The City of Chicago v. Big Pharma

Big Pharma has taken another hit.

A few days ago, the city of Chicago took Johnson & Johnson (JNJ) and four other drug companies to court for allegedly foisting painkillers on the public that are neither as effective nor as safe as advertised. The city is seeking compensation for years of financing palliative drug treatment based on false or deceptive claims.

“Since 2007, the city has paid for nearly 400,000 claims for opioid prescription fills, costing nearly $9,500,000, and suffered additional damages for the costs of providing and using opiates long-term to treat chronic non-cancer pain,” the city’s lawyers claimed in a state court complaint filed in Chicago.

Along with JNJ (makers of Duragesic), Purdue Pharma (OxyContin), Endo Health Solutions (Percocet and Percodan), Teva and Actavis were also named in the suit.

Now, the first reaction of many of us is to want to cheer. The sight of the giant pharmaceutical companies exposed as snake-oil salesmen, pummeled by lawsuits and slapped with heavy fines, gladdens many a heart.

The Chicago case further substantiates the increasingly popular view of drug companies as high-paid hucksters in white smocks. Recent studies show that the industry is ranked barely above tobacco and oil companies in terms of its perceived trustworthiness. Their health products, too, it seems, may be hazardous to your health.

Of course, we’ve come a long way since the days of the Wild West when snake oil, derived from the Chinese water snake (Enhydris chinensis), was used by Chinese laborers to treat joint pain. Whether or not the treatment worked (there were innumerable testimonials), the term became synonymous with medical fraud.

Revelations concerning the unsupervised production of drugs and food products so horrified the public that by the twentieth century the federal government was forced to intervene. As a result, the Food and Drug Administration and a vast machinery of regulation, testing and safeguards were put in place to protect the public.

But the science and technology of pharmacology, along with increasingly sophisticated marketing methods, have upped the ante. A simple laboratory test no longer suffices to determine the legitimacy of a medical claim. Drug companies must prove their products through years of testing and analysis before they are permitted to bring them to market.

Yet, the technical issues are often so complex, understood only by experts, and obscured by conflicting evaluations (some of them courtesy of the manufacturers themselves), that exaggerated claims are hard to pin down, and the dangers lurking in long-term use of drugs difficult to ascertain, even with the best intentions.

Add to that an overly robust profit incentive, spin well in centrifuge and you get law suits like the one in Chicago.

We doubt that the cure for this malady is regulation. In the United States, it takes an average of 12 years for an experimental drug to make its way from the laboratory to the local drug store. Only about 1 in 5,000 passes all the regulatory hurdles. The handful of successes cost their creators an average of roughly $1 billion to produce, when all the costs, including expensive clinical trials and the fortunes invested in the failed products, are factored in.

Of course, this serves as a powerful argument for high drug prices. But given the costs and given the results, it doesn’t look like imposing a heavier regulatory burden on Big Pharma would yield safer, more effective medicines, though they would surely be more expensive.

There is a limit to how far society can legislate morality, and we have arguably reached that limit with the pharmaceutical industry. More regulation and stiffer penalties for offenders could end up stifling the profit incentive and slowing the creation of vital medicines.

What is needed, instead, is the inculcation of higher ethical standards within the industry itself. Medical entrepreneurs, researchers, marketers and salesmen must be better educated regarding the solemn trust they hold to tell the truth about their products.

Courses in ethics could help. A pharmaceutical version of the doctors’ Hippocratic Oath has also been suggested. In addition to the traditional pledge to “do no harm,” they might consider such clauses as “not overselling benefits” and “not covering up risks.”

We would also encourage the proposal for ethical accreditation, a seal of approval attesting to product reliability. Only products whose manufacturers meet the most stringent requirements would be allowed to carry the seal.

This isn’t a panacea, either. Pharmaceutical companies are adept at “capturing” accreditation programs through funding and patronage. But rules for staffing and financing can be designed to ward off the influence of Big Pharma patronage.

There probably isn’t any single cure-all; all of the above should be tried.