That year, 1. But it only increased from there.
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By , at the peak of opioid prescriptions in Colorado, doctors wrote nearly 3. About , of those were for OxyContin; 8. The lawsuit portrays Purdue's marketing force as relentless in its pursuit of OxyContin sales. Doctors were visited dozens of times a year. Sales reps focused on specialty pain-management physicians but also family-practice doctors who were less experienced in treating pain. In one visit with a Purdue rep in , a Colorado medical provider said she was going to stop treating chronic pain patients.
The Purdue representative responded by saying she was not telling the provider she should specialize in pain, "it's just that pain is one of the main reasons patients come to the doctor ," according to the sales rep's notes quoted in the lawsuit. When the provider insisted that she wasn't going to treat any new chronic pain patients, the sales rep said, "What are you going to do when a current patient develops a pain condition? Let me show you what some of your peers are doing," according to the lawsuit. And, at least for some doctors, these tactics had an impact on their prescribing practices.
The lawsuit cites an instance from when a provider who rarely wrote high-dose prescriptions for OxyContin said she was "freaked out" by a patient who had been referred to her and who was on a milligram dose of OxyContin every 12 hours.
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The Purdue rep responded by saying there was no "ceiling dose and end organ damage with OxyContin," according to the rep's notes quoted in the lawsuit. In the five years prior to that interaction, according to the lawsuit, the provider had written only 17 prescriptions for more than 60 milligrams of OxyContin. But that visit kicked off a sharp increase in the provider's dosing. The next year alone, in , the provider wrote another 17 high-dose prescriptions. In , the provider wrote high-dose prescriptions. What changed? During the four-year stretch between and , Purdue reps visited the provider times, or more than twice a month, according to the lawsuit.
By the time the doctor was arrested and sentenced in to eight years in federal prison for illegal narcotics distribution, Purdue sales reps had visited his clinic dozens of times — and apparently never alerted authorities to any suspicions about the doctor's prescribing patterns. This may be the lawsuit's most explosive claim. Even in cases where doctors were breaking the law or violating medical ethics, such as with Clemmer or "Candy Man," the lawsuit alleges that Purdue didn't step in to stop them. In the case of "Candy Man," the lawsuit refers to the doctor only by the initials D. But the details included in the complaint make clear the doctor was Douglas Hammond, who is now serving a sentence at a federal prison in southern Colorado.
Hammond, according to his plea agreement in the federal criminal case, admitted to "routinely" writing prescriptions to patients for more than oxycodone tablets a month. Many of those pills were later diverted into illegal sales, according to state and federal court documents. When Eddie Brantner first visited Hammond's clinic in December , according to the lawsuit and plea agreement, he received 60 milligram OxyContin tablets and milligram oxycodone tablets without even having to produce medical records — just a story about a hiking accident some years prior.
At Brantner's next visit, a month later, Hammond upped the dose. Two weeks later, Hammond prescribed even more opioids. By April , Hammond had Brantner on milligram OxyContin tablets and milligram oxycodone tablets.
And the next month, Hammond and his physician assistant upped the dose again, to milligram oxycodone tablets for just one month, according to the plea agreement. The Medical Letter on Drugs and Therapeutics concluded in that oxycodone offered no advantage over appropriate doses of other potent opioids.
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The promotion and marketing of OxyContin occurred during a recent trend in the liberalization of the use of opioids in the treatment of pain, particularly for chronic non—cancer-related pain. From to , Purdue conducted more than 40 national pain-management and speaker-training conferences at resorts in Florida, Arizona, and California. More than physicians, pharmacists, and nurses attended these all-expenses-paid symposia, where they were recruited and trained for Purdue's national speaker bureau.
Through these profiles, a drug company can identify the highest and lowest prescribers of particular drugs in a single zip code, county, state, or the entire country. Unfortunately, this same database would also identify which physicians were simply the most frequent prescribers of opioids and, in some cases, the least discriminate prescribers. A lucrative bonus system encouraged sales representatives to increase sales of OxyContin in their territories, resulting in a large number of visits to physicians with high rates of opioid prescriptions, as well as a multifaceted information campaign aimed at them.
From to , Purdue increased its internal sales force from sales representatives to , and its total physician call list from approximately 33 to 44 to approximately 70 to 94 physicians. By , when the program was ended, approximately 34 coupons had been redeemed nationally. Purdue promoted among primary care physicians a more liberal use of opioids, particularly sustained-release opioids. Primary care physicians began to use more of the increasingly popular OxyContin; by , nearly half of all physicians prescribing OxyContin were primary care physicians. Prospective, randomized, controlled trials lasting at least 4 weeks that evaluated the use of opioids for chronic, non—cancer-related pain showed statistically significant but small to modest improvement in pain relief, with no consistent improvement in physical functioning.
In the long-term use of opioids for chronic non—cancer-related pain, the proven analgesic efficacy must be weighed against the following potential problems and risks: well-known opioid side effects, including respiratory depression, sedation, constipation, and nausea; inconsistent improvement in functioning; opioid-induced hyperalgesia; adverse hormonal and immune effects of long-term opioid treatment; a high incidence of prescription opioid abuse behaviors; and an ill-defined and unclarified risk of iatrogenic addiction.
A consistent feature in the promotion and marketing of OxyContin was a systematic effort to minimize the risk of addiction in the use of opioids for the treatment of chronic non—cancer-related pain. One of the most critical issues regarding the use of opioids in the treatment of chronic non—cancer-related pain is the potential of iatrogenic addiction. Both of these studies, although shedding some light on the risk of addiction for acute pain, do not help establish the risk of iatrogenic addiction when opioids are used daily for a prolonged time in treating chronic pain.
There are a number of studies, however, that demonstrate that in the treatment of chronic non—cancer-related pain with opioids, there is a high incidence of prescription drug abuse. Prescription drug abuse in a substantial minority of chronic-pain patients has been demonstrated in studies by Fishbain et al.
Misrepresenting the risk of addiction proved costly for Purdue. Although research demonstrated that OxyContin was comparable in efficacy and safety to other available opioids, 11 , 63 marketing catapulted OxyContin to blockbuster drug status. The remarkable commercial success of OxyContin, however, was stained by increasing rates of abuse and addiction.
Drug abusers learned how to simply crush the controlled-release tablet and swallow, inhale, or inject the high-potency opioid for an intense morphinelike high. Purdue's own MS Contin had been abused in the late s in a fashion similar to how OxyContin was later to be; by , MS Contin had become the most abused prescription opioid in one major metropolitan area. Opioid prescribing has had significant geographical variations. In some areas, such as Maine, West Virginia, eastern Kentucky, southwestern Virginia, and Alabama, from through , hydrocodone and non-OxyContin oxycodone were being prescribed 2.
By , these same areas had become high OxyContin-prescribing areas—up to 5 to 6 times higher than the national average in some counties Table 1.
In West Virginia, the first methadone maintenance treatment program opened in August , largely in response to the increasing number of people with OxyContin dependence. By October , West Virginia had 7 methadone maintenance treatment clinics with patients in treatment M. In southwestern Virginia, the first methadone maintenance treatment program opened in March , and within 3 years it had admissions E.
Data are for the counties or independent cities with the highest quantities of opioids in grams prescribed in each of the 3 states. With increasing diversion and abuse, opioid-related overdoses escalated. The high availability of OxyContin in these 5 regions seemed to be a simple correlate of its abuse, diversion, and addiction. With the growing availability of OxyContin prescriptions, the once-regional problem began to spread nationally.
The increasing OxyContin abuse problem was an integral part of the escalating national prescription opioid abuse problem.
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Liberalization of the use of opioids, particularly for the treatment of chronic non—cancer-related pain, increased the availability of all opioids as well as their abuse. In terms of illicit drug abuse, prescription opioids are now ahead of cocaine and heroin and second only to marijuana. Under the Food, Drug, and Cosmetics Act and implementing regulations, the FDA regulates the advertising and promotion of prescription drugs and is responsible for ensuring that prescription drug advertising and promotion are truthful, balanced, and accurately communicated. There is no distinction in the act between controlled and noncontrolled drugs regarding the oversight of promotional activities.
Although regulations require that all promotional materials for prescription drugs be submitted to the FDA for review when the materials are initially disseminated or used, it is generally not required that these materials be approved by the FDA prior to their use. The FDA has a limited number of staff for overseeing the enormous amount of promotional materials. In , for example, 39 FDA staff members were responsible for reviewing roughly 34 pieces of promotional materials. In , Purdue distributed 15 copies of an OxyContin video to physicians without submitting it to the FDA for review, an oversight later acknowledged by Purdue.
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After its review, the FDA concluded that the video minimized the risks from OxyContin and made unsubstantiated claims regarding its benefits to patients. In July , to reflect the available scientific evidence, the label was modified to state that data were not available for establishing the true incidence of addiction in chronic-pain patients. The labeling also deleted the original statement that the delayed absorption of OxyContin was believed to reduce the abuse liability of the drug.
OxyContin appears to be as efficacious and safe as other available opioids and as oxycodone taken 4 times daily. Compared with noncontrolled drugs, controlled drugs, with their potential for abuse and diversion, pose different public health risks when overpromoted and highly prescribed. Several marketing practices appear to be especially questionable. The extraordinary amount of money spent in promoting a sustained-release opioid was unprecedented. During OxyContin's first 6 years on the market, Purdue spent approximately 6 to 12 times more on promoting it than the company had spent on promoting MS Contin, or than Janssen Pharmaceutical Products LP had spent on Duragesic, one of OxyContin's competitors.
Although there are no available data for evaluating the promotional effect of free starter coupons for controlled drugs, it seems likely that the over- and misprescribing of a controlled drug are encouraged by such promotional programs and the public health would be well served by eliminating them. The use of prescriber profiling data to influence prescribing and improve sales is imbedded in pharmaceutical detailing. Very little data are publicly available for understanding to what extent this marketing practice boosts sales. Regulations eliminating this marketing tool might decrease some potential overprescribing of controlled drugs.
The public health would be better protected if the FDA reviewed all advertising and promotional materials as well as associated educational materials—for their truthfulness, accuracy, balance, and scientific validity— before dissemination. Such a change would require a considerable increase in FDA support, staffing, and funding from what is currently available. Public monies spent on the front end of the problem could prevent another such tragedy.
The pharmaceutical industry's role and influence in medical education is problematic. Particularly with controlled drugs, the potential for blurring marketing and education carries a much higher public health risk than with uncontrolled drugs. If our advocates cannot obtain your Oxycontin Oxycodone ER medication for you, we will never charge a fee for that medication.
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