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Tuesday, May 02, 2006

What Happened Here?

Drug makers are in a tough business. Here are a few companies and their failures.

DOV Pharmaceutical: ...DOV Pharmaceutical, Inc. (NASDAQ: DOVP) announced today high-level results recently developed from the first Phase III placebo-controlled clinical trial – study 020 – of its novel analgesic bicifadine in patients with chronic low back pain (CLBP). Bicifadine did not achieve a statistically significant effect relative to placebo on the primary endpoint of the study at any of the doses tested:

Nastech Pharmaceutical: ...Merck & Co. ended its collaboration with Nastech Pharmaceutical Co. on a spray treatment for obesity because the product wasn't effective in early studies.

CancerVax: ...Another round of disappointing clinical trial data has led CancerVax and Serono to abandon research on a treatment for malignant melanoma

Cell Therapeutics: ...said a late-stage clinical trial of its Xyotax treatment for non-small cell lung cancer didn't go well, falling short of its primary goal of showing that Xyotax works better than standard chemotherapy.

Targeted Genetics: ...said its experimental cystic fibrosis treatment failed to significantly improve lung function in clinical-trial patients over those who received placebo

NeoRx: ...The Skeletal Targeted Radiotherapy program has a long history of ups and downs, and the company has burned through millions of dollars in its development. The FDA suspended clinical trials of the therapy in October 2000 after several patients developed serious delayed side effects.

You get the point...

But what about this one?

TeGenero: ...six test subjects were hospitalized for several weeks after severe reactions to injections of the TeGenero medicine at a Parexel facility in north London on March 13. Five of the volunteers have since been released. The sixth may have to stay in the hospital for as long as six months, and is certain to lose the tips of three fingers

The first set of failures showed a lack of efficacy. The latter was highy effective but in a negative way. The latter drug was an antibody. There are currently 18 antibody drugs on the market. The one thing you can say about the antibody drugs is that they have an effect. I have personally used Rituxan in tumor studies using mice and that drug completely eliminated tumors in mice. I have no comments on their effects in human beings. The point is that some "drugs" make you well, some make you ill, and the ones that most pharmaceutical companies sell you don't do anything at all.

The Cargo Cult scenario: Many rituals were performed but no airplanes came. Someone found a radio and a book on the Japanese language. They put together some very offensive words and spoke them into the radio. They also gave their location. Planes came but they dropped bombs instead of cargo. What the cargo needs to do here is to find out how to apologize in Japanese and ask politely for cargo. At least with the hostile reaction, the cargo cult got something. When nothing happens they continue down the same path that leads to nothing.

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