U.S. drug regulators may have a hard time stopping millions of overweight Americans from taking a new obesity drug that many are likely to view as a miracle pill for slimming waistlines, despite its safety risks.
Regulators and doctors are hoping they can limit the pill, called Qnexa, to only those patients that need it most, helping fight the nation’s obesity epidemic while avoiding exposing people to unnecessary risks of birth defects and heart problems.
The Food and Drug Administration has been under considerable pressure from lawmakers and patient groups to approve a new obesity drug for the first time in 13 years.
There is also plenty of history with diet drugs that makes the FDA cautious.
The infamous diet drug “fen-phen” was pulled from the market in 1997 after reports of sometimes fatal heart-valve problems. Another diet pill, Meridia, was removed in 2010 after it was linked to heart problems.
“How will these medications be limited in their distribution… so we don’t have a repeat of the fen-phen days when people were opening up clinics on every corner, selling these pills for cosmetic purposes?” asked Joseph Nadglowski, chief executive officer of the Obesity Action Coalition, a patient and advocacy group.
As a condition for approval of Qnexa, the FDA and the drugmaker Vivus proposed a restrictive program to stop pregnant women from taking the drug, to provide training to doctors and to limit distribution to certified mail-order pharmacies.
Also, the drug will likely only be recommended for obese patients who have a body mass index over 30, or are overweight but have weight-related health issues. A normal BMI is below 25.
What is Fen Phen?
In the mid-1990s, a high number of overweight Americans were taking fen phen with the promise of quick and effective weight loss. Fen phen contained the combination of two drugs called fenfluramine and phentermine. While one drug suppressed the appetite, the other drug prevented drowsiness. Patients quickly experienced dramatic weight loss and the drug was dubbed a “miracle pill”.
Although health experts warned from the start that fen phen should only be used by the seriously obese, everyone wanted to get their hands on the weight loss drug. Seemingly overnight, new weight loss clinics began popping up prescribing fen phen to eager consumers.
The popularity of fen phen was short lived, and scientific evidence surfaced showing a link between serious heart valve damage and a fatal lung condition called Primary pulmonary hypertension (PPH). By then, millions of Americans had used fen phen.
On September 15, 1997, the FDA said it asked Wyeth-Ayerst Laboratories to remove fen phen from the market due to the potentially deadly effects. Soon after, fen phen users began filing lawsuits. A 1999 class action lawsuit ensued.
Since then, total charges for fen phen has cost Wyeth $21 billion. In October 2004, Wyeth warned it might need to set aside additional reserves to cover more fen phen liability, including tens of thousands of former patients who have filed lawsuits alleging they were harmed by the products and were not adequately warned of the risks.
The drugmaker lost $1.76 billion in the fourth quarter of 2004. Wyeth has proposed settlement involving about 60,000 people who opted not to participate or were not eligible to participate in a 1999 class action settlement that covered most people who took Redux and Pondimin, half of the diet drug combination fen phen. A settlement would resolve the opt-out fen phen cases from going to trial, but internal FDA documents regarding the questionability of fen phen’s safety have been clearly outlined.
It was these restrictions that ultimately convinced 20 out of 22 outside advisers to the FDA to recommend approval of the drug last week, after an expert panel rejected the drug in 2010.
The FDA is set to make its final decision by mid-April.
However, regulators have little power to force doctors to stick to this restrictive program because physicians have latitude to prescribe FDA-approved drugs for other uses, known as “off label.”
The prevalence of obesity continues to be a health concern that affects a large and growing proportion of the population, including more than one third (more than 78 million) of American adults. Worldwide more than 500 million people are obese. Obesity directly contributes to numerous life-threatening conditions: diabetes, cardiovascular disease, hypertension and stroke and is the second leading cause of preventable death in the U.S.
Beyond its impact on health, it is estimated that obesity economically accounts for 9.1% of U.S. annual health care spending - nearly $150 billion dollars. By 2030, if trends in the escalating rates of obesity continue, health care costs attributable to obesity may reach $956 billion, accounting for up to 18% of total health care costs, or $1 in every $6 spent on health care.
Qnexa® (phentermine and topiramate) Extended-release Capsules is an investigational, once-per-day, weight-loss therapy that combines low doses of two agents approved by the Food and Drug Administration (FDA), phentermine and topiramate, in a controlled-release formulation.
In addition, the two drugs in Qnexa are already approved for other conditions, raising the possibility some doctors may already be prescribing them for weight loss.
The FDA acknowledged that it is difficult to craft a restrictive program that sticks. “We struggled with this internally, but we did not find a perfect solution to this problem,” Joyce Weaver, senior analyst in the FDA’s division of risk management, told the advisers last week.
RISK VS. BENEFIT
There has been a clamor from patient groups, doctors and lawmakers for the FDA to provide more weight-loss options.
Obesity drugs are seen as the middle ground for patients who struggle with strict diet and exercise regimens, but do not want the risks of bariatric surgery.
A Senate appropriations committee has directed the FDA to provide a report by the end of March on how it plans to support the development of new obesity treatments.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with nearly 68 percent of the U.S. population considered overweight, and a third obese.