[Congressional Record (Bound Edition), Volume 147 (2001), Part 1]
[Extensions of Remarks]
[Pages 62-63]
[From the U.S. Government Publishing Office, www.gpo.gov]



                              TMJ IMPLANTS

                                 ______
                                 

                        HON. THOMAS G. TANCREDO

                              of colorado

                    in the house of representatives

                       Wednesday, January 3, 2001

  Mr. TANCREDO. Mr. Speaker, in April 1999, I received a phone call and 
correspondence from TMJ Implants, a company located in Golden, 
Colorado, in my district, which had been having problems with the 
review of its Premarket Approval Application of the TMJ Total and 
Fossa-Eminence Prosthesis by the United States Food and Drug 
Administration (FDA). Over the last year and a half--and delay after 
delay resulting in the pulling of the implants from the market, I have 
watched the process drag on, leading to the loss of millions of dollars 
by the company and countless number of patients who have been put 
through unnecessary pain. While I will let my submission speak for 
itself, suffice it to say that I sincerely believe that most of the 
frustration could have been avoided had everyone sat down and laid 
everything out on the table in the spirit of what was called for under 
the FDA Modernization Act. Unfortunately, the agency has been unwilling 
to do so--and it seems that these problems will continue into the 
foreseeable future.
  Over the last year and a half, my office has received numerous 
letters from physicians all across the country--from the Mayo Clinic to 
the University of Maryland--each relaying to me the benefit of the 
partial joint and the fact that the partial and total joint results in 
immediate and dramatic decrease in pain, an increase in range of motion 
and increased function. To date, there is no scientific reasoning for 
the fact that the total and partial joints are not on the market. All 
of this calls into question the integrity of the agency--something that 
I find very disturbing.
  Dr. Christensen is a true professional and a pioneer in his field and 
holder of the first patents. His implants are widely accepted as 
effective and safe throughout the dental and surgery community--indeed, 
several of my constituents have literally had their lives changed by 
the procedure.
  I am convinced that the work of TMJ is based on solid, scientific 
principles and the removal of the implants from the market has been and 
continues to be erroneous, contrary to the Agency's earlier findings 
and the statutory standard that should be applied.

[[Page 63]]

  I would like to take this opportunity to submit into the Record a 
copy of a letter from Mr. Roland Jankelson to the FDA urging the agency 
to come to an agreement as soon as possible so that this disaster is 
remedied and thousands of patients in the general public can receive 
relief.

                                                 Roland Jankelson,


                                     15 PONCE DE LEON TERRACE,

                                    Tacoma, WA, December 28, 2000.
     Mr. Les Weinstein,
     U.S. Food and Drug Administration, Ombudsman, Center for 
         Devices and Radiological Health,
     9200 Corporate Blvd., Rockville MD.

     Re: TMJ Implants, Inc.

       Dear Mr. Weinstein,
       With reference to our phone conversation today, please note 
     the following comments (especially the last point, which I 
     hope will shape your actions in the next couple of days):
       1. There is no need for another meeting with ODE. The 
     purposes of this meeting (as stated in the Blackwell E-mail) 
     are bogus--just more obfuscation and more delay. As Mike Cole 
     stated in his December 27, 2000 letter to Tim Ulatowski, a 
     copy of which you have: ``You say we must arrive at an 
     acceptable, consistent diagnosis criteria in order to write a 
     label''. I say we are already there, and have been for two 
     months . . .  (Underlining is my emphasis).
       2. There never has been any credible evidence before the 
     FDA of a safety problem (in over thirty plus years of use) 
     that would prevent the Christensen devices (total and partial 
     joint) from meeting the required standard of reasonable 
     assurance of safety. Approval was given to TMJ Concepts 
     device with limited data and little history. The information, 
     data and history given to FDA for the TMJ Implants device 
     exceeds many-fold, by every possible measure, the composite 
     of information used to approve its competitor. The 
     Christensen Company, its consultants and its attorneys have 
     responded to every issue, every hypothetical concern posed by 
     FDA, no matter how far-fetched these issues and concerns 
     were. See Mike Cole's notes attached for just a quick summary 
     of the Company's responses since the October Panel meeting. 
     As Mr. Cole states in his letter, the questions posed in the 
     Blackwell E-mail were addressed two months ago. Yet, for two 
     months, there has been no response from the Ulatowski side. 
     You and Mr. Ulatowski have been informed that this was a 
     company on the verge of financial ruin. This does not make 
     any difference to Mr. Ulatowski--It is not his concern, not 
     his focus. A man's reputation, ruined. A company financially 
     gutted. Patients suffering. ``Myotronics'' all over again. 
     How could this happen again? it has.
       With respect to the meeting called for in the Blackwell E-
     mail: There is no more explanation needed from the Company. 
     There is no more ``perspective (Blackwell's word) to share. 
     Just more delay.
       3. Forget that Dr. Christensen faces financial ruin. Forget 
     that his company's resources are nearly exhausted. Every day 
     that goes by without FDA approval of the TMJ Implants, Inc. 
     total joint, and partial joint in particular, is a day that 
     patients suffer. The PMA record is indisputable. Physicians 
     and patients have uniformly made it clear that the FDA is 
     harming them. The FDA is on notice that physicians are 
     withholding needed surgery, waiting for the Christensen 
     devices, both total and partial joint. The physicians have 
     uniformly made it clear to the FDA that the TMJ Concepts, 
     Inc. joint is unacceptable for their patients. Others have 
     made it clear that without the availability of a partial 
     joint, patients will be subjected to surgery that 
     unnecessarily destroys healthy anatomy. Witholding approval 
     of these devices is a willful disregard by FDA of the public 
     health. Ulatowski does not care.
       4. About five years ago, Rick Blumberg, Deputy Counsel for 
     Litigation, for whom I have great respect, persuaded me to 
     forego what would have extended FDA's involvement in the 
     Myotronics matter, i.e. litigation by Myotronics that would 
     have further publicized the already well-publicized findings 
     of more than two years of Congressional hearings, OIA and 
     IGHHS investigations. Rick assured me, and I believe he 
     believed, that the FDA was, indeed, changed in reaction to 
     the revelations of the multiple and extra-legal activities of 
     FDA employees intentionally directed at and intended to harm 
     Myotronics. BUT HE WAS WRONG! The abuse, misuse of agency 
     authority for the pursuit of a private agenda to harm a 
     targeted company, retaliation and punishment, is all repeated 
     against TMJ Implants, Inc., whose devices for thirty plus 
     years served a specialized ``salvage need'' and relieved 
     human suffering. Standing in the middle of these abuses: the 
     same Mr. Tim Ulatowski.
       5. The record cries out for intervention by you and other 
     responsible FDA officials. Neither Susan Runner nor Tim 
     Ulatowski have credibility in this matter. In reviewing this 
     matter, you and senior FDA and OIA officials should look at a 
     number of issues:
       (a) A phone call from Dr. Susan Runner to Dr. Christensen 
     days before the May 1999 Panel meeting informing Dr. 
     Christensen that his PMA would be disapproved, and advising 
     him to withdraw it.
       (b) Information leaked by the FDA prior to the 1999 Panel 
     that TMJ Implants, Inc. devices ``were either withdrawn by 
     FDA or would soon be''. Remember the FDA leaking in the 
     Myotronics case.
       (c) Treatment of TMJ Implants, Inc. PMA's with standards 
     different than used for its competitor, TMJ Concepts, Inc.'s 
     PMA: TMJ Concepts, Inc. was approved without delay in spite 
     of a device history covering only a few years and limited 
     data, compared to a device history of more that thirty years 
     for the Christensen devices, and much more data.
       (d) Removal of the partial and total joint form the market 
     in spite of a 9-0 Panel approval and a need acknowledged the 
     FDA Panel.
       (e) Allegations that Dr. Susan Runner had a conflict of 
     interest stemming from her past relationship with Dr. Mecuri, 
     TMJ Concepts, Inc. chief technical consultant--allegations 
     rejected by OIA without any apparent serious injury.
       (f) Data and evidence covering over thirty years of use 
     that demonstrates a remarkable safety record. Why has this 
     device been held hostage?
       (g) Staff's dismissal of TMJ Implants, Inc. request for the 
     addition of qualified experts for the October 2000 Panel.
       (h) The assembly of a Panel for the October 2000 meeting 
     which lacked balance and qualifications. Only one certified 
     Oral Maxillo-Facial surgeon among five consultants. Why?
       (i) Concerns about the independence of a number of October 
     2000 Panel members and consultants.
       (j) Acknowledgement by one of the October 2000 Panel 
     members to Dr. Christensen prior to the Panel meeting that he 
     believed (knew) the Panel would recommend disapproval.
       (k) Acknowledgement by the same Panel member that he knew 
     by the noon break in the October 2000 Panel meeting that 
     members intended to vote for disapproval.
       (l) Acknowledgement by the same Panel member that he 
     believed the PMA (the TMJ Implant, Inc. partial joint) should 
     be approved, but that he voted for disapproval (with the 
     majority) because he believed he would not otherwise be 
     invited to another panel. So much for the idea of 
     independence!
       (m) Questions concerning why the partial joint PMA was 
     subjected to a second Panel (the October 2000 Panel) after a 
     May 1999 Panel recommended approval 9-0 (what conditions).
       (n) Questions regarding the appropriate level of micro-
     management of diagnostic protocols, and pathology 
     indications, and why labeling provided by the company was 
     deemed unacceptable. On the issue of concern about improper 
     staff micro-management, see December 31, 2000 letter from 
     Roland Jankelson to Lee Weinstein.
       (o) Did the Ulatowski group, particularly Susan Runner, 
     ignore information and misrepresent data and information 
     provided by the Company? Incompetence? Deliberate?
       (p) Did the Ulatowski group ignore for two months the 
     Company's responses following the October 2000 Panel meeting 
     when it knew the delay threatened the financial viability of 
     the Company? See (1) Mile Cole notes, and (2) Mike Cole 
     letter to Ulatowski dated December 27, 2000.
       (q) Questions about Susan Runner's independence and 
     objectivity. Appearances of a personal agenda to favor TMJ 
     Implants, Inc. competitor. Differences of standards and 
     treatments applied to each are indisputable. Why did it 
     happen?
       (r) Concern about the extraordinary delay in the review 
     process, continuing to this date, and whether it is intended 
     to deliberately punish TMJ Implants, Inc. There are 
     similarities between this case, and a history of retaliation 
     by FDA employees revealed by 1995-1996 hearings of the House 
     Subcommittee on Oversight and Investigations.
       (s) Concern about Susan Runner's competence 
     (qualifications, training and experience) to review these 
     particular devices.
       (t) Questions about why the Ulatowski group has ignored the 
     physicians' claims of patient harm from the removal of these 
     devices from the market. See sample of physicians' letters. 
     See sample of patients' letters.
       6. No more meetings, please. No more conference calls that 
     just provide more delay. Have Tim Ulatowski put in writing 
     all matters with which he is not satisfied, any standing in 
     the way of approval. If he cannot state it in writing, ``it 
     should not exist''. Have this happen on Tuesday, Ulatowski's 
     first day back (while he took last week away from work, Dr. 
     Christensen continued to ``bleed'' more money). Get this PMA 
     done next week. We can argue about culpability, need for 
     investigations and legal remedies later. I thank you in 
     advance for doing what needs to be done.
       Sincerely,

                                             Roland Jankelson.

     

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