Steve Dubansky, M.D., SVP, Medical Director, Palio

Rather than explain inverse proportionality mathematically, you can simply visualize in the above equation that when “P” increases, “V” decreases, and vice versa. If that still isn’t clear, try these:

1. Usefulness is inversely proportional to its reputation for being useful.
2. Car size is inversely proportional to the intelligence of its owner.
3. The severity of an itch is inversely proportional to your ability top reach it.
4. The availability of a ballpoint pen is inversely proportional to how badly it is needed
5. In political debate, heat is inversely proportional to knowledge.

But is this true:

“PUBLIC SAFETY IS INVERSELY PROPORTIONAL TO THE MARKETING OF DRUGS” ?

That is, is there an inverse relationship between the aggressiveness of pharma marketing and the health of the general public? In a recent thought-provoking article by Drs. Brody and Light in the American Journal of Public Health, the author posit that increased and aggressive marketing of pharmaceuticals may help undermine the general public’s health.¹

While agreeing that not all marketing of prescription drugs is bad for public health, Brody and Light attempt to make the case that the benefit:harm ratio is decreased as pharma marketing becomes more aggressive and less supervised. They believe that if pharma companies marketed their products in an evidence-based manner, there would be fewer negative effects on individual and public health. They state, “Unfortunately, with such a small percentage of the population eligible to receive the drug, an evidence-based strategy yields low sales, much to the chagrin of the shareholders.”

The marketing measures they believe responsible for more patients getting unnecessary and less-than-carefully-proven medications are:

1. Reducing the thresholds for diagnosing diseases. For example, despite evidence that maintaining strict glucose levels doesn’t benefit most patients, guidelines have continued to lower the glucose level necessary for diagnosing diabetes. This lowered threshold raises the number of patients needed to treat (NNT), and many patients are unnecessarily exposed to the risks of a drug they may well not need.
2. Using surrogate endpoints rather than patient-oriented outcomes. Generally, using surrogate endpoints increases the NNT for preventing hard (patient-based) outcomes. “More prevention is better than less prevention” may not be true in regard to surrogate endpoints isolated from real outcomes. The authors conclude, “Drug manufacturers sometimes find it more advantageous to market the test that measures the surrogate endpoints rather than the drug itself.”
3. Exaggerating safety claims. An example is the professed improved safety profile of newer antipsychotics in the elderly – a claim that has proven untrue. Another example: with the presumed safety of SSRIs, patients with very mild depression are given drugs that previously would not have been prescribed for their degree of illness, drugs that they do not need but may well give them side effects.
4. Creating new diseases. They offer prediabetes, prehypertension, and osteopenia – three “diseases” where treatment may be of no benefit but of some unnecessary harm.
5. Exaggerating efficacy claims. They give as a cautionary example the selective COX-2 inhibitor group of NSAIDs, which, despite performing no better than older NSAIDs, had tremendous uptake due to “massive marketing to physicians and the public,” assuring both groups these drugs were more effective and even safer than standard NSAIDs. Then there was a push to recommend them for prevention of colon polyps. At about that time the increased cardiovascular risks became so obvious that one of these inhibitors – rofecoxib – was removed from the market.
6. Encouraging unapproved uses. Since this practice is illegal, it’s only when a company is fined for off-label marketing that we become aware of it. Recent examples are gabapentin and olanzapine, but there are many others. A 2003 report showed 60% of antipsychotic prescriptions were off label, and 75% of all off-label prescriptions generally lack evidence of benefit.²

The authors raise some thought-provoking issues for modern pharma companies and their promotional partners to consider. The relevance of their concerns can be debated, but the fact remains: drugs can be dangerous. Prescription drugs annually appear to cause about 46 million adverse reactions, 2.2 million hospitalizations, and 111,000 deaths annually in the United States alone.³ On the other hand, during 20 years of practicing oncology, I and my colleagues often reminded ourselves and our patients that the only thing worse than the side effects of chemotherapy was no chemotherapy when patients needed it. That’s the key: for patients who need the drugs, drugs can be life changing and life saving.

We in pharmaceutical promotions must aid the FDA in “helping” the pharma manufacturers police themselves, and, to paraphrase Abraham Lincoln, to behave according to the better angels of their nature. The public health demands that of us.

References:

1. Brody H and Light DW. Am J Public Health. The inverse benefit law: how drug marketing undermines patient safety and public health. 2011; Mar;101(3):399-404.
2. Stafford RS. Regulating off-label drug use-rethinking the role of the FDA. N Engl J Med. 2008; 358(14):1427-1429.
3. Light DW, ed. The Risks of Prescription Drugs. New York, NY: Columbia University

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