Tag Archives: pain killers

French drug trial disaster leaves one brain dead, five injured

PARIS | By Matthias Blamont

Fri Jan 15, 2016 11:30am EST

 

An ambulance is seen outside the Emergency Entrance at the CHU de Rennes hospital, in Rennes, France, where six people are in a serious condition after taking part in a medical trial for an unnamed European laboratory to test a new drug, France’s health ministry said January…Reuters/Stephane Mahe

One person has been left brain dead and five others are in serious condition after taking part in a clinical trial in France of an experimental painkiller made by Portuguese drug company Bial, the French Health Ministry said on Friday.

The medicine involved works by targeting the body’s pain-controlling endocannabinoid system, which is also responsible for the human response to cannabis.

The ministry said the six volunteers in Rennes, in western France, had been in good health until taking the oral medication at a private facility that specializes in carrying out clinical trials.

 

The brain-dead volunteer was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.

The volunteers are all men aged 28 to 49, French Health Minister Marisol Touraine told a news conference. They started taking the drug on Jan 7. One person started feeling ill on Sunday and the other five afterwards.

In total, 90 people have taken part in the trial, taking some dosage of the drug, she said, adding that others took a placebo.

All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.

A spokeswoman for the European Medicines Agency in London said it did not have full details of the case but was monitoring the situation.

Cases of early-stage clinical trials going badly wrong are rare but not unheard of. In 2006, six healthy volunteers given an experimental drug in London ended up in intensive care. One was described as looking like "the elephant man" after his head ballooned. Another lost his fingertips and toes.

"INHERENT RISK"

In the initial Phase I stage of clinical testing, a drug is given to healthy volunteers to see how it is handled by the body and what is the right dose to give to patients.

"Undertaking Phase 1 studies is highly specialist work," said Daniel Hawcutt, a lecturer in clinical pharmacology at Britain’s University of Liverpool.

Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they are finally approved for sale.

Europe has strict regulations governing the conduct of clinical trials, with Phase I tests subject to particular scrutiny. But Ben Whalley, a professor of neuropharmacology at the University of Reading, said these could only minimize risks, not abolish them.

"There is an inherent risk in exposing people to any new compound," he said.

The 2006 London trial led to the collapse of Germany’s TeGenero, the company developing a medicine known as TGN1412. The drug has since gone back into tests for rheumatoid arthritis and is showing promise when given at a fraction of the original dose.

(Additional reporting by Ben Hirschler, John Irish, Noelle Mennella and Ingrid Melander; Editing by Michel Rose and Larry King)

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Heroin use and addiction are surging in the U.S., CDC report says

Heroin use

Rate of heroin use in the U.S. has climbed 63% in the past decade, according to experts at the CDC and FDA

The rate of heroin abuse or dependence has jumped 90% between 2002 and 2013, new CDC report says

Heroin use surged over the past decade, and the wave of addiction and overdose is closely related to the nation’s ongoing prescription drug epidemic, federal health officials said Tuesday.

A new report says that 2.6 out of every 1,000 U.S. residents 12 and older used heroin in the years 2011 to 2013. That’s a 63% increase in the rate of heroin use since the years 2002 to 2004.

Opioids prescribed by doctors led to 92,000 overdoses in ERs in one year

The rate of heroin abuse or dependence climbed 90% over the same period, according to the study by researchers from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.

Deaths caused by heroin overdoses nearly quadrupled between 2002 and 2013, claiming 8,257 lives in 2013.

In all, more than half a million people used heroin in 2013, up nearly 150% since 2007, the report said.

Heroin use remained highest for the historically hardest-hit group: poor young men living in cities. But increases were spread across all demographic groups, including women and people with private insurance and high incomes — groups associated with the parallel rise in prescription drug use over the past decade.

The findings appear in a Vital Signs report published in the CDC’s Morbidity and Mortality Weekly Report.

"As a doctor who started my career taking care of patients with HIV and other complications from injection drugs, it’s heartbreaking to see injection drug use making a comeback in the U.S.," said Dr. Tom Frieden, director of the CDC.

Overdoses fell after 2 narcotic painkillers were taken off the market

All but 4% of the people who used heroin in the past year also used another drug, such as cocaine, marijuana or alcohol, according to the report. Indeed, 61% of heroin users used at least three different drugs.

The authors of the new study highlighted a “particularly strong” relationship between the use of prescription painkillers and heroin. People who are addicted to narcotic painkillers are 40 times more likely to misuse heroin, according to the study.

Once reserved for cancer and end-of-life pain, these narcotics now are widely prescribed for conditions ranging from dental work to chronic back pain.

“We are priming people to addiction to heroin with overuse of prescription opiates,” Frieden said at a news conference Tuesday. “More people are primed for heroin addiction because they are addicted to prescription opiates, which are, after all, essentially the same chemical with the same impact on the brain.”

 

Frieden said the increase in heroin use was contributing to other health problems, including rising rates of new HIV infections, cases of newborns addicted to opiates and car accidents. He called for reforms in the way opioid painkillers are prescribed, a crackdown on the flow of cheap heroin and more treatment for those who are addicted.

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