Sunday, August 03, 2008

The dangers of clinical trials

Today I'm angry! Very angry!
After reading some stuffs on FS i've got infuriated and I'm thinking about many problems at the same time.
Clinical trials. Remember the TGN-1412 scandal
Refresh your memory here.

When potentially hazardous drugs are being tested, it is common to use patients rather than healthy volunteers. That is often done in proposed treatments for cancer, where the new drug may be seen as a last resort. It is one thing to recommend something very risky to a person who seems likely to die soon if nothing is done (although the ethics of that is also debatable); it is quite another with an individual who is in good health.

It is also usual practice to try the drug on a single individual first, and not to give it to others until it seems safe to do so. That does not appear to have been the case in the TGN1412 trials, which is why all six volunteers suffered the violent reactions. Unfortunately, while the protocol did include a “time and events” table, this has been omitted from the version posted on the MHRA website [1].

In place of the table, there is a handwritten note referring the reader to an earlier statement (which is used to justify a number of other omissions as well): “Section withheld under section 43(2) of the FOI [Freedom of Information] Act as, in the MHRA’s view, disclosure would, or would be likely to, prejudice the commercial interests of TeGenero or associated third parties. In the Agency’s view the public interest in disclosure does not outweigh the private interest in withholding the information.”"

BBC has more accurate details:

Mr Wilson, who has left hospital, spoke of his anger at the companies involved, during an exclusive BBC interview.

He may lose all of his toes and parts of three fingers.

I'm not a weak person, and anyone who knows me knows that, so I'm not going to give up yet
Ryan Wilson

Mr Wilson is currently using a wheelchair, but will undergoing further surgery in about a month's time.

He said: "I can walk small bits now, but that is only heel-bearing and I have to wear these 'funky' shoes - they do the job, but they are horrid looking.

"Once I have surgery, it [walking] will depend on how long I take to do it - it could be a month, it just depends on determination."

Uncertain future

He adds that doctors are still unsure of the long-term damage that has been caused.

"There are a few parts of the immune system that are not right and they don't know if they will get back to normal, level off or decrease even more. It is hard to tell."

Mr Wilson entered the trial that took place at Northwick Park Hospital to pay for driving lessons.

He and five other volunteers were paid £2,000 to be given TGN1412, created by German pharmaceutical company TeGenero, by medical research company Parexel.

Ryan Wilson (BBC)
Mr Wilson will lose parts of some of his fingers

It was hoped that the drug would treat conditions such as rheumatoid arthritis and leukaemia, but the trial went disastrously wrong.

Mr Wilson, the worst affected, suffered heart, liver and kidney failure, pneumonia, and septicaemia.

"I wouldn't want anyone else to go through this - even people that I'd call enemies. It's undignified," he told BBC medical correspondent Fergus Walsh

This tragedy came public because it has happened in London. People in poor countries that are in hospitals make part on clinical trials without knowing. They can have any reaction, die and nobody will ever knows.

This is to Traci Johnson and the other 4 volunteers who committed suicide while testing Cymbalta.
Traci, your parents, family and friends must not pay attention on your tragic suicide. But many people care. You were 19 years old and your whole life ahead you!
Look what they've done with these 6 volunteers in London.
I'm sure you're fine!

No comments: