Just when responsible Senators, consumer groups and POAs thought the Senate Majority Leader might have learned his lesson about sneaking "Eli-Lilly-Get-Out-Of-Jail-Free" cards into unrelated legislation, he's back at it. Once again, he uses his favorite patsy, Sen. Judd Gregg of New Hampshire. The vehicle this time? S2061, innocously entitled, "Healthy Mothers and Healthy Babies Access to Care Act of 2003".
Frist has become a much better at hiding the obvious gift to thimerosal manufacturers this time. It took me two readings to find the offending sections, which read,
(1) IN GENERAL- No punitive damages may be awarded against the manufacturer or distributor of a medical product used in direct connection with the provision of obstetrical or gynecological services based on a claim that such product caused the claimant's harm where--(A)(i) such medical product was subject to premarket approval or clearance by the Food and Drug Administration with respect to the safety of the formulation or performance of the aspect of such medical product which caused the claimant's harm or the adequacy of the packaging or labeling of such medical product; and(ii) such medical product was so approved or cleared; or
(B) such medical product is generally recognized among qualified experts as safe and effective pursuant to conditions established by the Food and Drug Administration and applicable Food and Drug Administration regulations, including without limitation those related to packaging and labeling, unless the Food and Drug Administration has determined that such medical product was not manufactured or distributed in substantial compliance with applicable Food and Drug Administration statutes and regulations.
Many of my readers might be confused right now. Isn't mercury, in the form of the preservative thimerosal, only found in multi-dose childhood vaccines? Is vaccination during pregnancy even permitted?
Thimerosal, an ethylmercury-based preservative, was present in many childhood vaccines, until the FDA recommended phasing it out for the US market in 2000. (Thimerosal-ladened vaccines are still exported to other countries.) But it is still present in most flu shots, which are recommended for women in pregnancy. And then there are the RhoD products, including RhoGAM, administered to mothers who are RH negative, which, for some unexplained reason, also contain thimerosal. The argument the pharmaceutical industry put forth for the use of a preservative in vaccines and flu shots was that it was cheaper to produce multiple dose vials: Since the vial is no longer sterile once a needle in introduced, a preservative is necessary to prevent contamination of the remaining product. However, RhoGam was never distributed as multi-dose, which seems to support the alternative non-industry argument that thimerosal allows production and delivery of injected drugs and vaccines in non-sterile environments.
According to the well-respected Schafer Autism Report, "[a] recent study found that almost half of all children with autism were exposed to thimerosal during their pregnancy by RhoD products." While I'm away from the computer today, I will follow-up with the details of that study later this evening. It's possible that it is the same earth-shattering study released by researchers from Northeastern, Tufts, UNebraska and John Hopkins which we discussed a few weeks back.
Essentially what this law will do is put the onus completely on the federal government - if the FDA missed a side-effect of a drug, it's not the manufacturer's fault and therefore, they're no longer liable. Since the FDA does not require pharmaceutical companies to test on children or fetuses, this will wipe out nearly all liability, not only for thimerosal, but for any drug used during pregnancy.
Never content, Frist once again does his best to make sure BigPharma gets everything it needs.
(a) GENERAL VACCINE INJURY-(1) IN GENERAL- To the extent that title XXI of the Public Health Service Act establishes a Federal rule of law applicable to a civil action brought for a vaccine-related injury or death--
(A) this Act shall not affect the application of the rule of law to such an action; and (B) any rule of law prescribed by this Act in conflict with a rule of law of such title XXI shall not apply to such action.
(2) EXCEPTION- If there is an aspect of a civil action brought for a vaccine-related injury or death to which a Federal rule of law under title XXI of the Public Health Service Act does not apply, then this Act or otherwise applicable law (as determined under this Act) will apply to such aspect of such action.
[emphasis mine]
Since current law indemnifying vaccine manufacturers doesn't cover thimerosal (according to recent court decisions), and Frist failed twice with his own thimerosal bill, he figures he can once cover his benefactor's behind with such language slipped into an otherwise unrelated piece of legislation. And to make sure it passes, Frist is scheduling the bill for Super Tuesday, with the hope that John Kerry and John Edwards will be campaigning and unable to vote.
The Senators which will make the difference are Snowe, Collins, McCain, and Chafee. Please contact them TODAY and in the weeks leading up to the Super Tueday vote.
Collins, Susan (R-ME) 172 Russell Senate Office Bldg Washington, DC 20510
202-224-2523 Fax: 202-224-2693 http://collins.senate.gov/low/contactemail.htm
Snowe, Olympia (R-ME) 154 Russell Senate Office Bldg Washington, DC 20510
202-224-5344 Fax: 202-224-1946 olympia@snowe.senate.gov
Chafee, Lincoln (R-RI) 141A Russell Senate Office Bldg Washington, DC 20510
202-224-2921 Fax: 202-228-2853 http://chafee.senate.gov/webform.htm
McCain, John (R-AZ) 241 Russell Senate Office Bldg Washington, DC 20510
Phone: 202-224-2235 Fax: 202-228-2862
Email: http://mccain.senate.gov/index.cfm?fuseaction=Contact.Home
Please remember that we won the first battle against the Senate Majority kitty killer back when he tacked on his thimerosal legislation to the Homeland Security Bill back in 2002. We can prevent this horrible legislation as well.
Posted by MB Williams at February 23, 2004 07:07 AM | TrackBack