December 26, 2005

Protection for Makers Of Vaccine May Backfire

"Len Lavenda, a spokesman for vaccine maker Sanofi Pasteur of Swiftwater, Pa., said the liability exemption is needed because manufacturers can't secure liability insurance for bird-flu vaccines. Insurers regard such products as uncharted territory, he said."

Insurers are right. It is uncharted territory. If insurance companies, who make their living playing the actuarial tables and obsessively measuring the risks down to the person and the penny won't touch the avian flu vaccine, then why should I allow it to be put into my family?

If an insurance company won't insure a home for you on the side of a hill or in a flood plain, then you should not be building there. If an insurance company won't insure a vaccine, should you be taking it?

"Without insurance, "We'd be asked to put the company's entire economic future on the line to produce the vaccine, and we're not willing to do that," Lavenda said."

"Without recourse for compensation, "We'd be asked to put the family's entire economic future on the line to recieve the vaccine, and we're not willing to do that," Taylor said."

Protection for makers of vaccine may backfire
Monday, December 26, 2005
BY BRUCE TAYLOR SEEMAN
NEWHOUSE NEWS SERVICE

WASHINGTON -- A law shielding bird-flu vaccine manufacturers from consumer lawsuits could cause many Americans to refuse vaccination for fear they would have no recourse if it harmed them, some health experts say.

The legislation, which cleared Congress last week, could significantly undermine efforts to ensure widespread protection against a potential avian-flu pandemic, they warn.

Erin McKeon, associate director of governmental affairs for the American Nurses Association, said liability exemptions were partly to blame when other vaccination programs stumbled.

"Look at how the smallpox vaccination program went in 2003, when the president tried to vaccinate half a million health care workers, but really ended up with less than 40,000 because there was no compensation program," McKeon said.

The liability exemption was attached to the defense spending bill. The legislation contains about $3.8 billion to fund strategies for preparing the nation to fight a bird flu pandemic.

Supporters of the liability exemption insist it is necessary to encourage more companies to make vaccine. Vaccine manufacturing is financially risky, drug makers say, partly because the demand for vaccination is transitory. Also, vaccines generally are administered to healthy people who, if they get sick, might blame the vaccine and sue.

Len Lavenda, a spokesman for vaccine maker Sanofi Pasteur of Swiftwater, Pa., said the liability exemption is needed because manufacturers can't secure liability insurance for bird-flu vaccines. Insurers regard such products as uncharted territory, he said.

Without insurance, "We'd be asked to put the company's entire economic future on the line to produce the vaccine, and we're not willing to do that," Lavenda said.

But the Association of Trial Lawyers of America notes that Sanofi Pasteur has signed $100 million in federal contracts to develop bird-flu vaccine even though the liability shield does not yet exist. The association said federal health agencies have concluded liability concerns have little or no effect on vaccine production.

Blocking consumers' rights to take vaccine makers to court would remove an incentive for companies to make safe drugs, the lawyers group said.

Bruce Taylor Seeman may be reached at bruce.seeman@newhouse.com.

4 comments:

Kev said...

...insurers are right. It is uncharted territory. If insurance companies, who make their living playing the actuarial tables and obsessively measuring the risks down to the person and the penny won't touch the avian flu vaccine, then why should I allow it to be put into my family?

Sounds familiar.

Ginger said...

Not the same thing.

You are referencing insurance companies that don't want to cover chelation with for the treatment of specific ailments that they don't believe are related to metal toxicity (like cardiovascular disease), the specifics under which Medicare will cover chelation, and problems with individual doctors making claims they cannot back up. If we are going to determine what treatments should be used by the ways that people can abuse them, then there is not a medical treatment out there that would be acceptable for use. Drinking to much water can lead to Water Intoxication but we don’t stop giving it to thirsty people.

What you are not referencing is that are refusing to cover it at all. You certainly are not referencing insurance companies refusing to cover the companies that are manufacturing chelating agents. In fact, these chelating agents are available over the counter.

You certainly are not referencing insurance companies refusing to cover the companies that are manufacturing chelating agents. In fact, these chelating agents are available overthe counter.

Chelation for metal toxicity has been around for half a century. The benefits and risks are well established. That territory has been charted.

The only questions when treating autistic children with metal toxicity like my son, is will the recovery from metal poisoning abate autistic symptoms. They have for Chandler.

Allow me to address some of the concerns referenced and show how they don’t apply to my family:

* Chelation therapy for treatment of arteriosclerosis is not covered by Medicare.

Ok. My boy dos not have arteriosclerosis.

* The screening of symptom-free individuals for heavy metal toxicity is not a Medicare covered benefit.

Ok. Medicare can't cover everyone for everything. Does not mean that there is no insurer that will cover it for symptom-free individuals. Oh… and my son isn’t symptom-free.

* Services related to and leading up to non-covered services are not covered under Medicare. For example, if the chelation therapy is not covered, associated evaluation/management services, infusion codes, and laboratory tests are not payable.

Still good.

* History of past exposure and nonspecific symptoms and findings in the presence of elevated heavy metal levels in and by themselves do not constitute heavy metal toxicity. An effort corresponding to the standard of practice must be made to corroborate a cause-effect relationship and to establish the diagnosis. For example, the presence of paresthesias is not synonymous with lead neuropathy.

Someone is going to have to explain this to me. The presence of elevated heavy metals does not constitute metal toxicity if symptoms are non-specific? I guess that if the metals are there but symptoms are not then they are not considered toxic. Still not a problem with the merc/aut theory as loss of speech and digestive problems are hallmarks of mercury toxicity according to the CDC.

* The decision to initiate chelation therapy cannot be based solely on specific blood or urine levels but depends on the "whole picture," which includes the constellation and severity of clinical symptoms and findings.

Still good. See above.

* The efficacy of chelating agents in treating patients with subtle neurologic and renal abnormalities has not been established and is therefore not considered medically reasonable and necessary by Medicare's criteria.

Ain't nothing subtle about loss of speech.

* The "gold standard" for evaluating acute heavy metal toxicity is the blood level.

Note the word ACUTE. Ethylmercury (thimerosal) in the blood has a half life of around 8 days. If he were given a shot, onset of symptoms were noticted in the following week, and a doctor actually said, "hey... we should test for mercury, quick, draw some blood", then yes. That would be the best way to test for it. However Chandler story, like most autistic children with high Hg, is that he was immunized over 18 months and assaulted by whatever environmental Hg is around here and whatever he got from my fillings in utero, and not tested for Hg until 9 months after onset of symptoms. The mercury was long gone from his blood, and had settled nicely in his brain. Blook level is therefore useless.

* Although measuring the excretion of heavy metals in the urine after provocation with edetate calcium disodium may demonstrate an increased body burden with previous high-level exposures, this only indicates previous exposure, not past or current poisoning.

Again, someone is going to have to explain this one to me. It seems to me that high metal level plus symptoms equals metal toxicity. The working theory of Hg/autism theory is that these kids cannot detox on their own. The above postulate does not seem to take that possiblility into account. (Also note that they are only pointing out EDTA. Does the same hold true for DMSA, the most tried and true chelator out there.)

* Treatment with chelating agents may have significant adverse effects. The rationale for initiating and continuing therapy must be solid, in keeping with the standard of practice, evidence based, and well documented in the medical record.

No problem with that statement.

* Because of the risk of chelation therapy and the complexity of the treated syndromes, Medicare expects providers who render these services to be able to attend to our beneficiaries for the complications of therapy and the underlying condition, to include 24 hour coverage, hospital admitting privileges, etc., as is the standard of practice.

(I would like to point out a little something about the "risk" of chelation therapy. Chelators like DMSA and EDTA are OTC drugs that you can buy online right now. Why, for the love of Christmas, if they are dangerous, can any Joe with a credit card buy them. The FDA needs to get a little consistence here.)

So chelation for heavy metal toxicity IS covered by medicare.

Re: Quackwatch, Last summer I critiqued a piece that Dr. Laidler had done on chelation. I wrote to him and asked him to review what I had written. He very kindly said that he would and said that he would get back to me. Several months have gone by. He may have just forgotten. I will email him and remind him of his offer.

To sum up: Chelation is covered by insurance companies and my autistic son seems to fit the profile of someone who would be covered by Medicare.

Wade Rankin said...

Although I don't think I could give any better response to Kev than Ginger already has posted, I would also point out that the cites given are not specific to autism, and a distinction must be made. Many health insurers will not cover ANY biomedical treatments for autism because they consider it a "mental disorder" rather than a biomedical disease. Knowing Kev's disdain for the categorization of autism under the current DSM, I can only surmise that he would not agree with the insurer's reasons for denying coverage for particular treatments for autism.

Anonymous said...

Also, don't we need to look at the fact that vaccines are given to relatively healthy individuals? If you are going to give my healthy child a vaccination against bird flu (as an example) you better be able to say with confidence that it is safe and effective. You should be able to back up your product. You should NOT manufacture a product, hope for the best and then inject it into my healthy baby (or me). It defies logic. First, do no harm. Chelation is a different story. It is a TREATMENT for a medical condition. I wouldn't chelate my perfectly healthy, developmentally normal child. Now, I understand that Kev may disagree with whether or not an autistic child is, in fact, heavy metal toxic. He may disagree with the labs analysis of hair or urine samples, or whatever. That's ok. Let's improve that process. It deserves some more research. To compare the liability of vaccinations vs. the liability of chelation is like comparing apples to oranges in my book.

-Sue M