Archive for June, 2014
June 27th, 2014
When Dr. Mehmet Oz testified before a Senate subcommittee on June 17, 2014, he was challenged by Senator Claire McCatskill on a study he had conducted on green coffee bean extract, “ Green Coffee Bean Extract “The Fat Burner That Works!” which aired on September 12, 2012.
Senator McCatskill questioned the quality of the science in this show saying it would “not pass scientific muster”. Dr. Oz replied that it would not meet what the Food and Drug Administration required to approve a drug. (No foolin!). Dr. Oz continued that he would not publish the study because it was not conducted under the appropriate IRB (Institutional Review Board) guidance. He explained that is was not under IRB guidance because “ the purpose was for me to get a thumbnail sketch: was this something worth talking about.” See clip at 2:50 minutes.
Dr. Oz Testifying Before US Senate
The show described in detail the hypothesis Dr. Oz was testing; the protocol was described by two members of his Medical Advisory Board; the use of placebo was described vis a vis the intervention group. The necessity of using a food journal was described as well as the inclusion and exclusion selection criteria. The terms “experiment,” “study,” “clinical trial” “placebo,” “intervention group,” “duration,” “food log (or journal),”study design,” “who (green coffee bean extract) is good for and who it is not right for,” “outcome, and “results” were used 36 times. The recommendation from this study presented by Dr. Oz was that the extract probably should not be used by pregnant women and children under 18. For all others, they could expect to lose twice as much weight as using a food journal alone, about a pound a week. Some thumbnail sketch!
It is interesting too that Dr. Oz said the study was not done “under appropriate IRB guidance.” The IRB process is intended to protect human subjects of medical treatments. The Columbia University College of Physicians and Surgeons where Dr. Oz is on the faculty has comprehensive IRB procedures, as required by New York State Law and Federal Law. It would appear that any research conducted on human subjects by a faculty member of the College of Physicians and Surgeons must be submitted for approval by the IRB. Under limited circumstances a study can receive an exemption from the IRB requirements but the exemption is given by the IRB. Assuming that Dr. Oz received an exemption from the IRB, I’ve asked the director of the IRB program for an explanation of what the reasons for exemption were. They responded and said they are looking into it. Stay tuned.
June 27th, 2014
The New York State Court of Appeals has affirmed lower court decisions banning the sale of sugar sweetened beverages in cups over 16 ounces capacity. The Court of Appeals decision, as was the case in the lower courts, focused on the power of the New York City Board of Health to make several policy decisions in this area when the New York City Council and the New York State Legislature had not acted in this area.
Predictably, some activists pointed to the money employed to fight the City’s regulation. They miss the point. This regulation was bad policy at the outset. Those who think obesity is the result of “One Thing” are always disappointed when it turns out that changing the “One Thing” does not affect the accumulation of excess body fat. In addition, the regulation had numerous inconsistencies. It suffered from “over-inclusion” because it affected everyone buying a beverage in New York City and from “under-inclusive” in that other beverages of same or greater caloric content were not covered.
No doubt those who believe in the value of restricting marketing of food items will be back at work trying to find a way to work around this decision. These advocates need to keep in mind that the Supreme Court (and other courts) have set a very high bar on legislative restrictions on marketing. These cases are based on First Amendment (which was not even touched in the New York City case) to arbitrary restrictions on commercial practices. Restricting or banning advertising of food to children is a frequent mantra in prevention-of-obesity circles. The Supreme Court is pretty clear that such restrictions are not likely to be upheld.
June 27th, 2014
The Onion has found the solution to the obesity epidemic.
June 24th, 2014
John Oliver has done the best treatment of the charlatan Dr. Oz you will ever see.
June 20th, 2014
A new study on the use of antidepressants and suicides is roiling the Food and Drug Administration and the media. The study by Lu et al and published in the BMJ this week investigated whether widely publicized warnings in 2003-4 from the FDA about possible increased risk of suicide risks with antidepressant use in children and adolescents were associated with changes in antidepressant use, suicide attempts and completed suicides among young people. Researchers studied 1.1 million adolescents, 1.4 million young adults and 5 million adults.
Researchers found that the background studies behind the FDA warnings showed mixed outcomes. Nevertheless, after the FDA warnings, trends in antidepressant use and poisonings changed abruptly after the warnings. The FDA warnings received widespread and repeated media coverage becoming “frightening alarms to clinicians, parents, and young people.”
The decline was greatest among young adults, less among young adults and adults. Simultaneously, there were significant increases in psychotropic drug poisonings in adolescents and young adults but not among adults. Completed suicides did not change for any group. The study also found that there was no increase in alternative therapy usage
The researchers concluded that, “Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting.”
The media reaction to this study has been to shout that the warnings backfired and led to more suicide attempts. Meanwhile, the FDA is saying it sees no reason to change the warnings.
Why bring this study up in an obesity report? Several reasons.
First, obesity and depression co-occur in many people. There is so much overlap that most clinical trials of obesity interventions routinely exclude persons with depression from the study population. One reason is adherence. But another significant reason is that many antidepressants cause weight gain. In a recent study in JAMA Psychiatry found that people taking citalopram (Celexa) gained more than 2.5 pounds a year, on average. Those taking fluoxetine (Prozac) gained 1.5 pounds and those on sertraline (Zoloft) gained nearly 2 pounds in the course of a year. On the other hand, those taking bupropion (Wellbutrin) lost an average of nearly .5 pounds a year. (Bupropion is one component of the drug, Contrave, together with naltrexone, currently under consideration by the FDA for the treatment of obesity.) The discontinued drug, Meridia, was originally developed for the treatment of depression when its potential for weight loss was identified.
The main FDA warnings came out in 2003-2004.However in May, 2007, the FDA expanded the warnings to include young adults. The next month a FDA advisory panel recommended against approval of the drug rimonabant for the treatment of obesity, in part because of concerns of increase suicidial ideations. (See Stephanie Saul’s article in the New York Times.) Approval of rimonabant was reversed in 2008by the European Medicines Agency after the FDA’s negative decision.
Second, it seems evident now that the evidence base for the FDA warns was at best mixed. But the media so amplified the warnings that the crescendo did not admit of any doubt or consideration that maybe adolescents and young adults actually needed these medications and did not have any good alternatives. Unintended consequences are real but our current system, for all its reliance on scientific analysis, provides little room for doubt and discussion. The media like clean, crisp ‘talking points’ that fit their pre-defined “frames”, e.g. pharmaceutical companies are bad, natural remedies are good, etc. Changing the media’s approach is very difficult; there are just too many outlets. The FDA, on the other hand, is a single organization that can incorporate this experience into future activities.
June 20th, 2014
The Food and Drug Administration (FDA) is warning consumers about using bee pollen, a supplement used for weight loss. According to the FDA, bee pollen products have been found to contain hidden and potentially dangerous ingredients that can be harmful for people with conditions such as irregular heartbeat, high blood pressure and bipolar disorders. In April, the FDA advised consumers to immediately stop taking one specific product, Zi Xiu Tang Bee Pollen, because it contained at least one ingredient not listed on the product’s label. The company uses an elaborate marketing scheme to make consumers believe the product is not counterfeit.
June 20th, 2014
You heard that right! Dr. Gianluca Tognon of the University of Gothenburg and colleagues have found that, across 8 countries, children who were highly adherent to the Mediterranean were less likely to be overweight or obese than those who were lease adherent. Data were based on surveys of parents. Sweden and Italy ranked the highest while Cyprus was the lowest ranked country.
The irony is that the Eastern Mediterranean Region has one of the highest rates of overweight and obesity in the world, according to the World Health Organization.
June 19th, 2014
The Fiscal Times reports on new study from Scott Kahan MD at George Washington University and director of the STOP Alliance estimating costs of obesity at $300 billion.