Editor's note: As the good intentions of Bill Clinton and Bill Gates cause drugs such as Nevirapine to be widely distributed to thousands and thousands of helpless children and pregnant women around the world, it is critical that the disabling side effects of such drugs be considered and publicized.

When the very mechanism of HIV is being questioned and increasingly doubted by leading scientists, and evidence shows that the presence of HIV antibodies doesn't predict CD4 cell decline, nor AIDS, nor decreased lifespans, the wisdom of forcing drugs with horrifying side-effects on the most vulnerable in society must also be questioned. Food and nutrition, the most basic of human needs, treatments for tuberculosis and malaria, and parasite-free drinking water seem to be nobrainers in the quest to help people.

Crippling side effects
© 1995-2005 Star Publications (Malaysia) Bhd (Co No 10894-D)

Campaigners are fighting to place drug-linked allergies in the spotlight.

It was a few days before Christmas – and it would be a Christmas that would change Karine’s life. The six-year-old girl had sinusitis, for which her doctor prescribeda commonly-used antibiotic and an anti-inflammatory. After a few days, spots started to appear all over Karine’s body. She ran a raging fever and fell into a coma. Her nails and hair fell out. Eighty percent of her skin shredded away and sloughed off, leaving just the muscles underneath.

Over the next two months, treated in a sterilised bubble in a specialised unit for burn victims at Paris’ Henri Mondor Hospital, Karine suffered a heart attack. She lost the sight of one eye. Twenty-five operations were needed to save the other, for which she has only one-fifth vision. She had to learn all over again how to eat, to speak and walk – and to avoid the sun, whose rays destroyed her skin all over again.

Karine was the victim of a pharmaceutical lottery. Her condition, toxic epidermal necrolysis (TEN), also known as Lyell’s syndrome, is a cousin to Stevens-Johnson syndrome (SJS) – both extraordinarily severe but mercifully rare allergic events that, almost invariably, are induced by medication.

Around a dozen drugs, some of them commonly used, have been linked with these terrifying disorders. But this association remains vague and sometimes anecdotal, leaving many patients to wring their hands about legal or financial redress. The suspects include common antibiotics, anti-convulsants, anti-malaria pills, the now-withdrawn anti-inflammatory Bextra, a drug for gout, and the widely-used anti-HIV drug Nevirapine.

SJS and TEN are virtually unknown to the public – and to the likely dismay of those who have total faith in science, they remain a near mystery to experts, too. Even the number of victims is unknown. Estimates range from 1.2 to six cases per million people per year.

“The problem is that there’s no mandatory reporting by doctors and hospitals,” said Jean McCawley of a United States group, the Stevens-Johnson Foundation.

The biggest danger lies not in the infrequency but the effect. Mortality is extremely high – around 40% in the case of TEN and 6% in SJS – and survivors may suffer crippling, long-term effects. The hunch is that the body abnormally metabolises a drug, triggering a frenzy among specific kinds of T-cells, the heavy artillery of the immune system, which then attack the skin and other tissues.

Flu, viral hepatitis, tuberculosis, pneumonia and herpes simplex – the virus that causes cold sores – are also mooted as additional triggers, and people with the AIDS virus figure prominently among the victims. But exactly how this catastrophic event unfolds and whether some people are genetically more susceptible than others remain unclear.

“Sixty per cent of cases can be clearly attributed to a specific medication,” says Amalyste, a French association fighting for greater recognition of TEN and SJS.

The reaction on average starts about one to three weeks after a patient starts taking a drug. There is no cure, although immunosuppressors and corticosteroids may attenuate the effects.

“A lot is known in the etiology (cause) of severe skin reactions, but the pathogenetic mechanisms haven’t yet been clarified,” said Maja Mockenhaupt of the University Skin Clinic at Freiburg in Germany, who is one of a tiny handful of global experts on SJS and TEN. “A specific therapy aiming to stop the progression of the disease doesn’t yet exist.”

Charlie Gilks, co-ordinator for AIDS treatment and prevention at the World Health Organisation said the agency had set down clear guidelines to advise doctors administering Nevirapine to HIV patients. “Nevirapine is a very, very useful drug but it has the unusual side effect of this Stevens-Johnson and it also has a problem of liver sensitivity.”

Campaigners are calling for medical authorities to beef up reporting of suspected cases of TEN and SJS and finance more research into the underlying causes of the disorders. They also want the pharmaceutical industry to make bigger and more specific warnings about any risk – some drug labels refer only to the possibility of “a skin reaction” – and are lobbying for health insurance or compensation for those who suffer lasting damage to their health.

The pharmaceutical industry defends itself by saying that new drugs are exhaustively tested on animals and then on human volunteers; that SJS and TEN are extraordinarily rare; and that their linkage to medication is limited mainly to occasional case reports. – AFP Wednesday September 20, 2006

© 1995-2005 Star Publications (Malaysia) Bhd (Co No 10894-D)

Technorati Tags: