NCI offers explanation for changes to its medical marijuana database entry
Wednesday, March 30, 2011 at 7:02 pm
The National Cancer Institute (NCI) has now published online an explanation for changes made to its treatment database entry on cannabis that The American Independent previously reported on.
The explanation states that the information available in NCI’s so-called “PDQ” (Physician Data Query) summaries are not treatment recommendations and are not representative of any federal policy.
The full text of the explanation:
The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.
In writing Cancer Information Summaries, PDQ Editorial Boards review current evidence. They do not make recommendations. Their work is editorially independent of the National Cancer Institute (NCI). The summary on Cannabis and cannabinoids does not represent a policy statement of NCI or NIH. The summary statement represents an independent review of the literature; that review is not influenced by NCI or any other federal agency.
In light of the attention garnered by the PDQ summary statement on Cannabis and cannabinoids, reviewers for the summary on the PDQ Complementary and Alternative Medicine (CAM) Editorial Board reexamined the recently posted statement and decided to change the wording, in order to clarify the meaning that the Board originally intended to convey and to correct several possible misinterpretations. The changes made and the rationales for them are:
- In the General Information section, the wording was revised to make clearer that Cannabis is not approved by the FDA for any medical use.
- In the General Information section, a sentence was replaced to add clarification. The CAM Board lead reviewers realized that the previous wording could have been misinterpreted as being a recommendation for prescribing Cannabis, which was not the intent of the Board. In addition, the current evidence for the antitumor properties of Cannabis is discussed only in the context of laboratory studies and not in research involving human subjects. It is discussed only in the summary section titled Laboratory/Animal/Preclinical Studies.
- In the last sentence of the Adverse Effects section under Cannabinoids, the words “severe or abrupt” were added for clarification.
Readers of the PDQ Cannabis and Cannabinoids summary should note that no changes were made to the Overall Level of Evidence for Cannabis and Cannabinoids section. This section provides levels of evidence related to the use of cannabinoids and Cannabis.
As part of the regular process for all PDQ Editorial Boards, the CAM Editorial Board plans to further review the literature and discuss other potential revisions to the summary.
As the explanation mentions, there is now a further revision to the summary of cannabis. It states:
The U.S. Food and Drug Administration (FDA) has not approved the use of Cannabis as a treatment for any medical condition. To conduct clinical drug research in the United States, researchers must file an Investigational New Drug (IND) application with the FDA.
An IND application is the first step in initiating clinical trials that can lead to FDA approval of a drug. While the new sentence is certainly by no means intended to be an official endorsement of seeking FDA approval of medical marijuana, it’s interesting to note that the concept of applying for IND approval is even acknowledged. The FDA stopped discontinued IND trials of marijuana in 1991 because of the glut of people seeking legal, FDA-approved access to the drug.
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