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"Protecting the health and informed consent rights of children since 1982."

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FDA Week

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Senate Dems. say industry lobbyists caused cancellation

MARK-UP OF FRIST'S VACCINE BILL CANCELLED LAST MINUTE FOR THIRD TIME

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Date: April 11, 2003

 

Sen. Judd Gregg (R-NH) cancelled the third consecutive mark-up of vaccine legislation at the last minute on Wednesday (April 9) amid accusations from Democrat aides and patient advocates that lobbyists from two key vaccine manufacturers pressured Gregg into postponing it. Gregg, the Senate health committee chair, said he was postponing the mark-up until after recess because there was not a quorum.

Late the night before the markup committee leaders struck an agreement on the bill, the Improved Vaccine Affordability and Availability Act, and those involved with the negotiating said they were surprised it was cancelled. The bill, which Senate Majority Leader Bill Frist (R-TN) first introduced last Congress, would revamp the Vaccine Injury Compensation Program (VICP). The goal is to make it easier for parents to be compensated for their vaccine-injured children while also shielding vaccine makers from class-action lawsuits. Only four companies still make vaccines, and those that left the market did so in large part because they feared lawsuits.

Currently large class-action lawsuits are filed against Eli Lilly over the vaccine preservative thimerosal. The matter received much press late last Congress when a provision was slipped into homeland security legislation that would have dropped these cases.

Democrat staffers at the hearing said they saw Merck and Wyeth lobbyists speaking to Gregg minutes before the senator cancelled the mark-up. They said the lobbyists are pushing Gregg to change a provision that would retroactively extend the statute of limitations for those eligible under the program from three to six years. They said the vaccine makers oppose making the provision retroactive.

Although Merck has never taken a position on the bill as a whole, a company spokesperson said the statute-of-limitations provision is the company’s biggest concern. The spokesperson said that for weeks the company has been urging lawmakers to change the provision. However, the company’s lobbyists would never tell a lawmaker to cancel a mark-up, the spokesperson said, adding that he did not know of any Merck lobbyists speaking to Gregg prior to the mark-up.

Wyeth did not return phone calls.

An Eli Lilly spokesperson said the company supports the most recent compromise.

Democrats said the measure that retroactively extends the statute of limitations has been in the bill since negotiations started, and it is one of the reasons Democrats were willing to negotiate at all. One Senate aide said the two parties made a deal and if Republicans want to change the statute of limitations provision then the entire bill is once again fair game for amendments. Frist and Sen. Christopher Dodd (D-CT) were the main negotiators of the bill.

Lawmakers changed several areas of Frist’s original comprehensive legislation, but two areas dealing with statute of limitations were the most contentious. Under the compromise legislation, parents would have six years following the onset of a vaccine injury to file under the VICP. Those falling within this window would be able to pull their cases out of the no-fault program if the VICP special master either denied their claim or took longer than 240 days to rule on their case. Those falling outside the six-year statute of limitations would only be allowed back into the VICP, but would not be allowed to go to court.

The compromise also would allow anyone who does not have a pending or dismissed case to file under the VICP for one year following the enactment of the law, regardless of the statute of limitations. However, the bill would not allow back in those who had been denied compensation under the VICP based solely on the parents’ failure to file within the three years of the onset of an injury—the current statute of limitations.

Dodd felt that it was wrong to deny that group a chance to file claims. This was one of the only unfinished matters in the bill, sources say. The exclusion deals with a relatively small group of patients, and sources said Republicans had agreed to let Dodd offer an amendment during committee markup that would have allowed that group of people to file cases in the VICP program.

A second provision deals with “table changes.” The VICP vaccine injury table lists vaccines and injuries associated with those vaccines. The “no-fault” program presumes that these vaccines have caused the listed associated injury given certain circumstances, such as how long it took the child to become sick following an inoculation.

Thimerosal is not on the table. Parents who believe thimerosal has caused autism in their child must prove it if they file the suit under the VICP.

Under the compromise bill, if a vaccine or injury is added to the table, anyone who was injured within eight years prior to the table change are allowed to file under the VICP, and they also may sue outside the VICP if their case is denied or if it takes the special master longer than 240 days to decide the case. Those injured after 1988 but before the eight-year statute of limitation are only allowed to file their case in the VICP.

The VICP court is scheduled to hold a “causation hearing” on thimerosal in March of next year. Thimerosal has never been proven to cause autism, but trial lawyers representing about 1,500 plaintiffs will present evidence in an effort to prove that it does. If the plaintiffs’ lawyers win, vaccine groups will petition to include thimerosal on the vaccine injury table.

Thimerosal is mercury-based. A patient advocate says mercury is proven to cause brain damage that causes autism-like symptoms. The advocate says both the vaccine industry and the government have been slow to study thimerosal because both are conflicted — industry has used the preservative for decades, and the government promotes vaccines.

In 1999, FDA asked manufacturers to discontinue use of thimerosal in vaccine manufacturing. Europe banned the preservative much earlier.


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