Why America is Hooked on Drugs

As any medical advertising writer knows, you don’t need much to turn a sow’s ear into a silk purse. For example, I once had a writing assignment for an extended-release oxymorphone. The client told me to say their drug had a low likelihood of being abused. There was no clinical evidence to back up the claim. Instead, we implied less abuse potential by providing doctors with pharmacodynamic data showing that the new formulation was absorbed into the blood stream more slowly.

While print and digital advertising contributes to overtreatment, more insidious is the way marketers exploit scientific publishing, guidelines and industry-sponsored CME (continuing medical education).  This is accomplished through the use of key opinion leaders, also known as thought leaders.

The opioid epidemic is a classic illustration of how this occurs in American healthcare.  A look back at Purdue Frederick’s marketing strategy continues to be a template for building markets for drugs for cancer, diabetes, and rheumatology.

Building a blockbuster brand
The FDA approved short-acting oxycodone in 1950. For 40 years, prescribing of short-acting oxycodone was limited to pain management specialists and oncologists. This changed in the early 1990s as drug companies prepared to launch long-acting opioid medications. To create demand for their new products, companies set out to persuade physicians that long-acting opioids were safe for all kinds of pain.

Purdue Pharma* had particularly ambitious sales goals for the long-acting opioid, Oxycontin. Purdue’s key strategies: 1) promote Oxycontin to primary care physicians, expand use to conditions like low back pain, osteoarthritis, dental pain and migraine; 2) provide evidence that long-acting oxycodone had less abuse potential than its short-acting counterpart; and 3) overcome public health concerns about addiction. Sales of long-acting Oxycontin quickly exploded: from $45 million in 1996 to almost $1.5 billion in 2002.

How did this explosive growth occur?

  • Purdue’s ‘Partners Against Pain’ website stated that long-acting opioids were safer for chronic pain than non-steroidal anti-inflammatories, muscle relaxants or tricyclic antidepressants (TCAs).
  • Sales reps told physicians that there was “less than one percent” risk of addiction with Oxycontin, while handing out 34,000 Oxycontin patient coupons to encourage prescribing.
  • Purdue distributed 10,000 reprints of an article falsely stating that Oxycontin rarely caused withdrawal symptoms, even when abruptly discontinued.

Leveraging physician influencers
Purdue’s use of KOLs was more instrumental than advertising to Oxycontin’s phenomenal growth. KOLs are academic physicians hired by drug marketers to educate their physician peers about the company’s products. These thought leaders represent the company’s point of view at medical conferences, at dinner programs, on guideline committees and before government and accreditation organizations. While some KOLs compromise themselves for status and money, many are pawns in a game they do not fully understand. Manufacturers of opioids like oxycodone and fentanyl paid KOLs more than $29 million in speaking fees and honoraria in the two-year period (2013 – 2015).

The FDA approved oxycontin in 1996.  Within the year, Purdue started funneling millions of dollars to two pain organizations, the American Academy of Pain Management (AAPM) and the American Pain Society (APS), both headed by Russell Portenoy, M.D, a pain management specialist at Beth Israel Medical Center. His two pain management groups aggressively advocated for removal of restrictions on opioid prescribing. As early as 1997, AAPM and APS dismissed concerns expressed by those who feared lenient prescribing of opioids would lead to a public health crisis of addiction. The AAPM and the APS also crafted national pain management guidelines recommending opioid use for chronic non-cancer pain. Both pain organizations lobbied state medical boards and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to implement these new pain management standards. What was the evidence supporting the low abuse potential claims? An article, “Chronic use of opioid analgesics in non-malignant pain: report of 38 cases”, published by Russell Portenoy and Kathleen Foley of Cornell University Medical College.  The paper became the bedrock of evidence supporting use of chronic opioid therapy for non-cancer pain.

Criticism of low abuse potential
Pushback against the low abuse liability claims sprang up soon after the launch, however had little impact on practice . In 2009, the APS and the AAPM – responding to criticism about their links to opioid manufacturers – updated their recommendations. Their new guidelines however rehashed the original ones and stated, “the likelihood that treatment of pain using an opioid drug which is prescribed by a doctor will lead to addiction is extremely low.” As late as 2010, almost 90% of APS funding came from opioid manufacturers.

Shifting sales overseas
As media scrutiny intensified, Dr. Portenoy disassociated himself from Purdue. In reaction, Purdue created its own pain advocacy groups in 2011 – RxSafetyMatters and RxPatrol – to work with police, legislators and healthcare professionals to prevent abuse and diversion. However, as concerns about opioid abuse continued to grow in the United States, Purdue shifted their focus overseas. Today, Purdue sells oxycodone in 51 countries through MundiPharma. Former U.S. Food and Drug Administration commissioner David A. Kessler has accused Purdue of following Big Tobacco’s playbook. “As the United States takes steps to limit sales here, the company goes abroad.”

The opioid epidemic is  just one example of how drug marketing contributes to overtreatment. How can society protect itself from these types of public health crises? Under the current system, I doubt it can. Until medical professionals and consumers better understand how commercial forces shape the practice of medical care, history is doomed to repeat itself.

*Formerly Purdue Frederick.

Playing With Fire –The State of Pediatric Mental Health in America

Shire Pharmaceuticals recently introduced the first selective FDA-approved alpha-2A adrenergic receptor agonist for treatment of ADHD (attention deficit hyperactivity disorder) in children. Intuniv (guanfacine) is thought to stimulate receptors in the pre-frontal cortex. Shire initially positioned the drug for children with ADHD who displayed a subset of symptoms that included “arguing with adults, deliberately annoying others, losing one’s temper, and being easily frustrated or irritable.” Shire eventually received a FDA warning letter for implying that Intuniv treated individual behaviors (which were manifested by behaviors at home like  “bedtime blowups”, “toothbrushing tantrums” and “dinnertime defiance”.  In response, Shire modified all their marketing materials for Intuniv. However, you can view screenshots from the original DTC  consumer website here, at a site that archives web content. Read more → →

The Thimble Theory

A doctor’s mind is like a thimble.

Like a thimble, we can only retain a certain amount of information. Once you go over that limit, the content of the thimble overflows, leaving the thimble with nothing in it. All marketers know this, which is why promotional materials focus on two or three salient points that are repeated over and over again. In fact, these “sound bytes” are repeated so often, that we all start to believe them whether they are true or not. Read more → →