Opening Up The FDA
This campaign is organized by John The Revelator (JTR) in the Hair Multiplication & Research Forum. If you have questions about this campaign, please post your comments in the Research Forum. The following is a reprint of JTR's post.
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How can we get to a world where hair multiplication (HM), cell therapy for hairloss, and hair cloning are widely available, not just tentative experiments? This tantalizing vision is largely stalled, though not because of inadequate technology. Instead progress is held up by warfare among the hair transplantation (HT), pharmaceutical, and hair replacement industries with lawsuits and lobbying their weapons of choice. To get to the future of a true cure for hairloss that will benefit all bald and balding people, this has to end. But progress will require some important concessions among the various interests involved.

Sounds like another conspiracy theory, right?

For a long time, I've been saying that technological advancements like hair multiplication (HM) are being held up more by behind-the-scenes politics and Machiavellian maneuvering by those with vested financial interests, than by a lack of scientific and technical knowledge. And many people here have repeatedly called me a conspiracy fanatic.

Now, I give you this, from this week's edition of BusinessWeek Magazine (Nov. 4, 2002), page 28:

"How can we get to a world where online music, movies, and video are widely available, not just tentative experiments? This tantalizing vision is largely stalled, though not because of inadequate technology. Instead progress is held up by warfare among the entertainment, computer, and consumer-electronics industries with lawsuits and lobbying their weapons of choice. To get to the digital future that will benefit everyone, this has to end. But progress will require some important concessions on all sides."

That is a quote from BusinessWeek technology editor Stephen H. Wildstrom, and it just as well may apply to the current situation with hair regeneration technologies. The hair cloning, hair multiplication, and cell therapy tests and patents we read about here may well be held up in laboratories around the world, unable to reach consumers because of behind-the-scenes maneuvering and jockeying by hair transplant doctors, pharmaceutical manufacturers, and others bent on protecting their vested incomes. In particular here, I think the HT doctors have the most to lose in the short-term from HM (though they, along with dermatologists, would gain in the longer term). And I have elaborated in great detail (along with other posters such as Fred, WBBSG, and our old friend, Bill) about why in the short-term at least, most successful HT surgeons and clinics absolutely dread the prospect of HM and hair cloning. Because once the general public, particularly balding people, learn for sure that it is possible and the technology not only exists but is waiting to be implemented, ALL current HT business will dry up and people will stop booking appointments for HT until they know that they can get HM from the same doctors, or from other doctors. And HT surgeons depend on large, steady incomes to support their lifestyles. Any interruption of those incomes, no matter how brief -- even for six months or so -- would spell financial disaster to many of them. Just look at what is preached at the big HT surgeons' conventions, such as the recent ISHRS meeting in Chicago earlier this month. Many of the presentations are about BUSINESS: developing a HT practice, attracting new patients, keeping patients coming back for more and more hair transplants. It's a self-perpetuating industry dependent on a constant stream of new bookings, new business coming in the door. I've said this again and again.

We already know, from answers Dr. Gho has supplied to HairSite, that a key milestone in getting HM to the public in the United States, will be FDA approval of a HM or cell therapy protocol, and the standard that the FDA will use will be COMPLIANCE WITH FDA GUIDELINES ON TISSUE HANDLING -- that is, "Good Tissue Practices" standards. Indeed, Farrel posted information about FDA's latest set of guidelines on his website (www.hairlosshelp.com) when those new regulations were promulgated last year. Farrel was wise to post this link, because it pertains exactly to such procedures as HM and cell therapy methods for hairloss, which would include the procedures developed by Aderans/Bosley/BioAmide, Dr. Bazan in Mexico, Dr. Unger in Canada, and others in the US and around the world.

The means by which an applicant can get such a cell therapy procedure approved by FDA are fairly simple: Submit an application for FDA review and demonstrate that the procedure complies strictly with these FDA "Good Tissue Practices" guidelines, which include protocols to ensure safety from infections and other risks. In fact, since most of the cell therapy procedures developed or contemplated to treat hairloss involve using cells from THE SAME PATIENT, the review process is somewhat less exhaustive than, say, for a CT treatment which uses "allogenic" cells -- cells from another person -- for instance, in some of the cartilage cell replacement therapies developed for arthritis of the knee, etc.

The only problem with all this is almost that anyone who wants to interrupt or interfere with the approval process, or sabotage it for a while, or just nudge it in a direction which "gums up the works" and causes things to move slower, can do so. Especially doctors, surgeons, clinics, and those who know the inner workings of the system.

If such people know that someone has submitted an application to FDA for approval of a cell therapy procedure, and is threatened by such a development (because it might hurt his business), all he has to do is file a report with the FDA giving his "expert opinion" as to why the procedure might expose patients to unacceptable risks. All he has to do is point out possible dangers. He may cite specific examples of experiments where patients became ill or developed adverse side-effects, or if he has no such information to offer, he can simply offer informed CONJECTURE, speaking as a medical doctor or scientist, as to why the procedure MIGHT be dangerous. Even just a bit dangerous.

See where I'm going with this? The application procedure is fraught with risks of slowdowns or situations where things come to a screeching halt, behind the scenes, without the public even knowing about it!

Because, if virtually ANYONE with an "M.D." after their name -- a doctor, surgeon, clinic, hospital, ANYONE -- files a plausible report or complaint which brings to light a potential danger -- ANY potential danger -- the FDA *MUST* act on that report or complaint.

It's sort of like when they were trying to catch the "DC Area Sniper" recently -- in Rockville, Maryland -- the town in Montgomery County where the FDA has its headquarters, by the way, and where the snipers' shooting rampage began.

ANY plausible tip or call from someone who was in or around the scene of one of the shootings, HAD to be investigated. Just to be safe. And to avoid the embarrassment or political fallout in the event a plausible lead was not investigated but later turned out to be valid.

I am not telling you all that I am certain that HT doctors have used unscrupulous, behind-the-scenes tactics to slow down or stall the approval of cell therapy for hairloss, or that they might be planning this as I write, but I am not certain they aren't doing these things, either. And I believe they have at least some incentive to do it. I believe certain sectors of the HT industry have a strong incentive to slow down the process a bit. Not to stop it entirely, or to stop it for good, but to slow it down for awhile so that they can prepare and adapt, and so they can ensure the largest degree possible of control over the technologies on our doorstep.

And that is where "Opening Up The FDA" comes in.

I believe that we can use the Freedom of Information Act to glean valuable insights into what's going on behind-the-scenes at the FDA with respect to hair cloning, hair multiplication, and cell therapy for hairloss.

The US Freedom of Information Act (FOIA), passed by Congress in the 1970's, allows journalists, researchers, and just-plain citizens to assert a RIGHT to information held by federal government agencies, subject to a few exemptions which include one for national security.

Any US citizen or resident may submit a formal letter to any agency requesting that a search for information be done, and in most cases, the government agency must comply, run the search, and turn over the information requested.

Here is a link to a website which contains more information about the Freedom of Information Act and getting information from the government:

http://www.rcfp.org/cgi-bin/foi_lett.cgi

This website contains templates of "sample letters" that you can direct to government agencies like FDA and have them search for the information YOU want.

For the best general FOIA Letter, try
http://www.rcfp.org/foi.html

You can ask them to do the search, and in your letter ask them to notify you of the copying fees BEFORE you are charged for anything.

Here is a sample, generic FOI letter I have put together, directed at the FDA, using the templates provided. It is directed at the FDA's Freedom of Information (FOI) Director:

October 28, 2002

FOOD AND DRUG ADMINISTRATION Director, FOI Staff 5600 Fishers Lane (HFI-35) Rockville, MD 20857

SUBJECT: FOIA REQUEST

Dear FOI Officer:

Pursuant to the federal Freedom of Information Act, 5 U.S.C. Section 552, I request access to and copies of:

1) Any information pertaining to cell therapy procedures using human hair follicle cells;

2) Information and correspondence relating to applications for FDA approval of cell therapy procedures utilizing human hair follicle cells, intended for the treatment of alopecia or baldness;

3) Complaints and reports concerning the safety of said cell therapy procedures proposed to treat alopecia or baldness, received from medical doctors, laboratories, clinics, or other persons or organizations.

I agree to pay reasonable duplication fees for the processing of this request in an amount not to exceed $_________. However, please notify me prior to your incurring any expenses in excess of that amount.

If my request is denied in whole or in part, I ask that you justify all deletions by reference to specific exemptions of the Act. I will also expect you to release all segregable portions of otherwise exempt material. I, of course, reserve the right to appeal your decision to withhold any information or to deny a waiver of fees.

I look forward to your reply within 20 business days, as the statute requires.

Thank you for your assistance.

Very Truly Yours,

XXXX XXXXX

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The above letter is very general and can be adapted in many different ways, but you MUST refer to the Freedom of Information Act statute, and the U.S. Code section as I did above.

Also, the 20 day requirement has to do with the agency acknowledging your request by mail; they must do so within 20 business days. They are not required to actually FULFILL your request in that period of time.

I will have a lot more to say concerning FDA and FOIA requests. This is only the beginning to get us started. There is a lot more to say, and I'm continuing my own research into where, exactly, within FDA, this information is likely to reside (if it currently exists).

I would like (if possible) our group on HairSite to get a FOIA-letter writing campaign going to FDA, to investigate these issues. Each person does not have to write the exact same letter asking for the exact same things. In fact, it would be beneficial to our cause if the letters and requests varied a bit. This would give FDA little excuse to ignore a specific request because it didn't ask for things in "exactly" the way required by the bureaucrats there, who can be VERY particular (because in a sense they are looking for reasons to refuse your request, as they get paid the same whether they're complying with a request or not, and they have no incentive to increase their own workload.)

In my experience, bureaucracies like FDA are, however, more responsive to MASSIVE displays of public interest in a particular subject, than if an obscure request comes from just a lone individual. The more letters and requests we generate, the more pressure FDA will feel to release this information to the public QUICKLY.

More to follow...

John The Revelator (JTR)

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