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FDA approves cannabinoid

Via The Drug Update:

Valeant Pharmaceuticals International (NYSE:VRX) today announced that the U.S. Food and Drug Administration (FDA) has given marketing approval for Cesamet (CII) (nabilone) oral capsules. Cesamet is used to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments. “There is still […]

Loretta Nall on MSNBC

I haven’t been reminding people enough about Loretta’s campaign for Governor in Alabama, but she continues to be on a roll and gathering attention. The latest — this snickering report on MSNBC, which actually did manage to bring up the issue of marijuana legalization and Loretta’s campaign without completely dismissing it, by noting that degree […]

Best Headline

Drug Czar Jailed For 22 Years

Link

[Thanks, Tom!]

HHS pressured to respond

[Thanks to Dano in comments]

Well, it turns out that Americans for Safe Access has decided that the number of delays by Health and Human Services (see below) qualifies as illegal avoidance of the Data Quality Act. They have sent a letter to HHS:

Dear Mr. Jarman:
I write to request an immediate response to our appeal of your denial of our Request for
Correction of Information under the Data Quality Act, 44 U.S.C. Ű 3516, Statutory and Historical Notes, P.L. 106-554 (“The Act”). Although that appeal was received by the Office of Public Health and Science (“OPHS”) on May 20, 2005, your office has repeatedly delayed in issuing a definitive response, claiming a need for “additional time to coordinate Agency review.” See Letter from John S. Jarmin to Joseph D. Elford, dated April 12, 2006. Just eight days after the latest such letter, however, on April 20, 2006, the Food and Drug Administration (“FDA”) publicly announced the results of this coordinated agency review in an Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine. See Exhibit A. Now that these agencies — the FDA, Drug Enforcement Administration and Office of National Drug Control Policy — have already publicly announced that they “do not support the use of smoked marijuana for medical purposes,” id., there is no reason your office needs additional time to respond to our pending appeal for the reason you stated on April 12th.
As I explained previously, time is of the essence in a public health issue such as this one.
The Data Quality Act is an amendment to the Paperwork Reduction Act of 1995, which requires administrative agencies to (1) develop guidelines to ensure the “quality, objectivity, utility, and integrity of information” they disseminate to the public and (2) “[e]stablish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency that does not comply with the guidelines.” 44 U.S.C. Ű 3516, Statutory and Historical Notes. Because the Act is intended to “ensur[e] the timely flow of vital information from agencies to medical providers, patients, health agencies, and the public,” the Department of Health and Human Services (“HHS”) Guidelines require the agency to respond to such requests within 60 calendar days. See HHS Guideline D.2.c.2.
Pursuant to this law, on October 4, 2004, Americans for Safe Access (“ASA”) filed a
Request for Correction of information disseminated by HHS regarding the Marijuana
Rescheduling Petition filed by Dr. Jon Gettman in 1995. More than eighteen months have
elapsed since ASA filed this request and nearly a year has elapsed since ASA appealed the initial denial of this request. Coordinated agency review which caused this delay was unnecessary, see Letter from Joseph D. Elford to Dr. Steven Galston, dated December 20, 2004, but, now that it has been completed, this cannot possibly serve to justify an even greater delay. I hope and expect that HHS will issue a final determination of our appeal in the 60 days you anticipate. If not, ASA will file suit in federal district court to compel this.
Sincerely,
Joseph D. Elford
Chief Counsel
Americans for Safe Access

So HHS is under the gun now. What will they do? Remember that HHS is one of the four entities (along with Congress, the Executive, and the DEA) that has the power to re-schedule marijuana.
Here is what ASA is demanding:

* HHS states that: “there have been no studies that have scientifically assessed the efficacy of marijuana for any medical condition.” ASA requests that HHS replace this statement with the following statement: “Adequate and well-recognized studies show the efficacy of marijuana in the treatment of nausea, loss of appetite, pain and spasticity.”
* HHS states 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.” ASA requests that HHS replace this statement with the following statement: “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.”
* HHS states that: “a complete scientific analysis of all the chemical components found in marijuana has not been conducted.” ASA requests that HHS replace this statement with the following statement: “The chemistry of marijuana is known and reproducible.”
* HHS states that marijuana: “has no currently accepted medical use in treatment in the United States.” Based on the corrections above, ASA requests that HHS replace this statement with the following statement: “Marijuana has a currently accepted use in treatment in the United States.”

Go to comments and tell us how you think HHS will respond. Will they actually respond this time? If so, what will the response be?

HHS continues to stall

Eric Sterling reminds me of something I’ve neglected for awhile. You see, there’s this law called the Data Quality Act that allows for forcing the correction of inaccurate information disseminated by government agencies. The great thing about it is that the agency is required by law to respond in 60 days. Given the way the […]