Purdue Pharma Markets Deadly Drugs Through Facebook

Might be a good time for the FDA to make Purdue Pharma "honest" and require the word "addictive" along with "abuse liability" on their OxyContin label.

Oxycodone - OC 60

(MYRTLE BEACH, Calif.) - As the FDA finalizes their "Opioid Recommendations" by 2011, Purdue Pharma is "marketing directly to consumers" in Facebook - a social networking website Gary Ruskin, Executive Director and Co-Founder of Commercial Alert, was quoted in 2005 as saying "Direct-to-consumer marketing of prescription drugs should be prohibited. This advertising does not promote public health. It increases the cost of drugs and the number of unnecessary prescriptions, which is expensive to taxpayers, and can be harmful or deadly to patients. Prescription drug advertising pressures health professionals to prescribe particular medications, and often the ones that may be less effective and more expensive and dangerous. This intrudes in the relationship between medical professionals and patients, and disrupts the therapeutic process. It takes up valuable time to explain to patients why they may have been misled by the drug advertisements they have seen."

First dealing with REMS, the US Food and Drug Administration (FDA) reports that new opioid recommendations will be unveiled early next year. The agency told Medscape Medical News the risk evaluation and mitigation strategies, known as REMS, are scheduled to be approved in 2011, with roll out and implementation to follow.

Purdue Pharma issued the below press release regarding their compliance with the REMS initiative:

July 29, 2010 – Working with the FDA, Purdue has developed a Risk Evaluation and Mitigation Strategy (REMS) for OxyContin® Tablets. The goals of the OxyContin REMS Program are twofold:

1. To inform patients and healthcare professionals about the potential for abuse, misuse, overdose, and addiction of OxyContin; and
2. To inform patients and healthcare professionals about the safe use of OxyContin.

The OxyContin REMS includes:

• A Medication Guide to inform patients;
• A Dear Healthcare Professional Letter to inform healthcare professionals;
• A Training Guide to educate prescribers;
• An Education Confirmation Form for prescribers to confirm their training completion; and
• Timetable for submitting assessments of various elements of the REMS.

The REMS program encourages prescribers to sign and return the Education Confirmation Form, or it may be completed online at www.oxycontinrems.com, however, the prescriber’s ability to prescribe OxyContin is not dependent upon completion of the Education Confirmation Form.

REMS-related materials for OxyContin have been mailed to selected prescribers of OxyContin. In addition, content is available to all healthcare professionals at www.oxycontinrems.com or by calling Purdue Pharma’s Medical Services Department (1-888-726-7535, and through distribution by the Company’s field sales representatives. For patients and caregivers, the OxyContin REMS web site provides information in the form of the Medication Guide for OxyContin. Patients and caregivers should also request a copy of the Medication Guide from their pharmacist with every prescription of OxyContin they receive.

This is a product-specific REMS for OxyContin. FDA is requiring the ongoing development of a class REMS for several long-acting opioid analgesic products that, once approved by the FDA, will replace the OxyContin REMS.

Indications and Usage

OxyContin is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Usage

OxyContin is not intended for use on an as-needed basis.

As used here, "moderate" and "moderate to severe" pain do not include commonplace and ordinary aches and pains, pulled muscles, cramps, sprains, or similar discomfort.

OxyContin is not indicated for the management of pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time.

OxyContin is indicated for postoperative use following the immediate post-operative period only if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

OxyContin is not indicated for pre-emptive analgesia (preoperative administration for the management of postoperative pain).

OxyContin is not indicated for rectal administration.

The professional product labeling for OxyContin® Tablets contains the following boxed warning:

WARNING: IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR ABUSE

OxyContin contains oxycodone which is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. (9)

OxyContin can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. (9.2)

OxyContin is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. (1)

OxyContin is not intended for use on an as-needed basis. (1)

Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant or sedating effects of opioids. (2.7)

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. (2.2)

OxyContin must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone. (2.1)

The concomitant use of OxyContin with all cytochrome P450 3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir) may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse effects and may cause potentially fatal respiratory depression. Patients receiving OxyContin and a CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (7.2).

Contraindications

OxyContin® is contraindicated in patients who have significant respiratory depression, patients who have or are suspected of having paralytic ileus, patients who have acute or severe bronchial asthma, and patients who have known hypersensitivity to any of its components or the active ingredient, oxycodone.

Additional Safety Information

Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs such as benzodiazepines, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Use low initial doses of OxyContin® in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications.

Serious adverse reactions which may be associated with OxyContin® Tablet therapy in clinical use are respiratory depression, apnea, respiratory arrest, and circulatory depression, hypotension, or shock. The most common adverse reactions (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.

Full prescribing information for OxyContin is available at

purduepharma.com/pressroom/news/OxycontinPI.pdf.

About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

Contact:

James Heins

203-588-8069 (Office)

203-856-2121 (Mobile)

James.Heins@pharma.com Libby Holman

203-588-7670 (Office)

203-609-1291 (Mobile)

Libby.Holman@pharma.com

Interesting that Purdue Pharma's press release begins with .... "To inform patients and healthcare professionals about the potential for abuse, misuse, overdose, and addiction of OxyContin." Purdue Pharma has always avoided mentioning the word "addiction" in any press releases or documents referring to OxyContin -- and, in fact, in the black box label they provide at the end of their press release -- they indicate WARNING: IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR ABUSE -- no warning of "addiction." The labeling references abuse and diversion warning for OxyContin and in generalities says -- "Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids." I wonder why Purdue Pharma was never required to use the word "addictive" but rather got away with using the words "abuse liability." Strange.

Might be a good time for the FDA to make Purdue Pharma "honest" and require the word "addictive" along with "abuse liability" on their OxyContin label.

One of Purdue Pharma's paid consultants, Dr. Nathaniel Katz seems to be involved in the FDA REMS initiative. I have had problems with the good Dr. Katz having his "hands in the deep pockets" of Purdue Pharma over the years -- and Katz thought he should clarify his financial gains from Purdue by defending himself in a recent article I commented on:

"In the comments to this news piece there was some interest on whether I am a paid consultant to Purdue Pharma, and a comment that my “hands are deep in the pockets of Purdue.” It is true that I am a paid consultant to Purdue. In 2009 I received a total of $7367.55, $0 in 2008, $2000 in 2007. This is for providing advice on how to develop better treatments for pain, which is my mission. I have been outspoken on the benefits of opioids, and extremely outspoken on their risks, dating back to my first publication on prescription opioid abuse 14 years ago, and many since. It is important for us all to work together to make progress on this problem.

Posted by Nathaniel Katz on July 13, 2010, at 12:55 PM.

That certainly clarifies things for me -- except Purdue Pharma was criminally convicted of misleading physicians and patients as to the addictive and abusive qualities of OxyContin in 2007 -- when Katz only received $2,000 from the criminals. In 2008, no financial gain -- and in 2009 $7,367.55. In the years 2007, 2008 and 2009, I believe every consultant working for Purdue wouldn't have accepted a holiday fruitcake from them in an effort to distance themselves from the disgraced company responsible for a modern day Holocaust. I wonder what Katz was paid in the years prior to the criminal conviction. Yes I think it's important to work together to make progress on this problem Dr. Katz -- let me know when you're going to remember the victims of the company you consult for -- and offer financial assistance to them in the form of drug rehabilitation.

Recently Purdue Pharma announced a Facebook page to advocate for the undertreatment of pain in America.

Under the "Advocacy Voices" tab, the following is just one "expert" in the undertreatment of pain in America:

"The negative impact of unrelieved pain on the lives of individuals and their families, on the health care system, and on society at large is no longer a matter of debate. The unmet needs of millions of patients combine into a major public health concern. Although there have been substantive improvements during the past several decades, the problem remains profound and change will require enormous efforts at many levels. Pressure from patients and the larger public is a key element in creating momentum for change." — Russell K. Portenoy, MD Chairman, Department of Pain Medicine and Palliative Care Beth Israel Medical Center.

"Pressure from patients and the larger public" ??? How about pressure from every state in the country experiencing sky rocketing death and addiction because of the opioids you are pushing, Dr. Portenoy? I call that a major public health concern as well as "every parent's call for momentum for change."

In the meantime, I am calling upon the FDA to end the "pushing of drugs" through Facebook by Purdue Pharma and their rewarded consultants -- and end their marketing narcotics directly to consumers.

"I have seen the devil in my microscope -- and I have chained him." — Dr. Moreau, The Island of Dr. Moreau (1996) (in gratitude to Marlon Brando)

Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.

oxydeaths.com/news_chilling.htm
nytimes.com/2007/05/10/business/11drug-web.html?
blog.nj.com/njv_bob_braun/2007/07/sometimes_only_justice_can_rel.html
judiciary.senate.gov/hearings/testimony.cfm?id=2905&wit_id=6612
You can send Marianne an email at: mskolek@aol.com
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