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August 11, 2010
Posted by admin

Big Pharma losing sleep over stem cell approval?

Anyone reading this is no doubt aware of the fact that Geron (Nasdaq: GERN) just received FDA approval for the first human embryonic stem cell (hESC)-based human clinical trial, targeting spinal cord injuries.

This approval is great news for the industry, and is clearly a watershed moment for the regenerative medicine sector and embryonic stem cell research. The news received coverage from major media outlets in the US and abroad, much of which also discussed ACT’s RPE program using hESCs, for which it anticipates FDA approval this year (ACT news and media coverage here).

Less discussed, though, is the bigger picture. Not many commentators thus far have stepped far back and taken a look at what this approval could mean for the pharmaceutical industry over the long-term. Over half a trillion dollars (yes, trillion) worldwide is spent on pharmaceuticals each year. If hESC-based therapies fulfill their promise, they will offer actual cures for a variety of debilitating diseases and conditions, potentially tapping into a chunk of this massive annual expenditure, and saving untold tens of billions of dollars in medical and related expenditures in the process.

Drew Voros, Business Editor of the Oakland Tribune (Oakland, Calif.) recently took a hard look at this and related issues. Full Story; Voros: Drugmakers losing sleep over Geron’s stem-cell test, and highlights from his piece follow.

You’ve seen those TV commercials where someone lying awake in bed stares wide-eyed at the ceiling as if sleep will never come. Then, a patient spouse rises and pushes a pill from the gods ofslumber. The blurb ends with a deep-sleeping signoff.

Some folks in the pharmaceutical industry began wrestling with their own insomnia last week, but a simple pill won’t cure their newfound anxiety. Sleep becomes elusive when game-changing possibilities challenge your hugely profitable business.

Last Friday, Menlo Park-based Geron said that federal regulators will let it proceed with the world’s first human test of a treatment made from embryonic stem cells. Success in this preliminary safety trial could bring a type of health care reform that sounds like science fiction: drugless cures and treatments.

Imagine the obsolescence of pharmaceuticals for thousands of health problems. Of course, the savings would be astronomical, not to mention the quality of life would improve for millions of people. This is why drugmakers are losing sleep. Cures for diseases and serious injuries will be horrible for business.

But what is revolutionary about last week’s news is not the science but the fact the United States government has finally approved a test using stem cells on humans. The game is truly on, and the potential for change is great.

[snip]

This is just the beginning [...] Beyond the effects of injury and disease, patients also suffer from secondary conditions for which pharmaceutical companies market thousands of drugs.

Treating the millions of Americans who suffer from spinal cord injuries costs our health care system hundreds of billions of dollars.

If you like math, multiply that savings by the number of diseases that embryonic stem cell treatments might be able to cure. You can start to see how profound this change to health care economics would be.

We are still many years away from someone walking onto “Oprah” to explain how stem cells cured his or her paralysis, or how stem cell treatments wiped out a child’s diabetes. But if drugmakers want to sleep easier, they should consider investing in stem-cell research before their pills become obsolete.

Clearly, this editor’s piece raises a number of interesting questions. We invite you to log in and discuss them:

  • What impact could you see the field of regenerative medicine making on the larger pharmaceutical sector?
  • Do you agree with this editor’s view that Big Pharma should start to invest in stem-cell research? Clearly some Big Pharmas are already investing in such research, but do you see this trend now accelerating with this FDA approval?
  • If so, what form do you think the investments will take? In-house research? Investments in or even acquisitions of smaller biotech companies now conducting the research? Something else?
  • How does the Geron approval affect your investment strategy?
  • Are you considering decreasing your investment in the pharma sector in favor of the regenerative medicine sector, instead? Why or why not?

20 Comments

Posted Under Biotechnology human trials

20 Comments

Elizabeth L
August 11, 2010

I believe that this whole movement will solve the health insurance crisis in this country. It’s not just pharms but also health insurance compnies who will have to redefine their necessity and what they provide for people, if anything, once stem cells and regenerative medicine take off. It will redefine the aging process and may extend the retirement age to who knows? 100? I look forward to it as long as the movement is done ethically.

Bruce Jorgensen
August 12, 2010

Bill,
I was less than impressed by Geron’s clinical trials approval. When listening to business oriented presentations at stem cell conferences I have been struck by how far behind the adult stem cell advocates the embryonic-focused initiatives have been. Adult neural stem cells were repairing spinal column damage in pre-clinical studies circa ten years ago. A personal belief is that appropriate adult stem cell therapies will prove to be safer, as well. The “aha” for me in Geron’s headlines is around the tremendous challenge and cost of clinical trials, vs. the ease of filling our journals and conferences with pre-clinical work using animal subjects. The cost is particularly high for the industry, as all boats will rise, or sink, on any one company’s clinical success or failure.

emil slavik
August 12, 2010

I really hope stem cells can get the ball rolling, too many people out there with life threatening diseases, we can make a difference, and that day is coming!!

Mrs. Anti-Virus
August 15, 2010

I bet you wish george bush was still president now

Barbara Hanson
August 16, 2010

As the co-founder of the Stem Cell Pioneers forum which is a patient moderated forum for stem cell discussion and support, we are well aware of the impact Big Pharma has on our lives. The FDA has just sued Regenerative Sciences for giving autologous stem cell treatments to their orthopedic patients. The FDA says that our own stem cells are drugs. They have no regulatory authority to interfere with the practice of medicine and have not attempted to shut down fertility clinics which basically are doing the same thing, but we all know the ties the FDA has with Big Pharma and why this was done. If individual doctors are allowed to give adult stem cell therapies without Big Pharma’s involvement, billions of dollars will be lost. Patients who are cured or improved to the point that they no longer need pharmaceutical drugs will be another threat to the industry. Embryonic stem cell research is just that – research. Our own stem cells are ready and are working in clinical trials and treatments offshore, a fact that the pharmaceutical industry is frantic about. We are warned that stem cells are snake oil, that these offshore clinics are bogus and take our money when they promise cures. The fact of the matter is that millions of people in the U.S. are dying and many offshore clinics are reputable and don’t offer cures, but do offer treatments that can improve our lives tremendously. Many conduct clinical trials in their own countries under their regulatory agencies. What is going on in the U.S. is nothing short of a scandal. Patients are being denied treatment, the FDA is out of control, the media has no clue that there are different kinds of stem cells, politicians are all out to make the issue a political one and Big Pharma is fine with this as it gives them time to figure out how they are going to get more than their share of the pie. Things need to change. I have a terminal disease and was lucky enough to be able to get treatment offshore. Adult stem cells have stopped the progression of my disease. They work. A non profit group called ICMS has written safe treatment guidelines and they have a patient registry. These should be recognized by the FDA and they should immediately allow those of us with terminal disease access to our own stem cells if we choose.

Kaye
August 16, 2010

This is absolutely disgusting! The very thought of your organization trying to get Big Pharma on board so that you can research until the cows come home. Adult stem cells are way ahead of your “game.” You are an absolute disgrace to medicine. It is all about the money with you bunch. You are lower than pond scum! I believe it is only a matter of time before someone does “walk onto Oprah” and tell how they were cured with ADULT stem cells. I’m sure you are “many years away from someone walking” to use your terminology. Embryonic stem cells are still not “ready for prime time” but adult stem cells are. You need to quit wasting research dollars!

P.Neisman
August 16, 2010

The major drawback of putting all your eggs in one basket is that the basket is faulty. Embryo stem cells have a rejection factor that is not mentioned in the FDA funding proposal. Adult stem cells are far more preferred by the public and is proven to work without intervention from drugs or manipulation of genes. ie) the cloning of embryo cells in light years away. It is far better to invest in what works, not what is far more expensive, a trillion dollars is absurdity. ASC’s already is curing arthritis in dogs, the UK is starting adult cells for heart disease, and the US is falling behind because of needless delays, and profiteering interested parties. Adult stem cell clinics are being forced to close and threatened by the FDA. Why is this happening? Pharmas are controlling decisions -that is why. This should not go forward at all, adult stem cell clinics like Regenexx in Denver are being shut down. What ever happened to that Obama executive order to “support stem cell research” not shut it down as the FDA is doing. This all stinks of a corrupted FDA system.

Lanza Fan
August 20, 2010

Good Lord, could some of you people do some DD in present day before posting?

PS, to be the co founder of Stem Cell Pioneers, Barbara, you should know better!

It is no wonder this country is in the shape it is in.

college
August 21, 2010

Pretty nice post. I just stumbled upon your blog and wanted to say that I have really enjoyed browsing your blog posts. In any case I’ll be subscribing to your feed and I hope you write again soon!

pharmacy technician
August 22, 2010

found your site on del.icio.us today and really liked it.. i bookmarked it and will be back to check it out some more later

mrgreenjeans
August 24, 2010

Just heard about this earlier today and I couldn’t believe what I was
hearing! I cannot believe that our once great country that we live in
is so far behind in so many ways now! We were moving in a positive
direction since Obama signed the executive order for stem cell
research, but I fear that because of everything else that is going on
in the country now, that congress has their hands too full to really
deal with issues like this and energy, that’s another topic.
It is frustrating for me because I know of several people, one good
friend of mine has MS that could benefit one day from stem cell
research. Doctors don’t even know what causes this illness…. the
research is just not there for this, as one neurologist I recently
spoke with told me, “what it all boils down to is money”,
pharmaceutical companies can make more money off of cancer or
vascular/cardiac diseases then MS, that is why billions of dollars are
pumped in for the research for those diseases ……… Oh and
something else he mentioned, the big pharma co. he believes, don’t
really want a 100% cure for cancer or say cardiac disease….. You
know why? Money….. they will loose a shit load of money because all
those people that were once sick are now being cured by stem cell
therapy and will stop needing Big Pharma’s overpriced medicines…….
that to me is pathetic! Hopefully this is only a temporary ban, but we are already so far behind in this research!

Lanza Fan
August 24, 2010

Ms Hanson let me clarify my post. What exactly was ASC a few years ago? Maybe, JUST THAT, RESEARCH?????? I support all forms of stem cell research. Just because ASC research supplied you with the ability to control your disease, doesnt mean that it will do the same for others. Maybe it will be ESC that will be needed for someone elses cure? Did you ever think about that?! Your arguement seems very selfish considering your cure has been found, while others are still suffering! Are you sure your the co founder of Stem Cell Pioneers? Maybe you should resign!

Lanza Fan
August 24, 2010

LMAO at you Kaye. Now I get it! Duh. You are blasting ACTC for ESC research because YOU are worried about your FREE GRANT $$ being cut back. WHO IS ALL ABOUT $$$ AND BEING POND SCUM? I say pot/kettle!

Barbara, Bruce, P.Neisman,
and Kaye, who do you work for?

j. polachek
September 16, 2010

until you have suffered, like others with copd, heart problems, als,or any other uncurable disease like mrs hanson has,you all would realize the need for adult stem cells whatever kind they are msc, uc, bone marrow. we or somebody we know and love will need a cure someday. so lets all be human and americans and help each other and not for the money.

Lanza Fan
September 26, 2010

polachek, I have suffered, hanson is only promoting adult stem cell, so I’m not the one being inhuman! like I said, she found her cure and now thinks it is the only cure for others. if adult stem cell was all that, after 50 years of study it would have cured everything, dont you think? like you said, we should help each other, why isnt hanson trying to help me?

Mark
September 27, 2010

This is to all the un-informed people here that think that adult stem cells are the answer to the worlds medical problems: Yes, adult stem cells have cured some diseases, mainly blood cancers like leukemia. But lets get the facts out in the open here: Adult stem cells have been studied and researched for over 50 years. Yes, that’s right 50 years! The NIH has granted $500+ million to adult stem cell research in both 2009 and 2010. That’s over $100 million for 2 years. In contrast to that, embryonic stem cells have been studied for just 10 years now. Yes, that’s correct, only 10 years. And in those 10 years, the NIH has granted embryonic stem cell research only $500 million over the entire 10 year period.

Let’s go over the facts once again just to be very clear: Adult stem cells have been studied for over 50 years and just in the last 2 years alone, it has recieved over $100 million in grant money.

Embryonic stem cells have been studied for only 10 years now and for the entire 10 year period, has only recieved $500 million.

Now, if adult stem cells are soooooo powerful and the answer to all our medical problems, after 50 years of research, why hasn’t it proven to be more beneficial to other diseases like it has for blood cancers?

And to those of you ho say embryonic stem cells cause tumors when injected directly into patients: Well damn right they do. But who in the world would inject embryonic stem cells directly into a patient? Whoever does this is should be locked up. Embryonic stem cells are the precursor to all the cures that will someday be unlocked with more research. The cells specialized cells that are produced from embryonic stem cells are the real stars. But these specialized cells can only be produced by embryonic stem cells. These specialized cells are what are injected into people to cure their diseases. And they are working quite well and showing a lot of promise.

And one more thing: And pay close attention here: ACTC produces their embryonic stem cells from IVF clinics, which after all ethical considerations are weighed, are scheduled to be destroyed in a medical waste incinerator. ACTC’s embryo safe procedure safely extracts one single cell from the embryo (exactly the same treatment it would recieve at the IVF clinic before being implanted into a uterus) without destroying it. The embryo is then allowed to go on un-harmed to it’s final destination, which in this case is the incinerator. So all you people who think this is un-ethical, please focus your attention to the IVF clinics and away from embroynic stem cell research. IVF clinics have, and will continue to destroy far more embryo’s than research ever has or will.

People, please educate yourself before spouting off about something you are obviously un-informed about. You are only adding to the confusion and helping others to adopt faulty reasoning.

Mark
September 28, 2010

Correction to my post on 9/27/2010. The following figures came from Dr. Francis Collins, director of the NIH.

In FY 2009, the NIH gave $397 million to non-embryonic stem cell research.

In FY 2010, the NIH gave $380 million to non-embryonic stem cell research.

Since 2002, the NIH has given embryonic stem cell research $546 million in research money.

So if you do the math, just for the years 2009 and 2010 combined, non-embryonic stem cell research has receieved $777 million.

For the last 8 years combined (2002 – 2010), embryonic stem cell research has receieved only $546 million.

So the scales are certainly not equal in terms of funding provided to the different stem cell platforms. Non-embryonic stem cell research has recieved far more money than embryonic stem cell research.

nurse practitioner
November 15, 2010

Thanks for some quality points there. I am kind of new to online , so I printed this off to put in my file, any better way to go about keeping track of it then printing?

sales strategy
November 16, 2010

thanks for posting. Great article.

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December 1, 2010

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