Legal and ethical issues surround umbilical cord blood and bone marrow stem cell use
Many people may not be aware of obstacles that are slowing down the development of umbilical cord blood stem cell therapies. Two major obstacles that held back development of umbilical cord blood for many years: patents and regulations.
1. Patent battles. The discovery that cord blood is a source of pluripotent stem cells that can be collected and used for the treatment of diseases was patented by a biotechnology company called Biocyte Corporation. This company filed for a US patent in 1987 and was granted the patent in 1991. A continuation patent was filed in 1991 and then awarded in 1993. In 1996, Biocyte received a further patent in Europe. According to the following article http://www.ccels.cf.ac.uk/pubs/gunningpaper.html, these patents essentially give Biocyte monopoly rights over all stored cord blood cells and their therapeutic use. In Europe, the cord blood banking and transplantation community lobbied for the revocation of the patent both on legal and ethical grounds. Biocyte has been acquired by PharmaStem Therapeutics. After four years of legal battles, the European Patent Office revoked the PharmaStem's European patent ('681) on 7 April 2003.
However, the legal battle continues in the United States. In February 2002, PharmaStem filed a lawsuit for patent infringement agaisnt seven American cord blood banking companies, including ViaCell, Cryo-Cell Internation, CorCell, StemCyte, Nu Stem Technologies, Cord Blood Registry, Bio-Cell, and Birthcells Technology. In November 2002, Pharmastem achieved success in the courts and was awarded $7.1 million in damages against four of the defendent companies (ViaCelll, CorCell, Cord Blood Registry, and Cryo-Cell). The remainder settled or went out of business. Netcord and Thermogenesis Corp have challenged the judgment but PharmaStem is now pursuing another five private cord blood banks and is trying to collect royalties even from non-profit cord banks. By the way, PharmacStem was established by a single individual who is now holding the cord cell banking community to ransom. Fortunately, U.S. District Court Judge Gregory M. Sleet on 17 December 2004 ruled that the companies "did not infringe on the '553 patent, the first of the two PharmaStem patents in question. The judgment overturned a $7 million award to PharmaStem." http://www.corcell.com/about/press_12_17_04.html
It is not clear, however, that the battle has ended. The U.S. patent office agreed to re-examine two of the patents and other litigation is still ongoing. On 1 March 2005, the U.S. Patent Office re-examined patent 5,192,553 ('553) and rejected all its claims (Source). However, on 9 May 2005, the U.S. Patent Office announced that it has confirmed the key patent claims in two of its pioneering patents (Source). The implications of these new findings are not clear because litigation is continuing but it is likely that cord banking companies will have to pay some licensing fees to PharmaStem in order to avoid being sued. Indeed, the PharmaStem Therapeutics, Inc. web site http://www.pharmastem.com/licensing-program.htm lists 16 companies that are "licensed" and four (Viacord, Cord Blood Registry, Cryo-Cell International, and Corcell) who have not.
2. Regulations. Umbilical cord blood banking is become highly regulated. There is an excellent discussion of other ethical and legal issues affecting cord blood banking at http://www.nap.edu/openbook/0309095867/html/107.html The article summarizes several additional road blocks to collection and use of umbilical cord blood and adult stem cells. Everybody who has donated cord blood is aware of the lengthy taking of extensive family and personal medical history, extensive physical examinations. Because of the stresses of labor, these criteria for collection of blood often cannot be fulfilled before birth, leading to failure to collect cord blood because of lack of staffing or inability to bank the blood after collection. Some banks have gotten around these issues by collecting the blood first and then asking the women to go through the examination and history taking after the birth. However, this is not possible because a majority of banks require consent before labor and delivery. Finally, there is the problem of testing of umbilical cord blood before they are given to people. Because of the litigation culture in the United States, umbilical cord blood banks are held liable for any problems that may arise as a result of transplanted umbilical cord blood. This has resulted in a thicket of regulations concerning the testing of the cells before they are given to patients. This has added significantly to the cost and complexity of not only collecting but storing and use of the cells.
All of the above is adding to the costs of umbilical cord blood treatments. At the present, the going cost of transfusing a single unit of umbilical cord blood is approximately $23,000 (I was told that this is the amount that is reimbursed by insurance companies to the cord blood banking companies). The combination of patent battles and increasing regulatory burden not only increases costs but has slowed down the development of development of umbilical cord blood stem cell therapies.
For people who are interested in collecting umbilical cord blood at the births of babies, the following links might be useful reading:
Can Routine Commerical Cord Blood Banking be Scientifically and Ethically Justified?. Published in the Public Library of Science on 22 February 2005, this article gives the pros and cons of donating blood to commercial cord blood banks.
Cord blood patent portfolio license granted to umbilical cord blood bank. This article in 26 February 2004 in the Obgyn.net reports the cord blood patent portfolio of PharmaStem and the license that it is providing to other companies to use umbilical cord blood cells.
SCIENCE POLICY: ON CORD-BLOOD CONTROVERSIES Litigation. This article from ScienceWeek summarizes some of the issues raised by Robert Steinbrook (New England Journal of Medicine, 2004, 351: 2255).
[This message was edited by Wise Young on 05-25-05 at 08:59 PM.]
My aunt was just in the hospital for the past couple of weeks due to her cancer radiation therapy. She had to have 3 blood transfusions to recover. I was wondering if she could have requested an umbilical cord blood transfusion versus a regular blood transfusion?
Umbilical cord blood is much more expensive. It needs to be matched for HLA antigens. As I explain above, it would cost $23,000 for a matched unit in the United States.
Damn it, it's always peoples feelings, money, or religion holding any type of cure or cause back. Can't people just think clearly and open their minds enough to realize how all their selfish acts are literaly letting lives slip away? People everyday are sitting in wheelchairs in agonizing pain. This is sick, people are sick and greedy. Yes, I may be greedy to want a cure for my paralysis but that's not really a bad thing, is it? The leaders of countries are supposed to take care of their people but I don't see it happening on this side of the world. Canada doesn't seem to give a shit unless it's good PR for them at the time. Not nameing any other countries leaders because it's not right in my eyes to do so but he really needs to pull his head out of his ass. This could all be cleared up in a day if the people in power wanted it that way. Ha ha, that was funny, yeah right that would be a biblical maricle. I'm just waiting for aliens from a far planet to come cure me. It will be faster than the dicks holding the key in their hands. I hope the guy holding the cord cell banking community to ransom finds himself needing a cure that will only come from unlocking the banks. So he can learn how really ignorant he is. I never wish anything bad on anyone, just today and it felt good. Well that's enough ranting and raveing for me. I'd better stop before my sentences don't make any sence.
My Dirt Bike Misses Me
Northquad, sorry, I did not post this to upset anybody but to let people know what problems we need to work on. When I first started working on umbilical cord blood, I did not know abou the patent battles and the thicket of regulations that surround cord blood banks.
The good news is that
1. the patent battles have now been resolved in the Europe and the U.S. patent battles should wind down when the patents expire, which should be in 2008 (17 years after 1991 when the first U.S. patent was awarded) and 2010 (their second patent was warded in 1993).
2. Congress has taken an interest in umbilical cord blood and perhaps we will see more funding of research and clinical trials with umbilical cord blood stem cells.
3. The FDA is formulating its regulatory guidelines on umbilical cord blood and bone marrow transplants, hopefully streamlining the regulatory system.
4. As better technologies become available for collecting, storing, and expanding the cells, the cost should decrease, allowing companies to make more profit and invest more into research.
In the meantime, states can work with the new National Cord Blood Bank Network to boost the number of umbilical cord blood units.
Thank you, Dr. Young, for all your efforts to distribute accurate information on all aspects of your research. This is very useful information.
dz, you are very welcome. Umbilical cord blood is very interesting. Because it has perhaps 10 times more stem cells than regular blood, it should be able to provide cells that can make more blood and other cells than regular blood. At the present, we don't know how to isolate and grow the stem cells from umbilical cord blood. When that technology is developed, it will blow away the whole blood transfusion approach as we know it today. Can you imagine what a boon this would be for the quality of life of people who now have to get blood transfusions every couple of weeks because they have hemophilia and exposing themselves to the inevitable dangers of getting hepatitis and other diseases?
I am talking with a family right now that has a 4-month baby with spinomuscular atrophy (a horrendous genetic disease that is like amyotrophic lateral scleroris for infants). Nearly 100% of children with this disease die before age 2. Fortunately, the family had collected the umbilical cord blood from one of the siblings and the blood matches.
The above scenario is happening in thousands of families across the nation, whether it is SMA I, osteogenica imperfecta, or some other kind of disease. These desperate families are watching their babies die. It must be unbelievable agony for the family. Of course, we don't know whether the umbilical cord blood would work but, at this point, what choice is there? At the present, umbilical cord blood is the only option for this family. By the time embryonic stem cells becomes available, it will be too late from this baby.
Regarding your aunt, I have long believed that people who receive radiation therapy for cancer should get umbilical cord blood transfusions. Both chemotherapy and radiation therapy kill the stem cells in the body. Umbilical cord blood contains more stem cells and may replenish these. The main problem with umbilical cord blood transfusions that are not completely matched is that they may cause a graft-vs-host disease where the umbilical cord blood has cells that attack the host body. This only occurs in 1-2 cases out of 10. For some people and doctors, this is a too high of a risk to justify using umbilical cord blood transplants, unless of course there is a perfectly matched umbilical cord blood available.
Once the technology becomes available for expanding the stem cells in umbilical cord blood, the cost of stem cells will drop precipitiously. While it currently costs $23,000 for a unit of umbilical cord blood in the United States... if it is possible to grow the stem cells from umbilical cord blood, so that one unit of umbilical cord blood can treat 1000 patients, this means that the cost of collecting, storage, testing, and administration of the cells to a person will fall dramatically.
At the present, it costs about $1000 to collect a unit of blood, test it, and freeze it. It then costs $100 or more per year to store the cells. Shipping and pre-administration testing of the blood for diseases cost thousands of dollars. Of course, clinicians who administer the treatment gets paid, as well as technicians who administer the blood. All these costs add up.
Oh you didn't upset me Dr. Young. I'm glad you shared the information. I was already irritated with a bunch of other things unrelated. It was just another subject that's always on my mind. That's people dragging their A-holes when it's convenient for them when otheres have to pay for it. If you think about it you will number quite a few. So I really just had a little vent session.
My Dirt Bike Misses Me