#446 Friday, May 30, 2008 - FDA, THE CANCER SCARE, AND MY SECRET PLAN
Cancer is prevalent in my family. My mother died young (58) of breast cancer; my older sister died of leukemia, a form of blood cancer (age 23); my younger sister is battling both cancer and leukemia right now.
So when I hear that the field of stem cell research may be held up because of the possibility of cancer, how shall I feel?
Cautious, definitely. Cancer is a serious risk.
But the only way any of us can keep safe from cancer altogether is to live on a different planet.
The air we breathe, the water we drink—polluted. The food we take into our bodies—chemicals, pesticides, preservatives, all known carcinogens.
Should we stop the research because of that fear?
Should we say, no human trials with embryonic stem cells until we can guarantee there are no risks at all?
In other words, never?
As you know (if you have suffered through this column for any length of time) the FDA is considering allowing human trials for embryonic stem cell therapies.
April 10th was a hearing, and the transcript is available online, at the FDA page. (http://www.fda.
The number one topic—voiced on almost every page of the transcript—is the fear of cancer.
Over and over and over, statements are made about cancer and teratomas and tumors, as if our field was as dangerous as tobacco, which of course is allowed.
Numerous statements are made about not allowing the trials to go forward until all possible threats of cancer are removed.
Is there a risk of cancer?
Here are the facts, as plain as I understand them, and always with the proviso that I am neither scientist, nor doctor.
If a scientist were to put pure embryonic stem cells into my body, there would almost certainly be a teratoma. A teratoma is a lump, a growth, a tumor—not cancer. A teratoma is harmless of itself, unless it grows in a place where any lump would be dangerous—like the spine. We don't want it, but a teratoma is not cancerous.
Also—and this is important— a teratoma comes (if it does) only when undifferentiated embryonic stem cells are put in. To the best of my knowledge, no scientist wants to do this—nobody wants to put undifferentiated cells in. They want to differentiate (change) the cells first.
Think of a carpenter's nails, screws, nuts and bolts. These all begin as hot liquid metal, very dangerous to work with—but we do not use them in that formless shape—at the nail factory, the molten iron is poured into molds, and shaped, and cooled. We only use them when the metal is completely set.
Same with stem cells. The embryonic stem cells are differentiated—
In the Keirstead/Geron experiments, that means oligodendrocytes, cells to create myelin, cells to insulate damaged nerves in the spine.
These are already differentiated.
For the past few days I have been struggling with the nearly 300 page FDA report, the transcript of the April 10th hearing on embryonic stem cells and "safety". I put that in quotes because that is not all that is being debated; there is also the unsaid agenda which everybody carries.
All of us have a plan. With me, it is to advance the research.
With some of the folks in the hearings, it seems to be the opposite—what kind of logical-sounding excuse can they come up with that will delay human trials?
It is never easy, guessing the intent of people's minds. Honorable folks can disagree. Very intelligent folks, doctors and scientists, and as always, part of me wants to say, well, these folks are smarter than me, let them alone, don't make a fuss.
But everybody on earth is smarter than me in one thing or another—that does not mean I am going to keep silent. Not to mention I am a parent, and this affects my paralyzed son, and millions like him, all around the world, somebody's loved one, afflicted with one incurable condition or another.
I don't intend to be on my deathbed (many years from now!) and there is my son in his wheelchair beside me—still in his wheelchair? I am sure he would be polite and not actually say, gee Dad, if only you had stepped up to the plate…
No, before I head into the great beyond, I intend to see my son on his feet: walking around, kicking a soccer ball, or kicking an anti-science politician—sorry.
So I will always voice my opinion, no matter how much more qualified the opposition may be.
And I will also have a backup plan.
So here it is, my secret backup plan.
Roman and I will probably go to
Not now, of course. The research is not ready. But when it is, I think the Chinese will bring it together first. That's why I'm studying Mandarin every day, one hour, without fail: tapes in the car, books by my bedside, little cards in my wallet.
When the time is right, I will borrow on my house again, like I did when
I will work with a Chinese spinal cord injury surgeon (some of whom already do 300 traditional spinal cord operations in a year), and a scientist or two, make sure everyone knows exactly what has to be done (always assuming Roman agrees, of course) telling them in two languages exactly the mix of stem cells and neurotrophic agents or whatever has to be administered.
After the operation, I figure it will take six months of rehabilitation, which we will do in
Why
There is an American option, of course. I will write about that in the near future.
But to go from idea to implantation, the way it looks now, there are too many road blocks in the way. Naturally, I will be working to remove those obstacles, but… in a few minutes I will pick up my Chinese/English dictionary and start the morning practice.
Maybe I am wrong.
I hope I am.
But when I see cancer fear being systematically spread—even hyped!-- in the FDA report, it feels like they are just going through the motions, after which they fully intend to deny the trials.
Right now, as you know, the FDA orally notified Geron that the trials were "on hold", for unspecified reasons.
Geron is waiting for a letter from the FDA explaining those reasons.
It is my guess the FDA will deny the trials. The letter will say something like there are too many risks for the trials to go forward at this time, and here are a list of impossible conditions that must be met first, before embryonic stem cell research is allowed a chance.
If I am wrong, fine.
Some good people tell me, don't worry, be patient, just wait-- the next President will fix things.
But what if the FDA establishes guidelines that are impossible to meet, and those guidelines have to be overturned before human trials can take place?
It will be very hard for new FDA scientists to overturn safety standards, even misguided ones.
If the stem cell trials are blocked by unfair tactics, like setting the safety bar impossibly high, you and I will need to speak up.
Start thinking about this. Discuss it with your friends. Think about groups you belong to, media folks you may know.
Get ready.
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