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Eli Lilly halts two clinical trials of an experimental Alzheimer’s treatment

19 Aug

This has been reported in a number of places, including the New York Times in their article Lilly Stops Alzheimer’s Drug Trials.

From the NY Times:

Eli Lilly halted two late-stage clinical trials of an experimental Alzheimer’s treatment on Tuesday, representing a setback to one leading theory on treating the degenerative disease and a new blow to Lilly’s business prospects.

One defining feature of Alzheimers disease is the presence of amyloid plaque in the brain. The now-halted clinical trial was for a drug which reduces this plaque.

The basic idea is fairly straightforward: if plaque is present in the brains of those with Alzheimer’s, removing the plaque may help reduce or reverse the symptoms. Instead, researchers were finding that the drug was making symptoms worse. Again from the times:

The company said patients who had taken the drug, intended to reduce plaque in the brain, actually showed worse cognitive functioning and less ability to perform daily living tasks than patients who had taken a placebo.

Why bring this up on an autism blog? Because this trial gives a good example of why I am very concerned about the use of untested therapies on autistics. It isn’t because of some objection to a “cure”. There is no existing autism cure. There is no autism cure proposed or in any stage of a clinical trial. While there is some very good and important discussions about any potential cure, it is for the present a hypothetical discussion. No, it isn’t the cure debate which drives me. It is safety. Plain and simple.

Consider autism therapies (both alternative and off-label) from a viewpoint of safety for the moment with the lessons learned from the Alzheimer’s trial.

Clinical trials are all about safety and efficacy. Is the therapy (drug) safe? Does it work? Before a clinical trial is even started, there has to be some reason to believe that the therapy would be safe and effective. Researchers have to ask the question, “what will this do?” In the Eli Lilly Alzheimer’s trial, they had reason to believe that the drug would reduce amyloid plaque. They had (I assume) some earlier trials to prove the drug reached some level of safety. With that in hand, Eli Lilly went forward to large-scale testing with people and they found that, at least for their test group (people with somewhat advanced Alzheimer’s disease), the drug was harmful.

From the NY Times story:

Lilly’s drug was intended to reduce production of so-called amyloid beta plaques in the brain by inhibiting the activity of an enzyme called gamma secretase.

Dr. Siemers of Lilly said the failed trials might indicate that too much reduction in amyloid beta unexpectedly harms cognitive functions, or it may be that the problems arose from the drug’s effect on some 20 other proteins.

Unintended and unforeseen consequences.

Consider alternative therapies being applied to autistics. For example, consider anti-inflammatory drugs. These are existing drugs used off-label, so some safety data are available. There is evidence of inflammation in the brains for some autistics, so why not treat it?

Because we don’t understand why there is inflammation in the brains of autistics. Because of that, we don’t know if there are any unintended consequences of anti-inflammatory therapies. From a story last year in the Chicago Tribune, this section discussing the team from Johns Hopkins/Kennedy Krieger which first published on neuroinflammation in autistics:

“THERE IS NO indication for using anti-inflammatory medications in patients with autism,” the [Johns Hopkins] team wrote.

Meddling with neuroinflammation could actually be a terrible mistake, said co-author Dr. Andrew Zimmerman, director of medical research at the Center for Autism and Related Disorders at the Kennedy Krieger Institute in Baltimore.

“It may actually be an attempt of the brain to repair itself,” said Zimmerman, a pediatric neurologist. Suppressing the immune response “could be doing harm.”

There are other classes of alternative therapies used in autism. Therapies which most likely are doing nothing beyond the placebo effect are in one class. For example, homeopathy. I don’t spend a lot of time writing about homeopathy. In fact, I don’t know if I have blogged about it at all. Even though it is bad science, it isn’t really dangerous. Another class of alternative therapies are those based in really bad science and which carry the potential of harm. Lupron comes readily to mind. Lupron therapy is based on two levels of very bad science. First, that autism is caused by mercury poisoning. Second, that reducing testosterone in the body will aid it in eliminating mercury. Lupron has been through clinical trials (not for autism) demostrating some level of safety, there are serious known side effects. Worse, the manner in which it is used in autistic children is very problematic–delaying puberty.

Back to the Alzheimer’s trial–I actually welcome the trial itself. I consider those who undertake clinical trials to be very brave individuals. I for one hope there are effective therapies for Alzheimer’s and other forms of dementia soon. It is a great fear for most, if not all, of us that we spend the last years of our lives with dementia. For the parent of a disabled child, this fear is only compounded. The thought of spending my last years draining resources I would rather leave to my child is one of the worst futures I can imagine.

Another example of the workings of the vaccine court

4 Aug

This doesn’t involve the autism cases. Instead it is about the Hepatitis B omnibus proceeding which is also ongoing. It does involve some familiar names: Clifford Shoemaker (attorney), Dr. Mark Geier and his son David Geier. It does give us some insight into the billing practices of these gentlemen.

As background I’ll note that Clifford Shoemaker subpoenaed blogger Kathleen Seidel of Neurodiversity.com. He ended up being sanctioned for that action.

Dr. Mark Geier has been a frequent consultant to Mr. Shoemaker’s cases in the vaccine court. Ms. Seidel has covered some of the cases before where Dr. Geier has participated.

David Geier has so far not been compensated as a consultant to the Court.

In a recent case, Quinton O. Riggins, Jr. v. Secretary of HHS, we can see some of the decision processes involved in awarding fees to attorneys and consultants in the Court.

The application was for a total of $221,211.34:

On April 1, 2008, petitioner’s counsel, Clifford Shoemaker, filed an Application for Attorneys’ Fees and Costs (hereinafter referenced to as Petitioner’s Application), requesting a total of $221,211.34 in attorneys’ fees and costs. Counsel requests $16,592.16 in fees and costs related to the above-captioned matter, and $204,619.18 in fees and costs related to the “general hepatitis B proceedings.”

Of this, about $96k was paid:

Accordingly, petitioner is entitled to the following award for fees and costs for efforts in the Riggins case and for efforts on the hepatitis B cases in general: $95,801.72 for attorney’s fees and costs to be paid by check payable to petitioner and petitioner’s counsel; and $528.25 in petitioner’s costs to be paid by check payable to petitioner. The Clerk shall enter judgment accordingly.

The analysis of the application is lengthy. I will quote some sections below.

In regards to Mark and David Geier:

“Petitioner’s counsel requests $110,386.73 in costs related to S&A’s general hepatitis B work, of which counsel has earmarked $97,443.43 as costs (for fees and expenses) owed to Dr. Mark Geier and his son, David Geier.”

In the end, Dr. Mark Geier was paid $10,000 and David Geier was not compensated.

In denying payment to David Geier, who holds a bachelors degree, the Special Master noted:

“In summary, the undersigned finds the costs for David Geier’s efforts to be obviously unreasonable as Mr. Geier is not qualified to address the medical issues involved in the Program and his work was duplicative of the efforts by Dr. Geier. Thus, the undersigned denies the request for costs for David Geier in its entirety.”

In regards to Dr. Mark Geier:

However, Dr. Geier’s qualifications as an expert, testimony in the Program, and credentials, have been subject of considerable criticism over the years by the court. The undersigned questioned his expertise as far back as 1991. Daly v.Sec’y of HHS, No. 90-590V, 1991 WL 154573, at *7 (Cl. Ct. Spec. Mstr. July 26, 1991) (“[T]his court is inclined to not allow Dr. Geier to testify before it on issues of Table injuries. Dr. Geier clearly lacks the expertise to evaluate the symptomatology of the Table injuries and render an opinion thereon.”). More recently, in a published Order, my colleague, Special Master Vowell, addressed this criticism, as well as her concerns regarding petitioners utilizing medical articles authored by Dr. Geier, as follows:

I found that the articles authored by Dr. Geier unpersuasive and not scientifically sound, based on my prior reading of the articles and critiques of them. I am also aware that Dr. Geier is trained as a geneticist and obstetrician, not an immunologist, epidemiologist, or rheumatologist, and that my fellow special masters and several other judges have opined unfavorably on his qualifications and testimony as an expert.

It appears that since the Court has found that Dr. Geier is not qualified as an “expert”, he was retained as a “consultant”. However, he appears to have acted in ways overstepping the bounds of “counsultant”.

In the instant matter, the undersigned finds it was reasonable (and appropriate) for counsel to consult with Dr. Geier in a limited manner regarding the hepatitis B claims. Those efforts would entail Dr. Geier performing an initial review of the counsel’s hepatitis B claims and some initial research regarding vaccine injuries resulting from hepatitis B vaccine. Dr. Geier would then educate counsel as to the nature of the issues and the types of experts required. However, once Dr. Geier performed an initial review of these claims for counsel, and once counsel began reaching out to doctors who would ultimately serve as experts in S&A’s hepatitis B claims, it was no longer reasonable for Dr. Geier to be billing hours and incurring costs in S&A’s general hepatitis B efforts. Dr. Geier at this point was moving well beyond the role of a consultant.14 Thus by the beginning of 2002, when Mr. Shoemaker began to meet with experts15 to assist in the prosecution of the hepatitis B claims, Dr. Geier’s work on behalf of S&A’s general hepatitis B efforts was no longer needed and should have concluded.

Because of this, Dr. Geier was compensated at a reasonable amount for his consulting activities.

The undersigned notes an award of $10,000.00 represents an almost 90% reduction of the invoice submitted by the Geiers in this matter. The award of $10,000.00 is reasonable for Dr. Geier’s consultant efforts, and thus should not be viewed as a “reduction,” but viewed as reasonable compensation for Dr. Geier’s role as a consultant. The time not compensated is time largely spent by Dr. Geier duplicating the efforts of the experts, duplicating his own work, or performing work as an expert (work he is not qualified to perform). Stated another way, once experts were identified and became involved, Dr. Geier’s role as a consultant ended.

Mr. Shoemaker requested $221,211.34 in fees and costs:

On April 1, 2008, petitioner’s counsel, Clifford Shoemaker, filed an Application for Attorneys’ Fees and Costs (hereinafter referenced to as Petitioner’s Application), requesting a total of $221,211.34 in attorneys’ fees and costs. Counsel requests $16,592.16 in fees and costs related to the above-captioned matter, and $204,619.18 in fees and costs related to the “general hepatitis B proceedings.”

The court found that $64,254.45 was reasonable.

Here is an example of a charge that was denied:

The 5/30/2006 entry bills 0.5 hours to “[r]eview excel chart and update information; transfer information needed for SC to laptop,” P. App at 18. The “transfer information needed for SC to laptop” entry was explained by counsel asconstituting mere seconds and thus not administrative overhead. P Resp at 2, fn 1. However, counsel failed to address the remainder of the entry and identify what excel chart he was updating and how that activity was relevant to Mr. Riggins’ case. However, far more egregiously, counsel has billed for this exact same activity on precisely the same date twice before in two separate hepatitis B cases.

Trips to France and Italy were also excluded:

Another extreme example of counsel’s error in billing judgment is the request by counsel for fees and costs billed by Dr. Mark Geier and David Geier for trips to France and Italy in the summer of 2005 and winter of 2006 respectively, and for Mr. Shoemaker to travel to France with the Geiers in the summer of 2005. These requests represent a complete abdication of billing judgment.

Dr. Geier and Mr. Geier together billed a total of over $20,000.00, P App at 62-63, to travel along with Mr. Shoemaker to France and meet with various doctors and lawyers to discuss adverse events following the hepatitis B vaccination. Dr. Geier, in his affidavit, and counsel in Petitioner’s Sur-Reply, allege it was necessary to travel to France to discuss the doctors’ and lawyers’ experiences and research relating to adverse reactions stemming from the hepatitis B vaccination, and that this information could only be obtained in “face-to-face” discussions. In addition, Dr. Geier and Mr. Geier together billed $23,690.00 to travel to Italy to attend the 5th International Conference of Autoimmunity. Petitioner argues in Petitioner’s Response that the Geiers were invited to present their research at the conference by Dr. Shoenfeld, a leading expert in autoimmunity, and that at the conference they were able to secure Dr. Shoenfeld’s services as an expert in counsel’s cases. Petitioner further alleges the Geiers were able to discuss autoimmune disorders with experts at the conference and further “expedite the prosecution of various hepatitis b cases.” P Resp at 12.

and

Additionally, the Geiers provided absolutely no supporting documentation, such as receipts, to evidence the $9,399.68, see P App at 60, they allege they incurred in costs for airline tickets, other transportation costs, parking, hotel, “daily expenses,” food, and conference fees during these trips. P App at 61-62. By itself, this failure justifies not awarding these costs.

Many expenses for Mr. Shoemaker were questioned by the Special Master. Some based on the lack of adequate justification for the costs:

Petitioner’s counsel has failed to provide adequate information for the undersigned to determined exactly what the costs represent and whether or not the costs were reasonably incurred. No receipts are provided for any of these expenses. For example, for what did counsel pay costs to Federal Express? Who traveled to Boston and stayed at the Ritz Carlton? What expert was met with in Boston? Who traveled to Florida? And what attorney was met with in Florida?

Other expenses were considered to be “overhead”

Respondent objects to five hours of time billed by counsel for “‘meeting with consultants about scanning issues’” on April 19, 2000; one hour of time billed by counsel for “‘review[ing] computer breakdowns and update computer field’” on October 8, 2002; and three hours of time billed by counsel for a “consultation with Legal Nurses Association to discuss reviewing cases and preparing chronologies” on September 19 and 21, 2001. R Opp at 17; see also R Reply at 7. Respondent objects to these billings on the basis that the billings are administrative in nature, “more properly categorized as overhead” and would benefit “all petitioners represented by [counsel’s] firm.” Id. The undersigned agrees.

The entire decision is 37 pages long, detailing the requests for reimbursments, fees and costs.

Prof. DeSoto discusses mercury and autism

3 Aug

A recent issue of the journal Acta Neurobiologiae Experimentalis (ANE) focused upon autism. Not just autism, but autism causation with papers on vaccines, acetaminophen and, of course, mercury. The idea for this focus edition came from Professor Dorota Majewska who holds the EU Marie Curie Chair at the Institute of Psychiatry and Neurology in Warsaw, Poland. The authors for this focus issue are largely the same as those from a conference Prof. Majewska organized in 2008, Autism and Vaccinations.

One of the papers in the focus edition of ANE was the paper by Hewitson et al., that we have discussed at length here at LeftBrainRightBrain.

Another paper in this focus edition is Sorting out the spinning of autism: heavy metals and the question of incidence by M.C. DeSoto and R.T. Hitlan. DeSoto and Hitlan gathered some attention for a paper a few years back where they analyzed an existing data-set, that by Ip et al.. D’oC and Interverbal discussed this paper at the blog Autism Street, starting with A Tale Of Two Tails. In that piece, D’oC and Interverbal discuss the statistical analysis used by DeSoto and Hitlan. Prometheus at the Photon in the Darkness blog also discussed the DeSoto and Hitlan paper in Winter Potpourri. Pure Pedantry blog at ScienceBlogs also discussed this study in Mercury, Autism, and a Note on Scientific Honesty. Perhaps the best analysis of the original DeSoto and Hitlan paper was performed by EpiWonk, an epidemiologist.

The recent paper by DeSoto and Hitlan, Sorting out the spinning of autism: heavy metals and the question of incidence, is basically a review article. It has been touted as support for the mercury hypothesis with a commonly quoted phrase,

Fifteen were offered as evidence against a link between exposure to these metals and autism. In contrast, a sum of 43 papers were supporting a link between autism and exposure to those metals

I somehow doubt the authors intended the debate to boil down to counting papers. It would be a weak support, and rather ironic at that as this paper is placed in exactly the sort of journal that leads to large numbers of papers supporting the heavy-metal/autism link. The current DeSoto and Hitlan paper is in a focus issue on autism in ANE which selected papers which support autism as vaccine injury. Many papers on the mercury appear in lower impact journals and by authors such as the father-son team of Geier and Geier (which if I counted correctly account for 19 of the 43 articles on DeSoto and Hitlan’s list). If you are unfamiliar with that team, the neurodiveristy.com blog has many articles on the team such as Significant Misrepresentations: Mark Geier, David Geier & the Evolution of the Lupron Protocol (Contents).

That said, I was planning to avoid the recent DeSoto and Hitlan paper. It isn’t really new (adding to the number of articles on toxins and autism without adding to the knowledge base). I was going to avoid the paper, that is, until Prof. DeSoto gave an interview for the Age of Auitsm blog. I don’t understand why the Age of Autism considers Prof. DeSoto to be an expert on so many areas of autism and the environment. The breadth of her work is not great. Below is an exchange which shows what I mean. Prof. DeSoto was asked to comment on the recent study by Hewitson et al., comparing vaccinated and unvaccinated monkeys.

Q: There is a study published in Acta Neurobiologiae Experimentalis alongside yours that deals with vaccinated and unvaccinated primates. Do you have a reaction to the study or its conclusions?

Dr. DeSoto: All the primates were vaccinated, the difference was whether there was a heavy metal additive. This is a potentially important study. There are a few weaknesses that prevent strong conclusions. The size of the control group is small (apparently n=2). Given that rhesus neural development within the brain region of interest is not all that well documented, a larger control group would have been desirable. This weakness is acknowledged by the authors.

Isolating the infant monkeys shortly after birth is a significant change from normal environment. The severing of the maternal bond and being raised essentially alone (only visual contact was maintained with the peer infants) affects every aspect of development – including neural development. There is evidence that brain volume is specifically affected by isolation. The rearing situation in the study, in my mind, is not very comparable to normal development, especially if the outcome of interest includes brain volume.

That said, this is the only study that has compared the net effect of multiple vaccination additives on brain development. Above all, I have to editorialize and say this seems difficult to understand (that is – why is this the only study?). If some scientists and some parents question the safety of the vaccine schedule, such studies as this one are the way to investigate the concerns.

Now, the one study that exists (even if there are caveats that go with pilot research) suggests there are differences. Whether one is of the opinion that individually testing vaccines is as good as testing the combined effect or not – at this point it is imperative that additional studies be conducted on the additive effect of the full vaccine schedules.

To be clear and to repeat, if one thinks that the vaccines with additives given in close succession have no effect on neural development– this ought to be established empirically. One thing that I noticed in the study is the main effect for difference in brain volume (no time effect). It should be noted that this suggests the early administration of additive-containing vaccine (first four rounds) was a culprit of interest.

Prof. DeSoto did not take a careful look at the Hewitson et al. study. How do I know this? In the above interview, DeSoto states:

“All the primates were vaccinated, the difference was whether there was a heavy metal additive”

The paper states, “”Four infants were assigned to the unexposed study group and received saline injections according to the schedule in Table I””. The differences included the heavy metal additive, as well as all the ingredients that make a vaccine differ from saline.

What amazes me is that the interviewer at the Age of Autism missed that as well. Even though AoA has touted the Hewitson study greatly, they don’t appear to have read it closely.

This is not a minor detail. It is key to the study design and conclusions.

Another comment:

Given that rhesus neural development within the brain region of interest is not all that well documented

I think that Prof. DeSoto can be excused for not realizing that there is a study tracking the development of precisely the amygdala in macaques. This is because Hewitson et al. did not include that reference (which was easily found in a pubmed search).

“The size of the control group is small (apparently n=2)”

The control group was 4. One was excluded for “scheduling reasons” and the other for unknown reasons. This was a major problem with the study. Fatal, one might say, as the brain sizes of the control group didn’t grow between the two time periods tested (about 4 months and about 6 months of age) for the monkeys. At the same time, their amygdalas shrank. This was a big warning sign that something was amiss with the control subjects, but this was ingored by Hewitson, et al.. Based on this faulty premise, Hewitson et al. claimed that the brains and amygdalas of the vaccinated monkeys were on an abnormal growth path. It is amazing that Prof. DeSoto missed that.

A fact that I am not surprised that Prof. DeSoto missed is that in a previous IMFAR abstract on this group, Hewitson et al. came to the exact opposite conclusion: that the brains of the vaccinated monkeys did not grow as fast as the unvaccinated monkeys.

Back to the recent DeSoto and Hitlan paper. They make the following statement:

It is worth noting that there have been only three empirical articles directly comparing those with and without an ASD on mercury levels in the body to a control group of normally developing matched controls that report that report no link (Ip et al. 2004, Soden et al. 2007, Hertz-Piciotto et al. 2010). While, the most recent article appears to be the strongest, lacking any obvious errors or flaws (we think that this recent article does provide at least some legitimate evidence contradicting the hypothesis that autism and heavy metals are linked), the other two are seriously flawed.

In the end, this mention of the Hertz-Picciotto study is why I decided to write about the DeSoto piece, and in the process bring in the interview.

Part of what made the Hertz-Picciotto study strong was the fact that they controlled for fish consumption. Correct me if I am wrong, but I believe this is something that Ip did not do, nor did DeSoto and Hitlan in their re-analysis. I don’t see mention of fish consumption in the recent DeSoto and Hitlan paper.

Again, I’ll point out that the analysis by EpiWonk was thorough and clear. I wish he had published it. I don’t think consider fish consumption to state that the DeSoto/Hitlan re-analysis of the Ip data is likely not thorough enough to make the conclusions they draw.

The fact of the matter is, the Ip data just aren’t that profound. It was worthwhile to do a re-analysis given the errors in the Ip dataset and paper. But it was three years ago that DeSoto and Hitlan did their re-analysis. In the meantime, Hertz-Picciotto et al. have a better dataset and a more thorough analysis.

DeSoto and Hitlan editorialize a bit in their paper:

If a person has publicly staked his/her career on a certain position being right, it may become harder to keep a truly open mind, even when new data become available and even when the original intent was to be objective. A way this bias might manifest itself is an overstatement or slight misstatement of results. We feel that both sides have been guilty of this, and this happens when a person becomes so confident in the correctness of his/her own view that he/she no longer reviews evidence to the contrary. Unconscious bias may exist even in the best scientists.

This begs the question of whether DeSoto and Hitlan are as guilty of those they chide. Re-analyzing the Ip data is not staking their career on a certain position. Repeatedly publishing on such a limited dataset does make this reader start to question whether some piece of their reputation is now tied to this position. With apologies to Prof. DeSoto, but the fact that her misimpressions of the Hewitson et al. paper are skewed towards the mercury hypothesis makes me wonder even more.

The autism research community needs to have fresh eyes looking at questions and data. DeSoto and Hitlan did well to reanalyze the Ip data once the mistakes were shown. They just appear to this observer to have (a) overstated the interpretation of their analysis and (b) gotten very quickly in to exactly the sort of rut they accuse others of being in.

OSR pulled from the market….or is it?

3 Aug

Here on LeftBrainRightBrain we recently discussed a letter from Boyd Haley, Ph.D. announcing his decision to voluntarily remove his product, OSR #1 from the market. The letter from Mr. Haley stated (in part):

The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, http://www.ctiscience.com , for updates on OSR#1® in the future.

The CTI website is down, and has been for a few days. The message I get when try it is:

HTTP Status 404 –

type Status report

message

description The requested resource () is not available.

Two locations I checked are still selling OSR.

The Forrest Health site has the letter from Mr. Haley noting that he has pulled the product from the market. They not only let you buy it, but they require that you purchase 3 or more “Note: you must order at least 3 items”.

Living Well International has OSR on their site as well. In response to my email, they response to my email request, “Do you still have OSR#1 for sale?”, they responded “Yes we do. It is $60 for a box of 30”

I do wonder how long before someone decides to make his or her own batch of OSR. Mr. Haley has been quoted as stating it was not difficult. The published recipe for the chemical indicates a few potential concerns. First, the chemicals are themselves not without hazards.

Triethylamine

Liquid causes first degree burns on short exposure; [CHRIS] Corrosive to skin; [Quick CPC] Short-term exposure at high concentrations may cause pulmonary edema. [ICSC] A lachrymator; [CHEMINFO] Experimental animals exposed repeatedly to 100 ppm show evidence of liver, kidney, lung, and heart damage. [HSDB] A corrosive substance that can cause pulmonary edema; [ICSC]

Chloroform has relatively high LD50 values (the amount where 50% of exposed animals die). But the MSDS lists reproductive toxicity as:

Birth defects have been seen in rats and mice exposed by inhalation of chloroform at concentrations greater than 100 ppm in air. Ingestion of chloroform by pregnant laboratory animals has resulted in fetotoxicity but not birth defects, and only at levels causing severe maternal effects.

Isophthaloyl chloride is only listed as an eye/skin irritant. I won’t go down the list of all the chemicals. I think you get the idea. It is likely that a competent chemist with a reasonable laboratory (including a fume hood and access to nitrogen gas) could produce “bathtub OSR” reasonably safely. I frankly cringe at the thought of someone attempting this at home. I will add, the yield of the published process for producing this chemical is about 72% without optimization. This begs the question to me as to how clean the product is in this form.

An example of how alternate vaccine schedules endanger children

28 Jul

With apologies–this post has nothing to do with autism except in pointing out where groups like Generation Rescue give out bad advice.

There is an outbreak of pertussis (whooping cough) in California right now. It looks to be a major outbreak, possibly the largest in fifty years–since vaccination was implemented.

Generation Rescue has a number of alternative vaccine schedules that they promote on their website. Their “favorite” schedule was created by a doctor named Donald Miller. Let’s look at it, shall we:

In summary, this is a vaccination schedule that I would recommend:

1. No vaccinations until a child is two years old.
2. No vaccines that contain thimerosal (mercury).
3. No live virus vaccines (except for smallpox, should it recur).
4. These vaccines, to be given one at a time, every six months, beginning at age 2:
1. Pertussis (acellular, not whole cell)
2. Diphtheria
3. Tetanus
4. Polio (the Salk vaccine, cultured in human cells)

*No vaccinations until a child is two years old.* That’s right, don’t vaccinate infants. The deaths in California so far are for children under the age of 6. Dr. Miller’s schedule, the one most recommended by Generation Rescue, would leave children vulnerable to pertussis until at least age 2.

This is just plain dangerous advice.

It isn’t even well thought out. Not in the least. The reason is found in the FDA list of vaccines licensed in the U.S.. You can take a look or you can take my word for it: there is no single pertussis vaccine available.

It is impossible to follow Generation Rescue’s favorite vaccine schedule, which calls for a single pertussis vaccine to be given after age 2.

Even Dr. Sears acknowledges that (a) pertussis is a vital vaccine to give to infants and (b) you can’t get pertussis as a single vaccine. (also, (c) he sees rotavirus as an “immediate danger” to babies and children, contrary to the position of Generation Rescue).

Diseases that don’t exist in the U.S. or that don’t occur during infancy in the U.S. (so even though they can be very severe, a child has almost no risk of catching it in the U.S.) that could be safely delayed are polio, Hep B, tetanus, and diphtheria (although to get a pertussis vaccine, tetanus and diphtheria have to come along with it).

Diseases that DO pose an immediate danger to babies and children are HIB and PC meningitis, Rotavitus, and Pertussis. So, I would rather children stay on time with those four vaccines and delay the flu shots (if you feel comfortable delaying flu shots).

The whooping cough epidemic is getting a lot of coverage in the press. Just today, Dr. Nancy Snyderman of the Today Show discussed this:

Visit msnbc.com for breaking news, world news, and news about the economy

Dr. Snyderman has a lot of good points, including the fact that there are immune compromised people in the community are at risk from the spread of diseases like pertussis.

Dr. Snyderman also makes a mistake in the interview. She claims that children died of measles in the U.S. last year. Watch for groups like the Age of Autism to ignore all the facts and concentrate on that mistake.

Desiree Jennings back in the news

26 Jul

Remember Desiree Jennings? She was a cheerleader ambassador for the Washington Redskins who claimed that a flu shot gave her dystonia. She was highlighted by the Age of Autism blog and by Generation Rescue, who connected her with alternative medical practitioner Rashid Buttar. Mention of Desiree Jennings has been removed from the Generation Rescue website. Neurologist and blogger Steve Novella discussed how her case more closely resembled a psychogetic disorder. Dr. Novella’s take on the case prompted the American TV show Inside Edition to take a second look. We discussed the Jennings case then here on LeftBrainRightBrain as Successful blogging by Steven Novella: the Desiree Jennings story
.

Now the TV Show 20/20 has taken a look a the Desiree Jennings story in Medical Mystery or Hoax: Did Cheerleader Fake a Muscle Disorder?

First, one must stress that many people following this case have not been calling out “hoax”. A psychogentic disorder is quite real, just not dystonia and not physical.

That said, here is the trailer for the 20/20 episode:

http://abcnews.go.com/assets/player/walt2.6/flash/SFP_Walt.swf

I find the beginning to be really cheesy. The way they took the video to make it look like it was some film taken decades ago was, well, cheesy. Ms. Jennings is less than 30 years old. Somehow I doubt her wedding was recorded on film and, even if it was, it wouldn’t be so deteriorated in a few years. But, we get the idea–the wedding was in the past.

Ms. Jennings has been used as an example of how successful Rashid Buttar is. One article, copied to Dr. Buttar’s blog, states that shortly after beginning treatment with him:

The good doctor ran to his patient, fearing she had suffered another seizure but instead was elated to find that she was awake, coherent and carrying on a normal conversation with the nurses and her family. By the next day she was walking the corridors with limited affliction. (See the video at: http://www.desireejennings.com.) The AMA has remained silent.

(note–www.desireejennings.com is no longer active).

But just as she was leaving Dr. Buttar’s clinic on her last visit in December 2009 — with “20/20’s” cameras rolling — it all seemed to fall apart. Jennings was in distress again. She could no longer walk forward, and had to be taken out in a wheelchair.

In the early discussions of Ms. Jennings, much interest focused on the idea that she was diagnosed with Dystonia by doctors at Johns Hopkins. People complained that Dr. Novella shouldn’t make statements that contradicted doctors who actually saw Ms. Jennings. The 20/20 story states:

In search of a cure, Jennings and her husband Brendan visited countless doctors and four hospitals, among them Johns Hopkins Hospital. There, a rare movement disorder that causes the muscles to twitch or convulse involuntary. The symptoms resembled her own.

“a physical therapist told Jennings about dystonia”. That’s a bit different from a doctor diagnosed her with dystonia.

Yes, this isn’t about autism at all. But this story does shed some light onto groups like Generation Rescue who supported Desiree Jennings, sending her to Dr. Buttar. The story was compelling for them, even though it was not about autism. It was about alleged vaccine injury. Generation Rescue appears to have abandoned Ms. Jennings now. It sheds light on Dr. Buttar, whose claims of recovery for Ms. Jennings appear to be unsupported by the facts. Dr. Buttar is one of the more prominent names in the alternative medicine community marketing their services to the autism community.

Laura Hewitson has left the University of Pittsburgh

26 Jul

Laura Hewitson is the lead researcher on a series of studies on comparing vaccinated and unvaccinated macaque monkeys. This work became public first in the 2008 IMFAR conference. At that time and since, the work from these studies has been strongly criticized. Dr. David Gorski of Science Based Medicine discussed those abstracts. It is very likely that the new conflict of interest declaration policy for IMFAR resulted from Ms. Hewitson’s lack of declaration of her own COI at IMFAR (she has filed a claim with the vaccine court on behalf of her child). One paper resulting from that study was withdrawn before it was published (discussed by Countering Age of Autism and Respectful Insolence). More recently, a study from this series was published in which conclusions were drawn based on only 2 control animals. Those control animals underwent brain shrinkage during a critical period of infant growth. In other words, there was something seriously wrong with the control animals and, hence, the entire study. The study (and subsequent discussions by groups such as SafeMinds) spun the brain shrinkage around to claim that the “The vaccinated primates also showed altered maturation of their brains’s [sic] amygdalas.”

Ms. Hewitson has listed here professional affiliations as:

1Department of Obstetrics and Gynecology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA;
2Thoughtful House Center for Children, Austin, TX, USA;

In 2008 she was listed as Associate Professor of Obstetrics, Gynecology & Reproductive Sciences on the University of Pittsburgh’s website. That is the last date for an internet archive version of that page. A google cache version of the page from June 2010 listed her as “adjunct” Associate Professor. Adjunct faculty are typically part time or people from other institutions who are working in some capacity with the University.

Ms. Hewitson’s webpage link at Pitt is no longer active. She is no longer listed on the faculty page for the Pittsburgh Development Center (PDC). The PDC confirmed that she is no longer on the faculty there.

Before people start speculating, the most likely explanation is that it simply became too difficult to balance a career at Thoughtful House in Texas with a faculty appointment in Pennsylvania.

This will mean that in the future Ms. Hewitson will be unable to use her University of Pittsburgh affiliation to bolster the credibility of her research. Studies begun while at Pitt will likely continue to show that affiliation (such as the recently published study on the amygdalas of macaques).

Whatever the reason for her departure, I welcome it. I don’t believe that a fine institution like Pitt should have its name attached to the level of research in the recent paper. It is difficult to simply put into simply how poor the quality of that study was.

OSR to be pulled from the market?

22 Jul

OSR #1, a chemical invented as a chelator and now marketed as a dietary supplement, will be pulled from the market in about 1 week’s time if the message below attributed to Boyd Haley is accurate:

On 18 June 2010, the FDA wrote to CTI Science questioning whether OSR#1® fit within the agency’s definition of a dietary supplement, indicating that instead it appeared to be a drug. Although we believe the product meets the legal definition of a “dietary supplement,” we have decided not to contest this point but to work with the agency. While achieving formal drug approval is lengthy and costly, CTI Science will in the course of it prove to FDA’s satisfaction the safety and efficacy of OSR#1® and ultimately be able to offer OSR#1® to the public with FDA-authorized therapeutic claims.

As a result of this decision, *CTI Science has voluntarily agreed to remove OSR#1® from the market effective Thursday, 29 July 2010*. The product will not be available for sale after that date until new drug approval has been obtained. Please continue to access our website, http://www.ctiscience.com , for updates on OSR#1® in the future.

On a personal note, I have met most of the medical professionals we deal with, and your passion and dedication to excellence are rarely seen these days. It has been an honor to work with you, and I am deeply appreciative of the support you have shown in the past. Please accept my best wishes for your continued success. I look forward to working with you in the future again with OSR#1®.

Boyd E. Haley, PhD

President
CTI Science-Color-EM
CTI Science, Inc.

The Twitter account for CTI science has the following message posted earlier today which would suggest the above message is accurate:

Registered Medical Professionals: Please review your email for an important message about the future availability of OSR#1®. http://www.OSR1.com

I will say that I welcome this move. I agree with the FDA that OSR #1 is not a dietary supplement and, as such, should undergo much more rigorous safety testing before being marketed.

Withdrawn Monkey Study paper to re-emerge without Wakefield as an author

16 Jul

Consider this paper, now withdrawn:

WITHDRAWN: Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing Hepatitis B vaccine: Influence of gestational age and birth weight.

Hewitson L, Houser LA, Stott C, Sackett G, Tomko JL, Atwood D, Blue L, White ER, Wakefield AJ.

It was the big “Monkey Study” paper that was accepted for a major journal last year. It was called a “blockbuster” study at the time. Well, to Mark Blaxill at the Age of Autism it was a blockbuster. Caused a bit of a stir when Neurotoxicology withdrew the paper. Again, to the Age of Autism crowd. To the journal it only warranted a brief note, “This article has been withdrawn at the request of the editor. The Publisher apologizes for any inconvenience this may cause.”

The paper was withdrawn by the editors shortly after the Wakefield paper in The Lancet was withdrawn. It was withdrawn between the time it was published online but before it was published in a physical journal.

We’ve been told it will appear again. And, according to the references in the recent paper by Prof. Hewitson’s team, it will appear in the Journal of Toxicology and Environmental Health, Part A: Current Issues.

Hewitson L, Houser L, Stott C, Sackett G, Tomko J, Atwood D, Blue L, White ER
Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing hepatitis B vaccine: Influences of gestational age and birth weight.
J Toxic Environ Health Part A;
DOI: 10.1080/15287394.2010.484709.

Interesting. Andrew Wakefield has been dropped as an author.

When I do a search for Hewitson at that journal, I get no hits. I also don’t get a hit for the DOI number.

I also don’t find anything for a search “Delayed acquisition of neonatal reflexes” in pubmed.

If someone has a link to the paper already being published, let me know. But it looks to me like advance notice of where this paper will re-appear.

If you would like to read about that study, Orac at Respectful Insolence covered it in Some monkey business in autism research, 2009 edition. and 20 Monkeys by ScienceMom at JustTheVax

From IMFAR to Poland: how a monkey study can totally change

16 Jul

I just blogged about a new paper “proving” once again that vaccines cause autism. This is a paper from Mr. Wakefield’s team. Thanks to a link provided by KWombles of the Countering Age of Autism blog, we can compare the current paper to what the authors claimed two years ago.

Here is the new paper (published in a journal from Poland):
Influence of pediatric vaccines on amygdala growth and opioid ligand binding in rhesus macaque infants: A pilot study

by Hewitson L. Lopresti B, Stott C, Mason N.S., Tomko.

Here is the abstract from IMFAR in 2008:

Pediatric Vaccines Influence Primate Behavior, and Amygdala Growth and Opioid Ligand Binding

L. Hewitson , Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA
B. Lopresti , Radiology, University of Pittsburgh, Pittsburgh, PA
C. Stott , Thoughtful House Center for Children, Austin, TX
J. Tomko , Pittsburgh Development Center, University of Pittsburgh, Pittsburgh, PA
L. Houser , Pittsburgh Development Center, University of Pittsburgh, Pittsburgh, PA
E. Klein , Division of Laboratory Animal Resources, University of Pittsburgh, Pittsburgh, PA
C. Castro , Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA
G. Sackett , Psychology, Washington National Primate Research Center, Seattle, WA
S. Gupta , Medicine, Pathology & Laboratory Medicine, University of California – Irvine, Irvine, CA
D. Atwood , Chemistry, University of Kentucky, Lexington, KY
L. Blue , Chemistry, University of Kentucky, Lexington, KY
E. R. White , Chemistry, University of Kentucky, Lexington, KY
A. Wakefield , Thoughtful House Center for Children, Austin, TX

Background: Macaques are commonly used in pre-clinical vaccine safety testing, but the combined childhood vaccine regimen, rather than individual vaccines, has not been studied. Childhood vaccines are a possible causal factor in autism, and abnormal behaviors and anomalous amygdala growth are potentially inter-related features of this condition.

Objectives: The objective of this study was to compare early infant cognition and behavior with amygdala size and opioid binding in rhesus macaques receiving the recommended childhood vaccines (1994-1999), the majority of which contained the bactericidal preservative ethylmercurithiosalicylic acid (thimerosal).

Methods: Macaques were administered the recommended infant vaccines, adjusted for age and thimerosal dose (exposed; N=13), or saline (unexposed; N=3). Primate development, cognition and social behavior were assessed for both vaccinated and unvaccinated infants using standardized tests developed at the Washington National Primate Research Center. Amygdala growth and binding were measured serially by MRI and by the binding of the non-selective opioid antagonist [11C]diprenorphine, measured by PET, respectively, before (T1) and after (T2) the administration of the measles-mumps-rubella vaccine (MMR).

Results: Compared with unexposed animals, significant neurodevelopmental deficits were evident for exposed animals in survival reflexes, tests of color discrimination and reversal, and learning sets. Differences in behaviors were observed between exposed and unexposed animals and within the exposed group before and after MMR vaccination. Compared with unexposed animals, exposed animals showed attenuation of amygdala growth and differences in the amygdala binding of [11C]diprenorphine. Interaction models identified significant associations between specific aberrant social and non-social behaviors, isotope binding, and vaccine exposure.

Conclusions: This animal model, which examines for the first time, behavioral, functional, and neuromorphometric consequences of the childhood vaccine regimen, mimics certain neurological abnormalities of autism. The findings raise important safety issues while providing a potential model for examining aspects of causation and disease pathogenesis in acquired disorders of behavior and development.

Emphasis added by me.

Why? First, to point out the change in the author list. Of 13 authors on the original abstract, only 4 remain. One can speculate as to why the others were dropped (or pulled their names) from the author list.

A new author was added, N.S. Mason.

How about other changes? Well, 2 years ago they had data on 13 vaccinated monkeys. Now it is only 9. Two years ago they had data on 3 controls. Now it is only 2.

What happened?

OK, while you are working that one out, here’s the big one. Two years ago the vaccinated monkeys “showed attenuation of amygdala growth”

Now, the amygdalas are larger in the vaccinated monkeys. What? Yep. Before they had “attenuated growth” and now they are growing faster than the unvaccinated animals?

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