Clinical Notes: FDA Turns Up Heat On Compounders

By John Greer, Deputy Managing Editor, Medpage Today/April 14, 2013

FDA inspectors found all but one of 29 compounding pharmacies making sterile products to be violating federal standards. 

FDA Finds Fault With 28 Compounding Pharmacies

FDA inspectors issued violation notices to 28 compounding pharmacies after surprise inspections – that is, nearly every pharmacy they visited that was producing supposedly sterile drugs. 

Among the deficiencies:

“Unidentified black particles floating in vials of supposedly sterile medicine.”

Mold in clean rooms.

Workers handling sterile products with their bare hands and wearing nonsterile lab coats.

Following the inspections, several of the pharmacies issued voluntary recalls and others stopped production in order to correct problems, according to FDA Commissioner Margaret Hamburg, MD. 

For full story, see Medpage Today’s website. 

St. Jude Faces Fresh Crop of Riata Suits

By Damian Garde/Fierce Medical Devices

St Jude Medical is staring down another pair of lawsuits from patients claiming injury by the now-recalled Riata CD leads and the outcome could affect how devicemakers shield themselves from liability suits in the future. 

As The Wall Street Journal reports, two plaintiffs claim their Riata leads were faultily designed and manufactured, leading to inappropriate shocks and device failure. However, the suits stand out because they accuse St. Jude of skirting both FDA requirements and state product liability laws in effort to get around a 2008 Supreme Court ruling that has hamstrung patients trying to litigate against device manufacturers. 

 

The Court has upheld that FDA regulations supersede disparate state laws on product quality, making it very difficult to successfully sue a company that has complied with the agency’s PMA process and gotten its device on the market, even if the product was later found to be defective. 

For the full article, see Fierce Medical Devices online. 

Rest Up: Insomnia Linked to Future Heart Failure

theheart.org

Trondheim, Norway — Insomnia symptoms in middle age are strongly associated with the subsequent development of heart failure, a large Norwegian cohort study has found. The analysis, which considered over 54,000 men and women, linked insomnia symptoms and heart failure, even in subjects who had never experienced a coronary event.

Speaking with heartwire, (Dr. Lars E.) Laugsand stressed that the findings do not have immediate implications for physicians, beyond the fact that sleep is important to good health generally.

“That would be the ultimate goal, to do a randomized controlled trial This study is an observational study and saying anything too firm about causality is difficult,” he cautioned. “But from the studies done in insomnia and other sleep problems, we know that sleep problems affect the physiology of the heart.”

CDC Urges Hospital Action to Stop Deadly Bacteria

Fierce Healthcare/Mike Bassett/March 6, 2013

The Centers for Disease Control and Prevention (CDC) is calling on the hospitals and healthcare providers to act to halt the spread of deadly bacteria that has proven resistant to last-resort antibiotics. 

The bacteria, Carbapenem-Resistant Enterobacteriaceae (CRE), causes a fatality rate of 50 percent in patients who get blood stream infections from them. To make matters worse, CRE bacteria spreads its resistance to antibiotics to other bacteria within their family, putting other patients and individuals at risk. 

The CDC reports that while CRE is still rare, the percentage of enterobacteriaceae that are resistant to carbapenems has increased fourfold over the last decade. 

For full story see Fierce Healthcare or CDC website. 

Paced ED May Trigger PTSD in Heart Patients

By Cole Petrochko, Staff Writer, Med Page Today/February 11, 2013

Emergency department crowding may lead acute coronary syndrome patients to experience post-traumatic stress disorder, potentially resulting in ACS recurrence or mortality, researchers found.

In a small study, greater emergency department crowding was tied to higher levels of 1-month PTSD symptoms induced by ACS, according to Donald Edmondson, PhD, of Columbia University Medical Center in New York City and colleagues.

In an accompanying editorial, Patrick O’Malley, MD, MPH, of Walter Reed Army Medical Center, in Washington, DC, emphasized that the emergency department environment can be “extremely frightening” and that, to respond to this fear, healthcare professionals should “build structures and develop processes that make it easier to care for patients in optimal environments.”

“At the very least, our environments of care should not be contributing to morbidity,” he concluded.

Soccer Players Show Signs of Brain Damage

By Todd Neale, Senior Staff Writer/MedPage Today/Nov. 13, 2012

Repetitive hits on the head that are below the threshold for causing a concussion may still result in changes in the brain’s white matter a small study of soccer players suggested.

On average, elite male soccer players – who often use their heads to direct the ball – had a range of negative changes in white matter architecture compared with a group of competitive swimmers who were unlikely to have repetitive brain trauma, according to Inga Koerte, MD, of Harvard Medical Schools Psychiatry Neuroimaging Laboratory in Boston, and colleagues.

Those differences were observed even though none of the participants in either group had a history of concussion, Koerte and colleagues reported in a research letter in the Nov. 14 issue of the Journal of the American Medical Association.

Although it is possible that frequent heading of the ball could explain the impairments in the soccer players, “differences in head injury rates, sudden accelerations, or even lifestyle could contribute,” the authors wrote.

Previous studies have shown that repetitive traumatic brain injury can have negative long-term consequences – including impaired white matter integrity – but the effects of frequent subconcussive head impacts are less clear.

For the full story go to MedPage Today.

Witness: J&J Aimed Risperdal Patch At Children’s Doctors

Fierce Pharma 9-26-12/By Tracy Staton

“With every Risperdal trial — and there have been more than a few — we hear new allegations about Johnson & Johnson marketing techniques. That infamous doctor letter in South Carolina, for instance, in which J&J touted Risperdal as less risky and more effective than its antipsychotic rivals — and which cost the company $327 million in penalties, unless and until J&J wins appeal.

This time, we’re looking into a patent liability suit, one of many that attempt to link Risperdal use with boys’ breast development. The allegation itself is sensational enough to grab headlines. But yesterday’s testimony from an ex-J&J sales manager gave reporters plenty of sound bites — and the opportunity to use the word “popcorn” in a headline.

As Bloomberg reports, Tone Jones, a former district manager at J&Js Janssen unit, testified that part of his job was training sales reps to target doctors who treated children and adolescents. At the time, Risperdal was only FDA-approved for use in adults. Jones also said that he received more than $12,000 in bonuses tied to Risperdal sales to doctors treating children and teens.”

Please see Bloomberg for the whole article or Fierce Pharma online for the rest of their article.

Stanford Scientists Cast Doubt on Advantages of Organic Meat and Produce

By Kenneth Chang/Published in the NY Times/September 3, 2012

Stanford University scientists concluded that fruits and vegetables labeled organic were, on average, no more nutritious than their conventional counterparts, which tend to be far less expensive. Nor were they any less likely to be contaminated by dangerous bacteria like E. coli.

The researchers also found no obvious health advantages to organic meats.

Conventional fruits and vegetables did have more pesticide residue, but the levels were almost always under the allowed safety limits, the scientists said. The Environmental Protection Agency sets the limits at levels that it says do not harm humans.

“When we began this project, we thought that there would likely be some findings that would support the superiority of organics over conventional food,” said Dr. Dena Bravata, a senior affiliate with Stanford’s Center for Health Policy and the senior author of the paper, which appears in Tuesday’s issue of the Annals of Internal Medicine. “I think we were definitely surprised.”

See September 3, 2012 NY Times for full story.

Dire Diabetes Outlook Among U.S. Kids And Adolescents: Type 1 And Type 2 On The Rise

June 10, 2012/Michael O’Riordan/Heartwire

Philadelphia, PA – The prevelance of type 1 and type 2 diabetes is on the rise in children and adolescents in the U.S., with new data showing that both forms of diabtes mellitus increased across all ethnicities and in boys and girls, although the largest increase in type 2 diabetes occurred in non-Hispanic white and Hispanic children. Over the past decade, the prevalence of type 1 and type 2 diabetes increased 23% and 21%, respectively.

The findings, presented here at the American Diabetes Association (ADA) 2012 Scientific Sessions, are the latest from a large multicenter study known as SEARCH for Diabetes in Youth, an observational study launched in 2000 that is focused on learning more about diabetes in children and adolescents.

For the full story, go to Heartwire.com.

Air Pollutants Mediate Effects On Heart Health Through Inflammation And Thrombosis

Heartwire.com/ May 16, 2012/ Michael O’Riordan

Los Angeles, CA – Changes in air-pollution levels in China during the 2008 Olympic Games resulted in a reduction in biomarkers of inflammation and thrombosis, as well as other measures of cardiovascular physiology, a new study has shown. 

“The common wisdom among many people is that air pollution is bad for your lungs, and also many people know that air pollution can affect the heart as well, but they think it only affects old people with preexisting cardiovascular or other health conditions,” senior investigator Dr Junfeng (Jim) Zhang (University of Southern California, Los Angeles) toldheartwire. “It might not be a concern for the young and healthy. But in this study, we really show that air pollution can clearly affect a young and healthy heart. It really tells us that everybody is affected by pollution.”  

In addition, Zhang said the study, which tested the effects of pollution on 125 healthy medical residents, highlights how sensitive the human body is to pollution changes. The physiological changes in response to shifts in air pollution can be detected within a very short period of time, and this means that even short-term interventions, such as those performed in Beijing, can bring immediate health benefits to healthy people, he said.

The results of the study are published in the May 16, 2012 issue of the Journal of the American Medical Association.