According to AFP, Mediator, a drug licensed for use by diabetics that became widely prescribed in France as a slimming aid, “probably” caused at least 1,300 deaths before it was withdrawn, a study published on Thursday said.
Mahmoud Zureik of the National Institute of Health and Medical Research (Inserm), who co-led the probe, told AFP that around 3,100 people had required hospitalisation during the 33 years during which the drug was sold.
However, these figures could well be an “underestimate,” he said.
The study, appearing in the specialised journalPharmacoepidemiology & Drug Safety, finetunes an estimate by Zureik in 2010 that the death toll from the scandal was between 1,000 and 2,000.
Mediator, known by its lab name as benfluorex, was initially licensed to reduce levels of fatty proteins called lipids, with the claim that it helped diabetics control their level of blood sugar.
But it also suppressed appetite, which meant it gained a secondary official use to help obese diabeticslose weight.
In fact, it was widely sold on prescription for non-diabetics wanting to slim.
In 2009, Mediator was pulled from the European market amid evidence that it damaged heart valves and caused pulmonary hypertension.
Its French manufacturer, Servier, is being probed on suspicion of dishonest practices and deception.
The new study is an extrapolation based on figures for deaths from faulty heart valves, although not from hypertension, among major users of the drug.
The main data comes from France’s national health insurance system, which said that 303,000 patients used Mediator in 2006.
According to Mediator, 145 million packets of Mediator were sold on the French market before the drug was pulled.
MORE WEIGHT-LOSS MEDICAL NEWS:
FDA warns against quick weight-loss programs using hormone
SARATOGA, Calif. —
Proponents of a hormone-based diet claim you can lose 10 pounds in three weeks with no exercise, but this unusual weight-loss program some swear by comes with serious government warnings.
For Sanjay Mohindra, tennis comes easy. But losing weight doesn’t. With his 20-year high school reunion looming last summer, the then 230-pound Mohindra found a diet that finally worked for him.
“I was able to lose twenty-five pounds in three weeks and get under two hundred pounds. It got to a point where I didn’t even know what I was going to wear because I couldn’t fit into my suits,” said Mohindra. He went on to lose an additional 15 pounds. His parents were so impressed with his weight loss, they also signed up for the controversial plan.
“I started at 124 pounds. I’m at 109 pounds. Now, I don’t think I could have done this any other way,” said Nina Mohindra, Sanjay’s mother.
The way the family did it was the HCG or Human Chorionic Gonadotropin diet. HGC is a hormone produced by pregnant women. Under a doctor’s care, the diet required them to inject themselves daily with the hormone and follow a very strict diet of only 500 calories a day and not exercise.
“Not only did I not feel dizzy or weak, this is the best I have felt in my life,” said Raj Mohindra, Sanjay’s father. He still checks his blood pressure, but is off his medication after losing 24 pounds.
The HCG diet is not new. It first surfaced in the 1950s. Today, it’s FDA approved for fertility treatments, not weight loss. But the Mohindras’ doctor at a Saratoga anti-aging clinic is able to prescribe HCG as an off-label use. He has done so for roughly 500 patients. He calls it a short-term jumpstart rather than a long-term solution.
“For the patients who follow our program correctly, 90-to-95 percent lose our target weight, which for women is 20 pounds in 6 weeks. For men, it’s 25 pounds in 6 weeks,” said Dr. John Tang.
With a cost around $900, it can be successful for those willing to follow the detailed diet of only 500 calories a day. To give you an idea of what 500 calories is, that’s about a turkey sandwich with mayo and cheese. But on this diet, you can only eat from a strict list of proteins, fruits and veggies for two meals a day.
“I would say the mind is a very powerful thing. And I would say there’s a big placebo effect occuring here,” cautions Dr. John Morton of Stanford Hospital‘s Bariatric Surgery Department. He stresses the impact and any long-term effects of HCG as a weight loss program have not been studied and says some of his clients have tried and failed.
“Lemon, cayenne, pepper, and maple syrup diets all the way to HCG. I do think this appears to be a gimmick,” said Dr. Morton.
The FDA stresses there are no FDA-approved HCG products for weight loss. In December, they started cracking down on companies illegally selling them over the counter. The FDA calls the low-calorie diet reckless and says eating so little is likely behind the weight loss. Nutritionists warn it’s not a long-term solution.
“The minute you lose it and stop eating that way, you gain it back. In 99.99% of the cases, the individuals gained back even more weight than they lost,” said dietician Lillian Castillo.
But the Mohindra family says they have not gained the weight back thanks to the one thing all sides agree on: healthier eating.
To read more about the Federal Drug Administration warnings regarding HGC diets, you can go to the FDA web page on the subject.
- Weight-Loss Drug in France May Have Killed 1,300, Study Says (inquisitr.com)
- Mediral HCG Drops (answers.com)
- Obesity Drug ‘Mediator’ Likely Responsible For Thousands Of Hospitalizations And Deaths In France (medicalnewstoday.com)