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Supreme Court decides Bruesewitz v. Wyeth

22 Feb

As Ken has recently written, the Supreme Court has decided on the case of Bruesewitz v. Wyeth. This is not an autism case, but involves the rights to sue a vaccine manufacturer for design defect claims outside of the court system set up 25 years ago in the Vaccine Act.

Justice Scalia wrote the decision, with Justice Breyer submitting a concurring statement and Justice Sotomayor writing the dissent. It was a 6-2 decision, with Justices Sotomayor and Ginsberg dissenting and Justice Kagan not participating.

The parents had already brought their case to the Court of Federal Claims (“vaccine court”), which ruled against them. They did not accept the ruling and took their case to other courts. Eventually landing in the Supreme Court of the United States (SCOTUS). The U.S. Supreme court is an appeals court. As such, this case is an appeal of a lower court (Court of Appeals) ruling. The Supreme Court ruled:

For the foregoing reasons, we hold that the National Childhood Vaccine Injury Act preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects. The judgment of the Court of Appeals is affirmed.

The Court summarized a major part of the claim as:

Their complaint alleged (as relevant here) that defective design of Lederle’s DTP vaccine caused Hannah’s disabilities, and that Lederle was subject to strict liability, and liability for negligent design, under Pennsylvania common law.

The parents had argued that they could sue under a “design defect” argument, and “strict liability“.

Design defects are defined as:

In the law of products liability, a design defect exists when a defect is inherent in the design of the product itself. In a products liability case, a plaintiff can only establish a design defect exists when he proves there is hypothetical alternative design that would be safer that the original design, as economically feasible as the original design, and as practical as the original design, retaining the primary purpose behind the original design despite the changes made.

“Strict liability” “…applies when a defective product for which an appropriate defendant holds responsibility causes injury to an appropriate plaintiff.”

They claimed that the manufacturer of the vaccine can be sued because a safer vaccine could have been produced and avoided the injury.

Note that in this SCOTUS case, they aren’t arguing the facts of the case–whether the vaccine caused injury–just whether they had the right to sue in a civil court based on the “design defect” claim. SCOTUS did not rule one way or another on the injury claim that was rejected by the Court of Federal Claims.

As to the liability issue, Federal law states:

“[n]o 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.”

Much language is spent on the meaning of the “if” clause and the “even-though” clause. Many words to discuss a short paragraph. One which I thought was quite clear. But I’m not an attorney.

In the Court’s discussion is this paragraph:

Design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process. This lack of guidance for design defects, combined with the extensive guidance for the two liability grounds specifically mentioned in the Act, strongly suggests that design defects were not mentioned because they are not a basis for liability. The Act’s mandates lead to the same conclusion. It provides for federal agency improvement of vaccine design and for federally prescribed compensation,which are other means for achieving the two beneficial effects of design-defect torts—prompting the development of improved designs, and providing compensation for inflicted injuries.

Design defects are just not part of the equation in the Vaccine Act, and the Court decided that this is because the lawmakers intended it that way.

Does this mean that Americans have no recourse in vaccine injury claims? The claim has already been made, even as I was writing this post:

According to vaccine safety advocate Louise Kuo Habakus, “The Court is telling parents that they’re on their own. Parents know that 4 out of 5 cases of vaccine injury do not get compensation in the misnamed Vaccine Injury Compensation Program. The Supreme Court has slammed the courthouse doors shut.”

“Parents know that 4 out of 5 cases of vaccine injury do not get compensation in the misnamed Vaccine Injury Compensation Program.”

What a statement. I’ve never heard this statistic before. I guess I’m not a “parent” by the definitions of the self-styled “vaccine-safety” community. Or, maybe, just perhaps…the statistic is made up or manipulated and this is the time to try to get it into the national discussion.

Are the courthouse doors shut? Hardly. There is the Court of Federal Claims, which does compensate people by allowing Americans to petition the U.S. government directly. That is no small issue, by the way. Sovereign states can not be sued under normal circumstances.

Even aside from the Court of Federal Claims, is this 100% immunity from liability? I don’t believe so. Remember that phrase: “…even though the vaccine was properly prepared and was accompanied by proper directions and warnings”. What if a vaccine is not properly prepared? Or if it doesn’t have proper directions and warnings?

A legal term is used throughout the decision: “unavoidably unsafe products”. I was going to predict that this term would be used to scare people about vaccines. I can’t make that prediction, because it has already started. Again from Ms. Habakus:

Because the federal government recommends 70 doses of 16 “unavoidably unsafe” vaccines, and states compel 30-45 doses for school attendance, this issue affects all children.

Keep this in mind. Not vaccinating yourself or your child is an “unavoidably unsafe” decision. Also it is an “unavoidably unsafe” decision for others.

Justice Sotomayor wrote about “unavoidably unsafe” in her dissenting opinion, citing “… comment k of §402A of the Restatement of Torts (Second) (1963–1964)”. (comment k gets discussed much by both sides).

“Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.”

This is the entire point of the informed consent, by the way. If there is no chance of adverse events, there is no need to “inform” the patient about anything. I bring this up because informed consent is supposed to be a big issue for “vaccine-safety” groups.

Justice Sotomayor accuses the majority of writing a “policy driven” decision.

25Respondent notes that there are some 5,000 petitions alleging a causal link between certain vaccines and autism spectrum disordersthat are currently pending in an omnibus proceeding in the Court of Federal Claims (Vaccine Court). Brief for Respondent 56–57. Accord-ing to respondent, a ruling that §22(b)(1) does not pre-empt design defect claims could unleash a “crushing wave” of tort litigation that would bankrupt vaccine manufacturers and deplete vaccine supply. Id., at 28. This concern underlies many of the policy arguments inrespondent’s brief and appears to underlie the majority and concurring opinions in this case.

Perhaps I am naive, but I agree that such statements should not weigh into the decision. If these 5,000 petitioners have the right to sue, they should have that right.

Justice Sotomayor goes on to say:

In the absence of any empirical data, however,the prospect of an onslaught of autism-related tort litigation by claimants denied relief by the Vaccine Court seems wholly speculative.

It may be speculative, but is as good a speculation as you can get. Yes, if Bruesewitz had prevailed, there would be an onslaught of autism-related tort litigation.

Further, she states:

Trial courts, moreover, have considerable experience in efficiently handling and disposing of meritless products liability claims, and decades of tort litigation (including for design defect) in the prescription-drug context have not led to shortages in prescription drugs.

Which is a very strange statement in context. Yes, some autism-vaccine cases have been halted before they started in civil courts. But the entire basis for the Vaccine Act and the Court of Federal Claims taking on the vaccine issue is the claims that DPT was causing a huge wave of disability. A claim which was later found to be meritless, as later science showed no association. The litigation which prompted the Vaccine Act did lead to shortages and was well on its way to leaving the US without vaccine providers.

This all said, in the end it isn’t whether the court is right or wrong (as will no doubt be discussed at length in some circles). For practical purposes, what matters is that the court has decided. People are not able to take vaccine manufacturers to civil court on design defect claims.

With that and the end of the Omnibus Autism Proceeding, autism-vaccine litigation is essentially over. If some real evidence were to come forward which could make autism causation by vaccination a defensible idea, sure, cases would be heard again in the vaccine court. Until that time, legally as well as scientifically, the idea has had its day and it is time to move on.

Should a person who victimizes the disabled be allowed a short sentence?

18 Feb

A recent case in the Los Angeles area involved the sexual assaults of women in group homes. The case came to light when videos of the assaults were provided to the police. At least two of the assailants have been identified.

One of them has pled “no contest” to the charges. In return he is being offered a reduced sentence: 8 years (down from a maximum possible of 27). He would have to serve at least 85% of the time, and would have to register as a sex offender.

The deal is not sitting well with everyone:

The mother of one of the victims, a Rosemead woman, said that the deal came as a surprise and that she hoped the judge would reject it.

“Eight years is nothing for all the damage he has done to all these kids and their families,” the mother said.

A spokesperson for the LA district attorney’s office is quoted as:

“With these kinds of cases we never want to subject the victims to more trauma, and this was a difficult case because of the victims’ disabilities,” she said. “We felt that this [resolution] was appropriate.”

I am left with the question of whether the victims approached on this plea deal. Were the victims willing to testify, it should be their decision. The rationale put forth by the DA’s office that this is to prevent further trauma.

ARCA, the Association of Regional Center Agencies, has come forward calling the plea deal an injustice:

The Association of Regional Center Agencies, an advocacy group representing 21 California regional centers serving children and adults with developmental disabilities, says the plea bargain for Juan Fernando Flores is an injustice.

Russ Roberts hosts: Deer on Autism, Vaccination, and Scientific Fraud

2 Feb

I keep thinking I’ve blogged the last on this. But, I do think there is some interesting information here for some. In Deer on Autism, Vaccination, and Scientific Fraud, Brian Deer goes through the history of his investigation–how/why he got started, what tipped him off that something was amiss with Mr. Wakefield’s research, the mistakes Mr. Wakefield made in trying to handle and quash the story.

This post is long, but it covers a lot of material not about the investigation. It answers many questions that have been posed (such as what sort of job does Brian Deer have, how did he get access to information about the Lancet 12 children).

Investigative journalist Brian Deer talks with EconTalk host Russ Roberts about Deer’s seven years of reporting and legal issues surrounding the 1998 article in The Lancet claiming that the MMR vaccine causes autism and bowel problems. Deer’s dogged pursuit of the truth led to the discovery that the 1998 article was fraudulent and that the lead author had hidden payments he received from lawyers to finance the original study. In this podcast, Deer describes how he uncovered the truth and the legal consequences that followed. The conversation closes with a discussion of the elusiveness of truth in science and medicine.

Russ Roberts’ bio:

Russell Roberts, Associate Editor. Russell Roberts is Professor of Economics and the J. Fish and Lillian F. Smith Distinguished Scholar at the Mercatus Center at George Mason University. Before coming to George Mason University, Roberts was at Washington University in St. Louis where he was the founding director of the Center for Experiential Learning at the John M. Olin School of Business and a Senior Fellow at the Weidenbaum Center on the Economy, Government, and Public Policy. Roberts has also taught at the University of Rochester, Stanford University, and UCLA. He holds a Ph.D. in economics from the University of Chicago.

Roberts is a regular commentator on business and economics for National Public Radio’s Morning Edition. In addition to numerous academic publications, he has written for the New York Times and the Wall Street Journal. Professor Roberts is especially interested in communicating economics to non-economists. His first novel, The Choice: A Fable of Free Trade and Protectionism, a jargon-free book on international trade written for the non-economist, was named one of the top ten books of 1994 by Business Week and one of the best books of 1994 by the Financial Times. An updated and revised edition was published in the spring of 2000. His new book is The Invisible Heart: An Economic Romance (MIT Press, 2001).

Russ Roberts is the host of EconTalk, economics podcasts available here and through iTunes. He blogs at Cafe Hayek along with Don Boudreaux.

There is an audio podcast and a rough transcript on the site.

In 1998, when the Lancet paper came out with a big splash, Brian Deer was working on stories about the DPT vaccine. But he decided against working on the MMR story at that time. He knew that to do the story correctly meant a lot of work, not just publishing what Mr. Wakefield and the Royal Free put out in a news conference:

I happened to be looking at that purely by chance when Wakefield’s paper was published. I looked at his paper and thought there was something very odd about it, doesn’t sit right just reading it on the page. Said at the time I was absolutely not going to get involved in MMR. Journalistically at the time, allegations against vaccines, if you want to do them in a responsible way rather than simply go to government experts or parents or people with interests and write down what they say and present the clash of opinions–if you want to understand what the story is really about, they require an enormous amount of work.

Later, he got pulled into the story:

At the time people were already saying: MMR, Brian Deer, he’s our expert, based on what I’d done in DTP. But in 2003, one of the editors was changing jobs, taking over some feature pages; wanted some stories. Said to me: Can’t you do investigation? I said: Well, what? Three or four different ideas. One was MMR. Didn’t want to get involved because there was a lawsuit coming up. By serendipity the lawsuit was cancelled and we’ll just do a feature, spend 2-3 weeks on the outside on MMR. Three weeks turned into 7 years, though not the whole time. Did make a couple of TV shows about other things as well.

Brian Deer started on the story, and right away he got pushback from Andrew Wakefield:

When you started looking into that Wakefield study, how did you proceed and what did you discover? Did routine journalistic work. At the start, put a phone call in to Dr. Wakefield. He always works with professional publicists; this time his publicist, within about 3 hours of me calling, his publicist had made a complaint against me to the paper. A bit of a strategic mistake on their part. The essence of the mistake is I am self-employed. But I have worked for the Sunday Times since 1981–that is my home. I was a staff reporter, a specialist, they sent me to the United States, and so on. But they imagined that this meant I was some sort of outsider. When they got onto the paper and started making complaints, they were making complaints against somebody who actually sat at the next desk to the editor, who had worked with the head of the legal department since we were all young together. So, it didn’t work, the complaint. I was a known entity. Whilst I am regarded as being a difficult, mercurial person, I think it is true to say I am trusted. That was the first mistake they made.

Brian Deer made some phone calls. Talked to parents of the Lancet 12. He immediately found that there was a problem. The “case series” was heavily biased. The children were recruited. They were involved in litigation.

Right at the start I rung up some parents who had been in the original paper and interviewed them. Interviewed them in a way they had not been interviewed before. Produced important information within hours of beginning the story. Which was? I phoned a lady who had started a campaign group against the MMR back in the 1990s and she told me in the conversation that members of her group were in the Wakefield study; said: they are all members of our group and still in the group. So these parents who had turned up at the hospital, she told me they were all members of her campaign group. Immediately alarm bells started to ring, because nothing about that had been mentioned in the paper. They all just appeared to be routine patients of a big London hospital; but she was saying they were part of a group. A group that had been created before the study. It was the result of her campaigning. She put advertisements in newspapers and made approaches to a firm of lawyers.

He discusses the start of the interviews. How he interviewed one parent using “Brian Lawrence” and how the information he heard didn’t mesh with the Lancet paper:

How did you interview them and what did you discover? The key one in the series of 12 was family 2. The mother, it came out over a period of time, had been a long-time collaborator of Dr. Wakefield’s. I went to interview her; in fact, I used my middle name which had been editorially approved from my managers rather than my full name so they wouldn’t google me and see I was an investigative reporter. I said I was Brian Lawrence, my middle name. How were you representing yourself? My friends say I’m a journalist you wouldn’t want to write about you. You would google me. I asked her all the questions people ask, isn’t it awful; who do you blame? I then went into exceptional detail as to what actually happened when she said her child was vaccinated and developed these problems. Went over her story in great detail. She’d already recently been involved in litigation; so the matter was very clear in her mind. She told me a very detailed story. You could say: People forget, matter of time; but this was the moment when she was saying her child’s life had forever been destroyed. Have to expect she would have that in her mind. It was quite clear that the story she was telling me did not correspond with any case in Wakefield’s paper. What it boiled down to in her case was that she had changed her story, told one story when she’d gone to the hospital and now telling another story; and the two stories couldn’t be reconciled. The difference was when did the problems of autism first reveal themselves. In her story that she told the hospital, it was 14 days; but in her actual story, far from the case. In fact it was months. She’d given one story which suited the paper. She may have done so in complete good faith. Might have misremembered. But when she had the opportunity to study her child’s records, it was a different story.

He tells of the first stories coming out in the Sunday Times, revealing that Mr. Wakefield was working as a paid expert, his patent, and the fact that data from his own laboratory (from Nicolas Chadwick) showed that there was no evidence of measles virus in the gut tissues of the children.

As a result of that, Wakefield made his second big mistake. His first was to have complaints made against me to my employers. Second was to begin litigation. He sued for libel.

Because of the lawsuit, Brian Deer was able to obtain more information. He was pretty much forced to in order to defend himself in the legal action. He used the freedom of information act. This exposed the connection to the Legal Aid Fund and the documents from the ethics approvals for Mr. Wakefield’s research (which showed that Mr. Wakefield started before he had ethical approval).

He couldn’t have expected–maybe this was his second mistake and suing me was his third mistake–in late 1996, early 1997, going back to when Princess Diana was still alive, that the incoming Labour government, the Tony Blair government, with a commitment to produce a Freedom of Information Act. America’s had a freedom of information act for so long no one can remember when it began. We had one introduced by the incoming Blair government. Enacted in 2000, started to take effect in 2004. Because the government had told government bodies to act as if the Act was in force, I was able to get from public bodies the fact that Wakefield had been paid. Funding Authority, in Britain called the Legal Aid Fund. Kind of like public defender system except the government doesn’t provide the defenders–it provides the money. So, it was a government fund to allow access to poorer people to litigation which had funded Wakefield’s lawyer. He could never have expected when he was doing this research that all of a sudden his funding would be exposed to scrutiny, and also the Ethics Committee. In America called Institutional Review Boards. Bodies of doctors, scientists, others associated with medical centers which give permission for research to take place. The paperwork of that body of the Royal Free Hospital also moved into the public domain by the Freedom of Information Act. I think I was the first person ever to get hold of these kinds of papers.

Mr. Wakefield tried to get the lawsuit put on hold, but Mr. Deer was able to force the case to proceed. Mr. Wakefield kept the pressure up:

There were occasions. He also sued me for my website, for which I have unlimited liability, would have lost my home had it been true. I would be sitting at my computer doing some work and there would be a ring on the doorbell and there would be a man dressed in black leather with a motorcycle helmet on and he would present me with an envelope. This happened to me twice. I opened the envelope and there’s an [?] for Wakefield’s legal costs for the hearing that was going to take place the next day in court. The figures were about $30,000 U.S. dollars, that kind of money just for one hearing. That was the kind of pressure they were trying to put on me.

And this proved to be a tactical mistake for Mr. Wakefield. This gave Brian Deer access to the medical records:

The next stage which was very unfortunate for him was that we got a court order against him requiring him to hand over to our lawyers the hospital medical records of the children. I never took possession of them. The judge balanced the issues of the confidentiality of the children as opposed to the fairness of the litigation in front of the court. Ordered that I be allowed to read the unredacted–with their names and all their details–of the 12 children. There were just 11 at the time–the American wasn’t involved in this. So under strict supervision of my lawyers, with a lawyer sitting at the end of the table throughout, I sat and read the medical records of the children.

It appears that Mr. Wakefield knew that giving Brian Deer access to this information was a problem, as he chose this time to cancel his lawsuit. Brian Deer couldn’t use the information, but at this point he knew enough details to realize that there was an even bigger story here. So he attended the GMC hearings:

I have never said anything about what I read in those medical records. The position is that they were disclosed to me in the course of litigation and I may make no use of anything I saw in those records or disclose anything. As I was sitting there reading them, Dr. Wakefield’s lawyers were in a taxi travelling across London to the High Court to disband the lawsuit against me. When I got home that night–and I hadn’t taken any notes with me or documents–I went home, phone rang, and it was my lawyers saying: It’s over. They’ve thrown in the towel. So I’m in the position where I have read the medical records of these children but can make no use of the content of them. However, I have to say–I’ve talked to my lawyers about this–it is a fact that it’s impossible to un-know something. Once you know something, you can’t stop knowing it. Unrealistic. So, what I did was to ensure that I presented myself at the next opportunity where these medical records would go on display. And they would go on display at a Disciplinary Hearing which arose from my original stories.

Asked a “what next?” question, Mr. Deer responds that it is time to move on:

Not sure I want to spend a lot more time on long investigations. Saying of the Buddha: The things we dwell on become the shape of our minds. I’m kind of tired of the hunt aspect of it and the adversarial quality to investigative journalism, the extraordinary hours that have to be put in to it to get anywhere. The complex legal issues that are always coming up. In an ideal world I’d find something that didn’t require me to do more than write a couple of hundred words in a piece and be cheap and cheerful. But I have a feeling that is just how I am feeling at the moment and it won’t be long before something else comes along that I get interested in and get drawn off into. I think what I need now is a holiday! I for one now am grateful. Striking a blog against fraud doesn’t make up for all the pain and losses people suffered as a result of the fraud, but it will open people’s eyes down the road to other things.

Mr. Deer goes into the results of the investigation, both his and the GMC investigation. He discusses how Mr. Wakefield was found guilty of multiple ethical violations, including subjecting disabled children to procedures which were for research purposes and not in their clinical interest, dishonesty, financial issues, etc.. He discusses the costs, both in Mr. Wakefield’s expert fees (about $750,000) and the costs of the GMC investigation. The costs to public health as MMR uptake dropped in the UK and measles came back.

Most people in this subject have seen it in terms of vaccines, measles, infectious disease, autism, or things like that. From the start, I’ve always seen it as being as being an issue of the integrity of science. Whether this paper was true or not and how he could get away with how he got away with. I think it is a depressing picture. It’s been in the region of $10 million dollars to crack a case series of 12 patients. The money involved with the General Counsel hearing, the litigation involved, journalistic fees, and all the staff gone around this to get to the bottom of this little case series of 12 patients. The great bulk of science is not that interesting to the general public and therefore would not create the cause for a newspaper reported to be funded by a newspaper or television station to go after this for such a long period of time and get all this investigative work done with government regulators and what have you. So, you really would have to wonder what else is going on in laboratories and medical centers. The fact that Wakefield thought he was going to get away with it, and the casual way he went about it leads me to think he was working within a culture within which that wasn’t far from unusual, wasn’t far from extraordinary–the kind of misrepresentations he made were far from remarkable by common standards, I suspect. Part of it the nature of human beings; part of it the elusive nature of truth. Part of it is the nature of the publication process.

Special Education Court Decisions on the Rise

1 Feb

Christina Samuels at Education Week has a recent piece Special Education Court Decisions on the Rise. She describes a study from Lehigh University which shows that the number of special education court decisions is on the rise:

After two decades of decline, education litigation appears to be on the rise, with special education leading the way, according to an analysis from Lehigh University professor Perry A. Zirkel, an expert in special education law.

Zirkel’s paper on his findings will appear in full in an upcoming issue of West’s Education Law Reporter, but he walked me through the findings.

Using West’s Key Number System, Zirkel tabulated state and federal court decisions by decades, starting in the 1940s. In the 1970s, state and federal education decisions combined reached a high of about 7,600 decisions, but dropped to about 7,300 decisions in the 1980s and under 7,000 decisions in the 1990s. When Zirkel counted the cases for 2000 through November 2010, he expected to see the same downward trend. Instead, the number was higher even than in the 1970s, at about 8,000 reported decisions

The rise is due to an increase in Federal court cases. State court decisions are declining.

It is worth noting that not all cases are brought forth by parents. A story from May 2010 indicates that in California 4 of 9 decisions issued were brought forth by the district.

It is also worth noting that districts tend to prevail. The paper from Lehigh indicates that 65% of cases are won by districts and that this fraction hasn’t changed with time.

In the story from California, in only 1 of 9 cases were clearly won by the family.

In other Special Ed news:

A recent piece at Disability Scoop, Parents Threaten Suit Alleging Special Education Cuts ‘Disproportionate’, discusses how in a Connecticut district, layoffs are focused on special education:

Parents in one Connecticut town are threatening to sue after learning that special educators would bear the brunt of proposed layoffs while other teachers would be unaffected.

Under a budget plan from the superintendent of the Stamford, Conn. school district, 12 special education teachers would be let go in addition to five of the district’s social workers and four speech pathologists. Meanwhile, it would be business as usual for the regular education staff.

A story from Nashua, New Hampshire discusses rising special education costs, especially those involving out of district placements.

Placing special education students in schools outside the district can be expensive and unpredictable.

While most special ed placements run somewhere between $30,000 and $50,000, some cost the district more than $100,000. And when a new student moves in who needs extensive educational services, it can have a dramatic impact on the budget.

Just in the last month, the district has gone from 95 placements to 107, in part because of new students moving into the city, according to school officials.

The story caught my eye for a good statement from the special education director:

“We do everything we can to appropriately educate our kids, but some youngsters have challenges beyond what we can provide,” said Jan Martin, director of special education.

Jury awards family $1.7M for shooting death of autistic man

27 Jan

Family of victim killed by since-fired LAPD officer awarded $1.7 million is the title of a story by the LA Times.

After deciding this week that a former Los Angeles police officer fired for dishonesty was liable for killing a man, a federal jury Wednesday awarded the victim’s family $1.7 million.

Joseph Cruz killed Mohammad Usman Chaudhry early on a March morning in 2008, when Cruz and his partner encountered the 21-year-old autistic man lying in the bushes alongside a Hollywood apartment building.

The police officer argued that Mr. Chaudhry was using a knife to attack, and the shooting was in self defense. Jurors rejected that claim, in part because DNA on the knife came from only one person–who was not Mr. Chaudhry.

This part really bothers me:

After the verdict, the jury was asked to decide how much money, if any, to award Chaudhry’s parents. Attorneys representing Cruz and the city of Los Angeles had tried to limit the size of the award by arguing that Chaudhry had had a frayed relationship with his parents that lessened their suffering.

Lawyers for the family countered that the parents cared deeply for their son, despite the strain on the relationship caused by his autism.

I wonder how much the attorneys relied upon Mr. Chaudhry’s disability in their attempt to discount his value to his family.

Are you a petitioner in the Omnibus Autism Proceeding?

24 Jan

Families who have filed claims as part of the Omnibus Autism Proceeding, OAP, should read the latest update from the Court.

Many families who filed can’t be found, by the court or by their attorneys. They need to contact the court if they wish to keep their cases going. Otherwise they risk the cases being dismissed.

I find this an interesting point. People have moved on, literally. They filed and they haven’t kept in contact to continue their cases.

Also, the Petitioner’s Steering Committee (the group of attorneys working together on the Omnibus) has dissolved.

The Omnibus is over. Petitioners can either exit the vaccine program, go ahead with the theories the petitioners steering committee proposed and tried (and lost), or come up with new theories.

The Lancet’s two days to bury bad news

19 Jan

Part three of Brian Deer’s series in the BMJ, The Lancet’s two days to bury bad news, has just been released. As you can imagine from the title, he lays out how the Lancet responded to the news that Brian Deer was publishing a story on the Wakefield team’s article in The Lancet.

Brian Deer’s first article in the Sunday Times was published February 22, 2004. On February 18, Mr. Deer met with the editor of the Lancet and other senior staff for five hours.

I had assumed that when I finished Horton would say that an investigation was needed to untangle these complex matters. There were at least three strands: possible research fraud, unethical treatment of vulnerable children, and Wakefield’s conflict of interest through the lawyer. But within 48 hours, and working with the paper’s three senior authors, the journal was to publish a 5000 word avalanche of denials, in statements, unretracted to this day.

Mr. Deer has investigated what was going on behind the scenes at the Lancet and at the Royal Free. Statements to the press claim by Richard Horton, editor of the Lancet, claim that an investigation was made at the Royal Free which “cleared Wakefield of wrongdoing”. According to Mr. Deer’s investigation, no formal investigation was conducted. Rather, the Royal Free chose Doctors Wakefield, Murch and Walker-Smith, authors of the paper in question, to prepare the response.

The Lancet’s statements came on on Friday, 48 hours after the meeting with Brian Deer and 2 days before his article was set to run in the Sunday Times in an apparent attempt to

“The Lancet editor’s actions have been to regard the allegations . . . as allegations of research misconduct, and following the medical editorial code has carried out an investigation according to agreed guidelines, and intends to publish the result of the investigation pre-emptively,” Hodgson told his UCL superiors in a memo that Friday. “No doubt one—but I believe only one—motive is to safeguard the Lancet’s reputation by getting the riposte in first, and ‘spoiling’ the story.”

The media furor over these revelations led to, amongst other things, the GMC hearing which would eventually strip Mr. Wakefield of his license to practice medicine in the UK:

Wakefield attempted to brazen it out, issuing a further statement to media. “It has been proposed that my role in this matter should be investigated by the General Medical Council,” he said on the Monday. “I not only welcome this, I insist on it, and I will be making contact with the GMC personally in the forthcoming week.”

The same day, a caseworker for the regulator called me from Manchester. Did I have any further information? And two days later, at 12.16 Wednesday, I emailed him the conclusions of my research. I summarised what I had said to the Lancet’s senior staff and pledged my cooperation, in the public interest.

The above sets out the timeline for the onset of the GMC hearing. For those who continue to claim that Mr. Deer was the “claimant”, I doubt even more evidence will dissuade them.

The editorial that the BMJ published along side the Deer article is clear in how serious they take the lack of oversight that went into this research and the initial investigation, placing Mr. Wakefield’s work alongside some of the worst examples of medical research gone wrong in the past century:

Unfortunately, we have been here before. Investigators involved with the 1932 US Public Health Service Tuskegee Syphilis Study deceitfully enrolled subjects with latent syphilis and denied them available treatment for 40 years in order to study the natural course of the disease.(4) As part of a 1963 study to determine the body’s ability to reject foreign cells, patients at the Brooklyn Jewish Chronic Disease Hospital were injected with live cancer cells without their knowledge and without oversight from the institution’s research committee.(5) From 1944 to 1974, the US government conducted several radiation experiments, some of which involved the use of non-therapeutic radioactive tracers in children and increased their risk of developing cancer.(6) And in 1981, it was discovered that John Darsee, a clinical investigator at Harvard Medical School, had fabricated data in several experiments published in high profile medical journals that ultimately culminated in widespread retractions of his work and a ban from funding from the National Institutes of Health for 10 years.(7) These experiments have since become symbolic of unethical research on human subjects and of scientific misconduct, and there is little doubt that Andrew Wakefield’s 1998 study will too.(8)

They go beyond this and ask the pertinent question–how did this happen and how do we avoid it in the future?

How could this happen again? To answer this, perhaps we need to focus less on the people involved and more on the defects within the biomedical research enterprise that permit such egregious misconduct. After all, Wakefield was able to circumvent the existing safeguards established to ensure the responsible conduct of research, the protection of research subjects, and the accurate and honest publication of research findings.

The editorial discusses that “research incidents” like those surrounding Mr. Wakefield should be framed as adverse events and attacked similarly. It is a model which will no doubt be criticized by those who see autism as an adverse event to MMR, but it does lay out a framework of how to respond.

The editorial concludes:

Thirteen years later, we are only now beginning to understand the root causes of the multiple system failures involved in the Wakefield incident. We must strengthen our ability to investigate research adverse events. We need to use the tools and techniques available to protect the safety of patients in the clinical realm to protect research subjects. We also need to rethink and reform our customs and culture. The disastrous impact that Wakefield’s study has had on vaccine coverage, recrudescence of disease, public trust, and, most of all, science, requires that we do so in haste.

As we leave this subject, it is worth looking to the words of Andrew Wakefield himself. Words which resonate in a manner Mr. Wakefield did not intend, but resonate nonetheless:

The medical science, the medical system, the scientific system has failed you, for which I am ashamed.
–Andrew Wakefield, May 26, 2009.

He meant the statement as an accusation, that he was ashamed on behalf of the rest of the system, not his own missteps. I find the statement clearly ironic. He is correct, the medical science, the medical system, the scientific system has failed us. His efforts in the Lancet (and elsewhere) are an example of that failure. They do not stand outside of it.

Science has a very difficult choice. To choose between fidelity or collusion.
–Andrew Wakefield, May 26, 2009.

Too right, Mr. Wakefield. Too right. Of course, science had that choice in 1998 as well. You made the wrong choice.

Andrew Wakefield’s erasure from the UK medical register is complete

19 Jan

This just isn’t Andrew Wakefield’s week. Last year the General Medical Council (GMC) in the UK found Andrew Wakefield guilty of multiple counts of improper conduct. These include subjecting disabled children to invasive tests that were not in their clinical interest, placing children in a research program without first obtaining the safeguards of ethical approval, financial and commercial conflicts of interest as well as other breaches of ethical conduct.

Here is one example paragraph from the sanction of Mr. Wakefield:

With regard to nine of the eleven children (2,1, 3, 4, 6, 9, 5,12 and 8) considered by the Panel, it determined that Dr Wakefield caused research to be undertaken on them without Ethics Committee approval and thus without the ethical constraints that safeguard research. Ethical constraints are there for the protection both of research subjects and for the reassurance of the public and are crucial to public trust in research medicine. It was in the context of this research project that the Panel found that Dr Wakefield caused three of these young and vulnerable children, (nos. 3, 9 and 12) to undergo the invasive procedure of lumbar puncture when such investigation was for research purposes and was not clinically indicated. This action was contrary to his representation to the Ethics Committee that all the procedures were clinically indicated. In nine of the eleven children (2,1, 3, 4, 9, 5,12, 8 and 7) the Panel has found that Dr Wakefield acted contrary to the clinical interests of each child. The Panel is profoundly concerned that Dr Wakefield repeatedly breached fundamental principles of research medicine. It concluded that his actions in this area alone were sufficient to amount to serious professional misconduct.

The sanction includes the determination that Andrew Wakefield should have his name erased from the medical register:

Accordingly the Panel has determined that Dr Wakefield’s name should be erased from the medical register. The Panel concluded that it is the only sanction that is appropriate to protect patients and is in the wider public interest, including the maintenance of public trust and confidence in the profession and is proportionate to the serious and wide-ranging findings made against him.

Mr. Wakefield had a period of time to appeal to the High Court. I have word from Brian Deer, the journalist who first broke the story of the Mr. Wakefield’s misdeeds, that the time has passed and the erasure is now effective.

For those who want visual confirmation, here is the GMC’s registry page on Mr. Wakefield. (click to enlarge)

Two suspects in custody in LA abuse case

14 Jan

The sexual assault story out of LA continues to evolve. The LA County Sheriff’s department is posting updates on this case. They note that the first victim has been identified. Here is part of that statement:

The first victim in the videotaped sexual assaults of persons with disabilities was located on Monday. She was found by state investigators living at a residential care facility within the County of Los Angeles. Sheriff’s detectives immediately went to the facility to interview her. The 25-year old White female (Victim #1) is currently a resident of a residential care facility in the state of California. Her medical conditions have caused her to be physically defenseless; however, she was able to communicate with detectives. The young woman confirmed to detectives that years ago she had been the victim of sexual assaults at a residential care facility in the City of Los Angeles.

This had already been identified by Sheriff’s Special Victims Bureau detectives, thanks to information provided by detectives with the Los Angeles Police Department. Her interview on Monday with Sheriff’s Special Victims Bureau detectives was very emotional and painful for her. Detectives described her as very traumatized. She is being provided with victim assistance. She said she feels safe at the residential care facility where she is now living. She does not want her identity or current residence known. Sheriff’s detectives will not be releasing any information about the residence where the victim is located and are asking that everyone respect her desire for privacy and to feel safe where she now lives. In the interview, she alleged that a few years ago she was sexually assaulted by Suspect Lloyd (Suspect #1) at the residence where they both previously lived as residents.

The LA Sheriff’s department is also updating the public on the status of finding the alleged perpetrators. Two have been found so far. Suspect #1 was identified and brought in to custody. Suspect #4 is already in prison.

The booking photo of Suspect #1 Ernie Lloyd has also been provided with this update. The investigation involving Suspect Lloyd is continuing, as are many other investigative leads on several cases.

Suspect #4, Bert Hicks, is serving a sentence in state prison and is due to be released in 2012. He has not been arrested by the LASD and therefore there is no booking photo for him. His case is under active investigation by the sheriff’s department and LAPD.

Here are the two in custody:

Two suspects are still outstanding:

As noted above, the booking photo of Ernie Lloyd was made public:

According to the news source which posted the booking photo:

The informant who anonymously provided the 100 hours of videos that launched a massive sexual assault investigation, reached out to Sheriff’s Special Victims Bureau detectives on Sunday, January 9. He identified himself to detectives and agreed to meet face to face and discuss the case. The meeting took place for several hours on Sunday.

The informant explained to sheriff’s detectives that he had been given a desktop computer by a drug addict and asked to clean the hard drive. Without knowing what the videos were, he watched a portion of them. He was deeply disturbed by the videos and said what he saw made him sick. He immediately knew that he needed to report it to law enforcement, but feared for his safety. He decided that he would copy the videos onto eleven disks and send them anonymously to the Los Angeles County Sheriff’s Department, along with an anonymous explanation note. The informant still fears for his safety, which is why he does not want his identify to be released.

The Sheriffs are still looking for any information, especially that which could identify other suspects or the victims:

Information can be provided anonymously, by calling Crime Stoppers at 800-222-TIPS (8477), or by texting the letters TIPLA plus your tip to CRIMES (274637) or by accessing the Crime Stoppers website at www.lacrimestoppers.org.

Mr. Wakefield’s business plan as discussed at the GMC hearing.

13 Jan

As Kev has discussed, Mr. Wakefield has put out a press release denying all allegations about research fraud and an attempt to profit from the research he was engaging in. I had hoped to put this all behind us, but I thought for those interested, a more thorough discussion of Mr. Wakefield’s business venture might be appropriate here. I copy below a section of the GMC hearing testimony from Day 31. Mr Cengiz Altan Tarhan, who worked on the finance side of University College London and was brought in to discuss, amongst other things, Mr. Wakefield’s business venture.

Q I am going to be reverting to that role in more detail much later on in the story, but just so everyone knows that is a company that relates to technologies developed by the Medical School, is that correct?
A Not just the Medical School. It is the whole of the university. So it is University College London. The Medical School is a part of the university.

Immunospecifics is discussed below, but it went through name changes, including Carmel. I’ve wuoted a section of testimony below. Questions and answers in the hearing are italicized. The text of the documents is left normal.

The documents discussed involve the plan to spin-out a company from UCL to develop Mr. Wakefield’s invention (as put forth in his patent) into a therapy and as a vaccine replacement.

Q Sir, I am going to call this gentleman from now on in order to protect the confidentiality of the boy, his son, as “Dr 10”. Could we go, please, in volume 2, to page 756a. This is a letter that was sent to you before a meeting. It is from Dr Wakefield to you dated 26 February 1998.

“Re our meeting on Tuesday, 3 March 1997, please find enclosed two references for Alex Korda, our proposed Chairman. I have applied for references for Dr [10], our proposed CEO [Chief Executive Officer], and will pass these on as soon as these are available .

In addition, Dr Kirkpatrick from Denver, Colorado, will be giving a guest lecture on the use of Transfer Factor in the treatment of viral disease on the same Tuesday lunch time in the Department of Paediatric Gastroenterology. I realise that this may be of limited value to you other than reassuring you that Transfer Factor is a credible and rational alternative treatment for viral infections. Dr Kirkpatrick holds certain IPR [intellectual property rights] that may be relevant to our endeavours, and Alex Korda, [Dr 10] and I will be meeting with him to discuss this. I will feed back as soon as I have more information.”

Is that correct?
A Yes.

Q Would you go on to 797, please. That is a memo from you. I am told that is a document that needs to be put back into the bundle. Actually, sir, this is a tranche of documents which goes all the way from 797 to 816. Perhaps I can give them all to you at once so I do not do it piecemeal.

THE CHAIRMAN: I have 797a here.

MS SMITH: In that case you need 797 to precede it and then, after 797a, you go on with the rest of the documents, which go from 798 to 816. Could we go first of all, Mr Tarhan, to 797.
A Okay.

Q This is a memo from you and sent to Mr Dutton, Professor Zuckerman, Mr Blatch and Miss Bishop, dated 6 March 1998.

“Mr Wakefield and potential company proposal

Andy came to see me with two of his colleagues who expressed an interest in setting up a company and acquiring the patents from the School. I asked for some background papers on the two individuals. One is a XXX (10) and the other appears to be an entrepreneur with previous experience with start up companies and is prepared to raise funds for the company.

I have asked them to put forward what they saw as the business plan and way forward and will report back as soon as I have further information.”

Can we then go on to 798. This is your second memo, 6 March 1998, to the same people.

“Further to my memo of 4 March I have now received the attached document from [Dr 10] the Managing Director designate for Immunospecifics Biotechnologies Ltd.

Any comments would be appreciated.”

Attached to that, was there a business plan document?
A That is correct.

Q That starts at page 799. Can I just look in brief terms at the contents of that.

“Immunospecifics Biotechnologies Ltd is a new biotechnology venture specialising in the isolation, production licensing and marketing of a new range of immunotherapeutics, generically known as transfer factors. These compounds are a naturally occurring part of the human immune system and promote specific cell mediated immunity towards the target antigen.

The first clinical condition targeted will be measles virus induced inflammatory bowel disease. It is estimated that this disease costs the NHS about £15,600,000 per annum. The incidence of measles induced inflammatory bowel disease is increasing dramatically in Europe and the States. Immunospecifics … will undertake the start of a two year, double blind, phase 1 clinical trial into the effectiveness of measles specific transfer factor in the treatment of inflammatory bowel disease and an open label study into the effectiveness of the same product in ameliorating pervasive developmental disorder within 3 months of securing funding.

In parallel with the clinical trial the company will develop a clinical diagnostic for the presence of the measles virus. It is estimated that the market for this diagnostic is about £4,000,000 per annum in the UK alone. The company will also investigate the potential of transfer factors as vaccine alternatives. An animal model trial of the value of measles specific transfer factor in preventing inflammatory bowel disease will begin upon securing funding.

On completion of a successful phase 1 clinical trial the company will move towards phase 2 and phase 3 trials for the measles specific transfer factor whilst introducing new potential transfer factor therapeutics to its development portfolio. Prior to the completion of this first phase trial, the company expects to have finished the laboratory development of the clinical diagnostic, completed the open label study into pervasive developmental disorder and finished the animal study into the potential of transfer factor as a vaccine.

The company is looking to raise about £2,100,000 to undertake this development programme.”

Moving on to page 800,

“THE PRODUCTS

[Immunospecifics] will specialise in the production, formulation and sale of a wide range of immunotherapeutics, generically known as transfer factors (TFs). [Transfer factors] are a naturally occurring component of the immune system which have been shown to confer antigen specific cell mediated immunity. This form of immunity is important in overcoming viral infectious agents. Many viral agents have the capacity to suppress the body’s cell mediated immune system (e.g. Human Immunodeficiency Virus). Overcoming this suppression through the introduction of an antigen specific cell mediated immunity promoter has enormous potential clinical significance.”

Then it sets out the history. Would you go on to page 801, the top of the page and second paragraph down,

“It is [Immunospecifics’] aim to use a high potency, standardised TF preparation in one of the first properly controlled clinical trials of these materials. The target conditions for the trials will be specific forms of inflammatory bowel disease (IBD) and a condition affecting children known as pervasive developmental disorder (PPD). These trials will begin within the first three months of the company’s establishment. Whilst these trials are taking place, the company will be purifying and characterising the active compounds in the TF preparation. Once isolated and characterised, the potential for this molecule as a measles specific vaccine will be evaluated in animal model systems.”

Going on to page 802 and just past the middle of the page,

“STRATEGY AND OBJECTIVES

[Immunospecifics] is at present no more than a concept, but one with a unique opportunity. The strategic goal for the venture will be to achieve full regulatory approval for the use of antigen (infectious agent) specific transfer factors in a variety of clinical conditions where existing treatment regimes are either non-existent or have limited effectiveness. This strategy will permit the company to establish a clear technical and medical lead in this area with a resulting dominant market share. Paralleling the use of [transfer factors] as therapeutics will be a research programme aimed at demonstrating the value of [transfer factor] as a vaccine.

The objectives and associated tasks for the first two years to develop the concept into a full-scale venture are summarised in the following points.”

Turning back to page 801 for a moment, Mr Tarhan, and the bottom of the page, the last paragraph reads,

“It is [Immunospecifics’] aim to undertake a phase I clinical trial of a high potency measles specific transfer factor supplied by Fudenberg’s group at a very early stage in the life of the Company.”

Would you turn now to page 804 and this is still under the heading, “STRATEGY AND OBJECTIVES” and to number 7 of 9,

“Establish the potential of the high specific active preparations as a potential measles vaccine

This study will be done in conjunction with ‘Immuno’ a subsidiary of Baxter Health Care, in Austria using simian model systems. The efficacy of the [transfer factor] will be assessed by its ability to prevent measles specific IBD during challenge experiments. ‘Immuno’ have agreed to undertake the preliminary work with the [Royal Free Hospital] at no cost, although Immuno’s contribution is estimated to be of the order of £100,000. If successful this concept will be developed further in collaboration with a major pharmaceutical company, such as Glaxo Wellcome’s Jenner Institute. The full relationship between ISB and Immuno needs to be resolved.”

Going on to page 805,

“Medium term objectives for the venture will be: 1) to take the purified and characterised measles specific [transfer factor] through formal product registration by undertaking phase II and phase III clinical trials; 2) establish the most appropriate route for the commercial development of the product; 3) develop the potential for use of [transfer factors] as vaccine replacements; 4) introduce new anti-infectious agents TFs to the company’s product development portfolio and take them through to formal product registration.”

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