DCA Update – Big Pharma/Glacial Rate of Progress
| July 9, 2008 | Posted by Dave S. under DCA, Off Topic |
Dichloroacetate (DCA) Promising for Endometrial Cancer
DCA virtually disappeared from the news about a year ago when it was forced off the open market by the FDA and all research into its efficacy as a cancer therapeutic had to go through officially sanctioned channels. I’ve kept track of it all this time through Google Email Alerts. This is the first bit of news on it in relation to cancer in a long time.
To see the history check out the list of articles I wrote here under the sidebar category DCA.
I became interested in it because it’s another example of the science establishment exerting undue control over things they believe they “own” including science education in public schools and theories regarding the origin and diversification of life.
3 Responses to DCA Update – Big Pharma/Glacial Rate of Progress
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Dave,
Having worked on a little medical research and having been on an IRB (institutional review board) reviewing a lot more research for medical ethical problems, I can tell you that it doesn’t take much of a conspiracy to keep research from happening. All that has to happen is that nobody wants to fund some research, and the researchers and staff don’t have the money to do it themselves without money, and the studies don’t get done.
Dichloroacetic acid, AFAIK, isn’t patentable, so no drug company wants to fund the studies. Doing the studies may cost hundreds of thousands of dollars, ideally requiring multicenter studies, and one faces the choice of adding DCA to current therapy (which may, for all we know, work at cross-purposes with DCA), or substituting it for current therapy (in which case the evidence for the efficacy of DCA has to be of approximately the same quality as that for the efficacy of current therapy, or else there are ethical problems with the study). Those obstacles are formidable enough with funding, and are even more so without funding.
However, if there is enough promise, eventually studies of the kind you have cited will be done, and once DCA has been shown to be efficacious in one kind of cancer, the pace will pick up. That’s because the NIH will fund the research, if nobody else will.
Groupthink is a problem in medicine (for examples see the history of DES in preventing miscarriage, and H. pylorii and ulcers), but it doesn’t usually rise to the same level as one sees in evolutionary biology. The most obvious exception, the efficacy (or lack thereof) of embryonic stem cells, may have a similar underlying reason to the groupthink surrounding evolutionary biology.
Paul
I guess you didn’t read the history of DCA. After the researcher at Edmonton U published his studies of DCA activity in rats infected with human cancers, a guy in California partnered with a UC Berkeley chemistry professor who had developed a lot of anti-cancer drugs. Together they set up a facility to make & sell pharmaceutical grade DCA, which as you said is not (or WAS not) restricted in any way as it’s a common chemical that is a byproduct of water chlorination and is present in all the nation’s tapwater in tiny amounts. They were selling a month’s supply for $20 for a 150# dog and marketing it as PET DCA for use in animals.
Lots of people with terminal cancer were ordering it and self-medicating at known safe dosages for humans. Safe dosages are well known from years of clinical use of DCA in treating chronic lactic acidosis. It had simply never been tried as a cancer therapeutic before.
Many of the people who were self-medicating with DCA were detailing their experiences on a website. In effect, a non-sanctioned clinical trial was taking place and it wasn’t costing anyone anything and it was happening immediately.
This went on for about 3 months with some people reporting remarkable results and others reporting no change. Gradually it was being determined what kinds of cancers responded, which didn’t, how to manage blood pH so that DCA was more effectively delivered, etcetera. Keep in mind these were all walking dead men that had been told by their doctors there was nothing more that could be done for them (surgery, radiation, chemo) had all run the gamut and failed. They were waiting to die and had nothing to lose.
However, after a few months the FDA shut down the manufacturer of PET DCA and now, a year later, there’s still not a lick of progress been made in testing DCA. If it turns out DCA is a cheap drug that is effective in certain cases, how many people died because the FDA and big pharma can’t tolerate people self-medicating in a last ditch attempt to save their own lives?
Dave,
You raise a real problem with the current system.
The current system is set up to protect patients from charlatans, and from true believers in spite of evidence, and there are some out there, both inside and outside of organized medicine. There was the wonderful antianxiety agent thalidomide, that wound up giving children exposed in utero short to absent limbs. The company didn’t wake up to the problem as fast as it should have, probably partly because birth defects weren’t high on their radar screen, and partly because they didn’t want to believe that a cash cow could be that dangerous. There is also the case of laetrile, which had glowing testimonials, and cost an arm and a leg and, when finally put to the test, turned out to be ineffective.
Of course, vitamin C was touted as a cure for cancer, and never got pulled from the market, and there really isn’t much hard evidence for its efficacy either. But in all fairness, Vitamin C wouldn’t cause one to mortgage one’s house, as happened with laetrile, and side effects were minimal (except for kidney stones, which are not minimal, trust me
).
The problem is all the hoops that have to be jumped through in order to prove that the stuff works. That does slow down the ability of patients to get something that could be at least potentially lifesaving. If DCA turns out to be like laetrile, we will be thankful that the FDA was careful. On the other hand, if DCA turns out to be like gleevac, we’ll all wish it was available earlier.
The non-sanctioned clinical trial is not really adequate to assess the efficacy of DCA. The placebo effect is powerful (ask Denyse!) and often confounds trials that are not placebo-controlled. Furthermore, there is a selection effect, where people who try the drug and get results tend to report them, whereas people who do not get results do not do so as much. (People who die don’t report results at all.) It is really helpful, if one wants to know whether the drug works, to have a properly controlled and properly followed clinical trial.
I don’t think that Big Pharma shut down the distribution of DCA. I’m sure that they have their prejudices, and that some of them are financially rewarding and therefore less amenable to evidence than they should be. But they don’t control everything, and there are people in the FDA that are suspicious of the pharmaceutical industry’s motives, and won’t roll over for them without a good reason.
In this particular case, the FDA looked at DCA like it would any other drug, and decided that it should go through the standard process before being sold to the general public. And one year for published results is actually fairly fast as drugs go. It’s still awfully slow if you are a cancer sufferer and the stuff might cure you.
IMHO, the FDA should have done is made sure that the manufacturer did not make any claims other than purity, as there is no study evidence that DCA has clinical efficacy in cancer, and assessed that the pricing was not unreasonable, and then left it on the (veterinary) marked, somewhat like they do for vitamin C, while in the meantime encouraging clinical trials. But our country has chosen to go down the nanny state route in this regard, and we are living with the consequences.