Tag Archives: drug safety

IOM Unveils Hot Reads in Time for Summer

In case you’re looking for something more meaningful to read this summer than Fifty Shades of Grey or Abraham Lincoln: Vampire Hunter, The Institute of Medicine has released some dandy reports suitable for reading or for hiding those trashy beach novels.

First up, in May, IOM released Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation. The report focuses on five critical goals for preventing obesity:

  • integrating physical activity into people’s daily lives,
  • making healthy food and beverage options available everywhere,
  • transforming marketing and messages about nutrition and activity,
  • making schools a gateway to healthy weights, and
  • galvanizing employers and health care professionals to support healthy lifestyles.

The committee outlined specific strategies include: requiring at least 60 minutes per day of physical education and activity in schools, industry-wide guidelines on which foods and beverages can be marketed to children and how, expansion of workplace wellness programs, taking full advantage of physicians’ roles to advocate for obesity prevention with patients and in the community, and increasing the availability of lower-calorie, healthier children’s meals in restaurants.

Also in May, IOM published Ethical and Scientific Issues in Studying the Safety of Approved Drugs. In response to the passage of the Food and Drug Administration Act in 2007, the FDA asked the IOM to evaluate scientific and ethical aspects of safety studies for approved drugs. The IOM concluded that the FDA’s current approach to drug oversight in the postmarket setting is not systematic enough and does not ensure that benefits and risks of drugs are assessed consistently over the drug’s life cycle.  “Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent, and proactive. These changes could allow the FDA to better anticipate postapproval research needs and improve drug safety for all Americans.”

Finally, for the ambitious reader, the IOM had just released the discussion paper A CEO Checklist for High-Value Health Care. Despite risking costs, healthcare remains suboptimal in many areas. “To aid and accelerate the system-wide transformation necessary, we have assembled what we are calling “A CEO Checklist for High-Value Care” (the Checklist). The Checklist’s 10 items reflect the strategies that, in our experiences and those of others, have proven effective and essential to improving quality and reducing costs. They describe the foundational, infrastructure, care delivery, and feedback components of a system oriented around value, and represent basic opportunities—indeed obligations—for hospital and health care delivery system CEOs and Boards to improve the value of health care in their institutions.”

The 10 items include:

  • Governance priority—visible and determined leadership by CEO and Board
  • Culture of continuous improvement—commitment to ongoing, real-time learning
  •  IT best practices—automated, reliable information to and from the point of care
  • Evidence protocols—effective, efficient, and consistent care
  • Resource utilization—optimized use of personnel, physical space, and other resources
  • Integrated care—right care, right setting, right providers, right teamwork
  • Shared decision making—patient–clinician collaboration on care plans
  • Targeted services—tailored community and clinic interventions for resource-intensive patients
  • Embedded safeguards—supports and prompts to reduce injury and infection
  • Internal transparency—visible progress in performance, outcomes, and costs

Kerri Wachter (On Twitter @knwachter)

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Filed under Drug And Device Safety, Health Policy, health reform, IMNG, Primary care

Keeping Weight-Loss Drugs Safe

The steady, sometimes hyperbolic rise in American obesity continued through last year, according to new CDC data out last week on the body mass index numbers self-reported on the phone by more than 400,000 randomly-selected Americans.  In 2009, 27% of American adults were obese, up by 7% from 2000, a relative rise by a third in less than a decade. In nine states obesity prevalence rates stand at 30% or more, up from only three states as recently as 2007.

Nine states (black, bottom map) had obesity prevalence rates of at least 30% in 2009, up from 3 states in 2005 (and 2007) and none in 2000 (top map). Image courtesy CDC.

This makes for a worrying trend not only for the unremitting upward path, but because so few agents safely treat obesity. The weight-loss field is littered with agents cast aside over decades because of safety problems. At the International Congress on Obesity, which  I covered in Stockholm last month, European obesity specialists bemoaned that their only remaining prescription option was orlistat, a drug of limited efficacy, after European regulators pulled sibutramine last January. In what was likely exaggeration, a Melbourne obesity expert told me there that if he wasn’t able to prescribe sibutramine (still available in Australia, the United States, and several other counties) he’d close his weight-loss clinic.

It turned out that Melbourne physician Dr. Joseph Proietto reported that with rapid weight loss, based on completely swapping liquid meals for real food for three months, 59 of 60 people lost their goal of 15% of baseline weight, much better than what slower loss achieved. The keys to rapid loss are quick results, which aids motivation, and ketogenesis, which blunts hunger.The only problem is that patients can’t stay on a ketogenic diet indefinitely, and once they stop making ketones their appetite returns and weight creeps up unless appetite is curbed long-term by treatment. The world needs appetite-suppresion treatments that are safe, effective, and can used indefinitely, Dr. Proietto told me. It also suggests that drugs should mostly be tested for weight maintenance at a newly low level rather than as the means for losing weight. 

Safety has been the tripping point, from amphetamines through fen-phen and on to rimonabant and sibutramine. Last month a new candidate, a combination of phentermine and topiramate, Qnexa , got voted down as unsafe by a FDA advisory panel. At the Obesity Congress another combination of two old drugs, naltrexone and bupropion, Contrave, showed troubling evidence that it may acutely raise blood pressure and in the long-term blunt the blood pressure benefit from weight loss. On the positive side, two other drugs in development, lorcaserin and liraglutide, show efficacy and safety so far, with lorcaserin scheduled for review by the FDA’s advisory panel next month.

Spending a few days among obesity specialists at a place like the International Congress on Obesity it becomes clear that in addition to the checkered history of obesity drugs the field is haunted by a past where snake-oil salesmen stand beside serious clinicians. And patients can have mixed motivations for weight loss that go beyond just their health.  Unlike treatments for other, immediately life-threatening disorders, where a modest adverse effect profile is tolerated, weight-loss drugs must meet a safety bar set higher that takes into account the overall impact of treatment on the bad consequences of obesity, such as cardiovascular disease.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Filed under Cardiovascular Medicine, Drug And Device Safety, Endocrinology, Diabetes, and Metabolism, Family Medicine, Health Policy, IMNG, Internal Medicine, Practice Trends, Primary care