June 10, 2011
By Leah Voigt*
FDA Touts New Adverse Event Reporting Rule
U.S. Food and Drug Administration (FDA) officials took to the pages of the New England Journal of Medicine (NEJM) to highlight the agency's new system for reporting adverse events in clinical trials, which they hope will make such reports less numerous but more useful. In an online Perspective article published Wednesday in the NEJM, Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, and other top CDER officials explain the rationale for the new regulation, which was announced in September 2010 and implemented this past March.
The new system shifts primary responsibility from individual investigators to trial sponsors for determining when adverse events seen in a clinical study are potentially related to the investigational drug, Woodcock and colleagues indicated. At the same time, individual investigators will be required to report every adverse event to the trial sponsor.
Under the old system, sponsors were required to report every individual adverse event that they knew about in a trial to FDA, irrespective of whether the trial drug may have been responsible. But the individual investigators did not have to report every adverse event they saw to the sponsor. Instead, they were required to report only those events they believed were "probably" related to the trial drug.
This system misplaced the responsibility because site investigators are in a relatively poor position to make such determinations, wrote Woodcock and colleagues. "It's difficult . . . for an investigator to attribute a serious adverse event to a drug on the basis of an isolated incident, and individual investigators often do not have timely access to the entire safety database," the officials argued.
Instead, they said, trial sponsors should be the ones to determine when adverse events are drug related, and site investigators should report to the sponsors every serious adverse event they see.
John Gever, FDA Touts New Adverse Reporting Rule, MedPage Today (June 8, 2011).
Signing Bonuses Become Usual Part of Physician Recruitment Packages
Signing bonuses for new physicians have become a common hiring incentive, part of what can be lucrative packages for doctors who have just completed their residencies or fellowship training. Newly trained physicians in some highly sought-after specialties can command incentives worth six figures in exchange for their first years of work.
Surveys by the Medical Group Management Association (MGMA) and Irving, TX-based physician placement firm Merritt Hawkins that examined recruiting packages from 2010 show that signing bonuses—once an incentive offered on occasion for hard-to-fill jobs—have become the norm. "Signing bonuses have gone from carrot at the end of the stick to an expected part of the package," said a senior vice president for Merritt Hawkins. "It's an extreme negative these days if you don't have a signing bonus." Medical liability insurance, relocation expenses, and paid time off for continuing medical education also are common, if not standard, according to MGMA and Merritt Hawkins reports.
Other types of one-time incentives beyond cash bonuses are emerging, allowing hospitals and physician groups to stand out in a crowded field of potential employers. But bonuses remain a core part of employment offers.
MGMA's report, released in May 2011, was based on responses to a voluntary online survey during 2010 and looked at information on about 4,300 physician placements. Of the 2,971 answers about recruitment packages, 56% reported that signing bonuses were part of the deal. According to Merritt Hawkins' most recent report, 76% of the jobs for which the firm recruited between April 1, 2010, and March 31, 2011, included a signing bonus. That was stable from the prior year's level but down from the 2008-09 survey year, when 85% of searches included a signing bonus.
Even though the percentage of packages with bonuses was down slightly from a few years ago, the average bonus for the 2010-11 survey year was $23,790, up from $22,915 the prior year.
Both reports also show continued reliance on other one-time incentives, including loan forgiveness—the practice of paying off part or all of a new physician's student loans. New recruiting tools are emerging, as well. Amid a poor housing market, 6% of searches in the last survey year featured a housing allowance for relocating physicians to offset the loss of selling a home for less than the purchase price.
Emily Berry, Signing Bonuses Become Usual Part of Physician Recruitment Packages, Am. Med. News (June 9, 2011).
New Questions Rise in Cause, Trajectory of Germany E. Coli Outbreak
As Germany's tally of deaths increased in what has become one of the world's most lethal infections of E. coli, new elements of confusion surfaced Wednesday with conflicting signals about whether the outbreak is abating and what caused it. Initially, the German authorities blamed cucumbers, tomatoes, and lettuce from Spain for the infection, which has been spreading since May 1. Then last weekend, investigators switched their attention to sprouts grown in northern Germany as a potential cause.
On Wednesday, even as the authorities said the sprouts were still prime suspects, the hunt took a new and apparently baffling turn when the state authorities in Magdeburg, in eastern Germany—far from the original epicenter of the infection in northern Germany—said traces of the pathogen identified in the outbreak had been found on discarded cucumber leftovers in a garbage can belonging to a family among those sickened by E. coli.
So far, German Health Minister Daniel Bahr said Wednesday that the outbreak has claimed twenty-five lives in Germany—four more than reported Tuesday. One death has been reported in Sweden. In addition, 2,648 people have fallen ill, 689 of them with a potentially deadly complication that causes kidney failure and neurological damage, according to the Robert Koch Institute, the country's disease control agency.
Holger Paech, the state health ministry spokesman in Magdeburg, said it was unclear how the bacteria got onto the cucumber at the home of a family where three people had sickened, one of them with the virulent complication whose treatment has strained intensive care units in many other parts of Germany. The three family members had no known contact with the worst infected areas of northern Germany, he said.
The discarded cucumber had been in the garbage can for a week and a half, he said, and "there will always be an element of doubt" about how it had become contaminated.
On a broader scale, differences emerged Wednesday between the federal health ministry and the Robert Koch Institute over the status of the outbreak.
Bahr struck a cautiously optimistic tone on Wednesday during an emergency meeting in Berlin of health officials from Germany and the European Union. "There is much to suggest that we have put the worst behind us," he said. While this did not mean the outbreak was fading, he said, it seemed that fewer people were being diagnosed.
The Robert Koch Institute, however, was far from certain that the worst was over. "There is a declining trend in new cases but it is not clear that it is because the outbreak is really waning or whether it is because the population [is] being more careful in what they eat," it said in a statement.
Alan Cowell and Judy Dempsey, New Questions Rise in Cause and Trajectory of Germany E. Coli Outbreak, The New York Times (June 8, 2011).
Physicians Can Help Curb Teen Smoking
Physicians who talk with teenage patients about the dangers of smoking can have a significant influence on their attitudes about tobacco use, according to a study in the June issue of Pediatrics.
Adolescents whose doctors broach the subject become more knowledgeable about the ill health effects of smoking. Smokers who have such conversations with doctors are less inclined to see themselves still smoking after five years and are more likely to plan to try to quit within six months. Even so, about 57% of surveyed teenagers said their doctors had never offered advice on tobacco use, the study said.
"Our results showed that less than half of the students in our study had conversations with their physicians about smoking, and that is really a concern," said a study co-author and associate professor and director of clinical training in the department of psychology at the University of Memphis in Tennessee. "We're hoping [the study] will really encourage more pediatricians to talk with patients about smoking."
Researchers evaluated surveys from 5,154 11th graders in Memphis-area high schools. Fifty-four percent of students had never smoked. Of the 681 students who were smokers at the time of the survey, 53% said they had at least one cigarette a day. Both smokers and nonsmokers whose doctors had addressed the topic were less likely to see smoking as beneficial to their social status.
The study shows that physicians have an impact on adolescents' smoking behaviors, said the lead study author, a clinical psychology doctoral student at the university. Many doctors are reluctant to talk with teenagers about such issues. "They don't think it would make a difference," she said.
Previous studies have said that physicians feel that adolescents won't be honest with them or aren't mature enough to understand the consequences of smoking. Physicians also are discouraged by poor success rates of public health interventions aimed at reducing teenagers' tobacco use, the study's lead author said.
Several factors may influence a teenager's decision to smoke, including peer pressure, rebelliousness, tobacco exposure at home, and the misconception that smoking helps control weight gain, the researchers said. If more physicians talk with adolescents about smoking, fewer young people will be tempted to take up the habit and more teenage smokers will try to quit earlier, they said.
Caryolyn Krupa, Physicians Can Help Curb Teen Smoking, Am. Med. News (June 7, 2011).
Post-Pandemic Flu Shots Hit All-Time High
More people in the United States got a seasonal flu shot in 2010-2011 than ever before, according to estimates of vaccine coverage from the Centers for Disease Control and Prevention (CDC). Interim data—with information missing from seven states—showed that 42.8% of the population ages six months and older got vaccinated, the agency reported in the June 10 issue of Morbidity and Mortality Weekly Report. That's slightly higher than the previous record of 41.3% seasonal flu coverage achieved during the 2009-2010 H1N1 pandemic year, CDC reported.
The estimates are based on information collected by the Behavioral Risk Factor Surveillance System and the National Immunization Survey. Data from California, Louisiana, Michigan, Nevada, Oklahoma, Oregon, and South Dakota has not been reported yet. But in the remaining forty-three states and District of Columbia, the agency said, seasonal coverage for all age groups was comparable to that of the pandemic year, with the exception of children ages six months-to seventeen years old.
For children, the estimated coverage rate was 49%, up 6.7% from the previous season, while for those eighteen and older, it was 40.9%, similar to the 2009-2010 seasonal coverage rate of 40.5%. There were no notable differences when the adult population was broken down by age. For instance, for those eighteen-to forty-nine, the rate was 30.2%, compared with 30.3% for the 2009-2010 season, and coverage for adults fifty-to sixty-four was 45.6%, compared with 44.8% in the previous season.
There were also improvements in coverage along racial and ethnic lines, the agency reported. Specifically, adult coverage for non-Hispanic whites, Hispanics, and non-Hispanic others in 2010-2011 was comparable to the previous but was 3.6% higher for non-Hispanic blacks.
The agency noted that the 2010-2011 coverage levels varied widely among states, but were positively correlated with levels in the previous season. The implication is that successful states may have something to teach those with lower rates, the agency argued.
Michael Smith, Post Pandemic Flu Shots Hit All-Time High, MedPage Today (June 9, 2011).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers weekly and appropriate AHLA practice groups.
*We would like to thank Leah Voigt, Esquire (Spectrum Health, Grand Rapids, MI), for providing this week's update.