes can be important," Rabinstein said.

"I wouldn't want this to be interpreted as saying that stroke patients shouldn't get an air ambulance," Rabinstein said.

But, he added, the majority of tPA patients would either not need or not be candidates for those additional treatments. "For them, the only justification (for helicopter transport) would be to reduce complications, which we didn't find," Rabinstein said.

Of course, this study looked only at a small number of patients transported to one medical center. Rabinstein said he does not know if the findings would hold true for other stroke centers and their smaller "spoke" hospitals.

"I can only say that it applies to our experience," he said.

Hopefully, Rabinstein said, the results will prompt other medical centers to examine their own patient outcomes.

SOURCE: http://bit.ly/tfsrIH Stroke, online December 8, 2011.

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No heart risk from attention deficit drugs

Most adults do not face a higher risk of heart attack when taking stimulant medications to treat attention deficit hyperactivity disorder, US researchers said on Monday.

The study is the largest and among the first to look specifically at the risks of taking ADHD drugs for people aged 25-64, and is published in an early online version of the Journal of the American Medical Association (JAMA).

Previous studies have shown that some ADHD drugs can raise blood pressure and heart rate, but follow-up research has been unable to find any higher risk of death or major complications.

A separate study last month in the New England Journal of Medicine found no higher risk among youths aged two to 24 who take stimulant medications like Ritalin, after concerns were raised years ago about potential links.

The JAMA observational study, funded by the US Food and Drug Administration and the Agency for Health Research Quality, was based on pharmacy data and medical records for 150,000 people at four clinical sites in the United States.

Comparing those who used the drugs to those who did not, and honing on one the specific subgroups of ADHD drugs, researchers found no higher risk of heart attack, sudden cardiac death or stroke.

However, the study did have some limitations, such as spanning a relatively short period -- about one year -- and excluding people over 65.

"It's important to note that this is an observational study and not a randomized clinical trial," said lead author Laurel Habel, a research scientist with the Kaiser Permanente Northern California Division of Research.

The drugs included in the study were stimulants such as methylphenidate, dextroamphetamines, amphetamine salts and pemoline; and the non-stimulant atomoxetine.

All were labeled for treatment of ADHD in children or adults as of December 31, 2005.

According to the latest FDA data from 2005, about 1.5 million US adults are taking ADHD medication. Of all the US prescriptions issued to children and adults, grownups account for nearly one third.

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Electronic Cigarette Makers Must Prove Safety of Products: Report

WEDNESDAY, Dec. 14 (HealthDay News) -- A new report details exactly what kind of scientific proof the U.S. Food and Drug Administration should require from the makers of electronic cigarettes and tobacco lozenges to show that what they are selling is not harmful to the overall public health.

These "modified risk" products claim to offer individuals nicotine without the health risks, namely lung cancer and heart disease, that are associated with the use of traditional tobacco products such as cigarettes.

"These products are ones that might carry a claim that they have less risk to the user than a traditional tobacco product," said Dr. Jane Henney, a professor of medicine and public health sciences at the University of Cincinnati and chairwoman of the Institute of Medicine (IOM) committee that wrote the report. "We believe that if those claims are to be approved by the FDA, the sponsor will have to bring to the agency a series of data to support that claim."

These products are sold as part of a strategy to lower tobacco-related death and disease, especially among smokers who have had trouble quitting, but not much is known about the overall health risks of these products, according to the committee.

To determine that, the IOM report suggests that the FDA require testing in the laboratory and in animals, clinical trials with people, and post-marketing studies to see if any health problems show up once the products are in widespread use.

Given the "tobacco industry's well-documented history of improper conduct," the committee believes these studies should be done by independent third parties.

The authority for this kind of oversight was included in the 2009 Family Smoking Prevention and Tobacco Control Act, which requires that modified risk tobacco products undergo an approval process similar to drugs and medical devices.

Several groups applauded the IOM report's recommendations.

"The American Lung Association commends the IOM for its recognition that if a tobacco product is allowed to be marketed as 'safer' that the product must actually be safer," Charles Connor, president and CEO of the American Lung Association, said in statement.

"Decades ago, the tobacco industry developed light and low tobacco products that were no less harmful than those already on the market. Millions of Americans, who switched to those so-called 'light' and 'low-tar' products instead of quitting, died as a result of these claims. The scientific standards recommended by this expert panel are designed to prevent a repeat of similar attempts to deceive the American public. We encourage the FDA to heed these lessons and never lose sight of the deception and fraud perpetrated for decades by Big Tobacco," Connor said in the statement.

"This report lays out a comprehensive scientific roadmap for the FDA to follow in reviewing applications for modified risk tobacco products," Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

"It demonstrates the need for rigorous science, conducted and evaluated independent of the tobacco industry, before the industry is allowed to market any modified risk products," he added. "It underscores the importance of the FDA considering the broad public health impact of introducing such products, and not just the impact on individual tobacco users. And it properly puts the burden on tobacco manufacturers to produce adequate scientific evidence before allowing them to claim that any tobacco product reduces the risk of disease."

David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the Legacy Foundation, said he believes the IOM report is right on target.

"These products are worthwhile, provided the overall public health message is adhered to," he said. "It could cause, overall, long-term public health damage. For example, if it was more appealing to youth and young adults it might have a little less harm, but a lot more people would use it and that would violate the public health standard."

According to the report, among the things studies should look at are whether the product is addictive and whether the components of the product are harmful to health. In addition, these products should be tested on current and former smokers, new smokers, adolescents and groups at high risk for tobacco use.

Tests also have to "evaluate whether this product would draw people to the use of this product who now don't smoke, or who might have quit smoking and would be drawn back into this habit and therefore increase their risk," Henney said. "These products should only be targeted to individuals who absolutely have been unable to stop smoking."

The process should also be transparent, the report stated, with the companies and the FDA making all the data available to the public.

However, Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association, doesn't see safety and public health as the driving factors behind the IOM recommendations, but thinks instead it is a conspiracy by tobacco companies, drug companies and the federal government to keep these products off the market.

"I've been fighting this issue for quite some time, but you are fighting much larger groups," he said, noting that electronic cigarettes deliver nicotine without the risk of fire. "It does the same thing as a cigarette, without the 7,000 harmful chemicals and 65 carcinogens."

More information

For more on quitting smoking, visit SmokeFree.gov.

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