Study: Web Sites Touting Stem Cell Therapies Overly Optimistic

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barbara

Pioneer Founding member
I have always yapped about not putting too much stock into fancy websites and testimonials and that still stands. However, I do not know of any stem cell clinics that are strictly non profit, so of course they are going to do the best they can to attract a potential client's attention with a good website. I think this is done quite consistently with other products and services. A person needs to use common sense and go beyond the website when researching. This is one of the main reasons Jeannine and I started this forum so that others could learn from us and those that have gone after us in search of better health with a very promising technology. There will always be unscrupulous people in any industry or business, so it is Buyer Beware as always. I personally think Dr. Daley is not understanding that many people have terminal and chronic diseases that are seeking stem cell treatment. No one is making anyone go to a clinic for treatment. It is by choice and I for one do not mind being a Pioneer. It beats waiting for Dr. Daley to come together with a better plan in my opinion. Third world countries are not the only place where treatment is being done so to me this article is just another sour grapes article since the U.S. is lagging behind. Long term, published results, cannot be available for new treatments. There are published reports for some stem cell therapy so the article is misleading to me in that he doesn't indicate this. He is upset that websites are too optimistic and I challenge him to find any company that tries to promote its product or service with a negative ad. I used to use Advair which is an inhaled steroid product for people with asthma and COPD. The ads for this product on TV show people without O2 frolicking in a meadow blowing bubbles. I am asking our pulmonary members when the last time was that you could do something like this simply by taking a couple of puffs of Advair. That is beyond optimistic to me!
 
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barbara

Pioneer Founding member
Here's more from the International Society for Stem Cell Research. I agree that a person must be vigilant, but they should also practice what they preach and publish their findings that they seem so sure about concerning rogue clinics and unproven stem cell therapies. I dislike articles that decline to name names. If they have verifiable information, then give it so people can be protected which is what they are claiming they are trying to do. As for therapies being given around the world before they can be proven safe and effective, evidently this group thinks time will stand still for many that are very ill. It comes back to whether a person wants to pioneer a treatment or wait 10-20 years for groups like this to give their stamp of approval to stem cell therapy. No one is holding me hostage to try it or making me do it. I am responsible for my own decisions regarding stem cell treatment and do not need another "regulatory group" to hold things up for me if this is where they are going with this. Tell us who is not doing a good job. That's fine with me, but don't throw a wet blanket over all clinics because nothing has been proven. Our little forum here is able to run the red flag against companies such as Stem Cell Biotherapy. It seems to me that this group should be able to come out with whatever has caused a burr in their boxers and let us know what clinics should be avoided if they have this information.





"Rogue" stem cell clinics exploit hope: report
By Maggie Fox, Health and Science Editor
Thu Dec 4, 9:28 am ET
WASHINGTON (Reuters) ? Rogue clinics around the world may be exploiting hope and ignorance by offering unproven stem cell therapies, a group of stem cell experts said in a report released on Wednesday.The International Society for Stem Cell Research released guidelines for researchers and regulators, and a guidebook for patients, that criticized some clinics."The International Society for Stem Cell Research is very concerned that stem cell therapies are being sold around the world before they have been proven safe and effective," the guidelines said.
The group has declined to name any specific website or clinic but said they are widely advertised and reviewed in a study published in the journal Cell Stem Cell."The direct-to-consumer portrayal of stem cell medicine is optimistic and unsupported by published evidence," Timothy Caulfield of the University of Alberta and colleagues wrote."The average cost of a course of therapy among the four websites that mentioned costs was $21,500, excluding travel and accommodation for patients and care givers. And examples of serious treatment side effects can be found."Stem cells are the body's master cells and they come in a wide range of forms, from the cells in bone marrow that are widely used to treat cancer and other conditions, to embryonic stem cells -- those that give rise to all the cell types in the body.The field has received intense attention, in part because it carries the promise of tailored treatments and truly regenerative medicine that might transform treatment of diseases such as Parkinson's, as well as catastrophic injuries.It has also been sullied by scandal, notably the case of disgraced South Korean researcher Hwang Woo-suk, who admitted in 2006 to fabricating data to support claims he had made the first human embryos using cloning technology and then derived stem cells from them.
"Stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. Make sure you understand what to look out for before considering a stem cell therapy," advises the patient advisory, available at http://www.isscr.org/clinical_trans/index.cfm.For researchers and regulators, the group advises tough oversight and independent review.
The group, including Dr. Marina Cavazzana-Calvo of Hopital Necker-Enfants Malades in Paris, France, Dr. Giulio Cossu of Instituto San Raffaele in Italy and Dr. George Daley of Children's Hospital Boston, urged governments and regulatory bodies to enact the recommendations. "Regulators have a responsibility to prevent exploitation of patients in their jurisdictions, and where necessary, to close fraudulent clinics and take disciplinary action against the doctors involved," Daley said in a statement.
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Mysty119

New member
Frolicking in a meadow....

Let me see......when WAS the last time I was frolicking in a meadow without O2 and blowing bubbles after taking some Advair???
Well, I believe that was....um......let me see.......ah, yes! That would be never!!!!!!!!!!!!
 
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barbara

Pioneer Founding member
Financial conflicts at the FDA

Jan is really finding some interesting articles. Thanks, Jan.

Industry Ties Bind FDA Advisors

From our friends at OMB Watch

The Government Accountability Office (GAO) has released a new report describing how the Food and Drug Administration handles conflicts of interest on its advisory panels. Financial conflicts plague a significant number of FDA advisors and FDA panels, according to the report.

FDA advisory committees can provide valuable advice to decisionmakers inside the agency ?particularly concerning controversial issues or new products,? according to GAO. Committees can weigh in on the safety and efficacy of a pharmaceutical awaiting approval or the safety of chemicals found in every day products ? as FDA?s science board did in September when it considered the safety of bisphenol-A. ?The advisory committees? recommendations are not binding on the agency, but the agency usually follows the advisory committees? advice,? GAO says.

But committee members, or potential members, sometimes have financial conflicts (such as owning stock in a company with a product before the committee) that call into question their ability to provide unbiased input. In those cases, FDA can provide a waiver if it believes a person?s service is critical to the operation of an advisory panel.

FDA is not doing a good job of filling panels with impartial experts and issuing too may waivers. GAO examined a sample of advisory committee meetings and made these key discoveries:

* At least one member on 49 of the 83 meetings examined had a conflict;
* Two hundred of the 1,218 participants had a conflict ? about 16 percent;

FDA officials acknowledge that their source for expertise is the same as industry?s:

FDA contended that it sought the same leading experts to serve on its advisory committees as industry sought to conduct its research and product trials. As a result, the experts FDA deemed most qualified to serve on its advisory committees often had industry ties, according to the agency.

GAO says that FDA needs to improve its efforts to recruit committee members. FDA?s primary vehicle for recruitment is word-of-mouth which means committee members tend to be those experts known to agency officials or to an industry with a product under review. ?t may lead to self-perpetuating committee membership, in which a limited group of peers continually comprise an advisory committee.?

The report is available here: FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest

This entry was posted by Michael Stebbins on October 13, 2008 at 7:40 am and filed under FDA, OMB Watch.
 
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