Petition Against 90 Day Supply of Schedule II Drugs

DEA%u2019s Deadly Decision

As Prescription Drug Deaths Increase DEA Reduces Restrictions on Schedule II Drugs

On Wednesday December 19th, 2007, the DEA announced physicians are now allowed to write a prescription for a 90-day supply of schedule II drugs. Schedule II drugs are controlled and classified as legal narcotic and stimulant drugs with high potential for dependence and abuse, but still having therapeutic value.  Other drugs in this category include Cocaine, Methadone, Oxycontin, Morphine, Ritalin, and Fentanyl.

In the wake of a prescription drug abuse epidemic in this country, the DEA has reversed the 30-day rule, which was initially put in place to reduce the abuse of schedule II drugs. According to the CDC, the number of unintentional poisoning deaths increased from 12,186 in 1999 to 20,950 in 2004. The largest increases for prescription drug deaths were in the "other and unspecified" drug, psychotherapeutic drug, and "narcotic and hallucinogen" drug categories.[i] The National Institute on Drug Abuse (NIDA) has stated that non-medical use or abuse of prescription drugs is a serious and growing public health problem in this country%u2026an estimated 48 million people (ages 12 and older) have used prescription drugs for non-medical reasons in their lifetimes.[ii]

Methadone, a schedule II narcotic drug contributed to 3,849 poisoning deaths in 2004, and other opioid (prescription) drugs attributed to 5,242 poisoning deaths.[iii] The Substance Abuse and Mental Health Administration (SAMHSA) correlates the rise of Methadone related deaths to the increase of Methadone being used in the treatment of chronic pain; although there are no statistics to substantiate this at this time. Current statistics show that prescription drug deaths are killing more Americans than the illicit drugs. Patients selling or giving their medications to others, as well as medical errors on the part of the physician, cause many of these deaths.[iv] For the first time poisoning deaths have surpassed firearm deaths and are second to motor vehicle deaths.[v]

Marti Hottenstein, HARMD Inc. (Helping America Reduce Methadone Deaths) Diversion Specialist asks %u201CWhy is the DEA allowing more drugs on the street before fixing the problem of prescription drug diversion, dependency and death. What is the DEAs plan to prevent increased diversion and death as a result of this deadly decision?

Methadone and opioid drugs are killing our children and loved ones. James Pethel III (23), only child of Mary Haynes (HARMD Vice President) died from "acute methadone toxicity." Mary recounts how Jamie was placed on many drugs as a child for ADHD." I listened to professionals, going against my gut feeling and my son still died in the end, from someone else prescription. Now Mary joins thousands of other families throughout the United States fighting for tougher prescription drug laws.

Jessica Gerdes, (HARMD Treasurer) asks How many more of our loved ones have to die as a consequence of ignorance and the deficient management of narcotic drugs before modifications are made to protect and preserve life?  Where is the culpability? Her ex-husband, Colin Gerdes, went to the hospital trusting and seeking treatment, and the medications that were prescribed to help him, killed him.  There was no misuse or abuse no intentional overdose only a compliant patient following his doctors prescribing instructions.  He died in his sleep approximately 6 hours after taking his doses of Methadone and Valium, exactly as they were prescribed.  His parents had to watch their baby being carried out of their home encased in a zippered body bag. He was 33 years old. 

Another HARMD member who wishes to remain anonymous due to an ongoing investigation lost her daughter to Methadone prescribed by her Primary Care Physician for alleged Narcotic Withdrawal (from Percocets for back pain).  This member states, according to FDA Rules and Regulations this was illegal for him to do. My daughter died three years ago on what would have been her eighth day of treatment. I am still waiting for justice, for the doctor to answer to his crime; a justice that I dont think will ever come. Why put these rules and regulations in place if theyre not going to be upheld? Why is it OK for someone such as a physician to commit murder with prescription drugs, I just dont understand It.?

OxyContin is another schedule II opioid analgesic commonly prescribed for moderate to severe pain. It was approved in 1995 by the FDA, and was considered to be a viable source of pain relief for the millions who suffer from chronic pain due to its slow-release properties. OxyContin contains a very high dose of oxycodone formulated to be released over a 12 hour time period. However, its abuse has made headlines from its onset, as abusers bypass the "time release" protection by chewing, crushing and even dissolving the tablets.[vi]

• Statistics reveal that OxyContin abuse has "increased from 1.9 million in 2002 to 3.1 million in 2004."[vii]
  
•  In 2003, prescription sales of the drug topped a startling $1.2 billion.[viii]
  
• As if those numbers weren't eye opening enough, from 1998-2000 emergency

room visits due to the overdosing and abuse of OxyContin rose 108% and rose 63% for methadone.[ix]

• In January 2004, the General Accounting Office (GAO) issued a scathing report on Purdue Pharma regarding practices the pharmaceutical company used to inform Dr.s concerning the proper use of OxyContin.  The report stated, The maker of OxyContin, [Purdue Pharma,] sent doctors promotional videos that made unsubstantiated claims minimizing the dangers associated with the pain relief drug. Furthermore, Purdue did not submit one of the videos it had sent to Dr.s for FDA review.[x]
  
• In June 2007, Purdue Pharma along with 3 of its highest executives were fined a total of $634.5 million due to questionable marketing practices.[xi]

The DEA instituted this change as a result of lobbying groups, patients, and specifically mothers whose children are being treated with stimulant drugs for ADD/ADHD. What these mothers are not told and according to the DEA, childhood use of mind-altering drugs is a foremost contributing factor to later cocaine dependence and addiction.[xii]  Perhaps if these mothers were aware of the easy access to these drugs and the implications this might have on our society, they would feel differently.

Serious effects of treating ADHD with medication:

·        In 1972, Safer et al. reported severe growth suppression in children with methylpheniadare or dextroamphetamine.[xiii]

·        A startling report further indicates a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems."[xiv]

·        On December 17, 2004, the FDA warned that possible "severe liver damage may progress to liver failure resulting in death or need for a liver transplant..." from use of the drug Strattera.[xv]

·        On June 28, 2005, the FDA warned of the possible psychiatric adverse events in children treated with Concerta, Ritilan, and other drugs to treat ADHD such as %u201Cvisual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior."[xvi]

·        On September 29, 2005, the FDA ordered that black box warnings be placed on ADHD drugs linked to suicidal thoughts and behavior.[xvii]

·        On March 22-23, 2006, two FDA advisory panels held hearings on the risks of stimulants as well as thee new ADHD drug Sparlon after receiving almost 1,000 reports of kids experiencing psychosis or mania between January 2000 and June 2005.[xviii]

In addition to the dangerous side affects, another major problem with Schedule II medication is the potential for misuse and abuse among adolescents and adults.

·        The Ontario Child Health Study Hyperactivity Scale determined that 26% of students with prescribed methylphenidate gave or sold some of their medication.[xix]

·        In 2004, a survey of 8th, 10th and 12th graders conducted by the National Institute on Drug Abuse (NIDA) reported that Vicodin and OxyContin were the %u201Cmost commonly abused prescription drugs by adolescents.%u201D[xx]

·        According to the 2003 National Survey on Drug Use and Health (NSDUH), an estimated 4.7 million Americans used prescription drugs nonmedically for the first time in 2002 :  2.5 million used pain relievers, 1.2 million used tranquilizers, 761,000 used stimulants, and 225,000 used sedatives.[xxi]

The CDC reports among all age groups, the largest increase of prescription drug abuse occurred among persons aged 15--24 years (113.3%).[xxii] Unfortunately, the push from big business and thoughts of convenience will undoubtedly result in more harm from ill effects of these readily prescribed schedule II medications, addiction and even death for young and old alike. On July 26, 2006, the DEA testified before Congress, discussing this disturbing and tragic upward trend of increasing diversion and deaths associated with the abuse of prescription drugs, the following is an excerpt:

Addressing the growing problem of the diversion and abuse of controlled pharmaceuticals continues to be one of the top priorities of the Drug Enforcement Administration. An examination of youth drug abuse data reveals that the percentage of young Americans abusing prescription drugs is second only to marijuana and ahead of cocaine, heroin, methamphetamine, and other drugs. DEA, as the nations primary law enforcement agency dedicated to enforcing the Controlled Substances Act, plays an integral role in achieving the goals of the Administrations Synthetic Drug Control Strategy. As outlined in that Strategy, we have committed to an ambitious goal of reducing the abuse of controlled pharmaceuticals by 15 percent over the next three years. Distribution channels that are otherwise legal are often manipulated to acquire controlled substance prescription drugs for illegal purposes. Compounding this matter is the perception, particularly among teenagers and young adults that controlled pharmaceuticals are safe even when used recreationally. Abusers of controlled pharmaceuticals are using these medicines for non-medical purposes in a manner for which they were never intended. This practice, coupled with the erroneous perception of safety, makes these medicines much more dangerous.[xxiii]

How much is convenience worth?  How much is one willing to pay?  Is growth suppression, suicidal thoughts and psychosis, increased diversion, or increased risk of addiction too much of a cost?  Is lining the pocket of powerful lobbyists and pharmaceutical companies worth it?  How about burying ones own son, daughter, husband or wife?  The word inconvenience wouldnt be the first thought to ones mind at a time such as that.  Is it not too much to ask that safety weigh above what comes so easy?  Just because something is more convenient, doesnt mean that it is safe or the best option.  Dr.s cannot be expected to properly monitor these deadly and highly addictive schedule II medications by writing 90-day prescriptions.

Let your voice be heard, for the many whose voices have been rendered silent.  Let your voice be heard, for those who fall prey to the lobbyists and pharmaceutical companies.  Let your voice be heard, that will make Dr.s accountable to properly monitor their patients on such dangerous medications.  Let your voice be heard, for those who suffer daily with staggering pain.  Pain should not be left untreated, nor under treated, yet a 90-day supply of schedule II medications for convenience sake is not the answer.  Let your voice be heard, and instead of doing what is easy, the DEA should do what is right and stand by their testimony to reduce the abuse of controlled pharmaceuticals, because what the DEA has just instituted will have dire and devastating consequences, all in the name of convenience.  It%u2019s time we stand up and say, Enough is enough. Too many have already paid the price for silence to prevail

[i] CDC, (2007, February 9). Unintentional poisoning deaths --- United States, 1999--2004. Retrieved December 21, 2007, from MMWR Weekly website: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5605a1.htm

[ii] Volkow, N (2005, August). Research report series - prescription drugs: abuse and addiction. Retrieved December 21, 2007, from National Institute on Drug Abuse website: http://www.nida.nih.gov/ResearchReports/Prescription/Prescription.html

[iii] Fingerhut LA. Increases in methadone-related deaths: 1999--2004. Health E-Stats. Hyattsville, MD: National Center for Health Statistics; 2006. Available at http://www.cdc.gov/nchs/products/pubs/pubd/hestats/methadone1999-04/methadone1999-04.htm.

[iv] SAMHSA, (2007). Summary report of the meeting: methadone mortality - a reassessment. Rockville, MD: Division of Pharmacologic Therapies, Center for Substance Abuse Treatment, SAMHSA/DHHS.

[v] Fingerhut LA. CDC Presentation, Methadone Mortality Conference, 20 July 2007.

[vi] National Institute on Drug Abuse, (12 February 2007). Hearing before the Health, Education, Labor, and Pensions Committee United States Senate - "OxyContin: Balancing Risks and Benefits."  Retrieved December 26th, 2007, from National Institute on Drug Abuse website: http://www.nida.nih.gov/Testimony/2-12-02Testimony.html.

[vii] National Survey on Drug Use and Health, (June 16, 2006). Nonmedical Users of Pain Relievers:  Characteristics of Recent Initiates. Retrieved December 26, 2007, from http://oas.samhsa.gov/2k6/pain/pain.htm

[viii] Greater Dallas Council on Alcohol and Drug Abuse.  Retrieved December 26th, 2007, from http://www.gdcada.org/statistics/oxy.htm.

[ix] U.S. Department of Health and Human Services and SAMHSA's National Clearinghouse for Alcohol and Drug Information, (7 March 2003) Trouble in the Medicine Chest: Rx Drug Abuse Growing. Retrieved December 26th, 2007, from http://ncadi.samhsa.gov/govpubs/prevalert/v6/4.aspx

[x] Greater Dallas Council on Alcohol and Drug Abuse.  Retrieved December 26th, 2007, from http://www.gdcada.org/statistics/oxy.htm.

[xi] Vansickle, Abbie (21 June 2007). OxyContin Execs Hear Tampa Mom's Anguish at Sentencing.  Retrieved December 27th, 2007 from St. Petersburg Times website:

http://www.sptimes.com/2007/07/21/Worldandnation/OxyContin_execs_hear_.shtml.

[xii] Drug Use to Drug Abuse. Retrieved July 15, 2007, from Fight for Kids website: http://www.fightforkids.org/drug_use_to_drug_abuse.html

[xiii] U.S. Department of Justice Drug Enforcement Administration, Methylphenidate (A Background Paper). (1995). Washington D.C.

[xiv] U.S. Food and Drug Administration, (2007, February 27). FDA News. Retrieved July 15, 2007, from FDA website: http://www.fda.gov/bbs/topics/news/2007/new01568.html

[xv] Citizens Commission on Human Rights International, Report on the Escalating International Warnings on Psychiatric Drugs. (2007)

[xvi] Citizens Commission on Human Rights International, Report on the Escalating International Warnings on Psychiatric Drugs. (2007)

[xvii] Citizens Commission on Human Rights International, Report on the Escalating International Warnings on Psychiatric Drugs. (2007)

[xviii] Citizens Commission on Human Rights International, Report on the Escalating International Warnings on Psychiatric Drugs. (2007)

[xix] Poulin, Christine (2007, May). From attention-deficit/hyperactivity disorder to medical stimulant use to the diversion of prescribed stimulants to non-medical stimulant use: connecting the dots. Addiction, 102(5) 740-751, Retrieved July 13, 2007, from EBSCOHost.

[xx] Volkow, N (2005, August). Research report series - prescription drugs: abuse and addiction. Retrieved December 21, 2007, from National Institute on Drug Abuse website: http://www.nida.nih.gov/ResearchReports/Prescription/Prescription.html

[xxi] National Institute on Drug Abuse, (2006, August 2). Research report series - prescription drugs: abuse and addiction - trends in prescription drug abuse. Retrieved December 21, 2007, from National Institute on Drug Abuse website: http://www.nida.nih.gov/ResearchReports/Prescription/prescription5.html#Trends

[xxii] CDC, (2007, February 9). Unintentional poisoning deaths --- United States, 1999--2004. Retrieved December 21, 2007, from MMWR Weekly website: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5605a1.htm

[xxiii] DEA, (2006). News from the DEA - DEA congressional testimony 7/26/2006. Retrieved December 21, 2007, from DEA website: http://www.dea.gov/pubs/cngrtest/ct072606.html