|01-14-2008, 03:14 AM||#1|
Join Date: Jul 2003
Question For Dr. Young
I have read so many stories about people going to foreign countries for cell implants into their bodies. Places such as China and Mexico. Can you please share your thoughts on these procedures taking place in other countries. Are they safe? Are they effective? or are they taking advantage of people?
|01-14-2008, 10:40 AM||#2|
Join Date: Jul 2001
Location: New Brunswick, NJ, USA
I have posted many times concerning individual treatments that are being offered. Please search for topics relating to the individual treatments.
In general, you should keep the following in mind.
I have criticized several places claiming to offer therapies that restore function to people with spinal cord injury. This includes the following:
Some doctors offer experimental therapies and are collecting data but have charged for these therapies. These places have have been publishing the data. I have recommend that people don't go to these places.
Many groups are providing so-called "stem cells" to doctors who then transplant them. These range from fly-by-night companies that operate mainly out of countries with little regulation to legitimate and often non-profit organizations such as cord blood banks. The way that you can distinguish between legitimate and illegitimate groups is how much information they will provide concerning the cells. Legitimate groups will tell you everything about the source, the quality, and the characteristics of the cells. Illegitimate places will not know and often will tell you that they are secret. Please be very careful of the latter.
There are several tell-tale signs of scams:
I should point out that the stricture against charging for experimental therapies is a fairly recent development (since the 1970's) and one that came from the United States and Europe. Doctors in many countries have not yet adopted this standard and I am hesitant to condemn them on the basis of charging for experimental therapies. In many countries, there is simply no infrastructure or funding for testing experimental therapies. So, the patients end up paying for experimental therapies and this is the only way that new therapies are developed. In China, for example, there was no other way for clinical trials to go forward unless the patients paid. However, this is changing.
There is also a big difference between drugs and surgical procedures. Surgeons have long experimented with surgical approaches in people. That is how surgeons develop new surgical procedures. While drugs must be approved by regulatory agencies since the 1970's, surgical procedures are not similarly regulated. The vast majority of surgical procedures have never been tested in randomized double-blind clinical trials. Cell transplantation belongs in that gray zone between surgery and medicine. Until recently, there were little or no governmental regulation of cell transplantation, particularly of cells that come from the person's own body and cells that have not been substantially manipulated, such as umbilical cord blood cells.
So, companies that offer stem cells for transplantation and surgeons that transplant cells are often not doing anything illegal. For example, Carlos Lima's group is doing autografts (from the same person) when they transfer nasal mucosa to the spinal cord. While this is clearly an experimental procedure in the sense that they did not know the safety or efficacy of the procedure, it is not a procedure that was regulated by any government agency. They could charge for this procedure in much the same way a surgeon who did plastic surgery and skin graft could charge for the procedure. One cannot accuse them of illegal activities. Likewise, Hungyun Huang is practicing fetal cell transplants which is legal in China and he had obtained permission from the relevant authorities for this procedure.
So, what is wrong with charging for experimental procedures, especially if the patient knows that the safety and efficacy of the treatment has not been proven? After all, if this is a risk that the patient is willing to take and pay for, why should it be stopped? By the way, everybody agrees that it is unethical and illegal for a doctor or company to provide misleading information, claiming that a therapy is safe and effective when it is not. This is not the issue. Suppose that a doctor is telling the patients that a procedure has not been shown to be effective (i.e. may or may not work) and is accurately portraying the risks of the procedure, is the doctor being unethical if he or she charges for the procedure?
There are two problems with charging for experimental procedures and why this has now been strictly forbidden under Good Clinical Practices (GCP) guidelines. First, receiving payment for a therapy produces a potential conflict of interest for doctors who are suppose to be dispassionately evaluating the safety and efficacy of a therapy. If a clinic, for example, were to receive a majority of its income from a given experimental therapy, that clinic would be loathe to report any problems concerning the safety and efficacy of the therapy. The testing of therapies should be done by doctors or investigators who don't have a financial interest in the therapy being tested. The potential for abuse is high.
Second, allowing doctors to charge for experimental procedures would make nonsense out of regulatory approval of treatments. If this were allowed, any company wants to make money from its treatment, all it has to do is to claim that the treatment is experimental and then pay a doctor to apply the therapy. In other words, all treatments would be unregulated. Most people would agree that this is not a good idea and would be subject to many scams, as the stem cell transplantation field has become. While regulations are currently still very lax concerning stem cells, I anticipate that most countries are now considering and will soon impose strict regulations on all stem cell therapies.
I do not favor tight regulations of experimental therapies because regulatory requirements slow down clinical trials and also increase their expense. Most agencies that regulate clinical trials give little consideration to cost. One of the reasons why medical care and drugs are so expensive is because of the onerous layers of regulations imposed on all companies and doctors who are testing experimental therapies. On the other hand, some regulation is necessary for the protection of people. Therefore, public policy on cell transplant regulation should be based in what is necessary and sufficient to ensure the protection of patients. In my opinion, once safety has been established, there should be a some kind of intermediate time-limited approval of experimental cell transplant therapies to demonstrate efficacy. If such data is not collected within a period (which may have to be decided individually for different therapies) or if negative data were to become available, this intermediate approval would be withdrawn.
In any case, at the present, people have to be very careful. We are in a situation where regulations are sparse and unclear in many countries around the world, including the United States. Please don't think that scams do not occur in the United States. They have happened, especially to people with spinal cord injury. That is what CareCure is here for, so that you can read the opinions of many people (besides myself) and get to judge for yourself whether a experimental therapy or clinical trial is what you want to do. You have to know yourself, spinal cord injury, and the therapy in order to make a rational decision.
|01-14-2008, 10:51 AM||#3|
Join Date: Mar 2005
well written post Dr. Young. hopefully soon , something will get things on the right track to fixing us.
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