Vaccine-autism link: New investigation
Showing posts with label In The News. Show all posts
Showing posts with label In The News. Show all posts
Tuesday, May 10, 2011
A Review of Compensated Cases of Vaccine-Induced Brain Injury
You have no idea how bad I want to just post the whole thing here. Seriously. Just like I did when I first started this blog and contributed to the ruination of the internet with my lack of netiquette. But since I'm not ruining the internet anymore, I can only say: must read!
AoA has the Executive Summary here.
Check it out. Good stuff.
Sunday, April 10, 2011
Toxic baby food: is anyone really surprised?
Seriously, I'll never understand why this is okay? It's one thing to get toxins naturally from food - some foods contain toxins - but this is baby food. BABY FOOD. We're not talking about getting amounts of cyanide from eating bamboo shoots because it's naturally present in bamboo.
These are toxins introduced to our foods - and our babies. I'll never understand it.
Read the rest here.
These are toxins introduced to our foods - and our babies. I'll never understand it.
Arsenic and toxic metals found in baby food
Baby foods used to wean infants off milk have been found to contain "alarming" levels of toxic contaminants including arsenic, lead and cadmium.Read the rest here.
XMRV and autism
I've been of the opinion that XMRV is going to be hugely important since we found out about it. Kent Heckenlively does a fantastic job of breaking it down.
The Potential Importance of the XMRV Retrovirus to Autism
By Kent Heckenlively, Esq.
Although I’ve been a science teacher for the past five years I find that when I’m confronted with new information I want to explain to people I fall back on the strategies I used during the fifteen years I was a lawyer. I hope you'll consider this article in that light, as essentially an opening statement.
The Potential Importance of the XMRV Retrovirus to Autism
By Kent Heckenlively, Esq.Although I’ve been a science teacher for the past five years I find that when I’m confronted with new information I want to explain to people I fall back on the strategies I used during the fifteen years I was a lawyer. I hope you'll consider this article in that light, as essentially an opening statement.
Read the rest here on AoA.
Wednesday, February 9, 2011
Dr. Mercola interviews Dr. Wakefield
More evidence supporting Dr. Wakefield is surfacing. Scientists at Wake Forest University School of Medicine, North Carolina have tested 82 kids so far. 70 are positive for vaccine strain measles in the gut. Here is an article by Sally Beck that is sure to get you thinking.Dr. Mercola has a Youtube of his interview with Dr. Wakefield here.
I can't say that I won't be surprised if this new study gets completely ignored, or worse, trashed by the media.
What do you think will happen? Do you think this is a losing battle no matter what we do or do you think that people are going to start seeing the connection despite the media?
Wednesday, January 19, 2011
Silently winning in vaccine Court
I'm not sure who to credit this to, I think it's Sharyl Attkisson but I'm not positive. It does link to the post on CBSNews, though.
It's a wonder to me how little attention those that win get, while all those that lose get paraded around on TV. It's a wonder to me that a child that has as many problems as this, has to remove the autism connection in court to win. It didn't change the boy's situation, he didn't miraculously not have autism - but that's how far this controversy runs. Courts can't even think independently on it. It's a wonder to me that no one will step up to the plate. No one seems to care. Instead, they call us crazy. Never mind that my friend just told me that her infant son got another series of shots the other day and has been screaming in pain since. Another child down. I'm praying it'll all be over in a couple days and he'll make it out like so many other kids. I'm hoping she's exaggerating her son's reaction. I'm crossing my fingers for colic.
Forget about autism. Forget about all the controversy. Now think about all the kids and the vast range of disabilities that are stemming from vaccines. Can you honestly say that it's safe for everyone? Can you even attempt to ignore the list of side-effects in each package insert and say that even if it's not autism, those side-effects aren't real? Can you really believe that vaccines shouldn't be studied more thoroughly? What will you say when it's your child? When it's too late?
I don't think anyone wants to end vaccines. We just want some truth. We want to know what's wrong and why they hurt some kids and not others. Vaccines can't be improved upon and made safer if we don't know what's wrong with them. We can't take steps toward preventing this from continuing if we don't even know where to start. How many more children need to die? How many more need to have developmental delays and neurological disorders? What's the magic number?
I dunno. Call me crazy.
The tragic death of little Elias Tembenis is yet another vaccine injury case you probably won't hear much about. Yet some medical experts believe it could teach us something about how to make vaccination safer.
It's a wonder to me how little attention those that win get, while all those that lose get paraded around on TV. It's a wonder to me that a child that has as many problems as this, has to remove the autism connection in court to win. It didn't change the boy's situation, he didn't miraculously not have autism - but that's how far this controversy runs. Courts can't even think independently on it. It's a wonder to me that no one will step up to the plate. No one seems to care. Instead, they call us crazy. Never mind that my friend just told me that her infant son got another series of shots the other day and has been screaming in pain since. Another child down. I'm praying it'll all be over in a couple days and he'll make it out like so many other kids. I'm hoping she's exaggerating her son's reaction. I'm crossing my fingers for colic.
Forget about autism. Forget about all the controversy. Now think about all the kids and the vast range of disabilities that are stemming from vaccines. Can you honestly say that it's safe for everyone? Can you even attempt to ignore the list of side-effects in each package insert and say that even if it's not autism, those side-effects aren't real? Can you really believe that vaccines shouldn't be studied more thoroughly? What will you say when it's your child? When it's too late?
I don't think anyone wants to end vaccines. We just want some truth. We want to know what's wrong and why they hurt some kids and not others. Vaccines can't be improved upon and made safer if we don't know what's wrong with them. We can't take steps toward preventing this from continuing if we don't even know where to start. How many more children need to die? How many more need to have developmental delays and neurological disorders? What's the magic number?
I dunno. Call me crazy.
The tragic death of little Elias Tembenis is yet another vaccine injury case you probably won't hear much about. Yet some medical experts believe it could teach us something about how to make vaccination safer.
It could also add to the limited body of knowledge as to why the vast majority of kids are vaccinated safely, but a minority become seriously ill, brain-damaged or even die. Still, government officials have said they have no plans to study cases like Elias': cases that victims are winning against the government in the little-known federal vaccine court.
According to court and medical records, Elias was born on Aug. 23, 2000 and appeared healthy until Dec. 26 when he received his second dose of DTaP vaccine. His parents noticed some swelling around the injection site. According to court records:
"Early in the morning on December 27, 2000, Elias's parents found himseizing in his crib and took him to the emergency room ("ER")...Within one day, he developed a fever, which led to a complex febrile seizure. Subsequently, Elias developed epilepsy. This fact pattern is commonly seen in the Vaccine Program."
According to court records, after the DTaP reaction, the once-healthy baby ended up with debilitating medical problems, including features of autism, ear infections and developmental delay. His parents first filed their case as one of the "omnibus" group of autism cases to be heard in federal vaccine court.
According to those familiar with the case, the couple felt their chances of winning with the autism cases was slim because the idea of a link between vaccines and autism is so controversial. So they separated their case from the autism group and filed on the basis of their son's epilepsy and seizures.
They recently prevailed in court. It's one more example where vaccine-injured children who end up with autism are quietly winning their cases, but only when they focus on the more general argument of seizures or brain damage rather than autism.
Some victory. On Nov. 17, 2007 Elias' illnesses became to much for him. The little seven year old boy died. If the right people bothered to study the medical details of the case, they might learn something about why Elias got so sick from his vaccines, and how to identify ahead of time what babies might have the same problem. The former head of the National Institutes of Health, Dr. Bernardine Healy, has said such study would actually protect the integrity of the vaccine program, rather than threaten it (as she says many government officials fear). So far, though, no takers. Elias' case becomes quietly filed away in vaccine court archives with nearly 1,300 other vaccine brain injuries-none of them apparently being pooled for study. An undetermined number of them, like Elias', involving autism diagnoses.
What made these children get sick? Why couldn't they tolerate their vaccines when most kids can? Unanswered questions.
Read both sides of Elias' case, including the government's argument against it.
Thursday, January 13, 2011
Dr. Andrew Wakefield makes a rebuttal to BMJ
This is a man that doesn't have all the answers. Guess what? He has more answers than mainstream medicine will admit. We know more about autism because of him and others like him and yet, still, they won't listen. Still, they choose to defame and discredit them by not actually proving anything. Just saying it's not true and telling us vaccines do not cause damage or that there is no evidence is not proof. Name one vaccine that has purposefully been studied to see if there are developmental delays. Go ahead, give it your best shot. I will gladly post them.
If mainstream medicine believes it's all a hoax, how about effectively proving it? It doesn't seem like that is such an odd request. Put your money where your mouth is. A lot of dollars are spent on a smear campaign when those dollars could be spent on proving it if this issue needs to be put to bed. Why don't they do it? Afraid of what they might find, maybe? Afraid of what they'll have to disclose? His studies have been replicated. Where are the studies that say otherwise? Oh wait, they have studies. Like this one.
The original study never made such sweeping claims as the media would like to suggest.
Anyway, here's his statement, pulled from AoA.
January 13, 2011
BREAKING NEWS: Statement From Dr. Andrew Wakefield: No Fraud. No Hoax. No Profit Motive.
AUSTIN, Texas, Jan. 13, 2011 /PRNewswire/ -- Dr. Andrew Wakefield issued the following statement today on the recent British Medical Journal articles: "The British Medical Journal and reporter Brian Deer recently alleged that my 1998 research paper was 'a hoax' and 'an elaborate fraud' and that my motivation was profit.
"I want to make one thing crystal clear for the record – my research and the serious medical problems found in those children were not a hoax and there was no fraud whatsoever. Nor did I seek to profit from our findings.
"I stand by the Lancet paper's methodology and the results which call for more research
into whether environmental triggers cause gastrointestinal disease and developmental regression in children. In fact, despite media reports to the contrary, the results of my research have been duplicated in five other countries (to see citations to studies, visithttp://tinyurl.com/4hrdt5y.)
into whether environmental triggers cause gastrointestinal disease and developmental regression in children. In fact, despite media reports to the contrary, the results of my research have been duplicated in five other countries (to see citations to studies, visithttp://tinyurl.com/4hrdt5y.)"It is not unexpected to see poor reporting and misinformation coming from Brian Deer, the lead reporter of the recent BMJ coverage. But to see coverage in other media that cites Deer's shoddy journalism in the BMJ as a final justification to claim there is no link between vaccines and autism is ludicrous. The MMR is only one vaccine of the eleven vaccinations on the pediatric schedule that has been studied for causing developmental problems such as autism. That is fact, not opinion. Any medical professional, government official or journalist who states that the case is closed on whether vaccines cause autism is jumping to conclusions without the research to back it up.
"I continue to fully support more independent research to determine if environmental triggers, including vaccines, are causing autism and other developmental problems. The current rate of autism is 1 in 110 children in the United States and 1 in 64 children in the U.K. My goal has always been and will remain the health and safety of children. Since the Lancet paper, I have lost my job, my career and my country. To claim that my motivation was profit is patently untrue. I will not be deterred - this issue is far too important."
Friday, January 7, 2011
Be innovative. Be a questioner. Be a thinker./Safe Minds Special Weekend Edition
Before getting into the actual post below from Safe Minds, I just wanted to add that while Kathleen Sebelius may think that public health officials should be given more weight by the press than those who question vaccines, that's not the way life works, nor should it be.
If you want to teach your children to never question anyone or anything, Ms. Sebelius, go right ahead. But in my house, I want to raise thinkers. Without people questioning, we wouldn't have all the great science we have. Your TV wouldn't be flat and hanging on a wall. Women wouldn't be allowed to vote and you wouldn't be the Secretary of Health and Human Services. We would still have slaves and indentured servitude, still be riding on horseback (by necessity, not choice), and burning candles to see at night.
Society wouldn't advance, technology wouldn't advance and wait, a minute, healthcare wouldn't advance. We need people to question. We need people to ask, "How can we do this better?" or "Is it really safe?"
What we really need is for the "public health care officials" to care enough to find out the truth instead of doing every shady thing they can think of to "prove" the questioners wrong by using crappy studies to say, "See! It's all right here!" Why not put that time and energy and money into really understanding? Or is that too easy? Who knows, maybe you're right and we're wrong, maybe it's the wrong tree or maybe there are many trees and this is only one. But something isn't right, autism rates are only getting higher and why doesn't that concern you, Ms. Secretary of Health and Human Services?
If you want to teach your children to never question anyone or anything, Ms. Sebelius, go right ahead. But in my house, I want to raise thinkers. Without people questioning, we wouldn't have all the great science we have. Your TV wouldn't be flat and hanging on a wall. Women wouldn't be allowed to vote and you wouldn't be the Secretary of Health and Human Services. We would still have slaves and indentured servitude, still be riding on horseback (by necessity, not choice), and burning candles to see at night.
Society wouldn't advance, technology wouldn't advance and wait, a minute, healthcare wouldn't advance. We need people to question. We need people to ask, "How can we do this better?" or "Is it really safe?"
What we really need is for the "public health care officials" to care enough to find out the truth instead of doing every shady thing they can think of to "prove" the questioners wrong by using crappy studies to say, "See! It's all right here!" Why not put that time and energy and money into really understanding? Or is that too easy? Who knows, maybe you're right and we're wrong, maybe it's the wrong tree or maybe there are many trees and this is only one. But something isn't right, autism rates are only getting higher and why doesn't that concern you, Ms. Secretary of Health and Human Services?
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Wednesday, April 28, 2010
The Peer Review "Fig Leaf": Vera Hassner Sharav
The Peer Review "Fig Leaf": Vera Hassner Sharav
By SUZAN MAZUR
Vera Hassner Sharav
While the chief of the US National Institute of Mental Health this week stopped short of saying scientists are corrupt because of their ties to industry, as AP reported -- Vera Hassner Sharav does not give scientists a similar pass, partly because the testimonies she organized on unethical research on the mentally ill before the National Bioethics Advisory Committee in 1997 led to the shut down of 29 clinical trials at NIMH. Hassner Sharav is founder and president of the Alliance for Human Research Protection, a public interest watch dog group based in New York that aims to "unlock the walls of secrecy in biomedical research and to bring accountability to that endeavor". As a human rights champion, she has opposed experiments on children such as the EPA's CHEERS pesticide tests and pushed for a federal investigation into foster care children being used in AIDS drug experiments. She has appeared before various national advisory panels addressing her concerns about experiments on prisoners, about the use of antidepressants and the risk of suicide, among other issues. Hassner Sharav is also a former law librarian and has developed a database that tracks unethical research practices and the failure to disclose information on drug hazards.
I spoke with Vera Hassner Sharav earlier this week by phone about peer-reviewed science journals.
Suzan Mazur: Science peer review is regarded as censorship. That's the issue David Noble and I explored in my recent interview with him . . .
Vera Hassner Sharav: That's clearly not how peer review was originally supposed to work. Once reviewers are selected based on what's good for industry, they are not independent peers. But the process is so much more corrupt than even censorship. For example, Elsevier published propaganda favoring Vioxx as "peer-reviewed" inarticles in a phony journal paid for by Merck.
When reviewers are under contract and financially tied to industry, articles that get approved for publication, say in medical journals, are those that promote newly patented drugs or medical devices.
Suzan Mazur: What is the concern with peer review at the Alliance for Human Research Protection.
Vera Hassner Sharav: The concern is that this corruption of the peer review process leads to the promotion of defective drugs that cause harm and even kill people, whether it's Vioxx, Avandia, Zyprexa or the like -- toxic, dangerous drugs that were promoted within peer review. Independent scientists do not have access to the complete data on these newly patented drugs being promoted in scientific journals and elsewhere in the media. We should be able to ask authors for the actual data about which they are reporting.
Industry controls the process and the data, it controls the clinical trials, the selection and design of the trials. It controls what is disclosed and what is concealed. What gets published and what gets put in the so-called "drawer". Peer review has become a fig leaf covering up make-believe peer review. It's not rigorous, not independent and not honest. It's rubberstamp, paid for and controlled by the pharmaceutical industry.
The integrity of the scientific literature has been compromised. The clinical practice of medical doctors is jeopardized because physicians think these articles in influential journals have been vetted (i.e., peer reviewed). They then unwittingly prescribe to patients dangerous drugs that are being marketed widely. And people are harmed.
Suzan Mazur: With the passage of the Obama health care bill, do you see the beginning of a clean up of the peer review process?
Vera Hassner Sharav: No it doesn't touch corrupt practices at all. Obama health care is totally silent on this. The assumption is that science professions are policing themselves. But if science is under the influence of industry, receiving huge money from industry, then there is a disincentive to police.
Suzan Mazur: Can you tell me about the controversy surrounding the public being kept out of sessions at the upcoming American Psychiatric Association conference in New Orleans?
Vera Hassner Sharav: The American Psychiatric Association is having its annual meeting in New Orleans in May. Science journal publishers -- Wiley, Elsevier, etc. -- and pharmaceutical companies will be attending as well as psychiatrists.
Dr. Charles Schulz, chairman of psychiatry at the University of Minnesota Medical School, who has received hundreds of thousands of dollars as a paid consultant to AstraZeneca and Eli Lilly, whose favorable report about the antipsychotic Seroquel -- presented at an APA conference in 2000 -- was contradicted by an analysis of the drug's manufacturer AstraZeneca, is holding a session at the APA 2010 conference: "How to help parents of a first psychotic episode patient". A parent whose son committed suicide in a clinical trial conducted by Schulz wants to attend but was told the meeting is closed to all but APA members.
[NOTE Schulz office 3/29/2010 email to me: "He [Dr. Schulz] has been thinking about her [the parent Hassner Sharav refers to above is Mary Weiss, whose child died in a Schulz clinical trial] and is glad she wants to obtain more information. If you wanted to provide her name and address, Dr. Schulz would like to send her his book on the Early Stages of Schizophrenia, which is published by the APA and has chapters about psychotherapy and family therapy.]
So the question arises -- if this meeting is geared toward helping parents, what is it Schulz is going to say that he doesn't want parents to know? This is serious. This is peer review at its maximum corruption. These meetings are a commercial circus.
Suzan Mazur: Is the public completely barred?
Vera Hassner Sharav: Some meetings are open, but it costs a lot of money that individuals can't afford. [NOTE: APA advises admission is $860 - $950 for non-APA members.] But the Schulz session is closed.
Robert Whittaker, author of the forthcoming book Anatomy of an Epidemic, wanted to attend last year's APA meeting. The APA didn't want to let him in. His publisher, Crown, intervened to get him in. Whittaker attended and recorded quite a few of the sessions. They were humdingers. What's discussed at these APA meetings is information that does not reach the public.
[NOTE: -- APA has emailed me stating the following:
"Charles Schulz's Case Conference is only open to residents. Case conferences are closed to nonmembers because of the clinical nature of the discussions and the patient confidentiality restrictions inherent in presenting cases. Members are bound by ethics confidentiality and nonmembers are not, which is why nonmembers are restricted.
A few sessions are only open to residents to allow residents to have a more hands-on experience with less people, but all other sessions are open to members and nonmembers."]
Suzan Mazur: Regarding Wiley, one of the major science journal publishers attending the APA meeting -- it's been around for over 200 years but apparently just became profitable in the 1990s. Do you have any insight into that?
Vera Hassner Sharav: What this shows is that when industry began to influence the content of journals by paying Wiley hefty fees, Wiley became profitable.
Suzan Mazur: Advertising?
Vera Hassner Sharav: There are many ways to influence publishers, but two things especially. Advertising is one but at least with advertising you know an ad when you see one. And doctors are perhaps less influenced by ads than the public. Maybe.
What is even more insidious is the articles that are published as peer-reviewed scientific articles facing those ads. The reports are promotional pieces, not independently and rigorously reviewed. They are masquerading as scientific articles. That's deception of the worst kind.
Suzan Mazur: You have a Masters degree in Library Science.
Vera Hassner Sharav: Yes.
Suzan Mazur: Is there a movement on the part of libraries to challenge this corruption?
Vera Hassner Sharav: No they have no power, no say.
Suzan Mazur: Do they have any interest in dealing with it?
Vera Hassner Sharav: I don't know if they've even been asked about it. The librarians have been pretty much bypassed in the information explosion age. It was their own fault.
Suzan Mazur: They have to know about the bogus information.
Vera Hassner Sharav: They simply transmit it. You ask for an article, they'll fetch it for you. And now with the Internet, librarians are used less and less.
Suzan Mazur: One recent open-access journal called Philosophy and Theory in Biology, "a product of the Scholarly Publishing Office of the University of Michigan Library and DLXS" has come under criticism as a reflection of the gaming of the system. Here's a complaint from an independent investigator whose article was rejected by the journal after 36 hours. The journal editors include a half dozen Altenberg 16 cronies (esteemed cell biologist Stuart Newman is not among them):
"But the most insulting rejection came from Philosophy and Theory in Biology, a relatively new publication (started in August) whose senior editor is none other than Massimo Pigliucci. It took his team of editors only 36 hours to reject the paper on the grounds that it was not appropriate. The science and math in the paper, unless examined by specialists in the field, could not possibly have been understood by the editors in that amount of time. . . . I don't think Massimo ever saw the paper, trusting instead to his editorial scriveners to do their duty. In an embarrassing rant, presented in two emails, I raged that not only was his journal the most appropriate one, given its stated objectives, but also his editorial linemen were stultifying in their ignorance not just of current trends in the biosciences, but of the philosophy of science and the physical sciences. . . . [D]espite his posturing as a man of science and a skeptic, [he] is an obstacle to scientific progress although chief editor of a journal alleged to advance that very thing." -- Gregory O'Kelly
Any idea how that library affiliation works?
Vera Hassner Sharav: I'm not familiar with that particular arrangement. But many of the journals have university affiliation. Little journals. . . . What would make a huge difference would be if academia started to penalize faculty members who sell their name and append it to ghost-written articles. Simply fire them because it's unprofessional conduct.
Suzan Mazur: Here are five questions I submitted to Wiley that they refused to answer. I emailed the questions to Eric Swanson, who is the Wiley point person there in Hoboken in charge of science journals I was told by Susan Spilka in their press office that Swanson was "pondering" responding. I assume he found the questions too challenging. He emailed the Wiley template on ethics via his press office.
"1. As one of the top publishers of science journals and a public corporation, is Wiley aware that the public knows the science peer-reviewed journal system is a major factor corrupting science?2. Is Wiley concerned that science peer review is increasingly viewed by the public as censorship -- a way of keeping out the public, who actually fund science?3. Why does Wiley approve of anonymous peer review of journal articles? There are complaints that too often when a paper is submitted that exposes the errors of science journal editors, the paper is simply rejected and there is no avenue of appeal regarding such unethical publication practices. A psychologist complained this happened in submitting to a Blackwell, now- Wiley psychology journal. In the case of your anatomy journals, there are complaints about a possible conflict of interest regarding what is acceptable content because many of the journal editors [and the journals themselves] are based on the University of Utah campus where the LDS church has a significant presence and a gene-centered approach to science is favored.4. Is Wiley at all concerned by lack of operational financial transparency on the part of its science journals? For example, Wiley Evolution and Development journal editor-in-chief Rudy Raff told me each of his editors gets an allowance FOR an editorial assistant (he wouldn't say how much) but that the editors do not get paid nor do the anonymous referees. Raff says it's "traditional community service" -- but the public increasingly sees the practice as a gaming of the system. What is your response?5. Does Wiley see a serious disconnect between its corporate board of directors who endorse the Wiley journal product and pass it on to the public -- but may not understand the science -- and the scientists who actually write the anonymously-reviewed journal articles for publication?"
Vera Hassner Sharav: The arrogance of Wiley is overwhelming. No Swanson wouldn't respond because to answer would put him and Wiley in jeopardy. Yet they have a public responsibility.
Suzan Mazur: Wiley's got on its board of directors the current CEO of Moody's and the former CFO of Dow Jones.
Vera Hassner Sharav: Elsevier is intertwined with pharmaceutical companies such as Merck and GlaxoSmithKline -- whose board includes James Murdoch and Elsevier's former CEO Sir Crispin Davis. The challenge is, the way the corruption can be halted is if under Obama health care reform, if the publicly-financed reimbursement uses its muscle to not reimburse for drugs where it has been shown in court that they were illegally marketed, that the hazards were concealed and the benefits were made up. Medicare -- Medicaid should not reimburse for them. If that would happen, things would change very fast. The whole system would be shaken. Cutting off the money is the only way to get out of it.
Suzan Mazur: What about the drugs being produced now that may be detrimental to our health? How do you stop that process? Are you in favor of revoking the Bayh-Dole Act.
Vera Hassner Sharav: Bayh-Dole is what started it by encouraging corporate-academic collaboration. By removing the firewall between academia and industry, academic ethics and the integrity of science gave way to corporate ethics -- which above all, seeks to maximize profit. Since academia is far too dependent on industry money, they won't police corrupt practices. Stopping reimbursement in health care for harmful drugs illegally marketed is the way to go. As government gets more involved, they'll have more leverage. When government Medicare - Medicaid stops paying for these drugs and it involves tens of millions of prescriptions, you will see change. Once you cut the profit margin, industry will have no interest. The cycle can't continue without government subsidy.
Saturday, March 13, 2010
The perfect example of how one size does NOT fit all.
New Plavix Warning: Lack of Effect in Many People
Genetic Test IDs 'Poor Metabolizers' of Plavix but Time, Cost Are Issues
By Daniel J. DeNoon
WebMD Health News Reviewed by Laura J. Martin, MD
March 11, 2010 - The FDA has put a new "black box" warning on the anti-clotting drug Plavix, the second best-selling drug in the world.
The new label warns that normal doses of Plavix have a potentially deadly lack of effect in 2% to 14% of patients.
Such patients are so-called "poor metabolizers" who carry a variant CYP2C19 gene affecting the enzyme that converts Plavix into its active form.
A less strident warning about poor metabolizers first appeared on the Plavix labels in May 2009. Based on new information from a drugmaker-funded study and other research, the FDA has now strengthened the warning.
A genetic test can tell whether a person is a poor metabolizer. The test costs about $500, according to Courtney Harper, PhD, director of the FDA's division of chemistry and toxicology devices. But cost isn't the only issue.
"The time to get a test result varies. It may be a few hours to a day or two, or other labs may take a few weeks," Harper said at a news conference held to discuss the FDA action.
For many patients at risk of a second heart attack or stroke, time is of the essence, noted Robert Temple, MD, director of the FDA's office of medical policy.
"Unfortunately, waiting to see if Plavix will work isn't easy. This drug is to keep you from having a heart attack or stroke or dying, so waiting is not a good idea," he said at the news conference. "And this drug is used acutely, when a person is having angioplasty. So you really can't wait for the test results in that case. But for people who had a heart attack some time ago, they might want to wait for the test."
Different races are more or less likely to carry the CYP2C19 gene that makes them poor metabolizers.
"The frequency is about 2% of Caucasians, 4% of blacks, and 14% of Chinese," Mary Ross Southworth, PharmD, deputy director for safety in the FDA's division of cardiovascular and renal products, said at the news conference.
People carry two copies of each gene. Those who inherit two copies of the CYP2C19 gene are poor metabolizers of Plavix, and those with one copy are intermediate responders. There is also a variation of the gene that makes a person a "hyper-responder" to Plavix.
The FDA wants doctors to discuss Plavix options with patients. Right now, those options include using Effient, another anti-clotting drug that is not affected by the CYP2C19 gene. Another option is to use a double dose of Plavix.
"The data are not clear. There is more uncertainty than we wish we had about exactly what to do for these patients," Temple said.
Plavix, from Bristol-Myers Squibb and Sanofi Aventis, is used to prevent heart attacks and strokes. It's particularly useful in preventing deadly blood clots in patients who have received stents to reopen blocked arteries.
Genetic Test IDs 'Poor Metabolizers' of Plavix but Time, Cost Are Issues
By Daniel J. DeNoon
WebMD Health News Reviewed by Laura J. Martin, MD
March 11, 2010 - The FDA has put a new "black box" warning on the anti-clotting drug Plavix, the second best-selling drug in the world.
The new label warns that normal doses of Plavix have a potentially deadly lack of effect in 2% to 14% of patients.
Such patients are so-called "poor metabolizers" who carry a variant CYP2C19 gene affecting the enzyme that converts Plavix into its active form.
A less strident warning about poor metabolizers first appeared on the Plavix labels in May 2009. Based on new information from a drugmaker-funded study and other research, the FDA has now strengthened the warning.
A genetic test can tell whether a person is a poor metabolizer. The test costs about $500, according to Courtney Harper, PhD, director of the FDA's division of chemistry and toxicology devices. But cost isn't the only issue.
"The time to get a test result varies. It may be a few hours to a day or two, or other labs may take a few weeks," Harper said at a news conference held to discuss the FDA action.
For many patients at risk of a second heart attack or stroke, time is of the essence, noted Robert Temple, MD, director of the FDA's office of medical policy.
"Unfortunately, waiting to see if Plavix will work isn't easy. This drug is to keep you from having a heart attack or stroke or dying, so waiting is not a good idea," he said at the news conference. "And this drug is used acutely, when a person is having angioplasty. So you really can't wait for the test results in that case. But for people who had a heart attack some time ago, they might want to wait for the test."
Different races are more or less likely to carry the CYP2C19 gene that makes them poor metabolizers.
"The frequency is about 2% of Caucasians, 4% of blacks, and 14% of Chinese," Mary Ross Southworth, PharmD, deputy director for safety in the FDA's division of cardiovascular and renal products, said at the news conference.
People carry two copies of each gene. Those who inherit two copies of the CYP2C19 gene are poor metabolizers of Plavix, and those with one copy are intermediate responders. There is also a variation of the gene that makes a person a "hyper-responder" to Plavix.
The FDA wants doctors to discuss Plavix options with patients. Right now, those options include using Effient, another anti-clotting drug that is not affected by the CYP2C19 gene. Another option is to use a double dose of Plavix.
"The data are not clear. There is more uncertainty than we wish we had about exactly what to do for these patients," Temple said.
Plavix, from Bristol-Myers Squibb and Sanofi Aventis, is used to prevent heart attacks and strokes. It's particularly useful in preventing deadly blood clots in patients who have received stents to reopen blocked arteries.
The Fallacy of Thimerosal Removal & Autism Increase: A Failure of Science, A Bigger Failure to Children Worldwide - AGE OF AUTISM
The Fallacy of Thimerosal Removal & Autism Increase: A Failure of Science, A Bigger Failure to Children Worldwide - AGE OF AUTISM
By Jake Crosby
Readers of Age of Autism are aware of the term “the big hungry lie” coined by regular contributor J.B. Handley, used to describe the tactics of the CDC and the drug industry’s attempts to disassociate autism from vaccines in any way, shape, or form.
Perhaps the biggest lie of all is the one that has been repeated all too long, that after thimerosal was reduced or eliminated from vaccines, autism rates continued to go up. There have been multiple instances of this claim and each time it has been proven false, right up to the recent lie that after thimerosal was removed from vaccines in 2001, autism rates continue to increase. These two claims, the first that thimerosal was removed from vaccines, and the second that autism rates have not gone down as a result, continue to be used to justify the injection of thimerosal into pregnant women and children with flu shots. The claims have also been used to justify the immunization of children in developing countries with vaccines preserved with thimerosal. Sadly, neither claim is any more truthful than previous equally erroneous claims, the earliest of which originated from Scandinavia, then spread to Canada and most recently came out of California.
Cold-Blooded Lies
The paper by Stehr-Green et al., for example, purported to study autism rates in Sweden after thimerosal removal in 1993, but only hospitalizations in relation to autism were analyzed. Anyone remotely familiar with autism knows that it is not the kind of condition for which one would typically go to a hospital for treatment.
In the same study were also analyses of autism rates in Denmark, which were even more flawed. Many here remember the infamous Danish studies published in 2003, which served as the primary basis for the IOM’s predetermined conclusion in 2004, that autism rates shot up after thimerosal removal in 1992. In reality what happened was the Danish were worried there was a connection between thimerosal and autism, and right after thimerosal was eliminated from all their vaccines, they rapidly changed their registration program to include a lot more children. Such an interpretation of these studies -- designed by the CDC, and conducted by Statens Serum Institut, the largest vaccine-manufacturer in Denmark -- that autism rates skyrocketed after thimerosal removal, can be regarded as little more than propaganda.
When SafeMinds reanalyzed the data of the latest Denmark study, Hviid et al., by applying the same standards of higher case ascertainment to children born before 1992, they found a prevalence of 1 in 500, compared to a prevalence of 1 in 1,500 ten years later, a 66% drop. Unfortunately, this would not be the last time the CDC would design such self-contradicting studies.
In Canada, Eric Fombonne, a psychiatrist with ties to Sanofi-Pasteur, who is not even an epidemiologist, conducted his own combined thimerosal-MMR study on a school district in Montreal, and it was a total failure. His claim that autism rates went up after thimerosal was removed rested entirely on the Kindergarten cohort, for which enrollment was optional, so only about half the kids out of the total enrolled. However, all the children with autism enrolled because the school provides many services to autistic children. In fact, the school district Fombonne studied has an autism center for excellence, and even draws children with autism from other districts. Had enrollment been mandatory, the estimated prevalence would have dropped by one-half, indicating a decrease rather than an increase. According to biochemist Dr. Paul G. King, this is what is called “negative enrollment bias.” Furthermore, there was also thimerosal exposure during the years where exposure was labeled “nil.”
His MMR data were no more reliable. Instead of using local MMR immunization rates to compare to autism rates, he used immunization data from Quebec City, 145 miles away. Even though the Cochrane Collaboration had this to say about his previous MMR study from 2001, "The number and possible impact of biases was so high that interpretation of the results was difficult," and even though the collaboration included a person who also acted as a legal consultant to MMR manufacturers, such discrediting apparently has not stopped Fombonne from doing more completely flawed, post-marketing research.
But back to thimerosal, because just two years ago, Robert Schechter and Judith Grether of the California Department of Public Health accessed the records of the California Database for Evaluation and Research (CDER) of the California Department of Developmental Services in children ages 3-5. The purpose was to see if autism rates had declined after the supposed removal of thimerosal from vaccines. According to Schecter and Grether's analysis, they hadn’t. Using their interpretation, the two researchers determined that thimerosal must not be a primary cause of autism, in a study published in the Archives of General Psychiatry entitled “Continuing Increases in Autism Reported to California’s Developmental Services System: Mercury in Retrograde.” However, their own errors, it now appears, contradicted their conclusions.
3 Year Olds, A Reliable Age For The Final Cohort?
The very last cohort the study looks at are 3 years olds, which already is not a sufficient age group to base any conclusions from, as they would be hopelessly premature. This is especially relevant to point out because Schechter and Grether suggest that the first full thimerosal-free year was 2003, yet this was the final birth year fully studied, and children born during this year would have been diagnosed the earliest for reasons that will be explained later. Moreover, the claim that children received no more exposure to thimerosal after 2002 is not true either. Expiration dates on many of the vaccines that contained thimerosal were well after 2003. Furthermore, unpublished statistics show that there were sharp increases in thimerosal exposure from flu shots given to infants and pregnant women, while other sources of mercury exposure further confound the study’s conclusions.
Even if the premise for this study had been correct, that thimerosal was removed in 2002, it is still inherently flawed by the fact that its conclusions that thimerosal and autism are unrelated are based on one birth year of very young children (three year olds born in 2003), which is only the beginning of when autism cases start getting filed into the DDS CDER archives. Drawing any conclusions from this age group alone would be a false hope.
Perhaps recognizing this problem, the authors then proceed to combine cases designated as three years of age with those ages four and five, but this only adds to the problem, creating a simple ascertainment bias that would make the designated 3 year old age group, by virtue of having less time to enter the system, smaller than the group labeled as four years old, which would in turn be smaller than the age group labeled as 5 years of age. This is especially important because older kids would have been more likely to receive greater quantities of thimerosal than younger kids. Yet they are all combined into one whole age group from which to draw conclusions based on prevalence.
Mercury in Retrograde?
This relates primarily to the less quantifiable problems in relation to autism rates, which were issues with elemental mercury exposure from amalgam fillings, methylmercury exposure from coal-burning facilities, the remaining childhood vaccines preserved with thimerosal that were not taken off the shelves, and for that matter thimerosal exposure from the flu shot while exposure from other vaccines was being reduced.
Complicating this further is the fact that there seems to be no consensus on when the first year routinely recommended vaccines truly contained no thimerosal preservative. Schechter and Grether said the preservative was all gone from vaccines in the middle of 2002, citing the IOM Report. However, all the IOM said was that the ACIP gave an “expressed preference” that all thimerosal be removed by 2002, hardly reflective of actual thimerosal content in vaccines. The FDA said the last lots preserved in thimerosal expired at the beginning of 2003, but the Council of State Governments said it was early 2004, while parents have found vaccines on the shelves of doctor’s offices with expiration dates that surpass all these years. So no one really knows.
On top of all this, the parallel increase in uptake of flu shots, like those during pregnancy, may contribute to earlier onset autism, due to earlier exposure, and therefore contribute to the disorder being diagnosed earlier. Unfortunately, there is no available immunization data for prenatal flu shots.
What is available, however, is the immunization data for the rate of postnatal flu shots among children ages 6-23 months of age, as reflected among clients enrolled in the Northern California Kaiser HMO, which jumped from 5% during the 2001-2002 influenza season, to 45%, in the following season. By winter of 2004-2005, 57% of 6-23 month olds were getting flu shots, practically all of which were preserved with thimerosal. Data for pregnant women are not available, but they were also a target group for flu vaccines in the same period.
Continuing Increases?
That is the final and main problem I found with this paper, which has been used to support the untrue claim that autism rates have continued to go up. First, the claim that prevalence of autism was counted in 3-5 year old children is misleading. Schecter and Grether’s estimates of age rely on subtracting the year of birth of the child from the year the child is currently enrolled as an active client, but that does not mean the child really is that age For example, I was born in 1988, so by Schechter and Grether’s counts I would be 22, but I’m actually 21. So many children are getting counted as older than they really were. Many children labeled as four years old are actually three and many children labeled as five years old are actually four, and roughly half the five year olds are not included but actually classified in with children six or older. Children in the studied age group could be as old as five, but that’s not the same as including the entire five year old age group.
So the Schecter and Grether study only fully accounts for 3 and 4 year olds; the only other study I can recall which looks at children that young is the infamous Verstraeten study. This is key, especially since during the years it looked at the rates after thimerosal "removal" (which is also dubious), the California Department of Developmental Services’ regional centers made changes that may artificially skew autism clients, especially those in the youngest age groups, towards an upward trend.
According to a CDDS report “Controlling Regional Center Costs:”
“Responding to this concern (increasing autism rates), the Legislature enacted a requirement for the Department to develop evaluation and diagnostic procedures for the diagnosis of ASD and to develop a training program for regional center clinical staff in the utilization of the diagnostic procedures. These procedures were published in 2002.”
See HERE.
So, now the youngest possible autism age groups in the CDER archives of the CDDS, 3 and 4 year olds, the only ones Schechter and Grether fully account for, are heavily biased. Not only would developing procedures for diagnosis skew autism figures towards the youngest children, but also since they are done at reporting centers, children may now enter the DDS system as soon as they are diagnosed. This will mean the proportion of younger children to older children with autism will shoot way up, and that is exactly what we see in the Jaunuary 2009 Hertz-Picciotto study published in Epidemiology, where starting in 2002, new cases of autism in the CDDS of children ages 0-4 go up linearly but the rate for children ages 5-9 starts to flatline. It also means that, amidst all this, the increasing proportion of total numbers of new cases, assuming the autism rate were to continue to remain the same, must also balance out with the total number of cases leaving the system as well as the decreasing proportion of older children entering the system. So changes in the youngest clients would still be reflected indirectly in total new autism cases, as they are all part of the same system. As a result, looking solely at autism rates in the youngest children does not give the full picture.
What does, however, are the results obtained by Dr. Mark Geier, a fellow of the American College of Epidemiology, and his son David Geier, when they analyzed both the Vaccine Adverse Event Reporting System of autism-related adverse events and the California Department of Developmental Services data of total new autism cases and found a decrease in both, according to a study entitled “Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines,” published in the Journal of American Physicians and Surgeons.
Not only that, the CDDS graph of autism (page 12) from this study provides further evidence for early diagnosis bias in the Schechter and Grether paper. An increase in the proportion of younger children who enter the system, namely three, four and some five year olds who are the youngest clients enrolled in the CDDS CDER database, while it may positively affect the reporting system overall, would still mean that there would have to be a corresponding decrease of older children with autism being enrolled to the system; that would be offset by an acceleration of younger cases if rates were to remain stagnant, and as a result cause a stagnation in the number of new cases. New autism cases would also have to offset the increasing numbers of older cases reported from previous quarters leaving the system, if they do, then the autism rate has not gone down.
However, this is not the case based on the fact that the increase in prevalence among 3-5 year olds from 1995 to 2007 in Schechter and Grether is a straight line maintained at a constant rate, not an accelerating curve as would be expected with younger children entering the system, likely due to thimerosal removal. Further evidence for this can be seen from Figure 3 of Geier et al., showing the scatter plot of total new autism cases entered to the CDDS, which shows a downwards trend beginning in early 2002.
See HERE.
To be fair, however, the Geiers' study drew some criticism. Critics claimed the decrease was the result of state law that went into effect in mid 2003. However, the change in trend noted by the Geiers began in early 2002.
The role of changing methods in California
Those who use the California DDS data to exonerate thimerosal's role in autism will point to changes in the state law in 2003 that raised demands of those being served by CDDS, saying that clients must show “substantial disability” in three or more areas of life because the state was facing a budget crisis, and that therefore, the California database was if anything, taking fewer cases than it would have.
This, however, is unlikely to have made an impact on cases of full-blown autism admitted to the system, the only autism spectrum disorder for which this new law applied. Rick Rollins, autism parent and cofounder of the UC Davis MIND Institute, says “children with full syndrome autism generally fail in at least 3 and as many as 6 of the areas of 'major life activities' as defined above, therefore one would expect that autism would be the least impacted of all the categories by the new, additional requirements for eligibility.”
Furthermore, if one were to believe these changes have a significant impact on the reporting of full-blown autism at all, one would expect a disproportionately lower growth in full-blown autism as compared with Aspergers and PDD-NOS, since the “substantial disability” criteria only applies to classic autism between the years of 2002 and 2007. However, growth for autism compared with other ASDs for which “substantial disability” criteria does not apply increased at approximately the same rate during this period. (page 27): See HERE.
Then there are the changes that took place in the CDDS in 2002 that culminated in the emergence of early diagnosis and evaluation policies for ASDs that had not previously existed, that would positively skew the numbers of autism spectrum disorders enrolled in the database, especially in the youngest children. This is far more likely to bias the database in a positive direction than requiring extra proof of “substantial disability” in cases with classic autism, which is already a substantial disability.
While I have previously speculated that increased exposure to thimerosal from flu shots plays a role, the results are likely to be primarily due to drastic administrative changes as stated before in reference to the 2007 Report “Controlling Regional Center Costs.” The budget crisis that had been going on during this time period, if anything, caused the Department to divert more funds to early diagnosis and intervention programs for autism, given that autism has increased at a much higher rate than the other disabilities the system keeps track of. This change to the CDDS database came as a result of a state law passed the year before in 2001, the most widely cited year for alleged thimerosal removal.
Even slight fluctuations in the average age of diagnosis alone can have a major impact on autism rates in young ages. In Denmark, for example, in a study published in the Archives of Pediatrics and Adolescent Medicine entitled “Autism Prevalence Trends Over Time in Denmark: Changes in Prevalence and Age at Diagnosis,” a drop in the average age of autism diagnosis from 5.1 to 4.7 was attributable to a 37% autism increase in 3 year olds while the drop in the average age of ASD diagnosis from 5.9 to 5.3 as attributable to a growth of 66% in 3 year olds. Even modest shifts in the average age of diagnosis can have a huge impact on autism in the youngest age groups. So the change in age of diagnosis definitely would have impacted the studied age groups of 3, 4 and some 5 year olds. (19047542[PMID]) See HERE.
However, it should be noted that one of the study’s authors, Poul Thorsen, had a hand in one of the previous studies from Denmark “exempting” thimerosal, and another equally flawed study attempting to do the same with the MMR vaccine. He is currently under criminal investigation, facing possible charges of fraud and forgery.
Erasing the trail on the California autism data
Just as egregious was when the CDDS changed its reporting mechanisms in 2008 in a big way, which would include many more cases, one week before the Schecter and Grether study was published. This meant that the database from there on out would be unusable to track the autism rates to determine if there would be a decline any time soon. This had a profound impact on the monitoring of autism cohort systems in California, ultimately leading up to their closure for autism surveillance, This occurred one week before the publication of this premature and totally biased study looking at the autism rates in the CDDS. Such a sequence of events raises considerable doubt about the integrity of the research.
This was not unlike when the CDC blocked off all access to the Vaccine Safety Datalink Project after December 2000, after which, presumably, the thimerosal-phase out began. A fact worth noting is that these results are also consistent with the words of an anonymous CDC monitor who was quoted in “Evidence of Harm” by David Kirby as saying that the autism rate in the Vaccine Safety Datalink was going down during thimerosal reduction.
Even before this study, however, the California Department of Health has proven it is not credible, especially its immunization branch. The CDC funds it, and when this study in California was being done, Robert Davis was head of the Immunization Safety Office; he also helped Epidemic Intelligence Surveillance officer Thomas Verstraeten eliminate the relative risks with each draft of his study.
Robert Schechter, the lead author, is merely the successor of Loring Dales who did the glaringly flawed study from 2001 that tried to clear the MMR vaccine in a similar fashion. This study was later criticized for not having sufficient power to detect an association if one were to exist, according to a later study in 2002 by Madsen et al. which also attempted to exonerate the MMR, but omitted many children who received the MMR vaccine and developed autism because they were too young to be diagnosed. The 2001 California study also included Natalie Smith, then head of immunization in California, in its list of coauthors, as well as an attendee to the illegal Simpsonwood Meeting in June 2000 where officials discussed bringing down statistical connections between thimerosal and neurodevelopmental disorders while hiding data from the public.
The second author of the California thimerosal study, Judith Grether, prior to joining the California Department of Public Health was an epidemiologist for the March of Dimes, a charity founded on the premise of developing an effective polio vaccine. She coauthored a paper in 2002 with Lisa Croen of the Health Management Organization, Kaiser Permanente, to argue against a real rise in autism. Croen and Grether later retracted their findings after having their errors were pointed out to them by a research team led by Mark Blaxill, along with fellow autism father and professor of neurosurgery Dr. David Baskin of the Baylor College of Medicine and McGill epidemiologist Professor Walter Spitzer.
Ultimately, affiliations and prior discrediting on autism research makes it not surprising that the coauthors, Schechter and Grether, ignored a major artificial bias that would turn a decrease, especially in the youngest cases, post-reduction of thimerosal into an increase, not unlike the Denmark studies, the Swedish data, or Eric Fombonne’s “study.” The public’s knowledge of the thimerosal-autism link has been greatly skewed ever since.
The Media and the CDC’s Disinformation Campaign
Purveyors of spreading this misinformation include Eric Fombonne, who wrote a complementary article to this study entitled “Thimerosal Disappears But Autism Remains.”
Another familiar misinformant is Arthur Allen, author of “Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver,” having written on his blog, "The most convincing evidence comes from California, where the number of 3-to-5 year old children diagnosed with autism has doubled over the last five years, although children now being diagnosed with autism received little or no thimerosal-containing vaccines."
In The Los Angeles Times, Michael Fumento, a freelance writer noted for his strong industry connections, just wrote in a February 5, 2010 piece, “Anti-vaccinationists initially claimed California autism cases dropped. False. The ‘data do not show any recent decrease in autism in California’ despite the discontinuation of thimerosal use, the state's Department of Developmental Services found in 2008.”
Meanwhile, Gardiner Harris writes in The New York Times, “Because of concerns over the preservative, vaccine makers in 2001 largely eliminated thimerosal from routinely administered childhood vaccines.
But this change has had no apparent impact on childhood autism rates.”
USA Today also repeats this inaccuracy, claiming “autism rates continued to rise after thimerosl was removed from virtually all child vaccines in 2001,” even linking to Schechter and Grether’s completely flawed study.
This myth has even trickled down to academia and is currently being taught in universities. According to my own textbook, “Human Genetics” by Ricki Lewis, “Scientific evidence does not support a link to the mercury compound once used in vaccines-autism has increased since that ingredient has been removed.”
Even worse, the California Department of Public Health study is widely cited to claim that thimerosal is safe, and therefore fine to leave at preservative levels in seasonal flu shots routinely recommended for pregnant woman and children, despite the fact that the thimerosal exceeds EPA safety limits.
In fact, last January the CDC launched a press release to encourage pregnant women and children to get the multi-dose H1N1 vaccine that also contains the preservative. The last section is titled, “Research Shows No Link Between Thimerosal and Autism.” The last sentence of this reads, “In fact, sadly, autism rates have actually gone up since thimerosal was taken out of childhood vaccines in 2001, providing further evidence that thimerosal-containing vaccines are not related to autism.”
What is truly sad is that this big hungry lie continues to be repeated in order to justify the population-wide poisoning of countless infants and fetuses.
--
Jake Crosby is a college student at Brandeis University who is double-majoring in History and Health: Science, Society and Social Policy, and a contributing editor to Age of Autism.
By Jake Crosby
Readers of Age of Autism are aware of the term “the big hungry lie” coined by regular contributor J.B. Handley, used to describe the tactics of the CDC and the drug industry’s attempts to disassociate autism from vaccines in any way, shape, or form.
Perhaps the biggest lie of all is the one that has been repeated all too long, that after thimerosal was reduced or eliminated from vaccines, autism rates continued to go up. There have been multiple instances of this claim and each time it has been proven false, right up to the recent lie that after thimerosal was removed from vaccines in 2001, autism rates continue to increase. These two claims, the first that thimerosal was removed from vaccines, and the second that autism rates have not gone down as a result, continue to be used to justify the injection of thimerosal into pregnant women and children with flu shots. The claims have also been used to justify the immunization of children in developing countries with vaccines preserved with thimerosal. Sadly, neither claim is any more truthful than previous equally erroneous claims, the earliest of which originated from Scandinavia, then spread to Canada and most recently came out of California.
Cold-Blooded Lies
The paper by Stehr-Green et al., for example, purported to study autism rates in Sweden after thimerosal removal in 1993, but only hospitalizations in relation to autism were analyzed. Anyone remotely familiar with autism knows that it is not the kind of condition for which one would typically go to a hospital for treatment.
In the same study were also analyses of autism rates in Denmark, which were even more flawed. Many here remember the infamous Danish studies published in 2003, which served as the primary basis for the IOM’s predetermined conclusion in 2004, that autism rates shot up after thimerosal removal in 1992. In reality what happened was the Danish were worried there was a connection between thimerosal and autism, and right after thimerosal was eliminated from all their vaccines, they rapidly changed their registration program to include a lot more children. Such an interpretation of these studies -- designed by the CDC, and conducted by Statens Serum Institut, the largest vaccine-manufacturer in Denmark -- that autism rates skyrocketed after thimerosal removal, can be regarded as little more than propaganda.
When SafeMinds reanalyzed the data of the latest Denmark study, Hviid et al., by applying the same standards of higher case ascertainment to children born before 1992, they found a prevalence of 1 in 500, compared to a prevalence of 1 in 1,500 ten years later, a 66% drop. Unfortunately, this would not be the last time the CDC would design such self-contradicting studies.
In Canada, Eric Fombonne, a psychiatrist with ties to Sanofi-Pasteur, who is not even an epidemiologist, conducted his own combined thimerosal-MMR study on a school district in Montreal, and it was a total failure. His claim that autism rates went up after thimerosal was removed rested entirely on the Kindergarten cohort, for which enrollment was optional, so only about half the kids out of the total enrolled. However, all the children with autism enrolled because the school provides many services to autistic children. In fact, the school district Fombonne studied has an autism center for excellence, and even draws children with autism from other districts. Had enrollment been mandatory, the estimated prevalence would have dropped by one-half, indicating a decrease rather than an increase. According to biochemist Dr. Paul G. King, this is what is called “negative enrollment bias.” Furthermore, there was also thimerosal exposure during the years where exposure was labeled “nil.”
His MMR data were no more reliable. Instead of using local MMR immunization rates to compare to autism rates, he used immunization data from Quebec City, 145 miles away. Even though the Cochrane Collaboration had this to say about his previous MMR study from 2001, "The number and possible impact of biases was so high that interpretation of the results was difficult," and even though the collaboration included a person who also acted as a legal consultant to MMR manufacturers, such discrediting apparently has not stopped Fombonne from doing more completely flawed, post-marketing research.
But back to thimerosal, because just two years ago, Robert Schechter and Judith Grether of the California Department of Public Health accessed the records of the California Database for Evaluation and Research (CDER) of the California Department of Developmental Services in children ages 3-5. The purpose was to see if autism rates had declined after the supposed removal of thimerosal from vaccines. According to Schecter and Grether's analysis, they hadn’t. Using their interpretation, the two researchers determined that thimerosal must not be a primary cause of autism, in a study published in the Archives of General Psychiatry entitled “Continuing Increases in Autism Reported to California’s Developmental Services System: Mercury in Retrograde.” However, their own errors, it now appears, contradicted their conclusions.
3 Year Olds, A Reliable Age For The Final Cohort?
The very last cohort the study looks at are 3 years olds, which already is not a sufficient age group to base any conclusions from, as they would be hopelessly premature. This is especially relevant to point out because Schechter and Grether suggest that the first full thimerosal-free year was 2003, yet this was the final birth year fully studied, and children born during this year would have been diagnosed the earliest for reasons that will be explained later. Moreover, the claim that children received no more exposure to thimerosal after 2002 is not true either. Expiration dates on many of the vaccines that contained thimerosal were well after 2003. Furthermore, unpublished statistics show that there were sharp increases in thimerosal exposure from flu shots given to infants and pregnant women, while other sources of mercury exposure further confound the study’s conclusions.
Even if the premise for this study had been correct, that thimerosal was removed in 2002, it is still inherently flawed by the fact that its conclusions that thimerosal and autism are unrelated are based on one birth year of very young children (three year olds born in 2003), which is only the beginning of when autism cases start getting filed into the DDS CDER archives. Drawing any conclusions from this age group alone would be a false hope.
Perhaps recognizing this problem, the authors then proceed to combine cases designated as three years of age with those ages four and five, but this only adds to the problem, creating a simple ascertainment bias that would make the designated 3 year old age group, by virtue of having less time to enter the system, smaller than the group labeled as four years old, which would in turn be smaller than the age group labeled as 5 years of age. This is especially important because older kids would have been more likely to receive greater quantities of thimerosal than younger kids. Yet they are all combined into one whole age group from which to draw conclusions based on prevalence.
Mercury in Retrograde?
This relates primarily to the less quantifiable problems in relation to autism rates, which were issues with elemental mercury exposure from amalgam fillings, methylmercury exposure from coal-burning facilities, the remaining childhood vaccines preserved with thimerosal that were not taken off the shelves, and for that matter thimerosal exposure from the flu shot while exposure from other vaccines was being reduced.
Complicating this further is the fact that there seems to be no consensus on when the first year routinely recommended vaccines truly contained no thimerosal preservative. Schechter and Grether said the preservative was all gone from vaccines in the middle of 2002, citing the IOM Report. However, all the IOM said was that the ACIP gave an “expressed preference” that all thimerosal be removed by 2002, hardly reflective of actual thimerosal content in vaccines. The FDA said the last lots preserved in thimerosal expired at the beginning of 2003, but the Council of State Governments said it was early 2004, while parents have found vaccines on the shelves of doctor’s offices with expiration dates that surpass all these years. So no one really knows.
On top of all this, the parallel increase in uptake of flu shots, like those during pregnancy, may contribute to earlier onset autism, due to earlier exposure, and therefore contribute to the disorder being diagnosed earlier. Unfortunately, there is no available immunization data for prenatal flu shots.
What is available, however, is the immunization data for the rate of postnatal flu shots among children ages 6-23 months of age, as reflected among clients enrolled in the Northern California Kaiser HMO, which jumped from 5% during the 2001-2002 influenza season, to 45%, in the following season. By winter of 2004-2005, 57% of 6-23 month olds were getting flu shots, practically all of which were preserved with thimerosal. Data for pregnant women are not available, but they were also a target group for flu vaccines in the same period.
Continuing Increases?
That is the final and main problem I found with this paper, which has been used to support the untrue claim that autism rates have continued to go up. First, the claim that prevalence of autism was counted in 3-5 year old children is misleading. Schecter and Grether’s estimates of age rely on subtracting the year of birth of the child from the year the child is currently enrolled as an active client, but that does not mean the child really is that age For example, I was born in 1988, so by Schechter and Grether’s counts I would be 22, but I’m actually 21. So many children are getting counted as older than they really were. Many children labeled as four years old are actually three and many children labeled as five years old are actually four, and roughly half the five year olds are not included but actually classified in with children six or older. Children in the studied age group could be as old as five, but that’s not the same as including the entire five year old age group.
So the Schecter and Grether study only fully accounts for 3 and 4 year olds; the only other study I can recall which looks at children that young is the infamous Verstraeten study. This is key, especially since during the years it looked at the rates after thimerosal "removal" (which is also dubious), the California Department of Developmental Services’ regional centers made changes that may artificially skew autism clients, especially those in the youngest age groups, towards an upward trend.
According to a CDDS report “Controlling Regional Center Costs:”
“Responding to this concern (increasing autism rates), the Legislature enacted a requirement for the Department to develop evaluation and diagnostic procedures for the diagnosis of ASD and to develop a training program for regional center clinical staff in the utilization of the diagnostic procedures. These procedures were published in 2002.”
See HERE.
So, now the youngest possible autism age groups in the CDER archives of the CDDS, 3 and 4 year olds, the only ones Schechter and Grether fully account for, are heavily biased. Not only would developing procedures for diagnosis skew autism figures towards the youngest children, but also since they are done at reporting centers, children may now enter the DDS system as soon as they are diagnosed. This will mean the proportion of younger children to older children with autism will shoot way up, and that is exactly what we see in the Jaunuary 2009 Hertz-Picciotto study published in Epidemiology, where starting in 2002, new cases of autism in the CDDS of children ages 0-4 go up linearly but the rate for children ages 5-9 starts to flatline. It also means that, amidst all this, the increasing proportion of total numbers of new cases, assuming the autism rate were to continue to remain the same, must also balance out with the total number of cases leaving the system as well as the decreasing proportion of older children entering the system. So changes in the youngest clients would still be reflected indirectly in total new autism cases, as they are all part of the same system. As a result, looking solely at autism rates in the youngest children does not give the full picture.
What does, however, are the results obtained by Dr. Mark Geier, a fellow of the American College of Epidemiology, and his son David Geier, when they analyzed both the Vaccine Adverse Event Reporting System of autism-related adverse events and the California Department of Developmental Services data of total new autism cases and found a decrease in both, according to a study entitled “Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines,” published in the Journal of American Physicians and Surgeons.
Not only that, the CDDS graph of autism (page 12) from this study provides further evidence for early diagnosis bias in the Schechter and Grether paper. An increase in the proportion of younger children who enter the system, namely three, four and some five year olds who are the youngest clients enrolled in the CDDS CDER database, while it may positively affect the reporting system overall, would still mean that there would have to be a corresponding decrease of older children with autism being enrolled to the system; that would be offset by an acceleration of younger cases if rates were to remain stagnant, and as a result cause a stagnation in the number of new cases. New autism cases would also have to offset the increasing numbers of older cases reported from previous quarters leaving the system, if they do, then the autism rate has not gone down.
However, this is not the case based on the fact that the increase in prevalence among 3-5 year olds from 1995 to 2007 in Schechter and Grether is a straight line maintained at a constant rate, not an accelerating curve as would be expected with younger children entering the system, likely due to thimerosal removal. Further evidence for this can be seen from Figure 3 of Geier et al., showing the scatter plot of total new autism cases entered to the CDDS, which shows a downwards trend beginning in early 2002.
See HERE.
To be fair, however, the Geiers' study drew some criticism. Critics claimed the decrease was the result of state law that went into effect in mid 2003. However, the change in trend noted by the Geiers began in early 2002.
The role of changing methods in California
Those who use the California DDS data to exonerate thimerosal's role in autism will point to changes in the state law in 2003 that raised demands of those being served by CDDS, saying that clients must show “substantial disability” in three or more areas of life because the state was facing a budget crisis, and that therefore, the California database was if anything, taking fewer cases than it would have.
This, however, is unlikely to have made an impact on cases of full-blown autism admitted to the system, the only autism spectrum disorder for which this new law applied. Rick Rollins, autism parent and cofounder of the UC Davis MIND Institute, says “children with full syndrome autism generally fail in at least 3 and as many as 6 of the areas of 'major life activities' as defined above, therefore one would expect that autism would be the least impacted of all the categories by the new, additional requirements for eligibility.”
Furthermore, if one were to believe these changes have a significant impact on the reporting of full-blown autism at all, one would expect a disproportionately lower growth in full-blown autism as compared with Aspergers and PDD-NOS, since the “substantial disability” criteria only applies to classic autism between the years of 2002 and 2007. However, growth for autism compared with other ASDs for which “substantial disability” criteria does not apply increased at approximately the same rate during this period. (page 27): See HERE.
Then there are the changes that took place in the CDDS in 2002 that culminated in the emergence of early diagnosis and evaluation policies for ASDs that had not previously existed, that would positively skew the numbers of autism spectrum disorders enrolled in the database, especially in the youngest children. This is far more likely to bias the database in a positive direction than requiring extra proof of “substantial disability” in cases with classic autism, which is already a substantial disability.
While I have previously speculated that increased exposure to thimerosal from flu shots plays a role, the results are likely to be primarily due to drastic administrative changes as stated before in reference to the 2007 Report “Controlling Regional Center Costs.” The budget crisis that had been going on during this time period, if anything, caused the Department to divert more funds to early diagnosis and intervention programs for autism, given that autism has increased at a much higher rate than the other disabilities the system keeps track of. This change to the CDDS database came as a result of a state law passed the year before in 2001, the most widely cited year for alleged thimerosal removal.
Even slight fluctuations in the average age of diagnosis alone can have a major impact on autism rates in young ages. In Denmark, for example, in a study published in the Archives of Pediatrics and Adolescent Medicine entitled “Autism Prevalence Trends Over Time in Denmark: Changes in Prevalence and Age at Diagnosis,” a drop in the average age of autism diagnosis from 5.1 to 4.7 was attributable to a 37% autism increase in 3 year olds while the drop in the average age of ASD diagnosis from 5.9 to 5.3 as attributable to a growth of 66% in 3 year olds. Even modest shifts in the average age of diagnosis can have a huge impact on autism in the youngest age groups. So the change in age of diagnosis definitely would have impacted the studied age groups of 3, 4 and some 5 year olds. (19047542[PMID]) See HERE.
However, it should be noted that one of the study’s authors, Poul Thorsen, had a hand in one of the previous studies from Denmark “exempting” thimerosal, and another equally flawed study attempting to do the same with the MMR vaccine. He is currently under criminal investigation, facing possible charges of fraud and forgery.
Erasing the trail on the California autism data
Just as egregious was when the CDDS changed its reporting mechanisms in 2008 in a big way, which would include many more cases, one week before the Schecter and Grether study was published. This meant that the database from there on out would be unusable to track the autism rates to determine if there would be a decline any time soon. This had a profound impact on the monitoring of autism cohort systems in California, ultimately leading up to their closure for autism surveillance, This occurred one week before the publication of this premature and totally biased study looking at the autism rates in the CDDS. Such a sequence of events raises considerable doubt about the integrity of the research.
This was not unlike when the CDC blocked off all access to the Vaccine Safety Datalink Project after December 2000, after which, presumably, the thimerosal-phase out began. A fact worth noting is that these results are also consistent with the words of an anonymous CDC monitor who was quoted in “Evidence of Harm” by David Kirby as saying that the autism rate in the Vaccine Safety Datalink was going down during thimerosal reduction.
Even before this study, however, the California Department of Health has proven it is not credible, especially its immunization branch. The CDC funds it, and when this study in California was being done, Robert Davis was head of the Immunization Safety Office; he also helped Epidemic Intelligence Surveillance officer Thomas Verstraeten eliminate the relative risks with each draft of his study.
Robert Schechter, the lead author, is merely the successor of Loring Dales who did the glaringly flawed study from 2001 that tried to clear the MMR vaccine in a similar fashion. This study was later criticized for not having sufficient power to detect an association if one were to exist, according to a later study in 2002 by Madsen et al. which also attempted to exonerate the MMR, but omitted many children who received the MMR vaccine and developed autism because they were too young to be diagnosed. The 2001 California study also included Natalie Smith, then head of immunization in California, in its list of coauthors, as well as an attendee to the illegal Simpsonwood Meeting in June 2000 where officials discussed bringing down statistical connections between thimerosal and neurodevelopmental disorders while hiding data from the public.
The second author of the California thimerosal study, Judith Grether, prior to joining the California Department of Public Health was an epidemiologist for the March of Dimes, a charity founded on the premise of developing an effective polio vaccine. She coauthored a paper in 2002 with Lisa Croen of the Health Management Organization, Kaiser Permanente, to argue against a real rise in autism. Croen and Grether later retracted their findings after having their errors were pointed out to them by a research team led by Mark Blaxill, along with fellow autism father and professor of neurosurgery Dr. David Baskin of the Baylor College of Medicine and McGill epidemiologist Professor Walter Spitzer.
Ultimately, affiliations and prior discrediting on autism research makes it not surprising that the coauthors, Schechter and Grether, ignored a major artificial bias that would turn a decrease, especially in the youngest cases, post-reduction of thimerosal into an increase, not unlike the Denmark studies, the Swedish data, or Eric Fombonne’s “study.” The public’s knowledge of the thimerosal-autism link has been greatly skewed ever since.
The Media and the CDC’s Disinformation Campaign
Purveyors of spreading this misinformation include Eric Fombonne, who wrote a complementary article to this study entitled “Thimerosal Disappears But Autism Remains.”
Another familiar misinformant is Arthur Allen, author of “Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver,” having written on his blog, "The most convincing evidence comes from California, where the number of 3-to-5 year old children diagnosed with autism has doubled over the last five years, although children now being diagnosed with autism received little or no thimerosal-containing vaccines."
In The Los Angeles Times, Michael Fumento, a freelance writer noted for his strong industry connections, just wrote in a February 5, 2010 piece, “Anti-vaccinationists initially claimed California autism cases dropped. False. The ‘data do not show any recent decrease in autism in California’ despite the discontinuation of thimerosal use, the state's Department of Developmental Services found in 2008.”
Meanwhile, Gardiner Harris writes in The New York Times, “Because of concerns over the preservative, vaccine makers in 2001 largely eliminated thimerosal from routinely administered childhood vaccines.
But this change has had no apparent impact on childhood autism rates.”
USA Today also repeats this inaccuracy, claiming “autism rates continued to rise after thimerosl was removed from virtually all child vaccines in 2001,” even linking to Schechter and Grether’s completely flawed study.
This myth has even trickled down to academia and is currently being taught in universities. According to my own textbook, “Human Genetics” by Ricki Lewis, “Scientific evidence does not support a link to the mercury compound once used in vaccines-autism has increased since that ingredient has been removed.”
Even worse, the California Department of Public Health study is widely cited to claim that thimerosal is safe, and therefore fine to leave at preservative levels in seasonal flu shots routinely recommended for pregnant woman and children, despite the fact that the thimerosal exceeds EPA safety limits.
In fact, last January the CDC launched a press release to encourage pregnant women and children to get the multi-dose H1N1 vaccine that also contains the preservative. The last section is titled, “Research Shows No Link Between Thimerosal and Autism.” The last sentence of this reads, “In fact, sadly, autism rates have actually gone up since thimerosal was taken out of childhood vaccines in 2001, providing further evidence that thimerosal-containing vaccines are not related to autism.”
What is truly sad is that this big hungry lie continues to be repeated in order to justify the population-wide poisoning of countless infants and fetuses.
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Jake Crosby is a college student at Brandeis University who is double-majoring in History and Health: Science, Society and Social Policy, and a contributing editor to Age of Autism.
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