Wednesday, September 19, 2012
In The News 9-19-12
For this edition of "In the News with Panda..." I'm devoting the whole post to one in particular item. You can click the title to go to the article but I'm actually copying and pasting the full article below. My comments are in blue.
FDA-approved diet drug Qsymia now available with prescription
(CNN) -- A new diet drug approved by the U.S. Food and Drug Administration in July is now available for obese and at-risk overweight patients. The oral medication Qsymia can only be obtained with a doctor's prescription.
Qsymia (pronounced kyoo-SIM-ee-uh) is the second diet drug approved this year. The FDA approved a weight-loss pill called Belviq on June 27.
Patients in clinical trials experienced more dramatic weight loss with Qsymia than with Belviq. On Qsymia, patients went from an average 227 pounds to 204 pounds; on Belviq, the average weight dropped from 220 to 207.
Qsymia had been known as Qnexa until its approval. The FDA asked the company to change the name to avoid confusion with another drug on the market, according to the company.
Some consumer advocates worry that the medication's weight loss comes with a price. Some patients in the clinical trial suffered an increased heart rate and a condition called metabolic acidosis, which can lead to hyperventilation, fatigue and anorexia. Really? I've always joked about how an eating disorder could've benefitted from me but it was a joke. I think this is an indication that the drug works a little TOO well.
Concerns have also been raised about birth defects. One of the ingredients in Qsymia is topiramate, an anti-convulsant that has been linked to birth defects such as cleft lip and cleft palate in babies born to women who have taken it for migraines or seizures. Qsymia's other ingredient is phentermine, an appetite suppressant. Take note here. How many women got the band or try to lose weight in order to GET pregnant? Also, I always kind of worry about taking anything that causes birth defects even when I'm not trying to get pregnant. If it's not good for baby making, is it good for my body?
"Our belief is that women will be invited (through) compelling advertising and marketing messages to experiment on themselves with a drug that has some effectiveness with healthy weight loss but possible serious risks," said Cindy Pearson, executive director of the National Women's Health Network.
Qsymia's manufacturer, Vivus Inc., says that the drug helped lower blood pressure and cholesterol levels in obese people and that people taking it were less likely to get type II diabetes.
"Obesity is not being adequately addressed by diet and lifestyle changes or currently available therapies," the company said. "The need for new options is urgent, particularly nonsurgical options."
The FDA approved Qsymia only for obese people or for overweight people with a body mass index greater than 27 who also suffer from weight-related conditions like hypertension and diabetes. Hmmm...BMI of 27. I would weigh 138.5 lbs! Holy crap! I would KILL for that weight right now. I get down to 138, I'm not taking any freakin' diet pills!
Doctors are free to prescribe the drug to anyone, however, and there are concerns that physicians will open "pill mills" and prescribe Qsymia to people who just want to lose a few pounds. That's what happened in the 1990s with fen-phen, another diet drug combination that includes phentermine.
An FDA advisory committee voted against Qsymia's approval in 2010. The panel recommended the drug's approval with a 20-2 vote in February, after Vivus proposed a risk management program to limit Qsymia's distribution and published additional results from one of its three clinical trials.
Vivus is offering the pill only through mail order, so doctors can't sell it directly, said Dr. Barbara Troupin, Vivus' vice president of scientific communications and risk management.
"There will not be dispensing from doctors' offices," she said. "Seeing that issue and what has happened in fad and diet drugs in the past, that is not a path that we're going to be taking."
The 4,430 overweight and obese patients in the Qsymia studies experienced various levels of weight loss. About half of patients on the recommended dose lost 10% of their weight, while four-fifths lost 5%. That amounts to about 12 pounds for a 227-pound person.
Meg Evans, one of the patients, started out at 230 pounds and lost 48 pounds her first year on the drug and another two pounds the second year.
"I loved it," she said. "I wasn't hungry. I almost had to remind myself to eat."
At 5 feet 9 inches tall, Evans, now 63, describes herself as having been "Twiggy-like" in college, weighing 120 pounds. Then she gained weight after having four children. An avid cook and eater, she said the drug made it easier to resist tempting foods.
"If I saw a chocolate-chip cookie, it was easy enough for me to say, 'I'm not really hungry. I can pass on it,' " Evans said.
She said the weight came off gradually, about four pounds a month, and her blood pressure went down almost immediately.
In February, Dr. Michael Lauer was one of two FDA advisory committee members who voted against Qsymia's approval.
"I believe that if the public were to 'buy' (Qsymia) after FDA approval, it would run the risk of severe, even fatal, consequences from another diet lemon," Lauer wrote in Annals of Internal Medicine, also noting that the drug led to a slight increase in heart rates.
The FDA and Vivus both acknowledge that the three clinical trials meant to measure Qsymia's safety and effectiveness were not designed to properly assess cardiovascular risk. The FDA has required Vivus to do a study on the drug's cardiovascular effects. Vivus earlier said it would be done after the drug's approval. Seriously? We're going to go ahead and test the cardiovascular effects (for anyone not paying attention, this is the effects it has on your HEART!!) AFTER the FDA approval? Really? What the hell are we paying the FDA for anyway if not to make sure these things are safe before they're made available to the general public.
Despite the label's warning that women of childbearing age should use birth control while on Qsymia, there are concerns that women will still get pregnant while on the drug. The FDA recommends a pregnancy test every month while on Qsymia. Take heed. They bring this up TWICE in this article. Not good for babies!
In the drug-maker's two-year clinical trial, 34 women on Qsymia became pregnant, even though they were told repeatedly to use contraception. No birth defects happened in those pregnancies, according to the company.
Previous clinical trials of topiramate, one of the ingredients in Qsymia, have shown a risk of about five birth defects for every 1,000 pregnancies.
Comparing the anti-obesity drug to treatments for other chronic diseases, Troupin said patients will probably need to continue taking Qsymia long-term, though the new drug is not expected to be widely covered by health insurance plans. If they don't know the short term effects using something like this has on your heart, what about long term? And yet another thing that insurance companies aren't covering for you. They'd rather pay for your blood pressure meds and your insulin, etc. I'm not digging this product but if you need a prescription for it, health insurance should pay for it. Done and done.
Evans, the patient who lost 50 pounds on the drug, said she has gained back about 20 pounds since the clinical trial ended two years ago and looks forward to going on Qsymia once it's approved, even though it can have side effects.
"There are side effects to everything," she said. So she's already gained back 20. Between this paragraph and the one before it, it's not sustainable weight loss and you'll have to be on this drug forever in order to maintain your new weight...which is only 10% lower than your weight before. Is that worth taking a pill every day for the rest of your life with unknown cardiovascular risk? Brilliant.
She added that the drug wasn't the only reason she lost weight. Weekly counseling on nutrition and exercise were a big factor, too.
The counselor helped her change her diet -- choosing a salad for lunch instead of a burger, forgoing pasta and potatoes at dinner -- and encouraged her to walk a few times a week in addition to her regular exercise as goalie in a women's soccer league.
"Before the medicine, I had been telling the girls they'd have to find a new goalie, because I couldn't dive for the ball like I did before," she said. "Then I lost the weight, and I was diving and bouncing back up and having a great old time again." She lost an average of a pound a week. I don't suppose the nutrition and exercise had anything to do with that? No, no...it was the drug that made it easier for her to CHOOSE the right food and get the exercise in? Sorry...I'm not buying it.