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A cancer patient who was one of only a small percentage of trial patients who benefited from an experimental cancer drug can no longer get the discontinued drug, and may die. This has to change, or the promise of pharmacogenomics cannot be fulfilled.

The US Environmental Protection Agency has awarded $4 million in grants to study the health and environmental risks posed by manufactured nanomaterials.

Among the grants being funded, reports Rick Weiss in the New York Times, are:

• A study of the absorption and toxicity of nanoparticles on skin. (Several cosmetic products already contain nanoparticles.)
• A study of what happens to nanoparticles when they get into drinking water, how they interact with other pollutants there, and how toxic they are in water.
• Studies of nanoparticles’ effects on cultured human lung tissues and in the airways of live animals — including a test of whether nanoparticles cause especially severe inflammation, as some suspect.
• Studies of the environmental impacts of nanotubes that have settled into marine and freshwater sediments, and the effects of nanoparticles on aquatic bacteria, algae and plankton.
• A study of the conditions under which nanoparticles may absorb — and perhaps later release — environmental contaminants.

Critics say the amount is too small; that government needs to do a lot more.

Reference: Weiss, Rick (2004). “EPA Backs Nanomaterial Safety Research: Activists Say $4 Million Is Far Too Little for Studies.” Washington Post, November 12.

No Business Case for Pharmacogenomics

A cancer patient benefiting from an experimental drug made by a startup biotech firm was taken off the drug when early-stage clinical trials ended and the drug was discontinued because it did not benefit enough patients, making it too risky financially to move on to the next and costly round of clinical trials.

The patient has tried for two years to persuade the FDA to approve the drug and the company to continue production, to no avail. An FDA official told the Wall Street Journal’s Amy Dockser Marcus that this situation is becoming increasingly common. The biotech company making the drug has fewer than 100 employees and six drugs in various stages of testing. But it doesn’t have a product on the market.

The patient in this case did end up getting a 12-month reprieve in the form of a “single-patient compassionate usage trial” and 12 more vials for free, but that was still only a temporary solution. She got a further 12 vials after threatening to launch a publicity campaign.

Reference: Dockser Marcus, Amy (2004). “A Patient’s Quest To Save New Drug Hits Market Reality.” Wall Street Journal, November 16.