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Weight Loss drug linked to suicide and anxiety?

Byoliveridley

Bloomberg.com: Worldwide

Sanofi-Aventis SA’s weight-loss pill may raise the risk of suicide and suicidal thoughts, U.S. regulators said in documents that may help an expert panel decide whether the three-time delayed drug should be approved.

The FDA noted two suicides in clinical trials of volunteers testing the drug. The panel will be asked to discuss whether it can establish a causal link between the medicine and suicidal thoughts or actions.

Some patients who took part in clinical trials of Acomplia suffered from mood swings, anxiety and depression. Trial volunteers given the highest dose lost an average 5.3 kilograms (11.7 pounds) over a one-year period compared with a weight loss of 1.4 kilograms (3.1 pounds) among patients given a control pill. Acomplia significantly lowered the level of HbA1c, a measure of blood sugar, to within a safe range.

So, here’s the classic case for the FDA, as discussed earlier today! Accomplia is a drug designed for weight loss, what I would call a “life management” drug. In clinical trials, which are strictly controlled, and where patients/volunteers are selected and carefully monitored, it seems to increase the incidence of suicidal thoughts, increase anxiety, mood swings and depression. The drug acts by blocking certain receptors in the brain, which should hint at other unforseen effects on the brain. The FDA has been more cautious on this drug than the European regulators, who have approved this drug.

What would I do if I were the FDA? I would wait 2-3 years for post approval studies in Europe to catch any mental health effects. After all, out in the real world, people take drugs imperfectly. The ones who should not qualify take it any way, doctors over-prescribe to patients who would hardly need the drug, things just don’t work as well. So, the best thing for the FDA to do is, nothing! In fact, the FDA is expected to punt the decision to 2010, good job!

Let’s put the benefits of this drug in perspective, all it did was make people lose 10 pounds more than placebo over the course of a year. This is the functional equivalent of eating 100 calories less per day for the period. Is that worth taking a pill everyday to keep that weight off and risking depression, anxiety and suicide?

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    1. Fire retardants save lives (therefore good)
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    Sugar Pills, now more effective!

    Byoliveridley

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    Via Wired

    An interesting article that takes the reader through a recent history of placebos, why they seem to work better now than they used to, and tangentially, why the competitive research paradigm of the pharmaceutical industry delayed recognition, and continues to delay possible fixes and therapies.

    A few things about the placebo effect:

    1. There appears to be a physiological and neurological basis to the effect, something that can actually be turned off by deactivating the body’s natural production of opioids.
    2. This effect is triggered by various patient stimuli, including exposure to advertising, faith in the medicine, doctor bedside manner, etc. It appears that for minor ailments, these effects could be as strong as the medication prescribed.
    3. It is not short lived, the effects can linger well after consumption of sugar pills.
    4. Despite all this, the article states that we are no closer to finding the most appropriate way to administer placebos (Hmm, or are we? Read on!).

    Pharmaceutical companies conduct hundreds of clinical trials every year. They are not required to publish them in most countries, so negative results, failures, etc. which reflect badly on the company’s stock price are routinely hushed up. This means that the mounds of data that show tested drugs as no better than placebo are not accessible for research. This is one of the greatest drawbacks of competitive research paradigms, the lack of cooperation, the inefficiency that comes from duplication of negative results, and the lack of statistical power that comes from inability to use all the data available. In a milieu where knowledge = stock price, this is the logical approach, but something to note next time an Ayn Rand acolyte comes bleating to you about the beauty and perfection of the market. You might ask “What are some options to the current patent exclusivity driven regime”? My favourite economist Dean Baker of the Center for Economics and Policy Research has written extensively about the drug development process and alternatives in his excellent (and free to download) book The Conservative Nanny State, I suggest reading at least the chapter on drug development and patents!

    Anyway, back to placebos, what to do? How to administer sugar pills in a quasi-official setting for minor ailments. It’s almost like you need a parallel paradigm of medicine that dispenses sugar pills that did not have to go through double blind randomised clinical trials. it would help if this paradigm uses vaguely scientific terminology while doing very little harm. It would work in conjunction with the conventional approach, not in competition so there is little danger of people taking sugar pills for malaria!

    I give you, Homeopathy!!! This blog(ger) is no stranger to this wonderful form of medicine, involving concepts such as the memory of water, similars, dilution, etc. When I wrote about homeopathy last year, it was more in relation to the psychological aspects of my experience with it. I (and I assume you did not click through to read!) wrote about my parents’ great and enduring relationship with their homeopath, and the benefits it brought them. Back in India this time around, it was suggested that I take some homeopathy for a cold I was developing, which I did (yum, sugar!). The cold went away in a few days 🙂 There was some swine flu medicine being passed around as well (I did not partake), which worked too, nobody at home got swine flu 🙂

    So, how to make it work? It already works in India because belief in the efficacy of homeopathy is well established. As long as the homeopath is well qualified in basic diagnosis, and crucially, knows when to punt the patient into conventional therapy, the system works to a certain extent. But what about a society with no such foundation? Do you go to a clinic with both an allopath and a homeopath, and if your ailment is one where placebo works about as well, let the homeopath make some well diluted similars for you to consume? How to settle turf wars? Would it be better for the allopath to feign develop an expertise in homeopathy and make that work for her in treating the patient? Would they apply the most important lessons in homeopathic treatment, Listen, Empathise, Soothe?

    I don’t know. It is not my nature to believe in sugar pills, faith, or advertising. So it is hard for me to say what would work. But given that sugar pills work well, it is vital for society to find a way.

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    Smoking bans in North Carolina?

    Byoliveridley

    After this morning’s post about Tennessee, I got curious and wanted to see what we were doing in North Carolina on smoking bans. So, I looked up my very own NC General assembly homepage and used their full text bill search function (key word smoking!). Here’s what I found.

    In the State Senate

    Great! Senate Bill S635 will ban smoking in all public places indoors except in tobacco shops, designated smoking rooms in hotels and for “research”. Follow the progress of this bill using the bill’s very own rss feed!

    In the House

    Not so good, House bill H259 has been referred to committee. But it has giant loopholes for all bars and “private clubs”. It has its very own rss feed too.

    Observations

    1. It is good to see that my representatives Kinnaird (we share a yoga class on Monday nights!) and Insko are co-sponsors on the bills. But I live in that bastion of progressivism (in the South, anyways!) Chapel Hill/Carrboro, so this is pretty unsurprising!
    2. My question to the House is this: Why are bartenders, employees of bars and private clubs, and patrons of such establishments considered not worthy of protection from second hand smoke? As someone who goes out drinking often, this is where all my exposure to second hand smoke occurs.
    3. Kudos to North Carolina for designing an accessible and easily searchable bill repository complete with rss feeds, way to go!

    Once I hear back from Sen. Kinnaird on the prospects of legislation this session, I’ll be sure to post about it.

    Update: See this. The House and Senate bills have gotten a lot closer, and most of the loopholes are gone.