FDA set to ban caffeinated alcoholic drinks (in a response to widespread criticism and college campus bans of the "adult" energy concoctions on the grounds that they're dangerous, while the makers of Four Loko have announced they'll remove the... Read the rest of this post

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By Frederick Grinnell

On August 23, 2010, the United States District Court for the District of Columbia granted a preliminary injunction blocking NIH-funded research on human embryonic stem cells (hESC). According to Judge Lamberth’s ruling, NIH-funded research on hESC violates the Dickey-Wicker Amendment, originally passed by Congress in 1996, which prohibits use of federal funds for research in which human embryos are destroyed. The judge rejected the federal government’s claim that hESC research comes in separate pieces, i.e., human embryo destruction in the private domain on one hand vs. investigation of hESC by NIH-funded investigators on the other. Instead, he cited the holistic language of the Dickey-Wicker Amendment and the Random House Dictionary to conclude that the common definition of research includes development, testing and evaluation. According to Judge Lamberth’s ruling, destruction of human embryos and research on stem cells derived from human embryos are part of the same piece.

Destruction of human embryos occurs in the context of diverse research purposes. Some researchers aim to develop hESC-based therapeutic applications. However, others propose to improve the outcome of in vitro fertilization (IVF) procedures or to learn about early embryo development and disease progression. Currently, funding for research in which destruction of human embryos occurs is provided by non-Federal sources ranging from IVF clinics to biotechnology companies to state-sponsored biotechnology initiatives. Some of the research involving human embryo destruction has resulted in production of hESC lines. Some of the hESC lines that have been produced have been authorized to be used in NIH‑funded research, at least until the recent court order. Therefore, while one cannot deny that NIH-sponsored hESC research would be impossible without destruction of human embryos, destruction of human embryos is a research activity whose scope is much broader than and independent from the NIH‑funded work. From the point of view of research practice, the relationship between embryo destruction and hESC research is indirect.

In response to the judge’s preliminary injunction, the federal government has filed an appeal. The appeal challenges the judge’s understanding of the Dickey-Wicker Amendment regarding what constitutes the meaning of “research.” The appeal also challenges the judge’s conclusion that his decision would not seriously harm hESC researchers. On the contrary, if left in place, the injunction will have a potentially catastrophic effect because of its total disruption of NIH intramural and extramural hESC research.

One implication of Judge Lamberth’s ruling that has not been discussed but is of potential concern is whether the injunction against NIH-funding of hESC research might also apply to the FDA. The Dickey-Wicker Amendment concerns all of HHS not just the NIH. FDA is another major HHS agency that plays a role in hESC research. FDA develops guidelines and provides oversight for human clinical trials, including those involving hESC. As mentioned in the government’s appeal of the preliminary injunction, the FDA recently approved the enrollment of spinal cord injury patients in the first ever U.S. clinical trial of a hESC-based therapy. User fees from industry cover about half the costs of FDA drug review, but the remainder comes from federal f

FDA cracks down (on tobacco marketing to kids and teens, including magazine ads like the Camel No. 9 that recently came under fire. Also teen girls decide to diet based on their peers.) (CNN) (Reuters) - Kotex controversy (in a case of life... Read the rest of this post

Edward Shorter is the Hannah Chair in History of Medicine and Professor of Psychiatry at the University of Toronto.  His new book, Before Prozac: The Troubled History of Mood Disorders in Psychiatry is an unsettling look at how greed, lax regulations, and academic infighting have set the field back fifty years.  In the excerpt below, Shorter looks at how the psychiatrists in “the trenches” are making drugs work for their patients.

On a psychopharmacology listserv, one participant, himself a psychiatrist, posted a message seeking help for his ailing wife.  He thought, with a touch of professional rivalry, that her current psychiatrist was not serving her well, having prescribed two SSRIs.

“Does this make sense to anyone?” he asked the list.  “Is there anything in the literature, or from people’s experience, that supports the co-administration of two SSRIs?”

One member of the list responded,

Who really knows what causes depression? And for that matter who really knows what neurotransmitters or pathways are involved? New agents in research do not even touch the serotonergic pathways. I take the path of “whatever works.” Evidence-based medicine will never look at combinations and the like [which members of the list prescribe all the time] as it would not benefit the industry’s bottom line. As clinicians we have to tinker with the tools we have and see what happens. Or have I missed something over these years? Our evidence usually is sitting in front of us and is known as the patient.

These are words of wisdom: The evidence is in front of us and is how the patients respond to treatment.

We can find out all kinds of things by looking at the patients.  An example: trazodone was a mildly effective antidepressant developed in Italy in the 1960s and marketed in the United States by Mead Johnson in 1982 as Desyrel; it had indifferent success.  Today, trazodone is experiencing a big comeback, not as an antidepressant but as a hypnotic.  In the world of everyday psychiatry, trazodone is loved for its gentle qualities and its affordable price, in contrast to the patent-protected sleep aids that cost the moon.  Yet you will never see an ad in a medical journal for trazodone, nor will drug reps ever stop by your office with free samples in the hopes that your patients might start on it and stay with it.

Once you get away from the glossy ads in the journals, in psychiatry today it’s the Wild West out there. Clinicians are experimenting constantly with different combinations of treatments, many of them from psychiatry’s past, that promise new therapeutic effectiveness. They communicate their day-to-day experiences almost furtively on listservs such as this one, aware that they are pioneering the future of therapeutics in a way that industry will not countenance, because most of the older drugs are not patent protected; government agencies will not support this kind of clinical experimentation because the whole enterprise seems much too empirical for “science” and does not involve research in molecular genetics.

Academic psychiatry offers the image of a prescribing desert with just two tall cactuses, the SSRIs and the atypical antipsychotics.  But in the real world it’s a different story. Among community psychiatrists with a good knowledge of psychopharm, there’s a thoughtful pioneering of combos of the most diverse and imaginative variety.  This is not polypharmacy, the harmful proliferations of medications.  It’s combopharmacy of the kind that the Food and Drug administration rejected…the realization that the brain offers multiple pathways to the remediation of illness.

So there’s a big disconnect between what is happening the trenches and in the world of official medicine. The young community psychiatrists combining remedies from the shelf like kitchen spices rarely publish, although communication among themselves in listservs is lively.  Academica with honoraria from drug companies dominate the meetings with papers on patent-protected compounds for FDA-approved indications.  But this kind of disconnect is not good for a field.  It recalls the days when the bewigged courtiers of Louis XVI confronted the angry citizens of Paris over the barricades.  Perhaps the conflict between the arid desert of academic psychiatry and the vitality of community practice will have a similar outcome.