Pharmaceutical companies, doctors, and research scientist have been seeking to fight obesity for decades. And ironically they’ve apparently lost just about as many battles as the people who have been trying to battle their weight.
For almost a hundred years, scientists have labored to create a diet drug to aid in losing weight and do it without negative effects ranging from awkward and embarrassing bowel and digestive problems to deadly heart conditions.
This week, the FDA reversed its previous rejection of the drug Qnexa and chose instead to endorse. This comes on the heels of previous rejection mainly because of concerns that Qnexa can trigger cardiac palpitations, as well as birth defects in newborns when pregnant mothers take the drug.
The almost unanimous vote (22-2) of the FDA panel rescinding a previous decision and approving the diet drug Qnexa illustrates something about Qnexa, something about the obesity in the country, and something about the FDA. The decision brings hope to many that the country is on the right track as it approves the first medication in over 10 years for those suffering under obesity. But the writing is on the wall, and in fact the wall is screaming out about the dilemma that the US is in currently. The ominous nature of how obesity is plaguing the country is staggering.
“Yet this is just one single angle of responding to a condition that seems to have a million different causes,” says Pete Maughan, CEO of Weight Loss Wars a web site system designed to help people lose weight through competing in public or self-created and administered weight loss challenges.
“A safe weight loss pill that truly helps its consumers lose weight has always been easy to sell here in the U.S.” said Maughan. “Just about everyone knows the alarming statistics that obesity is a current condition for 80 million of our 300 plus million adults – 35% of the country. But because consuming food is so life sustaining, it is difficult to find a drug that targets this necessary function while not causing potentially deadly outcomes for large or even small portions of the population.”
Previous efforts to create medications for weight loss have failed to various degrees with the worst proving fatal.
Beginning in the 1930s, physicians targeted metabolism to speed it up and burn calories at faster rates. Dinitrophenol was chosen to accelerate metabolism but was shown in some patients to cause fever and fatal toxicity. Eventually, the FDA coalesced as a response to drugs like dinitrophenol that posed serious safety concerns to patients in the U.S.
Later, in the period from 1950-1970, amphetamines gained traction because they increase metabolism, suppress appetite, but unfortunately proved also to addictive and enslave many patients who used it. Doctors discovered that they also raise blood pressure, heart rate, and the amphetamine phentermine has been the only survivor of that class of drugs as an approved short-term method to lose weight in periods under twelve weeks. It is prescribed at extremely low levels, however, due to high rates of addiction among its patients.
And then in the 90′s came the biggest disaster in weight loss drug history. A combination of phentermine and fenfluramine marketed by Wyeth, dubbed fen-phen, did not receive FDA approval but was taken by more than 18 million patients with doctor prescriptions in the mid 1990′s. Many more millions consumed versions that were not accompanied by doctor supervision.
The news came in 1997 from studies indicating that as many as 1/3 of patients consuming fen-phen for weight loss received damage to their heart valve, and Wyeth was forced to issue a recall two of its drug versions and went on to pay out over $13 billion to close out 10′s of thousands of injury claims stemming from from many single and class action suits.
At present, only one single drug is actually approved to aid in long term weight reduction. The medication orlistat, which is marketed under the prescription brand name, Xenical, is also marketed and sold OTC under the brand name, Alli. The fat blocker has not garnered huge traction due to less than pleasant side effects–primary being exceedingly uncontrollable bowel movements. Introductory pamphlets for Alli even urge its users to begin the weight loss program preferentially when they have a week off work, or alternately to bring extra underwear and pants to work.
Qnexa is not the only major drug attempting FDA approval. The drug operates using the similar combination to fen-phen with the amphetamine, phentermine, to suppress the patient’s appetite, and additionally with topiramate, which is intended to make patients have the sensation of being full. FDA physician experts voted nearly unanimously with a 20-2 ruling to approve it.
The expert panel pointed to the drug’s upside– weight loss approaching 10% body weight for nearly all patients who take it for 12 months. Yet the group also stressed specifically that the drug maker must make extensive follow up efforts to monitor effects–especially on the heart which has been prone to react unfavorably over time to drugs of this nature.