Do you have a stem cell question?
Beginning in November, we will feature a stem cell Q&A with Dr. Dan Pepin here on Adult Stem Cell Awareness blog. Dr. Pepin is professor of Anatomy and Physiology at Edison College in Naples, FL and instructor of Human Biology at North Central Michigan College in Petoskey, MI. In addition, he is the Consultant on Bioethics for the Diocese of Venice, FL and the Diocese of Gaylord, MI. On invitation, he travels throughout the U.S. and Canada to speak about the critical bioethics issues we must confront. Can you believe he has agreed to take the time to answer our stem cell questions? Thanks, Dr. Dan!
So, send in your question via comment and perhaps it will be chosen for our upcoming Q&A. Stay tuned!
Hi Dan,
Having cared for an elderly relative with dementia, and now caring for my son with Down Syndrome, I have a natural interest in the human brain and how it works, and sometimes doesnt. What are the chances of stem cells being used to help with restoring damaged parts of the brain in say 30 or 50 years time do you think? What would be the ethical issues of using donor tissue - or even cloned animal/human hybrid tissue - in this respect?
Comment by Rob — October 30, 2007 @ 9:17 am
Dr. Dan, I have question, er - maybe three! Who controls clinical trials . . . is it the FDA or the NIH? Why do some projects get approval faster than others? Will the Patient First Act have the power to really expedite clinical trials, etc?
Thanks much, Dr. Dan.
Sincerely, Monica
Comment by benotafraid — October 30, 2007 @ 10:41 pm
[...] have questions about stem cells, Monica has given you the venue to get them answered. Go over and ask Dr. Dan your questions. TrackBack [...]
Pingback by Cosmos-Liturgy-Sex » Stem Cell Questions?? — November 1, 2007 @ 12:51 pm
Monica, even though I’m not Dr. Dan, I might be able to mostly answer your questions based on my knowledge of the drug industry. By “control”, I think you are basically asking “who runs/conducts the clinical trials?”. In general, it is up to the one developing the drug to conduct the clinical trials. The developing company will then apply for FDA approval based on the clinical findings.
Most drugs (stuff like Lipitor, Benadry, Augmentin…
have to pass through multiple clinical trials that each look for different issues. Preclinical studies (before going into humans) are usually performed by the drug company to test possible toxicity issues, drug metabolism, and pharmacokinetics (how the drug is absorbed, and processed). The later clinical trials are generally outsourced to other companies, but overseen by the drug company to ensure the data is collected in a meaningful way. The FDA does not, to my knowledge, ever conduct trials themselves - the burden of proof here is on the company that wishes to market the drug. There are four basic phases of clinical trials that each test a certain attribute of a drug in humans, and generally each is performed on a larger number of people and is consequently more and more expensive. Phase I trials test predominantly for safety issues and how the drug is processed in humans. Phase II trials test how well the drug works - usually starting with severe cases. Phase III trials test for widespread activity and efficacy of a drug on larger groups. Phase IV trials are even larger and longer in length and usually continue after the drug has been approved by the FDA to look for long-term effects.
Due to the cost, and time it takes to perform these trials, it can take anywhere from 5-10 years (or even longer) for a drug to pass through clinical trials. Many drugs fail in clinical trials, which is a huge loss for pharmaceutical companies. Due to the costs of trials, and the number that fail, most experts in the field estimate that it takes about $1.2 billion for one drug to make it to the market (in 2010 it’s estimated to reach $2 billion). Due to patent lifetimes, a drug company will often have only 2-7 years to recover from that cost by selling the drug before generic companies can legally make and sell the drug.
I’m not sure about the Patient First Act, but in order to provide affordable healthcare to people in a meaningful, this issue has to be resolved a bit. Sometimes the FDA can move a particular drug through trials quicker than others due to importance or if the drug is similar to another drug on the market. It looks like the Patient First Act (summary can be found here) merely assists financially the research and design of adult stem cell-based therapies. I don’t think this will really have an impact on expediting clinical trials, but it certainly will help in the research area.
I hope this can help to answer your question(s). Dr. Dan, please let me know if I am incorrect in my statements here. If you want more information on clinical trials, the Wikipedia entry is a pretty good source. Also, information on clinical trials is made available to the public here if you are interested. Thanks for reading - I know I’m a bit wordy.
Comment by bink — November 1, 2007 @ 8:28 pm
We typically hear a lot of “hoopla” surrounding the alleged superiority of embryonic stem cells over that of adult stem cells as it relates to the potential for curing diseases and spinal chord injuries. I am aware that adult stem cells are in fact improving the lives of patients as we now speak, but how far is the embryonic stem cell research from providing tangible proof that “they” can indeed provide a cure of any kind?
Comment by shelray — November 2, 2007 @ 3:11 pm
Dr. Dan, Jayson wrote in earlier in the month with a list of articles. I read the articles and found they fit into two categories: adult stem cell therapies are hype, and adult stem cell therapies are harmful. I emailed Jayson my responses - but I’m sure your take on these would be really insightful. Here is Jayson’s request for comment: http://adultstemcellawareness.wordpress.com/2007/10/10/announcing-the-campaign-cures-without-controversy/#comment-17
Comment by benotafraid — November 2, 2007 @ 8:01 pm
[...] Bink commented with an answer and Dr. Dan follows up [...]
Pingback by Q & A with Dr. Dan « Adult Stem Cell Awareness — November 8, 2007 @ 11:28 pm
how organs are produced from stem cells?. in plant tissue culture we have hormone to induce root or shoot. so hw can we produce a desire organ from stem cells
Comment by dipthi — January 12, 2008 @ 5:55 am