A pro-embryo group has filed a lawsuit against the National Institutes of Health (NIH) alleging that the new stem cell policy of the Obama administration violates federal law. According to the members of the group, they filed the court case in order to protect embryos. In fact, one of the plaintiffs listed in the filing is named simply as "embryos".

The lawsuit was filed in federal district court in Washington, D.C. in a 28-page-long document. Besides "embryos", additional plantiffs include Dr. James Sherley, Dr. Theresa Deisher, and Nightlight Christian Adoptions, each of whom is listed "individually and as next friend for Plantiff Embryos". Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association are also listed as plaintiffs, but not as "next friend for Plaintiff Embryos".

Dr. Deisher is director of R&D at AVM Biotechnology in Seattle, and Dr. Sherley is currently an adult stem cell researcher at the Boston Biomedical Research Institute although he is perhaps best remembered as the former Massachusetts Institute of Technology professor who went on a hunger strike in 2007 in order to protest a lack of faculty diversity at M.I.T. after he was denied tenure. Nightlight Christian Adoptions is an organization which encourages adoptions of left-over embryos from fertility clinics.

The defendants are listed as Kathleen Sebelius, Secretary of the Department of Health and Human Services, in addition to the Department of Health and Human Serivces itself, and Dr. Francis Collins, director of NIH, in addition to NIH itself.

Complaints filed in the lawsuit assert that the new federal policy on human embryonic stem cell research enacted by the Obama administration violates the Dickey-Wicker amendment. According to Drs. Sherley and Deisher, federal guidelines "authorize public funding of research that depends upon and, indeed, requires the destruction of living human embryos."

In March of last year, Nightlight and others filed a similar lawsuit in the U.S. District Court in the state of Maryland. According to Tony Mazzaschi of the Association of American Medical Colleges in Washington, D.C., the new lawsuit doesn’t stand "a chance in hell" of succeeding.

(Please see the numerous related articles on this website, including but not limited to: "Obama Decrees Changes in Embryonic Stem Cell Research, Though Not What One Might Expect", dated March 9, 2009; "Obama Rescinds Bush-Era Executive Order Pushing for More Ethical Stem Cell Research", dated March 10, 2009; "Obama Signs Law Restricting Federal Funding of Embryonic Stem Cell Research", dated March 11, 2009; "A High-Profile Proponent of Embryonic Stem Cell Research Sharply Criticizes Obama’s Policy", dated March 13, 2009; "Members of The President’s Council on Bioethics Object to Obama’s Stem Cell Policy", dated March 26, 2009; "NIH Issues Guidelines Restricting Embryonic Stem Cell Research", dated April 17, 2009; "Embryonic Stem Cell Advocates Protest NIH Guidelines", dated May 25, 2009; "Pros and Cons of the New NIH Guidelines", dated June 3, 2009; "NIH Receives Nearly 50,000 Comments", dated June 5, 2009; "Obama Scraps Bioethics Council", dated June 17, 2009; "NIH Issues New Guidelines", dated July 7, 2009; "New Director of NIH Chosen", dated July 8, 2009; "New NIH Stem Cell Guidelines are Slowing Research", dated July 14, 2009; and "Clinical Results From Embryonic Stem Cells are ‘Decades Away’", dated July 15, 2009, among other articles).

If you are between the ages of 18 and 60, in good health, and would like to do a good deed, the "Be The Match" registry would like to solicit the donation of your adult stem cells.

Operated by the National Marrow Donor Program, the Be The Match registry is the largest in the world, arranging approximately 4,300 transplants a year. Although originally begun for bone marrow donations, the registry has now expanded to include adult stem cell donations, for which the process is relatively simple, quick, and provides a valuable, life-saving service to others.

Upon signing up, new registrants will receive a collection kit in the mail, with which a swab of cheek cells may be collected and returned to the registry. Those registrants who are identified as a potential match will then be contacted for further testing.

Of particular interest to the registry are the type of adult stem cells known as hematopoietic stem cells, which are found in umbilical cord blood, peripheral blood, and bone marrow. Umbilical cord blood is the most easily collected, as it can be cryogenically stored immediately after a child’s birth. Bone marrow donation is the most difficult to collect, since it must be surgically extracted under general anesthesia, a process which is contraindicated in many patients who are already weakened by age or disease. The collection of adult stem cells from peripheral blood is performed by a process known as apheresis, in which blood that is removed from one arm is passed through an apparatus that extracts the stem cells and then returns the remaining blood cells to the other arm.

Currently approximately 60% of the registry’s transplant procedures involve adult stem cells that are derived from peripheral blood, while 20% of the procedures use adult stem cells derived from umbilical cord blood, and the remaining 20% of the procedures involve bone marrow.

As described on the website of the registry, "Donors never pay for donating and are never paid to donate. All medical costs are paid by the patient’s medical insurance or by the patient, sometimes with assistance from the National Marrow Donor Program (NMDP)." Nevertheless, the website also adds that, "The total cost to add a new member to the Be The Match Registry is about $100. This includes the cost of the testing needed to match donors to searching patients and related costs."

Individuals interested in donating their cells to the registry, or in finding a match for their own medical needs, may obtain more information at www.marrow.org.

Nearly two years ago, Sheila Weiler suffered a stroke during childbirth which left her paralized on her left side. Now, she has decided to travel to Germany in order to receive autologous adult stem cell therapy which is not available in her home country, the United States.

In Germany, Sheila’s own adult stem cells will be harvested from her bone marrow through her hip, and after being purified and expanded in the laboratory the stem cells will then be placed directly into the damaged tissue of her brain.

As Sheila describes, "At first I thought it was a pipe dream and I would never really go and this would never really happen. With this I have an opportunity to show my children determination and inner strength and never to give up."

Although none of the reports about Sheila actually mention the particular clinic in Germany to which she will be traveling, odds are that she will probably be visiting the XCell-Center, which is a private institute for regenerative medicine that has clinics in both Dusseldorf and Cologne. The Center is becoming increasingly renowned for its use of adult stem cell therapies in the treatment of a wide variety of medical conditions, including stroke, and since its founding in 2007 the XCell-Center has treated more than 1,600 patients with autologous (in which the donor and recipient are the same person) adult stem cell therapy.

The XCell-Center strictly uses only adult stem cells. At no time are embryonic stem cells ever used in any of the Center’s therapies. As described on their website, "The XCell-Center treats patients with their own autologous adult stem cels. It is the first private institute worldwide to hold an official license for the extraction and approval of stem cell material for autologous treatment." As further described on their website, "…therapy with embryonic stem cells is strictly prohibited in Germany. At the XCell-Center, we only use the patient’s own stem cells for therapy. … Because our adult stem cell treatments use stem cells harvested from the patient’s own body (autologous cells), there are no ethical or moral concerns."

As in the U.S., autologous adult stem cells are classified as "drugs" in Germany, and therefore require government approval before they can be used in any clinical treatment. Unlike in the U.S., however, German law makes a distinction between "drugs" of individual origin that are for personal use, and drugs that are manufactured by the pharmaceutical industry for large-scale commercialization. As explained on the website of the XCell-Center, "The use of endogenous adult stem cells is ethical and legally straightforward. Under German law, the extracted stem cells are categorized as drugs. Because they are exclusively for personal use, they are individual drugs, and under German law do not require the same governmental approval as other drugs. Despite this, the clinic still has to obtain a manufacturing license from the surveillance authority."

A "manufacturing license" is significantly different from the decade-or-longer, multi-million dollar, multi-phase clinical trial process in the U.S. to which all new "drugs" must be subjected before they can receive FDA approval. Currently in the U.S., even an individual’s own, personal, autolgous adult stem cells are required to be scrutinized by the exact same bureaucratic system to which pharmaceutically manufactured drugs are subjected, which involves a lengthy and outdated process that typically takes a decade or longer and costs the sponsoring company hundreds of millions of dollars.

If U.S. federal laws were different, and if autolgous adult stem cell clinics could be set up in the U.S. merely by obtaining a "manufacturing license", as such clinics in Germany are allowed to do, then U.S. citizens such as Sheila Weiler would not be forced to leave their own homeland to travel to foreign countries in order to receive a type of adult stem cell therapy which is not available in the United States but which was, in fact, pioneered in the United States.

Tissue injury is known to cause stem cells to exit the bone
marrow, where they normally reside, and enter into circulation, apparently en
route to attempt to repair the area of injury.  This concept has been
demonstrated in patients with heart attacks, in that following damage to the
heart muscle, an increased number of stem cells is observed in circulation, as
is described in this video

http://www.youtube.com/watch?v=NqEggEYilh0.  The same holds true in patients
with stroke, in that after a stroke, there is an association between higher
number of endothelial progenitor cells (a type of stem cell that gives rise to
blood vessels), and positive neurological outcome (Dunac et al. Neurological
and functional recovery in human stroke are associated with peripheral blood
CD34+ cell mobilization. J Neurol. 2007 Mar;254(3):327-32).  This is one of
the reasons why patients take nutritional supplements such as Stem-Kine that
increase the numbers of stem cells in circulation.

In a recent study from the Department of Genetics, of the
Southwest Foundation for Biomedical Research, in San Antonio, Texas researchers
attempted to dissect specifics of how tissue damage increases the number of
circulating stem cells.  Since heart attacks and strokes occur in different
degrees of severity in people, the scientists used a reproducible model of
tissue injury in baboons.  They blocked circulation to part of the leg by tying
off the femoral artery.  As a comparator approach, they injected other baboons
with the drug granulocyte colony stimulating factor (G-CSF) which is currently
used by hematologists to "harvest" stem cells from the blood of stem cell
donors. 

In baboons receiving G-CSF and the group inflicted with
circulation blockade, the increase in stem cells in circulation peaked at day
3.  The stem cells expressing CD34 were twice as high in the circulation of
animals that received G-CSF as compared to the animals with ligated femoral
artery.  In contrast, another type of stem cell, the CD133+/KDR+/CXCR4+/CD31+
cell, which represents endothelial progenitor cells, was detected at higher
levels in ligated animals as compared to G-CSF treated animals.  When these
cells were grown in tissue culture plates, they resembled functional blood
vessel cells called "endothelium"

This study suggests that different types of stem cells are
"told" by conditions in the body to leave the bone marrow and to go into
circulation.  Given that ligation of an artery is expected to cause damaged to
the endothelium, it is conceivable that the release of endothelial progenitor
cells is occurring in order for the body to attempt to heal injured tissue.  If
this concept is correct, it will be interesting to see if the stem cells that
increase in circulation in patients with a heart attack have a propensity to
become heart cells when placed in tissue culture.  The other interesting point
raised by this study is whether chemicals can be administered that would assist
the body in increasing the number of the proper type of stem cell in circulation
after injury.

In any commercial endeavor, caveat emptor must be the consumer’s guiding principle, and the medical profession is no exception to this rule. Now, as patients in increasing numbers continue to travel outside of their own countries in search of stem cell therapies that are only available in foreign lands, increasing problems and dangers are being reported.

Last month, for example, police in Hungary arrested four people in a raid that was conducted on a suspected "guerilla" stem cell clinic. According to a report in Reuters at the time, the clinic was charging patients as much as $25,000 per treatment with illegally obtained embryonic and fetal stem cells which were derived without authorization and without safety testing. Such a report is merely one instance of numerous similar events that are being reported with increasing frequency. In response to the escalating prevalence of such incidents, in December of last year the International Society for Stem Cell Research issued a new set of cautionary guidelines for patients.

According to Dr. Insoo Hyun, associate professor of bioethics at Case Western Reserve University School of Medicine in Cleveland, Ohio, "Stem cell research is progressing so rapidly and has sparked a lot of interest in translational research including among patients in hope for therapies. At the same time, legitimate science is speeding ahead and getting to the point where there needs to be more of a roadmap to take the basic knowledge to clinical applications." It was nearly a year ago when Dr. Hyun predicted it is "only a matter of time" before someone is physically harmed by bogus stem cell therapies somewhere in the world. According to Dr. Paul Sanberg, professor of neurosurgery and director of the University of South Florida Center for Aging and Brain Repair in Tampa, "We clearly need guidelines for around the world to make sure that appropriate research is done before clinical work is undertaken in patients. We see desperate patients all the time and want to make sure that any therapies they take come from responsible research groups." Similarly, Dr. Darwin Prockop, chairman of Genomic Medicine and director of the Institute for Regenerative Medicine at the Texas A&M Health Science Center College of Medicine, adds, "There is tremendous confusion about the two types of stem cells, embryonic stem cells and adult progenitor stem cells. The difference is monumental, and needs to be clarified." Although there do exist a number of clinics around the world which actually offer legitimate, scientifically based adult stem cell therapies, there also exist a number of clinics which do not offer anything of scientific legitimacy, even though they fraudulently purport to be legitimate.

Authored by a task force composed of stem cell specialists from 13 countries, the guidelines that were issued last year address, among other topics, questions of ethical review, quality and safety, voluntary informed consent of participants in research projects, careful monitoring of volunteers, and caution in using stem cell therapies outside of a research context. Hopefully, the ethical principles which are at the very essence of such guidelines will be given serious attention and consideration by stem cell researchers throughout all countries of the world, at least eventually. So far, however, such is not the case.

In addition to the need for ethical guidelines, there is another lesson to be learned from the increasing number of bogus stem cell clinics that are springing up around the world. Namely, the necessity and urgency of consumer-patient guidelines also highlights the necessity and urgency for formal, official government approval of those adult stem cell therapies which have already been proven to be safe and efficacious, so that more clinics that offer such therapies will be allowed to open in their native countries, such as the United States, instead of having to locate themselves overseas in foreign countries where they are competing against the clinics that offer bogus therapies. In other words, an updated revision of the FDA approval process, so that it is directly relevant to stem cell therapies, would allow more adult stem cell therapies to be available throughout the U.S. to more patients with various diseases and injuries, who could therefore benefit from such therapies, but for whom such therapies are not yet available within the United States. The current FDA approval process, which was designed decades ago with the specific goal of testing safety and efficacy in pharmaceutical drugs, is in many ways neither relevant nor logical when applied to the testing of stem cell therapies. Such a topic is highly complex and could constitute an entirely separate publication unto itself. Suffice it to say that a swifter, more precise and more modernized FDA approval process which is specifically tailored to stem cell therapies is desperately and urgently needed in the U.S., as is its equivalent in other countries.

As Dr. Hyun explains, "Most of the time, stem cell products are presenting entirely novel products that are unpredictable in humans. Unlike drugs, you can’t just create a batch and put them on the shelf and expect they will be the same. We need uniform quality control and manufacturing. And if they’re embryonic or pluripotent stem cells, they could form unwanted tissues or tumors. So, we have to be very careful about following up and monitoring patients."

At the crux of the problem, at least for people who reside in the U.S., is the fact that the U.S. FDA has designated each person’s own cells in their body to be "drugs". A prime example of the implications of such an official government stance maybe be seen in the biotech company Regenerative Sciences, which found itself at the center of this important controversy when, in July of 2008, the company’s founding CEO, Dr. Centeno, received a letter from the U.S. FDA stating that the autologous adult mesenchymal stem cells processed with Regenexx, the company’s proprietary product, are considered to be "drugs" since they are intended for therapeutic use. According to the FDA letter, "These cells are considered drugs because the therapeutic claims shown on your website demonstrate that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man." The letter concluded by stating, "Please be advised that in order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations… The mesenchymal stem cells utilized in your Regenexx procedure are not the subject of an approved biologics license application (BLA) nor is there an investigational new drug application (IND) in effect. Therefore, your implantation of the mesenchymal stem cells for which a valid license or IND is not in effect appears to violate the Act and the PHS Act and may result in the FDA seeking relief as provided by law."

Regenerative Sciences responded by posting the following notice on their website, which was most recently updated on March 31, 2009: "Last summer we got a letter from the FDA stating that they felt that our Regenexx medical procedure was actually the manufacturing of a new drug. The letter made no sense, as what we’re doing is practicing medicine. We kindly wrote back stating our position and then we didn’t hear back for more than half a year. Recently, the FDA has again asserted that they believe we are manufacturing a drug. They haven’t given any credible rationale for why they believe this, as what we’re doing with adult stem cells is no different than the average fertility clinic that grows embryos in culture for re-implantation. The fertility clinic is not regulated as a drug manufacture facility. The fertility specialists fought that fight and won."

This is a critically important issue, since it illustrates the frustration that many, if not all, adult stem cell scientists in the U.S. feel, as it this stance by the FDA which poses an insurmountable, not to mention entirely illogical, hindrance to the availability of adult stem cell therapies in the United States. For anyone who has ever wondered why it is that adult stem cell therapies are available in ordinary clinics in most countries outside of the U.S., but only in a limited number of FDA-approved clinical trials within the U.S., here’s your answer: the FDA considers each person’s own autolgous adult stem cells to be a "drug", and therefore those stem cells are subject to the same multi-year, multi-million-dollar clinical trial process through which all pharmaceutically manufactured drugs must pass before being considered legally marketable within the United States.

The statement on the website of Regenerative Sciences continues: "ASCTA (American Stem Cell Therapy Association) is a physician organization that was formed in opposition to the FDA’s position that adult stem cells are drugs. This group heralds a much bigger movement than what we’re doing here with the Regenexx procedure. We’ve found literally an outcry by patients with chronic diseases that the FDA would stand in their way of getting safe stem cell work performed by their doctors. We agree that there are hundreds of likely unsafe stem cell outfits around the globe injecting God-knows-what into whoever has the will to pay. All the more reason for an organization to step to the forefront to establish physician-run guidelines for safe lab practices and clinical oversight… The pre-clinical research on adult stem cells is much stronger than embryonic stem cells… When I’ve posed the question to numerous doctors and experts in the field, are your own stem cells drugs? They look at me like I’m crazy, and often reply ‘Of course my stem cells aren’t drugs!’ Why would the FDA take the position that your cells are drugs… The ASCTA physician group will be getting out its lab practices guidelines meant to hold new adult stem cell practices to the highest standards to protect patients. Our goal is clear and it’s worth fighting for: Safe Stem Cells Now!"

Likewise, the ASCTA has posted the following statement on their website: "The American Stem Cell Therapy Association (ASCTA) announced today the online publication of its mission statements and charter. The organization was formed in response to the Food and Drug Administration’s (FDA) recent position that the adult stem cells found in everyone’s body are drugs, a position the ASCTA opposes. This physician organization is establishing laboratory guidelines that will allow doctors to bring adult stem cell therapy to their patients more quickly. These guidelines will be similar to those used by fertility specialists in in-vitro fertilization (IVF) labs, where many of the same cell culture techniques are used."

Dr. Centeno, one of the founding members of the ASCTA, is quoted on the ASCTA’s website where he states, "Many patients are dying or suffering daily with incurable diseases or problems that require major surgery. These patients should have access to basic adult stem cell therapy now. ASCTA is establishing guidelines which will allow the safe use of the patient’s own adult stem cells under the supervision of doctors." According to Dr. Frank Falco, another ASCTA founding member who is also quoted on the ASCTA’s website, "The FDA’s position against someone using their own stem cells is taking it too far. We are talking about a person using their own tissue to treat a degenerative disorder or process safely without the use of medications or surgery. Although we agree that oversight and standards are necessary, this should be provided through a physician organization such as ASCTA rather than by a government agency."

Not all stem cells are created equal, of course, and it is vitally important that the FDA make distinctions between embryonic, fetal and adult stem cells. In this regard, the ASCTA website continues, "Adult stem cells are different than embryonic stem cells. Adult stem cells are found in the patient’s body in various tissues. In order to obtain enough stem cells for treatment, they often need to be cultured, similar to today’s fertility treatments. Adult stem cells have undergone much more research than embryonic stem cells and therefore are closer to real world treatments. These adult stem cells are taken from the patient’s own body (autologous) and ASCTA believes that they are therefore the safest for use in treating patients." To this Dr. Centeno adds, "While the Obama administration seems to have opened the embryonic stem cell door, their FDA seems to want to slam the adult stem cell door shut."

As also stated on their website, "The ASCTA is a physician group comprised of various medical and surgical specialists whose goal is to bring safe stem cell therapy to patients by establishing laboratory and clinical guidelines." More information is available at www.stemcelldocs.org. Additionally, in April of 2009 a patient movement called "Safe Stem Cells Now!" was formed in response to the FDA’s unfounded position that a person’s own adult stem cells are "drugs" and therefore should be regulated in the same manner. More information is available at www.safestemcells.org. As Barbara Hanson, cofounder of www.stemcellpioneers.com, states, "Adult stem cells are cells from our own body. They are very safe. There are no moral or ethical issues. They are safer than taking aspirin and yet the FDA has classified our own stem cells as drugs that require regulation. This means that prolonged investigations, including lengthy clinical trials, will be required for each and every disease and application that adult stem cells could be used for. This could take years and years. It smells of big pharma to me and many others."

Indeed, many people feel that this stance by the FDA is purely politically and economically motivated. At the very least, it is an entirely unscientific stance, and it is merely one example of the numerous ways in which the FDA needs to update its regulations so that these regulations are relevant and applicable to stem cells, which do not fall into any of the previously existing categories for which the FDA has ever had to formulate national law in the past. Such outdated laws are precisely what is driving many of the best and most accomplished adult stem cell physicians and scientists "off-shore", to set up their laboratories and clinics anywhere at all in the world, just as long as it is outside the borders of the United States. In the end, it is the U.S. patient who suffers, since the researchers and clinicians themselves are not stopped but are merely forced to relocate to other countries. Until the FDA is able to recognize the numerous and vast differences between an autologous adult stem cell and a pharmaceutically manufactured drug, it is no wonder that adult stem cell companies and physicians are forced to set up their businesses outside of the U.S., where the scientifically ethical and legitimate must compete against the scientifically unethical and illegitimate, and where the patient-consumer is not always able to distinguish between the two.

As with any endeavor, however, in any market, consumers must arm themselves with the power of knowledge, which is their greatest defense. Especially where the quality of a product or service can make the difference between life and death, such as with stem cell therapies, it is all the more critically important that the buyer beware.

On the one hand, there are those scientists who believe that cancerous cells originate from specialized "cancer stem cells", that exist in small numbers and reside only in specific "niches", and a number of publications in respected medical journals substantiate such a belief with persuasive evidence. On the other hand, however, there are those scientists who insist that such evidence is inconclusive, citing equally persuasive evidence to the contrary, and insisting therefore that the "cancer stem cell theory", as it is known, will eventually be disproven.

Since different types of cancer behave very differently from each other, with each type exhibiting its own unique properties and characteristics, no doubt the truth will eventually show that the "theory" applies to some cancers but not all. In other words, it is possible that some types of cancer originate from small numbers of cancer stem cells hidden in niches, while other types of cancers do not. Meanwhile, however, a new discovery now adds further fuel to the ongoing debate.

Scientists at the Broad Institute, a collaborative Harvard-M.I.T. genomics research project, have now devised a method for the utilization of drugs that can attack and kill the putative cancer stem cells, while leaving ordinary, healthy cells unharmed. Led by Dr. Piyush Gupta, the team of researchers has successfully screened 16,000 chemical agents for their ability to target and kill breast cancer stem cells. Included in the list of screened chemicals were all those currently approved by the U.S. Food and Drug Administration, from which the scientists found that 32 of the chemicals have the ability to selectively target and kill cancer stem cells, although only one of the 32 chemicals is currently approved as an anticancer drug. In particular, salinomycin was found to destroy both the cancer stem cells that were generated in vitro, in the lab, as well as those that occur naturally, in vivo. When compared to paclitaxel, the common breast cancer drug, salinomycin was found to reduce the number of cancer stem cells by more than 100-fold, while also inhibiting breast tumor regrowth in mice.

The technique, know as "epithelial-to-mesenchymal transition", generates large numbers of cancer cells with stem-cell-like qualities. According to Dr. Tamer Onder, formerly of the Whitehead Institute for Biomedical Research but now a postdoctoral fellow at Children’s Hospital in Boston, "A critical aspect of our work was to generate relatively homogeneous and stable populations of cancer stem-cell-like cells that could then be used for screening. We were able to achieve this by inducing the cancer cells into an epithelial-to-mesenchymal transition using novel reagents that we had developed in the lab."

The discovery has been met with great enthusiasm by some, and great skepticism by others.

It is a well known fact that many types of cancer are highly resistant to conventional medical treatments such as chemotherapy and radiation. Even though chemotherapy may successfully kill as much as 99% of the cells in a tumor, it is the remaining 1% that is the most virulent and is often the source of recurring cancer. Such a common, unsophisticated observation has added strong evidence to the "theory" that some types of tumors develop from specialized cancer stem cells, hidden away in specialized "niches", and it is these stem cells which are believed by some researchers to be so resistant to radiation and chemotherapy, and hence to play a prime role in metastasis. As Dr. Eric Lander of the Broad Institute explains, "If we make a drug that kills 99.9% of the cells in a tumor but fails to kill the 0.1%, that is the real problem. It’s a pyrrhic victory." As he further adds, this innovative new drug screening method may allow "a potential for a real renaissance in cancer therapeutics."

Skeptics remain, however. According to Dr. Bert Vogelstein, a cancer geneticist at Johns Hopkins University, "The cancer stem cell hypothesis has in the past year been challenged on many fronts. For example, a paper on melanomas last year showed that 100% of melanoma cancer cells were cancer stem cells." However, melanomas behave very differently from, say, breast or prostate cancers, for example, and in recent years there have also been numerous discoveries of stem cells that were found in niches in many types of solid tumors, including those of the breast, the prostate, the brain, the colon and the pancreas. Earlier this month, another team of researchers, led by Dr. Irving Weissman of Stanford University, reported the additional discovery of a similar type of stem cell in bladder cancer. Offering yet another counterpoint to Dr. Vogelstein’s stance is Dr. Robert Weinberg, a cancer biologist at the Whitehead Institute for Biomedical Research at M.I.T. and a coauthor with Dr. Lander of the new report, who states that, "Evidence is accumulating rapidly that cancer stem cells are responsible for the aggressive power of many tumors."

Instead of simply acknowledging that all cancers are different and that it is therefore possible for some types of cancers to originate from a small number of cancer stem cells residing in niches, while other types of cancer do not neccesarily need to match such a model, instead the experts in the field insist that there must be only one theory and one model with one explanation for all types of cancer, and thus the arguments continue to escalate over who is right and who is wrong. As Dr. Michael F. Clarke of Stanford University explains, "It’s the most amazing polarity that I’ve seen. It’s like two religions fighting."

Diplomatically offering a possible solution for both camps, Dr. Weinberg further states, "The possibility is that the non-stem-cell cells in a tumor may regenerate de novo new stem cells. If one had ways of treating both the stem cells and the non-stem cells, then the de novo generation of stem cells would be dealt with." Dr. Vogelstein further adds, in apparent agreement, that if it is true that stem cells are commonly found throughout solid tumors, rather than just in a small reservoir of "niche" cells, "then there’s no difference between the stem cells and the bulk cancer, so a screen for drugs to kill melanoma cells is by definition also going to kill the melanoma’s cancer stem cells." From either perspective, the new techniques developed at the Broad Institute may fall into exactly this category.

Somewhere in the middle of the debate, there are a number of scientists who believe that the new methods developed by the team of researchers at the Broad Institute have important clinical implications, regardless of whether or not the cancer stem cell niche theory is correct. As Dr. Vogelstein explains, "Because most of the compounds in use now clearly aren’t doing the job we’d all like, then novel methods for screening could be extremely valuable." According to Dr. Gupta, and in reference to conventional radiation and chemotherapeutic modalities, "You could probably lower the doses considerably with a combination of drugs that attacked specific types of cells."

Along those lines, and disregarding the ultimate outcome of the debate, researchers at the Broad Institute hope that their screening methods will be of possible commercial interest to pharmaceutical companies, for the eventual development of a new class of anticancer medicine.