Tuesday, February 13, 2007

Alternative medicine use might be affecting the results of trials

From here.

At issue is whether remedy-drug interactions are skewing the results of Phase I cancer trials. At present, this is hard to determine because it is hard to elicit (alternative) remedy use. To me, it's pretty clear that having remedy use out in the open is better than being secretive. However, what's interesting to me is the following, surveyed from 212 patients with advanced cancer enrolled in Phase I clinical trials:

  • 72 (34 percent) use alternative remedies, similar to general US population usage
  • 41 (19.3 percent) take vitamins and minerals
  • 40 (18.9 percent) take herbal preparations
In addition, we have the following:

Sometimes, patients are reluctant to tell the doctor they are taking
alternative medicines, either because they don't think it's important,
or they don't want to be told to stop taking them, Daugherty said.


And, since it's often difficult to get cancer patients to take part in
phase 1 trials, some researchers may be reluctant to turn any potential
patient away. "In addition, most doctors don't know very much about
alternative medicine," Daugherty said.
For research, I think these matters need to be out in the open. For one thing, we need to understand our drugs we are developing. For another, we need to understand the alternative remedies.

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Friday, February 9, 2007

Big news that's easy to miss -- FDA clears a molecular prognostic tool for breast cancer metastasis

The FDA just approved a prognostic device. So what's the big deal?

I'll let the press release speak:

It is the first cleared molecular test that profiles genetic activity.

That's right. Despite many years (ok, about a decade to a decade and a half) of use in basic research, microarray technology has matured (along with the analysis methodologies) enough to be used in clinical practice, and this approval marks a big step toward that. Microarrays were a buzz in the statistical community a few years ago when there were still some methodological hurdles to overcome (and were being rapidly overcome).

What's more, this marks the first time a genetic expression test (different from a genetic test -- this one identifies which genes are expressed [active] at a particular time) has been approved for the prognosis of a disease. 70 gene expressions are analyzed. Agendia has blazed some trails, and I expect to see more of this kind of test in the coming years. And that's a good thing.

And, hopefully for women with breast cancer, this will help a bit in the decision making for treatment.

Tuesday, February 6, 2007

Dichloroacetate (DCA) - not an easy road to "cheap, patentless cancer cure"

Posts that contain Dca per day for the last 30 days.
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Ginger, curcumin, and DCA have recently been touted for their anticancer properties, and, granted, in the Petri dish, they look pretty good. However, it's a long road from the Petri dish to the pharmacy shelves. Abel Pharmboy's coverage of DCA seems to be the most spot-on, and his points are worth repeating. Many compounds show promise in the Petri dish and animal models, but when it comes to human trials, they bomb. It is entirely possible, in fact, from drug development experience I would say very likely, that DCA will do very little for humans in trials. It may be ineffective when we actually inject it into human beings (for anticancer purposes; it's already approved for some metabolic disorders).

Remember, cancer is a complex disease. To "cure cancer" is really to cure a whole lot of different diseases, which is why our "war on cancer" applies some rather naive assumptions.

I'm all for supporting DCA research, and, unlike some of the more paranoid commenters on this issue, I think that Pharma companies are taking notice. It's not unthinkable that some NIH oncology funding is in the pipeline for the compound, or some small pharma company will in-license the compound/formulation/use and perhaps even bring some of Big Pharma's research dollars in if the compound passes Phase II trials (Phase I safety testing should be a breeze relatively speaking, since it's already approved for some indications). Before we get up in arms about what is patentable and whether research dollars will be spent on a promising compound, realize that nearly everybody in this industry is for helping others, and we will find a way to get the most promising compounds studied and, if they work, on the market.