Posts Tagged ‘FDA’

Information on dosing of drugs for children with obesity not available

October 9th, 2015

A new study has concluded that only 2 of 25 emergency care drugs for children contained dosing information on the FDA approved label for obese children and adults compared with 22 of 25 for normal weight children. Rowe and colleagues found no sufficient pharmacokinetic data in the literature for any of the emergency care drugs for children with obesity. Obesity is an important component of the appropriate dosing for drugs do to altered body composition and physiologic mechanisms. Another article by Kendrick and colleagues points out the uncertainties in prescribing information for children with obesity. Also, see this article by Oeser and colleagues on the same topic. Roux-en-Y gastric bypass surgery in adults can also affect the pharmacokinetics of drugs but the information, according to a paper by Srinivas, is mixed.


FDA Approves New Device for Treating Obesity

July 30th, 2015

The Food and Drug Administration (FDA) has approved a new medical device for the treatment of obesity. This device, a minimally invasive dual balloon delivered via an endoscope , is designed to make the stomach feel full and, thus, reduce consumption. While hailed by some groups like the American Society for Bariatric and Metabolic  Surgery, the importance of this approval may lie not so much in the specific device but in the greater willingness of the FDA medical device regulators to be open to more devices meant to assist in weight management. See here for more information.

The Food and Drug Administration (FDA) has approved a new medical device for the treatment of obesity. This device, a minimally invasive delivered via endoscope , is designed to make the stomach feel full and, thus, reduce consumption. While hailed by some groups like the American Society for Bariatric and Metabolic  Surgery, the importance of this approval may lie not so much in the specific device but in the greater willingness of the FDA medical device regulators to be open to more devices meant to assist in weight management. See here for more information.

FDA Spikes Concerns Over Dangerous Dietary Supplements

April 8th, 2015

Anahad O’Connor, writing in the New York Times, discloses an upsetting picture of the Food and Drug Administration inaction on policing an amphetamine-like substance in dietary supplements. The article describes how the leadership of the FDA division responsible for policing dietary supplements has been and is led by highlevel executives from the Natural Products Association, the trade association representing dietary supplement makers.


Antidepressant Study Roils FDA, Media

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.


FDA Panel Recommends Approval of New Obesity Device

June 17th, 2014 is reporting that the Food and Drug Administration Advisory Panel today recommended approval of a new medical device from EnteroMedics, the Maestro Rechargeable System. The voting was somewhat mixed regarding the effectiveness of the device.

The Maestro Rechargeable System uses an electrical system called V-Bloc. V-Bloc delivers the electrical signal to the trunks of the vagus nerve, which sends hunger signals to the brain. The company states that the device decreases hunger pangs, digestive enzyme secretion and calorie absorption and increases the feeling of fullness. It would be offered to candidates for bariatric surgery who do not want the full surgical intervention.

The company’s press release notes, “In the most recent clinical trial, the ReCharge Study, VBLOC Therapy treated patients demonstrated a clinically meaningful and statistically significant excess weight loss (EWL) at 12 months of 24.4%, sustained out to 18 months. The majority (52.5%) lost 20% or more of their excess weight and nearly one-third of VBLOC Therapy treated patients lost 30% or more. The 24.4% average EWL far exceeds the 10% to 15% thresholds at which patients experience substantial positive health effects. Statistically significant improvements were observed in the VBLOC Therapy treatment group in total cholesterol, LDL, triglycerides, systolic and diastolic blood pressure, heart rate and waist circumference.”

The approval by the panel is likely to encourage a number of other developers of advanced technological strategies to treat obesity. More.

Updates on Employer Wellness Programs

February 10th, 2014

The Hartford Business Journal has an interesting article on employer wellness programs incorporating sensor devices in their programs. For some interesting discussion of the development of passive sensor technology in nutrition and physical, see this video from David Allison’s program at the University of Alabama, Birmingham on wearable sensors for human behavior monitoring and biofeedback from 2012.

And Al Lewis and colleagues have a new book, “Surviving Workplace Wellness with Your Dignity, Finances and Major Organs Intact”, on the problems with employer wellness programs. Read this interesting review in Forbes on the three hazards of worksite wellness programs. Meanwhile the FDA has approved two wearable fitness trackers for use in clinical trials.


Politicians Beware of Dietary Supplement Businessmen

January 23rd, 2014


Virginia Governor Robert F. McDonnell and his wife for accepting gifts from a dietary supplement businessman. McDonnell had state health officials meet with Star Scientific Inc. representatives who wanted its supplement, Anatabloc, included in the basic health plan for state employees. The Governor and his wife openly endorsed Anatabloc.

Jonnie R. Williams, head of Star Scientific Inc., gave over $100,000 in corporate jet travel to the governor and personal gifts to the McDonnell’s over $145,000. Williams had run afoul of the Securities and Exchange Commission, which forced him to pay back nearly $300,000 for using research with false claims to promote a medical business. Star Scientific has three shareholder lawsuits against it alleging the company made false or misleading statements to boost Anatabloc.

Like all other dietary supplements, approval by the Food and Drug Administration before sale is not required. The company claims that Anatabloc helps “reduce inflammation and support a health metabolism.” However, as reported by the Richmond (VA) Times Dispatch, the company has put out at least 15 press releases on scientific studies it commissioned implying Anatabloc might mitigate the underlying causes of Alzheimer’s disease, multiple sclerosis, thyroiditis and traumatic brain injuries. It’s advertising also promotes Anatabloc for joint pain and inflammation, even though the active ingredient has only been tested in pre-clinical, animal studies. In December 2013, the FDA informed Star Scientific that it was improperly selling Anatabloc and the company needed FDA approval to sell it as a drug.

Somewhat ironically (or not) Governor McDonnell received a combined M.A./J.D. degree from Christian Broadcasting Network University (now called Regent University). Christian Broadcasting Network University was founded by Pat Robertson, conservative religious broadcaster and one time Presidential candidate. Robertson sold another dietary supplement, described as an “age defying shake” and was accused of using his tax-deductible contributions to the school  to promote a commercial product.  In one of his promotions, Robertson, then 76 years old, claimed that he could leg-press 1,000 pounds, more than the world record.

McDonnell should have seen in coming. In 2002, Tony Blair was Prime Minister of the United Kingdom. His wife, Cherie Blair, became involved with another dietary supplement businessman, Peter Foster. Foster was an Australian who had been convicted and jailed on three continents for offences involving weight loss products and property transactions. Foster became a financial advisor to Blair and assisted her with the purchase of two apartments. Cherie Blair denied the involvement but evidence came out to the contrary.

As long as the dietary supplement industry can operate without showing scientific basis for its products, it will remain an easy arena for scam artists who can pocket millions, often from weight loss products. The FDA and Federal Trade Commission can do a lot more enforcement of current laws but eventually Congress will have to bring the dietary supplement industry under tougher supervision.


Inventors, Investors, Regulators and Payors Struggle with New Technologies

December 20th, 2013

A two day meeting on the regulatory and reimbursement factors affecting medical devices for the treatment of obesity is now wrapping up in Washington, D.C. The workshop is jointly sponsored by the FDA Center for Devices and Radiological Health (CDRH)  and the American Gastroenterological Association. The meeting is one in a sequence bringing together young companies trying to develop new devices, researchers, venture capital investors, regulators and reimbursement experts from governmental and private payors. The challenges of getting a new device approved through the regulatory process and then getting it paid for.

The sponsors were kind to invite me to provide two short talks. One was on the reimbursement environment and I re-capped the changes brought about by the Affordable Care Act which is covered elsewhere. The other part I was asked to address was “What do Patients Want?” I indicated that the millions of patients with obesity did not fit any one pattern of what they wanted, nor did I have any particular data. But I did feel confident to offer that patients wanted their physicians to be respectful, competent and helpful in their weight management issues. I offered patients wanted health professionals to understand obesity as a disease, not a personality type and to recognize that stereotyping and stigmatizing persons with obesity is a defining characteristic of this condition.

I also indicated that the reasons why some patients undertake weight loss efforts, while some do not and while some take extreme risks while other do not, reflects the diversity of the population and the risks they are willing to undergo. And while health professionals often focus on weight loss for the prevention of type 2 diabetes or cardiovascular disease, patients may be just as motivated by more daily concerns, such as back or joint pain, mobility problems, incontinence, dealing with the shame and embarrassment, harassment and discrimination they experience or perceive. Finally, while the field has tried to minimize the ‘cosmetic’ goals of weight loss, we cannot avoid living in a culture in which personal appearance is so important.

It appears the AGA-FDA collaboration will continue with the goal of making the approval process more predictable and efficient and thereby facilitating getting new technologies to persons with obesity.