Drug trial victims - How are they doing?

The incident in which 6 healthy men developed a severe immunological reaction after being given TGN1412, an experimental drug, more than 2 weeks back had created a major furore. I was looking for the latest news on their condition.

A report from 28th March says that two of the six men have been discharged. Three others remain as in-patients at Northwick Park Hospital, London. One man is still in a critical condition after being administered an experimental immune treatment more than two weeks ago.

The hospital has not given any futher information on the prognosis for the critically ill patient, but says that he has shown some signs of improvement. The released volunteers will continue to receive treatment and be monitored as out-patients.

The tragedy of the six human "guinea pigs", hopefully, should lead to more stringent controls on new drug trials.

ADHD drugs incease heart risk

It has always been suspected that drugs used for ADHD (attention deficit hyperactivity disorder) cause cardiac side effects. ADHD is a disorder mainly seen in school age children and is characterized by increased activity, an inability to concentrate and poor school performance. Drugs used to treat ADHD are sympathetic stimulants. There have been a few reports of sudden death and myocardial infarction in patients taking these drugs.

The Drug Safety and Risk Management Advisory Committee of the FDA recently reviewed the adverse reports on ADHD drugs. They recommendeded the inclusion of a black-box warning describing the cardiovascular risks of drugs used to treat this condition. However, this recommendation has subsequently been toned down by the Pediatric Advisory Committee of the FDA who felt such a black-box warning will do more harm than good fightening off patients and parents.

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Hopes for new anti-HIV drugs involving natural host defence

BBC reports that scientists have discovered that cells use a previously unknown mechanism to fight off HIV, the virus which causes AIDS. The machanism involves 2 proteins that normally help repair cellular DNA. These proteins were found to destroy DNA made by HIV. The virus requires this DNA to survive inside the cell.

This has raised hopes of a breakthrough that could lead to treatments to which the virus might be less able to adapt. Current treatment of HIV infection uses combinations of drugs that target the virus itself, blocking its ability to reproduce and spread. They have proved to be very effective, but there are concerns that HIV may develop resistance to the drugs.

This study from Ohio State University study appears in Proceedings of the National Academy of Sciences.

Lead researcher Professor Richard Fishel said: "Our findings identify a new potential drug target, one that involves a natural host defence. HIV treatments that target cellular components should be far less likely to develop resistance."

Investigations are at a preliminary stage and it take years for anything useful to come out of this

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Celebrex Passes Cardiac and Gastric Safety Test

Focus has been on the COX-2 inhibitor Celebrex (celecoxib), ever since Vioxx was found to increase thromboembolic events in treated patients.

In a study, conducted by Gurkirpal Singh, MD, and colleagues at Stanford University, published in the March issue of The American Journal of Medicine, Celecoxib has been shown to be as effective for the treatment of osteoarthritis as are non-specific non-steroidal anti-inflammatory drugs (NSAIDs). Additional findings included that Celebrex posed a lower risk of serious gastric effects, while the frequency of cardiovascular thromboembolic events among patients taking Celebrex versus NSAIDs was similar.

The results of the study could mean patients who cannot tolerate NSAIDs can take treatment with Celebrex without fear of adverse cardiac events.

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High dose vitamin C found safe for cancer patients

Scientists from the RECNAC II project have published findings that verify the safety of high dose intravenous vitamin C. In this study, published in the Puerto Rico Health Sciences Journal, a phase one clinical trial with 24 terminal cancer patients receiving between ten and sixty grams of sodium ascorbate daily for eight weeks, adverse effects were reportedly minor.

"The results presented in this manuscript should allay fears about the safety of 'mega-dose' vitamin C," said Dr. Joseph Casciari, co-author of the manuscript.

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Four drug trial victims improving

Latest reports indicate that the conditions of four of six men who reacted violently to an experimental drug TGN1412 in London were improving, but two remained critically ill.

Cholesterol drug reverses heart disease and clears clogged arteries!

A cholesterol-lowering drug has for the first time been shown to shrink the kinds of blockages that cause most heart attacks, indicating that such pills may offer the first non-surgical way to start to clear clogged arteries.

A Cleveland Clinic-led study has found that intensive use of statins, the most commonly prescribed cholesterol-lowering drugs, can reverse the build-up of plaque in coronary arteries. Previous studies have shown only a slowing or halting of the progression of coronary disease, but never regression or reversal. A new study of 500 patients found that high doses of a “statin” drug began to reverse the buildup, causing plaques lining the artery walls to recede. Statins are already widely used to prevent or slow heart disease. This study of more than 500 patients found that after two years of treatment with a high dose of Rosuvastatin, plaque volume was reduced by 7 to 9%.

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Catastrophic immune response may have caused drug trial horror

Staying the drug trial mishap, the New Scientist reproted that a catastrophic over-stimulation of the immune system may have caused the horrific reactions suffered by six men taking part in the first human clinical trial of an experimental drug.

An investigation suggested the possibility of a super-immune response, sending T cells rampaging through the body destroying its own tissues. Several experts contacted by New Scientist agreed to this explanation for the terrible incident which put all six men in hospital intensive care in London, UK, with two in a critical condition. The victims, who were healthy, paid volunteers, are said to have suffered multiple organ failure.

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Parkinsonism drug link to gambling probed

Medical researchers are investigating suspicions that drugs prescribed to treat Parkinson's disease could turn patients into compulsive gamblers, the Washington Post reported on Sunday.

Scientists at the Food and Drug Administration have found a strong association between pathological gambling and the drugs, which boost the level of dopamine in the brain, according to the newspaper. Dopamine, a chemical naturally produced in the human body, plays a key role in the way the brain controls movements. A shortage of dopamine causes Parkinson's disease. But the chemical is also associated with addictive behaviors such as drug use and pleasurable experiences such as sex and food.

Researchers, according to the Washington Post, are looking into the possibility that drugs for treating Parkinson's are turning "some patients into obsessive pleasure seekers." But the article also said no firm links have been made between dopamine enhancers and compulsive gambling.

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Six men seriously ill after UK drug trial fiasco

Six volunteers fell seriously ill while taking part in clinical trials of a new drug in UK. The trial was conducted by German pharmaceutical firm TeGenero AG which said the clinical trials were of TGN1412. The drug is intended to fight leukemia, rheumatoid arthritis and multiple sclerosis.

Eight men were part of the trial at a research unit at the Northwick Park Hospital, and six were given the drug. Two men who received placebo escaped unscathed. Some of the six volunteers have been treated for organ failure and two are critically ill.

The men, who were all healthy, paid volunteers, were admitted to the north-west London hospital and are being treated.

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