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Another Hepatitis C Drug Development

January 22, 2005

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The following article is from the Orange County Business Journal. I am posting it for a few reasons. First of all, the article shows that pharmaceutical companies are working hard at coming up with other viable therapies for Hepatitis C. This is enouraging for all us patients.

The second reason is that the article also gives insight into the business of drug development for Hepatitis C and any other disease. The article touches on some of the hows and whys. Valeant is developing Viramidine because their other drug, Ribavirin is losing sales to competitors. They are looking for a replacement drug to slow their loss of sales in the Hepatitis C marketplace. It is a competitive business decision, not a compassionate humanitarian one. Which is okay. Either way they are helping patients. In fact, their desire for profits and business growth is probably a more dependable and powerful motivator than humanitarinaism anyway. It still ultimately works to the patients advantage.

Let's face it, pharmaceutical companies are not non-profit charity organizations, they are businesses. I, for one, have no problem with that---as long as they are ethically looking for better ways to help people get healthy (the key word here is ethically). As patients, though, we need to keep this reality in mind and not think that pharmaceutical companies, or doctors for that matter, are sitting at the right hand of God.

The third reason I'm posting the story is the lawsuit they mention. This woman joined a clinical trial. They key word here is "trial". Right in this description there is a tacit understanding that the risks and rewards of the drug are not entirely known. How could she have ever thought for a moment there was no risk? Even the current approved treatment for Hepatitis C has very serious possible side effects that are clearly outlined before treatment begins.

From my perspective, there is no way she could have thought this was risk-free, unless she was purposely lied to and mislead by the doctors and researchers (which I highly doubt. Remember, Valeant is a business in a high risk industry with lots of litigation. They know their high level of possible liabilities. They get plenty of people to participate without lying, so why would they lie?)

Unless this woman lives on another planet, she had to know there were very real risks involved. People's refusal to take personal responsibility for their own decisions and quickness to blame someone else for their own lapse in judgement has become one of my pet peeves. This seems like another classic case of responsibility avoidance. Yes, it is tragic that she was hurt. But, no one did it to her. She chose to participate in a clinical trial. It was her decision. Nuff said.

Posted date: 1/21/2005

Valeant's Study of Viramidine Drug: Comparable Efficacy to Ribavirin

Drug Is Critical Plank in Growth Strategy

Valeant Pharmaceuticals International said a key drug undergoing testing has proven to be similiarly effective at treating hepatitis C as its fading flagship ribavirin.

The Costa Mesa-based drug maker also said it has enrolled patients in a third-phase study of Viramidine. A filing of a new drug application with the Food and Drug Administration could follow the third phase.

"We are excited about Viramidine's potential and look forward to continuing the phase three pivotal trials, which both finished enrollment in record time," said Chief Executive Timothy Tyson in a release.

Valeant's study, conducted through the liver transplant program at the California Pacific Medical Center in San Francisco, involved 180 patients with chronic hepatitis C.

The company has a lot riding on Viramidine. Ribavirin has been Valeant's key product but has lost sales of late as competiting drugs have taken away sales.

The second-phase trial of Viramidine, meanwhile, has led to a lawsuit against the drug maker from a Bay area woman who alleges she suffered brain damage and permanent disabilities.

In her complaint, Linda Iacovetta said that while seeking treatment for hepatitis C at California Pacific, she was encouraged to be in the trial, which looked at how Viramidine and pegylated interferon worked in concert to fight the liver disease.

Iacovetta's suit said that she was on the drug combination for five months in 2003. She alleged that Valeant and California Pacific doctors who conducted the trial failed to warn users of the risks of taking the drug.

Valeant spokesman Jeff Misakian said earlier this week that Iacovetta's complaint was "completely without merit," but didn't comment further because it is active litigation.

Posted by Ralph at January 22, 2005 7:46 AM