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Tuesday, August 2, 2011

Pharma and the Pill


Purdue Pharma L.P. claims to be "a pharmaceutical company committed to improving patients' lives and serving the healthcare community." The company believes it has taken a leading role in addressing the serious public health issues of pharmaceutical drug diversion and abuse through a wide variety of educational and interventional programs.

Please read Purdue's information for yourself at their site: http://www.purduepharma.com/Products/Prescription/Pages/default.aspx. Here is Purdue's "Important Safety Information" about OxyContin® (oxycodone HCl controlled-release) Tablets C-II:

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)

Guns and Oxys?

We all are familiar with the bumper-sticker slogan of NRA supporters: Guns don't kill people; people kill people. Many accept this slogan as sound logical reasoning. But, as Tom Hoppi reminds us:

"This argument is an attempt to divert attention away from the fact that guns make it much easier to kill people. Guns do this in two ways: enhanced ability and feasibility. We can see the enhanced ability from suicide statistics: the most successful suicide attempts are those that involve firearms. And this greater ability also makes murder feasible in a greater number of circumstances. To anyone entertaining murderous impulses, a gun makes it feasible to attack larger people, multiple people, people from a distance, from secrecy, etc. No one in their right mind would try to rob a bank with a knife. But a gun inspires confidence of success in a would-be bank robber, allowing a crime to occur when it wouldn't have otherwise." http://www.huppi.com/kangaroo/L-gunskill.htm

I guess some would make a similar analogy to OxyContin and overdose death. In other words, they would say, "OxyContin doesn't kill people; people who abuse OxyContin kill themselves." What is wrong with considering such an analogy? Consider the "enhanced ability and feasibility" for abuse presented in the form of the drug and the fact that it is so widely distributed.

Yes, addiction and death result from abusing the medication, but how many risks are associated with the use of OxyContin? Let's re-examine the literature presented by Purdue.

First of all, OxyContin has an "abuse liability similar to morphine." In truth, the warning should be made very clearly: OxyContin has a high potential for abuse. It was specifically developed to help cancer patients treat their chronic pain. It has a controlled release formulation to allow for up to 12 hours of relief from moderate to severe pain. Schedule II drugs have the highest potential for abuse of any approved drugs.

While Purdue acknowledges that it "can be abused in a manner similar to other opioid agonists, legal or illicit," they fail to admit the obvious: OxyContin is the painkiller of potential abuse preferred by the masses.

The U.S. Department of Justice's Office of Diversion Control states, "OxyContin has become a target for diverters and abusers of controlled substances because of the larger amounts of the active ingredient in relation to other previous oxycodone products and the ability of abusers to easily compromise the controlled release formulation." The site for the information is  http://www.deadiversion.usdoj.gov/drugs_concern/oxycodone/abuse_oxy.htm

One very real and long-term danger of abusing OxyContin is that of dependence and an eventual withdrawal similar to that experienced by heroin abusers.Dependence on oxycodone also generally leads to chronic abuse, with users increasing the amount of the drug to satisfy their body's tolerance. It needs to be simply stated: The abuse of OxyContin often leads to a heroin-like dependence on the drug.

Of course, doctors and patients are warned that OxyContin is not intended for use on an "as-needed basis." Unfortunately, either significant numbers don't believe this warning or they underestimate the risks. People do the unthinkable: People take OxyContin "as-needed" for pain. OxyContin has been very commonly prescribed by doctors for pain resulting from major surgery or even dental work, bad back pain or headaches, serious and painful injury, and a disease or condition like cancer or severe arthritis.

Patients who take OxyContin may be at serious risk. Misuse can cause "fatal respiratory depression." The drug presents particular problems "for those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression)." People do die from misusing OxyContin.

In the real world many patients are not being adequately "assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids." Instead, many receive little or no assessment in the pill mills that litter the country. It happens all the time: OxyContin is prescribed to people without proper assessment.

Patients even purchase prescriptions without physical examinations and without proper medical records. Some have purchased fake MRIs. Many of these people are addicted to OxyContin, and many are cashing in while dealing the product. Some addicts and pill dealers obtain a scan from an injured person, then make computer copies to attach their own names in order to persuade a doctor to give out pills.

Are doctors effectively monitoring the use of OxyContin? The warning, again, is clear: "all patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction." The answer is "no": Doctors are not monitoring the use of OxyContin. A new study found that primary care physicians may not be diligently monitoring patients who are taking opioid painkillers such as OxyContin, even those who are at risk for becoming dependent on them. (Kim Carollo, "Many Doctors Fail to Monitor Potential Opioid Abuse Appropriately," ABC News Medical Unit, March 17 2011)
 
"We studied a cohort of more than 1,600 primary care patients prescribed long-term opioids and looked at how frequently they received three strategies for reducing the risk of misuse," said lead researcher Dr. Joanna Starrels, assistant professor of medicine at the Albert Einstein College of Medicine and Montefiore Medical Center in the Bronx, N.Y. The three risk-reduction strategies are urine tests, face-to-face office visits at least every six months and within a month of changing an opioid prescription, and limiting the number of early refills.

Data showed that only 8 percent of the patients in the study had any urine drug testing, less than half had regular office visits and nearly 25 percent received multiple early refills.

"This suggests that primary care physicians are not using these risk reduction strategies very frequently," said Starrels.

Here is the site for the article: http://abcnews.go.com/Health/primary-care-physicians-fail-monitor-patients-opioids-abuse/story?id=13149464 



What Can Be Done?

On their site, Purdue proudly states the following:

"Purdue has long-standing expertise in pain management and has transformed clinical practice to better serve the needs of patients with pain. We have conducted extensive research into the development of analgesics that provide safe and effective pain relief to patients. We work extensively with physicians, opinion leaders, and patient advocacy groups to ensure that pain is appropriately recognized and treated.

"Purdue and Shionogi & Co., Ltd., one of Japan's largest research-based pharmaceutical companies, are collaborating on the discovery and development of novel, non-opioid medications to treat pain. The research, which targets cellular receptors known to modulate pain responses, is being conducted jointly at Purdue's research center in Cranbury, New Jersey, and Shionogi's laboratories in Osaka, Japan.

"Purdue has an exclusive U.S. licensing and co-promotion agreement with Labopharm Inc. of Laval, Canada for Ryzolt (tramadol HCl extended-release tablets), an extended release formulation of tramadol."

This is the link to Purdue: http://www.purduepharma.com/About/Pages/Partner-With-Purdue.aspx.

I hope Purdue cleans up much of the mess caused by the use and misuse of their product. They need to do this at once by pouring money into education, intervention, and first-class treatment. Of course, this will do nothing to compensate those who have suffered the greatest losses -- those who have lost loved ones in the rx drug epidemic.

Maybe their work in "the discovery and development of novel, non-opioid medications to treat pain" will help alleviate future death and destruction. I sincerely hope so.

And, of course, Purdue could tighten controls over distribution. Yes, they could even stop manufacturing OxyContin.

It is very difficult to write about OxyContin without sounding like an alarmist. I do not intend to sound as if I blame Purdue Pharma for every casualty of rx abuse. But, I do believe they should do more to pay for their share of the misery.

According to a report by the Citizens Commission on Human Rights International, "Oxycodone, the addictive prescription pain-killer also known by its Purdue Pharma brand name OxyContin, directly caused more deaths in Florida in 2009 than cocaine, heroin and morphine combined."

The report continues, "Prescription drugs as a whole are killing far more Floridians than illegal drugs, with some 8,600 deaths last year involving at least one prescription drug, according to an annual report released today (July 1 2010) by the Florida Medical Examiners Commission. That’s 5 percent of all deaths in Florida in 2009, when 171,300 people died in the state." Read the report here: http://www.cchrint.org/tag/oxycontin/
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