Labor Day is right around the corner and since I have not posted since the Fourth of July, I had better get in gear! I’ve had a very good summer, doing some teaching and traveling to Europe. I’m back in the groove now, though, and will take this opportunity to look at some of the things that the FDA has been up to. Some of these will relate to previous subjects on this blog and others are just kind of a “hey, look at this” tidbit.
The whole e-cigarette thing is becoming a fiasco in my mind. The FDA seems to be dragging its feet in regulating this new nicotine delivery strategy, while marketing continues to target our youth. All this as we continue to hear about devices exploding in peoples hands and in their faces. Emergency room visits continue as children and even adults misuse the liquid nicotine products that are out there. Warning letters are not enough. It is time to fully enforce tobacco-related regulations on electronic cigarettes.
There are still people pointing out the all too cozy relationship between Big Pharma and the FDA. One of them likes to point to this page on the FDA web site that 2 million adverse drug reactions and over 100, 000 deaths per year.The FDA apparently finds that perfectly acceptable and continues to approve marginal drugs or drugs of questionable value and safety. It’s not just Big Pharma, of course, many of the experts in other fields like food or cosmetics come from industry. It makes sense, where else are you going to become an expert in your field? What seems lacking, to me, is integrity.
It took three tries to get the new lady sex pill approved by the FDA, but, by golly, they got ‘er done! The studies supporting flibanserin were somewhat lackluster in demonstrating efficacy, with patients reporting 1/2 to 1 additional “satisfying sexual experiences” per month on the drug. It was unclear if that meant that orgasm was reached or that there was a sexual event with or without the big O. I assume the latter. Flibanserin is a post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist, so is does not affect blood flow (so not a “female Viagra”), nor is it hormonal. It works on brain neurotransmitters. And it purports to treat Hypoactive Sexual Desire Disorder (HSDD), or as I’ve been told a few times or more, “not interested!”
Anyway, there’s a significant fainting risk when used with alcohol, although how significant is yet to be accurately determined. The study on flibaserin’s interactions with alcohol performed by manufacturer Sprout included 23 men but only 2 women! WTF?
Two days after the FDA approved flibaserin (brand name Addyi) Sprout was bought by the larger Canadian company, Valeant Pharmaceuticals for $1 billion. The new owner has to honor the promise made to the FDA to do three more alcohol-flibaserin studies AFTER THE DRUG HITS THE MARKET!
By the way, FDA is on a roll lately, approving close to 90% of drugs submitted for approval this year.
New nutrition labels are on the way. The biggest change will be seen in serving size. FDA wants “more realistic” serving sizes. One example given is changing a serving of ice cream from 1/2 cup to 1 cup, saying that’s a more likely real-life scenario. Doubters are saying that it just encourages people to actually eat a full cup instead of limiting themselves to 1/2 cup. That’s a load of crap. Most folks are going to eat however much ice cream they want. For me, I just would like serving sizes to be easy to measure and make the math easy to do if I’m having a fraction of a serving or multiple servings.
Oh, FYI, a food labeled as having “zero grams of trans fat” may actually have 1/2 gram of trans fat per serving! I’m still waiting to see if FDA changes this clever ploy in the new labeling. One side effect of reducing trans fat in our foods has been the increase in demand for palm oil, further accelerating the loss of rain forest habitat as palm oil plantations spring up in places like Indonesia and Malaysia. On the plus side, last September big food companies like General Mills, Kellogg, Cargill and others pledged to use only palm oil from “sustainable sources.” I’m not sure how much of a plus that is though.
Apparently FDA believes it can regulate tweets. After Kim Kardashian boasted on Instagram (and so to Twitter) about how wonderful Diclegis can be to combat morning sickness, the FDA sent a warning letter to the manufacturer. The so-called twitterverse went crazy saying that FDA was over-reacting and Kim could say whatever she wants to on social media because she is a private citizen and has free speech, dammit! I was leaning in the same direction, until I discovered that Kim K was paid for that little bit of promotion. You can view the FDA warning letter here. It makes for an interesting debate, with several facets to consider. Kim Kardshian is said to have over 43 million followers, which although not up there with the 100 million plus that saw the Super Bowl, it’s a pretty big number and certainly worth monetizing. Diclegis is just two old products combined into one. Pyridoxine (vitamin B-6) and doxylamine are fairly benign and have been around for decades without many problems so why would the FDA be so concerned that a celebrity put in a good word for this stuff? Another thing to consider with a drug like this that takes older (inexpensive) drugs that are formulated into a new product is that the price tag to the patient is always incredibly high. I’ll let you hash all that out on your own.
Aspartame, not one of my favorite sweeteners, is being newly marketed with a cute new brand name: AminoSweet! Christ.
Originally studied for treatment of ulcers, aspartame is actually a result of mixing aspartic acid, phenylalanine and methanol. Granted that it does start with two amino acids, but the resulting aspartame molecule has been linked to adverse reactions from seizures to cancers. According to FDA, about 3/4 of complaints of adverse reactions to foods involve aspartame!
So watch for that new brand, AminoSweet, and stay the Hell away from it!
And that’s just for starters!