Stem Cells for Autism

Danny is an 8-year old on the very functional part of the autism spectrum. He’s happy, has friends, and is in a mainstream class where his work is on grade level. He’s a success in nearly every important way a parent could want. Still, at his most recent visit, his mom gave me a flyer for a company offering fetal stem-cell transplant as a cure for autism. She asked me to take a look at it (she insisted it was dad’s idea) and let them know what I thought. Having, as I do, such a large number of patients on the autism spectrum has helped me learn a lot about treatments that are available. I hadn’t heard of this one, so I was particularly interested in learning about it.

First, here’s a dependable stock tip. People who really know how to make money in the financial markets never, ever, consider selling or sharing that knowledge. If they knew a sure way of making money through a technical analysis system, computer program, or any other way, why would they have an infomercial?

I took a careful look at the brochure. I looked at the website, looked up the people involved.

Have you heard of stem-cell transplants? Sure you have. I’m no expert in this, but here’s the general idea. A person has a specific disease caused by some cells that aren’t working right. We give them new cells, that have the sense to replace the ones that aren’t working right. In this way, a cure becomes possible. Most cells have a certain function. But stem cells are cells that can take on different functions, depending on what’s needed. It’s a promising idea, but hasn’t really resulting in major cures yet.

So is autism caused by a problem with the way that specific types of cells are working? There’s no evidence for this. No one knows what causes autism. A working treatment for autism would be a shortcut to financial and Nobel prizes.

Have you heard of a cure for autism? No? We all know that autism is a mystery. Among ways to achieve fame and fortune, finding a cure for it isn’t something that would be unnoticed. If you had a for-profit business that had such a cure, would you keep it quiet?

You’d be right again, even if you don’t follow the details of ongoing stem-cell research news, to think that you haven’t heard much about using stem cells for autism. Maybe you’ve heard about researchers trying it with some forms of cancer, and some awful neurological and brain diseases for which there aren’t other good treatments. Though there aren’t other good treatments for autism, nobody knows what causes autism. For this very reason, there’s no reason to think that stem cells will help. I can’t swear that they won’t help, but I also don’t know if seawater will help, or radio waves, or marshmallows.

Oh, did I mention they propose to use stem cells from rabbits? Have you been hearing a lot about transplanting rabbit cells into humans? Me neither.
It might occur to you that this must be an exotic, cutting-edge research facility that is pushing the envelope in xenotransplantation to give hope to the hopeless. Some place like UCSF or Yale. The rabbit cells are ‘manufactured’ in Europe. The transplantation into humans and claim that it will cure autism would result, even there, with lost licenses, criminal charges, and likely jail time. So the company has a courier carry the processed bunny cells to an undisclosed--seriously--site in Asia somewhere. There, an unnamed practitioner of some sort does the actual transplantation. On your child.

I guess by now you must have guessed that this is very expensive, they require payment in cash up front, and that there are no refunds if it doesn’t work. If your previously healthy, though autistic, child gets some sort of side effect, adverse effect or worse from the treatment, there’s nobody to sue, and I couldn’t find an address on the website. The only person you actually meet is the person in Asia. Will they still be there, with that name, when you contact the embassy?

I’m not done. I looked at the brochure I had been given, and read it carefully. There were lots of grammatical errors. This is an ominous sign for me. If I give them the benefit of the doubt, and assume that they just don’t have anyone really fluent in English, that would still make me concerned that if you have a question, if something goes wrong, who in the company can you talk to?

I looked at every page in their website, which was entirely in English, riddled with language errors. There was a photograph of a worker in their manufacturing facility, wearing protective equipment. But no gloves. This tells me that the protective outfit was to protect him or her, not prevent contamination of the product.

Another page in the document bragged about the medical advisors of the company. In most biotech companies, these are very impressive people who have little to do with the company, but lend their names in return for stock or money or both. The company touts their involvement as a way to add scientific credibility to their presentations when trying to raise venture capital. This particular group was different than others I had seen or been involved with. None, zero, were scientists or researchers or physicians in this or related fields. Nobody even claimed that their degree in naturopathic medicine gave them any expertise in stem cells, xenotransplantation, or autism or any of the other diseases their company claimed to treat by this method. One of their board members, with MD and PhD degrees, was quite clear in noting that these degrees were awarded “by thesis.” Think about that. MD degree: pay a fee, write a paper. No anatomy course, no patient contact, no classes of any kind. This is a guy that wants a lot of your money to put rabbit cells inside your child someplace in Asia by somebody you will never see again.

At the center of this company isn’t stem cells, autism, or science. It’s money. So I will finish this post with this note, and I’m embarrassed to mention it. How much do I get paid for spending 5 or 6 hours researching a treatment for your child? I do it because I have to. Would your other practitioner do the same? For the same payment?

This is part of the email I wrote back.

With so many 'alternative' treatments, I usually say that it's OK to try it if it's safe and won't hurt the kid.  With this, I am very scared that a courier delivers some product--who knows what, rabbit cells?  contamination?--to a practitioner in Asia somewhere who somehow gets it into your unconsenting child, and then everybody walks away after they get paid.  You couldn't even sue them if something bad happened, and certainly couldn't get your money back.  What about the child?  How will he feel--assuming that he did OK with the rabbit cells--if he 'fails' this treatment?  Won't he feel like he let you down?  Won't he feel like there's something wrong with him in your eyes?  Will rabbit cells make that better?  So, in this case, I'm going out on a limb.  Please don't do this. 
Wolffe

This is their procedure:

STEM CELL IMPLANTATION PROCEDURE
1) Patients consult with their respective medical doctors.
2) Doctor writes a brief medical summary or fills up the medical standardised questionnaire. Doctors can also make 1 attachment in "pdf" file or "jpeg" file comprising all relevant medical report if they think are of significant importance.
3) Doctor sent email to:- 
4)      ’s professional team analyzes the medical summary and/or medical questionnaire. A prescription of individualised preparation of different type of cells
is made if the patient is found to be an ideal candidate for Fetal Precursor Stem Cell Implantation. Doctor will also be informed of otherwise.
5) Doctor consults with the patient. A decision is made to take or not to take up the fetal stem cell Implantation by patient.  Doctor will then email to                  .com upon conformation of consent.
6) Full Payment made to                         (or Minimum: 50%) at least 17 days before carrying out the procedure on the pre-schedule.
7)  Proprietary Primary Cell Tissue Culture harvesting commence (time frame of 14 to 17 days preparation)
8) European Human Couriers transport down the cells from  Lab/Plant fromVienna airport to different parts of ASIA in special packaging while maintaining the                cells at room temperature
9) Individualised prepared cultured Fetal Precursor Stem Cells should be implanted on patient within 24 hours generally and not exceeding 72 hours from time of completion of culturing in our European Plant
10) Post Fetal Precursor Stem Cell Implantation progress report in 3.5 months to 4 months from Doctor to   coordinating team for evaluations as well as database updating.

This is a list of disease they can cure with this technique:
INDICATIONS FOR STEM CELL THERAPY
Ageing Disease
• Menopause
• Depression
• Impotence and loss of libido
• Memory loss
• Arteriosclerosis
• Impaired liver function
• Osteoarthrosis
• Immune deficiency
Autism
Autoimmune disease
• Scleroderma
• Rheumatoid arthritis
• Dermatomyositis
• Systemic lupus erythematosus
• Polymyositis
• Sjogren syndrome
• Hashimoto’s thyroiditis
• Addison’s disease
• Chronic active hepatitis
• Primary biliary cirrhosis
• Glomerulonephritis
• Good pasture syndrome
• Myasthenia gravis
• Bronchial asthma
• Pemphigus
• Bullous pemphigoid
• Vitiligo
• Atopic dermatitis
• Autoimmune hemolytic anemia
• Autoimmune thrombocytopenic purpura
• Pernicious anemia
• Muscular dystrophy
• Neurofibromatosis
• Tuberous sclerosis
• Cornelia-de-Lange syndrome
• Gaucher disease
• Metachromatic leukodystrophy
• Fabry's disease
• Gangliosidoses
• Refsum disease
• Mitochondrial genetic disease
Genetic and Chromosomal Disorders
• Down Syndrome
• Noonan syndrome
• Turner syndrome
• Wolf syndrome
Hematological Diseases
• Thalassemias
• Sickle cell anemia
• Aplastic anemias
• Hereditary hemolytic anemias
• Thrombocytopenia
• Erythropoiesis disorder
• Primary hemachromatosis
• Werlhof disease
Immune System Disorders
• AIDS
• Chronic fatigue syndrome
• Disorder of non-specific immunity(e.g. defects of natural
killer (N.K) cells)
Kidney Diseases
• Genetic diseases of renal tubules
Cancer Treatment
• Enhanced weakened immune system
Cardiovascular Diseases
• Intractable arrhythmia
• Myocardial infarction
• Congestive heart failure
• Peripheral arterial disease
• Chronic cardiac disorder
• Arteriosclerotic vascular disease
• Migraine
Central Nervous System Diseases
• Neurodegenerative disease
• Parkinson’s disease
• Demyelinisation diseases
• Old/new spinal cord injuries
• Apallic syndrome
• Encephalitis
• Locked-in-syndrome
• Amyotrophic lateral sclerosis
• Friedreich’s ataxia
• Werdnig-Hoffman disease
• Duchenne & Becker muscular dystrophies
• Dementia
Chromosomal Diseases
• Down syndrome
• Noonan syndrome
• Turner syndrome
• Wolf syndrome
Digestive System Diseases
• Atrophic gastritis
• Chronic pancreatitis
• Malabsorption syndrome
• Crohn’s disease
• Ulcerative colitis
• Peptic ulcer
Endocrine Diseases
• Diabetes mellitus
• Vasculopathy
• Adrenocortical hormonal insufficiency
• Premature menopause
• Retarded puberty
• Female infertility
• Imbalance state of autonomous nervous system
• Endometriosis
• Female infertility
• Uterine myomas
• Habitual abortion of adrenal atiology
• Parathyroid insufficiency
• Hypothyroidism
Genetic Diseases
• Wilson's disease
• Nephrotic syndrome
• Glomerular disease
Liver Disease
• Liver cirrhosis
• Chronic hepatitis
• Crigler-Najjar syndrome
• PrimaryBiliary cirrhosis
• Primary Sclerosing Cholangitis
• Hepatorenal syndrome
Locomotor System Disease
• Non-healing fractures
• Osteoarthrosis
• Aseptic necroses
• Chronic osteomyelitis
• Osteogenesis imperfecta
• Achondroplasia
• Marfan syndrome
• Arthrogryposis multiplex
• Chronic osteomyelitis
• Chronic arthritis
• Rheumatoid arthritis
• Osteoporosis
Lung Diseases
• Bronchial asthma
• Pulmonary fibrosis
• Emphysema
Metabolic Diseases
• Atherosclerosis
• Lipoprotein metabolism
• A-β-lipoproteinemia
Neonatal & Perinatal Diseases
• Cerebral palsy
• Inborn errors of metabolism
Skin Diseases
• Psoriasis
• Chronic eczemas
• Deep burns
• Acne vulgaris
• Ulcus cruris
• Various eczemas
• Sarcoid Darier-Roussy
• Hereditary keratosis
• Palmaris et plantaris
• Chronic lichen
• Scleroderma
• Vitiligo
• Frostbite of big toes
• Alopecia areata
Radiation Injuries
e.g Post radiation ulcers

Addendum, April 20, 2010.  Just a few days after posting this, and completely by coincidence (as if 60 Minutes coordinates their schedule with mine), a substantial portion of 60 Minutes was devoted to just such a stem-cell scam.  The one they investigated had recently treated a child for autism.  This is a link to part 1 of the segment.  This is a link to part 2 of the segment.

Problems with Medical Ethics: Holistic Ethics

It’s been established that doctors who own their own x-ray machines do a lot more x-rays on their patients than doctors who don’t own their own machines. Some of this, no doubt, is because it’s so convenient, and the doctor could get results right away. But part of it is also the fact that the doctor will earn money not just from the visit but also from the x-ray. Knowing this, I recently changed dentists.

I had a good dentist. But it really bugged me that every time I was there, he was selling me on…whitening products, tooth grinding products, and x-rays. That was the final straw. He told me that I needed a full set of x-rays every year. I had no dental insurance, and would be paying in cash. I asked if it were really necessary, and he told me it was essential. I asked him if this had ever been studied, and if he could send over to my office any papers about the difference in outcomes between those people who went to the dentist and had x-rays and those who went to the dentist and didn’t have annual x-rays. He said he didn’t have a paper like that. So I got a new dentist, who is very nice. She examined me and told me that a crown was worn on one side. She said, “We should replace that.” It would cost $1200. I chose to wait until something went wrong with it.

Why does the dental profession think it’s OK for every dentist to have their own x-ray machines? Is their conflict-of-interest somehow less powerful than a medical doctor’s? Are dentists immune from the influences of conflict-of-interest?

Every now and then, I am sent a flyer from a company looking to produce for me bottles of vitamins and ‘supplements’ with my name on them. The idea would be that I’d sell the products in my office, telling patients that they need these products, and that the products are not available elsewhere. Obviously, they would be a lot more expensive than similar (maybe identical or superior) products you could get at the supermarket. I would give everyone the same advice: be cautious about the so-called professional—wait, anybody—who says you need to buy something you can only get from them.

Of course this applies to physicians as well. Do you really need that follow up visit if you are fully recovered? Do you really need that follow up x-ray? Do you really need to return for all 16 visits? (I don’t want to seem too cavalier about this. It’s tempting to think we don’t need follow up care when we’re feeling OK. But that’s a serious mistake for many problems, especially the ones we might not feel, like diabetes or high blood pressure. Sometimes, even when the baby looks great, I really need to weigh and examine the baby every day.)

The never-mentioned elephant in the room—one of several—will get me in trouble here. [Maybe by burying it in the middle of this 4th post on ethics will I prevent the storm of backlash I expect.] Alternative Medicine.

I want to keep this to a reasonable length, and not focus on safety or efficacy of alternative treatments. I reserve the right to rant at another time. The topic is ethics.

A PubMed search of ethics has 139,072 references. A search of ethics AND chiropractic has 63. How come when my patients go to the acupuncturist, for example, they are told they need another visit, and another visit and another? How many visits does it take? Has this been studied? How come they are so often sold on various supplements and herbal remedies only available there in the practitioner’s office? Is it ethical to do business that way? Is it ethical to prescribe products which are untested? Do they need to disclose that the products have not been tested? Do they have to disclose that what’s on the label may not include stuff that’s in the product? Do the practitioners need to obtain some sort of informed consent for their procedures or for these untested products? Is it ethical for these other practitioners to raise doubts about the treatment plan I proposed? Is it ethical for me to raise doubts about the alternative treatments and medications my patient is taking? In Squirmy, I think it was the pharmacist at the ‘natural’ pharmacy who advised the parents to put calendula cream on their baby. Exactly which health care provider is ethically restricted in what they can say and which provider isn’t?

In many places, there are laws and liability precedents that restrict what licensed physicians do. But surely the ethics of what is done with patients doesn’t vary with the initials after your name. I don’t think that my patients should get cheated or carelessly harmed by a doctor. Or a chiropractor, ayurvedic practitioner, naturopath or guru with a fleet of Rolls-Royces.

In this series of posts, I complain that there’s too much attention placed on really unusual medical situations and not enough on common situations. But the field has developed a cadre of smart, perceptive thinkers who are very quick to understand some of the problem issues in patient care. It would be great if they looked at patient care from a holistic point of view, not just the patient-physician interface. Real-world medical decisions, faced by patients every day, touch on all aspects of their care. Their personal relationships, their supplemental caregivers, their medications and supplements, financial situation and alternative practitioners all influence the patient’s wellness. It would be great if our field of medical ethics could take its eye away from the telescope and see the whole Milky Way.

There is still an ongoing debate about whether physicians can refuse to provide certain services depending on their own consciences. One side believes that doctors shouldn’t reasonably be forced to give a patient advice they don’t believe in—like using birth control, for example. The other side thinks that the patient won’t know what the doctor believes, and as their medical expert who is supposed to have their best interest at heart, so the doctor should present all available options, including choices they wouldn’t make personally, such as abortion. In 2005, there was an editorial in the New England Journal of Medicine discussing the case of pharmacists who refused to fill prescriptions for pills that could terminate a pregnancy. My letter in response was published, but here’s what I said, and I believe it more today, 4 years later:

To the Editor: It is curious that pharmacists might refuse to fill a prescription. Must all the prescriptions they fill result from morally acceptable diagnoses? The Health Insurance Portability and Accountability Act of 1996 (HIPAA) does not allow breaches in confidentiality about diagnoses and therapies so that strangers can make individual judgments about whether to cooperate in treating a patient. A prescription may be written for a diagnosis of which the pharmacist is unaware (e.g., oral contraceptives to treat ovarian dysfunction). There are many other people involved in every patient's care. What if receptionists refused to make an appointment or refused to give the physician a telephone message because they did not approve of something? The pharmacist might refuse to fill a prescription, the cashier might refuse to sell the prescribed item, or the driver of the distributor's delivery truck might refuse to transport it. Why is the pharmacist's moral judgment dominant? Ethically, there should be open disclosure that some prescribed drugs, products, or services will not be provided. Disclosure is also ethically required for diagnoses, symptoms, or clinical issues about which the pharmacist, health care worker, or others in the chain of health care delivery have such feelings that their cooperation in the care of patients is compromised. Will this trend inevitably lead to a balkanization of medicine, whereby patients will go only to doctors of their own sect, who prescribe only for pharmacists of that sect, and refer only to specialists of that sect? Shouldn't patients be warned?

Wolffe Nadoolman, M.D., M.B.A.