Lose very little weight, and gain lots of nasty side effects!
FDA has just approved a new weight loss drug called Belviq. It’s the first new prescription drug for long-term weight loss to enter US in over a decade. As we noted in February, the pharmaceutical industry is desperate for new blockbuster drugs. The patents on their biggest money-making drugs are expiring, which will cause drug prices and profits to plummet when generic versions become available, so the drug-makers are in a frenzy to find a new pill for a mass market.
Whether Belviq is that golden ticket is in serious doubt. First off, the weight loss it achieves is extremely modest—only 47% of patients lost more than 5% of their body weight over a year’s time, with the average patient losing between 3% and 3.7%. In other words, if you weighed 200 pounds, you might lose about seven pounds over the course of a year.
Then there are the acknowledged side effects: depression, migraines, memory lapses, and attention disturbances. But for some reason, FDA thinks the benefits of taking an expensive pill to lose a tiny bit of weight outweigh the crippling headaches, mental problems, and depression. Hey, maybe they can add an antidepressant in there and make it a “two-fer”! That is exactly what they did with another diet drug, Contrave, which has not yet been approved.
Drug giant GlaxoSmithKline was just fined $2 billion because, among other violations, it marketed its antidepressant medications Paxil, Wellbutrin, and Avandia for unapproved uses—particularly for weight loss, even though there is no evidence it would be effective for this purpose. It is also worth noting that antidepressant drugs don’t even appear to work for depression and can be highly addictive. Someone trying to lose weight is not likely to know about the addiction problem or be told about it.
Oddly, those who lost at least 5% of their body weight using the newly approved Belviq were specifically not patients with Type 2 diabetes—yet the FDA approved it for overweight people with at least one weight-related health condition, such as Type 2 diabetes. Patients with diabetes may experience extra side effects, like low blood sugar, headache, back pain, cough and fatigue.
In 2010, FDA denied Belviq’s approval because of potential heart-valve risks and increased brain and breast tumor development. The drug’s manufacturer, Arena Pharmaceuticals, decided not to reformulate the drug—they merely submitted new studies that showed that it wasn’t a risk at low doses! Which of course means the risk still exists at high doses. That’s reassuring.
Belviq likely won’t be the only new diet drug on the market. Two other drugs have been resubmitted for approval. An FDA drug advisory panel has already recommended approval of one of them, Qnexa, a diet pill that has documented risks of causing birth defects and heart problems. FDA’s final decision is expected some time in July. The only other currently FDA-approved weight loss drug is Alli, which has particularly nasty side effects like oily stools and flatulence—not to mention causing vitamin deficiencies and possible liver damage.
Patrick O’Neil, president of the Obesity Society, said he was encouraged by Belviq’s approval because “it underscores the notion that lifestyle changes alone are not enough to treat obesity.” But he was also the lead researcher on several studies on Belviq.
There are certainly some excellent natural alternatives to help manage weight. One recent randomized, double-blind study points to the potential of unroasted coffee bean extract. The extract contains chlorogenic acid, which helps tame blood sugar spikes and decrease weight. Study participants lost an average of 17.6 lbs. and reduced their body fat, without changing the number of calories they consumed, the macronutrient ratios (protein, carbs, and fat) of what they consumed, or the amount they exercised. Just compare these numbers to the small gains under Belviq.
Best of all, 37% of the patients using coffee extract went from overweight (the pre-obesity range) back to their normal weight range. Other studies show that drinking twelve cups of coffee a day lowers the risk of diabetes by 67%. But few of us can (or should) drink that much coffee each day, so research into a coffee extract is extremely promising indeed.
Unfortunately, green coffee bean extract and other nutraceuticals are always vulnerable to a rapacious drug industry that might want to turn such natural substances into drugs. This is what precisely happened to pyradoxamine and could happen to P5P, the most bioavailable form of vitamin B6. The only barrier to this theft under FDA rules is that pharmaceutical companies prefer to rely on synthetic versions of natural substances because they can be patented, and the companies can then charge whatever they wish.
Readers may recall that drug giant GlaxoSmithKlein has actually petitioned the FDA to ban supplement companies from making weight loss claims—specifically, because obesity is a disease, and only drugs can claim to treat disease. The FDA has still not ruled on the petition, so please tell FDA you will not allow pharmaceutical companies to use the Citizen Petition process for their own financial gain. Please take action now with this Action Alert!
A New Diet Pill Hits the Market
Lose very little weight, and gain lots of nasty side effects!
9 thoughts on “A New Diet Pill Hits the Market”
Who watches the FDA? Who are they working for? It seems they want to take away our natural suppliments but approve pharmaceutical drugs that are not a for sure thing.
It is hard to tell whether the FDA’s incompetence exceeds it’s corruption, or vice versa! The conflicts of interest are so blatant. Some statements and decisions are so bureaucratically obscure and even ludicrous.
I am finished with being a guinnea pig for those stupid P(HARM) Companies. There is not one drug that I have been given throughout my entire 73 years that has not been worse for me than not taking anything. I am a Doctor’s worst nightmare! Start looking for “Natural” things that “Granny” used to help with the ailments and take those “manufactured foods” off the store shelves because they are the problem, no solution to anything. If it is “man made” it is toxic to the human body! I will lose my excess weight by trying to “Undo what the P(HARM) Companies have done to add this weight!” Almost every prescription that was sold to me over the past years had the side affect of “RAPID WEIGHT GAIN” and no doctor ever read those side affects before prescribing them. Get real! I’m not taking your P Harmful Drugs!
At al most age 73, I have been living by the same rules all of my life except when I was given Cipro prior to a hip replacement, as well as the same stuff in shampoo form by Galderma. This poison has netted me severe tendon-as well as joint damage.
Later, one doc insisted that I take the purple pill when I’d never suffered from GERD, either. He got nasty when I declined, even thou’ that was my right to do. I can only surmise that his quota for a Hawaiian trip bonus had not been met. “First Do Not Harm”, my foot.. I don’t do routine doctor visits anymore. That old saw, “Don’t fix it if it ain’t broke”, has been working well for me.
WHAT a hatchet Job
“”lots of nasty side effects!””
Nope what they found was the worst side effect was a headache at 7% of the 8000 in the trials. In many cases it went away or was treated temporarily with aspirin!
“”First off, the weight loss it achieves is extremely modest—only 47% of patients lost more than 5% of their body weight over a year’s time,””
Obviously you did not read the study results or the FDA briefing documents! The average included people who dropped out even if it was 1 day into the study. OF THE COMPLETERS of the trial 35% lost over 9% of their body weight and 25% lost 16.7 pounds. Even the proposed label says that if you do not see results in the first month they recommend that you stop use. IE it works great fror 35% of the people taking it.
“”Drug giant GlaxoSmithKline was just fined $2 billion””
So what this is not the same drug. Hey that guy was in a car accident so nobody should drive a car.
“”Oddly, those who lost at least 5% of their body weight using the newly approved Belviq were specifically not patients with Type 2 diabetes””
That is not true if you look at the completer’s of the trial. ALSO a side benefit was a reduction in the HbA1c levels of 0.9 to 1.0 and a reduction in fasting glucose levels of 27. Those would take someone in a pre-diabetic state to a normal state and those who are full diabetics would require less diabetic medicine. THERE is you 2 fer.
“”In 2010, FDA denied Belviq’s approval because of potential heart-valve risks and increased brain and breast tumor development.””
NOOO Wrong again there were no indications for hear risks NONE. It was rejected due to controversy over interpretation of rat cancer slide. These slide were readjudicated by an FDA approvel panel of 5 pathologists and were found NOT to have any cancer risk. Subsequently the drug was approved. 8000 patients underwent the trials and all had extensive cardio vascular screening and no issues were found and there were no increases in cancer.
YOUR HATCHET JOB is a scare piece that will do damage to people who will benefit from this treatment.
The FDA (Food & Death Administration) is…..Patently corrupt….greedy and…self-serving…and no one has the balls to dismantle them….OR Big Pharma. Just another *Corrupt* entity of the corrupt United States Government.
Wow you are dangerous. Absolutely dangerous. If your readers had any idea of the statistical differences between FDA approved medications and “green coffee been extract” you would be paraded as a fool playing with Legos while everyone is building circuit boards. Misinformation is dangerous.
I want everyone to know that the green coffee been extract was a “pilot study”, it used 16 people, not the 1,000s in the FDA trials. They are designed as a preliminary investigation to determine whether or not it is worth devoting resources to the question at hand and to determine what is called “beta or power”. Beta or power is the number of patients (=N) that a study needs to include for the results to mean anything.
“37% of patients” the author champions! Oh do you mean .37 * 16 = 6 people? You want to compare the results of testing 1000’s of people to … 6 people? Did you care to also explain that the study was done in India on a traditional Indian diet which doesn’t correlate to Americans or Europeans, they were supposed to monitor exercise but there was no data on their exercise regimens- including those six people or that there were no side effects… Because they only used 16 people!
The author of the study is a good scientist, but people like you and Dr. Oz made off the wall conclusions on what the author himself described as too little evidence for now.
There should even be a Ku Klux Klan against pharmesudical companies who use citizen patition process for their own financial gain.
Because this is not even forgivable! Tricking us to take drugs that are harmful having us thinking they are helpful…for financial gain?
AND I was told of MEDS that reportedly help with weight loss CAUSE weight gain…along wiith mental illness as a side affect!
KEEP IT UP! THATS WHY
MICHAEL JACKSON WANTED TO BE WHITE!!!!!!!!!!!!!!!!!!!!!!!!!!
There should also be a KKK against these phamosutical companies because they are so powerful. They killed Kennedy, they should kill these guys! Raw O Wah!!!!