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New diet pills expected to launch, just watch out for the brain frying thing…

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It looks like we can all begin to eat with abandon again (please clap loudly in appreciation) with the possible introduction (if big pharmaceuticals get their way) of two drugs that until recently the FDA wasn’t exactly too thrilled to bring to the market on the account of them giving you irate bowel movements (yes very yucky), magic heart palpitations (as if life didn’t give you enough already?) and of course mini sizzles in your brain (one of the drugs being proposed is used in the treatment for epilepsy which use of has been shown to play havoc with ones memory and if you happen to be a rat die of cancer). Which two drugs are we talking about?- Qnexa and Lorcaserin.

jezebel: In 2010, the FDA rejected Qnexa over concerns that it caused “suicidal thoughts, heart palpitations, memory lapses and birth defects.” The agency asked for more data, and in December 2011, Qnexa developer Vivus released research on the drug’s relationship to birth defects. Their study found that women who took topiramate in their first trimester of pregnancy had a 0.29% risk of having a baby with a cleft palate, compared to a 0.07% risk in the general population. Women who took the drug before but not during pregnancy still had a somewhat elevated risk, at 0.16%. This looked like bad news for Vivus, and its share price dropped. The company had already resubmitted Qnexa to the FDA, with a warning that it wasn’t for women of childbearing age.

Share price dropping? Heart palpitations? Hmm, I think I’ve already lost my appetite. But where there is a dollar will there’s a way:

But this week, the FDA asked Vivus to remove that warning. If approved, the drug could be prescribed to women of childbearing age, as long as they weren’t actually pregnant. It’s unclear why the FDA saw fit to remove the warning, since Qnexa appears to approximately double the risk of cleft palates even when women take it before they get pregnant. A representative from the FDA’s Office of Public Affairs told me the FDA doesn’t comment on pending drug applications, so no help there.

No help there? So what exactly is the FDA thinking? Is there something wrong with the FDA or is it just a case that the FDA is metaphorically in bed with big pharma and one way or another it just has to say yes despite the public appearances of resisting your pet rat getting cancer and of course all your unborn children getting cleft palates.

Vivus is playing it cool by saying that the removal of the warning doesn’t necessarily mean the FDA will approve Qnexa. But the company’s stock price jumped at the news, and securities analyst Jason Butler told the AP the removal did signal that approval could be in the offing. He said that “women of child-bearing potential are currently the primary treatment-seeking population for medical obesity therapy,” and that the FDA was becoming “more collaborative on the path to approval for obesity drugs in recent months.” The agency is slated to announce its decision on Qnexa on April 17, so the drug could be coursing through America’s bloodstream within the year.

Well if the stock price is jumping it can’t be all that bad for you right? What self respecting banker or pharmaceutical would take advantage of the average American consumer? I can’t think of any. Can you?

And then there’s the part that the FDA have become more ‘collaborative’ on the path to approval in recent months which must infer that politically the will to pass this new drug is there especially since all the backroom deals we aren’t hearing about are underway. Right? Or maybe it’s got to do something with the upcoming elections and big pharma reaching into their checking accounts to write some very much needed bribes campaign contributions.

This despite the fact that Vivus doesn’t appear to have any new research to allay concerns about cardiovascular or mental-health side effects — at least, none that they’ve released publicly. One 2011 paper commissioned by the company, which argued that Qnexa was “very safe” despite the fact that some users reported depression and anxiety, turned out to be based on old data the FDA already had. Vivus’s latest clinical trial, dubbed SEQUEL, does appear to have been modified in September 2011, but its “final data collection date” is listed as June 2010, well before the initial rejection. It’s unclear whether Vivus actually has new data for the FDA, or whether it’s just reinterpreting old numbers — a representative for the company couldn’t comment beyond some general information about the drug.

Well this sounds like we are in no man’s land and when in no man’s land it’s best not to upset the apple cart too much. Of course it’s only your life and health on the line, but then again let’s admit it- who wouldn’t do almost anything to shed a few unwanted pounds? Personally I’ve long abandoned eating in moderation or exercise. Well I actually haven’t but the temptation is always there to join the rest of America….

Meanwhile, Qnexa’s got a competitor on its tail. Lorcaserin, a drug also rejected in 2010 — because it didn’t work very well and gave rats cancer — has also been resubmitted by its manufacturer Arena, and the FDA is scheduled to make a decision on its approval on June 27. And according to Seeking Alpha, Congress is pressuring the FDA to approve new obesity drugs. So for Vivus and Arena, this could be an exciting year. For people who like healthy hearts, brains, and pregnancies, the forecast is less clear.

The moral of the day? Politicians, big pharma, and the FDA are in possible cahoots to make America a very lean place to live in even if you end up getting very sick or have your unborn babies come out with cleft plate issues.

Aren’t you glad you live in a greedy society that makes every effort to line each others pockets and keep the pockets of power squarely in line with big business?

Well at least you’ll look good until your brain starts frying but then it wont even matter anymore…and to think street drugs are supposed to be more dangerous than ‘legal’ drugs….

 

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4 COMMENTS

  1. Major brands always give out their popular brand samples (in a way to promote the products) best place on the internet is “Get Official Samples” find them & enjoy your samples

  2. Scallywag,

    With all due respect, you are mixing up your companies.  Vivus is the company who created Qnexa which is a combination of 2 generics; Phentermine (still the most prescribed weight loss drug and a generic that has been around for 50 years) and Topirimate, which is a very dangerous drug that is linked with the cleft pallet issues and cognitive effects you described. I agree with you, I don’t think that drug should be approved.  It also causes an increase in heart rate which increases one’s risk for a heart attack.  Their market cap is around $1B and they have no current revenue. 

    Arena is the company that created a novel new compound, Lorcaserin, that has the benefits I described with no real side effects.  8,000 patients treated in trials and the only adverse event statistically relevant above a sugar pill was a mild and transient headache.  A good risk when you can lose 8% of your weight (if you respond to the drug) and reduce your risk of a heart attack by 60%.  Their market cap is only $240M. 

    If we could solve the issue of over 200M Americans being overweight through getting them to eat better, good luck.  Everyone knows they need to eat better and exercise and we’ve known this for decades yet the rate of obesity has skyrocketed the last decade along with the rest of the developed countries.  China now has over 90M diagnosed Type II diabetics and another 200M pre-diabetics.  20 years ago, it was almost nothing.  Thank you KFC and McDonalds.

    Until we outlaw processed foods, fast foods and crap in our kids schools and only let people eat vegetables, clean meat, fish, fowl, fish, nuts and berries we’ll have a problem.  And we both know how unrealistic that is.  A drug for people that can’t stop the cravings for food, especially carbs and sugar, is good for society and physicians are desperate for new SAFE tools.  Qnexa is a dangerous drug in my opinion but special interests may still get it approved.  Lorcaserin is a safe drug in my opinion but special interests may keep it off the market.  Hopefully it gets approved and can help people.  America needs it.  Thank you for writing this article.

  3. Scott,

    Vivus has a market cap on just $1 billion. They hardly register as small cap and with respect to analysis showing as you put it ‘In addition to the weight loss, patients experience a .8% reduction in HbA1c, reduced fasting glucose, lower heart rate, lower blood pressure, reduced cholesterol and improved quality of life.  ‘ that’s hardly good news if that comes at the expense of my memory or unborn children with cleft palate issues.

    What society needs is  a change in attitude about how it consumes food, what it consumes and lots of existence exercise. It’s all there- nature gave it to us.

  4. Just a couple of quick comments.  First, neither of these companies are “Big Pharma.”  Both are struggling baby biotechs with no political clout whatsoever.  Big Pharma are companies like Pfizer, Merck, Sanofi, J&J, etc.  I agree that Qnexa is a not a good drug. It requires titration and has a lot of side effects.  You should look more into Lorcaserin however.  Those who complete 1 year of treatment lose on average 26lbs or 8% of their body weight.  You are 3X more likely to lose more than 10% of your body weight than a placebo.  The only side effect greater than placebo is a mild and transient head ache.  In addition to the weight loss, patients experience a .8% reduction in HbA1c, reduced fasting glucose, lower heart rate, lower blood pressure, reduced cholesterol and improved quality of life.  It was rejected in 2010 because of uncertainty in pre-clinical studies on rat neoplasms.  The FDA erred in combining tumor types and couldn’t come up with a margin of safety.  Recent studies included in their revised NDA demonstrate a 24X margin of safety for any increased risk in cancer.  That would be equivalent to taking 48 pills a day every day for months before you had any increased risk of developing cancer.  Unfortunately 2/3 of Americans are overweight or obese and there are 50M pre-Type II diabetics and 20+M Type II diabetics in this country.  Disease caused by obesity is bankrupting our healthcare system and country.  New novel drugs are needed to help and yes, the companies who can get these drugs through clinical trials (5+ years) and the FDA approval process deserve to make money on their investment.  In the case of Arena who is developing Lorcaserin, they already have lost $600M developing the drug.

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