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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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    Lead from toys not the real problem

    Byoliveridley

    Here’s what happens when you make a long verbal rant to someone about how the risk of lead exposure from water and air probably exceeds the risk from toys with lead paint, and then don’t blog about it because that means doing an hour or two of research and you don’t find the time… Someone else has the same notion, and actually writes about it AND gets published in a mainstream website!

    The lingering danger to children from lead. – By Darshak Sanghavi – Slate Magazine

    While tainted toys are in the news now, kids historically have gotten lead from two sources: the atmosphere and house paint. Roughly a quarter-million tons of lead compounds entered the atmosphere annually beginning in 1922, after a General Motors scientist developed a lead-based gasoline additive that prevented auto knocking. Lead’s chemical durability, recognized centuries ago, also made it an attractive paint additive. Toddlers are particularly susceptible to eating lead paint because it has a sugary taste; ancient Romans used lead powder to sweeten wine. By 1980, more than half a million American children—4 percent of all toddlers—had quite toxic blood lead levels from these sources.

    Lead is a serious problem in the US, and the bulk of exposure is from crumbling infrastructure, the inability (or unwillingness) to fix and replace decaying lead pipes, and the still ubiquitous presence of lead paint layers in older houses.

    The article doesn’t still give you exposure comparisons or numbers, so I guess I still have to do the work.

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    Colonialism: Environmental Edition

    Byoliveridley

    Does put recycling in context…

    Independent Online Edition > Environment

    Regardless of how carefully you separate your waste, there is a good chance a disposal firm will dump it all in together with other kinds of plastic trash and ship it to the developing world to be dealt with by a family of migrant workers earning a pittance. They will deal with the salad-bar container, the pistachio ice-cream container and the superfluous bag for carrots in your shopping basket in a variety of different ways – it may be recycled, it may become landfill or it may simply be burnt. Whatever happens, it is generally not a priority for the waste disposal company. Britain dumps around two million tonnes of waste in China every year, everything from plastic mineral water bottles to shopping bags and other forms of superfluous packaging from some of the country’s biggest supermarkets.

    Same for India as well. The article says that all of this “recycling” is illegal. But how do you hide 200,000 tonnes of plastic waste?

    Read the whole article, it is tragic. Some highlights:

    So too are the many and varied health complaints suffered by the local population, who risk multiple skin ailments and exposure to potent carcinogens as they touch the contaminated materials. Poisonous chemical effluents stream into their water supply, turning it black or lurid red, and studies by Greenpeace show that acid rain is the norm in this region. Children are prone to fevers and coughs. Their skin is often disfigured by the toxic plastic waste they have to process.

    A report by the University of Shantou on the town of Guiyu, another Guangdong recycling hub, showed that more than 80 per cent of local children suffer from lead poisoning.

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    Colonialism, Pharmaceutical style

    Byoliveridley

    Legal wrangle puts India’s generic drugs at risk – health – 29 January 2007 – New Scientist

    Tens of thousands of people being treated for AIDS will suffer if Swiss pharmaceutical company Novartis succeeds in changing India’s patent law, the humanitarian agency Medecins Sans Frontieres warned on Monday. Novartis is challenging a specific provision of India’s patent law that, if overturned, would see patents being granted far more widely, heavily restricting the availability of affordable generic medicines, MSF says.

    In 2000, antiretroviral (ARV) treatment cost was estimated at $10,000 per patient annually. But the availability of generic drugs produced mainly in India, allowed costs to plummet to about $70 per patient per year, Mwangi adds.

    You’ve got to love the friendly multinational arguing to make extra billions while people die. But I don’t think any Indian judge will overthrow Indian patent law. And there is a national interest  exemption built into most patent statutes, per the TRIPs agreements.

  • Is Chronic Occupational Pain a Class Issue?

    Byoliveridley

    Americans in households making less than $30,000 a year spend nearly 20% of their lives in moderate to severe pain, compared with less than 8% of people in households earning above $100,000

    Millions of Americans in Chronic Pain – TIME

    Based on a study published in the Lancet (much moolah required to read, funny that the authors of an article on the class/money based nature of pain would publish in a journal that requires all kinds of money to read, heard of PLOS?), one would have to say yes. People in low paying service jobs don’t have the luxury of mid afternoon yoga, or that once a week massage, or being able to take a “mental health” day, or any such luck. Also, the work is physically demanding, long hours of standing, heavy lifting, and repetitive motions the body was not designed for.

    Krueger notes that the type of pain people reported typically fell on either side of the rich-poor divide. “Those with higher incomes welcome pain almost by choice, usually through exercise,” he says. “At lower incomes, pain comes as the result of work.” Indeed, Krueger and Stone found that blue-collar workers felt more pain, from physical labor or repetitive motion, while on the job

    It is very sad, but a lot of this pain is avoidable. Next time you go to the grocery store, notice that the people at the check out counter stand all the time. Why? What about their job requires continuous standing? I’ve been to other countries, Germany for instance, where they are provided with high chairs that help them move the items from the conveyor through the scanner to the bagging area with much less effort. How many chairs have you seen in a grocery store lately?

    Why can’t this very simple system be implemented? It would provide much relief. Three major issues:

    1. Lack of bargaining power: Unions are a dirty word. Last I heard, the unionization rate in the states was 12%. No one speaks for the cashier. It is considered a low paying, low skill occupation where people can be replaced easily and without “pain”. So, you’re on your own, ask for a chair, and you’ll be seated in one very soon (at home, your ass fired and tired).
    2. Money: And this is linked to point 1. Implementation of any programs designed to make workers’ lives a little easier costs money up front. Since workers are expendable and have no voice, it’s easiest to steal from them and deny them basic comforts.
    3. The American notion of individualism: You deserve what you get based on how hard you work and how intelligent you are. Grocery store cashiers must be lazy and dumb to be where they are. they “deserve it”

    I don’t see it changing at all. But next time you walk into a grocery store and find a rather sullen clerk, it’s not that she’s lazy or has a bad attitude, she may just be in a lot of pain.

    Happy Sunday!

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    Brazil successfully hardballs Abbott on AIDs drug

    Byoliveridley

    I mentioned in May that Brazil had introduced compulsory licensing on a Merck AIDs drug Efavirenz, and heartily recommended that Brazil and other third world countries continue to play hardball with big pharma whenever they could. It looks like Merck decided to not bargain, but Abbott did on Kaletra. Note that Abbott got into a similar controversy with Thailand, and agreed to drop the price when Thailand rejected the Kaletra patent.

    Keep it coming, third world countries. Bargaining is perfectly acceptable in the marketplace!

    Brazil says Abbott to cut price of AIDS drug | Health | Reuters

    razil’s health ministry said Wednesday that Abbott Laboratories Inc. agreed to cut the price of its Kaletra AIDS drug by 29.5 percent.

    The lower price for the drug, also known as lopinavir and ritonavir, will help Brazil supply free drugs for its AIDS treatment program.

    In May, President Luiz Inacio Lula da Silva authorized Brazil for the first time to break the patent on an AIDS drug, one made by Merck & Co.. It then started importing a generic version of the drug Efavirenz from India.

    Under WTO rules, countries can issue a “compulsory license” to manufacture or buy generic versions of patented drugs deemed critical to public health.

    Drug makers often reduce prices to keep countries as clients and avoid compulsory licenses.

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    Endocrine Disrupting Chemicals – A new Resource

    Byoliveridley

    Critical Windows of Development is a timeline of how the human body develops in the womb, with animal research showing when low-dose exposure to endocrine disrupting chemicals during development results in altered health outcomes.

    Critical Windows of Development

    This promises to be an easy to use database showing development timelines of infants, and the documented effects of endocrine disrupting chemicals at these timelines. The prime focus is bisphenol A and phthalates at this point in time. The Environmental Health News has more about the program here. It is not out for public consumption yet, so stay tuned…