FDA Petition Comments

Reference docket #FDA-2007-P-0415-0002 Enact stricter guidelines in prescribing methadone for any reason

Please support the above petition to the FDA, docket # FDA-2007-P-0415 to Enact Stricter Guidelines in Prescribing Methadone for Any Reason. Please send your comments of support to U.S. Food and Drug Administration, Division of Dockets Management, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852. In 2005 Methadone was indicated in over 4,600 deaths nationwide and this number is underestimated due to an error in ICD10 coding and non-uniform procedures in reporting and determining causes of death. Methadone is killing more people than any other prescription drug, killing 2 people for every 100 exposed. The American Journal of Medicine recently released new research stating Methadone kills at therapeutic levels and creates a risk of sudden cardiac death. Please assist in stopping this epidemic and protecting the American public from dangerous drugs, like Methadone, that have killed and will continue to kill so many.

Methadone is now the #2 Killer drug in the U.S. It is a legal drug that has been thought to be safe for the past 40 years. Only recently when its use became approved for pain management patients have the cardio toxic risks emerged. Previously, Methadone has been used exclusively for replacement therapy for heroin patients and death was thought to be an effect of the accumulation of many years of drug abuse. With the surge in pain medication misuse and abuse, more patients are being referred to Methadone clinics and physicians treating pain. Many of these prescribers believe the myth that Methadone is safe or non addictive because of its indication for weaning addicts from heroin. Methadone is more addictive and dangerous than any other pain medication, including heroin, because of its extremely long half life, cardio toxic risks, numerous fatal drug interactions, dosages based on tolerance, and small margin of error. Up until November 2006, the government and pharmaceutical companies have been suppressing the numerous health and fatality risks related to Methadone.

There are between 800,000 & 900,000 (some statistics and sources provide different numbers) heroin addicts in the U.S and 1,881 people died from heroin in the U.S. during 2004.

Methadone deaths have increased nearly 400% between 1999 and 2004 according to the CDCP (Centers for Disease Control and Prevention). There are at least 200,000 people currently on Methadone for drug treatment alone and an undetermined number of people on it for pain. In 2004, there were 3,849 reported deaths resulting from Methadone. How many additional deaths were Methadone "related" and went unreported?

From these statistics, it appears that the "gold standard" is killing more people than the drug it's supposed to save people from!

Every day, 10.9 people die from Methadone (according to 2004 statistics, not

including car accident deaths caused by drivers under the influence of Methadone).

Methadone-related deaths have resulted from abuse of the drug after it is illegally diverted from hospitals, pharmacies, pain management centers, physician offices, and opioid clinics. However, other deaths have been resultant of valid Methadone prescriptions that were taken accordingly in which the patient may or may not have been properly assessed for dosing or was not properly counseled about contraindications and/or potential interactions. Current statistics show that nearly 4,000 people a year die from Methadone. These deaths are mostly happening to pain management and detoxification patients within the first 10 days of taking their initial dose. Many of these deaths are related to Methadone that has been prescribed and taken with other medications that react as additives with the Methadone. Diversion of Methadone is a serious problem because it lands this most deadly drug on the streets. Statistics also state that Methadone is contributing to more deaths nationwide than heroin and is second only to cocaine deaths.

We (the families of Methadone victims) are requesting new legislation dictating who can prescribe Methadone, more stringent clinic rules and regulations, as well as stiffer penalties for those caught selling their take home doses hence worsening the diversion epidemic. The entire Methadone maintenance system needs an overhauling. We cannot continue to allow a legal medication to be killing more people than illegal drugs. Our government should not be allowed to use taxpayers' dollars to fund "legal" drug dealing operations.

We are asking government agencies to enact stricter guidelines when prescribing Methadone for any reason. We advocate that assessment, dosing, and prescribing of Methadone and Methadone-related therapies should be limited to specialized providers certified in pain management and/or anesthesia. The clinical indications for which Methadone are currently prescribed include treatment of moderate to severe pain, detoxification of opioid addiction, and maintenance treatment of opioid addiction. We are advocating that any licensed individual professional that assesses, prescribes, doses, or administers Methadone must be approved, accredited, and licensed by the DEA (Drug Enforcement Agency), FDA (Food and Drug Administration), SAMHSA (Substance Abuse and Mental Health Services) and ASAM (American Society of Addiction Medicine) to prescribe Methadone for only the indications referenced above to prevent general practitioners and other unspecialized doctors from doing so. In clinic settings, the medical director assumes responsibility and liability for all medical services performed by the program, either by performing them directly, or delegating them to physicians or other healthcare professionals who may or may not be properly licensed in accordance to the guidelines suggested above. We advocate that CSAT (Center for Substance Abuse Treatment) or another government agency would provide the names and locations of such qualified physicians to patients seeking treatment. We are encouraging the DEA and SAMHSA to work with the manufacturers of Methadone to develop a thorough and comprehensive risk-assessment plan for both pain management and clinic patients that concentrates on education, evaluation, and ongoing surveillance as well as preventing diversion. We advocate that Methadone should not be used as a first line treatment for pain management or opioid addiction. We are suggesting that alternatives, such as Bupernorphine (Suboxone, Subutex), are prescribed in place of Methadone initially or abstinence is practiced. These alternatives have been proven safer by producing far less respiratory depression and less physical dependence than Methadone and are thought safer in the event of an overdose. Should Methadone be the recommended treatment, we suggest that informed consent occurs at any Methadone prescribing facility. The recommended initial induction dosage for Methadone ranges from 5-30mg. We are advocating that the initial daily dose be set to 5-10mg and be accompanied by an initial and ongoing urine drug screening to detect Amphetamine, Methamphetamine, Morphine, Codeine, Barbiturates, Benzodiazepine, Cocaine, Phencyclidine, THC, Synthetic Opiates (Oxycodone, Hydromorphone, Fentanyl, etc...), Methadone and Methadone Metabolite (EDDP), also in conjunction with an ekg at initial dosage and again at dosage increase intervals. The purpose of the urine screen is to determine the type and approximate amount of legal and illegal drugs in the patient's system for detection of misuse and/or abuse in an effort to monitor drug dependency, prevent potential accidental or intentional overdose, and avoid potential contraindications or toxicity upon Methadone introduction and ongoing management. To improve assessment, we encourage that the patient's general health, past 12 months of medical history, current weight, pain therapy, opioid dependence, and tolerance level should be accounted for and documented in a thorough medical and psychiatric exam. The Federal standard is currently 8 random urine analyses per year. The standard suggests the following criteria is met before dispensation of take home doses of Methadone from a clinic setting are allowed: (1) no recent drug use, (2) attends clinics regularly, (3) no serious behavioral problems, (4) no criminal activity, (5) stable home environment and good social relationships, (6) length of time in treatment , (7) assurance that take-home medication will be safely stored, and (8) judgment that the rehabilitative benefit to the patient will outweigh the risk of diversion. We recommend that ongoing monitoring and frequency of screening should occur no less than every 30 days and include the same criteria. If a patient presents as inebriated at a clinic, the clinic should also document such activity and take necessary measures to prevent the patient from driving, which otherwise, would pose further risk to innocent civilians on the roadways. Should 3 dirty urine tests occur, the patient should receive severe consequence and humane mandatory detoxification from the Methadone program.

There is currently no maximum suggested dose for Methadone. We advocate that there should be a maximum suggested dose imposed an are suggesting that the maximum suggested dose per day does not exceed 80mg/day, due to the growing number of deaths and increase in diversion activity. For any and every patient receiving Methadone, it is our opinion that the licensed practitioner should also prescribe Narcan (which prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension...often causes of overdose and fatality). We also believe that MMT (Methadone Maintenance Treatment) clinics should be open daily 7 days per week and holidays to reduce the frequency of take home doses and help avert diversion, misuse, or overdose. These MMT clinics should also be a recovery oriented system of care, holistic in their approach, and address all facets of the individual's substance abuse (bio, psycho, social disorders and their etiology, etc...beyond just that of treating opioid addiction alone). Take home doses for all patients receiving Methadone should be eliminated thus preventing the risk of diversion or precautions such as a pill safe should be implemented. ( ). Should the sale of take home Methadone doses occur, the patient must be terminated from the Methadone program permanently and this policy should be enforced nationwide. We agree that Methadone and Methadone-related therapy can be more effective and less dangerous if the suggested improvements outlined are considered, thus reducing opioid dependency, improving physical and mental health, and ensuring quality of care.

The potential of abuse, misuse, diversion, and overdose to new patients being prescribed Methadone is overwhelming. The unique properties of Methadone, its long half life, and its negative interaction and contraindications with numerous other drugs should make this drug a last resort treatment for chronic pain and addiction, (addiction solely for heroin and other IV drug abuse).

There is a legitimate and justifiable public interest to tighten controls on Methadone prescribing and an understandable and logical public concern pertaining to Methadone diversion.

Thank you for taking the time to read this letter.