Report finds funding threat to mental illness drugs (Reuters)

LONDON (Reuters) – European neuroscientists said on Tuesday that the withdrawal by some big drugmakers from research into illnesses like depression, schizophrenia and Alzheimer's could halt the discovery of new drugs.

A report published by the European College of Neuropsychopharmacology (ECNP) said brain diseases and mental disorders like depression, dementia and addiction account for more a third of the burden of disease in Europe, but public and corporate research and development (R&D) funding is being cut.

"These are dark days for brain science," David Nutt, a professor of Neuropsychopharmacology at Imperial College London and a former president of the ECNP told a briefing in London.

Some European big pharma companies such as GlaxoSmithKline and AstraZeneca have in recent years backed away from brain research, citing the difficulty and expense of finding new drug candidates.

The ECNP report said public funding for research in Europe into disorders of the brain lags significantly behind similar investment in the United States.

Yet experts estimate that in any given year, almost 80 million Europeans, or 27 percent of the European Union's population, are affected by disorders of the brain.

"The issue here is not just that a very key part of Europe's knowledge economy is under serious threat, it's that the withdrawal of research resources means the slowdown, and even outright cessation in some areas, of new treatments being developed," said Guy Goodwin, a co-author of the report and head of Oxford University's psychiatry department.

"This will inevitably affect patient well-being."

Nutt and Goodwin said a major part of the problem in persuading public and private organizations to fund research into mental illness is the stigma that it carries.

Unlike research into cancer or heart disease, they said, which commands huge public support and can return a swifter profit to drugmakers who find successful treatments, research into brain diseases is seen as difficult, expensive and ultimately less fruitful.

According to the report, the economic cost to the EU region of brain diseases and mental disorders was conservatively estimated at 386 billion euros ($555 billion) a year in 2005, the last time a full costing analysis was done. That cost, the authors said, far exceeds the cost to the region of any other disease area, including heart disease and cancer.

"The human cost, in terms of illness-related work disability, social role failure and premature death, is similarly immense," they wrote. And as Europe's population ages, those costs are likely to rise further.

Alastair Benbow, executive director of the European Brain Council, said the report showed the urgency of the region's funding crisis in neuropsychiatric drug discovery.

"If steps aren't taken now ... to stimulate research and investment in both the public and private sector, the field could really suffer lasting damage," he said.

(Editing by Jon Hemming)

Seizure drugs tied to pregnancy risks (Reuters)

NEW YORK (Reuters Health) – New research on the links between seizure medication and pregnancy complications highlights the hard choices that pregnant women with epilepsy must make.

Scientists from the University of Bergen in Norway found that women with epilepsy are more likely to have pregnancy complications, and that the added risks were largely "associated with the use of anti-epileptic drugs in pregnancy."

Women who suffer from epilepsy, a brain disorder that involves periodic seizures, face especially difficult decisions about how to treat their condition while pregnant.

Previous research suggests that seizures during pregnancy can harm both mother and child. To prevent seizures, physicians often advise expectant mothers to continue taking their seizure medication.

To assess the range of risks to epileptic mothers and their babies, the authors compared medical records covering the pregnancies of nearly 200 women with epilepsy to those of the same number of women without epilepsy. They also looked at differences between the epileptic women who were taking seizure medications and those who were not.

Overall, epileptic women were more than twice as likely as women without epilepsy to experience preeclampsia -- and four times more likely to have a severe case.

Preeclampsia is characterized by high blood pressure and protein buildup in the urine, and severe preeclampsia is a serious condition that can lead to the death of both mother and child.

Women with epilepsy were also at higher risk for vaginal bleeding early in pregnancy (3.8 times more likely than non-epileptic women), of needing a Cesarean section or induced labor (1.8 times), of giving birth prematurely (nearly 6 times), and of having a baby with malformations (6.5 times the risk of women without epilepsy).

When the researchers analyzed pregnancy risks among just the women with epilepsy, those who were not taking seizure medications had similar risks for some complications -- bleeding and induced or cesarean birth -- as women without epilepsy.

Women taking seizure medications still had the raised risks for all complications.

Nearly 8 percent of women who took epilepsy medication suffered from severe preeclampsia, compared to just under 3 percent of women with epilepsy who did not take medication.

Women who took seizure drugs were also more than twice as likely to have labor induced and emergency Cesarean sections as epileptic women who did not take the medication.

The study does not prove that seizure medications caused the complications. Women who took medication could be different from the women who were not on medication in other ways, for instance.

These results don't mean women with epilepsy should stop taking their medications while pregnant, said the study's lead author, Dr. Ingrid Borthen. The apparent risks from taking epilepsy medication don't outweigh the known potential costs of suffering seizures during pregnancy, she told Reuters Health.

"The overall risk (of complications associated with medication) is low, and it is important to continue the medications during pregnancy to avoid seizures," Borthen said.

Dr. Autumn Klein, a neurologist at Brigham and Women's Hospital in Boston who was not involved in the study, agrees. "It's best to treat them with medications, because convulsions can be dangerous to the mom and the baby," Klein told Reuters Health.

Given the risks that women with epilepsy face during pregnancy, Klein believes that physicians "really need to pay close attention to these patients from an obstetric standpoint and an epilepsy standpoint. Problems come up when patients don't follow up with their physicians."

Klein advises that women with epilepsy visit their neurologists and obstetricians before and during pregnancy to minimize the risk of complications, and encourages specialists to cooperate and communicate in the care of these high-risk patients.

SOURCE: http://bit.ly/jwca8i, BJOG: An International Journal of Obstetrics and Gynaecology, July 2011.

Drugs for Enlarged Prostate May Raise Risk of Aggressive Cancer (HealthDay)

THURSDAY, June 9 (HealthDay News) -- The U.S. Food and Drug Administration is calling for new warning labels on a class of drugs used primarily to treat enlarged prostates, because the medications may raise the risk of developing an aggressive form of prostate cancer.

In a statement released Thursday, the agency said the drugs involved include popular medications sold under the brand names Proscar and Propecia (sold by Merck & Co.) and Avodart and Jalyn (sold by GlaxoSmithKline).

According to the FDA, almost 5 million men were prescribed one of these medications between 2002 and 2009. Of these, nearly 3 million men were between the ages of 50 and 79.

The agency is advising doctors not to start patients on these drugs until prostate cancer -- which can mimic the symptoms of an enlarged prostate -- and other urological conditions have been ruled out.

According to the agency, this new warning is based on the results of two large prostate cancer trials.

Although these trials did not include Propecia, which is prescribed to treat hair loss in men, its label is also being updated. However, the FDA said "the applicability of the Avodart and Proscar studies to Propecia, is currently unknown."

All of these drugs are part of a class of medications called 5-alpha reductase inhibitors (5-ARI). According to the FDA, Proscar, Avodart and Jalyn are approved to treat symptoms of enlarged prostate, while Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is a lower-dose version of Proscar.

Merck issued a statement Thursday on the FDA ruling.

"Merck stands behind the demonstrated safety and efficacy of Proscar [finasteride, 5mg] and Propecia [finasteride, 1mg]. Both products have been prescribed to millions of men, with Proscar prescribed to those suffering from benign prostatic hyperplasia (BPH or enlarged prostate) since 1992, and Propecia prescribed to men with male pattern hair loss since 1997," the company statement said. "Merck's goal is to ensure the product labeling includes all relevant trial information to help health-care professionals and their patients make informed treatment decisions."

Less than a year ago, GlaxoSmithKline asked the FDA to approve the use of Avodart to prevent prostate cancer, although the FDA declined that request in January. The company based its reasoning on the results of one of the trials on which the agency is now basing its new warning.

In addition to this new side effect, recent research has shown that Proscar, Propecia and Avodart are all associated with increasing the risk of erectile dysfunction in men who take the medications.

Commenting on the FDA warning, prostate cancer expert Dr. Anthony D'Amico, chief of genitourinary radiation oncology at Brigham and Women's Hospital in Boston, said, "I think that the warning is appropriate. The risk is very small, but not zero."

"What both studies show conclusively is there is about a 1 percent increase in being diagnosed with high-grade prostate cancer if you got these drugs -- even though you are less likely to get a low-grade cancer."

Why that is is not clear, D'Amico said. "But I think the warning is fair," he added.

The drugs really do work in preventing prostate cancer, D'Amico said. "You have to weigh the 24 percent reduction against the 1 percent increased incidence of high-grade disease," he said.

"These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention," D'Amico said.

More information

For more on prostate cancer, visit the American Cancer Society.

Treatment for Abuse of Anti-Anxiety Drugs Tripled Over 10 Years (HealthDay)

THURSDAY, June 9 (HealthDay News) -- Admissions for treatment of benzodiazepine abuse nearly tripled in the United States between 1998 and 2008, while overall admissions for substance abuse rose only 11 percent, according to a government study released Thursday.

Benzodiazepines -- a class of drugs prescribed to treat anxiety, insomnia and seizure disorders -- include Valium, Halcion, Xanax, Ativan and Librium. Abuse of benzodiazepines, which were introduced in the 1950s to replace barbiturates, can lead to addiction, injury and death.

The Substance Abuse and Mental Health Services Administration (SAMHSA) study found that admissions for treatment of benzodiazepine abuse among patients 12 and older rose from 22,400 in 1998 to 60,200 a decade later. Benzodiazepine-related admissions accounted for 3.2 percent of all substance abuse admissions in 2008, compared with 1.3 percent in 1998.

Most admissions involved white patients (84.8 percent), males (56 percent), and those ages 18 to 34 (55.3 percent). Ninety-five percent of patients who abused benzodiazepines also abused other substances, and in more than three-quarters of those cases, benzodiazepine was the secondary drug of abuse.

Opiates were the primary substance of abuse in more than half of all the cases where benzodiazepine was the secondary drug of abuse. But there were age-related differences. Among teens, marijuana was the most common primary substance of abuse. Among patients 45 and older, alcohol nearly equaled opiates (42.1 percent vs. 47.1 percent) as the primary substance of abuse.

"The misuse of benzodiazepines along with other prescription drugs is fueling the rise of treatment admissions," SAMHSA Administrator Pamela S. Hyde said in an agency news release.

"Prescription drug misuse is dangerous and can even be deadly. Everyone has a role to play in helping to prevent prescription drug misuse. Simple steps such as locking up medications and proper disposal of unused medications are easy ways people can contribute to reducing the problem," she said.

More information

The U.S. National Institute on Drug Abuse has more about prescription drug abuse and addiction.

Drugs for Enlarged Prostate May Raise Risk of Aggressive Cancer (HealthDay)

THURSDAY, June 9 (HealthDay News) -- The U.S. Food and Drug Administration is calling for new warning labels on a class of drugs used primarily to treat enlarged prostates, because the medications may raise the risk of developing an aggressive form of prostate cancer.

In a statement released Thursday, the agency said the drugs involved include popular medications sold under the brand names Proscar and Propecia (sold by Merck & Co.) and Avodart and Jalyn (sold by GlaxoSmithKline).

According to the FDA, almost 5 million men were prescribed one of these medications between 2002 and 2009. Of these, nearly 3 million men were between the ages of 50 and 79.

The agency is advising doctors not to start patients on these drugs until prostate cancer -- which can mimic the symptoms of an enlarged prostate -- and other urological conditions have been ruled out.

According to the agency, this new warning is based on the results of two large prostate cancer trials.

Although these trials did not include Propecia, which is prescribed to treat hair loss in men, its label is also being updated. However, the FDA said "the applicability of the Avodart and Proscar studies to Propecia, is currently unknown."

All of these drugs are part of a class of medications called 5-alpha reductase inhibitors (5-ARI). According to the FDA, Proscar, Avodart and Jalyn are approved to treat symptoms of enlarged prostate, while Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is a lower-dose version of Proscar.

Merck issued a statement Thursday on the FDA ruling.

"Merck stands behind the demonstrated safety and efficacy of Proscar [finasteride, 5mg] and Propecia [finasteride, 1mg]. Both products have been prescribed to millions of men, with Proscar prescribed to those suffering from benign prostatic hyperplasia (BPH or enlarged prostate) since 1992, and Propecia prescribed to men with male pattern hair loss since 1997," the company statement said. "Merck's goal is to ensure the product labeling includes all relevant trial information to help health-care professionals and their patients make informed treatment decisions."

Less than a year ago, GlaxoSmithKline asked the FDA to approve the use of Avodart to prevent prostate cancer, although the FDA declined that request in January. The company based its reasoning on the results of one of the trials on which the agency is now basing its new warning.

In addition to this new side effect, recent research has shown that Proscar, Propecia and Avodart are all associated with increasing the risk of erectile dysfunction in men who take the medications.

Commenting on the FDA warning, prostate cancer expert Dr. Anthony D'Amico, chief of genitourinary radiation oncology at Brigham and Women's Hospital in Boston, said, "I think that the warning is appropriate. The risk is very small, but not zero."

"What both studies show conclusively is there is about a 1 percent increase in being diagnosed with high-grade prostate cancer if you got these drugs -- even though you are less likely to get a low-grade cancer."

Why that is is not clear, D'Amico said. "But I think the warning is fair," he added.

The drugs really do work in preventing prostate cancer, D'Amico said. "You have to weigh the 24 percent reduction against the 1 percent increased incidence of high-grade disease," he said.

"These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention," D'Amico said.

More information

For more on prostate cancer, visit the American Cancer Society.

Prostate drugs raise risk of prostate cancer: FDA (Reuters)

WASHINGTON (Reuters) – A class of drugs meant to improve symptoms of an enlarged prostate gland actually increase the chance of getting a more serious form of prostate cancer, health officials said on Thursday.

However, they also said the drugs' benefits outweigh the risks.

The drugs in this group include Merck & Co's Proscar and GlaxoSmithKline's Avodar and Jalyn, as well as Merck's Propecia, which is approved to treat male pattern hair loss.

The Food and Drug Administration said it revised the labels on all such drugs, called 5-alpha reductase inhibitors (5-ARI), to include the risk after reviewing two large studies.

The randomized controlled studies found that daily use of 5-ARIs for several years decreased the chance of getting lower-risk forms of prostate cancer but made it more likely that patients would get a high-grade prostate cancer, which grows and spreads more quickly.

"This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," the FDA said on its website.

5-ARI drugs are known clinically as finasteride and dutasteride and are used to treat benign prostatic hyperplasia (BPH), or prostate enlargement, a common condition in men over 40. Propecia, for male baldness, includes a smaller dose of finasteride.

The FDA said about 5 million male patients were given a prescription for a 5-ARI from 2002 to 2009. The drugs' benefits in treating BPH still outweighed any risks, it said.

Another class of medicines known as alpha-blockers can also be used to treat symptoms of BPH. Drugs of this type include Astellas Pharma's Flomax, Pfizer Inc's Cardura, and Rapaflo from Watson Pharmaceuticals.

(Reporting by Anna Yukhananov; editing by John Wallace)

British celebrities call for softer drugs laws (AFP)

LONDON (AFP) – Actress Judi Dench, entrepreneur Richard Branson and pop star Sting joined three former police chiefs in urging the British government to decriminalise drugs possession.

They signed a petition drawn up by campaign group Release and sent to Downing Street on Thursday that calls on Prime Minister David Cameron to review the effectiveness of current drug laws in tackling abuse and addiction.

The petition calls for those caught possessing illegal substances to be fined rather than jailed and for addicts to be referred for treatment rather than given a criminal record.

"It is clear that the present system of applying the criminal law to the personal use and possession of drugs has failed," says the petition.

"Conversely, the harm caused by pursuing this approach has been significant.

"Criminalising people who use drugs leads to greater social exclusion, making it more difficult for them to gain employment and to play a productive role in society," it adds.

Release describes itself as a group that "campaigns for changes to UK drug policy to bring about a fairer and more compassionate legal framework".

Branson, founder of the Virgin brand, supported the call for change, which he said he hoped would take power "out of the hands of organised crime".

"We need more humane and effective ways to reduce the harm caused by drugs," the former record-label chief said.

"The one thing we cannot afford to do is to go on pretending the 'war on drugs' is working."

1. www.release.org.uk