ML19247D047
| ML19247D047 | |
| Person / Time | |
|---|---|
| Issue date: | 09/20/1979 |
| From: | Minogue R NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| Shared Package | |
| ML19247D045 | List: |
| References | |
| REF-10CFR9.7 SECY-79-542, SECY-81-094, SECY-81-94, NUDOCS 8102280186 | |
| Download: ML19247D047 (26) | |
Text
.
September 20, 1979 SECY-79-542 O.
For:
The Commissioners From:
Robert B. Minogue, Director Office of Standards Development Thru:
Executive Director for Operatio'ns M hivg
Subject:
THERAPEUTIC TREATMENT OF CARDIAC DYSFUNCTION BY 10 DINE-131
Purpose:
To obtain Commission approval of a Federal Register Notice of NRC's intent to retain the therapeutic treatment of cardiac dysfunction in the regulations.
Category:
This paper covers a minor policy question.
Issue:
Should NRC continue to allow physicians to use iodine-131 for the therapeutic treatment of cardiac dysfunction since the Food and Drug Administration has reclassified this treatment as lacking substantial evidence of effectiveness?
Alternatives:
1.
Delete tf[e therapeutic treatment of cardiac dysfunction by iodine-131 from NRC regulations.
2.
Publish for public comment in the Federal Register NRC's intent to retain the therapeutic treatment of cardiac oysfunction in NRC regulations (a minor exception to the Medical Policy Statement).
3.
Change the Medical Policy Statement's handling of the therapeutic uses of radionuclides to allow for exceptions as regards FDA approv Discussion:
Background
NRC's Mcdical Policy Statement specifies regulatory policy for restricting the uses of therapeutic radioactive drugs to the clinical procedures that have been approved by the Focd :snd Drug Administration.
In 1976, FDA reclassified the therapeutic treatment of cardiac dysfunc-tion by iodine-131 as lacking substantiti evidence of effectiveness.
Contact:
Deborah A. Bo ik, SD 443-586D 86 MUocaO1
~ ~ "
The Commissioners 2
The Problem In order to be consistent with the Medical Policy Statement, NRC should delete the therapeutic treatment of cardiac dysfunction from S35.100(d)(1) of 10 CFR Part 35, since FDA has removed this treatment from its list of approved procedures.
However, NRC's Advisory Committee on the Medical Use of Isotopes, the American College of Cardiology and several physicians have indicated that this treatment should not be removed from NRC regulations since this would be detrimental to the health of some patients.
Facts Bearino en the Problem a.
Iodine-131 for use in the treatment of patients with cardiac dysfunction was introduced approximately thirty years aco.
The treatment employs iodine-131, in the form of sodium-iodide, as a therapeutic agent for management of euthyroid heart diseases such as angina pectoris and congestive heart failure.
b.
FDA has on record clinical studies which document safety when iodine-131 is used to treat cardiac dysfunction.
While the appli-cation of iodine-131 to the thyroid during the therapeutic treat-ment of cardiac dysfunction does damage the thyroid, the net effect on patients has been demonstrated through clinical tests to be beneficial and no major advarse side effects have been identified.
c.
In 1971, the FDA classified the treatment of cardiac dysfunction with iodine-131 as possibly effective and invited persons to submit any data in support of this possibly effective indication.
d.
Since no clinical data'were submitted in support of the possibly effective indication, in 1976 the FDA reclassiTied the treatment of cardiac dysfunction as lacking substantial evidencr of effec-tiveness.
(However, lack of evidence of effectiveness does not constitute evidence of ineffectiveness.)
e.
FDA's action, which removed cardiac dysfunction from the official labeling, by itself, does not prevent physicians from using iodine-131 for the therapeutic treatment of cardiac dysfunction.
Indeed, we are aware of several physicians who still claim that there is adequate evidence for using the drug for this purpose, although it is neither on the package insert nor on the official labeling.
(The physician can determine that the benefit-risk of using a particular drug in a particular patient is justified.)
f.
Other alternatives to the use of iodine-131, principally nonradio-active drug therapy, are currently available and used much more often for treatment of cardiac dysfunction.
g.
Iodine-131 has been and still is used for treatment of hyper-thyroidism, and the reclassification by FDA did not significantly affect manufacturers which still have a market for iodine-131.
The Commi:sioners 3
Therefore, there was 'ittle incentive to perfor.: clinical trials to show FDA the ef fectiveness of iodine-131 for treatment of cardiac dysfunction.
h.
Since 1951, the FDA has recorded three adverse reactions to the use of iodine-131 in the therapeutic treatment of cardiac dysfunc-tion.
Two of these reactions were classified as possibly drug elated and the third was classified as remotely drug related.
i.
For whatever reasons, including lack of monetary resources, individual physicians who wished to continue using iodine-131 to treat cardiac dysfunction did not conduct clinical experiments and thus prove effectiveness to FDA.
j.
NRCcurrentlyauthorizestheuseofiodine-131forgreatmentof hyperthyroidism and cardiac dysfunction in Group IV nf S35.100(d)(
of 10 CFR Part 35.
However, if NRC removes the authorization, then iodine-131 could not be used by any physician for the thera-peutic treatment of cardiac dysfunction.
k.
When the Medical Policy Statement was written, the staff looked to prospective FDA approval rather than retrospective denial, that is, it thought of NRC adding to its regulations new treatments already approved by FDA rather than deleting already allowed treat-ments.
This is the first time NRC has had to consider deleting a therapeutic procedure that has been removed from an approved list by FDA.
i.
We believe that this is a unique situation and do not anticipate any future administrative removal actions by FDA.
The proposed action will not require any additional Commission resources.
The alternatives are evaluated as follows:
Alternative 1:
Delete the therapeutic treatment of cardiac dysfunction by iodine-131 from NRC regulations.
Pro: a.
Consistent with NRC Medical Policy Statement; and, b.
Nonradioactive drug treatment is now 6a3+ often used for cardiac dysfunction.
11n: a.
Deletion of this therapeutic p.ocedure would remove this option from the physician's use in those cases where other treatments may not be ef fec.ive; and, 1Group IV refers to the use of prepared radiopharmaa uticals for certain therapeutic uses that do not normally require hospitalization for purposes of radiation safety.
The Commissioners 4
b.
Deletion of this toerapeutic use could possibly jeopardize some patients; and, c.
FDA's action was based on lack of evidence of effective-ness (not evidence of ineffectiveness or patient safety considerations).
Alternative 2:
Publish for public comment in the Federal Recister NRC's intent to retain the therapeutic treatment of cardiac dysfunction in the regula-tions (a minor exception to the Medical Policy Statement).
Pro: a.
FDA's action was based on lack of evidence of effectiveness (not evidence of ineffectiveness or patient safety considera-tions); and b.
The possibility exists that individual physicians lacked the monetary resources to conduct clinical trials to show sub-stantial evidence of effectiveness; and, c.
This would retain for physicians the option to use iodine-131 for cardiac dysfunction.
Co_n: a.
Inconsistent with that part of the Medical Policy Statement which says that NRC will authorize only those therapeutic procedures approved by FDA; and, b.
NRC would be approving the use of a radioisotope for patient therapy which has no established finding of efficacy.
Alternative 3:
Change the Medical Policy Statement's treatment of the therapeutic uses of radionuclides to allow for exceptk' as regards FDA approval.
Pro: a.
The Medical Policy Statement was intended to deal with the addition of drug uses approved by FDA and does not specifi-cally cover the separate problem of deletion of procedures reclassified by FDA; and, b.
FDA's action in removing this use of iodine-131 was adminis-trative.
It was not based on any adverse evidence.
Con: a.
NRC would be approving the use of a radioisotope for patient therapy which has no established finding of efficacy; and, b.
We believe that this is a unique situation; therefore, the effort to change the Medical Policy Statement may be unnecess
The Ccemissicners 5
Recommendation:
That the Commission:
Approve Alternative 2 (Publish for public ccmrent in the Federal Recister NRC's intent to retain the therapeutic treat-ment of cardiac cysfunction in the regulaticns as a minor exception to the Medical Policy Statement).
A Federal Register Notice cetailing this is provided as an enclosure.
Since the Federal Recister Notice is only stating that the therapeutic treatment of cardiac dysfunction by iodine-131 is being retained in
$35.100(d)(1) of 10 CFR Part 35, the Congressional Cormittees are not being informed of this Commission action.
Coordination:
This has been concurred in by the Office of Nuclear Material Safety and Safeguards and the Division of Rules and Records.
The Office of the Executive Legal Director has no legal objection. OGC recc--cnded deletion cf treatment cf cardiac dysfunction by Iccine-1;l frcm l,RC renulations; CPE's ccnnents on safety have been incer;crat2d in the paper (see Enclosure 2 for responses to 03C/CPE comments).
~ l$
INGh' SE? 2 0 197c Robert B. Minogue, Director Office of Standards Development
Enclosures:
1.
Federal Recister Notice 2.
Response to OGC/ OPE Comments
- E:
Commissioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b.
Thursday, October 4, 1979.
Ccamission Staff Office ccaments, if any, shculd be submitted to the Commissioners NLT September 28, 1979, with an information copy to the Office of the Secretary.
If the paper is of such a nature that it recuires additional time for analytical review and centent, the Commissierers and the Secretariat shculd be apprised of when connents may be expected.
DISTRIBUTID'i Commissioners Conmission Staff Offices Exec Dir for Cperations ACRS Secretariat
[7590-01]
NUCLEAR REGULATORY CCMMISSICN THERAPEUTIC TREATMENT OF CARDIAC DYSFUNCTION BY ICDINE-:31 AGENCY:
U.S. Nuclear Regulatory Commission.
ACTION:
NRC intent to retain the treatment of cardiac dysfunction by iodine-131 as an accepted therapeutic procedure.
SUMMARY
The Nuclear Regulatory Commission is issuing this notice of intent to retain in its regulations the treatment of cardiac dysfunction by iodine-131 as an accepted therapeutic procedure.
In 1976, this procedure was reclassified by the Food and Drug Administration as lacking substantial evidence of effectiveness.
NRC has generally restricted the uses of therapeutic radioactive drugs to procedures that FDA has approved.
However, NRC's Advisory Committee on the Medical Use of Isotopes, the American College of Cardiology and several physicians have recommended that this treatment should not be removed from NRC regulations since this would be detrimental to the health of some patients.
DATES:
Comment period expires ADDRESSES:
Interested persons are invited to submit written comments and suggestions on this notice to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C.
20555, Attention:
Docketing and Service Branch.
Copies of comments received by the Commission may be examined at the Commission's Public Document Room at 1717 H Street, NW., Washington, D.C.
" Insert date 60 days from publication in the FEDERAL REGISTER.
1
te;.v-ulj FOR FURTHER INFORMATION CONTACT:
Deborah A. Sozik, Office of Standards Development, U.S. Nuclear Regulatory Commission, Washington, DC 20555 (phone 301-443-5860).
SUPPLEMENTARY INFORMATION:
ladine-131 in the form of sodium-iodide is used as a therapeutic agent in the treatment of euthyroid heart diseases such as angina pectoris and congestive heart failure.
This treatment of cardiac dysfunction with iodine-131 was introduced approximately thirty years ago.
FDA has on record clinical studies which document safety when iodine-131 is used to treat cardiac dysfunction.
While the application of iodine-131 to the thyroid during the therapeutic treatment of cardiac dysfunction does damage the thyroid, the net effect on patients has been demonstrated through clinical tests to be beiaficial and no major adverse side effects have been identified.
In 1971, the Food and Drug Administra-tion classified the therapeutic treatment of cardiac dysfunction with iodine-131 as possibly effective.
Since no person submitted any clinical data to support the possibly effective indication, in 1976, the FDA reclassified the treatment of cardiac dysfunction as lacking substantial evidence of effectiveness (41 FR 38800).
Other alternatives, principally non-radioactive drug therapy, have largely replaced iodine-131 for the treatment of cardiac dysfunction.
Although FDA's action is based on lack of evidence of effectiveness, this should not be taken as a definite conclusion that the treatment of cardiac dysfunction with iodine-131 is ineffective.
Since 1951, the FDA has recorded three adverse reactions to the use of iodine-131 in the therapeutic treatment of cardiac dysfunction.
Two of these reactions were classified as possibly drug related and the third was classified as remotely drug related.
2
[7590-01]
On February 9,1979, NRC published a final Medical Policy Statement, 44 FR A242. which included a policy of restricting therapeutic radioactive drugs to the procedures which have been approved by the FDA.
- However, NRC's Advisory Committee on the Medical Use of Isotopes, the American College of Cardiology and several physicians have indicated that the therapeutic treatment of cardiac dysfunction by iodine-131 should not be removed from NRC regulations since this would be detrimental to the health of some patients.
Group IV of S35.100 of 10 CFR Part 35 is a list of prepared radio-pharmaceuticals for therapy which does not normally require hospitalization for radiation safety.
Iodine-131 for the treatment of cardiac dysfunction is listed in Group IV of S35.100.
Since deletion of this therapeutic proredure would remove an option for the physician in cases where other treatments may not be effective, NRC has decided to retain the therapeutic treatment of cardiac dysfunction by iodine-131 in Group IV of $35.100.
(Secs. 81, 161, Pub. Law 83-703, 68 Stat. 935, 948 (42 U.S.C. 2111, 2201);
Sec. 201, Pub. Law 93-438, 88 Stat. 1242 (42 U.S.C. 5S41)).
Dated at this
_ day of
___158_.
For the Nuclear Regulatory Commission.
Samuel J. Chilk Secretary of tha Commission 3
Office of General Counsel and Office of Policy Evaluation Comments I.
Office of the General Counsel A.
Comments:
OGC stated the following:
(1)
If the therapeutic treatment of cardiac dysfunction by iodine-131 is important to the few doctors who use it and threatened to sue NRC if it is removed, then these doctors should have expressed this to FDA when it was soliciting comments.
(2) Such comments from a small segment of the medical community do not seem to provide a strong basis for departing from NRC's general policy of deferring to FDA on matters within its sphere of influence.
(3) The question of whether NRC would conform to its own Medical Policy Statement and delete this procedure makes this issue additionally significant.
OGC recommended that the staff paper be redrafted to propose deletion of the therapeutic treatment of cardiac dysfunction by iodine-131 from NRC regulations.
B.
Response
We have the following responses to OGC's comments:
(1)
Iodine-131 has been and still is used for treatment of hyperthy-roidism, and the reclassification by FDA did not significantly affect the drug manufacturers which still have a market for iodine-131.
There was little incentive for the manufacturers to perform the clinical trials which are needed to show FDA the evidence of effectiveness of iodine-131 for treating cardiac dysfunction.
In addition, NRC's Advisory Committee 1
on the Medical Use of Isotcpes, the American College of Cardiclegy and several physicians have indicated that this treatrent should not be removed from NRC regulations since this wculd be detrirental to the health of sc:e patients.
(2) FDA's action of removing cardiac dysfunction from the official label-ing, by itself, dces not prevent physicians frca using icdine-131 for the therapeutic treatment of cardiac dysfunction.
Indeed, we are aware of several physicians ho still claim that therr is adequate evidence for using the drug for this purpose, although it is neither en the package insert nor on the official labeling.
(The physician can determine that the benefit-risk of using a particular drug in a particular patient is justified.)
(3) When the Medical Policy Statement was written, the staff locked to prospective FDA approval rather than retrospective denial.
That is, it thought of NRC adding to its regulations new treatments already approved by FDA rather than deleting al:eady allowed treatments.
This is the first time NRC has had to conside'. deleting a therapeutic procedure that has been removed from an approved l!3; by FDA.
We believe that this is a unique situation and do not anticipate any future administrative removal actions by FDA.
Therefore, NM55 and SD believe that the use of iodine-131 for the treatment of cardiac dysfunction should not be removed from NRC's regulations.
2
II.
Office of Policy Evaluation A.
Comment:
Discussions with CPE revealed their concern that the paper should indicate somewhere a position on safety to show that NRC would be approving the use of a radioisotope for patient therapy which has an estab-lished finding of safety even though there is lack of substantial evidence of effectiveness.
B.
Resoonse:
OPE's suggestion is responded to by including an indica-tion of safety both in the Commission paper (page 2, Part b.) and in the Federal Register Notice.
While the application of iodine-131 to the thyroid during the therapeutic treatment of cardiac dysfunction does damage the thyroid, the net effect on patients has been demonstrated through clinical tests to be beneficial and no major adverse side effects have been identified.
3
ENCLOSURE 2 PP 129-136 - EXCERPT FROM MINUTES OF ACMUI 8/18/80 MEETING THIS DOCUMENT CONTAINS POOR QUALIT( PAGES
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[7590-01]
NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 Therapeutic Treatment of Cardiac Dysfunction by Iodine-131 AGENCY:
Nuclear Regulatory Commission.
ACTION:
Notice of intention to retain existing regulation.
SUMMARY
The Nuclear Regulatory Commission is issuing this notice of intent to retain in its regulations the treatment of cardiac dysfunction by iodine-131 as an accepted therapeutic procedure.
In 1976, this pro-cedure was reclassified by the Food and Drug Administration (FDA) as lacking substantial evidence of effectiveness.
However, NRC's Advisory Committee on the Medical Use of Isotopes, the American College of Cardi-ology and several physicians have recommended that this treatment should not be removed from NRC regulations since this would be detriroental to the health of some patients.
DATES:
Comment period expires (60 days from date of publication).
ADDRESSES:
Interested persons are invited to submit written comments and suggestions on this notice to the Secretary of the Commission, U.S.
Nuclear Regulatory Commission, Washington, D.C.
20555, Attention:
Docketing and Service Branch.
Copies of comments received by the Commis-sion may be examined at the Commission's Public Document Room at.1717 H Street, NW., Washington, D.C.
FOR FURTHER INFORMATION CONTACT:
Deborah A. Bozik, Office of Standards Development, U.S. Nuclear Regulatory Commission, Washington, DC 20555 (Phone 301-443-5860).
1
[7590-01]
SUPPLEMENTARY INFORMATICN:
Section 35.100(d)(1) of 10 CFR Part 35, " Human Uses of Byproduct Material," permits the use of iodine-131 as therapeutic treatment for cardiac dysfunction.
This notice sets out the reasons for the Commission's decision to retain this regulation.
Iodine-131 in the form of sodium-iodide is used as a therapeutic agent in the treatment of euthyroid heart diseases such as angina pectoris and congestive heart failure.
This treatment of cardiac dysfunction with iodine-131 was intro-duced approximately thirty years ago.
FDA has on record clinical studies which document safety when ioaine-131 is used to treat cardiac dysfunction.
While the application of iodine-131 to the thyroid during the therapeutic treatment of cardiac dysfunction does damage the thyroid, the net effect on patients has been demonstrated through clinical tests to be beneficial and no major adverse side effects have been identified.
In 1971, the Food and Drug Administration classified the therapeutic treatment of cardiac dysfunction with iodine-131 as possibly effective.
Since no person sub-mitted any clinical data to support the possibly effective indication, the FDA reclassified the treatment of cardiac dysfunction as lacking substan-tial evidence of effectiveness in 1976 (41 FR 38800).
Other alternatives, principally non-radioactive drug therapy, have largely replaced iodinc-131 for the treatment of cardiac dysfunction.
Although FDA's action was based on lack of evidence of effectiveness, this should not be taken as a definite conclusion that the treatment of cardiac dysfunction with iodine-13' is ineffective.
Since 1951, the FDA has recorded three adverse reactions to the use of iodine-131 in the therapeutic treatment of cardiac dysfunction.
Two of these reactions were classified as possibly drug related, and the third was classified as remotely drug related.
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On February 9, 1979, NRC published a final Medical Policy Statement, 44 FR 8242, which stated in part that "NRC will continue to restrict the uses of therapeutic and certain diagnostic radioactive drugs to the indi-
'ated procedures that have been approved by FDA."
Ho' wever, FDA's basic regulatory policy does not infringe on the physician's medical treatment prerogatives.
NRC's Medical Policy Statement establish &s that, in ;he best interest of the patient, a proper balance and flexibility should exist between the exercise of governmental regi f atory authority in the nuclear medicine area and the prJctice of medicine by physicians.
The Policy Statemcnt conveys this idea as follows:
"The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be part of the practice of medicine."
"The Commission recognizes that physicians have the primary responsibility for the protection of their patients.
The Coc..-
mission believes that basic decisions concerning the diagnosis and treatment of disease are a part of th3 physician patient relationship and are traditionally considered to be a part of the practice of medicine.
NRC regulations are predicated on the assumption that properly trained and adequately informed physicians will make decisions in the best interest of their patients."
Both the American College of Cardiology and several physicians have indi-cated that the therapeutic treatment of cardiac dysfunction by iodine-131 should not be removed from NRC regulations since this would be detrimental to the health of some patients.
In accord with this indication, at its most recent meeting on August 18, 1980, NRC's Advisory Committee on the Medical Uses of Radioisotopes recommended that cardiac dysfunction therapy with iodine-131 should be unconditionally retained in the regulations.
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The Commission has concluded that NRC shouid unconditionally retain in S 35.100(d)(1) of 10 CFR the use of iodine-131 for the therapeutic treatment of cardiac dysfunction.
The Commission believes that this decision is in consonance with the expressed intent of the Medical Policy Statement which was formulated to encompass a proper balance and flexi-bility so that the best interests of patients would not be compromised.
The Commission believes that this position exemplifies and accentuates the balance which was built into the Medical Policy Statement.
Comments, suggestions, or recommendations concerning this action by the Commission are invited from all interested persons.
(Secs. 81, 161, Pub. Law 83-703, 68 Stat. 935. 948 (42 U.S.C. 2111, 2201);
Sec. 201, Pub. Law 93-438, 88 Stat. 1242 (42 U.S.C. 5841)).
Dated at this day of 1981.
For the Nuclear Regulatory Commic 'on.
Samuel J. Chilk Secretary of the Commission 4