The FDA had previously rejected this very same drug for safety reasons. So how do they explain the sudden flip-flop?
Last week, the FDA’s Endocrinologic and Metabolic Drug Advisory Committee voted 20 to 2 to recommend approval of Qnexa, a diet pill that has documented risks of causing birth defects and heart problems. The committee’s approval pretty much paves the way for full FDA approval. If approved, Qnexa would be the first new prescription weight-loss medication since 1999. There is only one other diet prescription medication currently on the market: Orlistat (marketed under the trade name Xenical), which tends to cause loose, oily stools, along with a host of other possible side effects, some of which may be serious.
Qnexa was rejected twice, once in October 2010 over heart risk concerns, and again in January 2011 because one of its ingredients can cause cleft lips in the children of women who take it. Qnexa is a combination of two existing drugs, the appetite suppressant phentermine and the anti-seizure medication topiramate. Both have serious risks.
PubMed Health lists 63 side effects for topiramate. It can prevent you from sweating and make it harder for your body to cool down when it gets very hot. It can also harm fetuses and cause birth defects, cause kidney stones and osteoporosis, and alter your mental health “in unexpected ways” and cause you to become suicidal. Last year, the FDA reclassified topiramate as a class D drug, meaning that it carries risks to a fetus but may still be acceptable for use in pregnant women despite the risks!
Side effects of phentermine include cardiovascular adverse effects (heart palpitations, dizziness, chest pain, edema, and increased blood pressure), not to mention vomiting and diarrhea. Other reported adverse effects include convulsions, hallucinations, hostility with urge to attack, mania followed by depression, and panic.
Put the two together and you have a real winner of a diet drug! What’s more, diet drugs often exert their weight loss effects only while the drug is being taken. This promotes “yo-yo dieting,” which leads to more weight gain and is more likely to increase the risk of heart attack, metabolic syndrome, diabetes, and other serious health problems.
Does anyone imagine that the average overweight patient who is prescribed this drug will have a clue what’s in it, or what they could be letting themselves in for?
Officials for Vivus Inc., Qnexa’s manufacturer, have proposed a “tightly controlled system” for prescribing Qnexa to prevent birth defects, including “limits on which pharmacies can dispense the medication, such as registered mail-order pharmacies.” Of course, we can think of another way to prevent birth defects or cardiovascular problems from Qnexa: don’t approve it in the first place! As Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, points out, “Diet drug history is littered with those banned only after they found out about cardiovascular risk areas.”
What is causing the reckless and irrational approval of such an obviously dangerous drug? One of the driving forces is the pharmaceutical industry’s sense of panic. 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 Big Pharma is desperate for new blockbuster drugs—and FDA is beholden to the pharmaceutical industry. The drug industry, having been exposed for over-hyping the “cholesterol problem” for the sake of its own profit, now sees the obesity epidemic as the next opportunity for exploitation.
Predictably, according to investment experts, Qnexa is poised to become “the next Lipitor” (as if that’s a good thing!). The cholesterol drug Lipitor had $10.7 billion in sales in 2010 before losing patent protection last year. Analysts say Qnexa, if approved, may generate $448 million in sales in 2015.
With so few weight loss medications on the market and obesity at epidemic levels in America, the panel felt that the risks posed by obesity outweighed the drug’s side effects. Dr. David Katz, of the Yale Prevention Research Center, said, “This is far from a great drug. The FDA panel recommended approval of Qnexa only because the ranks of useful weight loss drugs are so thin, and desperate times call for desperate measures. Approval of Qnexa would reflect that…desperation.”
The irony, of course, is that healthy, natural solutions for weight loss and management are being ignored, as we explained in our popular article on the subject. And just last week, natural health expert Dr. Joseph A. Mercola explained how eating fat does not make a person fat—but the overconsumption of carbohydrates does: “Overeating carbohydrates can prevent a higher percentage of fats from being used for energy, and lead to an increase in fat production and storage. It also raises your insulin levels, which in short order can cause insulin resistance, followed by diabetes. Insulin resistance is also at the heart of virtually every chronic disease known to modern man.”
The FDA is expected to decide by April 17 whether or not to accept the advisory panel’s recommendation to approve Qnexa. The agency usually follows the recommendations of its advisory panels but is not required to do so.
How outrageous is it that FDA will consider green-lighting an incredibly toxic drug, but won’t let supplement producers make weight loss claims for safe, natural products? FDA has created a situation where consumers cannot be told about the health benefits of nutritional supplements and natural foods because FDA is censoring the manufacturers. This forces consumers into a situation where they only hear the endless advertisements from drug makers and major media—something that will increase dramatically if Qnexa gets approved.
A drug manufacturer has petitioned FDA to stop supplement producers from even mentioning the words “weight” or “weight loss” in ads. If the FDA agrees, food or supplement competition for weight loss drugs will be wiped out in one stroke. Don’t let them think we’ve fallen asleep on this issue—take action now!
I’m almost afraid that this is an attempt to do away with obese people/people with hard-to-manage weight problems, as they a burden on the medical monopoly and have too many medical needs. Everyone keeps saying that medical costs are out of control; what better way to control those escalating costs than to “do away with” those who are incurring the most expenses and using up the most medical resources?
I pray I’m wrong, but I can really see the medical/pharma monopoly moving in this direction. They want you slightly sick, yes, so they can keep you perpetually on drugs, but they don’t want you so sick that you continually suck up all the medical supplies and cost the insurance companies a lot of money.
I mean, doesn’t it seem like the trend is heading that way?
Dr. Mercola is right. Still it’s not coming out in mainstream news or medicine and so many people don’t believe it. You have to try it for yourself.
Actually cholesterol that’s too low is worse than high cholesterol.
It is time to replace all the members and staff of the FDA. Replace them with true scientists who fully test (at Big Pharma’s expense) the medical offerings and permit or deny their use based on discrete, empirical science only. (Big Pharma’s tests and assertions will bear no weight.) This new FDA panel and staff will bill their costs only. Other than this billing, there will be no discussions by any means between the FDA and Big Pharma. Its panel and staff would be forbidden to interact at any level with Big Pharma personnel or representatives. Science rules!
This is the kind of insider manipulation going on throughout our government agencies. They are all in bed with big money interests. God forbid if we could be free enough to allow an herb or marijuana or hemp into our lives. Thanks for the protection you government lackys. the land of the free? It appears there is no moral highground left. Do a situp, eat a salad.
I forgot to add, look at Gary Johnson for President 2012. He has the right ideas, maybe not all of them. Also Dylan Ratigan and all his ideas could solve our problems and get us back on top.
As always with BIG PHAT PHARMA & The Food & Death Administration, who are constantly in collusion….and in bed (same thing)…it is ALL about $$$$$$$ and NEVER looking out for America’s best interest. And the really sad thing is, the mainstream sheeple-people will be the ones first in line…..the ones who go to allopaths who are nothing more than drug whores for BIG PHAT PHARMA to get this drug that will endanger their lives……and very likely kill many. Both of these “Government Entities” need to be on trial for MURDER and diabling people.
From all of the news I have been reading for the last few years, I am really disappointed in the FDA.
It seems as if they have been bought just like our politicians. They should be ashamed of this
decision. Drugs, and pills are being sold way before their approval. This is irresponsible at best.
What needs to happen? We have had problems with weight loss drugs before. I hope one of
their family members is not a casualty. But, maybe even that would not change things. The
FDA is corrupt.
The ranks of “useful” weight loss drugs are so thin precisely because anything that forces a body to lose weight in the absence of a proper diet and exercise regimen can only do so by creating pathology. It is in the best interests of pharmaceutical companies to create illness – what a boon for them that the FDA will allow them to leverage existing pathology (obesity) to create more dangerous levels of disease! And soon, there will be drugs to counter the side effects of these drugs, and so on, and so on, and so on.
Physicians should know more than a layperson who can copy/paste from Google search results. They disparage direct-to-consumer ads but are honest enough to disparage herbal products ads along with prescription ones.
Obesity is killing people and a calculated risk may be better than an actuarial probability of death? A diet, drug or surgery that results in a significant weight loss for 5% of a test population is good because it translates to millions of lives saved over a population.
Qnexa is indicated for sleep apnea and for type II diabetes which have different prognoses and different side-effect sensitivities from obesity and obesity-related cardiovascular failure. Broad strokes do not apply.
Low-carb diets have dangers. Authors do not admit iatrogenic hypothyroidism. The pituitary depends on insulin to determine whether a mammal is eating or starving. Starvation turns off TSH which turns off T4 and T3 which turns off metabolism. I experienced simultaneous low blood sugar, blood insulin, TSH and T4 (central hypothyroidism) which resolved with restoration of carbohydrate intake.
Some such as my wife do not recover and become permanently dependent on supplemental levothyroxine. The cardiovascular side effects of levothyroxine are similar to those mentioned above for stimulant anorectics.
The supplement industry complains that their products are blamed for coincident symptoms. That is an absolute rule for prescription drugs. If one test subject gags on a steak, passes out while drunk or gets hit by a bus, that count as a side-effect of the drug. Please read a few trial reports and note that random events which occurred in both drug and placebo arms were reported as drug side effects. That rule allows dishonest people to frighten others with side effects that may never occur in practice.
The “natural” “herbal” anorectics share the same mechanisms and the same side effects as the synthetics but have a multitude of other side effects deriving from unknown or unreported constituents of their botanic source. Absent greater candor from the manufacturers and advertisers, greater latitude of health claims is unwise.
The statutes that require a product to be managed as a drug by the FDA are driven by product claims. If a product claims to change the body (losing weight) or to cure disease (obesity), it is a drug. Anyone may ask congress to change the law but may not ask the FDA to stop enforcing it.
With all the risks and with the two previous denials, there is no reason to harm women and future generations. Please do not approve this drug.
NOT only consumers but also the federal government would save a lot of money by having a free market for weight loss products.
No Surprise that’s what these untouchable criminals do!
This keeps drs. income up, hospitals incomes steady, helps drug copanies etc. Eat a good diet instead.
What’s really mind-boggling about all this, is that all things considered, (and I’m by no means advocating this…)Crystal Methadrine, if administered by a Physician, would be much safer, as it’s mostly, if made in it’s purest form, crystallized Ephedra. Sad that it’s come to this.
Do not approve this drug.