This Rang Alarm Bells Here

The Food and Drug Administration in the USA have fast tracked Gardasil, a vaccine for cervical cancer, produced by US pharmaceutical firm Merck, after a six-month fast-track clinical test. Why it's a worry….

Gardasil looks the business. The six month clinical trial showed almost 100% effectiveness against the human papilloma virus that causes genital warts that can in turn lead to cervical cancer.

The alarm bells ring though whenever the regular medical press corps reports a cancer breakthrough.

Reportage that queries clinical trial results is woefully lacking. These trials were extremely short and Merck has an obligation to follow up with more research to check safety and to look at long term effectiveness.

In the meantime the vaccine will go global.

We can hope there is cause only for joy. However, Merck has a tainted reputation after its handling of Vioxx, also a wonder drug but now described as a debacle.

Another reservation I have about cancer drug reporting relates to these long term issues – I am not saying Merck is wrong to go ahead and distribute Gadasil. I am saying the we the public have a rightful expectation that there will be independnet scrutiny of Gardasil.

The other recent cancer wonder drug, one which caused controvery over in the UK where women sued the health authorities to gain acess, Herceptin can have a demonstrable adverse effect on a woman's heart. I know. My wife takes it and is now showing left ventricular enlargement.

Afte chemo (some chemo drugs are harmfuf to the heart) left side radiotherapy (close to the heart) and Herceptin, women can be on the rack.

But ask any woman would she decline these treatmentes and the answer is a universal No,despite our lack of understanding of long term effects.

OK so the new Merck drug will fly but doubts over the FDA's procedures need to rumble on.