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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.

United States of Pharma: Why Drug Marketing Rules American Healthcare

I often hear medical and pharmacy directors at public and private health plans express frustration over how physicians prescribe. These payers feel forced to use prior authorization to combat irrational prescribing. ”Why,” they ask, “do doctors ignore the evidence? Why don’t they follow guidelines?” Read more → →

Spare the Rod, Spoil the Child – How the Prescription Pad Replaced the Paddle.

child getting paddledFifty years ago, if a child misbehaved, he got a good paddling. Today, society frowns on slapping and spanking kids, with corporeal punishment outlawed in all but 19 states.

While RxBalance is happy that our society no longer sees spanking as an appropriate response to misbehavior, we are concerned that Americans seem so at ease with drugging kids who are irritating, moody and temperamental. Sadly, there are children so destructive to themselves and others that medication is necessary. We are not addressing children such as these in this blog. Read more → →

Why Falling Cholesterol Trumps Cancer Rising – The Galileo Factor and Pharma Marketing

Today, we take it for granted that high cholesterol is a risk factor for coronary heart disease. This medical wisdom is so pervasive that USA statin sales were $14.5 billion in 2008, according to IMS.

I don’t plan to use this blog to debate cholesterol risks or statin benefits. However, based on my experience, the pharmaceutical industry was a contributing factor to the worldview that believes high (LDL) cholesterol is bad regardless of age, sex, race, and/or personal or family medical history. Read more → →

In Brain Chemistry We Trust – The Gospel According to Pharma

The rise of the biopsychiatric model of mental illness

If anyone has doubts about America’s faith in a Higher Power, all you need to do is to take a look at how we have come to worship the biomedical model of mental illness. This biomedical model is so entrenched in our culture that it has become gospel. Please note, however, that RxBalance is not saying that antidepressants don’t work or that brain chemistry and genetics do not contribute to mood disorders. Quite the contrary – psych meds have a role in treatment . We also respect the pharmaceutical industry’s role in helping to destigmatize mental health disorders like schizophrenia, depression and bipolar disorder. Read more → →

All that Glitas is Not Gold – Musings on Pharma Marketing & Type 2 Diabetes

In the past several years, the second-generation glitazones Avandia (rosiglitazone) and Actos (pioglitazone) – once touted as breakthroughs that could reduce cardiovascular mortality in patients with type 2 diabetes – have been tarnished by controversy. The story of the glitazones (also known as thiazolidinediones or TZDs) reflects everything that is good, bad and ugly about the pharmaceutical industry. Read more → →

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 → →

Risky Business – How Buying a Ford Explorer is Like Taking Zometa

Last week, Peggy Stevens, a woman in Missoula, Montana who developed osteonecrosis of the jaw (ONJ) while being treated for lymphoma, was awarded $3.2 million. The settlement was based on Ms. Stevens’claim that Novartis did not disclose risks associated with the bisphosphonate, Zometa (zoledronic acid).

Imagine this scenario.

You walk into your local Ford dealership intending to buy a Ford Explorer for your daughter’s 17th birthday. The salesman says he’s happy to help. With this scenario in mind, which of the following questions do you think the salesman is least likely to ask?

  • How much do you want to spend?
  • What options are you looking for?
  • Did you know that Ford Explorers are notorious for overturning at low speeds, that SUV rollovers account for 33% of passenger vehicle fatalities and that close to 10,000 people died in SUV rollover crashes in 2002 alone?
Read more → →

Altered Reality – Are Declining Cardiac Death Rates Attributable to Drugs?

Sometimes I feel like I live in an alternative reality. This seems particularly true when promoting certain drugs for asthma, hypertension or high cholesterol. What do these chronic conditions have in common?  For all, there is ‘big buck’ value to providing medications to people who are sick.

Reality depends on which side of the fence you stand on.  If a pharmaceutical client markets an ACE inhibitor, the medical writer’s reality is that ACE inhibitors are ‘knights in shining armor’ that protect people with hypertension from heart disease, kidney failure and death. However, if my client markets an ARB,  I am waving the flag that calls for the’death’ of ACE inhibitors, suggesting to providers that their patient’s chance of survival will increase if they take an angiotensin receptor blocker. And of course, telling doctors over and over again about the “high incidence” of cough reported in patients taking ACE inhibitors. Read more → →

Scientific Publishing– Color Me Cynical

When it comes to scientific publishing, I am a true-blue cynic.

Medicine and marketing go hand and hand. Whether reading a published meta-analysis, systematic review or randomized clinical trial, bias is frequently interjected into journal articles because so much money rests on a favorable result appearing in the scientific literature.

The topic of publication bias has been covered extensively in the academic literature. If you want to read up on the topic, I suggest ‘Googling’ articles by Joel Lexchin (York University, Toronto, Ontario, Canada) and/or Lisa Bero at UCSF. Bottom line, if a drug company is in anyway involved in article development or placement, it is likely to color the content. Read more → →