PLACEBOS ONLY JUSTIFIED IN STUDIES WHEN NO EFFECTIVE TREATMENT IS AVAILABLE:
A brilliant article just appeared in the British Medical Journal documenting the total absence of "placebo-controlled random assignment clinical trials" that "prove" that it really is the parachute that protects against injury and death when people jump out of airplanes. Those experts and politicians who demand ever more and more clinical trials to prove what is already known, or what is intuitively clear strictly on a common sense basis, should take heed.
Sure there are a great many clinical interventions where placebo is indicated. But the Helsinki Convention clearly states that placebos are only justified when no treatment is available that is known to have a modicum of efficacy. Meanwhile, more and more studies on detoxing opioid-dependent people, maintain patients with opioid agonosts, track long-term recidivism rates, etc, etc, etc, utilize hapless "control" groups that receive placebo, and whose death rate in the studies are not infrequently the basis for concluding that placebo aren't so great in absolute or relative terms.
ADDITIONAL POST SEPT 25, 2008
SUBCUTANEOUS BUPRENORPHINE YIELDS "STATISTICALLY SIGNIFICANT RESULTS COMPARED TO PLACEBO FOR OPIOID ADDICTION:
urine test results are not cited, but are said to have been better for buprenorphine subjects; one-third of buprenorphine subjects and 69% of placebo recipients dropped out within 6 months. Ethical issues are not mentioned in the report by Titan Pharmaceuticals. Full report (July 29, 2008)
HOW MANY MORE ADDICTS TO BE SUBJECTED TO PLACEBO? It is difficult to comprehend how any trial of a new medication or route of administration can be tested against placebo in the treatment of addiction (see news item this site, 18 Sept 08). A million people worldwide receive "substitution" treatment with oral opioid agonists; this treatment has (for over a quarter century!) been declared effective by the US government, and has also been endorsed by the Institute of Medicine, by WHO/UNODC/UNAIDS, and by the authorities of many dozens of countries that have approved its use. How can researchers and their academic institutions and "review boards" continue to condone placebo trials? And why would FDA apparently demand that hapless addicts seeking care be recruited into placebo-control trials when approval of a new treatment is being sought?
As for the results touted by the company: so subcutaneous buprenorphine was "statistically" better than placebo in terms of urine tests and retention - so what? Is someone counting the number of instances of HIV transmission, arrest and incarceration, destroyed families, and deaths among the placebo subjects? No ethical provider would ever consider putting an opioid dependent person on placebo, so its lack of efficacy compared to some new drug or means of administration is a total irrelevancy! And yet the results of this "study" have been heralded by one of the principal investigators as being "very promising," asserting the "success of [the medication] should have a very significant impact on our ability to effectively treat opioid addiction."