Friday, May 8, 2009

Will The FDA Kill Adult Stem Cell Medicine?

I usually try to take a humorous approach to the serious issues involved with dealing with chronic illnesses such as multiple sclerosis. This issue is so serious, though, that I'm not finding much funny about it.

A recent news article raises some questions that are of utmost importance to any patient dealing with serious/chronic illness. Although the article is more an opinion piece then straight up journalism, the issues it talks about are vitally important.

In a nutshell, the piece is concerned with the fact that the FDA is currently in the process of deciding whether to classify adult stem cells as prescription medicines, which would thereby give the FDA the right to regulate the way such medicine will be administered. Please keep in mind, we're not talking about embryonic stem cells here, so there are no moral politics involved in this matter. At issue is adult stem cell therapy, which comes with none of the complicated moral questions surrounding embryonic cells. Instead, it's money, scads and scads of dollars, that are at the heart of the issue.

The drug companies (Big Pharma) are lobbying hard to get the FDA to declare stem cells "prescription drugs", thereby giving the drug companies considerable control over this revolutionary medical technology. Stem cells hold the promise of completely changing the face of modern medicine. They are the key to unlocking the human body's own ability to heal and regenerate itself. Stem cells could make the way medicine is currently practiced, with all of its invasive surgeries and use of potentially toxic pharmaceuticals, as obsolete as the medical practices of the 1700s are today.

This all presents a great threat to the pharmaceutical industry. Over the last 50 years, the marketing of pharmaceuticals has become an industry that generates hundreds of billions of dollars each year. Much of this money is generated by drugs used to treat "chronic" illnesses, such as diabetes and multiple sclerosis. Diseases such as these are cash cows for the industry, because patients stricken with them are forced to be consumers of the industry's products for life. Medicine is well on the way to transforming previously fatal diseases, such as some forms of cancer and AIDS, into chronic illnesses, creating yet more lifelong consumers of expensive pharmaceutical therapies.

The success of stem cells would mean that many of the medicines used to treat chronic illnesses would be rendered instantly obsolete. Big Pharma stands to lose billions and billions of dollars if the promise of stem cells turns out to be even only partially fulfilled.

It's important to remember that all of the companies that make up "Big Pharma" are public companies, and as such are by law beholden to their stockholders, not to the patients that take their products. Their primary mandate as public companies is not to benefit mankind through the creation of medical miracles, but to earn ever increasing amounts of money.

While on the face of it this would seem to be all well and good, as the best way for pharmaceutical companies to make money is to create effective drugs, there is actually a basic conflict to this equation. Turning potentially fatal or disabling diseases into manageable chronic illnesses generates huge amounts of wealth, but curing those same illnesses puts an end to the cash flow. Thus, we see great amounts of effort and capital going into researching drugs that treat illnesses, but not much going into research that might actually cure them.

I'm not suggesting that there is some evil conspiracy afoot, or that there is a cabal of miserly old men sitting in an opulent conference room somewhere, casually devouring infants as they plot to make untold billions of dollars by ensuring that illnesses are never cured. If that were the case, the solution would be easy, simply eradicate that opulent conference room and the baby eaters in it, and proceed on to the cures. Instead, the problem is much more insidious.

Over 70% of medical research in the United States is funded by the pharmaceutical companies. As stated before, the primary mandate of these companies is to make money, which they do best by discovering "blockbuster" drugs that will generate billions of dollars. Therefore, pharmaceutical research money is funneled towards projects that hold the promise of just such discoveries.

Research scientists, as well-meaning as they might be, still must rely on grants from pharmaceutical companies to fund their research (and therefore pay their rent, feed their families, and advance their careers), and thus are naturally inclined to conduct research that will attract pharmaceutical company dollars. In a way, it's a vicious cycle; pharmaceutical companies tend to fund only those projects which they think have the biggest profit potential, thereby influencing researchers and scientists, who, after all, need to make a living, to embark upon research that is likely to have the profit-making potential that the drug companies are looking for.

Stem cells threaten to throw this whole system on its ear. The process of extracting stem cells from a patient (usually from bone marrow or fat tissue) can be done in a doctor's office, and the processing of such cells can take place in laboratories outside the purview of the pharmaceutical companies. These procedures are not so complicated that the industrial might of the pharmaceutical industry is needed to make them a reality. They are more on the scale of fertility treatments, which are administered in local clinics by local doctors without the "help" of Big Pharma.

If the pharmaceutical industry is successful in its lobbying efforts to get the FDA to declare stem cells "prescription drugs", the power of stem cells will be ripped from the hands of physicians and placed in the hands of public companies whose profit-making mandate could actually lead to the suppression of potentially revolutionary stem cell therapies. This would have tragic consequences for the millions of patients that could potentially benefit from stem cell treatments.

Laboratory models and animal testing have shown that these treatments are extremely viable, and many could likely be ready to treat human patients within the next five years, if left in the hands of physicians and researchers. If, instead, stem cells are declared "prescription drugs", these therapies might not see the light of day for decades.

If you or a loved one suffers from a chronic illness, it is time for your voice to be heard. Call your senators, call your congressman, write letters to your newspapers. Demand that your friends and family do the same. Climb up on soapboxes and scream from mountaintops. Bang drums, put on face paint, and go on the warpath. Treat this issue as if your very life depends on it, because it does...


  1. It will interesting to see how Obama approaches this issue. He's supposed to be for the little guy and against the evil corporations.

  2. I find it hard to understand how FDA regulation of stem cells will cause stem cells "to be ripped from the hands of physicians and placed in the hands of public companies". Having the FDA regulate stem cell research is not the same as giving Stem Cell research exclusively to pharmaceutical companies and excluding the rest of the scientific community from working with this treatment.

    I worked in the pharmaceutical industry for years. While I no longer work in the idustry, I know that the FDA is respected world-wide as setting the standards for controlling the international pharmaceutical industry. The FDA is a watch-dog. It is not a lap-dog.

    I strongly believe that the medical community, pharmaceutical companies and doctors alike, NEEDS a strong regulator. Diethylstilbestrol (DES) and Thalidomide were attrocities that the medical world brought BEFORE the FDA was in charge.

    Stem Cell treatment is not a panacea, yet without regulation, charlatans could offer it as such.

    While I am not sure if the FDA is the best regulator of stem cells, the FDA is an established and well respected regulator.

  3. Pride, thanks for your comment. Opposing viewpoints are always welcome on this site.

    I agree 100% that all aspects of medicine need fair and efficient regulation. Unfortunately, over the last decade or so, the FDA has been seriously underfunded and the political frenzy to deregulate almost everything has stripped the FDA of some of its regulatory teeth.

    Over the last 12 months, we've seen multiple examples of drug companies withholding negative information and suppressing nonsupportive research data in their quest to get products approved. Also documented other questionable practices of paying researchers to put their names on ghostwritten reports, and their widespread efforts to influence the opinions of medical community through a very selective presentation of information.

    I don't object to the FDA regulating the medical practice of using stem cells as a therapeutic treatment. I do object to them labeling stem cells "prescription drugs", thereby slowing down ongoing research by imposing an already codified regimen of strict trial protocols that weren't designed with stem cell therapy in mind.

    Hypothetically, why should the FDA stand between me and my Dr., if my Dr. has the means and expertise needed to administer autologous adult stem cell therapy, once such therapy has proven to be safe and effective? The cells would be supplied by the patients themselves, in the form of bone marrow aspiration or fat cells harvested through liposuction. The processing of those cells could take place in the lab very similar to the fertility clinics that currently operate throughout the country.

    My fear is that the corrosive influence of the profit motive will impede what should be steady advances in stem cell research. The fact remains that the success of stem cells will have negative impact on the bottom line of pharmaceutical companies, entities that have been shown in the past to sometimes engage in activities antithetic to the public interest in order to protect their bottom lines...

  4. To piggyback on what Pride says, I think maybe you're overstating the simplicity of stem cell therapies a bit. I don't think it'll ever be something that can be completely managed within a relatively small doctor's-office-based-lab.

    To use your fertility analogy, some aspects of this are pretty simple (here's your magazine, sir, please use this little cup), but much of the rest is highly invasive and highly drug intensive, very much involving big Pharma.

    I would imagine that stem cell therapies would have similarities. The actual harvesting could happen in a clinic, but the differentiation/engineering and growth of the cells would require a pretty big lab, and for many therapies, I think it's safe to assume that the patient would require quite a bit of drug-based preparation for implantation of the cells.

    In this context, I would want to see a very robust regulatory structure. If the FDA were to take on this responsibilty, and at the same time be both politicized and de-fanged as it was during the Bush Era, this would be problematic. But I think the signals we're getting now (a green light for Federally funded adult stem cell research, revitilzed FDA, and the door opening on embryonic stem cell research) bode well.

  5. Hey John, it will certainly take large, sophisticated facilities to do the research that will hopefully develop into proper protocols for cell differentiation and transplantation, but once those protocols brought to maturation, I don't believe the application of stem cell therapy will be overly complicated.

    Not that this could be done in a typical internists office, but a facility with a lab dedicated to the processing of stem cells will not necessarily need to be something so sophisticated as to be the province only of University hospitals on the such. Something along the order of fertility clinic would probably suffice.

    As far as patients needing to "precondition" themselves for the stem cell transplant, I'm sure that this will vary from condition the condition. Obviously, there's a lot yet to be discovered.

    My main concern, though, is the threat stem cells post to mainstream medicine. The successful application of stem cells has the potential to redefine the medical landscape, and the "medical industrial complex" (Obama's words) might be quite resistant to such profit warping changes...

  6. Kamikaze:

    "Why should the FDA stand between me and my Dr., if my Dr. has the means and expertise needed to administer autologous adult stem cell therapy, once such therapy has proven to be safe and effective"

    The FDA does not stand between you and your doctor. Your doctor has the freedom to prescribe any drug for any reason. If your doctor wanted to prescribe a cancer medication for acne, s/he is free to do so. Your doctor is responsible for this decision.

    "The fact remains that the success of stem cells will have negative impact on the bottom line of pharmaceutical companies" This is a myth. I have heard something similar for years. For example there are stories that doctors already have a cure for cancer and the wicked drug companies are supressing it because they may lose profits. Stem cell research is a great breakthrough, but it is not a panacea. There are no pharmaceutical deamons trying to suppress every medical breakthrough. Such actions could not stay secret long. Can you imagine if Anderson Cooper got his hands on evidence of this? He would have a field day with such a story.

    Again, I would be more concerned about an unregulated medical community, then I would be about pharmaceutical companies trying to take advantage of this. I am not defending the pharmaceutical industry, like any industry they are profit minded and have been responsible for many disasters.

    However, regulating the medical industry (doctors and pharmaceutical companies alike) is important. Look what deregulation in the financial industry recenty did to the world. The medical community has also brought many evil deeds. The FDA may not be perfect, but it is pretty damn good and until someone else suggests a better alternative, I would not be so quick to condemn them.

  7. Pride: I think we actually agree more than we disagree. Regulation of the medical industry should be very rigorous. Unfortunately, the FDA has been underfunded for the past decade, and, like other government regulatory agencies, has been de-fanged in Washington's frenzy to deregulate everything.

    Since 2000, most of our regulatory agencies have grown uncomfortably close to the industries that they are intended to regulate. As you've noted, this has led to several disasters, the financial crisis being the most prominent example.

    And, of course, you are correct when you say that a doctor can prescribe any drug to any patient for any reason. The caveat there, though, is that they may prescribe any approved drug. My Dr. might want to prescribe me Sativex for my spasticity, but he would be unable to do so despite the drugs proven effectiveness, because the drug has not been approved by the FDA (it's cannabis-based). Likewise, if stem cells are classified as "prescription drugs", the cells themselves will be subject to FDA approval, and would be required to undergo the extremely long clinical trial protocol required of all prescription drugs. This would delay their use as therapeutic agents in the clinical setting.

    As I said in my original post, I don't believe that the drug companies are actively suppressing any medical breakthroughs or technology. Instead, the research model as it has evolved in this country revolves around studies that are apt to create huge profits for their sponsors, which 70% of the time are the pharmaceutical companies. There are a litany of possible MS remedies (LDN, 4-AP, various vitamins and supplements) that have not been investigated because they lack profit potential. This is a fundamental flaw in medical research as conducted in the United States.

  8. Stem cell therapy has been explained to me as kind of a reverse laparoscopy -- instead of deconstructing tissue and removing it, tissue is put in and expected to grow in a beneficial way. Adult stems cells themselves are just tissue. We all have them. I don't see how they could possibly be considered a prescription drug.

    Now if special equipment is required to extract, process, insert, or nurture the tissue as part of stem cell therapy, the FDA should be all over that equipment. The procedures for the therapy itself should be standardized by the research community, just like an organ transplant, or fat injection to make my lips more luscious.

  9. I would have to look it up but I recently read about people being denied treatment [sorry, I don't remember for what] because the GENE on which it was based had been patented to another company so no one else could use it. So no surprise that the drug companies want to have stem cells designated as prescription drugs. What a country!