Anyone have objective data on the effectiveness of the …

@StemCellPioneers I think you raise an interesting argument, but not for the reasons you list. The FDA is at least trying to base decisions on ACTUAL DATA, whereas there IS NO VERIFIABLE DATA on the therapeutic use of stem cells. What the FDA is saying is that the study is limited, and thus should be interpreted with caution. Therefore, they are being CONSISTENT. Flawed or limited data does not equal legitimate data on which to base decisions. So yes, if a study is limited, according to the FDA, then it is acceptable that a potentially dangerous drug should be continued to be given to children.

I dont have access to this particular study from home, but I can already tell you that retrospective case control studies can have significant problems with bias and confounding. See, this study states in the methods The primary exposure measure was the presence of amphetamine, dextroamphetamine, methamphetamine, or methylphenidate according to informant reports or as noted in medical examiner records, toxicology results, or death certificates. Now, even without reading the paper, which I will, I can already identify a potential source of bias. Kids who experienced sudden death were probably a lot more likely to have an autopsy, where drugs would be found by toxicology, whereas the kids who died in auto accidents probably were less likely to have autopsies, and the investigators likely relied on interviews with the family (less reliable). Thus, I predict that when I read the study tomorrow, I will find more autopsies in the sudden death group, and thus a greater association of sudden death with stimulants (because they were found more frequently by a better method). We shall see.

In any event, at least the FDA is weighing DATA, pros and cons, etc. There have been many cases of the FDA pulling medications and-or issuing black box warnings (for example, the diet drug fen-phen). This is how the system works. No drug is perfect, and as such needs to be approved through prospective studies, and constantly reviewed via aftermarket analysis. If more proof accumulates indicating that stimulants are harmful in ADHD, you can be sure the FDA will pull the drugs from the market. In contrast, the stem cell pioneers are just pushing forward, without so much as a hint that there could be some benefit (save lots and lots of anecdotal stories, which could easily be attributed to placebo affects).

I will say this again (perhaps for the 5th or 6th time). As a physician-scientist I truly believe in the promise of stem cells. I really, really do. However, no one will ever know if stem cell treatments are effective if they arent studied in rigorous, well-controlled clinical trials. This is true of all new treatments. And I would ask, why are the purveyors of this treatment not the leaders in the field of stem cell research? You talk about reputable stem cell clinic or doctor, but I consider that a misnomer. No reputable doctor would perform these infusions without it being part of a clinical trial or as an already verified procedure. Furthermore, this thread has piqued my interest in this area, and Ive been doing a lot of web research over the past few days. Interestingly, quite a few of the doctors and clinics discussed on your very site have had major legal and ethical issues (including doctors that are heavily promoted), which argues against them being reputable. The doctors who run these clinics may claim to be scientists, but in reality, the bulk of cutting edge stem cell work is going on in major academic hospitals, not small, private clinics run by doctors with little to no scientific training.

Finally, I really hope you find what you are looking for in stem cell infusions. Neither I nor any doctor wants patients to suffer needlessly, but apparently the majority of the medical community views the current status of stem cell treatments to be in its infancy. Many of us are concerned that the quixotic pursuit of highly experimental stem cell treatments could be detrimental on an emotional, financial, and possibly biologic level.

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