Health Highlights: May 23, 2005
Rodent Virus Kills 3 Transplant Patients Privacy Rules Make Research Costlier: Study Maker Cites Positive Tests of Premature Ejaculation Drug Company Covered Up Breast-Implant Rupture Rates: Report Criticism Forces Revision of New Medicare Handbook Medicaid Pays for Viagra for N.Y. Sex Offenders
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Rodent Virus Kills 3 Transplant Patients
A virus transmitted to people by exposure to rodent waste has killed three organ transplant recipients in New England, according to the Associated Press.
Rodents at a Warwick, R.I., pet store have been quarantined following the death of one state resident and two other people in Massachusetts, the wire service said. The three deaths were caused by a viral infection called LCMV, and they represented only the second known case of the infection being transmitted via organ transplant, health officials said.
A pet hamster belonging to the Rhode Island organ donor who harbored the virus has tested positive for the germ, the AP said. The unidentified donor died of unrelated causes.
Animals at the Warwick Petsmart store where the rodent was purchased have been quarantined, officials said.
Privacy Rules Make Research Costlier: Study
The 2-year-old laws that govern medical privacy in the United States are hampering research and increasing the costs of medical studies, University of Michigan scientists said in a report released Monday.
The researchers, writing in the Archives of Internal Medicine, focused their analysis on how the laws collectively known as HIPAA affected heart patients who were asked to participate in post-surgical follow-up surveys. Patient participation in these surveys fell from 96 percent to 34 percent after the regulations became law, and skewed the data because certain types of patients were more likely to participate, the researchers said.
HIPAA (Health Insurance Portability and Accountability Act) dictates that most types of patient-participation research require written authorization from patients, even if the data obtained is used anonymously, the researchers said. These and other federal guidelines mean that the authorization forms are often long and overly cumbersome, they said.
And the regulations added more than $8,700 worth of computing time, staff, and office supplies to the first year of an average research project, the researchers said.
Maker Cites Positive Tests of Premature Ejaculation Drug
The drug that could become the first prescription medicine to treat premature ejaculation is showing promise in late-stage clinical testing, maker Johnson & Johnson said.
J&J's Ortho-McNeil Pharmaceuticals unit said the U.S. Food and Drug Administration is now reviewing its new drug application for dapoxetine. More than 50 percent of users who took the drug reported "fair to very good" control over ejaculation, compared with fewer than 3 percent before they took the drug, the Associated Press reported.
More than 2,600 men involved in monogamous relationships of more than six months are participating in the trials, the wire service said.
Data from the trials were released Monday at the annual meeting of the American Urological Association in San Antonio, Texas.
Company Covered Up Breast-Implant Rupture Rates: Report
In allegations contained in a 2003 lawsuit against breast-implant manufacturer Mentor Corp., two former employees charged that the company covered up high implant rupture rates.
The employees also alleged that workers hid defective implant parts in the ceiling because they were so afraid of bosses finding the defective parts, the Associated Press reported.
That 2003 lawsuit was dismissed. Mentor Corp. recently received a recommendation from U.S. government scientific advisers that, under certain conditions, the company be allowed to resume sales of silicone-gel breast implants.
Details of the sworn depositions by the two former workers were reported Sunday in The New York Times. One of the employees alleged that senior Mentor officials told him to destroy reports about high implant rupture rates. The employee, John C. Karjanis, was manager of product evaluation from 1996 to 1998, the newspaper said.
The other employee, Cynthia Fain, was supervisor of Mentor's complaint unit in the mid-1990s. In her deposition, Fain said she received 6,000 complaints of ruptured implants in each of her three years at the company. That number was far higher than the figures Mentor gave federal authorities, the AP reported.
The deposition details were released by Kim Hoffman of Springfield, Mo., who filed the 2003 lawsuit, and by the Command Trust Network, a group for women with breast implants, the AP said.
"All of these allegations are old news," said Josh Levine, Mentor's president and chief executive. The two depositions were taken as part of a lawsuit filed that, "after a thorough review by the court," was dismissed on summary judgment, he said.
Criticism Forces Revision of New Medicare Handbook
The preliminary draft of the 2006 Medicare handbook is being revised after it was found to contain inaccurate, unclear or misleading statements.
The Bush administration was forced to revise the new handbook after insurance companies, members of Congress, state insurance regulators and advocates for beneficiaries pointed out numerous flaws, The New York Times reported.
Even people who've worked in Medicare for decades found it hard to understand parts of the handbook describing the new prescription drug benefit and other services. The handbook is meant to be the main tool for educating Medicare beneficiaries, the Times said.
The 106-page handbook is being revised to address the concerns, according to Gary R. Karr, spokesman at the Centers for Medicare and Medicaid Services. He said the revised version will include a more detailed description of the drug benefit and will also clarify differences between private health plans and traditional Medicare.
The final version will be mailed to beneficiaries this fall, the Times reported.
Medicaid Pays for Viagra for N.Y. Sex Offenders
For the last five years, Medicaid has paid for Viagra for 198 convicted high-risk sex offenders and rapists in New York state, according to audits by the state comptroller's office.
The audits found that the sex offenders, including some who committed crimes against children as young as 2 years old, received Medicaid-reimbursed Viagra between January 2000 and March 2005, the Associated Press reported.
On Sunday, Comptroller Alan Hevesi sent a letter to Michael Leavitt, secretary of the U.S. Department of Health and Human Services, to "take immediate action to ensure that sex offenders do not receive erectile dysfunction medication paid for by taxpayers."
Hevesi said this situation was the unintended result of a 1998 federal directive that told states they must include Viagra in Medicaid prescription drug programs, the AP reported.