STEM CELL BATTLES

Dear Friend of Stem Cell Research:

 

As you know, the world’s first human trials with embryonic stem cells is (or should be) underway this year.

 

But first, there is a crucially important FDA hearing to be held, on April 10^th and 11^th.

 

It has the harmless sounding title, “Scientific Considerations for Safety Testing for Cellular Therapy Products Derived from Human Embryonic Stem Cell”.

 

I hope it will be just about science. But I worry that it may be politicized.

 

The Food and Drug Administration is highly respected; famous for being above political pressures. That standard of excellence is vital now, for they face a crucial decision.

 

At stake is the human trials of the Keirstead/Geron spinal cord injury embryonic stem cell experiment to remyelinate damaged nerves. The experiment was originally funded by the Roman Reed Spinal Cord Injury Research Act of 1999: a law named after my paralyzed son, the first state funding of embryonic stem cell research in the nation.  

 

March 1, 2002, six years ago… in the Reeve/Irvine Research Institute, UC Irvine, I held in my hand a rat which had been paralyzed, but which now had regained some measure of its walking ability, thanks to human embryonic stem cells. This was the work of Dr. Hans Keirstead.

 

The next step, to turn theory into therapy, is hugely expensive; America is fortunate that Geron Corporation was willing to invest many millions in the new endeavor.

 

Between that time and this, the Keirstead/Geron work has been going through the FDA safety wringer. As is only right and proper, the FDA has made Geron, the funding corporation, go through test after test after test, and the months dragged on, and became years.

 

The patients wait.

 

The reasons for six years of safety checking are legitimate; anything to be tried on people must be given every reasonable safety check.

 

As one top scientist told me privately: “…it is really important that people understand that there really hasn’t been a delay. It is important for the future of stem cell trials—this is just how long it takes. Rushing things is dangerous, and in the long run counterproductive because a single adverse event could set things back many years. We all have to remember that this will be a trial for recently injured people. If something goes wrong, even something trivial, it could be a long time before there is another stem cell trial for spinal cord injury.”

 

But six years of waiting—and a 25,000 page paper trail—seems long enough to me.

 

The hearing will be held April 10-11, next month, in Bethesda, Maryland, home of the Food and Drug Administration, the world-famous FDA. (complete information follows).

 

Written comments from the public will be allowed, but only until  March 26^th.

 

If you or your organization would like to write a letter (better yet, attend the hearings) just to say, let science and safety be the issue, not politics—here is the address.

 

If you want your testimony to be part of the considerations, time is running short. I am sending mine by overnight mail.

 

Here is the letter I will be sending, followed by the information on the hearing’s location, and conditions for those who want to attend or provide testimony.

 

Division of Dockets Management (HFA-305)

[Docket No. 2007N-0471]

Food and Drug Administration

5630 Fishers Lane, rm. 1061,

Rockville, MD 20852

 

Attn: Gail Dapolito/Danielle Cubbage “Stem Cell Safety Hearing”

 

Honorable Committee Members:

 

The decision before you, on the safety of human trials with the Keirstead/Geron stem cell line, is one with deep significance to my family, as we were involved in the project’s initial funding.

 

A law named after my paralyzed son, Roman Reed, (The Roman Reed Spinal Cord Injury Research Act of 1999) funded Dr. Hans Keirstead’s remyelination experiment, which Geron Corporation has moved closer becoming an actual therapy to alleviate acute paralysis.

 

On March 1, 2002, in the Roman Reed Laboratory of the Reeve-Irvine Research Institute, University of California at Irvine, I held in my hand a rat which had been paralyzed, but which now walked again—thanks to the injection of human embryonic stem cells.

 

In a larger sense, however, this is not about the effort of a single man, or corporation: this is the first major entry of an entire new field, built on the contributions of thousands of scientists, supported by patient advocates, people in wheelchairs and hospital beds, their families, and literally hundreds of medical and scientific organizations.

 

It is my understanding that the trials will involve approximately 40 people in hospitals, who have just been injured. They will have the chance my son did not have. Instead of being told, there is no hope, they will have the opportunity to—perhaps-- get better.

 

There is always an element of risk. Even with standard medicine, practiced in every hospital, there is a chance things may go wrong, which is why we fill out all those release forms when we have an operation.

 

During the past six years, as you know, the Keirstead/Geron work has been exhaustively scrutinized, and his experiments have been replicated by responsible organizations.

 

To the best of my knowledge, every request, guideline, and regulation has been complied with, developing a paper trail of more than 25,000 pages.

 

Every realistic expectation has been met. It is time to let research become therapy, to  ease the suffering of spinal cord injury paralysis.

 

This research must, as Christopher Reeve would say, “go forward”.

 

I must add a word about stem cells and politics. 

 

America’s Food and Drug Administration is renowned for being above the winds of political favor, deciding on a product’s merits for safety and efficacy alone.

 

We are glad for that strength now.

 

Even though the stem cell lines used are those approved by President Bush’s August 9, 2001 embryonic stem cell policy, still there are those who would not be glad to see the research progress.  Embryonic stem cell research has always faced enormous political opposition, every step of the way, from those with religious or political objections.

 

Neither ideology nor the wishes of patient advocates can play a part in what is before you now. Just as it would be a mistake to rush an untried procedure through without careful consideration, so it would also be wrong to set safety regulations prohibitively high, blocking the hopes and dreams of cure for suffering patients and their families.

 

Both sides must now wait outside the door; science and safety alone must decide.

 

Please accept our blessings and best hopes, as you make this tremendous decision.

 

Thank you,

 

Don C. Reed

 

 

 

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE

DATE AND TIME: April 10-11, 9:00 a.m. (8:00 on the 11th)
LOCATION: Hilton DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD
CONTACT: Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research, 301-827-0314. On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. On April 11, 2008, the committee will meet to discuss updates on the following topics: (1) Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; (2) FDA's Somatic Cell Therapy Letter; and (3) recently released FDA guidance documents. More Information

 

 

[Federal Register: December 19, 2007 (Volume 72, Number 243)]

[Notices]              

[Page 71922-71923]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19de07-81]                        

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0471]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

 AGENCY: Food and Drug Administration, HHS.

 ACTION: Notice.

 -----------------------------------------------------------------------

     This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will

be open to the public.

    Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee.

 [[Page 71923]]

     General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

    Date and Time: The meeting will be held on April 10, 2008, from 9 a.m. to approximately 6 p.m. and on April 11, 2008, from 8 a.m. to

approximately 12 noon.

    Addresses: Electronic comments should be submitted to 

http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

 Select ``2007N-0471--Scientific Considerations for Safety Testing for Cellular Therapy Products Derived

From Human Embryonic Stem Cell'' and follow prompts to submit your statement. Written comments should be submitted to the Division of

Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on

March 26, 2008. All comments received will be posted without change, including any personal information provided. Comments received on or

before March 26, 2008, will be provided to the committee before or at the meeting.

    Location: Hilton DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD.

    Contact Person: Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research (HFM-71), Food and Drug

Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-

0572 in the Washington, DC area), code 3014512389. Please call the Information Line for up-to-date information on this meeting. A notice

in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be

published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate

advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

    Agenda: On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy

products derived from human embryonic stem cells. On April 11, 2008, the committee will meet to discuss updates on the following topics: (1)

Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies,

Center for Biologics Evaluation and Research; (2) FDA's Somatic Cell Therapy Letter; and (3) recently released FDA guidance documents.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post

the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of

the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is

available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on

 the year 2008 and scroll down to the appropriate advisory committee link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before April 3, 2008. Oral presentations from the public will be scheduled on

April 10, 2008, between approximately 1:45 p.m. and 2:15 p.m. and on April 11, 2008, between approximately 10:15 a.m. and 10:45 a.m. Those

desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the

evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time

requested to make their presentation on or before March 26, 2008. Time allotted for each presentation may be limited. If the number of

registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may

conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested

persons regarding their request to speak by March 27, 2008.

    Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical

outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with

physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at

least 7 days in advance of the meeting.   FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at 

http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm

 for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: December 12, 2007.

Randall W. Lutter,

Deputy Commissioner for Policy.

[FR Doc. E7-24629 Filed 12-18-07; 8:45 am]

BILLING CODE 4160-01-S