Rats. Rats. Poison. Autism.

Michael Merzenich is a professor of Otolarygology and Neuroscience at University of California at San Francisco (UCSF). He's a somewhat heroic character in Portia Iversen's book "Strange Son." Ms. Iversen described her contacting him to examine an autistic young man, Tito Mukopadhyay, and how she was so proud to get such a big name scientist interested in autism. Dr. Merzenich is quoted in an article on the CBS website from 2003 about Iversen and Mukopadhyay.

Iversen's book describes research done on Mukopadhyay at the UCSF. It tells how they used some kind of computerized intervention that allowed the young man to hear his own voice in a way that he usually can not. The book describes how it was very upsetting to Mukhopadhyay. When Autism Diva was a research assistant carrying out social psychology research at the University of California at Davis, one of the post-doc investigators described how their Institutional Review Board had told these social-psychology researchers that they were not allowed to impose or inflict "unintended insight" on the research subjects. In other words, the subjects (university students) had the right to have their minds tested in research without going away knowing something about themselves that they did not know before they entered the experiment. But Mukopadhyay was not emotionally prepared ahead of time for what he was subjected to, to put it mildly, (neither was his mother), and he was not debriefed afterwards, from what the book describes. Debriefing is an important part of the ethical treatment of psychology study participants.

Mukhopadhyay later described that he felt badly-used by Iversen and the researchers at UCSF, and further that they had promised him a report of what they found out about him but that he never got a report.

It is also unclear whether or not any Institutional Review Board at UCSF reviewed the research done on Tito. It seems clear that an IRB should have been involved.

Autism Diva was very surprised to discover that Dr. Michael Merzenich has a blog, Autism Diva was even more surprised to read Merzenich defending his friend Portia Iversen and taking exception to Tito Mukopadhyay's detailed and compelling complaints about how he was treated by Iversen as posted by Mukopadhyay on Amazon.com here is a quote from Merzenich's blog:

Reactions to a book about an autistic boy and his mom

...
The second highly caustic review [on Amazon.com] was written by the autistic boy, Tito, who almost single-handedly showed the world that near-genius can lie behind the silence in this class of severely autistic, normally non-expressive individual. In Portia Iversen’s account, to his very great distress, Tito’s autism was necessarily graphically described. From his review of the book at the Amazon website, it is clear – and perhaps understandably so – that he was both deeply offended and deeply distressed by these blunt statements of fact. Tito is absolutely remarkable, but he is also absolutely autistic. I hope that he can come to understand that his own important efforts have contributed to a better life for many thousands of severely impaired ASD kids, and that Portia Iversen and CAN have played an important role in making that a reality.

Autism Diva recommends that no one buy Iversen's really awful book, but there are interesting things in there, so you might want to get it from a library. One gets a clear view of a Hollywood egotista who wants the world to know that she not only has refined taste in home decor, a way with mango-colored prose, and a moneyed husband, but that she also is a major player in autism research (this without a college degree in any area of science.) One gets the feeling that Iversen is a mother who keeps her autistic son at arm's length and who studies him more than mothers him. Shades of refrigerator mothers.

Merzenich seems to be a quart low on empathy. He seems to have a real deficit in perspective taking, a problem with theory of mind.

In a strange twist on this researchers-and-misanthropists-abusing-autistics story ... remember how one of the moms on the EoHarm Yahoo! group got enraged at the idea that someone was showing that PCBs could be cause of autism in rats (taking attention away from mercury), to the point where that mom said "someones 'bout to die"? Well, Dr. Merzenich as well as Dr. Isaac Pessah of UC Davis were involved in that study. It would appear that the mom might have been angry at Merzenich and Pessah among others.:

PCBs cause autism-like condition in newborn rats

The banned chemical scrambles brain development, a UC San Francisco study finds.
By Marla Cone, Times Staff Writer
April 25, 2007

Traces of a chemical banned 30 years ago cause brain abnormalities in newborn lab animals that are similar to defects in children with autism, according to a new study by University of California scientists.

Many scientists say that an array of chemicals in the environment are scrambling brain development and could play a role in children's learning disorders.

The new study adds to the evidence by showing that PCBs, polychlorinated biphenyls, disrupt the auditory cortex, a part of the brain that is impaired in autistic children.

In the research at UC San Francisco, rats exposed to low levels of PCBs in the womb and during nursing had disorganized, malfunctioning auditory centers. The auditory cortex controls the brain's processing of sounds, which is essential for language development.

"This is a red flag," said neuroscientist Michael M. Merzenich of UCSF's W.M. Keck Foundation Center for Integrative Neuroscience, the study's senior author. "The impact of this class of chemicals must be studied in human populations, and fast."

The new research shows brain development is skewed when animals are exposed to amounts of PCBs in the same range as some highly exposed people. It will be published in this week's online Proceedings of the National Academy of Sciences.

...

PCBs were one of the world's most widely used chemicals, their use peaking in the 1970s, mostly as insulating fluids in large electrical equipment.

Although banned in the United States in 1977, they are still among the most pervasive contaminants on the planet, and exposure is difficult to avoid because they have spread globally and built up in food chains.

...

Researchers in the 1990s reported that children in the Great Lakes region exposed to high levels of PCBs during their mothers' pregnancy had impaired cognitive development that led to reduced motor skills and short-term memory.

In the new study, "we linked PCBs to an area of the brain that impacts one aspect of autism, language delays or language loss," said co-author Isaac N. Pessah, an autism researcher at the UC Davis M.I.N.D. Institute and director of the university's Center for Children's Environmental Health and Disease Prevention.

"We don't see any reason why the PCBs in human tissues wouldn't be causing this mis-wiring of the auditory cortex too. Not necessarily in every child. We suggest that because of the mechanism involved, there may be populations of kids with predisposition to sensitivity," he said.

The scientists compared the auditory cortex and nerve signals of unexposed rat pups to pups exposed to one type of PCB during gestation and nursing. One of the most profound disruptions from the PCBs involved abnormalities in signals sent by the brain to inhibit or trigger reactions to sounds. The brain also had diminished capacity to learn and change how it responds to sounds.

Scientists believe that autistic children have such signaling imbalances.

They respond differently to sound and other sensations, and their communication and language skills are impaired.

"The animals could hear, but their brain's representations of what they heard was grossly disturbed," Merzenich said.

Kenet urged human studies to see if babies breast fed by highly exposed mothers experience similar effects, particularly those with a family history of developmental disorders.

They are unsure if damage to the rats occurred prenatally or during nursing. Researchers generally have found that benefits of breastfeeding outweigh risks.

The Centers for Disease Control and Prevention reported in February that one in every 150 8-year-old children in 14 states had autism or related syndromes.

And how fortunate for lovers of psychology, Dr. Merzenich has blogged about this study, too. Dr. M seems to have the same gift for crafting the written word that Portia Iversen has:

Studies from the Center for Disease Control and elsewhere have compellingly documented a rapid increase in the incidence of autism in the United States. WHAT THE HELL IS CAUSING IT? Given the enormous human and societal costs of this malady, few practical scientific questions are more important to we Americans, in our current era.

For some reason Dr. Merzenich didn't get the memo that there hasn't been an autism epidemic, so he keeps going on about how urgent everything is. "Urgent" and "epidemic" are really good words to use when making applications for funding. Implying that one might have the key to ending this "epidemic" is a really good way to open those coffers, which is why so many articles reporting autism research include introductory statements about the horrible and expensive worldwide epidemic of autism. The authors are hoping to get more funding and more funding as they inch ever closer to (steady employment and) discovering that evil cause that has triggered this imaginary "epidemic." Dr. Merzenich probably couldn't use the all-caps sentence, "WHAT THE HELL IS CAUSING IT?" in any of his grant proposals and so maybe he was dying to use it somewhere. Fortunately he has a blog now. If there hasn't been an increase in the real rate of autism cases if the rate of autism in children is the same as always, as it would seem is the case, then we really don't need to go get panicked and chase after chemicals that might cause autism.

What Autism Diva thought about the PCBs as cause of autism idea is that the folks, moms, dads and kids in the Faroe Islands seem to have been getting large doses of PCBs and large doses of mercury in their diet (which includes lots of whale meat) and apparently there has been a study that associated the Faroese diet with some hearing loss in the population, but the rate of autism in the Faroe Islands seems to be the same as elsewhere. If that's true, it would seem that the Pessah and Merzenich (et al) panic over non-coplanar PCBs as a cause or contributor to autism in humans is baseless, though creating such a panic might get them some more funding, and funding is what some scientists are in search of, above all else.




Speaking of rats, and poison. This one next news item is interesting. Autism Diva readers may remember the blog entry about compounding pharmacies "Compounding Problems". Apothecure was mentioned. Apothécure is this big ol' compounding pharmacy in Texas, and it even has a very fancy, sort of animated, discotheque-inspired homepage found at apothecure.com. The following is a quote from a magazine article. Autism Diva quoted it in that compounding pharmacy blog post:

In April 1996, when the FDA received reports of skin infections from a contaminated batch of injectable adrenal cortex extract (ACE), a drug the agency has not approved, it recalled all such products on the market. In addition, the FDA recently investigated the Apothecure pharmacy, which had distributed ACE.

Apothécure does business with Dr. Garry Gordon, and Dr. Gordon said he was the supplier of Dr. Roy Eugene Kerry's disodium-EDTA , and disodium-EDTA is what Dr. Kerry used on Abubakar, which is how Abubakar ended up dead. Showing the connection between Apothécure and Gordon, this is a quote from an Apothecure flier (pdf file):

ApotheCure, in association with the Texas Institute of Functional Medicines, has formulated some of the most innovative and effective Heavy Metal Detoxification products and protocols in today’s market. As members of many alternative medical organizations, ApotheCure has become familiar with the needs of physicians and patients to be aware and educated in this fast-developing practice. ApotheCure is one of the exclusive compounders of Calcium EDTA. Along with Dr. Garry Gordon, ApotheCure helped develop many products and protocols. Our affiliation with the Gordon Research Institute allows us to be your complete Heavy Metal
Detox partner.

So, maybe the toxic medicine that killed Abubakar originally came from some rats in Texas.


And look, more stuff sold by Apothecure. And look, more people dead.

Bad medicine led to deaths
Texas firm that supplied fatal drug to Portland clinic escaped FDA oversight

A toxic drug that was 10 times as potent as labeled, sent to a Portland clinic by a Texas supplier, was responsible for the recent deaths of a Portlander and a Washington state resident, officials said Wednesday.

State officials are investigating whether the drug caused the death of a third person, also a Portlander.

In addition, state and federal public health authorities are looking into whether any improperly mixed drugs still are being prescribed to patients around the country.

The supplier, according to experts, has largely escaped the oversight and inspection afforded typical drug manufacturers.

“We’ve got a shadow drug industry that operates in this country with little or no regulatory oversight that leaves patients potentially at risk of needless harm,” said Larry Sasich, an Erie, Pa., pharmacist who is a consultant for the nonprofit Public Citizen watchdog group.

In addition, the drug that is thought to be responsible for the deaths may have been sold in Oregon illegally.

Last week, the Oregon Poison Center at Oregon Health & Science University sent a warning to the state’s naturopaths about use of the drug colchicine, which was discovered as a possible connection between a death in Portland and another in Yakima, Wash.

Authorities have released few details about the patients who died, but they believed last week that both were under the care of naturopaths and that both had received injections of colchicine as a treatment for back pain. Colchicine is a rarely used medication approved as a treatment for gout that, at the wrong dosage, can be fatal.

Lab tests this week on vials of the colchicine remaining at the Portland clinic that dispensed the drug revealed that the patients died from medication that was incorrectly manufactured, not from errors by prescribing doctors.

Christopher Young, Oregon deputy state medical examiner, said the colchicine administered in the two deaths had a potency of 4 milligrams per milliliter, rather than the 0.5 milligrams per milliliter stated on labels. One injection of the mislabeled colchicine would be potent enough to cause death, according to Young.

Geoffrey Wiss, a Portland emergency room physician, told authorities that either he or a partner at the Center for Integrative Medicine, which employed medical doctors and naturopaths, supplied the colchicine to the three Oregon and Washington patients who died.

The patient whose death still is being investigated died March 30 at Legacy Good Samaritan Hospital and Medical Center, Wiss said.

Wiss and state officials said he voluntarily alerted the state medical examiner that his prescription of colchicine may have contributed to the deaths.

The March 20 death of the Yakima woman and another woman at Providence St. Vincent Medical Center on April 2 have been traced to the same batch of colchicine.

Wiss said in a Wednesday interview with the Portland Tribune that he informed the medical examiner’s office of the third death. Young, of the medical examiner’s office, said an investigation has been launched into that case.

Wiss was a partner in the Center for Integrative Medicine, a clinic on Southwest Macadam Avenue that was operated by physicians and naturopaths. The colchicine involved in all three deaths came from the center, Wiss said. As a result of the deaths, Wiss said, the center has been permanently closed.

‘It’s a negligent batch’

The colchicine the center came from ApothéCure Inc., a Dallas-based compounding pharmacy that distributes its drugs throughout the country. Sasich, a spokesman for the Health Research Group at Public Citizen, said ApothéCure and other large compounding pharmacists represent a public danger because they have escaped oversight from the federal Food and Drug Administration.

“It’s not a bad batch,” Sasich said. “It’s a negligent batch.”

The FDA doesn’t regulate the manufacture and distribution of drugs that come from compounding pharmacies such as ApothéCure. Compounding pharmacies traditionally have been small operations that mix drugs for individualized uses, such as turning tablets or capsules into liquids.

But not all compounding pharmacies are corner drugstore affairs, according to Sasich. ApothéCure, for instance, sells its products throughout the country.

Despite its corporate size, ApothéCure still is considered a formulating pharmacy rather than a manufacturer. But according to Gary Schnabel, executive director of the Oregon Board of Pharmacy, ApothéCure may be operating as a manufacturer.

Label tells the tale

Schnabel said that compounding pharmacies that sell in Oregon, even from out of state, must be licensed with the state board and that ApothéCure is not.

Even more significant, Schnabel said, is how ApothéCure labeled the colchicine it sent to the Center for Integrative Medicine. Medication for a compounding pharmacy should have labels that show it was mixed for an individual, Schnabel said.

“It would be compounded if they sent it for a particular patient,” Schnabel said. “But if it was a package of vials for the doctor to use, that would be manufacturing.”

The medical examiner’s office is holding the unused vials of colchicine from the clinic. Young said the drugs do not meet Schnabel’s description for compounded medicines.

“There’s nothing on the vials to indicate they’re for a specific patient,” Young said. “All that’s on it is the drug, colchicine.”

Wiss, of the Center for Integrative Medicine, said that he was not even aware of the distinction and that his clinic had ordered large batches of the medication from ApothéCure without specific patient prescriptions. The drug, Wiss said, is available from manufacturers, but is much less expensive when ordered from ApothéCure.

Officials from ApothéCure did not return phone calls from the Portland Tribune.

Agencies take a closer look

Pharmacist Sasich said the Oregon and Washington deaths point out the dangers of what he called a largely unregulated manufacturing sector — compounding pharmacies — that has grown into a $200 billion-a-year industry.

A number of public health agencies, including the Centers for Disease Control and Prevention and the FDA, have been informed of the colchicine deaths and are launching their own investigations.

Gay Dodson, executive director of the Texas State Board of Pharmacy, said Wednesday that her office had contacted ApothéCure and suggested the company stop making colchicine. The company, Dodson said, agreed, and the board has begun an investigation.

Dodson said ApothéCure officials indicated that they believed the bad colchicine was limited to the vials sent to the Center for Integrative Medicine. But other colchicine produced by ApothéCure might still be in medical offices around the country, Dodson said.

FDA officials declined to comment on the investigation. The Oregon Pharmacy Board has begun its own investigation, as has the state Department of Human Services.

But Sasich said he holds out little hope that the three area deaths will substantially change the way ApothéCure and other large compounding pharmacies do business. And he said he doubted that the seizure of the Portland clinic’s remaining inventory means there is no more danger from colchicine produced by ApothéCure.

“I don’t have any expectation or hope that the FDA or the Texas Board of Pharmacy will walk in there and either shut them down or figure out what happened,” Sasich said. “If there was an error like this one product that killed two people, what was the rest of the factory like?

“The appropriate thing to do from a public health standpoint would be to close down the factory and do a thorough investigation of what transpired,” Sasich said. “And not risk other patients (from) who knows where from a product that is made by ApothéCure.”

So maybe there really are some big problems with compounding pharmacies. The mercury parents are still in a tizzy over a proposed law that would put more controls on what compounding pharmacies can sell. There sure seems to be a big problem with Apothécure and what they are selling. There also seems to be a big problem with Garry Gordon and his partner Dr. Amy (Yasko). They are apparently fighting in court over who gets what from their very large profits associated with selling brewer's yeast derived "RNA" drops that are supposed to somehow change what a person's RNA is doing inside one's cells. Generation Rescue's JB Handley swears by the stuff. He says it can cure autism, or something like that.

They sell "Longevity Plus" which has "stem cell like properties"!! It's a bizarre claim to say the least. It looks like Dr. Amy and Dr. Garry are selling baseless hope in little bottles for $75 a pop. And it looks like they are raking in millions of dollars and it looks like all this money is causing some strains in their relationship.

Someone interested in quackery sent the publicly available court records to Autism Diva and to others. Here's part of what is recorded. Mr. Slaughter is an "executive vice-president", maybe he's speaking on behalf of Dr. Garry, it's hard to keep track of the players ...

21. By letter dated January 24, 2007, a copy of which is attached hereto as
Exhibit A, Mr. Yasko followed up with Mr. Slaughter and again demanded prompt
payment of past due royalties. Mr. Yasko also demanded that LP RNA resume making its biweekly royalty payments to Nature’s Formula from that point forward.
22. By letter dated January 31, 2007, a copy of which is attached hereto as
Exhibit B, Mr. Slaughter responded to Mr. Yasko. Mr. Slaughter again alleged that LP RNA had “possibly” overpaid royalties to Nature’s Formula, this time alleging that such overpayment amounted to $470,000.00. Mr. Slaughter also repeated that LP RNA was conducting a forensic accounting to establish the exact amount of the alleged overpayment.
23. In response to LP RNA’s allegations, Nature’s Formula denied that it owed
any amount of money to LP RNA.

In the letter dated January 31, 2007 Mr. Slaughter wrote to Mr. Edward Yasko:

Please make no mistake, despite our desire to settle this matter amicably, we are willing to "SCORCH EARTH'" in the collection of sums your company ows and to protect the health of Longevity Plus.

Whoa. People asked why Dr. Amy didn't show up at the recent DAN! conference, maybe she was still busy fighting it out with Dr. Garry over who gets what in profits from the sale of hope in bottles. It's hard to tell from the accounting that's described in the court documents, but it looks like for every $75 bottle of RNA drops they sell they are splitting quite a bit more than half of that pure profit. As one might expect, they are selling a brewers-yeast based liquid, logically it probably doesn't cost that much to make.

It's amazing how people are willing to believe the worst about Big Pharma (which is guilty of some amazing abuses, to be sure) but they are also willing to give un-Big-Pharma a free pass on what they are doing and selling and how much profit they are making.


Autism Diva
amazed