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Saturday, September 13, 2008

Drug Companies Rebuked for Withholding Clinical Trial Data Revealing Negative Results

by David Gutierrez

British officials and researchers scolded the drug industry for withholding negative drug trial results after a new study demonstrated that many antidepressants offer no significant benefit over a placebo to most patients.

The new study marked the first time that researchers in Canada, the United Kingdom and United States had used freedom of information laws to gain access to the studies that drug companies are required by law to provide to regulatory agencies like the Food and Drug Administration in the United States. Looking at the data from both published and unpublished studies, researchers found that while selective-serotonin re-uptake inhibitor (SSRI) antidepressants may be big moneymakers for drug firms, they provide little benefit for most people who take them.

"The regulatory authorities have access to everything," said Peter Littlejohns, clinical and public health director of the United Kingdom's National Institute for Health and Clinical Excellence (NICE), which is responsible for making national drug use recommendations. "Obviously we have access to the published data, and we do ask the industry for unpublished data, but it is up to the companies whether to deliver it or not. We have no power to demand it. The issue is that it relies on the good will of the industry."

Mike Clark of the UK Cochrane Center, which conducts reviews of published trials to come up with recommendations for good medical practice, echoed this sentiment.

"When we ask for details of a trial, the company might tell us nothing," Clark said. "We have even less power than NICE."

In February, the Commons Health Select Committee called for NICE to have access to all clinical trial results, published or not. But the British government responded that forcing industry to divulge these results would be illegal.

The government is advocating for a voluntary program to make a searchable database of all clinical drug trials conducted in the United Kingdom. It has also called for the European Union to make its confidential drug trial database public.

Friday, September 12, 2008

Prescription Drugs More Deadly Than Cocaine, Heroin, Amphetamines

by Sherry Baker

When handsome and talented young actor Heath Ledger died last winter, the New York City medical examiner's autopsy report revealed his death was due to an unintentional life-ending cocktail of prescription drugs, including anti-anxiety medications Alprazolam (Xanax), Diazepam (Valium) and Lorazepam (Ativan), the sleeping pill Zopiclone (Lunesta) and the sedative Temazepam (Restoril), which is also used for insomnia.

So this was just one of those rare tragedies that mostly happens to troubled or hard living Hollywood stars, right? Wrong. Unfortunately, people from all walks of life are dying by the thousands across the U.S. due to prescription drugs. And a new study, Florida’s annual report on Drugs Identified in Deceased Persons, dramatically illustrates this truth.

Relying on autopsies performed in 2007, the state report concludes prescription drugs (anti-anxiety benzodiazepines, the muscle relaxer carisoprodol and all opioids, excluding heroin) continue to be found in both lethal and non-lethal amounts in the dead far more often than illicit drugs.

The bottom line: the rate of deaths in Florida caused by prescription drugs is over three times as high as the rate of deaths caused by all illicit drugs combined.

The study shows 2,328 Floridians died of opiate, or painkiller, overdoses while another 743 lost their lives from over-consuming benzodiazepines, which include the drugs Valium and Xanax. On the other hand, about a third less number of people, 989, died of overdoses from illegal drugs like cocaine, heroin, or methamphetamine (“speed”).

In a statement for the press, Bill James, Director of Florida’s Office of Drug Control, said: “Prescription drugs are not safe and must be secured. Doctors and pharmacists must help law enforcement identify and stop doctor shoppers. We are also looking for ways to curb illegal Internet sales. Only through a comprehensive, coordinated strategy will we be able to reverse this tragic, unacceptable trend."

That’s a nice goal and it is true some people abuse prescription drugs. However, the Drug Enforcement Administration states as many as 7 million Americans are abusing prescription medication -- far more people than those using cocaine, heroin, hallucinogens, Ecstasy and inhalants combined.

And the truth is, even when legal medications are taken as prescribed, they are too often dangerous and even deadly. In fact, according to a study published in the Journal of the American Medical Association (JAMA), an estimated 1.9 million adverse drug reactions occur each year, and up to 180,000 of them could be life threatening or even fatal.

The Department of Health and Human Services (HHS) has released data showing that at least half of all Americans take one prescription drug and one in six of us takes three or even more prescribed medications. And this love affair with pharmaceuticals for health problems is no doubt why prescription drug deaths are now the fourth leading cause of death in the United States, after heart disease, cancer and stroke.

About the author:

Sherry Baker is a widely published writer whose work has appeared in Newsweek, Health, the Atlanta Journal and Constitution, Yoga Journal, Optometry, Atlanta, Arthritis Today, Natural Healing Newsletter, OMNI, UCLA’s "Healthy Years" newsletter, Mount Sinai School of Medicine’s "Focus on Health Aging" newsletter, the Cleveland Clinic’s "Men’s Health Advisor" newsletter and many others.

Dennis Quaid's Children Nearly Killed by Heparin Drug

by David Gutierrez

Admitted to a hospital for a routine staph infection treatment, the newborn twins of movie star Dennis Quaid were almost killed when hospital workers gave them two massive overdoses of a blood-thinning drug.

In addition to antibiotics, Quaid's children were supposed to be given the blood thinning medication Hep-lock, in order to prevent blood clots and flush their IV lines. Instead, they were given the adult medicine Heparin, which is 1,000 times stronger.

"We all have this inherent thing that we trust doctors and nurses, that they know what they're doing," Quaid said. "But this mistake occurred right under our noses; the nurse didn't bother to look at the dosage on the bottle. It was ten units that our kids are supposed to get. They got 10,000. And what it did is it basically turned their blood to the consistency of water."

Nurses became aware of the problem when blood began oozing from every small wound and band-aid on the infants' bodies. The children were given an antidote and their condition stabilized after 41 hours. They were released after 12 days in the hospital.

It was not the first high-profile dosing error with Heparin; a year earlier, three children in an Indianapolis hospital died after being given Heparin instead of Hep-lock.

"What we see with Heparin is that it is almost always in the list of top ten drugs that are reported for medication errors, and almost always in the top ten that are harmful," said Diane Cousins, president of the nonprofit U.S. Pharmacopoeia, which monitors drug errors.

Croft said that the labels of Heparin and Hep-lock are very similar, contributing to the frequency of errors. Other medications prone to confusion include Lidocaine, a pediatric anesthetic, and a lithium oral solution used to treat bipolar disorder.

The manufacturer of the Heparin that caused the bleeding in the Quaid children has since changed the label, but did not recall bottles already distributed with the old ones.

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