Ummm... Huh?

As I am three years older than him, and have put more hours in as a therapist as he has has a doctor, I plan on submitting my resume for consideration for the number 2 position at the APA on Monday.

Wall Street biotech insider gets No. 2 job at the FDA
By Alicia Mundy
Seattle Times Washington bureau


Only a month ago, Dr. Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors.

Now Gottlieb holds the No. 2 job at the Food and Drug Administration (FDA), the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted.

Wall Street likes the appointment of Gottlieb, 33, who believes in faster drug approval and fewer news-release warnings to the public about potential side effects of drugs.

But some medical experts are shocked by his July 29 appointment, coming at a time when the public is increasingly concerned about the safety of popular medicines. In addition, the federal government has just begun scrutinizing the growing financial ties between Wall Street firms and doctors researching new drugs.

Gottlieb's new job "further impedes the independence of the FDA," said Dr. Jerome Kassirer, former editor of The New England Journal of Medicine. "Gottlieb has an orientation which belies the goal of the FDA."

"I've never heard of anything like this," said Merrill Goozner, a director at the liberal Center for Science in the Public Interest.

"If he's had dealings regarding companies whose products are up for review at the agency, it strikes me as a potential conflict of interest. You want a barrier between the regulated and the regulators. It's fundamental," Goozner said.

Dr. Scott Gottlieb


FDA deputy commissioner for policy

Age: 33

Salary: About $140,000

1994: Bachelor's degree in economics, Wesleyan University

1994-1995: Alex. Brown & Sons, investment bank

1995-1999: Mount Sinai Medical School, New York

1996-2001: Wrote for The Journal of the American Medical Association

1997-2005: Staff writer, British Medical Journal

2000-2002: Author, Gilder Biotech Report

2003-2005: Medical internist, Stamford (Conn.) Hospital

2003: Resident scholar on medical policy, American Enterprise Institute

March 2003-May 2004: Senior adviser, then director of medical-policy development, FDA

June-October 2004: Senior adviser, Centers for Medicare & Medicaid Services

Late 2004-July 2005: Resident scholar on FDA and Medicare policies, American Enterprise Institute

Late 2004-July 2005: Author, Forbes/Gottlieb Medical Technology Report

Late 2004-July 2005: Private consultant/speaker to investment firms and the pharmaceutical industry

Source: AEI and Dr. Scott Gottlieb

A half-dozen current or former officials at the FDA say they do not know of anyone from Wall Street moving directly into such a high-level job at the agency.

Until last month, Gottlieb was editor of a popular biotechnology investor newsletter, Forbes / Gottlieb Medical Technology Investor. Forbes touted Gottlieb's stock-picking success on its Web site in mid-May:

"Special Offer: In the last few months, Dr. Scott Gottlieb recommended two cancer cure stocks to subscribers that have already climbed 38%. Click here for the latest report from Forbes / Gottlieb Medical Technology Investor, 'Three Biotech Stocks To Buy Now.' "

Now, as one of three deputy commissioners, Gottlieb will help oversee such major policies as the FDA's fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry.

Gottlieb said he has cut his ties to Wall Street and discontinued his newsletter. He doesn't see a conflict between that work and his new role as a high-ranking regulator.

"What I learned while working on Wall Street has informed almost everything that I have done since, but especially my work in the government," he responded in an e-mail to questions from The Seattle Times. (The FDA would not allow the Times to interview Gottlieb or provide answers to questions about his background. The FDA has not released his financial-disclosure forms.)

"[It] has helped me appreciate where regulatory policy can be improved upon to help enable medical innovation and to turn scientific breakthroughs into practical medical solutions that can help patients."

Gottlieb was an analyst for a Wall Street investment firm before going to Mt. Sinai School of Medicine in New York. He earned a medical degree in 1999, then did an internal-medicine residency. From 2003 until a few weeks ago, he saw patients during weekend shifts two or three times a month at Stamford Hospital in Stamford, Conn., he said.

Since becoming a physician, he has worn many hats. From 2000 to 2002, Gottlieb wrote the Gilder Biotech Report, an investment newsletter, reporting on potential FDA decisions, drug and biotech developments. He also worked as a staff writer for the British Medical Journal.

In 2003, he was a full-time resident scholar working on FDA policy issues at Washington, D.C.'s most formidable conservative think tank, the American Enterprise Institute (AEI).

Along the way, he became a leading proponent of doctors increasing their income by selling their understanding of drugs and the federal regulatory process to stock analysts and investment firms — "Moving your Career from Main Street to Wall Street," as Gottlieb wrote in an investment column in the American Medical Association newsletter.

He joined the Food and Drug Administration in March 2003 as a senior adviser on policy and soon made an impression. Later that year, the SG Cowen brokerage house sent a report to subscribers, "A Recap of What's Gone Right at the FDA," that praised Gottlieb and other new FDA officials under then-Commissioner Dr. Mark McClellan for working to streamline the drug-approval process.

"Should McClellan's team succeed in getting their strategies adopted into the framework of the approval process, the team's impact on FDA policy could last well beyond the current administration."

Gottlieb moved with McClellan, brother of White House spokesman Scott McClellan, to the federal Centers for Medicare & Medicaid Services in June 2004 and left that October.

He then returned as a full-time scholar at the AEI and started the Forbes / Gottlieb Medical Technology Report.

Gottlieb, a Bush administration appointee making about $140,000, comes to the FDA with an agenda. In addition to advocating faster drug approvals, he has complained the FDA sends out too many "shotgun warnings" on any particular drug's emerging side effects, which he said may cause patients to overreact.

He wants the warnings to be sent to doctors first, and without "overstating a product's risk."

He also has urged that the FDA change longstanding policy and release data on experimental drugs at different stages of the research, from animal tests to final patient studies.

Releasing more data at each stage would help investors put money behind promising drugs and products earlier and would better protect patients in the clinical trials, he has explained.

Three years ago, Gottlieb wrote about an issue that was spotlighted last month in a Seattle Times investigation — the practice of doctors leaking details of ongoing drug research to investment firms, which can then profit from the information by selling or buying stocks.

The Times found 26 cases in which doctors leaked confidential and critical details of their ongoing drug research to Wall Street firms. The report has led to a Securities and Exchange Commission investigation.

"Traders will go to great lengths to get market signals from medical researchers," Gottlieb wrote in Barron's, an investor publication, "and the tight lid the FDA keeps on clinical-trials data has spawned a thriving niche of boutique investment-research firms that link money managers with medical experts capable of giving investors a wink and a nod."

Gottlieb is against such leaks. But he did not call for better enforcement of confidentiality agreements that should preclude such behavior. He instead urged that the FDA open up its drug-approval process to investors and the public.

"Bizarre FDA rules allow companies to hide clinical information practically in perpetuity. Something needs to change," he wrote in the Gilder Biotech newsletter in 2002.

"The FDA could and should release data contained in a company's (FDA) filings at each stage in the process. ... Why shouldn't markets know what bureaucrats and insiders do?"

Kassirer, the former editor of The New England Journal of Medicine, said early release of clinical-trial information "strikes me as potentially good for investors but bad for the validity of clinical research."

"Releasing data early could result in premature and erroneous conclusions about the drug or device being tested, premature ending of clinical trials and even inappropriate enrollment of patients," he said.

The FDA would not comment on Gottlieb's ideas on changing policy to allow for earlier release of clinical trial information, except to note that the articles were written before Gottlieb joined the agency.

He also has consulted for, and written positively about, a major matchmaking firm that links doctors with Wall Street investors, the Gerson Lehrman Group in New York.

He has known founder Mark Gerson for several years, and both are part of the conservative establishment in D.C. With his pro-market views "Scott is popular with some people at the White House," said Robert Goldberg of the Manhattan Institute, a conservative think tank. He is a friend of both men.

Gottlieb highlighted Gerson's firm in investment columns he wrote for the AMA newsletter, and encouraged doctors to join Gerson's network and others. Not only can doctors increase their income, but they can help Wall Street investors decide which new technologies to put their money behind, he wrote.

Gottlieb said by e-mail that he was not paid to recruit physicians for Gerson's group. He added he had recommended a handful of policy-makers to Gerson Lehrman and was paid for probably fewer than eight hours of work.

Gottlieb said he also did a little work for the SG Cowen brokerage house but has not taken part in any conference calls between drug researchers and investors discussing ongoing clinical research.

When the FDA announced Gottlieb's hiring last month, it noted Gottlieb had been a practicing physician, a scholar at AEI and correspondent for the British Medical Journal. The agency did not mention Gottlieb's stints as editor of the two popular biotech investment newsletters or his work with Wall Street firms.

Different Types of IV EDTA Chelation

I didn't even know that IV chelation existed until a few weeks ago, so I have little to offer to the conversation. I will try to post any information I find on it and how it differest from oral chelation. I wanted to post this letter from a doctor who advocates IV EDTA chelation to his colleagues, as it offers some ideas on specifically what may have happened in PA.

Dear Health Care Professionals:

You may soon read and hear the kind of hysteria and negative press that I expected to see, but it will get FAR WORSE before it gets better. As of this moment, I can only assume that there must have been a substantial deviation from the standard procedures that I, and all of you, have established for the safe administration of Calcium EDTA. As incredible as it may seem to those of you belonging to this discussion group, the possibility exists that the child was treated with Disodium EDTA administered by IV Push. I am forced to consider this unfortunate explanation unless there was some major undiagnosed illness in the child that no one suspected, such as a major heart defect or perhaps an aneurism that ruptured at the exact time the patient was receiving the IV Push of Calcium EDTA. However, the autopsy has been completed and the results were inconclusive so that they have ordered additional tests, which may take up to 5 months to complete.

This means that there is no obvious explanation for the death of this child. My fear is that if someone who is not knowledgeable in chelation and has not learned that this is complex chemistry assumes, for example, that all that they have to do to provide magnesium EDTA or Calcium EDTA is just add either magnesium or calcium to a syringe containing Disodium EDTA.

We could have a serious problem because Disodium EDTA has a black box warning about rapid administration to children and simply adding something like Calcium or Magnesium does not fully convert Disodium EDTA to Calcium EDTA. Then there is also a problem with discomfort, if you tried to give yourself an IV push of diluted Disodium EDTA the pain could be extreme so you might wind up increasing the dose of Lidocaine and again we can get into problems with the heart if too much of a "caine" if given intravenously.

So let's look at the big picture, there are NO DEATHS occurring when EDTA, either calcium or Disodium are PROPERLY administered. Now the media will try to make chelation out to be fraudulent and the tests that we do to measure lead etc as being meaningless. Amazingly they will bring out Quack buster Barrett who with a little more effort we may be able to one day put behind bars for his lies and incompetence.

Thus I have to conclude some error in rate of administration, dosage, method of preparation probably occurred; in fact, I now believe this is most likely rather than administering the correct drug, Calcium EDTA, intravenously, which even in children is safe and effective.

Doctors who have been providing this treatment to children can hardly stop talking about the remarkable successes they have been witnessing with children responding far more rapidly than we could ever do with just the oral Calcium EDTA that I have been advocating for so long.

We know that worldwide sales of all forms of EDTA have been steadily increasing and that based on logical calculations it appears that well over 10 million patients have been safely treated with either Calcium or Disodium EDTA over the past 32+ years without a single documented fatality, as long as the established protocols were followed. All the evidence to date that EDTA is perhaps the safest therapy offered in medicine, outside of placebos.

To my knowledge, EDTA has been safely administered for nearly 50 years with the only deaths occurring in the beginning, with terminal cancer patients suffering uncontrolled hypercalcemia where inappropriate doses of Disodium EDTA were administered by rapid infusion to patients with known compromised renal status.

With the extensive proof now existing that everyone today has nearly 1000 times too much lead in their bones and Harvard publishing that this bone lead will compromise vision there can be no argument that we all have some heavy metal toxicity. Then once we conclude that government cannot stop the mercury, cadmium, lead etc from going in the air, and thus into everyone anywhere on earth, then it becomes a matter of personal choice, live with these heavy metals or remove them. Oral chelation is clearly necessary since bone lead will take 10 years to turn over for the average adult, but some of us want results NOW. Nothing is as effective as the 147 fold increase in lead excretion over base line that IV Calcium EDTA, PROPERLY FORMULATED, was documented to induce by Doctors Data with the help of Dr Whitaker's staff.

Thus I must extend my sympathy to the family of the deceased 5-year-old boy from Nigeria whose brave mother came to the Pittsburgh area from the United Kingdom to seek treatment for her autistic child. She was seeing clear improvements in her son. This was the third infusion he had received. He apparently had a cardiac arrest and was unable to be resuscitated immediately following this third infusion of what I fear was not Calcium EDTA, which is the ONLY form of EDTA that I have advocated for the exciting rapid infusion technique.

I hope those who have experience with it in their practice are NOT GOING TO STOP USING it that you have the "rest of the story", as best as we can establish it at this time. Please understand that the involved doctors cannot be expected to admit anything on advice of their attorneys. I have only checked to see if they have ever purchased Calcium EDTA and found the answer was ?no??. leading me to compose this email in an attempt to diminish the harm that the media will do to everyone who otherwise could have been receiving oral and or IV chelation and will now be afraid.

This email may be copied and handed to your patients in an effort to meet the need for a fully informed consent.

Sincerely,
Garry F. Gordon MD, DO, MD(H)

Kirby on Abubakar

Autism and Chelation: Where is the Science?
David Kirby
HuffingtonPost.com

Nearly four years ago, the Institute of Medicine recommended
research into chelation therapy and autism. But that never happened,
and now a little boy in Pennsylvania is dead.

The heartrending tragedy of Abubakar Tariq Nadama, an autistic five-
year-old who died while undergoing chelation this week, is one of
the saddest chapters in the very sad saga of autism in America.

But even as the grieving immigrant mother makes funeral arrangements
for her beloved boy, opponents of the theory that drew the family to
America (the theory that mercury triggers autism, and removing it
through chelation may improve symptoms) are holding his death up as
proof that the idea is bogus. They claim that the use of chelation
to treat autism is foolishly dangerous, and should be shut down at
once.

Some people have come perilously close to exploiting this tragedy to
further their own political or personal agendas. Some blame the
boy's death on his mother, who has been labeled as reckless
and "desperate." Others blame the Pennsylvania doctor -- and any
autism doctor willing to try chelation (the use of certain chemicals
to remove heavy metals from the body) – for the tragedy. Some fault
me, for writing a book that dared to include the topic of chelation
and autism within its pages.

It's time to take a deep breath and look at the facts.

First of all, only an autopsy will reveal the actual cause of death,
and I think it is prudent to wait before jumping to any conclusions
about the general safety of chelation and autism. That said, the boy
did die while undergoing the procedure, and it's possible the
controversial treatment is what killed him.

But here is where things get more complicated. Abubakar was given a
substance known as EDTA, and he was receiving it intravenously. EDTA
is used mostly (and legally, I might add) for the treatment of lead
poisoning. EDTA is not typically used in mercury cases, and it is
not clear why it was used to treat autism here.

In fact, I am unaware of any autistic child who's been chelated with
EDTA, nor am I familiar with any autism cases where IV chelation was
employed. The chelation methods I have written about (I do not, and
cannot recommend treatments, for the record, I only report on them)
were either oral or trans-dermal, and they used substances that are
significantly different than EDTA.

Furthermore, I cannot find any reference in the medical literature
about any patient dying from chelation. (Please post them if you
have them).

Does chelation therapy work? We just don't know. Could it be
dangerous, even deadly, for children with autism? Perhaps, but
there's no hard science available one way or the other. And if
chelation does improve symptoms, what are the best agents, at what
doses and timing, and through which route of administration? No one
can say, of course, because no one has bothered to study these
questions in double-blinded trials.

Which brings us back to the IOM recommendation of 2001. The
committee assigned to look into thimerosal (the mercury containing
vaccine preservative) noted that some autism practitioners
report "clinical improvements following chelation." And though the
committee said that chelation "is not a benign treatment," it
nonetheless recommended "careful, rigorous, and scientific
investigations of chelation when used in children with
neurodevelopmental disorders, especially autism."

That report was issued on October 1, 2001, nearly four years ago.
But few paid attention to the recommendation, and no one did the
hard science on chelation. This left parents and doctors flying half-
blind in pursuit of chelation -- not out of "desperation," but out
of strong evidence their children had suffered from mercury exposure.

Just think, if the government had listened to the very IOM report it
commissioned back in 2001, we might know a lot more about chelation
and autism than we know today. If clinical trials had gotten
underway then, we would know with certainty whether chelation could
heal, or kill.

If hard scientific proof had been uncovered that chelation was 100-
percent worthless in the treatment of autism, no parent or doctor
would still be pursuing the therapy today. If evidence had surfaced
in clinical trials that children could be harmed or even killed by
chelation, no one would be using it today. The doctor in
Pennsylvania would have halted chelation therapy long ago, and this
poor grieving family would never have crossed the ocean from the UK
in pursuit of its false promise.

But what if the opposite were true? What if the "rigorous science"
recommended by the IOM had yielded proof that chelation can indeed
help some kids -- provided that it's done with the safest agents, at
the safest doses, and through the safest routes of administration
(not to mention in combination with other therapies)?

Either way, if America had done its scientific homework, as
recommended by its top science professors, Abubakar might still be
alive today.

If chelation is quackery that kills, let's outlaw it today. But if
it can be done safely, with demonstrated clinical benefit to some
autistic patients at a minimum of risk, then it should be approved
by the FDA for the treatment of autism.

Does chelation in autism kill or cure? Only hard science will answer
that question. What a shame we have wasted four long years not
finding out.

In Defense of My Ire

Yesterday in “A Potential Much Brighter Than Our Fears”, Kathleen Seidel wrote about Leo Kanner, Dan Olmsted and Donald T. She used my mini-rant and subsequent comments about the story as a launching point. She made the case that my rage against Kanner is misplaced. Please allow me a little further defense of my anger and a little of my own perspective on Dan Olmstead’s reporting.

In her piece, Kathleen takes the position that Dan’s reporting and Donald’s brother’s memory may not be an accurate account of what happened to Donald when he was 12. I certainly recognize her the right to go back and question all that has been reported to see where the published story could have changed in the last half century, but for the purposes of this discussion, I am going to go ahead and assume that the story is a basically accurate one until we have any evidence to think otherwise.

Looking around, I seem to be the only one who is so upset with Kanner for not giving Donald’s medical treatment the consideration it deserved in assessing his considerable improvement from his ‘nervous condition’. I think my anger at him for this stems more from a professional place than the place of a parent, although the two together are a potent combination.

As I have mentioned elsewhere, I am a former marriage and family therapist and earned my masters degree at Johns Hopkins. I also worked there as a grad student, doing my practicum in the psychiatry department working in an outpatient program for adolescent substance abusers.

With my professional history, I feel able to put myself in Kanner’s shoes, in a basic way, in that I treated 12 year olds at Hopkins, and I know what a huge responsibility it is. My criticism of him I believe is founded because I know how irresponsible it would have been for me if I had done a history on a patient, and not to included something so vital as a the near death, extensive medical treatment and subsequent vast improvement of two very serious medical conditions, of said patient.

If I took patient histories this seriously as a 27 year old grad student getting her masters, then Leo Kanner, seasoned Medical Doctor and Psychiatrist, sure should have taken it all the more seriously.

If I went to the home of a patient to do follow up after not seeing him for a few years, and noted that he had managed to kick heroin in during a break in drug treatment, after a change in living arrangements and after a three month hospitalization for a life threatening illness, and I only reported the great living arrangement that he was in, I would not be doing my job. It could end up harming the patient, his family and heroin users every where who could be offered a treatment that might have stemmed from what ever medical treatment could have sped his recovery.

Is there a new medical treatment that can help heroin users kick the habit? Who knows? Ginger didn’t write it down, so no one looked into it.

Even if the family had not mentioned the hospitalization or attributed his recovery to it at the time, it would still be my responsibility to get a hold of his medical records even if only to assure continuity of care. This would be so much more true of Dr. Kanner as he defined autism and therefore took responsibility for every aspect of the diagnosis and all of the subjects that he took under his care. Add to the fact that he was a Doctor at Hopkins in the first half of the 20th century, when doctors were considered godlike and few people questioned them, and his breach becomes all the more egregious.

In defense of Kanner, I don’t think that he was a heartless parent-basher and he should not be placed any where near Bettelheim who destroyed so many lives and families. I just don’t think that he was thorough enough at a moment where it really, really counted. He made a freshman mistake that cost many people dearly and left the door open for Bettelheim.

In further defense of Kanner, I have not read his follow up paper that is referred to above, and I am taking the word of Olmsted and others who have written about it. I tried to read it last week but got so emotional about what happened to these children and couldn’t continue. I will reserve the right to amend my judgment of Kanner after I get the guts to read his paper. With learning of the death of Abubakar yesterday, there is not a chance that I will be able to do this for at least a few weeks. I am much too raw to take that on right now. I hope you will excuse my less than thorough research before writing.

Now onto Dan Olmsted’s less than thorough research before writing.

His decision at the beginning of the year to take nothing for granted and start from scratch in his investigation has broken new ground in the understanding of autism. We can certainly discuss his biases and any unintended consequences of his reporting, but I personally don’t hold him to the same level of accountability as I do Kanner. He is a reporter and his job is to tell as much of the story, as objectively as possible. We can certainly discuss how objective he is, but we should keep in mind that in the autism debate, almost no one can claim objectivity. However, even if you question his motives, no one can deny that he is telling as much of the story as he can find. In that respect he is doing his job very well.

The criticism of Olmsted for seeking out Donald’s brother seems to me a theoretical discussion on patient privacy until we know whether or not Donald gave his brother permission to give the interview. It could be that Donald did not want to talk to reporters himself, but that he didn’t mind his brother talking to Olmsted.

In respect to gold, I did not read his discussion of how the gold salts treatment may have impacted his ‘nervous condition’ as a recommendation for parents to run out and try gold on their children, but merely as a discussion of how gold may have made a change in this specific case and what that might tell us about autism and its potential treatments. What I took away was not that gold could mitigate my son’s autistic symptoms, but that Donald’s treatment represents another case that points to the toxicological and autoimmune features of autism.

I don’t see gold as the answer to my son’s autism any more than I see kitchen mold as the answer to his ear infection. But the happy accident of a moldy petri dish in 1928 has lead to hundreds of antibiotics to treat everything from a skinned knee to anthrax. The happy accident of Donald’s recovery might have meant the same for autism, had Kanner written it down.

If it had come to the attention to the medical community that gold salts had improved autism, then it autism may have been recognized as an autoimmune disorder long before the 21st century. It may have also have shed light on how the body’s immune system works and how autoimmune responses are triggered, giving immunologists information that could have moved the entire field forward. It could have led to a better understanding of toxicology and how heavy metals could contribute to neurological disorders, and lead may have been removed from paint decades earlier than it was.

At the very least, we may know what autism, in all its forms, is by now.
If that were the case, it very well may be that there would be no divide between the neurodiversity and biomed communities, as we might know how much of ‘autism’ is a metabolic disorder and how much is just who that person was born to be.

Would any of these things happened? Who knows? Leo didn’t write it down.

Kathleen ends here piece with these two thoughts:

Although Dr. Kanner was not omniscient (what human is?), there is no need to rage at him.

Dr. Kanner is of course subject to human error and should ultimately be forgiven for his mistake. I am working on that, and my anger at him is subsiding. But no matter the emotional reaction of his critics, the fact still stands that he made a costly mistake.

Rather, the story he told of his patient, Donald T, should reassure parents that our autistic children have potential much brighter than our fears.

The title of Kathleen ‘s piece is beautiful.

I love being told that many of the fears I have for my son will likely fall away as he grows and becomes the man that he will be. I am grateful for the much needed reminder. Donald’s story does give me hope, although I want to point out, that it is hope that he will respond as positively to a medical treatment as Donald did.

Ironically, the thing that gives me the most hope is the existence of the Nurodiversity Community who so often strongly oppose parents like me and even, on a few occasions, me specifically. The attacks from this group sting sometimes, but they show me if that if medical treatment is not fruitful for my son, he still may be able to grow up to advocate for himself. It is an odd thing to take such comfort in such criticism, but I will take the comfort from where ever it comes. Thank you.

Boy Dies During Chelation

This sad story came out yesterday.

A few points that were not in the article:

There are several different types of chelation, DMSA, EDTA, DMPS and ALA, and they are administered in several different ways, oral (capsule or powder), transdermal (lotion) and intravenously.

(We have chosen oral DMSA as it is the safest approach with the longest treatment history, and we have given Chandler long breaks in between with mineral supplementation to replace the essential minerals that can be stripped away with the toxic metals.)

Dr. Jacquelyn McCandless reports that the boy had an allergic reaction to EDTA, but I don’t know if she has some inside information, or if this is her professional opinion based on her practice. If that is the case, this may be an isolated incident, but much more information needs to be released before we can draw to many conclusions.

It has been reported that this is the first case of a child dieing during this process, but I am sure that we will have to wait to hear the final word on that as well.

IV EDTA is not a DAN approved method of chelation, nor was Dr. Kerry a DAN doctor. It has been reported by parents who have worked with him that he is considered a good doctor.

IV EDTA is an FDA approved treatment for metal poisoning and has been for decades. It is a more aggressive form of chelation, and apparently is used most often for serious lead poisoning. If this is what Abubakar had, then despite his autism, as long as the treatment was administered properly (I have heard that IV chelation should be done in hospitals), this would seem a case of an unforeseen reaction to an appropriate treatment. The comparison to vaccine injury has been made by parents in the autism community.

Despite all this, Abubakar’s death illustrates the caution that should be used in approaching chelation.

This episode presents so much information for discussion, and will be investigated and analyzed by the medical and autism communities in depth as details on exactly how and why this happened emerge. Other discussions of the incident can be found here.

While we are waiting for that important information, here is something that should be discussed.

I see this as, among other things, a further indictment of the FDA and the CDC. As I mentioned redundantly in my post, File under: Things That Call For A CDC Study, the health authorities have not, and have no plan to, study chelation for autistic children with metal poisoning.

In that post, I originally wrote that DMSA was only available by prescription, but in the last week I found out that it, along with EDTA, are over the counter drugs.

So... FDA… which is it? Is chelation a potentially dangerous procedure that should only be done under a doctor’s care in a hospital setting? Or should we consider it as safe a cold medicine?

Is mercury safe enough to be injected into babies at 100x the EPA limit? Or is it dangerous enough to shut down an entire school and call in a hazmat team to clean up a dime sized spill?

Will you please give us researched, parsimonious information on autism, metal poisoning and their potential treatments?

Will the death of this child spur health authorities to safety and efficacy studies on the effect that different forms of chelation of metal poisoned autistic children? Or will they just react by saying that this treatment should not be done with out even looking into it?

I want to again call on the FDA and the CDC to DO THEIR JOB and give us guidance on how to treat our children.

UPDATE: Abubakar Tariq Nadama's death was a medical accident. The wrong drug was administered (Disodium EDTA rather than Calcium EDTA) and no one caught the error before it was given to Abubakar.

Seeking Stories from Parents

From Bonnie Sayers at Bella Online

A Cup of Comfort seeking submissions from parents of children on the Autism Spectrum

This call for submissions has a deadline of November 15, 2005. A Cup of Comfort seeks honest, original stories from parents and family members of children on the Autism Spectrum. This includes Asperger's Syndrome, Rett's Syndrome, Pervasive Development and Disintegrative Disorder.

They review submissions throughout the timeline. They do list some possible themes of interest, but are not limiting submissions to just these stories - effective treatments; reasons for hope; adult children with autism, breakthroughs; impact
on other family members.

A Cup of Comfort will also consider stories submitted by professionals with intimate knowledge of the child and parents in
question. There will not be an acknowledgement or receipt of your submission due to the number of responses they receive. It is also noted that manuscripts are not returned. Submissions can be mailed, faxed or emailed, which is the preferred mode of submission. There is no cost incurred for submitting your story. You must cut and paste the story into the email, do not send any attachments. The site gives clear instructions on what to include in your submission and what to state in the subject line.

The story must contain between 1,000-2,000 words and be written in the first or third person. " For this inspirational volume, we seek personal anecdotal stories (not prescriptive articles) about the unique aspects of parenting a child with autism and related disorders." The stories need to be uplifting and in English. It is also mentioned on the site that some previously published material is acceptable. You are free to submit more than one story for any publication.

"A Cup of Comfort is a bestselling anthology series featuring compelling true stories about the experiences and relationships that inspire and enrich our lives. These engaging personal essays — written by people from all walks of life — are carefully selected for inclusion in A Cup of Comfort based on originality, creativity, emotional impact, and substance."

If your story is selected as a finalist you will be mailed a publishing agreement. The website - www.cupofcomfort.com will post a list of the contributors for A Cup of Comfort for Parents of Children with Autism on the site and the grand-prize
wining story. This winner also receives $500 on publication and a complimentary copy of the book. All other stories in the book will receive $100.00 each and a copy of the book as well.

I am very excited to learn about this book and plan on submitting a story or two myself. I encourage all parents and especially those with adult children to start composing your true stories sharing the tales of raising your child to help benefit other parents and professionals.

The site also has samples from other A Cup of Comfort books to help get a feel for what stories they accept. Books cost $9.95 at the site and can be ordered over the phone. Learn about previous contributors and visit Amazon.com to read the positive reviews on any number of A Cup of Comfort books.

I am looking forward to this process and hope to hear from other parents in the Forum. Let's brainstorm together and if need be assist others in proofreading submissions.

Good Luck to all who take part in this endeavor and submit their story.

A Cup of Comfort Writer's Guidelines

So skoot on over to Bonnie's place to work on your story.

Gold

The Age of Autism: Gold?
By DAN OLMSTED

Why would treatment with gold help someone with autism?

That is the question raised by The Age of Autism's report last week that the first child ever diagnosed with the disorder appeared to improve significantly after treatment with gold salts.

We've heard from a number of readers -- some with autistic children they're trying to help -- asking the same question.

So far, we've found a couple of possible explanations, both courtesy of those who believe autism is triggered by some sort of toxic exposure in susceptible children. The idea -- dismissed by federal health authorities -- is that the culprit in autism is the mercury preservative that was used in vaccines or, in some cases, the actual vaccines themselves.

That first autism patient, known as "Donald T.," is now 71 and lives in the small Mississippi town he grew up in. Diagnosed with autism at age 5, he had a life-threatening attack of juvenile arthritis at age 12, according to his brother; his temperature spiked uncontrollably, his joints stiffened and were extremely painful. He stopped eating.

"It looks like Don's getting ready to die," his father told a small-town physician after specialists failed to diagnose the ailment or find an effective treatment. That doctor suggested it might be juvenile arthritis, and after treatment with gold salts at a Memphis clinic, Donald's autism as well as his arthritis improved.

Injectable gold salts -- sodium aurothiomalate -- were used to treat arthritis because they have anti-inflammatory properties.

"He had a miraculous response to the medicine," his brother told us at his Mississippi law office. "The pain in his joints went away. When he was finally released, the nervous condition he was formerly afflicted with was gone. The proclivity to excitability and extreme nervousness had all but cleared up." Donald also became "more sociable," he said.

We couldn't find any record of that in subsequent writings about the first patients with autism. Instead, the child psychiatrist who diagnosed those cases attributed Donald's remarkable success in life -- he belonged to a college fraternity, was a bank teller and now, in retirement, travels the world -- to four years he lived with a "wise, intuitive" farm couple.

An alternative explanation -- biomedical rather than behavioral -- involves the body's immune system as a triggering agent of autism:

-- Start with the idea that gold salts reduce the autoimmune response that causes juvenile arthritis. Although the mechanism is unclear, they appear to do so by suppressing a type of immune-signaling cell called cytokines.

-- Brain cells called microglia produce a specific type of cytokine, which can be activated in the presence of mercury or neurotoxic viruses including measles. That type of cytokine has been found on autopsy in the brains of people with autism.

-- The cytokines that are produced chronically in an autoimmune condition may contribute to neurological problems, including oxidative stress, overstimulation of brain cells and abnormal growth signals during development.

So the state of immune activation that is present in juvenile arthritis may contribute in parallel to autistic symptoms. Suppressing the immune activation, as gold salts do with arthritis, may have additional benefits on the autism-symptom side.

We found a version of this idea in a 2002 report by the Meridian Institute, titled "Gold and Its Relationship to Neurological/Glandular Conditions."

The four authors suggest that a useful experiment would be "attending to the side effects of gold medications in cases where there is co-morbidity of rheumatoid arthritis and a neurological, psychiatric, or glandular disorder. For example, one could ask, do patients with epilepsy, depression, or adrenal insufficiency who may be receiving gold for arthritis show any improvement in neurological/glandular symptoms?"

One could just as well ask: How about patients with autism? That experiment may inadvertently have taken place in Mississippi in 1947. Subject: Donald T.

Gold and other elements have been used since antiquity as "nervines" to treat mental conditions. The authors note that lithium is an element that has proven highly effective against bipolar disorder.

"It is clear there is a long tradition of gold as a nervine," they write. "But there were no multi-center clinical trials; that is a modern phenomenon. There were only observations and reports of individual cases."

They quote a 1983 study on animals that showed gold "localizes in nervous system tissue." And they cite a small, preliminary 1996 study that showed after four weeks of colloidal gold treatment, IQ scores increased dramatically in test subjects.

"While a study of this small size is very preliminary, it is encouraging evidence of the potential of gold as a nervine, and as a demonstration of a non-toxic preparation," they wrote.

In the next column, we'll look at how the controversial treatment called chelation might fit with all this.

--

E-mail: dolmsted@upi.com

Terbutaline's Contribution to Autism

Terbutaline is a new piece of the autism puzzle, and I am learning how exactly it fits into the picture in Chandler’s autism. Duke University says that it has a causal link to the disorder, and it does so by making the brain more vulnerable to toxins. In the case of the Duke Study, the toxin that they identified was a pesticide. I don’t know if they looked at increased risk of mercury toxicity, although it seems logical that if the brain has been made vulnerable to one kind of toxin, increased vulnerability to all is possible/probable.

I had not heard about the Hopkins twin study.

If you are a terbutaline mom, you might want to take a listen:

- Terbutaline and autism connection? Listen to Dr. Larry Kaplan on AutismOne Radio, Tuesday, August 23rd at 10:30 am ET. (http://autismone.org/radio/)

- Is there a connection between the pre-term labor drug Terbutaline and autism? To
find out additional information about this controversial issue, listen to AutismOne radio at http://autismone.org/radio/ this Tuesday, August 23rd at 10:30 am Eastern Time. Teri Small interviews Dr. Larry Kaplan to discuss this off-label drug prescribed for pre-term labor. Hear the facts about maternal, fetal, and neonatal side effects, the Johns Hopkins study of fraternal twin pairs, and the Duke University study.

Common Ground

Good words from Wade at Injecting Sense:

As parents, we know that our autistic children are capable of far more emotion than stereotypes portray. I know the gut-wrenching experience of seeing “typical” kids ignore my son, or, worse yet, seeing idiotic adults assume my son is mentally retarded. Members of the neurodiversity community know that same pain, but they seem to feel it is caused as often by the actions or words of anti-thimerosal/biomedical advocates as much as it is by unfeeling members of the general public. It is incumbent on all of us to learn why they feel that way, and perhaps look at ourselves.

Read the whole thing.

The discussion in the comments section IMHO is what the discussion between the neurodiversity community and the biomed community should be like. Hat's off to Wade for creating such a safe place for people who clash to often to be transparent with each other.

More Evidence of Harm

Observations by Lujene Clark of NoMercury and A-CHAMP. Look at these trends:

Notice anything significant? Do we think this is just a coincidence? Or are doctor's able to do a better diagnosis when the children are 7 and 12, but have difficulty diagnosing them at 8, 9, 10, and 11? I wonder if these authors realize they have just added more support to the autism/immunization hypothesis. Do you think that maybe they are beginning to see the result of the recent research done by James, Deth, Hornig and others, and they know the previous position of 'no association is beginning to look problematic? Attached is a recently published study and some Power Point slides to accompany this study produced by Dr. Richard Deth, Northwestern University. This is a very powerful visual aid.


Trends in Diagnosis Rates for Autism and ADHD at Hospital Discharge in the Context of Other Psychiatric Diagnoses
David S. Mandell, Sc.D., William W. Thompson, Ph.D., Eric S. Weintraub, M.P.H., Frank DeStefano, M.D., M.P.H. and Michael B. Blank, Ph.D.
Psychiatr Serv 56:56-62, January 2005
© 2005 American Psychiatric Association

OBJECTIVE: Concerns have been raised over observed increases in the number of children who are given a diagnosis of a neurodevelopmental disorder. The goal of this study was to examine trends by age and calendar year in the diagnosis of two of these disorders, autism and attention-deficit hyperactivity disorder (ADHD), in the context of other psychiatric disorders in a sample of hospitalized children.

METHODS: Data from the Healthcare Cost and Utilization Project (HCUP) were used for descriptive analyses of secular trends of diagnosed psychiatric disorders between 1989 and 2000. Changes over time in rates of diagnosis of autism, ADHD, affective disorders, and substance-related disorders were examined and compared.

RESULTS: Substance-related disorders were the most common mental disorders recorded at hospital discharge and increased by 39 percent between 1989 and 2000. Affective disorder was the next most common diagnosis and increased by 138 percent. Although autism and ADHD were far less common, their diagnosis rates nearly quadrupled over the course of the study. Although rates of diagnosis of affective and substance-related disorders generally increased over the lifespan, diagnosis of autism and ADHD followed a very different pattern, with peaks in rates at ages seven and 12.

CONCLUSIONS: Increases in rates of diagnosis of etiologically unrelated mental disorders suggest that there have been changes in diagnostic practices over time, increases in community prevalence of these disorders, and increased likelihood of hospitalizations for different mental disorders.

A New Database to Track Thimerosal Damage

FOR IMMEDIATE RELEASE—AUGUST 10, 2005
The Alexis Foundation for Angelman and Autism Advancement
Po Box 916263
Longwood, FL 32779
Erica Kosares, Director
407-862-8833
ekosares@alexisfoundation.org

Foundation launches database to link Thimerosal and autism

Orlando, Fla.—In August 2005, the Alexis Foundation launched a national database to research the connection between thimerosal and autism. This nonprofit organization, which was founded by parents with autistic children and related disabilities, is using information in the database to explain why some children received more doses of thimerosal than others.

Thimerosal, which contains 49.6 percent ethylmercury, is believed to be the cause of autism. Ethylmercury is a highly toxic neurotoxin. The symptoms of autism and the symptoms of mercury poisoning are identical.

Prior to 1986, children received a total maximum dose of 100 micrograms of ethylmercury in the first two years of life. By 1991, this dose was up to 246 micrograms of ethylmercury in the first two years of life, an increase of 147 percent. This increase came from the introduction of the Haemophilus Influenza Type B (Hib) and the Hepatitis B (Hep B) vaccines. Both vaccines contain thimerosal.

Despite its known neurotoxicity and its use in children, thimerosal has not been tested for safety. The Mercury-Free Act of 2004 introduced by U.S. Representatives Dave Weldon, MD (R-FL) and Carolyn Maloney (D-NY) would reduce human exposure to mercury through vaccines. It has yet to pass.

The Alexis Foundation is asking for assistance of families living with autism to forward their child’s vaccine information to help research the link between autism and thimerosal. The foundation will use this information to find out if mistakes were made during the manufacturing process and to determine if incorrect amounts of thimerosal were combined in childhood vaccines. This database could also show if thimerosal is currently being used as a preservative in childhood vaccines.

For additional information and to input vaccine information please visit http://www.Alexisfoundation.org/Vaccineinput.html or e-mail admin@alexidsfoundation.org.

Toni's Story

A letter from the mother of an autistic little girl

I have a beautiful 3 year old Daughter.

She had her Hep B at birth. On the day we took her for Her two month shots she had a fever so we put them off. Upon our return to the health dept she was injected 4 times, Two shots in each leg, She reacted almost immediately with a high fever, shakes and listlessness.

When we called the health department and her pediatrician, they told us that she would be fine. We decided that we would never allow them to do another "double" immunization again.

The next round of shots were the "normal" amount, but she again reacted with a fever. We again called the health department and pediatrician and were told to give her Tylenol.

The last set of immunizations we gave her were at 12 months, after the shots she again reacted like she had when she had received the huge dose. She had a 104 temp, screamed through the night and the next two days. We called the pediatrician and scheduled an appointment. She decided that all further immunizations should be delayed until our Daughter was 5 years old, We were relieved.

Two months later at a routine well baby check up our pediatrician warned us that the flu was expected to be deadly that year and that we needed to get our daughter a flu shot. So We did what We thought all "good" parents do, we held down our daughter for that last blow.

Within 48 hours our typically developing daughter who was speaking and engaging and delightful deteriorated in front of our eyes. We knew there was something severely wrong but when we franticly told the pediatricians that she does not talk anymore, she does not hear us anymore, she stares off into nothingness for hours, they said that toddlers typically temporarily give up skills to gain other skills.

We knew this was not what was going on but we took the referral to the audiologist and left.

After a few more frantic trips to this pediatrician along with a normal hearing test, I was told by the pediatrician that she felt that I wanted something to be wrong with my daughter, that immunizations do not cause the symptoms I was stating.

We have since switched pediatricians and have been on a frantic search for help for our daughter. We will be seeing Dr. Demio in Cleveland, Ohio this coming Wednesday and are hoping that chelation may be the key.

I do not know how the vaccine theory will play out, I obviously have reasons to believe that it will in the end be proven to be a huge factor.

I lay awake at night and stare at my daughter sleeping and wonder "where will she be in 20 years" Will she be happy? Will she live independently? and I am angry that we live in America and that she was not protected. If I lived in some third world country maybe (probably not) I could excuse the fact that my country did not have the money to manufacture a vaccine for the greater good without putting a known neurotoxin into it that might affect a portion of the children, but AMERICA?

But where were my daughters rights on the day that she received all of those shots at once?

The nurse acted as though it were routine. They said nothing about mercury.

I always related autism to Rainman. I had a pretty much perfect life, the "American dream" some might say.

Now I have the life of someone who tries to figure out how I can swing the mortgage and groceries as well as mounting medical bills ($80,000) last year alone.

Toni Smith

Experts Suck

I am sorry that I lost my temper on my last post. And I am sorry that I am insulting every expert on everything everywhere in the title of my post here. But I am going to leave it there because that is how I feel right now.

Reading these two columns has just made me sick. I feel like someone punched me in the stomach.

Here is Olmsted's follow up. If you haven't already, read my previous entry first.

The Age of Autism: March of the experts
by Dan Olmsted
Aug 17, 2005, 21:49 GMT

WASHINGTON, DC, United States (UPI) -- The news that the first child diagnosed with autism got better after medical treatment -- while leading experts didn`t make the connection -- suggests how research and reality have been distorted for decades.

As The Age of Autism reported Monday, the child known as Case 1 is alive and doing remarkably well in the same small Mississippi town he grew up in. Although we didn`t talk directly to "Donald T.," his brother told us that he had a "miraculous response" to gold salts treatment at the age of 12.

It cleared up a devastating case of juvenile arthritis and -- astonishingly -- made a marked difference in Donald`s autism, he said.

"When he was finally released, the nervous condition he was formerly afflicted with was gone," his brother said of the two- to three-month gold salts treatment in 1947.

"The proclivity to excitability and extreme nervousness had all but cleared up, and after that he went to school and had one more little flare-up (of arthritis) when in junior college." He also became "more sociable," his brother said, and was invited to join a college fraternity.

That was 58 years ago, yet we`re not aware of any mention in the millions of words written about autism that this very first case may have gotten better following a novel medical treatment.

Instead, today`s mainstream medical experts dismiss the idea of biomedical interventions such as anti-inflammation and detoxification therapies as dangerous hooey perpetrated by quacks and charlatans.

Yet the treatment Donald got was patently biomedical: Medicine prescribed by a doctor to treat a physical illness appears to have had a positive effect on his mental disorder.

The official hostility to such approaches is currently so great that the only research under way on the topic is funded by parents. An official at the National Institutes of Mental Health told The New York Times last month that it "isn`t responsible" to prescribe chelation, which is designed to eliminate heavy metals from children with autism.

Yet dozens of parents -- and, for that matter, dozens of doctors outside the mainstream treatment community -- say the treatments have made huge improvements.

Some of them have banded together at generationrescue.org; they argue that autism is mercury poisoning (primarily from a preservative that was used in vaccines) and that getting the mercury out has cured some children of autism and vastly improved the condition of others.

Other doctors, many of them connected with Defeat Autism Now!, a project of the Autism Research Institute, are using everything from special diets to B vitamins to folinic acid. They cite similar successes, and many parents agree.

These parents and doctors get the modern equivalent of what awaited the parents of early autistic children -- skepticism and scorn.

In the beginning, there was strong suspicion -- in many quarters, certainty -- that bad parenting caused autism. This came in part from the striking fact that so many of the parents of those early cases were successful, affluent, career-oriented professionals. Even more suspiciously, many of the mothers had college degrees and -- alert the mental-health authorities! -- their own careers.

"One other fact stands out prominently," wrote Leo Kanner, the child psychiatrist who first identified autism, beginning with DonaldT., in his landmark 1943 paper on the disorder. "In the whole group, there are very few really warmhearted fathers and mothers. ... The question arises whether or to what extent this fact has contributed to the condition of the children."

While Kanner also noted that the children appeared to have been autistic from birth -- and thus the parents` personalities could not entirely explain their children`s disorder -- it set the stage for a tragic morality play over the next several decades.

The worst was Bruno Bettelheim, who wrote in "The Empty Fortress" in 1967: "I believe the initial cause of withdrawal is rather the child`s correct interpretation of the negative emotions with which the most significant figures in his environment approach him. ... The tragedy of children fated to become autistic is that such a view of the world happens to be correct for their world."

We couldn`t help thinking of all that when Donald`s brother told us Kanner suggested "the best thing that could happen" would be to place Donald with another family -- a childless farm couple. The parents complied, but it was only after the
juvenile-arthritis attack four years later, and the subsequent gold-salts treatment, that Donald dramatically improved.

Yet Kanner attributed the change to "the intuitive wisdom of a tenant farmer couple, who knew how to make him utilize his futile preoccupations for practical purposes and at the same time helped him to maintain contact with his family."

It wasn`t until Bernard Rimland wrote Infantile Autism in 1964 that the idea of the "refrigerator mother" began to change -- slowly.

What makes Donald`s case all the more interesting is that none of the specialists his family took him to -- including the Mayo Clinic -- could identify the cause of his uncontrollable fever and joint pain when he was 12, his brother said. It wasn`t until Donald`s father happened to mention the affliction to a practicing physician in a nearby small town that juvenile arthritis, a rare autoimmune disorder, was identified.

Here is how one of our correspondents summarized this sequence:

1. The world expert (Kanner) was incompetent with respect to medical assessment of illness.

2. He assumed that they needed to get Donald away from his parents. They really did think it was a parental abuse problem back then.

3. Kanner mistakenly attributed Donald`s progress to the "therapist" when it was really the medicine.

4. Recovery is possible with biomedical treatment.

5. Biomedical treatment ideas are not likely to come from the autism experts (Kanner) or the prestigious clinics (Mayo). They come from real medical doctors who know how to recognize real illness and autoimmunity in the kids.

Contrast that analysis with the standard dismissals when parents claim biomedical treatments have helped:

-- They may be indulging in wishful thinking -- wanting their child to improve so badly that they delude themselves;

-- They may have tried another treatment such as behavior therapy that is actually responsible;

-- Their child may not have been very autistic in the first place.

Does anyone think Donald T., the first child diagnosed with autism, was not very autistic in the first place? Surely, Donald`s family was not "imagining" his improvement, since they weren`t even trying to treat his autism.

Of course, that intuitive, wise, childless farm couple may have made all the difference -- that is, if you think autism is caused by unwise, non-intuitive mothers and fathers (bad parents).

We don`t know what to make of Donald`s evident improvement -- and the fact that it has stayed buried for so long even as parents and researchers frantically turn over every stone to uncover treatments for this burgeoning, awful disorder.

We acknowledge we have not met Donald and are unable to vouch for his brother`s account, although we certainly found him credible and convincing.

But it does make us wonder whether much has changed.

These days, parents aren`t condemned for having autistic children -- just for doing something about it without the permission of experts who are certain nothing can be done.

In upcoming columns we`ll look at the implications of Donald`s treatment.

E-mail: dolmsted@upi.com