In my last post about Seroquel’s future, I mentioned the Hatch-Waxman Act (PDF), which was passed in 1984. The Act was supposed to speed up the adoption of generic drugs when the patents behind name-brand drugs ran out. This happened at first, but as pharmacy has expanded, the Act has created a bottleneck at the FDA. It is speculated that the bottleneck is Big Pharma itself: creative lobbying seems to have resulted in a reduction in the budget for the Office of Generic Drugs — which in turn has limited its capacity to approve generic drugs to some 400 per year.

Unfortunately, I can’t seem to find which drugs’ patents will expire without a generic equivalent to take its place — I suspect that none of them are massively profitable by themselves — but all told, the market value of these 800 drugs is a whopping $78 billion per year for their manufacturers. For comparison, the entire generic drug industry is only worth just over $22 billion — even though it accounts for over half the prescriptions dispensed each year in the United States. Broken down, that’s almost $100 million per drug, ceteris paribus. Regardless of the specifics of each case, the aggregate dollars involved are huge.

Continue reading 800 drug patents backlogged at the FDA →

Back in January, I wrote about a new type of therapy called resiniferatoxin where polymodal nociceptors were destroyed by a cousin of capsaicin. Now a new treatment involving resiniferitoxin’s cousin, capsaicin, is showing promise in killing tumor cells.

Capsaicin is what’s found in spicy foods — it’s what gives these food their burn. It’s also remarkably good at dulling pain (it’s the active ingredient in Zostrix, for example), and now it appears that it can also kill prostate cancer cells by increasing the rates of apoptosis. Apoptosis is programmed cell death; for instance skin cells undergo apoptosis to make way for newer cells. Cancer cells, on the other hand, are notorious for proliferating without ever dying, which is the definition of cancer: uncontrolled cellular proliferation.

In any event, a baseline rate of cell death of 3% was established with low concentrations of capsaicin. By increasing the dose, researchers at Cedars-Sinai Medical Center were able to increase the rates of apoptosis to as high as 75%.

He believes that capsaicin jump starts a pathway that triggers cell death. Molecular tests suggest that it achieves this by causing a cascade of events inside the cell that lead to the release of a protein complex called NF-kappa Beta, which subsequently causes the cell to self-destruct. This is crucial since cancer is characterised by the uncontrolled growth of cells.

The team also found that capsaicin suppressed the growth of human prostate cancer cells – grafted into mice with suppressed immune systems – by about 80%.

There is no indication that increased capsaicin intake decreases one’s risk of developing prostate cancer; rather, it only appears to slow its rate of growth. Nonetheless, Phillip Koeffler, head of the research team hopes to see clinical trials within the next two years to determine capsaicin’s actual effect on men with prostate cancer.

It would be interesting to see if resiniferatoxin can kill bone cancer cells via a similar pathway — while it might not save a terminal patient’s life life, it could prolong it.

[tags]prostate cancer, capsaicin, cancer, medicine[/tags]

The FDA just approved the first transdermal one-a-day anti-depressant: Emsam, an MAO inhibitor. In theory, this patch allows patients to continue eating the foods that they enjoy — at least at the lowest dose, which they wouldn’t be able to do with a tablet. Higher strengths allow no such luxury.

With the amazing assortment of drug interactions that MAOIs have, I question whether this is really beneficial for anyone. I can honestly say that I’ve seen one prescription for an MAOI in the last three years. With the advent of safer anti-depressants — the SSRIs — and the rightfully-earned stigma against MAO inhibitors, I wonder if Emsam really has a market. Sure there will be some sales, but given that it costs ~$500 million to bring a new drug to market, will it recoup its own R&D costs before its patent expires?

[tags]selegiline, MAO inhibitors, Emsam, SSRIs, anti-depressants[/tags]