By Leah Voigt Romano*
January 16, 2009
FDA Eases Restrictions on Marketing Use of Reprints
The pharmaceutical industry may have written off logo-laden pens and pads, but drug representatives now have a new way to promote their products. For the first time, starting January 12, the FDA is allowing distribution of reprints of peer-reviewed studies that discuss off-label uses of drugs. The new rules on reprints lift the ban on the use of the reprints to point out the benefit of a drug for an unapproved indication.
The easing of reprint restrictions coincided with the pharmaceutical industry's voluntary moratorium on branded freebies such as pens, mouse pads, and Post-it® notepads. In its new guidance document, the FDA makes the case that easing the reprint restrictions was a recognition of reality because once a drug or device has received FDA approval "healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product's approved labeling."
But the FDA still maintains that not all reprints are equal. So while it now permits marketing use of reprints from papers published in peer-reviewed journals that require full disclosure from all authors of conflicts of interest or biases, it does not permit use of reprints from single-sponsored publications.
The FDA's final approval of the new policy is likely to be an issue as the agency is reorganized by President-Elect Barack Obama and Health and Human Services Secretary-Designee Thomas Daschle.
Peggy Peck, FDA Eases Restrictions on Marketing Use of Reprints, MedPage Today, Jan. 13, 2009.
New York Times Article Examines Tactic to Cut ICU Trauma: Get Patients Up and Moving
A recent article in The New York Times examines a new tactic physicians are using to limit ICU trauma: getting patients to move. According to the article, while patients may be suffering lingering effects from illnesses that landed them in the ICU, researchers are increasingly convinced that spending days, weeks, or months on life support in the units can elicit unexpected, long-lasting effects.
Now some ICUs are trying what seems like a radical solution: reducing sedation levels and getting patients up and walking, even though they are gravely ill, complete with feeding tubes, intravenous lines, and tethers to ventilators. In a recent study, researchers reported that 25% of patients who had spent at least five days on ventilators could not use their arms to raise themselves to sitting positions. Many could not push back against a researcher's hand.
Researchers say the questions about how and why an ICU stay can be so devastating—and new efforts to bring a marked change to the experience—are of increasing importance because, as the population ages, more people are being admitted to the units. And with medical advances, more patients are surviving.
Gina Kolata, A Tactic to Cut ICU Trauma: Get Patients Up, N.Y. TIMES, Jan. 11, 2009.
Salmonella Strain in Contaminated Peanut Butter Matches National Cases
Health officials confirmed this week that the strain of salmonella isolated from contaminated peanut butter at a Minnesota nursing home matches that implicated in the national outbreak. The Minnesota Departments of Agriculture and Health announced that testing revealed "a genetic match between the strains of Salmonella found in a container of King Nut peanut butter and the strains of bacteria associated with thirty illnesses in Minnesota and nearly 400 illnesses around the country."
Salmonella Typhimurium has been reported in forty-three states since September 3, according to the Centers for Disease Control & Prevention (CDC). The infections may have contributed to three deaths—two in Virginia and one in Minnesota.
On January 10, the distributor of the tainted peanut butter found in Minnesota, King Nut Companies of Solon, OH, recalled all peanut butter distributed under the King Nut and Parnell's Pride brands, but the company denies responsibility for the nationwide outbreak. "We only distribute in seven states," said the president and CEO of King Nut Companies, "and therefore King Nut peanut butter could not possibly be the source of a nationwide outbreak of salmonella," he said.
The company distributes peanut butter manufactured by Peanut Corporation of America to Ohio, Minnesota, Michigan, Arizona, North Dakota, Idaho, and New Hampshire. The FDA, CDC, and state health agencies are continuing to investigate whether these products are the source of the national outbreak.
Todd Neale, Salmonella Strain in Contaminated Peanut Butter Matches National Cases, MedPage Today, Jan. 13, 2009.
OIG Report Concludes That FDA Needs to Do More to Ensure Disclosure of Conflicts of Interest
According to a report released this week by the HHS Office of Inspector General, the FDA should do more to ensure that clinical trial sponsors investigate and disclose their researchers' financial conflicts of interests.
Current FDA rules require clinical trial sponsors to collect and submit financial disclosure information on their investigators as part of the product marketing application, but the FDA often fails to follow up on incomplete disclosure information or investigate the effects of potential conflicts of interest on clinical trial outcomes, said officials at the inspector general's office.
The review found that only 1% of researchers listed as investigators on clinical trials during 2007 disclosed that they had conflicts of interest. Forty-two percent of FDA-approved marketing applications were missing required financial disclosure information, and the agency failed to document a review of any reported conflicts of interest in 31% of applications. Furthermore, neither the FDA nor clinical trial sponsors took action to minimize potential investigator bias in 20% of marketing applications that disclosed financial conflicts.
Inspector general's office officials have recommended that the FDA take several steps to disclose and mitigate researchers' financial conflicts, including requiring clinical trial sponsors to submit financial disclosure information as a part of the pretrial application process, updating due-diligence requirements for trial sponsors, and providing additional conflict-of-interest guidance and training to product-approval reviewers. According to the report, FDA officials agreed with most of the recommendations but rejected the one that would require sponsors to disclose their investigators' financial conflicts as a part of the pretrial approval process.
Access the OIG's report.
Shawn Rhea, More Scrutiny of Researcher Financial Ties Urged, Modern Healthcare's Daily Dose (Jan. 12, 2009) (note: registration is required to view this content).
Huge Children's Health Study Begins Recruitment
Recruitment began this week for a massive NIH-sponsored study of children's health issues that will follow 100,000 children from before birth to age twenty-one. Eight years in planning, the National Children's Study is expected to shed new light on both common and rare conditions.
At a press briefing, Duane Alexander, MD, director of the National Institute of Child Health and Human Development, said that investigators would contact women who are early in pregnancy or are hoping to become pregnant to invite their participation.
Enrollment is beginning in stages. It starts this week at two "vanguard centers," in rural Duplin County, NC, and in the New York borough of Queens. Five additional centers will start recruiting in April. Each is expected to enroll 300 to 375 participants. During the vanguard phase, study leaders will evaluate recruitment and sampling methods. Eventually, some forty study centers will recruit participants from 105 nationally representative, geographically diverse locations.
Peter Scheidt, MD, MPH, the study's director, said that volunteers would not be accepted into the study. Inclusion will be by invitation only to ensure that participants are genuinely representative of the American population. Families will be recruited with letters and telephone calls, followed by in-home visits to explain the study protocol. Investigators will work with local healthcare providers to identify potential participants.
Dr. Scheidt said data collection would include periodic physical exams and biological sampling, as well as environmental studies of air, water, and dust in participants' homes. Not only will the study improve understanding of pediatric health issues, said Dr. Alexander, but it should also provide new information on the sources of adult diseases.
John Gever, Huge Children's Health Study Begins Recruitment, MedPage Today, Jan. 13, 2009.
Senate Finance Committee Review Might Delay Confirmation of HHS Secretary-Designate Daschle
The confirmation process for HHS Secretary-Designate and former Senate Majority Leader Tom Daschle (D-SD) has slowed as Republican staff members on the Senate Finance Committee review his tax records and his association with an education loan provider that the committee is investigating separately. Staff members said that the complexity of the review has slowed their progress and does not suggest impropriety. According to the staff members, the committee will not schedule a confirmation hearing for Daschle until they complete the review. As a result, the Daschle nomination "likely won't be considered by the Finance Committee before President-elect Barack Obama is sworn into office," according to The Wall Street Journal.
A spokesperson for the Democrats on the committee said, "The Finance Committee has a very full plate and is in the process of vetting several nominees," and "we are moving in all deliberate haste." A Daschle aide said that his confirmation faces no problems other than the delay. The aide said, "Like every nominee in front of the Finance Committee, we have submitted our tax records, and we feel confident that he will be confirmed."
Kaiser Daily Health Policy Report, Senate Finance Committee GOP Staff Review Might Delay Confirmation of HHS Secretary-Designate Daschle, Henry J. Kaiser Fam. Fdn (Jan. 15, 2009).
*We would like to thank Leah Voigt Romano, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.