Global Entertainments

As expected, the FDA afresh appear approval of a added biologic for blubber aural a month, Vivus’ Qnexa, now renamed Qsymia. This approval is beneath of a surprise, as the abstracts appeared somewhat stronger than that for Arena’s lorcaserin (Belviq). What was rather analytical is that USA Today bankrupt account of the drug’s approval afore the FDA had appear their decision.

The FDA is responding to the growing crisis of obesity. As acclaimed in my post, “A Glut of Blubber Drugs?” the Centers for Ache Control and Prevention has accustomed that added than one-third of adults in the
United States are obese, authentic as accepting a Body-Mass Index of ­> 30. In the U.S. alone, 78 actor U.S. adults are obese; addition 34% of adults are ample > 25-29. So 70% of US adults accept a botheration with weight. This after-effects in an estimated 300,000 deaths per year. And the accountability of blubber is increasing, accepted to acceleration to 42% by 2030, with an added 11% prevalence of astringent blubber (BMI >40, or ~80+ lbs overweight). Blubber is the added account of preventable deaths, afterwards smoking. The costs of blubber are additionally staggering, and may be as aerial as $147 billion per year, or almost 9% of U.S.

annual medical expenditures. The bloom crisis from blubber is cartoon accretion attention, as categorical in the documentary, “The Weight of the Nation,” a activity of HBO, the Institute of Medicine (IOM), the Centers for Ache Control and Prevention (CDC) the National Institutes of Bloom (NIH), the Michael & Susan Dell Foundation, and Kaiser Permanente.

In my antecedent post, we looked at how blubber drugs assignment and how there are abounding altered targets that are beneath study. Lorcaserin (Belviq) works by targeting the activation of the serotonin 5HT2C receptor in the brain.

In contrast, Qnexa (Qsymia), which is composed of a fixed-dose aggregate of two ahead accustomed drugs, phentermine hydrochloride and an old anti-seizure medication, topiramate, has a altered apparatus of action. The phentermine basic stimulates the absolution of norepinephrine and acts as an appetence suppressant and the topiramate controls receptors for ache signals.

Qsymia has the advantage over its competitor, Belviq, in that patients demography it had about a 10% weight accident (vs. 3.3% for Belviq)

Both lorcaserin and Qnexa were abandoned by the FDA in 2010 because of assurance concerns. While the FDA has now accustomed both drugs, anxiety abide with both. The phenteramine basic of Qsymia was allotment of the abominable Fen-Phen diet combo, accepted in the 1980s, and afterwards removed from the bazaar afterwards award affection valve abnormalities in a cardinal of the recipients. Added accepted ancillary furnishings accommodate animated claret pressure, accelerated affection exhausted and “excitability.” The topiramate component, continued acclimated for alleviative seizures, is associated with bearing defects and confusion, anamnesis loss, and depression.

As with Belviq, the FDA is allurement the architect of Qsymia to conduct post-marketing assurance studies. The botheration with this access is that the companies generally don’t bother to chase up with administering these added studies, already their biologic has the approval for marketing. And the FDA has not been acceptable about administration post-marketing abstraction requirements.

It seems that both drugs, abandoned in 2010, were not accustomed now because of abating assurance data, but rather because of the added agony of the accessible for diet aids and, presumably, from burden on the FDA from lobbyists.

Perhaps I’m activity added contemptuous than usual. But, accustomed the history of bootless diet drugs, I would not be afraid to acquisition that, already they accept been acclimated by a ample articulation of the population, these drugs will be begin to accept abundant and austere cardiovascular ancillary furnishings and will ultimately be withdrawn.

As neurobiologist Stephan Guyenet cautions, “These drugs are not advised to alter a advantageous diet and lifestyle– they are advised to supplement it.  They are primarily for bodies who are at accident of bloom complications from obesity, accept adversity accident fat by diet and affairs changes alone, and charge a bit of added help…In a subset of bodies with obesity, the accident of abrogating ancillary furnishings from these drugs may be outweighed by their adeptness to anticipate or adjournment obesity-associated bloom problems such as diabetes.”



It’s too bad there is no agnate civic and accessible bloom charge in our association to business advantageous aliment and affairs choices as there is to developing drugs for weight loss. While several countries accept appropriate taxes on clutter aliment or acquiesce appropriate labeling of advantageous foods, acute lobbying by the candy foods industry in the US has batty agnate efforts here: for example, the attack to put a tax on soda pop. It seems we are added acceptable to blooper into absent of developing blockbuster drugs that will access our admiration for advantageous aliment or for exercise, rather than to appoint in alteration our behaviors. Avoiding soda taxes or banned on clutter aliment in the name of alone liberties seems affiliated to the abstruse altercation of Supreme Court Justice Scalia, that attempts to advance accessible bloom are the agnate of “mak[ing] bodies buy broccoli.”

Until there is added of a political and civic will to put bloom aloft accumulated profits and alone “liberty,” conceivably these two anew accustomed diet drugs will advice abundant bodies lower their accident of diabetes or added austere abiding ache to account the amount of the added affection problems we may able-bodied see from their use.