Tuesday, May 16, 2006

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 a significant unmet need in treating one of the most feared and severe consequences of life-saving cancer therapies,"said Timothy C. Tyson, Valeant's president and chief executive officer. "With the approval of Cesamet, Valeant is proud to offer a solution that will help alleviate one of the most common side effects of chemotherapy." [...] The American Cancer Society estimates that there will be nearly 1.4 million new cancer cases in 2006. Approximately 70 to 80 percent of all patients receiving chemotherapy experience chemotherapy-induced nausea and vomiting (CINV). Although the use of anti-emetic agents decreases the incidence and severity of CINV, symptoms continue to occur in 40 to 60 percent of patients. "There is a need for cannabinoids, such as Cesamet, for patients who have exhausted conventional treatments but are still coping with the debilitating side effects of chemotherapy," said Neal Slatkin, M.D., DABPM and director, Department of Supportive Care, Pain and Palliative Medicine at City of Hope.[..] Cesamet should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence and marijuana use, since Cesamet is similar to the active ingredient found innaturally occurring marijuana. Excuse me while I go bang my head against a wall. 11:51:39 PM |  drug policy | Links | permalink | comment []

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 of attention her campaign is receiving. Keep at it, Loretta! 10:50:17 PM |  drug policy | Links | permalink | comment []

Best Headline Drug Czar Jailed For 22 Years Link [Thanks, Tom!] 10:40:25 PM |  drug policy | Links | permalink | comment []

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. § 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. § 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? 10:32:12 PM |  drug policy | Links | permalink | comment []

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 government has tried block drug policy reformers at every step through delays and circular appeals processes, this seemed like a great avenue to pursue (the first petition to reschedule marijuana took 22 years to go through the process). Americans for Safe Access put forth a petition in October, 2004. Ah, but it turns out that the law doesn't have much by way of teeth and if the agency doesn't respond in 60 days it can turn to... itself and grant itself an extension. Once it issues a ruling, you can appeal that ruling... to the same agency, which then must respond within 60 days or... grant itself an extension. Yes, this is how our government works. Here are a few of my posts on the subject. My first post on it, in October, 2004 My disappointment with a second extension by HHS Recap of the first three extensions so far in April, 2005 and my conjecture of how HHS would respond. Late April, 2005 HHS finally responds by saying it doesn't need to respond at this time. ASA appeals the "response." Update on appeal process in August, 2005 as HHS continues to grant itself extension after extension on the appeal. And now, 19 months into the 60 day process comes the latest: Date: April 12, 2006 To: Joseph D. Elford, Esq. Americans for Safe Access Dear Mr. Elford: Your appeal of the denial of your Request for Corrections under the Office of Public Health and Science (OPHS) Guidelines for Ensuring the Quality of Information Disseminated to the Public, received by OPHS on May 20, 2005 is still under review. We wrote to you on February 07, 2006 indicating that we would need additional time to complete our response to your appeal. At this time we are continuing to prepare our response but require additional time to coordinate Agency review. Our goal is to have a response to your appeal within 60 days of the date of this letter. Sincerely, John S. Jarman, Excutive Officer, Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services 8 days later, the FDA came out with its outrageous statement against medical marijuana with the statement: A past evaluation by several Department of Health and Human Services (HHS) agencies, including the Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA) and National Institute for Drug Abuse (NIDA), concluded that no sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use. This, of course, is precisely the incorrect information that the ASA petition is trying to correct and that the HHS is dragging their heels in responding. The deceit and delaying tactics are unbelievable! Despite my interest in the process, I even dropped the ball for a while because it just dragged on so long. That's what they want -- that we'll lose interest (or die) before they actually address the issues. But they won't get away with it in the long run. Eventually, they'll run out of stalling tactics and the courts will have to step in. 12:09:34 AM |  drug policy | Links | permalink | comment []