OPHS — Medical Marijuana: HHS Response to Rfc

04/20/2005

Date: APR 20, 2005

To: Mr. Joseph D. Eiford, Staff Attomey, Americans for Safe Access

Dear Mr.Elford:

This letter is in response to your October4. 2004 request for correction concerning the Department of Health and Human Services (HHS) response to the Marijuana Rescheduling Petition of 1995 1, pursuant to Section 515(a) of the Treasury and General Government Appropriations Act for Fiscal Year 2001, Pub. L. No. 106-554, 114 Stat. 2763A-153 (2000), (Federal Data Quality Act). In your request, you ask the HHS to “correct” several statements made in its response to the 1995 petition.

Your request alleges that the HHS review of the 1995 Marijuana Rescheduling Petition violates the Data Quality Act requirement that information used and disseminated by federal agencies meet standards for "quality, objectivity, utility, and integrity of information" because it lacks "objectivity, utility, transparency, peer review, and public participation." You request that HHS replace "each of the following statement(s)" within the HHS response to the 1995 Marijuana Rescheduling Petition with alternative statements, as described below:

(a) The HHS statement that "there have been no studies that have scientifically assessed the efficacy of marijuana for any medical condition," should he replaced by:

"Adequate and well-recognized studies show the efficacy of marijuana in the treatment of nausea, loss of appetite, pain and spasticity."

(b) The HHS statements that "a material conflict of opinion among experts precludes a finding that marijuana has been accepted by qualified experts" and "it is clear that there is not a consensus of medical opinion concerning medical applications of marijuana," should be replaced by:

"There is substantial consensus among experts in the relevant disciplines that marijuana is effective in treating nausea, loss of appetite, pain and spasticity. It is accepted as medicine by qualified experts."

(c) The HHS statement that "a complete scientific analysis of all the chemical components found in marijuana has not been conducted" should be replaced by;

"The chemistry of marijuana is known and reproducible."

(d) The HHS statement that marijuana "'has no currently accepted medical use in treatment in the United States," should be replaced by:

"Marijuana has a currently accepted use in treatment in the United States."

The 1995 Marijuana Rescheduling Petition in the Federal Register, Vol. 66, p. 20038, April.18, 2001, was published by the Department of Justice/Drug Enforcement Administration (DEA), based in part on input from HHS, The Controlled Substances Act (CSA) establishes a mechanism by which any interested party may petition the DEA to change the schedule of given substance (section201(a)). Under the CSA, the Secretary of HHS has the responsibility to make the recommendation to DEA as to whether a specific drug or substance should be controlled under the CSA. We have consulted with DEA on your information quality request and we are providing them with a copy of our response.

Both the Office of Management and Budget (OMB) and the HHS Information Quality Guidelines provide that federal government agencies may use existing processes that are in place to address correction requests from the public. In the case of marijuana HHS currently is in the process of conducting a review in response to the petition for change that was submitted to DEA in October 2002 by the Coalition for Rescheduling Cannabis (CRC), an association of public-interest groups and medical cannabis patients that includes the ASA. 2 In the course of the review, HHS will evaluate all the publicly available peer reviewed literature on the efficacy of marijuana

In accord with HHS implementing guidelines, if you do not agree with this decision on your request, you may send a request for reconsideration within 30 days of receipt of this decision. Your request for reconsideration should be designated as an "Information Quality Appeal" and should include a copy of your original request as well as this decision. Your appeal should state the reasons why you believe this response to your complaint is inadequate.

Sincerely,
RADM Arthur J, Lawrence 
Assistant Surgeon General
Acting Principal Deputy Assistant Secretary for Health

1The HHS review of the 1995 marijuana Rescheduling Petition was published by the United States Drug Enforcement Administration (DEA) in the Federal Register, Vol. 66, p. 20038, April 18, 2001, and at http://www.access.gpo.gov/su_docs/fedreg/a010418c.html andhttp://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_register&docid=01-9306-filed.pdf

2You may wish to consider submitting the new data you cite in your data quality complaint to the DEA as an addendum to this petition.