(Circulation. 2000;102:e9016.)
© 2000 American Heart Association, Inc.
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Paying for Clinical Trials
On June 7, 2000, when President Clinton directed the federal Health Care Financing Administration (HCFA) to pay for the costs associated with clinical trials, he opened the door to such therapies for many older Americans. He did not, however, define what costs and which trials would be covered. In a "national coverage decision" issued in mid-August, HCFA defined the kinds of trials that would be covered and what "routine patient care costs" are.
As expected, routine costs mean all items and services usually available to Medicare beneficiaries, such as hospital and physician services and diagnostic tests. Excluded from coverage are the investigational item or service itself, items and services needed exclusively for data collection, or those that are provided by the trial’s sponsor without charge.
More difficult is how to define the kinds of trials that will be covered. For example, HCFA wants to cover only those trials set to answer questions about an item or service that would normally fall within the benefit category of Medicare, such as physician services, durable medical equipment, and diagnostic testing. Trials involving cosmetic surgery and hearing aids, which are excluded by law from coverage, would not be part of the covered clinical trials. Studies that test toxicity levels or the basic biology of a disease would not be covered, nor would those that enroll healthy volunteers rather than people with a diagnosed disease.
The agency would also deem some trials as automatically covered, such as those funded by the National Institutes of Health, the US Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality (AHRQ), the HCFA, the US Department of Defense, and the Veterans Affairs Administration (VA), as well as trials conducted at National Cancer Institute cancer centers and all trials of patients that are either conducted under an investigational new drug application or are exempt from having this application for legally defined reasons. The trials’ principal investigators would be required to enroll the trial in the Medicare clinical trials registry for tracking purposes.
Those studies that fall outside these rules would have to meet the following guidelines.
- The principal purpose of the trial is to test whether the
intervention potentially improves the health outcomes of the
participants.
- The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
- The trial does not unjustifiably duplicate existing studies.
- The trial design is appropriate to answer the research question being asked in the trial.
- The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully.
- The trial is in compliance with federal regulations relating to the protection of human subjects.
- The trial is conducted according to appropriate standards of scientific integrity.
- The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
Trials that are not federally preapproved should follow the guidelines that will be set by a multiagency federal group convened by the AHRQ and composed of members from the Department of Health and Human Services research agencies, the Centers for Disease Control and Prevention, the Office of Human Research Protection, and the research arms of the Department of Defense and the VA. A trial’s principal investigator would submit a certification form indicating how the study meets qualifying criteria along with a copy of the protocol to a Medicare clinical trials registry. If the completed certification form shows that the study meets the HCFA criteria, then it would be entered into the database as an approved trial.
Hospital Closings Reach 22 in the Year 2000
US hospitals, beset by market pressures and managed care, continue to close; 22 have shut their doors since January 1, 2000, according to Dynamis Health Care Advisors, a Cleveland-based company. The most recent closing involved Pittsburgh, Pa’s 136-bed St Francis Central Hospital on August 15, 2000.
The hospitals that have closed have >2500 inpatient beds and >7500 employees, according to the company. The most recent figures from the US Department of Health and Human Services were for 1998, when 43 hospitals closed.
Typically, the hospitals that close are small (<300 beds in an urban area) and heavily dependent on Medicare and Medicaid money to pay their bills. Often, closures are the result of the consolidations that occur when a group of hospitals in a particular area is bought by a single entity, such as a for-profit or nonprofit system. The system closes hospitals that are losing money. Often, these are small rural facilities or those in the inner city.
Botswana Wants to Make HIV Reporting Mandatory and Push Counseling to Reduce AIDS Chaos
Botswana, one of the nations hardest hit by the African AIDS epidemic, is proposing a new law that would require people infected with HIV to disclose their health problem to sexual partners, according to a report from the British Broadcasting System. In this nation in which 1 in 3 adults carries the virus associated with AIDS, the law is intended to change sexual behavior, said Botswana’s health minister Joy Phumaphi to officials of the United Nations.
The health minister is also proposing a door-to-door AIDS counseling program that would start in September and is anticipated to cost $4.5 million. The AIDS disclosure law was pronounced unworkable by officials of UNAIDS, the agency charged with fighting the epidemic. However, they said the counseling effort is likely to be more successful in reducing the rate of HIV transmission in the beleaguered nation.
This Little Piggy, That Little Piggy, Which Little Piggy?
In reports that were simultaneously released, 2 international research teams announced in the journals Science and Nature that they had cloned pigs. The clonings are considered a first step toward using animals to grow replacement organs for humans whose own hearts and vital organs are failing.
"Pigs have an enormous potential for xenotransplantation (transplanting organs from one species to another) in humans," said Tony Perry, a researcher at Rockefeller University and coauthor of the Science study to the Associated Press. "This is a breakthrough toward that goal." His team, which was led by a Japanese researcher, announced in the journal Science that it had cloned a single piglet (Science. 2000;289:1188–1190).
In a separate publication in Nature (2000;407:505–509), researchers at a Scottish company reported cloning a litter of 5 pigs. This feat, which was reported by Alan Colman, PhD, and his colleagues, from PPL Therapeutics, was accomplished by a new "double nuclear transfer" procedure that might allow the production of pigs genetically engineered so that their organs are not rejected by the human immune system.
However, a report by Daniel Salomon, PhD, and colleagues from the Scripps Institute in La Jolla, Calif., which was published in the same issue of Nature (2000;407:501–504) sounded a warning note. Much concern has been expressed about the dangers of endogenous retroviruses. Because pigs are considered preferential animals for the transplantation of the heart, those in the field have been looking at the effects of porcine endogenous retroviruses (PERVs).
Dr Salomon and his colleagues evaluated 
50 PERVs and found that some
could infect isolated human cells. They also found that the virus is
active when pig pancreatic cells are transferred into immunodeficient
mice. In fact, the PERVs can infect mouse tissues away form the site of
transplantation. The studies raise the question of what risks organs
transplanted from pigs might pose to human beings.
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