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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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  • American feed makers used melamine as well

    Byoliveridley

    Well, turns out all that China baiting was for naught, because right in America’s heartland, Ohio, some feed manufacturer was using melamine as a binding agent.

    Melamine From U.S. Put in Feed – New York Times

    Ever since pet food contaminated with an industrial chemical was traced to shipments of wheat flour from China, American officials have concentrated on cracking down on imports.

    It turns out the problem was closer to home, too.

    Yesterday, federal officials announced that a manufacturing plant in Ohio was using the same banned substance, melamine, to make binding agents that ended up in feed for farmed fish, shrimp and livestock.

    Apparently, it is Tembec, a Canadian company with a plant in Ohio. I am sure the effects to humans are not significant, but where’s the control? Where’s the list of things you can’t put in food. More importantly, where’s the list of things you’re allowed to put in? Food being a very easy mode of pollutant ingestion, the ingredients list must be exclusionary, that is, only approved ingredients are allowed. If something is not approved, it is not allowed…

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    Chemical agency ties under review – Los Angeles Times

    Byoliveridley

    As I mentioned a couple of days back, Sciences International has some conflicts of interests in this bisphenol A issue. I am glad that NIEHS is taking note.

    Chemical agency ties under review – Los Angeles Times

    The National Institute of Environmental Health Sciences has begun a review of ties between a federal health center that evaluates the risks of chemicals to reproductive health and a consulting firm funded by companies that produce chemicals linked to reproductive disorders.

    The investigation follows a Times report on Sunday that Sciences International, an Alexandria, Va., firm funded by more than 50 industrial companies, helps manage the federal Center for the Evaluation of Risks to Human Reproduction.

    Among the firms with financial ties to Sciences International are two that produce bisphenol A, a chemical in polycarbonate plastic bottles that has been linked in animal testing to prostate and breast cancer and reduced fertility.

    Since 1998, Sciences International has helped manage the federal reproductive health center and prepared draft reports analyzing bisphenol A and 16 other chemicals. The company has a $5-million contract with the center.

    The center’s scientific advisory panel was scheduled to decide today whether bisphenol A endangers reproductive health in humans.

    But on Tuesday, director Michael Shelby announced that the panel, after two days of reviewing the 372-page report that Sciences International prepared on bisphenol A, known as BPA, still had too many unresolved questions and was postponing its decision for six weeks.

    Good investigative journalism still makes a big difference.

    As always, as I was writing this post, I noticed that the ever excellent folks at the pump handle read my mind and posted about it (2nd time in 3 days!), so I will stop writing (and thinking about Bisphenol A) and direct your attention to their post!

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    Melamine Adulteration investigation gets cracking

    Byoliveridley

    FDA agents raid pet food plant, offices – Yahoo! News

    WASHINGTON – Federal agents searched facilities of a dog and cat food manufacturer and one of its suppliers as part of an investigation into the widening recall of pet products, the companies disclosed Friday. Food and Drug Administration officials searched an Emporia, Kan., pet food plant operated by Menu Foods and the Las Vegas offices of ChemNutra Inc., according to the companies. Menu Foods made many of the more than 100 brands of pet food recalled since March 16 because of contamination by the chemical melamine. ChemNutra supplied the manufacturer with wheat gluten, one of the two ingredients tainted by melamine used in recalled pet products. Both companies said they were cooperating with the investigation.

    The initial “let’s blame China for everything” drumbeat is subsiding a little as the FDA finally begins its inspections, and we find the tangled web of the food import business unraveling just a little bit. At this point in time, the charges are flying like crazy.

    The origin within China of the wheat gluten and rice protein concentrate remains murky. For example, ChemNutra’s source for the twovegetable proteins, Suzhou Textile Import and Export Co., told The AP that food ingredients aren’t part of its business — but that employees often take on side deals. Stern said ChemNutra dealt with the company’s president.

    Side deals? How quaint? The solution is simple: Quarantine every food item from China until it has been tested for melamine. You do not know the extent of the problem yet. It only seems to get worse everyday. Make the manufacturers pay for the testing.  Tighten up the paperwork, exercise tighter control over where the ingredients come from, get everything in writing.

    Meanwhile, the manufacturers are getting their press releases out. From Blue Buffalo foods…

    We at the Blue Buffalo Company have just learned that American Nutrition Inc. (ANI), the manufacturer of all our cans and biscuits, has been adding rice protein concentrate to our can formulas without our knowledge and without our approval. This is product tampering, and it apparently has been going on for some time. The can formulas that we developed, and trusted them to produce, never contained any rice protein concentrate. It appears that only an FDA investigation of ANI’s rice protein concentrate supplies forced them to reveal this product tampering to us.

    While this activity by ANI is in itself unlawful, the situation is further clouded by the fact that ANI has been receiving rice protein concentrate from Wilber-Ellis, some of which the FDA has determined to be contaminated with melamine.

    If this is true (and we don’t know that for a fact), it’s plain ol’ cheating and food adulteration. What does American Nutrition have to say?

    The FDA has urged American Nutrition to issue a voluntary recall of pet foods manufactured using Wilbur-Ellis rice protein. None of these products is sold under an American Nutrition brand, but are sold through other independent companies. No American Nutrition brands or other products they manufacture for other businesses are affected by this recall.

    Why would I trust the word of anyone who’s accused of adding ingredients off the label? This story gets curiouser and curiouser, and it is pretty clear that between the “side dealers” in China and some greedy middlemen suppliers here, we have plenty of blame to go around.

    Stay tuned for more…

  • NC Smoking bill dead this year

    Byoliveridley

    The vote was 55-61, and one of the arguments advanced was by Representative Paul Stam (h/t N&O’s new political blog):

    This is pushing smoke out of places where only adults are, but into places where children are. A person who’s addicted to tobacco and can’t smoke all day will get in that car and have to light up three or four or go home and do what they didn’t do during the day. That seems common sense to me.”

    Yeah, and if you stop a murderer from killing in public, he will kill at home, so we should just let him shoot people randomly in public.

    North Carolina General Assembly – House Bill 259 Information/History (2007-2008 Session)

    Whatever, it does not matter, smoking in public will be history even in the South in a decade or less, just a few lawsuits away. I think we first need to overturn the laws against local government passing anti smoking legislation.

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    Soda = Fat

    Byoliveridley

    Sodat Fat

    From The New York Department of Health

    Try this experiment at home: Take two and a half cups of water, add 15-20 teaspoons of sugar and stir to dissolve. If you haven’t broken your wrist with all this action, take a sip or two, or gulp it down. No worries, you’ve just had all the nutrition in a typical soda!

    That’s the message the NY Department of health is sending out with its new PR campaign against soda. Pretty gross and effective, I must say, though I would go one further and put it on every label of Coke, now wouldn’t that be nice!

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    PFOA emissions from Non stick cookware and Popcorn Bags

    Byoliveridley

    Important research coming out of NY. See here for previous PFOA posts. Perfluorinated compounds are used in the manufacture of Teflon, and are bioaccumulative. The theory is that the salts left over in the manufacture (residuals) are offgassing during use, and exposing consumers to bioaccumulative compounds.

    Cast Iron, anyone!!

    Quantitation of Gas-Phase Perfluoroalkyl Surfactants and Fluorotelomer Alcohols Released from Nonstick Cookware and Microwave Popcorn Bags

    Fluoropolymer dispersions are used for coating certain cookware products and food-contact packaging to impart oil and water repellency. Since salts of perfluorooctanoic acid (PFOA) are used as a processing aid in the manufacture of many fluoropolymers, it is necessary to determine if these compounds are still present as residuals after the process used to coat nonstick cookware or packaging, and could be released during typical cooking conditions. In this study, we identified and measured perfluoroalkyl carboxylates (PFCAs), particularly PFOA, and fluorotelomer alcohols (FTOHs; 6:2 FTOH and 8:2 FTOH), released from nonstick cookware into the gas phase under normal cooking temperatures (179 to 233 C surface temperature). PFOA was released into the gas phase at 7-337 ng (11-503 pg/cm2) per pan from four brands of nonstick frying pans. 6:2 FTOH and 8:2 FTOH were found in the gas phase of four brands of frying pans, and the sources of FTOHs released from nonstick cookware are under investigation. We observed a significant decrease in gas-phase PFOA following repeated use of one brand of pan, whereas the other brand did not show a significant reduction in PFOA release following multiple uses. PFOA was found at >5 ng during the fourth use of both brands of pans. FTOHs were not found after the second use of either brand of pans. PFOA was found at 5-34 ng in the vapors produced from a prepacked microwave popcorn bag. PFOA was not found in the vapors produced from plain white corn kernels popped in a polypropylene container. 6:2 FTOH and 8:2 FTOH were measured in the vapors produced from one brand of prepacked microwave popcorn at 223 ± 37 ng and 258 ± 36 ng per bag, respectively, but not measured at >20 ng (LOQ) in the other two brands. On the packaging surface of one brand of microwave popcorn several PFCAs, including C5-C12, 6:2 FTOH, and 8:2 FTOH, were found at concentrations in the order of 0.5-6.0 ng/cm2. This study suggests that residual PFOA is not completely removed during the fabrication process of the nonstick coating for cookware. They remain as residuals on the surface and may be off-gassed when heated at normal cooking temperatures.

    More later.