Mar 24, 2013

Stem Cells, Embryonic and Otherwise: The Big Maybe Not


I'm not taking sides. I'm just reporting the facts.

Right about at the midway point 2 years ago, 5 English stroke patients were given, in what has been termed a revolutionary new approach, millions of embryonic stem cells in a clinical trial from a 12-week-old aborted fetus. They injected the stem cells into their brains and waited 18 months, after which the stroke survivors saw some improvement in their mobility and speech. But the researchers, considering the small number of survivors being tested and the lack of a control group for the placebo, expressed some concern that people shouldn't get overly excited about the results.

Dubbed "master cells," the stem cells are regenerative, and that means they have the ability to keep producing--more, and more again.

Michael Hunt, CEO of ReNeuron, the company that supplied the stem cells, said, "The goal is to help patients to live more independently and cut health and social care costs," which makes so much sense to me. (Uh, I think I just chose a side).

On the other side of the fence are the religious crowd who thinks that injecting stem cells from aborted fetuses is just plain wrong. One woman, Philippa Taylor, of the Christian Medical Fellowship, said, "For many, it will be ethically troubling that this treatment involves injecting several million cells from an aborted fetus."

But if the mother decides to abort the fetus, it might as well help a load of somebodies than just wait for trash day to come and haul the fetus away. What are they going to do with the fetus anyway? Use it for compost? (Oh, boy, have I gone too far?)

It is estimated that around 250,000 Britons live with disability caused by a stroke, many of them severe strokes, and finding a treatment that repairs brain damage is life-changing. But the controversy continues: practical vs religious.

So, I wondered, can I achieve the same thing as the five British men? I googled (recently becoming a verb) "stroke stem cell," and variations of that search, and soon I came upon Stem Cell of America (why is stem cell singular?) which purported to have all the answers on stem cell therapy.

The following is an excerpt from their website:

Does the Stem Cell treatment have any age requirements?
No, Stem Cell Of America accepts patients of all ages.

Do you accept patients from outside of the United States?
Yes, we routinely accept patients from Canada, England, Australia and other countries all over the world.

Am I eligible for Stem Cell treatment?
There are many factors in determining whether a patient is a candidate for Fetal Stem Cell treatment. We test for 14 different criteria, including viral, bacterial, and fungal infections, as well as viability. Moreover, we use PCR DNA testing, which is far more sophisticated and expensive than the screening tests routinely used in the United States for other Stem Cell treatments.

Will my body reject the Fetal Stem Cells?
No, Fetal Stem Cells have no antigenicity, which is a cellular “fingerprint” that can cause a dangerous and sometimes lethal rejection by the body. This phenomenon is called graft-versus-host disease. Our Stem Cells are free of this “fingerprint”, there is no threat of rejection and therefore no need for immunosuppressive drugs, which can leave the body vulnerable to serious diseases and infection.

How quickly will I see results after the Stem Cell treatment?
Every person is of course different. Each of our body’s healing mechanisms work at a unique pace as they are influenced by many factors. Commonly, significant positive changes are seen between three to six months post treatment. At times, these changes can occur in as little as weeks or even days after receiving treatment.

How many Stem Cell treatments will I need?
After the first treatment, the Fetal Stem Cells will continue to proliferate and repair. Some patients choose to receive treatment more than one time to expedite the healing process. The decision is yours. If you decide to repeat the treatment, usually a waiting period of 6 months is recommended.

How do the Fetal Stem Cells actually work to bring about healing?
Fetal Stem Cells are the cellular building blocks of the 220 cell types within the body. The Fetal Stem Cells used by Stem Cell Of America remain in an undifferentiated state and therefore are capable of becoming any tissue, organ or cell type within the body.

Fetal Stem Cells also release Cytokines. Cytokines are cell-derived, hormone-like polypeptides that regulate cellular replication, differentiation, and activation. Cytokines can bring normal cells and tissues to a higher level of function, allowing the body’s own healing mechanisms to partner with the transplanted Fetal Stem Cells for repair and new growth.

How many people have been treated with my specific disease or condition?
Stem Cell Of America has treated over two thousand patients with Fetal Stem Cells.

What diseases and conditions is the Stem Cell treatment available for?
A partial list of disease and conditions that Stem Cell of America has successfully treated includes:
    Alzheimer's
    Arthritis
    Autism
    Brain Damage
    Cancer
    Cerebral Palsy
    Chronic Pain
    Cystic Fibrosis
    Diabetes
    Epilepsy
    Fibromyalgia
    Heart Disease
    Liver Disease
    Lung Disease
    Lupus
    Multiple Sclerosis
    Muscular Dystrophy
    Parkinson's
    Seizures
    Spinal Cord Injury
    Stroke
    and others

Stroke! It was on the list. So I called the number listed on the website. An amiable person spoke to me about all the positive things that could come about if I got this stem cell therapy from Stem Cell of America, repeating much of the same wording that was on the website. I was waiting for the ball to drop, and it dropped twice about thirty seconds later, going something like this:

"The cost is $25,000 and the therapy is done in Mexico."

The cost was one thing, but Mexico? Tiajuana, no less, the hotspot for all things bad? But I was getting ahead of myself.

"Let me think about it," I said, and I went directly to my computer to learn more.

 First, I emailed the EuroStemCell organization because that's where the idea originated--in Europe. I received this reply (and the parentheses are my comments):

Dear Joyce,

Thank you for your email to EuroStemCell, I’m sorry to hear of your stroke.

EuroStemCell is not directly involved in research, treatments or clinical trials.  We are an online grouping of people who work in stem cell research (didn't they say they were not involved in research?), and have set up the website to provide more information about stem cell research in Europe.

Have you seen our information on 'What diseases and conditions can be treated with stem cells?' You can read it here: http://www.eurostemcell.org/faq/what-diseases-and-conditions-can-be-treated-stem-cells. (The list was somewhat the same as Stem Cell of America). It gives a good overview of what stem cell treatments are currently proven and available.

Stem cell therapies are generally at an early stage of research and development. More work is needed before safe and effective treatments can be made available for a condition such as stroke. You can read more about current research on this condition here:
·       
Our FAQ information for patients about stem cell research and Stroke: http://www.eurostemcell.org/faq/what-stroke-and-can-stem-cells-help
The Stroke Association provides specialist support and information for patients (including on current stroke research): http://www.stroke.org.uk/

Unfortunately, we are not able to offer advice on specific treatments or clinics.We recommend that if you are concerned about your condition, you discuss this with your doctor (who guesstimates anyway) and perhaps contact the Stroke Association (who guesstimates, too).

I have also attached a patient handbook on stem cell therapies produced by the International Society for Stem Cell Research. It contains information and advice to help you assess the reliability of any treatment offers you may receive. (They were all pricey). More information for patients and other language versions of the handbook are available at http://www.closerlookatstemcells.org.

I am sorry not to be of more immediate help, but I hope this information is of some use. (It wasn't).

Best wishes,
"Mary"


I continued to research and found this article:

LAS VEGAS -- Dr. Ralph Conti and Alfred Sapse were found guilty on all counts in federal court Wednesday of defrauding patients out of more than $1 million in promising bogus experimental stem cell treatments.

They faced charges for an alleged scheme to defraud people with incurable diseases with a so-called miracle stem cell cure that involved injections of placentas.

Sapse, 86, recruited Conti, 51, a pediatrician, for the scheme. The problem entails his adult patients who prosecutors say were given intoxicating promises. The pledges included cures for multiple sclerosis, cerebral palsy and claims the handicapped could walk again. Instead, prosecutors say Conti delivered infected injections and unproven science.

Conti and Sapse were accused of defrauding patients out of upwards of $1 million with a medical practice that injected people with stem cells from placentas. They faced 24 felony charges for the financial part of the fraud.

Prosecutors say the money paid by the incurable patients went to Sapse's personal accounts and to pay for gambling.

He hired Conti to do the injections on adults. Prosecutors say he did no follow-up with patients, tracked no data and flatly told one patient the so-called treatment wouldn't even work. He also allegedly injected cells he knew had been infected.

This whole treatment could have been stopped five years ago. The I-Team found the U.S. Department of Health and Human Services, the Food and Drug Administration and the Nevada Board of Medical Examiners tried to shut Conti down.

Instead, the board only gave him a public reprimand and a $7,000 fine for not responding to questions.

Conti and Sapse were each convicted of conspiracy to commit mail fraud and wire fraud. Conti was convicted of two counts each of mail fraud and wire fraud.

Sapse was convicted of seven counts of mail fraud and 11 counts of wire fraud. They face up to five years in prison on the conspiracy count and up to 20 years on each fraud count. They also face fines up to $250,000 for each count and must forfeit money and property up to $913,748.

Their sentencing is scheduled for Feb. 27.

Las Vegas, NV (KTNV) -- A local pediatrician convicted of fraud has died.

The Clark County Coroner said Dr. Ralph Conti of Henderson passed away Sunday, but the exact cause of his death is under investigation.

Conti was convicted of mail fraud, wire fraud and conspiracy charges connected to a million-dollar stem cell scheme.

He was awaiting sentencing on that conviction.


And more.

The following is a script of "Stem Cell Fraud" which aired on Jan. 8, 2012, and was rebroadcast on Aug. 26, 2012. Scott Pelley is the correspondent.

(CBS News) There's no greater desperation than to be told that you, or your child, has a disease for which there is no hope. Many people with incurable illness look forward to the promise of stem cells. Stem cells have the potential to turn into any kind of cell and, in theory, they could repair damaged cells, though, scientists tell us that we are years away from realizing that dream.

There is no stem cell miracle today, so con men, have moved in to offer the hope that science cannot. Just look online and you will find hundreds of credible looking websites offering stem cell cures in overseas clinics.

Two years ago we began investigating stem cell charlatans. We worked with patients suffering from incurable diseases, and we discovered con men, posing as doctors, conducting dangerous medical experiments.

[Scott Pelley: You know, Mr. Stowe, the trouble is that you're a con man.]

Our report started a federal investigation and since that story, we have been digging into the rapidly growing trade in fake stem cell cures. As we reported last January, we've found something even more alarming: illegal stem cell transplants that are dangerous and delivered to your doorstep. They are scams that often bilk the desperate out of their last dollar of savings and their last ounce of hope.

[Brandon Susser: I know you're tired.]

Adam and Brandon Susser are 11-year-old twins. Adam has cerebral palsy, his brain was damaged by a lack of oxygen before he and his brother were born.

Gary Susser: He's confined to a wheelchair. He needs assistance with all his daily living activities from cleanliness to feeding, to clothing.

Gary and Judy Susser have searched for anything that might improve on the judgment handed down by Adam's doctors.

Gary Susser: The sentence of being a quadriplegic, the sentence of being totally blind, the pronouncement by physicians that we should put him away.

Scott Pelley: Those were the things that his regular doctors were telling you?

Gary Susser: Correct. We were being advised literally, "Put him away. He's gonna destroy your life."

So back in 2003, the Sussers took a chance on the theory of stem cells. Adam was three. They brought him to a doctor in Mexico who injected stem cells with no idea whether they would work.

Judy Susser: We both decided that in the severity of his condition that we'd have to try it.

Apparently, there was no harm and no miracle.

Gary Susser: The progress that he made after that was minimal at best and therefore we didn't see any good coming out of it.

Today, people like the Sussers can find hundreds of sophisticated websites offering stem cell treatments for every hopeless disease.



Gary Susser: I see how people are preyed upon by hucksters and charlatans. And people who have a special child don't need any more expense, don't need any more heartache, and don't need any more false promises. They need the truth and they need hope.

To help us learn the truth about the illicit stem cell industry, the Sussers agreed to work with us in an investigation of one stem cell laboratory. We focused on Stem Tech Labs of Ecuador because it offers cures for cerebral palsy and a long list of 70 incurable diseases. The website claims a "modern day medical miracle" and says "we are FDA registered," apparent approval from the Food and Drug Administration.

The founder and director of Stem Tech Labs is an Alabama doctor named Dan Ecklund. We've been tracking Dr. Ecklund for months.

[Gary Susser: Hello, is Dan Ecklund there please?]

In October, we asked the Sussers to contact Dr. Ecklund. Ecklund sent them a letter which offered the blind and paralyzed Adam the possibility of an improved level of consciousness, improved ability to see, to speak, to stand and walk. What can stem cells really do today? We asked a scientist who's doing some of the world's most advanced studies in stem cells, Dr. Joanne Kurtzberg.

Dr. Joanne Kurtzberg: I believe stem cells have a lot of promise. But we are way at the infancy. Because real stem cells are very difficult to control as therapy. I personally think we're 10 years away from seeing real cell therapies that are working and are safe, but I do believe it will come.

Dr. Kurtzberg is a physician and the chief scientific officer of a stem cell research program at Duke University. She advises the federal government and she's co-director of this multimillion dollar laboratory which works with stem cells harvested from umbilical cord blood. Dr. Kurtzberg told us there's no evidence yet that stem cells can treat cerebral palsy.

Pelley: Some of the diseases that we see stem cell cures offered for on the Internet include multiple sclerosis.

Kurtzberg: There are no stem cell cures yet for multiple sclerosis.

Pelley: Lou Gehrig's disease?

Kurtzberg: I wish there were but there are not.

Pelley: You know, I wonder how often it happens that you have to tell a patient, 'I'm sorry. There's nothing we can do.' And then they come back to you two days later and say, 'Well, I see all these cures on the Internet.'

Kurtzberg: I get many of those calls and emails and, and, see many of those patients. But it's very dishonest to mislead people when there's nothin' you can do.

But there's a lot that can be done for Adam Susser according to Dr. Ecklund who spoke to the Sussers from his lab in Ecuador.

[Gary Susser: Say hello to Dr. Dan, Adam.]


Dr. Ecklund's only examination of Adam came by teleconference. Ecklund didn't know we were watching.

[Judy Susser: Do you think it would help him, you know, make him improve?

Dr. Dan Ecklund: I think it's likely to help him, yes. I would say 75 percent chance that if-- that he would have a noticeable improvement.]

Ecklund proposed four treatments costing a total of $20,000. The Sussers asked Ecklund to treat Adam near their Florida home.

[Ecklund: Again, my concern would be the legalities of it.]
He's right to be concerned. It would be a felony to use stem cells in an unapproved therapy or to sell them for export to the U.S. That's why we were surprised to see this on many websites: a shopping cart. We clicked on Ecklund's Stem Tech Labs cart and - with no medical or scientific credentials - we bought 20 million umbilical cord stem cells for $5,000; shipped to America.

We had the cells sent by the highest medical standard. Duke University suggested we use something called a dry shipper, cooled with liquid nitrogen. We sent the dry shipper to Stem Tech. Stem Tech sent the frozen cells to us, and we forwarded them to Joanne Kurtzberg. A computer chip inside our package, verified the cells were properly frozen all the way.

Dr. Kurtzberg analyzed the cells. For comparison, look under the microscope, healthy umbilical cord stem cells look like this. The cells we got from Stem Tech had disintegrated.

Kurtzberg: So these are the cells you purchased. And they are dying, or dead.

Pelley: We see all of these dead and disintegrating cells, and essentially cellular debris. Are there dangers of injecting that into someone?

Kurtzberg: There are huge dangers if you injected that into someone's blood or spinal fluid because all these little fragments and debris would get trapped somewhere in the blood stream and could cause a stroke, or in the brain could cause an inflammatory reaction.

Pelley: This could actually do harm?

Kurtzberg: Yes. This could do a great deal of harm.

Remember, the Sussers asked Dr. Ecklund to treat Adam in the U.S. and last winter, he got out of a van to meet Gary Susser at a Florida hotel where Ecklund planned to do the transplant.

We dug into Dr. Ecklund's background and we found things he hadn't told the Sussers. This is the document in which the state of Alabama revoked his medical license in 2005. The State Medical Commission said Dr. Ecklund admitted that he:

- Prescribed controlled substances to a patient with whom he was having sex

- Prescribed controlled substances to a patient who he knew was a drug addict

- And had sexual experiences with young female children

We also tracked down his laboratory in Ecuador, not exactly the state of the art facility claimed in his website.

The hotel room Gary Susser and Dan Ecklund headed for was set up with a number of cameras that were tucked out of sight.

Susser excused himself. Ecklund was expecting to meet Judy and Adam, the blind and paralyzed 11-year-old in whom he intended to transplant stem cells, cells from his lab that sold us dangerous biomedical junk. Instead, we came in.

Pelley: Dr. Ecklund, I'm Scott Pelley, with "60 Minutes."

Ecklund: Oh, great.

Pelley: How are you today?

Ecklund: I am--uh- surprised.

Pelley: We've been working with the Sussers on a story, and I want you to know that we're being recorded. And I wanted to ask you about the treatment that you propose for Adam. What would that be?

Ecklund: The treatment that he asked about was for stem cells. Human stem cells.

Pelley: And you think they're applicable for cerebral palsy?

Ecklund: Yes. I have seen them be effective in cases of cerebral palsy.

Peley: How does that work, exactly?

Ecklund: Well, stem cells contain-- excuse me, here. No one knows exactly. Okay? But stem-- stem cells do contain and give off chemicals which cause other cells to repair themselves.

Pelley: In the letter that you sent the Sussers, you described possible effects for Adam. Which could include improved ability to see, improved ability to speak, improved ability to move arms and legs. You believe those things are possible?

Ecklund: I do.

Pelley: What is your training in stem cells?

Ecklund: My training in stem cells was I studied for about six years going over the literature. And then I started producing stem-- stem cells, in my lab.

Pelley: You're self-educated, self-taught?

Ecklund: Uh-huh (affirm).

Pelley: Have you published any research?

Ecklund: No.

Pelley: Frankly, Dr. Ecklund, you have nothing to base your results on. There's no clinical trial, there's no-- there's no blind study. There are no medical papers published.

Ecklund: That doesn't make any difference.

Pelley: You know, you say you-- it doesn't make any difference, that you haven't done these studies. I would imagine--

Ecklund: The studies have been done in other countries.

Pelley: I would imagine it would make a big difference to the Sussers.

Ecklund: The studies have been done in other countries. These are not published in the United States, because they cannot be published in the United States.

Pelley: Where is this seen in the medical literature, anywhere in the world? If you did the things that you describe in this paper, you would win the Nobel Prize.

Ecklund: No, if I did the things that are described in that paper, it would not be published, it would be suppressed. And you wouldn't see-- you wouldn't hear about it.

Ecklund told us breakthroughs with stem cells aren't published in scientific journals because of a conspiracy of drug companies and governments that he had trouble defining. That's when we told him we bought cells from his lab.

Pelley: When your cells are delivered, they're functioning, living stem cells?

Ecklund: Yes.

Pelley: We purchased some stem cells from Stem Tech Labs six months, or so, ago. And had them delivered to Duke University, which did tests on the stem cells. And they determined that the stem cells were dead.

Ecklund: Well, they must not have handled them appropriately, then.

Pelley: You're thinking that you handled them appropriately, but the stem cell laboratories at Duke University did not?

Ecklund: That would be my assumption, yeah.

Kurtzberg: I don't think that there's any chance they were damaged in shipment.

We asked Dr. Kurtzberg to listen to Ecklund's theories.

Ecklund: Yes. I have seen them be effective in cases of cerebral palsy.

Kurtzberg: This is pretty scary actually that he would be saying these things, that he would be leading them on this way because what he's talking about is very dangerous.

Pelley: Is this a con, Dr. Ecklund?

Ecklund: No, it's not a con. I have taken the stem cells myself. Would I take the stem cells if I thought that they were a con? No.

Pelley: Putting them in an 11-year-old boy is entirely a different matter.

Ecklund: That's why I took care to explain the remotest possible difficulties, which have never been reported.

Pelley: Without any medical studies that have been published in major journals, that have suggested that stem cells have any efficacy in cerebral palsy--

Ecklund: You keep going back to this point. That they're not published in major eth-- in major medical journals. I'm telling you--

Pelley: It is the standard of the world. I do keep going to that point.

Ecklund: I'm telling you that they are not going to be published in this country. Because when someone does try to do it, then they have "60 Minutes" come and visit them. And I think that's enough for me, thank you.

We don't know where Dan Ecklund went, but we do know the whereabouts of the two con men,  who were the subjects of our first stem cell story two years ago.

In that investigation, we worked with patients, Steven Watters and Michael Martin, who suffered with ALS, also known as Lou Gehrig's disease. They were promised miracles from Frank Morales and Lawrence Stowe who offered a $125,000 stem cell therapy.

[Steve Watters: Will it keep me out of a wheelchair?

Lawrence Stowe: Oh, yeah, absolutely.]

Our story launched a federal investigation. And last January, Morales and Stowe were indicted. The indictment alleges they made $1.5 million with stem cell fraud. If convicted, they could face 20 years in prison.

The patients who helped us, Steven Watters and Michael Martin, lost their lives to ALS last year.

Anthony Atala, M.D., director of the Wake Forest Institute of Regenerative Medicine and editor of Stem Cells Translational Medicine, commented on the situation. "As with any treatment," he said, "it is imperative for patients to seek medical advice only from licensed physicians at reputable medical centers. Patients need to be aware of the safety and efficacy of any treatment offered."

"This is even more important when dealing with newer treatments, such as any type of stem cell therapy."

Jan Nolta, PhD, is editor of SCTM's sister journal, STEM CELLS. She also directs the University of California Davis's Stem Cell Program. She noted, "Without regulations and reputable centers, desperate patients could be infused with a simple saline solution or worse: infected, dead, or dangerously mismatched cells that could cause terrible infusion reactions and later side effects. The public is cautioned to seek more information on these centers and their associated clinicians than that which appears on their websites."

"The leaders of reputable clinics and hospital centers should have trials ongoing that have received FDA clearance, as can be found at the clincialtrials.gov website," she added. "There should also be a history of scientific and medical publications from the associated scientists and physicians related to the proposed therapy in scholarly journals such as STEM CELLS and others."

I was starting to think that this was a bad idea. I researched more, and I came upon this article:

Scottdale, AR--Stem Cells Fraud Scheme in U.S. Leads to Arrests

Four people were recently indicted on federal charges in the United States for selling unapproved stem cell treatments and other biological products to seriously ill patients. The patients were falsely told that the treatments were approved by the U.S. Food and Drug Administration, according to the indictment.

Francisco Morales, Larry Stowe, Jesus Alberto Ramon and Dr. Vincent Dammai are charged with collecting in excess of $1.5 million from people suffering from Lou Gehrig's disease, Parkinson's, muscular dystrophy and cancer over a period from 2007 to 2010. Ramon, a licensed midwife and owner of the Maternity Care Clinic in Del Rio, Mexico, allegedly sold the umbilical cords of women giving birth at his clinic to Global Laboratories LLC, in Scottsdale, Ariz., which forwarded them to Dammai, an assistant professor at the University of South Carolina's medical school. Dammai harvested the stem cells for Global using university facilities. He did this without FDA or university knowledge or approval, the indictment says.

It then alleges that Morales falsely represented to the public that he was a physician licensed to practice medicine in the United States and provided medical advice to individuals regarding the benefits of stem cell treatments. Morales also falsely represented that he operated a medical clinic in Brownsville, Texas, according to the indictment, to convince the public that he specialized in using stem cells to treat incurable diseases. He would then take patients across the border into Mexico to perform the stem cell procedures, the indictment says.

Stowe allegedly ran the companies that marketed and sold the stem cells and other biological products.

The four are facing 39 counts including conspiracy, mail fraud and illegally manufacturing, distributing and selling stem cells and related procedures. Dammai, who has worked at the University of South Carolina since 2001, has been placed on administrative leave pending resolution of the matter.


And more.

Los Angeles--Six residents of Los Angeles, California, are suing South Korean company RNL Bio and associates in a Californian court for alleged fraud. They claim the company convinced them to travel to clinics in South Korea, China or Mexico to donate fat tissue and have stem cells from it re-administered to cure diseases and even reverse ageing.

Stem cells hold great medical promise, but only one treatment is licensed in the US and that is for a rare blood disorder. Others are experimental and offering them commercially is in a legal grey area, subject to investigation, and possible shut-down, by US regulatory authorities. Some companies avoid this risk by touting stem-cell "cures" performed outside the US. RNL Bio calls its fat-tissue stem cells "safe technologies" for treating various disorders.

There have been protests against these treatments for years, but this is the first civil lawsuit for damages, says Paul Knoepfler of the University of California at Davis. It "serves notice to the purveyors of unproven stem-cell treatments" that they may face litigation if they market in the US, says Bernard Siegel of the Genetics Policy Institute, a stem-cell watchdog in Palm Beach, Florida.


And this:

San Diego--Cow stem cell fraudsters sent to jail for almost killing human patients: some patients still support them

Two women in San Diego County are heading to jail after being convicted and sentenced for fraud related to stem cell treatments.The women injected concoctions of bovine stem cells from Germany and DMSO into patients. You can read the details of the original arrest here on the FBI website. Kathleen Ann HelmsAccording to a Modesto Bee article, Kathleen Ann Helms (aka Catherine Bright-Helms) pictured at right (photo from News10.com) of Encinitas, CA will spend 18 months in jail and have 18 months of supervised release.
The article says:

City News Service says a judge told 57-year-old Kathleen Ann Helms that she endangered people’s lives and nearly killed two.

Helms pretended to be a doctor and treated patients as such. Helms’ nurse, Jacqueline Smith, who pleaded guilty to practicing medicine without a license, will spend a year in jail.

Remarkably, despite the fraud and dangers treatments, some patients still support Helms.

A News10.com piece says:

“There are as many of us who really believe she saved us and sent us on the right path to being able to someday get rid of this bad disease,” said Fallbrook resident Franzie Epperson. “I’m just very supportive of her. We feel like she saved our lives.”

I find it astounding how some patients will support fraudulent stem cell practitioners who break the law and take large sums of money from them. I just don’t get it.

The News10 piece goes on to report:

Helms was charged in connection with the treatment of four patients along with a fifth uncharged victim.

According to an affidavit filed in the case, Helms diagnosed a patient with the inflammatory illness after looking at a sample of blood under a microscope, then prescribed a treatment plan that included shots of bovine stem cells from Germany.

Helms directed the patient to go to a Tijuana hospital to have a peripherally inserted central line put into one of her arms so Helms could give treatments intravenously. The patient agreed to pay $300 for the insertion of the line and $30,000 for the treatment Helms recommended, according to the affidavit.

Another patient was misdiagnosed by Helms as having Lyme Disease when he really had prostate cancer, illustrating just reckless and dangers this situation was.

The criminal case began after patients complained to the California State Medical Board.


OK. Enough already. I had a bad taste in my mouth, metaphorically speaking.

And I'll present one more thing about stem cells, but it's not about humans. Rats injected with stem cells 30 minutes after a stroke had almost normal brain function restored within 2 weeks. The research team from Bolivia said the method has potential in human trials, but not yet. The team from La Paz University Hospital "extracted stem cells from fat and bone marrow, then injected them into the blood vessels of rats shortly after they had suffered an artificially-induced stroke."

Translated, that means stem cell therapies for humans are a long way off. It also means, I was born too soon.

Mar 5, 2013

Nothing Says It Like the Norovirus, aka I Hurt So Much, I Wanna Die

In 1968, in the tiny town of Norwalk, Ohio, 85 times smaller than Philadelphia, midway between Cleveland and Toledo, acute gastroenteritis victimized the Bronson Elementary School, so much so that the gastroenteritis closed the school for awhile, and the virus became known as the "Norwalk agent." The people of Norwalk, Ohio,  unfortunately, were dubbed as the folks where that virus originated, and the name was shortened to norovirus.

The virus must have been around for a long time, but now it is identified from stool samples to make it officially that virus. Since 1968, the norovirus has run rampant on the close quarters of cruise ships, sending hordes of people, at times, to their respective toilets to vomit, along with bouts of diarrhea and stomach pains, the ships sometimes returning to port earlier than expected. In fact, noroviruses are the number one cause of diarrhea in adults. Also on the list, nursing homes and schools breed the norovirus as well.

The norovirus is what causes gastroenteritis, or swelling of the gastrointestinal tract. I've become a quasi-expert by now. I never even heard of the norovirus until my doctor said the symptoms point to my having it.

Needless to say, and forgive me for getting a might graphic, the norovirus is messy and painful, and that's why I didn't write for almost eight weeks. The virus left me lethargic, weak, and powerless. The virus also gave me chills, low-grade fever, and muscle aches, all of which, being in a state of denial, I said would disappear tomorrow. And when tomorrow came, there was a whole new set of tomorrows.

Let me start at the beginning. My friend was going to Philadelphia close to eight weeks ago and wouldn't be home for dinner, so I ordered a pizza from the local joint I used so many times before. It was delivered to my house--hot, crispy, and taste-worthy. I ordered a medium pizza cut into six slices, three for today, three for tomorrow. After I ate the three slices, I developed heartburn. I never get heartburn. People sometimes get heartburn from peppers (which I had on my pizza), but to repeat, I never get heartburn.

So I did it again, just like I did with my insane headache just hours before my stroke--I didn't listen to my body, not taking the hints my body was giving me. Not that there was anything to do with my hemorrhagic stroke, but a little heads up would have been nice. The same with my heartburn which went from bad to worse in a matter of minutes. I couldn't do anything about the virus either, but a warning would have been nice, too.

I waited four weeks, until on a Saturday, the pain got so bad, I couldn't stand it any longer. I called up to my friend on the second floor and said, "I have to go to the hospital. The pain just reached that point." Of course, having heard me complaining incessantly for four weeks, he didn't question me.

It was a cold, blustery day as I navigated the ramp to the Emergency Room while he parked the car. I could barely wait for relief. I ambled in to the ER. Then my friend soon joined me, and I was taken back to a room. After drinking the contrast solution that would enhance my CT-scan, I threw up three times. The nurse said there was enough contrast solution left inside me. Then I took an X-ray and I drank some barium to enhance the picture. I felt awful, and I was too powerless to protest.

After the tests, the doctor admitted me because he didn't know what was wrong with me. The norovirus never came up in conversation. But why not? He had to know what a norovirus was, didn't he? Or maybe he cut that class in medical school.

Anyway, I was in the hospital for a week, crying often from the pain in my gut. The rest of the time, I was zoned out on Dilaudid, a pain killer. I was released from the hospital with a low-grade fever and no clear diagnosis. Five days later, the pain was starting to subside and I wasn't taking pain meds anymore, but I developed a rash that was itching so bad, at times, I thought it was the end of me. (Viruses can produce a rash anytime, I learned later from the primary doctor).  

So how did I get it? The norovisus is part of  group of viruses that inflames the intestines and is the leading cause of gastroenteritis in the United States. It is often thought that contaminated food is the culprit, but not always so. 

Norovirus is often called, colloquially, the stomach flu, but it isn't the influenza virus. It usually comes about if you touch contaminated surfaces or if you eat (which I didn't) undercooked or raw seafood like clams and oysters. It is highly contagious, and sharing utensils or shaking someone's hand, if you are infected, spreads the virus. Despite a stool sample which confirms that you have the norovirus, most people are diagnosed purely on their symptoms.

Diarrhea and vomiting heads you down the dehydration path, causing bigger problems than the virus. I was dehydrated at one point along the way, but I was aware of it and so knew the steps to correct it, which are drink, drink, drink water and juices, even if you don't feel like it. Alcohol and caffeinated beverages can dehydrate you further. Dizziness when standing, a decrease in urination, and dry mouth all can point to symptoms of dehydration. Severe dehydration like I had is also treated with intravenous (IV) fluids which were given to me in the hospital.

Like other viruses, noroviruses don't respond to antibiotics, which are designed to kill bacteria, not viral infections. So there's nothing to do but wait, until it all goes away. It's the eighth week now.


To ward off the norovirus, some of the things you can do are:
--Disinfect surfaces with a mixture of detergent and chlorine bleach after someone is sick.
--Wash your hands with soap and warm water for at least 15 seconds.
--Cook all shellfish thoroughly before eating them.

I still have the rash, though it is fading, albeit slowly. The most important thing is, I'm back, happily writing this post. (*itch, itch*) And what about the stroke that was so horrible? I'm glad to report that the stroke is currently on the back burner.

Jan 9, 2013

Mitt Romney, A Stroke Patient, and Facebook, aka The Good, The Bad, and The Ugly (Not Necessarily in That Order)

"What's this mean?" I asked my friend. "I don't get it." It was a cartoon.

First frame: One dog asks another dog, "Do you think Romney will win the election?"
Second frame: "Nah," the second dog says.
Third frame: "Why not?" asks the first dog.
Fourth frame: "Where have you been!?! He hates dogs! That's why!"

As the story goes, in 1983, Seamus, the Romneys' family dog, was transported on the roof of the family's car, windguard and all, to vacation in Ontario, a 12-hour trip from Massachusetts. The Governor and his wife were interviewed about that experience by Chris Wallace, Diane Sawyer, and so many others in the months before the election.

The Romneys said the story was overblown, emphasizing the trip on the roof was just as if Seamus were riding a motorcycle or on the flatbed of a truck. In August 2012, three months before the election, Devo, a band, released a single called "Don't Roof Rack Me, Bro (Seamus Unleashed)," to keep the high-profile story in the news.

And all the while, through the still-talked-about, 30-year-old Romney incident and updates on issues like KONY 2012, YOLO, Pinterest, Whitney Houston, and more, I missed it, because for close to a year, I was writing my book, "The Tales of a Stroke Patient," intently pouring over the laptop like the book was a mission to end all missions. After the book was published on September 26, 2012, I tried to find readers to buy my book. I don't know yet how many books were sold. A handful? Just shy of the Best Sellers List? Really, I have no clue, but most likely somewhere in between handful and humungous.

Writing a book and typing with one hand is no small feat, but concentrating on my disability, how it took me twice as long to type, feeling sorry for myself, crying in my soup, had to stop, and it did. Originally, the book started out as a blog to give stroke patients fond, but more not-so-fond, memories of their respective stays in rehabilitation hospitals and nursing homes all across the globe. Around the 10th post, I decided to turn the blog into a book.

The world seems small now, with people writing to me for copies from all corners of the globe--literally, except Antarctica. But I can't blame those Antarcticans. Maybe when global warning hikes the temperature a little bit higher, the Antarcticans will come, when their fog-filled, collective breath isn't hampering them from writing me an email.

I wrote to publishing houses for about six months, telling them why a biography about strokes was so important. I told them, coming right out of the World Health Organization's literature, "15 million people suffer stroke worldwide each year. Of these, 5 million die and another 5 million are permanently disabled. High blood pressure contributes to more than 12.7 million strokes worldwide. Europe averages approximately 650,000 stroke deaths each year." Still, no one was interested.

Then I heard about self-publishing. So I went to the "do-it-yourself" houses. That's how I found Xlibris, one of the originators of print-on-demand (POD). POD means they print the books as they're requested, helping Xlibris from storing books that can't be sold and keeping customers, and in turn authors, happy as their book orders come right away. It's a win-win situation, all the way around.

The one requirement I wanted the most was total control over my work. Fortunately, that requirement was familiar to Xlibris because, as they say, "we help hundreds of authors every month publish their work in the manner and form that they envision."

Xlibris started sending email attachments around July 2012. The attachments were arranged in the order expected, telling me the "next steps" I needed to take for the final step--publishing. I designed the cover, telling them that I wanted a pink brain and, on it, black letters that spelled out the title of
my book and my name on the front and spine. I chose the color, format, and style.

I designed the back cover, relating all the reactions from my blog and advance copies of the book. The people were all grateful that I was forthright with them. Many told me about the service I was providing, to educate people about strokes everywhere around the world.

I sent them three successive drafts of the entire book. When I was satisfied there were no more errors, at least none that I noticed, I sent in the final paperwork saying, "Yahoo. It's finished" (to myself), and then I was done. My package came with extra books, a press release, and a host of resellers that would advertise my book like Amazon and Barnes & Noble. 

Then I got the quirky idea to advertise the book on Facebook. If 15 million get strokes every year, it stands to reason that some stroke survivors would be on FB. So often, I put out a post on my book. That's when the ugly--and in my opinion, jealous--emails and just-plain-nasty posts arrived. There were 12 altogether and they hit me like the proverbial ton of bricks. They posts weren't threatening; they were just unnecessary and annoying, and the comments all used the second person "you" which adds a hint of animosity. Here is what some of them said (and my reactions in parentheses):

You obviously don't know how to market a book. I have an agent that does all that for me. (Big deal. You're rich enough to afford an agent).

You wanna sell your book? Give me three reasons to buy it. (I'll give you a lot of reasons, starting with "you might learn something").

You didn't even greet me before you posted on my personal page. (Oops. Where are my manners?)

 You can't advertise on Facebook. (Actually, you can).

(And this was the last one:) If you wanted to make a real difference, you would try to make an audio version for those people who can't f**king read because of their damned stroke. (Language, language).

Most--maybe all--of those 12 people reported me to Facebook as sending spam and I received a 7, then a 14, then a 30-day suspension from either acquiring new "friends" or from messaging new people. Facebook said that I can only write to people I know. What if you want to make new friends? Shame on you, Facebook and Mark Zukerberg, its founder.

I couldn't do anything about all the naysayers, but to make a audio version that works with the I-pad, I converted the book from a manuscript document into an Adobe .pdf version (remember, I had technical skills once?) and it worked. I had a "friend" whose name was Nicole test it. The I-pad now delivers an audio version of "The Tales of a Stroke Patient." So now how do you feel, saying I don't help the ones with poor vision from brain impairment. I think his name was Pat from Ireland. Or maybe Bob from Africa. No. That's not right.

Anyway, people can be petty, and you sometimes see that phenomenon in Facebook--and everywhere else, for that matter. Hey, Mitt Romney is a member of Facebook. He must get a slew of unnecessary and annoying posts, more than I do. From dog lovers, for example. Maybe I'll learn how he handles it.





Dec 23, 2012

Something REALLY New to Help Stroke Survivors

I'm just taking a guess. I never met him. But Robert Thornton is probably one of those guys that you meet every so often because, as it turns out, he is a humanitarian. Sharon, his girlfriend, had a stroke on April 4, 2012, and as a result of the stroke, developed, among other things, a subluxed shoulder, common in stroke survivors. She had severe pain that was caused by the misaligned shoulder. First, a little history on subluxation so you can understand what Robert did.

Taking all the medical mumbo-jumbo out of the picture, the shoulder joint, a ball and socket formation, is the most flexible of any joint in the body. It also makes the shoulder the most unstable joint. In a subluxed shoulder, popular wisdom, in plain English, explains that the shoulder joint's failure of the socket to completely cover the ball of the upper arm bone makes the shoulder reliant on soft tissue instead to hold it in position. When the upper arm comes substantially out of the shoulder socket, it allows for less mobility, and subluxation results.

With a shoulder subluxing, the patients sometimes feel a popping sound as the ball joint moves out of the socket then returns. Some patients feel their arms losing feeling. Others get a sense if they raise their shoulders too high, the shoulder will pop out permanently which, of course, it sometimes does. When a shoulder subluxes, pain occurs and is positioned primarily in the shoulder joint. The American Academy of Orthopaedic Surgeons (AAOS) says most of shoulder subluxations happen because the shoulder slips forward, starting the patient's pattern of avoiding motions which give pain to the patient, thus resulting in weakness for those motions the patient can't--or won't--do anymore.  The AAOS says the shoulder will often sense numbness and tingling, traveling down the arm.

Visual signs are often these:
     * Swelling or bruising over the spot where the injury occurred
     * Less rounding of the subluxed shoulder as compared to a healthy shoulder
     * Dimpling below the bony protrusion at the top of the shoulder

Even if you can't interpret the visual signs that accompanies subluxation as needing HELP, there is the pain, and that's where Robert comes into the picture. This excerpt comes from Robert, and I offer it to you, coming right from the man's heart:

"The ER ...man what a scary place...not much compassion there. They deal with death every day and it shows they do what they can, but honestly, how would you like the job of trying to calm down family members of a patient on the brink of death...that's gotta be hard on your heart and soul. Sharon was in ER for a week. The doctors told us not to expect her to recover and said if she did recover at all, she would have total loss of her left side. Ok, with that news shocking the family, what was I supposed to do? This is my soul mate and I knew if I gave up, she would, too. There was no way I was going to let that happen. So first things first. I taught her to eat so they wouldn't put a feeding tube in her (tough fight there they kept ordering a tube and I kept telling them to wait. I knew she would eat on her own given the chance). Ok, now we're off to recovery center.

"In-patient rehab....These people do great things and they’re very positive and encouraging (what a refreshing change). The therapy she received helped her leg, her speech,her eating and swallowing, just about everything but her arm and hand...this is what I would like to talk about. I have been by her side since her stroke every therapy she got. I repeated it in her hospital room and her recovery was amazing, but they couldn't really do anything for her arm (mainly due to the pain). I asked them about a sling to hold her arm and shoulder joint in place (they said the pain and swelling was from pinched nerves in the shoulder). They said that she just had to work through the pain because there was no sling that really worked for the sublux shoulder. My answer to that: bull****.

"I watched her therapist hold her arm in place and her pain went away. I started searching for a sling ...and sadly they were right. Every sling I found caused more harm than good...and they wouldn't let me put any on her. (They did try the givemore sling, but it just didn't work. Every time she bent her arm, her shoulder fell down). Well, I didn't stop there.

"When she got home, she had in-home care and I started making different slings while her therapist kept telling me what was wrong with each sling (I made 10 kinds). Finally, they started liking where I was going with number 11. When I finished it, her therapist loved it. Her pain level dropped to where she no longer takes pain meds. The recovery of her arm jumped 80% in two weeks. Now, all of her doctors and the therapist require her to wear the sling I made.

"All of her doctors and therapists kept telling me to patent the sling and get it out to the public because there were so many people out there that needed one. So I applied for a patent and put together a workshop to make them.

"Over the years, many people have tried to make an arm support for patients with shoulder problems. For a sling to meet the needs of the patient, it has to conform to criteria considerations such as subluxation reduction, easily worn/put on, ability to wear under clothing comfortably, weight distribution, freedom of movement of both upper and lower parts of the arm while keeping the shoulder in place. Our sling meets all these requirements.

"My sling starts with a comfortable arm support. I start with an elastic arm band with non-elastic cloth ends with elastic hook and loop fastening system for arm size and comfort . This is placed over the bicep of each arm. Each arm support has a strap permanently mounted on the top front and one strap grommet and one quick-release buckle mounted to the top rear.




"The straps are made of semi-elastic material. The top 2 straps start in front of the shoulder and go over the shoulder, crossing each other in the top middle of the back, and the strap from the top front of each arm support connects to the opposite arm support at a point at the top of the arm pit in the back at the buckle so you can adjust the upward pull on the injured shoulder. The third strap runs across the back from arm pit to arm pit with a hook and loop adjustment for lateral support of the shoulder joint."





If you, or somebody you know, has a subluxed shoulder, go to this site:

http://www.subluxsling.org/

Robert, who communicates through the therapist, says it might help me restore my arm somewhat. My sling arrived a few days ago and it's already working!

Dec 9, 2012

Babies and Strokes


This is a brain. It is also the unfortunate outcome of a baby whose mother experimented with cocaine, resulting in a premature birth and a bleed in the baby's brain. A bleed in the brain means the baby had a stroke. Hey! Wait a minute! Babies and strokes don't go together, or do they?

Note: for all you baby-makers out there, I'm not trying to scare you from having kids. This post is just a dose of reality.

You probably don't know the name Duncan Guthrie. He started a charity in 1952 for his daughter, Janet, who had polio, and he was determined to find a cure for the disabling disease. With money funded by the charity, research, in time, led to the first oral polio vaccine which wiped out new cases of polio in the UK. Now called Action Medical Research, the charity encompasses so many other afflictions, and that leads us to babies and strokes.

In 2009, Action Medical Research estimated at least one baby out of 2,300 in the UK born full-term were victimized by a stroke. These strokes often were unexpected at the time of birth or before, i.e. some developing babies had strokes in utero. The researchers didn't know if the babies, who are now barely three years old, had trouble using language because they hadn't matured to the point where anybody could tell the difference between a three year old saying gibberish or not.

But of the 100 or so children in the study, the researchers are working feverishly to know how stroke affects their language skills. Magnetic Resonance Imaging, most commonly known as MRI, is administered to the child to watch how stroke affects different parts of the brain. Sometimes, the brain readjusts itself, said the researchers, especially in a newborn, to compensate for the section that was harmed. Known by the medical term as plasticity, the brain takes charge of the imperfect tissue with the good part of the brain. In fact, in the first 28 days of life, stroke is more common than after.

So the big question is, how do you know if the newborn had a stroke? Newborns most likely would show no signs of a stroke unless they have a seizure. Seizures symptoms include staring, rhythmic and spasmodic episodes in the face, arms, and legs, stiffening of muscle groups, and pauses in breathing. Generally, newborn stroke survivors show less movement on one side of their body. "Handedness," the term given when newborns favor one hand over the other, could be a symptom of stroke.  Parents often mistake this as meaning that the baby is advanced for his or her age. In healthy babies, handedness appears at about 12 months.

According to the American Heart Association Journal (AHAJ), the incidence of stroke in newborns in the first 28 days is very elevated compared to infancy and childhood years. The following can happen at a rate of 1 in 4000 newborns:

     * Arterial Ischemic Stroke (where blood flow is stopped in an artery to the brain by a clot)
     * Sinovenous Thrombosis (where a clot appears in one of the veins in the brain)
     * Hemorrhagic Stroke (where an artery bursts in the brain).

After the newborn period, the risk of stroke decreases significantly and remains low until post-55.

This is what can happen in pregnancy and childbirth:
     * Proteins travel from mother to fetus, which aids in clotting. But if there's too much clotting, a
        stroke for the baby is more likely.
     * At the point of labor and delivery, childbirth can result in physical stress on the baby’s head with
        the arteries and veins in the baby’s head leading to clots and stroke.
     * Newborns have twice as many red blood cells as an adult which can lead to excessive clotting.
       (Stroke can sometimes be prevented by giving newborns blood transfusions the blood is diluted
       with saline).
     * Dehydration can cause the blood to clot, some signs of which are a dry mouth, dry skin, and
        fewer than six wet diapers a day.

A number of factors that can put a newborn at risk for stroke include:
     * If the newborn has a hole in the heart, it facilitates a clot going up to the brain.
     * If there is a genetic history of clotting problems, the risk of stroke increases.
     * If serious infections such as sepsis exist, clotting may result.
     * If the mother takes an illicit drug, like cocaine or heroin, a stroke, albeit needless, may occur.

For expectant mothers, if clotting disorders are part of your genetic history, tests can be done in-utero ahead of time to help the baby's outcome. All expectant mothers should eat nutritiously, stop cigarette smoking, and avoid dehydration.

Here's the bottom line: there’s not much research so far on how to treat strokes in children, including newborns and fetuses.

An excerpt from a blog, Raising Arizona Kids, tells one story of thousands:



"Chandra Whitfield, of Mesa, learned just a few months ago that her son, Joey, suffered a stroke in-utero.

At first, Joey was an easy going, happy, typical baby, welcomed by his parents and brother Daniel (3 ½).

But at around 8 weeks, Chandra began noticing a few things about Joey that seemed different from her experience the first time around with Daniel. She mentioned her concerns to Joey’s pediatrician at the next well check.

The doctor diagnosed Joey with tortocollis, which can occur while a baby grows in the womb if the muscles or blood supply to the fetus’ neck become injured.

He prescribed some stretching exercises and suggested that Chandra put toys on on Joey’s left side to encourage him to turn his head.

That helped, but at four months, Chandra begin to notice that Joey wasn’t reaching for toys with both hands- just his right hand.

At his six month well check, he still didn’t seem to be using his left arm and hand – and Chandra decided to trust her 'mommy gut' feeling that something wasn’t right.

She asked the pediatrician for a referral to a pediatric neurologist, just to rule out that anything was seriously wrong.

Finally, Chandra and her husband, Chris, received some tough news about their little boy.

Joey was diagnosed with left-sided hemiparesis (weakness on the left side of the body) due to a stroke in-utero. An MRI followed and confirmed the diagnosis.

Since the diagnosis, Chandra says she feels 'as if a fire has been ignited in me.' She began working to raise awareness about childhood stroke.

She and her family have walked in the Stroke Walk, a fundraising event.

She’s been selling purple awareness bracelets and donating the funds to the Children’s Hemiplegia and Stroke Association (CHASA), she’s got plans for a website, and volunteers for CHASA.

Chandra also sent a letter to Governor Jan Brewer requesting that May 7 be declared 'Childhood Stroke Awareness Day.' Here are Chandra and Joey on the day just a couple of weeks ago when they received the news that the request was granted, and more.

Arizona now joins several other states in declaring May as Childhood Stroke Awareness Month. CHASA hopes to build a grassroots effort to add more states to the list.



"Joey is a year old now and doing well. He works with a physical and occupational therapist to help strengthen his left side. The testing and therapy will continue, but so will Chandra’s will to get the word out to others to raise awareness—and to grow a community. Because what Chandra says has helped the most is the connection she’s made with other parents of children who have suffered stroke in-utero."

My God. Babies and strokes. It happens. And now you know.