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PARKINSN  August 2009, Week 1

PARKINSN August 2009, Week 1

Subject:

quack clinics

From:

"schild.m" <[log in to unmask]>

Reply-To:

Parkinson's Information Exchange Network <[log in to unmask]>

Date:

Wed, 5 Aug 2009 19:01:40 +0200

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (156 lines)

Reuters recently reported on the raid of a stem-cell clinic in Hungary. This 
is welcome news, if the allegations are correct, but really is only 
scratching the surface of this problem – clinics offering dubious stem cell 
therapies to desperate patients. And in fact this is only one manifestation 
of a far greater problem – the quack clinic. They represent a serious problem 
for patients, doctors, and health care regulation.
Stem Cell Clinics
There is a very disturbing trend in the last few years – the proliferation of 
clinics offering stem cell therapy for a variety of serious, often incurable, 
diseases such as spinal cord injury, ALS, Parkinson’s disease, and other 
neurological disorders. These clinics claim to improve and even cure these 
diseases by injecting stem cells into the spinal cord or other parts of the 
body. Treatments typically cost 20-25,000 dollars, plus travel expenses, for 
a single treatment.
The problem is that these clinics do not have any published evidence that 
their treatments are valid. There is good reason to think that they are not – 
stem cell technology is simply not at the point yet where we can use them to 
cure such diseases. There are many technical hurdles to be overcome first – 
knowing how to control the stem cells, to get them to survive and become the 
types of cells necessary to have the desired therapeutic effect, and also 
figuring out how to keep them from growing into tumors. Basic issues of 
safety have not yet been sorted out.
So in essence what these clinics are claiming is that they are years, perhaps 
decades, ahead of the rest of the world. And yet they have no science to show 
for it. They should be able to produce dozens of studies demonstrating their 
technology, but they can’t.
Further, they should ethically be giving such treatments as part of clinical 
research, to establish their safety and efficacy, but they haven’t. What 
little information we have comes from outside observation. For example, Bruce 
Dobkin published a review of cases at one Chinese stem cell clinic. He 
concludes:
The phenotype and the fate of the transplanted cells, described as olfactory 
ensheathing cells, are unknown. Perioperative morbidity and lack of 
functional benefit were identified as the most serious clinical shortcomings. 
The procedures observed did not attempt to meet international standards for 
either a safety or efficacy trial. In the absence of a valid clinical trials 
protocol, physicians should not recommend this procedure to patients.
In other words – we don’t even know what the clinic doctors are injecting into 
patients and what happens to the cells, if any are even present. There are 
risks to the procedure without any evidence of benefit. And the clinic is not 
following standard ethical procedures for experimental treatments.
Although China seems to be a hot spot for such clinics, the recent raid 
occurred in Hungary. The reason for the raid was that the clinic in question 
did not have the permits necessary to use human tissue – the stem cells 
allegedly used by the clinic are reported to come from aborted fetuses. What 
is not clear is, if it were not for this issue, would the clinic still be 
free to offer a dubious treatment for serious diseases.
Robin Lovell-Badge of the National Institute of Medical Research in London is 
quoted as saying:
“I hope it scares others from offering untested treatments and will be a 
cautionary tale to members of the public.”
I share her sentiments but this statement strikes me as hopelessly naive. Such 
clinics have been in operation continuously over the last century, and they 
are increasing in number – not decreasing.
The Quack Clinic
Regardless of the treatment, the formula for operating a so-called quack 
clinic is now well-established. Typically such clinics are created by an 
individual, who may or may not be a physician. Often they are based upon one 
dubious treatment – this can be ozone therapy, an unconventional use of 
approved drugs, or an imagined new agent. Typically the therapy is based upon 
a fanciful and unproven philosophy of disease, such as the notion that all 
cancers are caused by fungal infections, or that all disease is caused by a 
liver fluke.
Clinics sometimes focus on one disease or condition to start, but over time 
the claims tend to expand to include more and more conditions (a good way to 
expand the customer base).
Here are the features of such clinics that should make any patient very 
cautious:
- The clinic often has an impressive name, such as “The Institute Of,” but 
lacks any formal affiliation with an established institution, like a 
university or hospital, and was founded and may even continue to be operated 
by one person. Essentially, a lone practitioner can easily surround 
themselves with the trapping of prestige and legitimacy by attaching fancy 
names to their operations.
- The clinic claims to treat or cure one or more diseases that is currently 
believed to be incurable. Their claims sound to good to be true.
- There is only one clinic in the world that can perform their special 
procedure or that uses their proprietary treatment. Sometimes, like with the 
stem-cell clinics, the treatment offered is a new and experimental treatment. 
The clinic takes advantage of the hype surrounding a new technology, but is 
premature in their claims.
- The clinic claims to cure a variety of diseases all with different causes 
and pathophysiology with a single treatment – the one cure for all diseases 
approach.
- The clinic is located in a country with little or no regulation.
- The clinic claims that it is the victim of repression. Typically they will 
say that either Big Pharma, the medical establishment, the insurance 
industry – or some other convenient villain is trying to suppress their 
revolutionary treatment.
- Testimonials are used to promote the treatments offered by the clinic, but 
they have not published appropriate research in legitimate peer-reviewed 
journals. Often this failing is defended with the excuse that they are “too 
busy curing patients to publish research.”
- When challenged by professional organizations, the clinic defends itself by 
appealing to politicians, using the testimonies of previous patients who 
believe they have been helped by the clinic and the accusation of a 
conspiracy of those trying to protect their monopoly. It is not difficult to 
find a sufficiently naive and scientifically illiterate politician to take up 
their cause and shield the clinic from efforts at regulation.
Of course, not every dubious clinic has every feature I outline above, but 
they tend to have most of them. Any of these features should be treated as a 
red flag and provoke extreme caution. Unfortunately, patients and  families 
of patients with serious or terminal diseases are often desperate. They want 
to believe the extraordinary claims, and are encouraged to believe that they 
have nothing to lose. However, I have seen first hand that they do. Such 
clinics have bankrupted families who could not deny their loved-one the 
chance of a cure. They have also robbed the terminally ill of whatever time 
they had left to spend with their families.
Occasionally I have had patients admit with anger that they wasted tens of 
thousands of dollars and wasted the last six months of their life on a false 
hope. But most of the time such a realization is too painful – there is too 
much insult being added to injury. Patients and families often convince 
themselves that the dubious treatment was worthwhile, despite all the 
evidence to the contrary. One patient of mine, after having stem cells 
injected into their behind to treat Parkinson’s disease, was convinced that 
their disease would have been worse without the treatment – despite the fact 
that their disease was end-stage and about as bad as it gets. Another 
patient’s father convinced himself that taking his son with muscular 
dystrophy to Mexico, at a cost of about $50,000, was worthwhile because now 
his son seems to be drooling a bit less (his neurological exam was 
unchanged).
There is also the recently reported case of the mother who was convinced that 
her blind child could see after getting stem cell therapy in China, despite 
the fact that objective opthalmological exams showed the child to still be 
blind.
These stories are extremely sad. These are also the same people who will give 
glowing testimonials that will help ensnare the next victim, and who will 
come to the aid of the clinic when the regulatory agencies finally catch up 
with them.
Conclusion
Regardless of where along the spectrum the operators of dubious clinics are 
from well-meaning and self-deluded to deliberate and callous frauds, the harm 
they do to the most desperately ill is incalculable. It is frustrating that 
regulatory bodies are generally ineffective in dealing with such clinics, 
unless they run afoul of a specific law like a ban on using fetal tissue.
In the US, it is actually getting more difficult. So-called “health care 
freedom” laws are being passed in more and more states – these laws erode the 
standard of care and create a safe zone where dubious clinics can thrive 
without fear of regulation.
Lovel-Badge, quoted in the article about this recent stem-cell clinic raid, 
says:
“Many of us have been deeply concerned about some of the clinics that are 
offering untested, and often illogical ’stem cell’ treatments,” he 
says. “They take advantage of desperate individuals or their family members, 
charging them large sums of money for procedures that are unlikely to work, 
may in fact be dangerous, and may use cells of dubious origin.”
You can remove the words “stem cell” from her first sentence. There are 
clinics offering many types of treatments that are equally harmful and 
exploitative. I am glad to see some mainstream media attention to this 
problem, but they vastly underestimate the nature and scope of the problem.
Without the ability and political will to enforce a reasonable science-based 
standard of care, the public will continue to be victimized by quack clinics.

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December 2004, Week 5
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December 2003, Week 5
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December 2002, Week 5
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December 2000, Week 5
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December 1999, Week 5
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December 1995, Week 5
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