Here’s an article from the US news agency KCPQ about the FDA and WHO being divided on whether to promote an obesity drug to young people after obtaining results from a clinical trial. Apparently, hundreds of thousands of people taken part in the research received 18 VITROL beta blockers – and the effects are dramatic, in the same way as the effects of a drug called Contrave, which is approved in the US and Europe for adults.
Both Contrave and VITROL beta blockers are actinolateral Beta-blockers, which means that “after we’ve taken the one action to lower our blood pressure, we can take the second action in order to relax the blood vessels”, says Grady Bennett, managing director of NPH Clinical Research (NPH). “So this actually provides a nicer double impact”.
And that it does. During treatment with Contrave, 94 percent of participants lost at least 5 percent of their body weight. The same time – 18 VITROL beta blockers were given to overweight or obese 16 to 24 year olds who were either overweight or obese but still weren’t overweight and never had type 2 diabetes. The drug lost 12 percent of the weight of at least 5 percent – and 35 percent of the weight of at least 10 percent. And now, after seven years of follow-up, which is the standard time for such studies, the picture for the participants who had received VITROL beta blockers is clearer.
The results are good, and even better, better than the control group, which was a placebo. And since about 300,000 young people took part in the study, these results are indeed major. The positive effects of VITROL appear to last for 6-12 months, after which patients who stay on the drug lose an average of another 10-17 percent of their weight.
Why are the results so dramatic? VITROL beta blockers are exactly the kind of drug that has been proven to be effective in adults, and the clinical trial presented at the time of the drug’s approval in the US was evaluated by 76 doctors across the country, who suggested changes. The FDA’s response to the studies was critical of the FDA. “What are we doing by approving the drug?” the FDA’s panel of advisers said. “Should we stop approving it?”
Now, there is some controversy at the FDA, and there are questions about the ethics of prescribing a drug to young people and whether it is a good idea. But overall, it is clear that these effects are much stronger than what was the effect of Contrave or NPH’s other drugs.
At a recent meeting of the World Health Organization in Malabo, Equatorial Guinea, panel members also questioned whether the large number of people who took part in the study influenced the results – if their use of the drug had any effect at all.
One member of the WHO advisory committee had argued that “the magnitude of the placebo effect is so great” that the studies showing efficacy could not possibly have been made under the current conditions.
Another said that “worse still is that in these studies, the placebo was given in person by the same health workers who gave the patients the drug”.
All sides point to the similarities between these drugs – which both act as quick and effective “pills” in lowering blood pressure – which are taken just before a meal to limit high blood pressure, and the results. Contrave/VITROL has been approved since 2012.
The future of VITROL beta blockers is still up in the air, but it is clear that something extraordinary has occurred, and the effects that two drugs appear to have on weight loss and health are pretty exciting. It is possible that Contrave will also work for people who are obese and overweight, but this must be far more complex than in the study. Still, the NIH recently gave NPH one million dollars for another study using VITROL beta blockers on obese children and teens.
This is the kind of unexpected impact that’s happening in this new scientific world. I wonder if Contrave will also be more effective than VITROL beta blockers on subjects, or if there’s something else we should know about this drug. Or maybe it will be impossible to study both in a controlled way.
Sources: KCPQ News, which translates as Klamath and Cowlick, NBPH Study. Library of Medicine, put notes in brackets.