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Government Watch

GOVERNMENT WATCH

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LIABILITY REFORM LEGISLATION MOVES FORWARD IN CONGRESS

It is several months since media buzz about doctors striking to protest out-of-control medical malpractice insurance costs headlined the news. But the issue is very much alive for physicians around the country. In Neurology Today this month (page 4), neurologist Damon Fellman, MD, argues for stronger legislation in this area – and Congress seems to agree. The House passed a tort reform bill earlier this year, the HEALTH Act of 2003, a bill that has been placed on the Senate calendar for consideration.

The bill may face problems in the Senate, however. A similar liability reform bill, passed by the House last year, never cleared committee in the Senate, and the slim Republican majority in the Senate may not be enough to allow this Bush Administration-supported legislation to become law. A particular sticking point for Democrats is the $250,000 cap on non-economic damages, supported by doctors but considered too low by some Democratic Senators.

Other highlights of the bill include a statute of limitations on injury suits of one year from the discovery of the injury or three years from the occurrence of the injury, and a periodic payment system where future economic and non-economic damages can be paid over time rather than in a lump sum.

Not holding out for federal liability legislation, several states have passed laws similar to the HEALTH Act, reports AMNews, the newsletter of the American Medical Association. West Virginia, Idaho, and Arkansas have all passed liability reform legislation bills, all of which include the $250,000 cap on non-economic damages. Washington, Missouri, and New Jersey legislatures are working on liability legislation as well.

The non-economic damage cap is credited with holding down malpractice insurance premiums in states such as California, which has experienced only a 20 percent premium increase in the last two years. In fact, according to Department of Health and Human Services (HHS) data, states with a $350,000 cap have had an average two-year premium increase of 18 percent, whereas states without a cap have had a 45 percent increase(http://aspe.hhs.gov/daltcp/reports/medliab.htm#sectionVI).

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SENATE PUSHES PEDIATRIC DRUG TESTING

In another attempt to encourage clinical drug trials in pediatric patients, the Senate is considering a bill, the Pediatric Research Equity Act of 2003, that would allow the Food and Drug Administration (FDA) to require pediatric trials to determine safety, efficacy, and dosing guidelines in both new and already approved drugs. This follows on the heels of a district court decision that negated the FDA's Pediatric Rule, which allowed the FDA to require drug trials in children. The district court ruled that the FDA does not have statutory authority over this matter. Rather than enter a lengthy series of appeals, the Bush administration encouraged Congress to pass legislation on the subject.

The Senate bill, sponsored by Michael DeWine (R-OH), requires that each drug submitted to the FDA for approval have data from pediatric clinical trials, a deferral allowing pediatric data to be submitted at a later date, or a HHS waiver.

The HHS could grant a waiver for these and other reasons: the pediatric trials could be impossible or impracticable; the drug is likely to be ineffective or unsafe in pediatric patients, it is not likely to be used in children, or it will not offer significant benefits over existing drugs. The bill would also allow the HHS to require data for approved drugs that are already on the market and are often used in – but not approved for – pediatric patients, or drugs that could offer a major benefit to the pediatric population.

The bill would not replace the Best Pharmaceuticals Act, which offers financial incentives to companies that test their drugs in pediatric populations, but would provide a means to require clinical trials for drugs not deemed financially beneficial to test in children. At press time, the Senate bill was being considered by the Committee on Health, Education, Labor, and Pensions. No sister bill has been introduced in the House, although Bush administration officials have voiced their support for the Senate bill.

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VACCINE INJURY DEBATE IN CONGRESS

The legislative battle surrounding injuries from childhood vaccines – which could affect the lawsuits of parents of autistic children and the vaccine manufacturer that they blame for their children's disorder– continues in Congress. Under Democratic pressure, the Senate abandoned a clause in their Biodefense Improvement and Treatment for America Act that could direct suits over thimerosal-caused vaccine injuries to a no-fault federal court that addresses vaccine-related injury claims. (Thimerosal is a preservative containing mercury used in some childhood vaccines.)

Meanwhile, the House is considering a bill to expand the number of parents that can sue vaccine manufacturers on the grounds that a vaccine caused their child's disability. But autism expert Max Wiznitzer, MD, Assistant Professor of Pediatric Neurology at Case Western Reserve University, told Neurology Today that this will only affect lawsuits on autism if the condition is added to the list compensated for under the National Vaccine Injury Compensation Program (VCIP), available online atwww.hrsa.gov/osp/vicp/table.htm.

Under the VCIP, he explained, plaintiffs do not have to prove that their injury was caused by the vaccine. If an injury occurs within a specific time of vaccine administration, it is compensated under the program. This saves on legal costs and lengthy court battles for both injured parties and vaccine manufacturers – but this “vaccine court” does not award large sums for pain and suffering, as do traditional courts. The VCIP was originally set up to encourage the continued production of vaccines by protecting manufacturers from costly multiple lawsuits, while still compensating those injured by vaccines.

The House bill, the National Vaccine Injury Compensation Program Improvement Act of 2003, sponsored by Dan Burton (R-IA), expands the time limit in which parents must file injury claims under the VCIP to six years. A common concern in thimerosal-related cases is that parents did not become aware of the injury or of the compensation program until after the statute of limitations – three years – had expired. The bill also raises the compensation for a vaccine-related death from $250,000 to $300,000. It is currently being considered by the House Subcommittee on Health.

Both Dr. Wiznitzer and Michael Chez, MD, another autism expert who is Assistant Professor of Pediatric Neurology at Rush Medical School, agree that the expanded statute of limitations would not greatly affect autism cases, because three years after vaccination should be sufficient to identify autism. However, they both point out that there is no scientific evidence to date linking autism with thimerosal, which could make the statute of limitations a moot point.

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WILL HHS GUIDELINES MAKE RESEARCH PARTICIPANTS SAFER?

Will the new HHS draft of guidelines, Guidance for Human Research Subject Protection, improve safety, or does it not go far enough?

The guidelines for research institutions, institutional review boards (IRBs), and investigators, aim to help researchers identify conflicts of interest that could negatively affect the safety of human research subjects, and suggest ways to mitigate or eliminate conflicts of interest.

The guidelines identify these and other potential conflicts of interest: financial sponsorship of research; the conditions under which data are analyzed and published; and the forms of compensation that institutions or investigators receive, including equipment, honoraria, or a financial stake in the research outcome.

If an institution determines that potential or actual conflicts of interest will negatively affect participant safety, it should reduce or disclose the conflict of interest, add additional levels of oversight, or separate financial and research decision making, the guide asserts. One specific suggestion is that institutions set up conflict of interest committees to work with IRBs, administrators, and researchers to address volunteer safety. Another is to train key individuals on what can constitute a conflict of interest, and how to address such conflicts.

Finally, the guidelines stress that investigators should be conscious of conflicts of interest when drafting research participant consent forms, and when obtaining consent.

Commenting on the guidelines, Arthur Caplan, PhD, Chair of the Department of Medical Ethics and Director of the Center for Bioethics at the University of Pennsylvania, noted that they are not a significant improvement over the current system, as many IRBs already require disclosure of conflicts of interest. He does believe that the guidelines should be binding, however, and that “no researcher should ever be involved in the assessment of a drug, device, or procedure in which they hold a financial interest.”

The guidelines, which are non-binding and apply only to FDA- and HHS-funded research, are available online atwww.fda.gov/OHRMS/DOCKETS/98fr/02n-0475-n000001.pdf, and are open for public comment until the end of the month.

©2003 American Academy of Neurology

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