Diet drug pulled after red flags

By now, most people are aware of the US obesity statistics. In 2016, almost 70 percent of US adults were obese of overweight says the U.S. Centers for Disease Control and Prevention (CDC). That means normal sized people are in the minority. (Some are even considered “anorexics.”)

Today, the average American man weighs almost 198 pounds up from 166 pounds in the 1960s and the average American woman weighs 170 pounds up from 140 pounds in the 1960s. (The trend brings to mind an old New Yorker-style cartoon in which a doctor tells a fat patient “according to this chart you should be eight feet and two inches tall.”)

The US obesity epidemic has led to the creation of special-sized ambulances, operating tables and coffins as well as bigger seats on planes and trains. We won’t even talk about the size inflation and stretchy, “forgiving” fabrics that now dominate the fashion industry.

The issue is not aesthetics. People carrying excess weight are at greater risk of mortality, hypertension, high LDL cholesterol and triglycerides, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and many cancers says the CDC. In addition to the harm their weight causes them they raise healthcare costs for everyone.

Big Food tries to shift the blame for obesity from its processed, fattening, aggressively advertised junk food to “inactivity” and blame its victims. The truth is, food technologists spend millions to create foods that cannot be resisted and are addictive. A recent book called How Not To Diet debunks Big Food’s “lack of exercise” myth and reveals that when it comes to obesity, “it’s the food, stupid.”

Previous drug failures

Once upon a time a drug preparation called Fen-Phen which combined the drugs phentermine and dexfenfluramine/fenfluramine helped people fight the obesity which has now taken over this nation. But Fen-Phen was withdrawn in 1997 for causing primary pulmonary hypertension (PPT) and heart valve deaths. The drug’s lethal side effects were especially embarrassing to the FDA since its own reviewer had predicted them if the two drugs were combined according to the Atlanta Journal-Constitution in 1997. The skeptic’s veto was overridden and the drug was approved anyway.

The same year Fen-Phen was withdrawn, the FDA approved the diet drug sibutramine (Meridia) which was also withdrawn from the market for cardiovascular problems, this time in 2010. Does anyone see a pattern here?

It turned out the appetite reducing action of diet drugs and heart problems can be so closely linked, an FDA advisory committee voted in 2012 to require all obesity drugs to undergo clinical trials that assessed cardiovascular risks.

Still, the concerning track record of diet drugs did not stop San Diego-based Arena Pharmaceuticals from seeking FDA approval for a diet drug candidate called Belviq (lorcaserin), a never-before-approved antidepressant-like preparation containing the phentermine found in Fen-Phen. The drug in common with Fen-Phen, phentermine, should have raised red flags and it did.

In 2010, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted against approval of Belviq citing questions about potential cancer risks and valvular heart disease.

Industry fights back

Arena, Belviq’s developer was livid about the FDA rejection, claiming it would have to eliminate as many as 66 positions because of the financial setback. In an open letter to the FDA on behalf of Arena, Michael Murphy of New World Investor charged that “The dramatic elevation of concern over rat cancer,” could “result in irreparable damage to the bio-technology and pharmaceutical industry as a whole.”

Two years later in 2012 the Belviq was approved by the FDA—but the triumph was to be short lived. In September, 2020, the FDA officially requested the drug’s withdrawal from the market. Why? More patients taking Belviq were diagnosed with cancer compared to those taking a placebo, said the FDA, including pancreatic, colorectal, and lung cancers.

In addition to Meridia and Fen-Phen, Belviq is hardly the first drug withdrawn by the FDA because of dangerous safety signals that emerged after millions took the medications. Also withdrawn were Vioxx, Bextra, Baycol, Trovan, Seldane, Hismanal, Darvon, Mylotarg, Lotronex, Propulsid, Raxar, phenylpropanolamine (PPA) and phenacetin. How many were rushed through approval from industry pressure? Other drugs like Paxil, Avandia, Cylert, Ketek and Xarelto are under severe safety clouds.

Anyone who watches TV knows that ads for fattening, health destroying foods predominate (followed by ask-your-doctor drug ads.) Instead of approving and withdrawing new diet drugs to treat obesity, why don’t government regulators curtail processed and junk food advertising like other countries? But of course there is more money in making people fat and then selling diet aids.

Martha Rosenberg is a freelance journalist and the author of the highly acclaimed “Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health,” published by Prometheus Books. Check her Facebook page.

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