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Bioethics Medicine Quackery

Oh, goody. Suzanne Somers has found new woo

Bizarrely enough, Suzanne Somers has been a common topic of discussion on this blog since the very beginning. Indeed, in one of my earliest substantive posts, way back in December 2004 when I had just started this blog on Blogger, I used her as an example of how misleading breast cancer testimonials can be. At the time, I only knew Somers as a breast cancer survivor who had decided to turn to “alternative” therapy. What she really meant was that she had undergone surgery and radiation but had decided not to undergo chemotherapy, opting instead for mistletoe extract

I also explained at the time that the reason “testimonials” for “alternative” medical therapies for breast cancer often sound convincing is that people don’t understand that in early stage breast cancer surgery is 90% of the cure. Radiation reduces the risk of local recurrence in the breast from about 1 in 3 to under 10%, and chemotherapy only reduces the risk of systemic recurrence (recurrence of the cancer anywhere in the body) by around 3%. Of course, the benefit of systemic therapy increases as an absolute percentage the nastier the tumor. As tumor stage increases, the relative benefit of chemotherapy increases–at least until Stage IV, metastatic disease, where the disease has become incurable and only palliation remains. Of course, in these cases, the woo-prone almost always attribute their survival more to the “alternative” therapy than any of that old-fashioned nasty “cutting” or “burning,” and Suzanne Somers appeared to be no exception.

Another characteristic of the woo-prone is that, well, they are woo-prone. Too much woo is never enough for many of them, and that certainly seemed to apply to Suzanne Somers as well. Her next misadventure was becoming enamored of so-called “bioidentical” hormones, which in reality are nothing more than female hormones synthesized to be chemically identical to the hormones normally produced in the body. Indeed, Suzanne Somers became the poster girl (actually, “girl” may not be an appropriate description of a 62 year old woman) for these hormones. But there was more to “bioidentical” hormones than just the hormones. Somers, like many of their advocates, attributed almost mystical properties to them, taking huge quantities. She seemed to view them as some sort of “fountain of youth” that would keep her appearance young and luscious forever–or at least until she dropped dead of old age, as all of us who manage to survive long enough without first dying of some other cause cause will do some day. She took it even farther than that, too, in that she postulated that hormone levels could be measured in the saliva and a cocktail of “bioidentical” hormones could be whipped up at a special pharmacy to replace exactly what hormones she was supposedly deficient in. Ultimately, her advocacy went straight into quackery in that she made claims that postmenopausal women should really have the estrogen levels of a 20-year-old.

As an aside, I can’t resist interjecting here how strange I find it that advocates of “natural” therapies don’t see anything incongruent about claiming that their therapy is based on “nature” as they pump themselves full of synthetic hormones. But that’s just me.

In any case, for a breast cancer survivor to pump herself full of estrogen is a very bad idea indeed. We know Somers’ tumor was estrogen receptor positive, meaning that estrogen could stimulate it to grow. Indeed, I’m guessing that her doctors probably tried to persuade her to take an estrogen blocking drug such as Tamoxifen or Arimidex daily for five years after her surgery, particularly if she was refusing chemotherapy. In actuality, estrogen blockade produces more bang for the buck than chemotherapy for patients with early stage estrogen positive tumors, and it’s a lot less toxic. Of course, the beneficial effects of estrogen blockade and chemotherapy are additive; so the best odds are associated with using both. Indeed, a breast cancer survivor who takes massive quantities of estrogen to “rejuvenate” herself is playing Russian Roulette with her life, plain and simple. That Somers has been lucky enough thus far not to have a recurrence of her breast cancer is just that–luck–and nothing to do with any of her health regimens. Worse, she made millions selling books advocating “bioidentical” hormone therapies and since her breast cancer treatment has diversified into a veritable cornucopia of “anti-aging” treatments that she hawks at her website Ageless-Diva.com.

I guess all that bioidentical hormone woo wasn’t enough for Somers, though. Once again following the premise of the woo-prone that too much woo is never enough, it appears that Suzanne Somers has decided that some new pseudoscience is necessary to–shall we say?–rejuvenate her business. But what? What would be the perfect complement to her existing portfolio of pseudoscience? What new technology that actually has a great deal of promise on a scientific basis but is still in its–excuse me–embryonic form? What technology has been abused again and again by charlatans and quacks in the quest for anti-aging, cures for blindness, or even as a “cure” for autism?

Yeah, baby! We’re talking stem cells! Except this time instead of embryonic stem cells we’re talking adult stem cells:

Successful Actress, Author, Businesswoman and Medical Advocate to Assist NeoStem in Public Awareness Program

07-29-08

NEW YORK, July 29, 2008 /PRNewswire-FirstCall via COMTEX/ — NeoStem, Inc. (Amex: NBS) has announced an alliance with Suzanne Somers to create a multi-year awareness program to help educate the public on the increasing importance of adult stem cell collection and long term storage. Ms. Somers has authored 17 books to date focusing on healthy living and anti-aging medicine and is a number 1 New York Times bestselling author. In her latest book Breakthrough, Ms. Somers explores cutting-edge science and delivers a smart, proactive review of the newest treatments for breakthrough health and longevity.

Because Suzanne Somers knows so much about biology and science. Yes, if I were forming a startup company to offer a legitimate, science-based therapy or service, Suzanne Somers is definitely the first person I’d approach to be my spokesperson. Who could instantly give my product more scientific cred than Suzanne Somers, I ask? Indeed, if I wanted to learn about the latest breakthroughs in stem cell biology and therapies, Suzane Somers is clearly the go-to person whose book I’d read first. If this press release is any indication, it looks as though we’re in for a long fall of infomercial hell featuring Suzanne Somers:

“Stem cell therapy is the most exciting new breakthrough in medicine. It gives me great peace of mind to know that my own stem cells will be banked as bio-insurance for me. Now I am prepared for my future as the beneficiary of medical benefits while I am alive.”

This adult stem cell public awareness program is expected to be launched in September of 2008. The timing of the campaign was designed to coincide with the establishment of new stem cell collection centers in certain major metropolitan areas. Ms. Somers is scheduled to have her stem cells collected at the new location of the California HealthSpan Institute in San Diego, so that they are available to her for her use in the future as physician confidence in adult stem cell therapy grows. In addition to distributing the filming of Ms. Somers’ own adult stem cell collection, NeoStem may feature her in print, TV and online promotions. Ms. Somers has become a supporter of adult stem cell research and the potential of using one’s own stem cells as part of a conventional therapy to treat disease and reverse tissue damage.

As I said, infomercial and commercial hell. Be sure to be very careful about watching late night TV. But what, exactly, is NeoStem? This is what its press release states:

NeoStem is developing a network of adult stem cell collection centers that are focused on enabling people to donate and store their own (autologous) stem cells when they are young and healthy for their personal use in times for future medical need. The Company has also recently entered into research and development through the acquisition of a worldwide exclusive license to technology to identify and isolate VSELs (very small embryonic-like stem cells), which have been shown to have several physical characteristics that are generally found in embryonic stem cells.

I see several problems with this service. First, there is no data that banking stem cells when you’re healthy is any better as far as their function goes than just harvesting them at the time they’re needed. In hematopoietic malignancies, like leukemias and lymphomas, stem cells are routinely harvested. It’s true that autologous stem cell therapy doesn’t work as well for leukemia in older people, but it’s not because the stem cells don’t work. It’s because it’s much harder to get older patients into a durable remission. Indeed, stem cells isolated after combination chemotherapy work just fine. Another problem is that we have no idea how long these cells can be stored with full activity. The company claims that “only 3%” die off every 20 years, but that doesn’t necessarily mean that the cells surviving are as functional as stem cells isolated and used immediately.

Here’s another problem:

Advances in technology now allows NeoStem to increase the number of stem cells in the peripheral blood. The process is called mobilization, which involves 2 injections of a medication that temporarily causes your stem cells, which reside in your bone marrow, to the peripheral blood.

Once you have completed mobilization the next step is apheresis a painless and safe procedure (similar to donating blood) which separates and collects, through a sterile, closed and disposable system, your stem cells from your peripheral blood.

In other words, they pump people full of Neupogen®, which is human granulocyte colony-stimulating factor (G-CSF) manufactured through recombinant DNA technology. It’s a hormone used as a drug, and it’s not without potential risks. For example, here are some potential, albeit uncommon, adverse reactions:

True, most of these adverse events are generally only seen with long term use of Neupogen®, but if you consider that there is no good science to suggest that harvesting and banking stem cells now is any better than doing it at the time they’re needed then why take even that small chance? It’s all risk, albeit small, for, as far as I can tell, no defined benefit.

Rick Lewis, blogging at blog.bioethics.net, while lamenting how he’s been scooped writing a book about stem cells, points out a number of other problems:

Suzanne must know something that I don’t. Said she in the news release, “Stem cell therapy is the most exciting new breakthrough in medicine. It gives me great peace of mind to know that my own stem cells will be banked as bio-insurance for me. Now I am prepared for my future as the beneficiary of medical benefits while I am alive.” Odd. When I left the International Society for Stem Cell Research (ISSCR) annual meeting in June, all I could think about was how much more we need to learn about how stem cells and their descendants talk to each other as they sort themselves into developmental pathways, and then reawaken to replenish and heal tissue.

Exactly. Particularly disturbing it this full-color, glossy brochure aimed at physicians and designed to sell NeoStem’s services. It concludes:

Collection and storage of adult stem cells is a joint process. By offering your patients access to NeoStem’s adult stem cell collection and banking services, you provide a unique opportunity for them to invest in their own health. In addition, your practice can collaborate with NeoStem to open an adult stem cell collection center in your area. For information about this exciting opportunity, please ask about our physician collection center program at 1.888.STEM BANK.

I’m sorry, but in the absence of a lot more evidence, selling this service to physicians and offering in essence to sell franchises of NeoStem’s centers to physicians strike me as profoundly unethical. Think about it this way, as well. A while back, I heard about similar services that harvest umbilical cord blood for stem cell isolation from babies. Looking into it, I saw that they charged several hundred dollars a year to store the blood, and I would expect that NeoStem probably charges at least in the same ballpark for its services. Even if it works exactly as described, the very concept strikes me as an extremely expensive “insurance policy” against an event that is very unlikely to happen, namely that the “insured” develops a disease requiring stem cell transplant for which his or her own stem cells can’t be harvested and used. Otherwise, as I said before, there’s no reason to bank stem cells; they can almost always be harvested when needed, except in the cases of certain malignancies, for which autologous stem cell transplant is not possible and donated stem cells are required.

The bottom line is that it’s important to realize that not all woo is mystical or magical, (like reiki) or complete pseudoscience (like homeopathy). A considerable amount of it is often the misapplication of science that is simply not ready to be used in patients yet. Stem cells represent just such woo. Other than already defined uses in hematopoietic and a few other malignancies, there is no science- and evidence-based use for them as yet that has accumulated sufficient data regarding efficacy and safety. Of course, I could be snarky and point out that the fact that Suzanne Somers is NeoStem’s spokesperson should tell you all you need to know about the service, but I won’t.

OK, I lied. I couldn’t resist. It’s just too easy, and, my pseudonym notwithstanding, I am human after all.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

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