Category Archives: Drug And Device Safety

Counties Pursue Safer Drug Disposal

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

–Sherry Boschert (@sherryboschert on Twitter)

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Filed under Cardiovascular Medicine, Dermatology, Drug And Device Safety, Endocrinology, Diabetes, and Metabolism, Family Medicine, Gastroenterology, Health Policy, Hematology, Hospice and Palliative Care, IMNG, Infectious Diseases, Internal Medicine, Nephrology, Neurology and Neurological Surgery, Obstetrics and Gynecology, Oncology, Pediatrics, Primary care, Psychiatry, Rheumatology, Uncategorized

New Anti-Inflammatory Drugs Will End Anti-TNF Dominance

Tumor necrosis factor inhibitor drugs began to dominate treatment of inflammatory diseases like rheumatoid arthritis, psoriasis, and the inflammatory bowel diseases ulcerative colitis and Crohn’s disease a little over a decade again. Now, the time when the importance of the anti-TNFs will wane and newer drugs will take their place is clearly visible on the horizon. It hasn’t happened yet, but the era of anti-TNF dominance for treating inflammatory diseases that persisted throughout the 2000s will end in the next 5 years.

The anti-TNF era began in 1998 with the approval of etanercept (Enbrel) for rheumatoid arthritis and infliximab (Remicade) to treat Crohn’s disease. In subsequent years, the list of approved anti-TNFs expanded to include adalimumab (Humira), golimumab (Simponi), and certolizumab (Cimzia), and the approved indications grew to include many inflammatory disease of joints, the GI tract, and skin. The anti-TNFs revolutionized inflammatory disease treatment and made treatment to remission possible for many patients.

tumor necrosis factor (green, purple, black) and TNF receptors (blue)/courtesy Bassil Dahiyat; Science

But reports from just the past month show that new agents are overtaking the anti-TNFs.

In May, I reported from Digestive Disease Week on phase III trial results with vedolizumab, which was compared against placebo for patients with ulcerative colitis. One of the study investigators noted that vedolizumab beat the placebo arm for steroid-free clinical remission by 30 percentage points. “Nothing else is that good,” Dr. William Sandborn, professor of medicine and chief of gastroenterology at the University of California, San Diego, told me, and the benchmark he had in mind was the performance of the anti-TNFs in similar patients.

More recently, at the European Congress of Rheumatology earlier this month I heard a report on a head-to-head comparison of the anti-IL-6 drug tocilizumab (Actemra) and the anti-TNF adalimumab in patients with rheumatoid arthritis. After 24 weeks of monotherapy, patients on tocilizumab had nearly a fourfold higher remission rate than patients on adalimumab. Though the monotherapy trial design did not mimic the way most rheumatoid arthritis patients get treated, the new drug tocilizumab absolutely blew adalimumab out of the water in a rare head-to-head comparison among different classes of anti-inflammatory drugs.

And at the same meeting several talks highlighted another new anti-inflammatory class of agents coming soon to the U.S. market, the Janus kinase (JAK) inhibitors, such as tofacitinib, which is expected to received FDA approval later this summer. Phase III results show that tofacitinib has safety and efficacy that seems at least comparable to anti-TNF drugs, with the advantage of oral dosing.

Vedolizumab, tocilizumab, and tofacitinib are just the tip of new waves of anti-inflammatory drugs that will soon substantially alter a landscape that the anti-TNFs have mostly had to themselves for the past 14 years. For the moment, the anti-TNFs have the advantage of a longer track record for safety, but changing that is only a matter of time.

—Mitchel Zoler (on Twitter “mitchelzoler)

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Filed under Allergy and Immunology, Dermatology, Drug And Device Safety, Family Medicine, Gastroenterology, Health Policy, IMNG, Internal Medicine, Practice Trends, Primary care, Rheumatology, The Mole

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

PMA Process Taking Longer and Longer

In the medical device arena, pre-market approval (PMA) submissions to the FDA keep taking longer and longer to process, according to Bob Rhatigan, senior vice president of facial aesthetics for Allergan Inc. 

“A decade ago we used to see a PMA approval time of 9-12 months,” Mr. Rhatigan told attendees of the Summit in Aesthetic Medicine 2012. “In the middle of the last decade, that increased to 16 months, and as recently as 2010, that time frame is over 2 years. It’s something that we are anxiously watching. We don’t see any signs of that abating.” 

The implications are gloomy for clinicians engaged in research of medical devices who wish to continue working in the United States. The current regulatory environment, Mr. Rhatigan said, “is working to push clinical research and studies outside of the U.S. market. It is not inconceivable, looking forward, to think about the bulk if not all of clinical research moving offshore as a result of companies like Allergan needing to get products approved more quickly. We are a bit pessimistic right now but [are] attempting to influence [legislators], as we want to make sure innovation in this industry continues to be ripe in the U.S. market.” 

— Doug Brunk (on Twitter@dougbrunk)

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Filed under Dermatology, Drug And Device Safety, health reform, IMNG, Practice Trends

FDA Takes the Measure of Nanotechnology

The  Food and Drug Administration is paying attention to the little things—the very little things. The FDA recently released guidelines for industry on the use of nanotechnology in food and cosmetics. The draft guidelines have been issued for public comment, according to the FDA website.

Courtesy Wikimedia Commons/KoS/Creative Commons License


The Nanodermatology Society issued a statement in response to the guidance for nanotechnology use in cosmetics—an issue that will continue to interest dermatologists as the technology evolves. The NDS stated its belief that the FDA has a responsibility to ensure the evaluation of nanomaterial use in cosmetics, including both over-the-counter and prescription products.

The guidelines must measure up to the science, however. “The NDS believes that the guidelines should not be based on controversial evidence, weak evidence, or pure conjecture,” according to the NDS statement. To that end, the NDS pointed out a few areas of the guidelines where scientific evidence could be more complete. For example, with respect to titanium dioxide, the NDS notes that “TiO2 can accumulate in tissues such as kidneys, but can also be eliminated, for example, in the liver in some animal models.” In addition, the NDS notes that a guideline proposing that penetration studies should be conducted on both intact and impaired skin might not be appropriate in cases where products are recommended for use on intact skin only.

In addition, the NDS recommended an expiration period for the final guidelines, due to the swift evolution of nanotechnology.

Check out the draft guidance on the use of nanotechnology in cosmetic products at the FDA’s website:

What’s your take? Should the FDA monitor nanomaterials in cosmetic products?

–Heidi Splete (@hsplete on twitter)

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Filed under Dermatology, Drug And Device Safety, IMNG

Adolescent Misuse of Prescription Pain Medicine Starts Early

In stark contrast to most research that suggests senior year in high school or later is the peak time for misuse of prescription pain relievers, it is younger 16-year-olds who are the mostly likely to report their first use of these agents outside their intended prescription within the previous year, a new study finds.

Courtesy Wikimedia Creative Commons/Kandy Talbot

The time for physicians to identify risk and intervene is the young to middle teenage years, Elizabeth A. Meier, Ph.D., and her associates at Michigan State University in East Lansing reported.

“With peak risk at age 16 years and a notable acceleration in risk between ages 13 and 14 years, any strict focus on college students or 12th graders might be an example of too little too late in the clinical practice sector and in public health work,” they wrote in the Archives of Pediatrics & Adolescent Medicine, published online May 7, 2012.

“We suspect that many physicians, other prescribing clinicians, and public health professionals will share our surprise that for youth in the United States, the peak risk of starting extramedical use of prescription pain relievers occurs before the final year of high school [and] not during the post-secondary school years,” the authors wrote.

Another reason to screen your young adolescent patients is the risk of hazardous consequences associated with prescription pain misuse, which is greatest during early adolescence, Dr. Meier and her colleagues noted.

They assessed self-reported extramedical prescription pain reliever use among 119,877 U.S. teens and young adults (ages 12-21 years) using 2004-2008 data from the National Survey on Drug Use and Health (NSDUH).

They calculated the highest risk estimate, 2.8%, at 16 years of age. This is an increase from 0.5% at 12 years; 0.7% at 13 years; 1.6% at 14 years; and 2.2% at 15 years. After the peak in mid-adolescence, risk dropped steadily by 0.3% or 0.4% each year, down to 1.1% among 21-year-olds.

Reliance on self-reported misuse of prescription pain killers is a limitation of the study. A strong point of the research, however, was including adolescents and young adults regardless of whether they were still in school.

Earlier and stronger school-based prevention and outreach programs are warranted, according to the researchers. There also is a distinct role and reason for pediatricians, dentists, and other clinicians to work toward misuse prevention in their practices, they added: roughly 15% of the youths surveyed were not in school during the peak time of risk.

–Damian McNamara

@MedReporter on twitter

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Filed under Anesthesia and Analgesia, Drug And Device Safety, Epidemiology, Family Medicine, IMNG, Internal Medicine News, Pediatrics, Uncategorized

Everlolimus-Eluting Coronary Stents Notch a Major Thrombosis Victory

What a difference a few years, and a new generation, has meant for the fortunes of drug-eluting coronary stents.

In the late summer of 2006, at that year’s meeting of the European Society of Cardiology, the specter of stent thrombosis first rose around the drug eluting coronary stents of that era, the sirolimus- and paclitaxel-eluting devices. The concern led to an abrupt plunge in the use of drug-eluting stents, routine use of more prolonged dual antiplatelet therapy with aspirin and clopidogrel, and eventually the development and marketing of second-generation stents, which used new drugs—everolimus and zotarolimus—and new polymers to bind the drugs to the stent.

Over the past couple of years, the second generation has given drug-eluting stents a renewed, more robust profile. And now, a new meta-analysis published online in The Lancet brings the best news so far for the new generation: the cobalt-chromium everloimus-eluting stent–marketed as both Xience V and Promus—fared significantly better than bare metal stents in their rates of stent thrombosis both 1 and 2 years after placement, and the cobalt-chromium everolimus-eluting stent also significantly surpassed all of its competition, both first- and other second-generation coronary stents.

image courtesy Abbott Vascular

image courtesy Abbott Vascular

The Lancet article that described the meta-analysis, which included 49 trials with more than 50,000 patients, called the finding “a paradigm shift,” something that, if confirmed in a prospective trial, “would have profound clinical implications.” A drug-eluting coronary stent that’s actually substantially safer than a bare-metal stent for the important safety endpoint of stent thrombosis. Who would have thought it possible just a few years ago?

The editorial accompanying the new analysis, by New Zealand cardiologists John Ormiston and Mark Webster, cautions that as a meta-analysis the finding can strictly be regarded as only hypothesis generating, but they also note that a head-to-head randomized comparison of the cobalt-chromium everolimus-eluting stent and a bare-metal stent for this endpoint is unlikely to ever happen. They also said that while the new finding was “unexpected,” the cobalt-chromium everolimus-eluting stent must now be “regarded as the standard against which future design improvements [in stent technology] are compared.” The “firestorm” about stent safety, first set ablaze 5.5 years ago at the ESC  “is now barely smoldering,” they concluded.

The authors of the meta-analysis said that the suggestion that this everolimus-eluting stent could actually best bare-metal stents for stent thrombosis first became plausible at last August’s ESC, in results from the EXAMINATION study, which compared the two stent types in about 1,500 acute myocardial infarction patients. The meta-analysis pooled results from two head-to-head comparisons of the cobalt-chromium everolimus-eluting stent against a bare-metal stent in a total of about 3,800 patients (including the EXAMINATION population), and found that the everolimus-eluting device cut the 1-year thrombosis rate by 86% and the 2-year rate by 65% compared with bare-metal stents. The cobalt-chromium everolimus-eluting model also significantly surpassed every other first- and second-generation drug-eluting stent for their 1-year rate of definite stent thrombosis.

Hypothesis generating or not, it’s a result that cardiologists will find hard to ignore.

—Mitchel Zoler (on Twitter @mitchelzoler)

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