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Listen to parents…except when they say things you don’t want to hear

25 Mar

How many times do we hear, “Listen to the parents” on medical issues involving their autistic kids? Usually this comes from alternative medical groups who don’t have the science to back up the safety and efficacy of their therapies. What happens when a parent disagrees with these groups?

In Lawsuit against alternative medical practitioners Usman and Rossignal we discussed a father who has brought suit against prominent Defeat Autism Now (DAN) doctors Usman and Rossignol, and the laboratory Doctor’s Data.

Orac, at Respectful Insolence, has discussed this case as Suing DAN! practitioners for malpractice: It’s about time, where he uploaded the actual complaint.

In that complaint the father is alleging many things. High amongst them is the question of whether the “challenge” chelation tests are valid, These were used on his child and supposedly showed heavy metal poisoning. In a challenge chelation test, a chelator drug is given to a child before a urine test is taken. Chelators are designed to draw metals out of the body and allow them to be excreted through the urine (and other ways). There are no standardized references for metal contents in challenge testing. The American College of Medical Toxicology has made a very clear statement about challenge chelation testing. Here is their conclusion:

It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

Recall, challenge testing is noted in the lawsuit. From the section of claims against the Doctor’s Data (who are also defendents in the lawsuit):

The non-standardized method of testing that Defendant utilized on or about April 22, 2004, January 27, 2006, January 13, 2007, February 26, 2007, May 26, 2007, August 6, 2007, October 30, 2007, November 13, 2007, January 12, 2008, January 26, 2008, April 26, 2008, October 29, 2008, and March 27, 2009, wherein specimens were collected after the administration of a provoking agent and compared to unprovoked or unchallenged specimens was an improper method of determining whether A.J. had a potentially toxic level of heavy metals in his system

So, challenge chelation testing isn’t scientifically validated, has no benefit, but was used to justify certain therapies on this child. How did the Autism Research Institute respond to this? They blame the parent’s marital situation.

No, really, I’m not making this up. Rather than accept the complaints on their face and give this autism parent respect, they dismiss his multiple complaints as being…well, you read it:

Recent articles by ABC News and the Chicago Tribune on M.D.s who subscribe to the Defeat Autism Now! approach to treatment indicate the spread of misinformation and misunderstanding in recent months. The complaints about Drs. Usman and Rossignol resulted from a custody case– a painful situation for any family, one that can lead to accusations that must be sorted out in a court of law—not the media

Yes, it isn’t because the father is really annoyed that he was told challenge chelation testing is valid, or that his family spent lots of money on testing and on chelation. It couldn’t be that the father has not seen benefit from these therapies. It isn’t any of that. It is a custody battle issue. For the record, the defendants in the case do not include his wife.

ARI defends their approach in rather vague terms:

The Defeat Autism Now! approach to autism invites the medical community to be more responsive, inquisitive, and knowledgeable about treating these disorders.

The approach is not in itself a source of controversy, since many treatment interventions are commonly prescribed by traditional health professionals.

My view differs from the ARI statement. It would seem to this observer that the approach is the source of controversy. From their own website:

The best diagnostic test for toxic metal overload is the chelation challenge test. The chelation drug is administered, followed by a timed urine test to help assess the body’s burden of toxic elements.

This is in direct contradiction to the statement from the American College of Toxicologists. The ARI approach (including challenge testing) is a key point of the lawsuit. I am not able to reconcile this with the idea that the “approach itself a source of controversy”.

The great problem is rather that chronic, unaddressed illness plagues many, if not most, of the children and adults on the autism spectrum. These conditions, thoroughly documented in the scientific literature, often involve the gastrointestinal system and/or the immune system, but the medical establishment has been professionally insensible to what is a desperate situation in the expanding autism population.

Odd. If anyone outside of the alternative medical community ever makes a statement that the is driven by “desperation”, they are sure to get jumped on.

The focus of the Defeat Autism Now! approach is twofold: to provide patients with allergen-free nutritional support, to uphold and to repair the immune system as needed, and, if appropriate, to reduce the body burden of environmental toxins; to provide clinicians in-depth medical and scientific information, with Continuing Medical Education credits.

There is the mention of what is a main crux of the lawsuit, “body burden of environmental toxins”. That’s it. No mention of challenge testing. They mention that the approach includes reducing “the body burden of environmental toxins”, but doesn’t address the key question: when is this approach “appropriate”. How is that decided? The challenge testing approach has not, to my knowledge, ever been defended in court. This case is

The ARI press release doesn’t discuss the real questions here. Brushing this off as a custody issue is not doing anyone any good and is rather insulting to the parent bringing this suit forward and his child.

Arthur Allen in Readers Digest and the false claims of false vaccine safety groups

17 Mar

For some reason I like Arthur Allen. Something about his approach appeals to me. This was solidified when he covered the Green our Vaccines rally in Washington DC. I thought Mr. Allen demonstrated pretty clearly that Jim Carrey didn’t really understand the subject, with one simple question. Mr. Allen was removed from the rally for no other reason than he disagrees. What has stuck in my mind is this phrase from his piece:

I walked over to the little retaining wall around the monument and greeted Dan Olmstead, a former UPI editor who runs Age of Autism, a Website that champions the vaccines-cause-autism line and belittles those who disagree. Despite our profound differences, Dan’s an old journalist like me, and he thought it was wrong they’d sic’d the cops on me.

I like the idea of both Arthur Allen and Dan Olmsted recognizing the fact that they are both “old journalists” and finding common ground. That’s stuck in my mind.

Arthur Allen has a new piece, H1N1: The Report Card, in Reader’s Digest. In it he interviews Secretary Kathleen Sebelius, Secretary of the Department of Health and Human Services in the U.S.. I wouldn’t know about the piece except for the fact that two bloggers (both from the Age of Autism) covered it claiming censorship. One piece, Sebelius Asks Media to Censor Autism Debate and another Did Kathleen Sebelius Pressure Media to Deny Vaccine Safety Voices?

What caused this concern on their parts? Well, this quote from Secretary Sebelius:

There are groups out there that insist that vaccines are responsible for a variety of problems despite all scientific evidence to the contrary. We have reached out to media outlets to try to get them to not give the views of these people equal weight in their reporting to what science has shown and continues to show about the safety of vaccines.

I agree with what Secretary Sebelius says–don’t give equal weight. As Orac at Respectful Insolence says: “Censorship.” You keep using that word. I do not think it means what you think it means. Asking the media to not give equal weight to groups whose science is poor at best (consider the decisions from the Omnibus hearings–“these are not close cases”) is not censorship. A well-researched article on the “vaccine debate” would be, precisely because it is well researched, clear that this is not a debate of groups with an equal standing. The science used to promote, say, the vaccines-cause-autism idea is of very poor quality (again, read the Omnibus decisions).

I have to say, I even take issue with the idea that this is some suppression of the voices of the “Vaccine Safety Voices”. Really? Vaccine safety?

The section of the Reader’s Digest article that stuck in my mind is this:

[Reader’s Digest]: You recently took part in the ribbon-cutting for a new Holly Springs, N.C., factory that will produce cell culture-based flu vaccines as early as 2012. Do you think cell culture vaccines will help?

[Kathleen Sebelius]: That plant is a big deal for two reasons, not the least of which is that it brings manufacturing capacity back to the United States. That’s a significant step forward—we’re not so reliant on production elsewhere. During the current epidemic, two companies had to fill orders in their own countries before they could make the vaccines available to us. Secondly, cell-based culture doesn’t necessarily speed the growth time, but it is more reliable. Once the growth is there, you have yield that is much more stable than with egg-based technology. It isn’t a silver bullet, but egg-based technology is 50 years old and we need to get to a variety of approaches that could be used in the future. So the investments need to continue: What are the alternative growth strategies? What else should we be looking at?

Why would a cell-based flu vaccine plant catch my eye? Because it would likely reduce adverse events from flu vaccines. Egg based technology leaves the risk for allergic reactions to egg proteins that might remain in the vaccine. By moving away from this technology, the U.S. could have a safer vaccine in place.

Did the “Vaccine Safety Voices” mention this at all in their pieces? Not at all.

Have the loudest voices in the so-called “Vaccine-Safety” movement in the U.S. ever stressed simple improvements such as this?

Quite simply: no.

This is one reason why I don’t consider groups like those represented by the Age of Autism or the “National Vaccine Information Center” to be true vaccine safety advocates.

Bogus Urine Metals Testing Fails In Vaccine Court

13 Mar

The Thimersoal “test cases” in the OAP relied on bogus urine mercury testing. Among many other common problems the petitioners had in providing any sound scientific support for the notion that mecury can cause autism, that, was at least in part, the apparent conclusion of all three of the special masters.

I just skimmed through the recent decisions by the US Court Of Federal Claims in the Thimerosal “test cases” that were part of the Omnibus Autism Proceeding, and the expert testimony provided by Dr. Brent (respondent) in this regard is pretty clear:

From the Mead Decision

When specifically asked about the urine mercury tests that were performed on William, Dr. Brent said that the tests “showed pretty much exactly what you’d expect for the normal population, that their unprovoked specimens are normal. Yet, when they give chelators, most of [mercury excretion results] are increased.” Id. at 1852-1853. Dr. Brent expressed a concern about the use of data in this way to suggest that a condition exists that, in fact, does not. See id. at 1853. He stated that “it’s data like this that has been used as an excuse to subject these children to chelation therapy where the data supports [a finding] that their urine mercury status is totally normal.” Id. at 1853.

From the King Decision

Moreover, Dr. Brent explained that when the results of mercury testing of Jordan, both provoked and non-provoked, are viewed in their entirety, they are exactly what one would expect from an individual without any mercury-related problem. That is, Jordan’s non-provoked test results were within the normal range for non-provoked testing. (Tr. 1852-53, 4340.) At the same time, while his provoked results were outside the normal range for non-provoked testing, that is not surprising since the provocation/chelation process is designed to specifically provoke an increased excretion of metals. (Tr. 1852-53, 4340-41, 4347.) As Drs. Brent and Fombonne explained, administration of a chelating agent to anyone, autistic or not, mercury-poisoned or not, will always be followed by increased excretion of mercury.118 (Ex. M, p. 74; Tr. 1852, 4340-41, 4343.)

Interestingly, the added scientific clarity of the special masters with regard to bogus urine metals testing is also present to some degree in all three test cases:

Here’s one example from the Mead Decision

Moreover, a subsequent study, as reported in the 2007 Soden article filed as RMRL 458,150 could not confirm the 2003 Bradstreet study results. See Mead Tr. at 1844. The investigators found that “DMSA provoked excretion testing did not produce evidence of an excess chelatable body burden among the autistic [study] participants.” RMRL 458 at 480. The investigators concluded that “[i]n the absence of a novel mechanism of heavy metal toxicity or an alternate therapeutic action of chelators, the data presented provide[d] no justification for chelation therapy for the [study] participants.”

Many will remember the conclusion of Soden et al.

“In the absence a proven novel mode of heavy metal toxicity, the proportion of autistic participants in this study whose DMSA provoked excretion results demonstrate an excess chelatable body burden of As, Cd, Pb, or Hg is zero.”

But perhaps the most interesting of all, is the common thread that the reliance upon the bogus mercury testing seems pretty much acknowledged for what it is by both the special masters and the petitioners’ expert:

From the Dwyer Decision

Doctor Mumper’s willingness to rely on Colin’s mercury test results as evidence of high levels of mercury in his body was particularly troubling. She admitted that his results were not typical of those she saw in other autistic children. She admitted that she knew of no research into normal mercury excretion levels after chelation against which Colin’s one positive mercury test could be measured.741 It appeared that regardless of the results for mercury levels, Dr. Mumper was willing to opine that they reflected mercury’s role in ASD.

From the King Decision

In short, a careful analysis of the record demonstrates that there is no valid basis for Dr. Mumper’s view that the results of mercury excretion testing on Jordan King offer support for a conclusion that thimerosal-containing vaccines played a role in causing Jordan’s autism. To the contrary, the evidence supports a conclusion that Dr. Mumper’s reliance on such mercury tests has no basis in science or logic. Indeed, upon cross-examination even Dr. Mumper acknowledged that there is no particular profile or pattern of post-provocation test results that points to a finding that a child has mercury-induced autism. (Tr. 1555-60, 1568-69.) When pressed, Dr. Mumper could not even suggest an example of any type of result on a post-provocation mercury urine test that would not, in her analysis, support a claim of mercury-induced autism. (Tr. 1558-60.) Dr. Mumper’s analysis in this regard was illogical, and completely unpersuasive.119

Yep, regardless of the results of a scientifically meaningless test, it’s the mercury. Right.

Remember, these were the three Thimerosal “test cases”, presumably chosen by the Petitioner’s Steering Committee (PSC) because they offered the best opportunity to introduce good, and representative scientific evidence for the hypothesized role of thimerosal in the etiology of autism. It looks like they failed miserably, and this doesn’t seem surprising when it’s clear the cases leaned on at least one form of laboratory testing that’s clearly scientifically meaningless.

It won’t be surprising when many of the die-hard anti-vaccine and “alternative” autism medicine brigade ignore the fact that bogus urine toxic metals testing just had a bright light shined on it by the vaccine court. They’ll be likely to claim some form of conspiracy or politics about the cases, despite the fact that the spotlight revealed an apparent decision-making tool of many a “DAN! doctor” to not only be worthless in medicine, but also worthless in court.

On a related note, there has been recent news that a couple of “DAN! doctors” are facing a lawsuit in which bogus urine toxic metals testing is called out directly. Aside from numerous other problems they face in the complaint, it should be interesting to see how the defendants (Dr. Dan Rossignol, Dr. Anjum Usman, and Doctors Data, Inc.) explain the potential role of comparing chelator-provoked urine metals levels to a non-provoked reference range. If the three test cases in the OAP are an indication of the state of actual scientific support for such testing, the defendants would seem to have plenty to worry about.

Additional reading:

Mead v. Secretary of Health and Human Services Case No. 03-215V
King v. Secretary of Health and Human Services Case No. 03-584V
Dwyer v. Secretary of Health and Human Services Case No. 03-1202V
Thimerosal-Autism Test Cases Dismissed
Doctors sued over ‘dangerous’ autism treatment
Suing DAN! practitioners for malpractice: It’s about time
How the “Urine Toxic Metals” Test Is Used to Defraud Patients
24-hour provoked urine excretion test for heavy metals in children with autism and typically developing controls, a pilot study

Autism-study doctor facing grant probe

13 Mar

A story in the Philadelphia Inquirer today sheds some light on the situation involving Dr. Poul Thorsen.

Background for anyone who needs it: Dr. Thorsen is a Danish researcher who is co-author on a number of important studies. These include epidemiological studies on vaccines and autism. Dr. Thorsen did this work at the University of Aarhus, and has since left. There is an investigation ongoing apparently implicating Dr. Thorsen in a possible shortfall of about US$2M from the University.

Dr. Thorsen’s work was funded largely by the CDC. He started working for Emory University before leaving Aarhus (and this is a point of contention with Aarhus, as they state that Dr. Thorsen was not allowed a joint full-time appointment). He was also listed as adjunct faculty at Drexel University. Dr. Thorsen has also left Emory and his adjunct appointment at Drexel.

There has been a lot of speculation and discussion on this for the past week or so. The story has broken into the mainstream media, who have been good enough to get us some facts to work with. I have sent many emails over the past week, and almost all have been unanswered. I finally heard from one group in Denmark yesterday, and they to are unaware of the details of this case.

Today’s Philadelphia Inquirer has a story about Dr. Thorsen, Autism-study doctor facing grant probe by Jeff Goldstein:

A Danish scientist involved in two major studies that debunked any linkage of vaccines to autism is suspected of misappropriating $2 million in U.S. grants at his university in Denmark.

He also notes that Dr. Thorsen’s appointment at Drexler was unpaid, and he resigned it this week. (Drexel University is local to Philadelphia, where Mr. Goldstein works). Also of note, Dr. Thorsen was working with Emory University for about 6 years, much of that part time. The complaint by Aarhus involves him working “full time” in both Aarhus and Emory. This may go to the fact that it was pretty clear that Dr. Thorsen was at both Emory and Aarhus from his publication record. The complaint may not be about working in both places but, rather, having changed to full time status at Emory.

Mr. Goldstien notes that some groups have “seized” on these allegations to discredit the studies Dr. Thorsen worked on:

Anti-vaccine groups have seized on the allegations to contend that scientific studies disproving the vaccine link to autism are wrong. Those groups have long argued that thimerosal, a preservative in some vaccines, can cause autism, as can the MMR vaccine for measles, mumps, and rubella.

“I think it is quite significant,” said Dan Olmsted of the Age of Autism. “I think someone allegedly capable of ripping off his own university by forging documents from the CDC is capable of pulling off anything.”

And this is where the this situation becomes very important. If these allegations are true, does this negate the studies Dr. Thorsen worked on?

Mr. Goldstein addresses this with quotes from Mr. Olmsted (above) and people at the CDC and Denmark.

“Poul Thorsen had absolutely no influence on the conclusions regarding this paper,” wrote Mads Melbye, head of the division of epidemiology at the Statens Serum Institut in Copenhagen and senior author of the study, in response to e-mailed questions.

“Thorsen was not actively involved in the analysis and interpretation of the results of this paper,” Melbye said.

The second study, published in Pediatrics in 2003, examined 956 Danish children diagnosed with autism from 1971 to 2000. It concluded the incidence of autism increased in Denmark after thimerosal was removed from vaccines.

Kreesten Meldgaard Madsen, the lead author, said Thorsen played a minor role.

“Dr. Thorsen was not in a position to change or compromise the data,” Madsen wrote. “Dr. Thorsen was part of the review cycle, but never very active in giving input. Dr. Thorsen never had access to the raw data nor the analysis of the data.”

I doubt these statements will mollify Mr. Olmsted’s readers.

In a piece on WHYY (a public radio station in Philadelphia) has a story, Investigation of autism researcher’s conduct sparks controversy.

Dr. David Mandell of the Center for Autism Research agrees the studies Thorsen worked on should be reviewed. But he doesn’t believe the research has been compromised. He noted that Thorsen was not a lead researcher, the studies used government data, and they were peer-reviewed. This view is echoed in a statement from the Centers for Disease Control, which partly funded the vaccine research.

So, where does this leave us? With a lot more questions than answers still. One question in my mind at least is whether Dr. Thorsen is accused of transferring money to his own use or if he is accused of transferring money to fund his research at Emory when he left Aarhus. That aside, no matter what happens from here, this will be used to imply that vaccine-autism research (and not just that by Dr. Thorsen) is performed by corrupt individuals and should not be trusted.

Assume that the allegations are real. I can state that I am very angry at that possibility. I do not like dishonest people. I do not like dishonest researchers.

Mostly, I don’t like the fact that this will be (and already is being) used to put doubt in a lot of people’s minds about the role of thimerosal and MMR and autism. $2M is a small sum compared to the amount of suffering that will go on as this breaths a little life back into that movement.

My guess is that some readers are now ready to blame me of bias, of believing that Dr. Thorsen’s studies are accurate when I should be questioning everything he did. Let’s ignore the statements by his collaborators that Dr. Thorsen didn’t have access to the data to manipulate. Let’s just stick with the fact that the studies Dr. Thorsen worked on agree with the results of multiple other studies. The surprising outcome would be if on review the conclusions changed.

I am sure this story isn’t going away. And it should not. We need to know and we deserve to know what the details are here. Beyond that, I am sure that this will be forever in the lore of the vaccines-cause-autism community and will be used to convince ever more people to join.

For that, whoever is responsible for this mess, I am angry.

Barbara Loe Fisher’s lawsuit against Paul Offit dismissed

11 Mar

If you recall, last October Wired Magazine had an article: An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All. Barbara Loe Fisher of the self-named National Vaccine Information Center took issue with a section of that article and sued Dr. Paul Offit. The complaint is here.

Ms. Fisher was suing Dr. Offit, Amy Wallace (who wrote the story for Wired) and Conde Nast Publishing (who publish Wired).

For background, you can read Respectful Insolence Suppression of speech through legal intimidation, anti-vaccine edition: Barbara Loe Fisher sues Dr. Paul Offit, Amy Wallace, and Condé Nast for libel, as well as One possible reason why Barbara Loe Fisher chose to sue Paul Offit in Virginia?

Autism News Beats “Barbara Loe Fisher: “Not a person to be believed””

SkepticBlog (Steve Novella) Another Libel Suit – This Time Against Paul Offit ,

And Terra Sigillata’s Paul Offit, Amy Wallace, and Conde Nast being sued by anti-vaccinationist

The complaint centers around this section of the Wired story:

Paul Offit has a slightly nasal voice and a forceful delivery that conspire to make him sound remarkably like Hawkeye Pierce, the cantankerous doctor played by Alan Alda on the TV series M*A*S*H. As a young man, Offit was a big fan of the show (though he felt then, and does now, that Hawkeye was “much cooler than me”). Offit is quick-witted, funny, and — despite a generally mild-mannered mien — sometimes so assertive as to seem brash. “Scientists, bound only by reason, are society’s true anarchists,” he has written — and he clearly sees himself as one. “Kaflooey theories” make him crazy, especially if they catch on. Fisher, who has long been the media’s go-to interview for what some in the autism arena call “parents rights,” makes him particularly nuts, as in “You just want to scream.” The reason? “She lies,” he says flatly.

“Barbara Loe Fisher inflames people against me. And wrongly. I’m in this for the same reason she is. I care about kids. Does she think Merck is paying me to speak about vaccines? Is that the logic?” he asks, exasperated. (Merck is doing no such thing). But when it comes to mandating vaccinations, Offit says, Fisher is right about him: He is an adamant supporter.

Ms. Fisher argued:

“If defendants are correct, Plaintiff Fisher is not a person to be believed and because her stock and trade is information and opinion derived from it, she has no business worthy of acceptance and use, honesty being the foundation of every such reliance.”

The court’s decision is online.

The decision is quite clear. Ms. Fisher has no case against Dr. Offit, Amy Wallace or Conde Nast.

In this case, the article’s quotation of Defendant Offit’s comment that Plaintiff “lies” cannot reasonably be understood to suggest, as the Complaint alleges, that Plaintiff is “a person lacking honesty and integrity . . . [who should be] shunned or excluded by those who seek information and opinion upon which to rely.” Rather, the context of the remark – in a lengthy article describing an emotional and highly charged debate about an important public issue over which Defendant Offit and Plaintiff have diametrically opposed views – plainly signals to readers that plainly signals to readers that they should expect emphatic language on both sides and should accordingly understand that the magazine is merely reporting Defendant Offit’s personal opinion of Ms. Arthur’s [Barbara Loe Fisher’s] views.

In my opinion, this case was an attempt to shut Dr. Offit up, restrict his right to free speech by forcing him into costly litigation. In my opinion, the key section of the Wired article was this paragraph:

[Dr. Offit], meanwhile, still rises every morning at 4 am and heads to his small, tidy study in a spare bedroom. Every morning, he spends a couple of hours working on what will be his sixth book, a history of the anti-vaccine movement. Offit gets excited when he talks about it.

I wish Dr. Offit well in his next book. I thank him for standing up for free speech. In my view, Barbara Loe Fisher and the organizations that ally with her are very dependent on the very right that Dr. Offit just defended. They have the ability to voice opinions which are in direct contradiction to established science. I would think they would cherish the first amendment to the U.S. Constitution.

Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.

U.S. Supreme Court to hear vaccine-autism case

11 Mar

The Supreme Court of the United States (SCOTUS) has agreed to take on a vaccine injury case. SCOTUS is an appeals court, i.e. they only hear cases that have been already heard in other courts and this case is no different, having been heard in Vaccine Court and at least one appeals court. SCOTUS only hears a fraction of the cases that are submitted, choosing cases that set important precedents to help define U.S. laws. It is also worth noting that SCOTUS tends to decide on issues involving interpretation of law. In this case, they are not going to decide whether the child in question was injured, but, ratehr, the Court is to decide if a vaccine manufacturer can be sued directly. The question posed by the family in their petition is:

Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 [“the Act”] expressly preempts certain design defect claims against vaccine manufacturers “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” 42 U.S.C. § 300aa-22(b)(1). A-104.

The Question Presented is

Whether the Third Circuit erred in holding that, contrary to its plain text and the decisions of this Court and others, Section 22(b)(1) preempts all vaccine design defect claims, whether the vaccine’s side effects were unavoidable or not?

As noted above, the case was heard previously in the Third Circuit Court of Appeals. The plaintiffs (family) lost in that case:

We hold that the plaintiffs design defect claims are expressly preempted by the Vaccine Act. We also conclude that the plaintiffs have failed to establish either a manufacturing defect or a warning defect claim under the Vaccine Act. For the reasons discussed above, we will affirm the District Court’s grant of summary judgment in favor of Wyeth.

In other words, they were not able to prove that the had the right to bring a “design defect” claim at all, and they failed to prove if there was a manufacturing defect or a warning defect.

The SCOTUS docket is online. I found it interesting that the self-named “National Vaccine Information Center” has filed a “friend of the court” brief, with Jim Moody listed as the attorney. Mr. Moody is on the board for SafeMinds, a group active in promoting the notion that mercury causes autism, and has been active in the public relations effort to support Dr. Andrew Wakefield.

The paragraph of the Vaccine Act covering this is partially quoted in the question posed to SCOTUS above. This is from § 300aa–22. Standards of responsibility

(b) Unavoidable adverse side effects; warnings
(1) No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
(2) For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
(A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa–23 (d)(2) of this title, or
(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).

I often read comments by parents claiming that vaccine manufacturers have zero liability. This is not accurate, as noted below (and referenced in the quote above):

(2) If in such an action the manufacturer shows that it complied, in all material respects, with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and this chapter applicable to the vaccine and related to the vaccine injury or death with respect to which the action was brought, the manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in—
(A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under section 262 of this title,
(B) intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or
(C) other criminal or illegal activity relating to the safety and effectiveness of vaccines,

which activity related to the vaccine-related injury or death for which the civil action was brought.

In other words, if there is really the corruption many parent groups claim, the vaccine manufacturers are liable for lawsuits. But, this is a diversion as the present case before SCOTUS is not about this. As noted above, they are trying to define the question of whether the Vaccine Act precludes suits for design defect claims.

They had argued (and lost) in previous cases that the vaccine was “negligently designed because the defendant knew of a safer alternative and failed to produce it”.

As noted in a recent post by Mary Holland at the Age of Autism blog:

A three judge panel of the Third Circuit unanimously decided in March 2009 that petitioner Hannah Bruesewitz did not have the right to sue vaccine manufacturer Wyeth, Inc. to assert that its vaccine design was unsafe. [See Bruesewitz-Decision] Hannah was born in October, 1991, and received her third DPT shot on schedule on April 1, 1992. Shortly thereafter she developed “residual seizure disorder,” recognized as a Table Injury at the time, meaning that causation was presumed. “Residual seizure disorder” was deleted from the Table just one month before she filed her case. Finally, on December 20, 2002, more than ten years later, Vaccine Court categorically rejected her claim. This hardly complies with Congress’ promise in the 1986 NCVIA that awards be “made to vaccine-injured persons quickly, easily, and with certainty and generosity.” The Bruesewitz family argues that the safer acellular DTaP vaccine was long available by the time Hannah received the DPT and suffered seizures, and that her vaccine injury was avoidable had the manufacturer used this demonstrably safer vaccine design.

There is a lot of history involved in the above paragraph. Let’s start with the fact that the NCVIA (National Childhood Vaccine Injury Act) was put into place largely because of a number of claims filed about the safety of the older, whole cell, DPT vaccine. “Whole-cell” means that the pertussis vaccine component (the “P” in DPT) was made from whole pertussis bacteria which were killed. The concept of the pertussis vaccine, and the DPT vaccine in particular, as being dangerous is largely due to a study in 1981, Pertussis immunisation and serious acute neurological illness in children. That study claimed, “A significance association was shown between serious neurological illness and pertussis vaccine, though cases were few and most children recovered completely.”

Another study (in 1981) showed a significant number of temporary adverse reactions, Nature and Rates of Adverse Reactions Associated with DTP and DT Immunizations in Infants and Children.

Given Ms. Holland’s statement above (and similar statements I have read recently by others), one might assume that the removal of seizure disorders from the Table Injuries was somewhat arbitrary. This is not the case. Between the time of the 1981 study and 1995 (when seizure disorders were removed from the Table), numerous studies were performed which showed no link between DTP and seizures or other neurological injuries. One large study, published in 1994 (shortly before the Table injury was removed) is Risk of serious acute neurological illness after immunization with diphtheria-tetanus-pertussis vaccine. A population-based case-control study. They found no increased risk due to DTP in about 380,000 doses given. A more recent study (2001) The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine, concluded “There are significantly elevated risks of febrile seizures on the day of receipt of DTP vaccine and 8 to 14 days after the receipt of MMR vaccine, but these risks do not appear to be associated with any long-term, adverse consequences.”

The question before the Supreme Court is not whether the vaccine causes an injury. But, it would seem that the plaintiffs might be able to argue that the DTP vaccine resulted in more short-term adverse effects, but not that the science supports the idea that seizure disorders were caused by the vaccine.

Vaccine injury cases must be first heard in the special “Vaccine Court”. This case is no different. The decision can be found on the Vaccine Court’s website. The girl, Hannah, started having seizures after her third DPT vaccination. These progressed to a very serious seizure disorder, including times of status epilepticus (a continual state of seizures).

On April 14, 1992, Dr. Ira Bergman, a pediatric neurologist, wrote that she was entirely well until April 1, 1992 when she went for her third DPT and HiB which were given at 10:00 a.m. She did well until 12:30 p.m. when she suddenly began screaming and had a stiffening spell of her arms and legs that lasted for less than one minute. She was mildly groggy afterwards and, then, within a few minutes, was back to normal.

Her parents argued that Hannah suffered an acute encephalopathy (which is a table injury), with their expert witness defining it as ““any disease of the brain.” The Court, however, recognizes a different definition, where brain function must be depressed for a significant time. In other words, even though Hannah suffered seizures, the fact that she appeared normal, even happy, between the seizures was taken as evidence that the seizures were not the result of an acute encephalopathy.

The statement by Ms. Holland above notes the long delay between when the vaccine was administered and when the hearing was held (10 years). This is, of course, not acceptable. However, it is worth noting that it appears that the family’s attoney (Mr. Clifford Shoemaker) was not prepared when the first

1) April 1992, the third dose of DPT was administered
2) April 1995, the family filed with the vaccine court.
3) July 2001, the hearing is scheduled (for late August)
4) August 2001, the hearing is postponed at Mr Shoemaker’s request
5) February 2002, the trial was postponed again at Mr Shoemakers request
6) March 2002, the one of the family’s expert witnesses withdraws and another is unavailable to testify on the specified date. The Special Master (judge) allows the family another extension.
7) July 2002, the hearing is held. The family is requested to submit some medical information.
8) November 2002 (there appears to be a typo of 2001 here), the final reports are submitted by the Government (HHS).
9) December 2002, the claim is denied.

Could the system have been more efficient? Yes. That includes the family’s attorney and expert witnesses.

While we are talking about the expert witnesses, I realized as I read this decision that there were familiar parts. First, one regular expert witness, Dr. Marcel Kinsbourne was supposed to testify for the family. He “chose to withdraw” from the case. Another regular expert witness to the vaccine court, Dr. Mark Geier was also involved. Dr. Geier’s “expert” report left something to be desired.

First, his second report has obvious mistakes:

Petitioners filed Dr. Geier’s second affidavit, dated August 28, 2001. P. Ex. 22. In it, Dr. Geier confuses Hannah’s case with someone else’s because he refers to her death and subsequent autopsy. Hannah is still alive. Based on a meta-analysis from the Institute of Medicine (IOM), Dr. Geier concludes that DPT caused her purported encephalopathy. He also refers to the VAERS reports regarding arthritic symptoms and hepatitis and rubella vaccines. (Hannah does not have arthritic symptoms; hepatitis and rubella vaccines are not at issue here.)

His fourth report has some odd statements, including using a movie as a reference (yes, a movie):

Petitioners filed Dr. Geier’s fourth report, dated March 22, 2002. P. Ex. 33. Here, inter alia, he discusses the movie “A Beautiful Mind” as evidence that DPT can cause afebrile seizures because the lead character was administered insulin in order to cause him to have afebrile seizures which was hoped to be a cure of his schizophrenia. Dr. Geier thinks DPT lowered Hannah’s blood sugar, causing afebrile seizures.

Why use a movie? I can’t be certain, but from what I’ve heard, there is no scientific evidence that pertussis vaccines (either DPT or DTaP) can reduce blood sugar.

Dr. Geier’s testimony was not convincing:

Regarding Dr. Geier, the specialist in genetics and forensic medicine, his affidavits and report are not credible. First, being a board-certified geneticist and forensic medicine specialist does not qualify him to diagnose neurological diseases and offer an opinion as to how doctors who do specialize in neurology define “encephalopathy.” Dr. MacDonald’s testimony about the definition of acute encephalopathy is more credible than Dr. Geier’s and is well-supported in the medical literature. Hannah did not have acute encephalopathy.

Beyond that, the facts were not convincing. As noted above, the fact that between seizures Hannah appeared normal was evidence against an acute encephalopathy.

The family’s counsel also argued a “non-table” encephalopathy. However, this argument also did not prevail. The girl’s EEG’s did not indicate an encephalopathy, and the seizure activity in the EEG’s did not appear unusual for someone with epilepsy.

I do not know if the arguments the family would put forth would be different in civil court, but it doesn’t seem likely that the arguments they made in vaccine court (which has rules

Back to the present case in front of the Supreme Court (SCOTUS). Why would the Court hear this case? The Vaccine Act is a major piece of legislation. Whenever the U.S. Government (or any sovereign power) alloys itself to be sued (which is what the Act does), it is a big deal. But, this case actually involves what happens outside of the vaccine court. This affects the vaccine program, a major piece of the American public health program. The government extended protection to vaccine manufacturers by taking on liability itself. The question is how far does this protection go? A recent case (2008) from an appeals court in Georgia stated that people could sue the vaccine manufacturers for a “design defect”, contrary to the decision from Colorado that is the basis for this SCOTUS case. We have two different appeals courts with two different decisions on a very important piece of legislation. In addition, the Obama administration, through the Department of Justice, filed a “friend of the court” brief in regards to the Georgia case. The administration would like to see the “design defect” question answered before the Omnibus Autism Proceeding completes and thousands of families look to the civil courts for their next step. The Georgia case was withdrawn by the family, but the DoJ requested that the Supreme Court take on the Bruesewitz case in order to answer this question. This is perfect territory for the Supreme Court. They won’t decide if any child was injured, but they will clarify the definition of a key piece of legislation.

This case isn’t specifically about the question of vaccines causing autism. The Bruesewitz case, as argued in vaccine court, involves a seizure disorder. The impact for the many families who may be denied claims in the Omnibus Autism Proceeding is obvious: if the Supreme Court allows “design defect” claims, this will open a window for these families to sue in civil court.

Vaccines Don’t Cause Autism

4 Mar

That’s the title of an article at Smithsonian.com. The introduction spells out one of the dilemmas that face skeptics to the “vaccines cause autism” story:

It’s rare in science and science writing to make definitive statements, particularly about causation. We like to add what I call “wishy washy” words like “may” and “probably” and “perhaps.”

It’s the “you can’t prove a negative” thing. Can someone say that in all of history, for every person, vaccines have not caused autism through some mechanism not yet described? No. But, is there “overwhelming evidence”?

So when scientists or science writers make definitive statements like “vaccines don’t cause autism” and “vaccines save lives,” it’s because we have overwhelming evidence to back it up.

I expect that soon the author, Sarah Zielinski, will see what happens to blogs that dare make such bold statements. Links to the embarrassingly bad “fourteen studies” website will be posted. Comments that “only one vaccine and one ingredient” will be trotted out by people who lack the courage to acknowledge that the studies clear that vaccine (MMR) and that ingredient (thimerosal). “Too many too soon” will be spouted as though this is some real hypothesis rather than a mere slogan.

Ms. Zielinski finishes with:

Vaccines work. They don’t cause autism. Now, perhaps, scientists can spend their resources on figuring out what does instead of wasting them on a debunked theory.

And that is where the frustration comes in. Groups like SafeMinds and Generation Rescue, while they claim to be interested in environmental causes of autism, really only care about vaccines.

Sorry for yet another vaccine story, but it is nice to see people coming down with hard, clear statements. Real people use strong language all the time. Those pushing the vaccine-causation story use language that is completely unsupported by the facts.

Sometime scientists need to speak like regular people, as Sarah Zielinski has just done.

One reason why I vaccinate

3 Mar

I know this isn’t at all autism related, but this story just keeps bugging me.

South Bend couple loses baby to pertussis

The story is heartbreaking. A couple has fertility problems and tries for years to have a baby.

But the couple’s desire to have children soon turned to heartache as Katie suffered miscarriage after miscarriage.

“We started to think that it would never happen,” Craig said during a recent interview at the family’s home.Katie later went to see a specialist in Chicago and was diagnosed with a rare blood clot disorder that doctors said was affecting her ability to carry a baby to full term. She was prescribed medication.

Finally, after five years, Katie became pregnant with a baby girl that far surpassed previous pregnancy terms.

They finally have a baby, only to lose her at one month from pertussis.

Days later, pertussis tests came back positive.The diagnosis blindsided the family. How could Callie have contracted the illness? She had been far too young to yet be immunized against the bacterial infection. Series of shots against pertussis do not begin until infants are 2 months old.

The couple had also kept outside family and friends away while Callie was home in an effort to protect her from sickness. She had been home from the hospital only 2 1/2 weeks.

St. Joseph County coroner Dr. Michael O’Connell confirmed to The Tribune that Callie likely died of an infectious-type illness such as pertussis, but he said conclusive tests will not be complete for several more weeks.

These sorts of stories are very difficult to discuss. This family is going through pain beyond anything in my experience and I certainly don’t want to add to that. But this story is a real example of one reason I vaccinate myself and my family. I can’t imagine thinking that I or one of my family had passed on an infectious disease to a family with an infant or someone else vulnerable.

Parental Vaccine Safety Concerns in 2009

1 Mar

A paper in today’s issue of pediatrics looks at vaccine safety concerns amongst parents. The paper

Parental Vaccine Safety Concerns in 2009
by
Gary L. Freed, Sarah J. Clark, Amy T. Butchart, Dianne C. Singer, and Matthew M. Davis. All of the University of Michigan.

the abstract states:

OBJECTIVE: Vaccine safety concerns can diminish parents’ willingness to vaccinate their children. The objective of this study was to characterize the current prevalence of parental vaccine refusal and specific vaccine safety concerns and to determine whether such concerns were more common in specific population groups.

METHODS: In January 2009, as part of a larger study of parents and nonparents, 2521 online surveys were sent to a nationally representative sample of parents of children who were aged ?17 years. The main outcome measures were parental opinions on vaccine safety and whether the parent had ever refused a vaccine that a doctor recommended for his or her child.

RESULTS: The response rate was 62%. Most parents agreed that vaccines protect their child(ren) from diseases; however, more than half of the respondents also expressed concerns regarding serious adverse effects. Overall, 11.5% of the parents had refused at least 1 recommended vaccine. Women were more likely to be concerned about serious adverse effects, to believe that some vaccines cause autism, and to have ever refused a vaccine for their child(ren). Hispanic parents were more likely than white or black parents to report that they generally follow their doctor’s recommendations about vaccines for their children and less likely to have ever refused a vaccine. Hispanic parents were also more likely to be concerned about serious adverse effects of vaccines and to believe that some vaccines cause autism.

CONCLUSIONS: Although parents overwhelmingly share the belief that vaccines are a good way to protect their children from disease, these same parents express concerns regarding the potential adverse effects and especially seem to question the safety of newer vaccines. Although information is available to address many vaccine safety concerns, such information is not reaching many parents in an effective or convincing manner. Pediatrics 2010;125:654–659

The study was a survey of households with children. They contacted extra Hispanic and African-American households to get better statistics on those groups. But they normalized the data to account for this “oversampling”.

Table 3 shows that 11.5% of parents have rejected at least one recommended vaccine. Most listed the HPV (human papillomavirus) as the rejected vaccine. HPV is new, and is given to teenage girls to prevent a viral infection known to be a cause of cervical cancer. (click to enlarge)

Parental Vaccine Refusal

Table 4 shows parental attitudes for a number of vaccines. Reasons for rejecting vaccines vary from “I would rather my child got this disease” to “I personally know someone who experienced a harmful adverse event”. (click to enlarge)

Parent experiences and attitudes on childhood vaccines

The survey explored the views of parents on the autism/vaccine question:

One current specific immunization safety concern has been the spurious association of vaccines with autism. Although peer-reviewed original scientific research and multiple expert committees that have reviewed all available data on this issue have failed to show any association between vaccines and autism, anecdotally the concern continues to affect parents. Our study indicates that a disturbingly high proportion of parents, >1 in 5, continue to believe that some vaccines cause autism in otherwise healthy children. This finding indicates that current public health education campaigns on this issue have not been effective in allaying the concerns of many parents. Officials must attempt to develop more effective and targeted education campaigns that focus directly on this issue if their goal is to match parents’ level of concern with the available scientific evidence. Recently, the use of newer social marketing techniques have been suggested as potential strategies to address vaccine safety concerns.

>1 in 5 believe the “vaccines cause autism” story. Amazing. I’m sure that will be seen as a both a victory and a challenge to the groups pushing that message.

I hate to say it, but someone needs to. This study may be the most valuable study the trial lawyers working on autism/vaccine cases have seen. Much more so than the bad science of the Geiers or the speculation in Medical Hypotheses. Where this will be valuable will be in helping select a jury that is as sympathetic to their cause as possible.

Successful blogging by Steven Novella: the Desiree Jennings story

26 Feb

I stayed away from this story until now. It isn’t about autism at all, except that “Jenny McCarthy and Jim Carrey’s Autism Organization–Generation Rescue” decided to take the story on. Why a supposedly autism organization took on the story of an adult who was supposedly injured by a flu vaccine is not clear to this reader. But, this story shows the power of quality blogging to affect the discussion of a national topic.

Short version of the story: Desiree Jennings was given a seasonal flu vaccine. Sometime after that she developed problems in movement and speech. She attributed these problems to the vaccine, citing dystonia as the condition. This was questioned by some bloggers, including a neurologist, Dr. Steven Novella. As a neurologist, Dr. Novella is experienced in conditions such as dystonia. Ms. Jennings was treated by a well known name in the autism-alternative-medicine community, Dr. Rashid Buttar. The story was given national attention, including a segment on the U.S. TV show Inside Edition.

The whole story of the alleged vaccine injury is long and strange. The current status, it gets even stranger. Ms. Jennings appears to have made a full recovery, walking and driving a car. She talks better, with the addition of a rather strange accent. This was found when Inside Edition decided to do a followup on Ms. Jennings, apparently after reading Dr. Novella’s take on the story. From Dr. Novella’s recent blog post:

Another angle to this case was the mainstream media coverage. The story was made national primarily by an Inside Edition segment in which they took her claims of being horribly injured by the flu vaccine at face value. They did throw in a caveat that doctors say the story should not dissuade the public from the vaccine (the “not” was incredibly and deceptively edited out in the YouTube version of the story). But generally it was among the worst science reporting of 2009.

So I was a bit surprised when I was contacted by a producer from Inside Edition about a possible follow up segment on the story. He had read my blog posts on Ms. Jennings and realized they got the story entirely wrong. To his credit he wanted to do follow up (unfortunately rare in mainstream journalism) and tell the real story. This resulted in the segment that aired last night

One reason to bring this story up now is highlighted by Dr. Novella: the effect of science bloggers on a major news story:

And finally (if you will forgive the self-serving observation) the story highlights the new power of the science-blogging community. The Inside Edition follow up segment was entirely due to the science bloggers who covered the story – and told the real story behind the media sensationalism. We are influencing the media cycle in a good way. At the very least we are making ourselves a valuable resource to the mainstream media, and hopefully raising the quality of science journalism in general.

Dr. Novella did well in blogging this story, and Inside Edition did well to reconsider the story in light of the well-reasoned discussion of Dr. Novella.

Video of the recent Inside Edition segment is here:

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