New committee to advise on protection of human embryos
A new federal advisory panel that will provide ethical guidance for researchers engaged in studies involving human subjects has been charged by the Bush administration to consider human embryos to be human subjects, deserving of the same protections currently afforded fetuses, children, and adults.
The committee will not have the ability to enact legislation. It can only recommend changes to the Department of Health and Human Services (DHHS), which would then choose whether to go through the legislative or rulemaking process to enact a change in policy.
However, depending on whom the administration selects to sit on the committee, it could be the start of a process that could result in greater restrictions on embryo research at some fertility clinics, universities and research labs, experts told The Washington Post on Oct. 30.
"I’m very concerned that this addition [of the word "embryos"] will serve to seriously politicize the reconstituted committee," said Robert R. Rich, executive associate dean of research at Emory University School of Medicine in Atlanta, a member of the now-defunct National Human Research Protections Advisory Committee. "Embryos are not included as human research subjects, according to [current federal regulations]. It will be impossible to gain consensus around this issue if appointees to the new committee represent both sides of this very contentious issue since it is governed by emotions and beliefs and is really not amenable to rational or scientific discourse."
The National Human Research Protections Advisory Committee was formed at the direction of former president Bill Clinton to recommend new protections for human volunteers in research trials following several scandals in which people participating in research trials were harmed. Following the change in administration, President Bush allowed the committee’s mandate to expire and announced the formation of a new committee, the Secretary’s Advisory Committee on Human Research Protections, which will now advise DHHS on similar matters. At press time, no committee members had been appointed.
Tenet hires auditor to examine fraud charges
Santa Barbara, CA-based Tenet Healthcare Corp. has hired an outside medical auditor and sent a team of investigators to Redding (CA) Medical Center, its hospital. The team will look into charges that two cardiac surgeons there performed unnecessary surgeries in generate large medical payments for themselves and the hospital, The Wall Street Journal reported on Nov. 5.
The federal government is investigating the accusations against the two doctors, but hasn’t filed any charges against them.
Tenet representatives told the Journal it hired Mercer Consulting Group to assist in reviewing treatments by the two doctors. Mercer also will retain expert cardiologists to review patient records and internal documents regarding cases of alleged unnecessary surgery and other procedures. The outside cardiologists also will review any future cases the two physicians intend to perform at the hospital.
Tenet added that it will extend its internal review to all of its hospitals where there are heart programs or other specialized programs that generate high levels of outlier payments. Outlier payments are designed to defray losses suffered by hospitals when patients’ care exceeds fixed reimbursements. The Department of Health and Human Services said last month that it would review such payments next year as part of its routine work.
Pfizer to pay millions for fraud case settlement
New York City-based Pfizer Inc. has agreed to pay $49 million to settle allegations that subsidiary Warner-Lambert Co., which Pfizer acquired in 2000, defrauded Medicaid by overcharging the government payer program for its cholesterol-lowering drug, Lipitor.
At issue in the lawsuit were the educational grants that Parke-Davis, Warner-Lambert’s prescription drug unit, provided to the Ochsner Health Plan, a health maintenance organization with members in Louisiana and eastern Texas, according to an Oct. 29 report in The Wall Street Journal (WSJ).
Pharmaceutical companies are required to provide the best price for their medicines to the government program. Calculation of the best price is supposed to take into account any rebates and price adjustments that drug makers give to health plans to induce them to put their drugs on their formularies. Educational grants to a health plan, payments that are supposed to cover unrestricted educational offerings, are not included in the best-price calculation.
In its lawsuit, the federal government charged that $250,000 in payments sent to Oschner and classified as "unrestricted educational grants" and "program funding" really were rebates in disguise.
The payments came to light as a result of a whistle-blower lawsuit filed by a former Parke-Davis national sales manager, David Foster. In 2000, Foster learned his company had offered to provide Ochsner with funds to support educational programs for patients and physicians, underwrite the salaries of pharmacists, and implement a management program to improve patient care.
Foster, however, believed these payments were not educational grants and should be used to figure the best price to be paid by Medicaid. According to the settlement, Foster complained to a supervisor, but was ignored and later placed on administrative leave. He filed suit in 2000, with the federal government joining the suit later.
Pfizer will likely not be the only company required to pay up, Alice Gosfield, JD, a Philadelphia health care attorney told WSJ. "There are more of these in the pipeline."
Other drug companies, notably Schering-Plough Corp., have disclosed that they are facing federal and state investigations into their Medicaid pricing practices.