About the author

Paul Feldman is a FairWarning staff writer.

2 comments to “Drug Companies Pony Up in Illegal Marketing Cases, But Critics Wonder if Penalties are Enough”

  1. Charles M Hodge

    It’s a shame that profits have been put ahead of healing and safety.

  2. Doug Baldwin

    This is a good story about an interesting and fresh reality. The fact that such a huge billion dollar stream of penalty payments flows out from Big Pharma on a constant basis quietly and without much knowledge is indeed a powerful point of interest. Eye brows do get raised. And where does all that money go in the government? Do the enforcers get to keep it?

    But, of course, the vital central question of this article is to assert that maybe, the payment of all this money is insignificant to the transgressions being policed. The story wonders whether or not this is in effect chump change and a minor cost of continuing to do business in the illegal and immoral way that results in the penalty. The story is correct in asserting this needs an answer. But nothing in the story analyzes that answer or the path to that answer or indirect evidence to that answer. The penalties are said to equal about 5% of the profits of Big Pharma, and the implication is that this is small (!!!), but is that a fair point of comparison? If a giant contractor is found to be over charging the Pentagon by 1000% on the cost of toilet seats and hammers, as they have done, should they have to pay 10% of their worldwide profits as a penalty? Yes, we hate them for their hubris and contempt, but still, is something more proportional in order? We have no information about the value of off label prescribing or use and importantly, we have no information as to the patient/doctor motivations for that — why not use authorized drugs for that purpose? We might all assume that off label business might be huge, because of the huge normal sales and huge penalties, but why? Are there no competitors who are legal? And if there are no legal competitors, and if there is a health need, does that change the moral equation? To answer the questions posed by the article, we need data about off label sales, or some exploration about the data difficulties of that topic. For example, one would assume in levying the huge penalties, that there is some formula being used by the regulators. Surely, they don’t pull out of a hat their penalty numbers? What is the formula? Is it secret? Is it based on the overall drug sales, or the overall entire corporate parent’s total sales? Is is 5% of profits? Do the penalties remain static, or, as in criminal penalties, do they increase as the transgressions continue?

    I believe that “off label” promotion is properly and sensibly illegal. I also believe that is not the same as saying that off label use is always immoral and criminally and punitively harmful and it must be crushed with nuclear penalties. It depends on the extremity of health need, it depends on effectiveness, and it depends on what else is legally available. It does happen that certain medications have off label medicinal values and for various reasons, getting licensing for that is not in the cards any time soon, and other good choices not available. Is this risky? Of course. Should this remain illegal? Yes. Is our system of drug regulation good and deserving our trust and support? Yes. But is off label use always a transgression equivalent to a money grubbing felony level blatant contemptuous corruption of moral values deserving of a much larger nuclear financial penalty? Maybe so, maybe not. We are in a world full of pot, alcohol and constant abuse of over the counter meds like antihistamines, ibruprophen and tylenol, much less prescription pain killers. In other words, there are larger perspectives. Some off label uses have proven to be really medically helpful to desperate patients. Some of these patients travel to foreign countries to get that relief. So, it isn’t just all about profit and contempt for the law and there are doctor and patient pressures beyond the control of drug companies in the mix also. These thoughts have impact on deciding on the level of financial penalty, not just the level of corporate profit.

    I completely agree red flags fly here, something seems wrong. This seems to marry with the “ginormous” penalties levied on Wall Street banks for transgressions handling toxic mortgages, and the suspicion that it was all ho-hum to them. But on the other hand, there is always this general cry for more punishment and revenge at all levels, more jail time, etc. Is more punishment always the answer? We have all been reading how motor vehicle fines in some states are keeping poor people in an endless state of poverty — they can’t pay, they go to jail, they lose their jobs, then they can’t afford a car to get a job. In short, the relationship of maximizing punishment to maximizing societal benefit is complex.

    We have a great entry story here, but now we need more. It well may be that penalties at the level of 5% of corporate profits is not a bad level to be at, and if the drug companies are willing to pay that, well, good! That doesn’t automatically mean the off label use is evil and all about profit, a fraud on trusting and poorly informed patients, a conspiracy to enrich the undeserving. Surely in some part the bad motivations are absolutely true. We all believe it. Still, those big numbers may actually mean that there are ALSO big health and patient needs here and there, and that the regulatory process presently is preventing properly licensed medications to fill those needs in the marketplace, creating a void, and presenting doctors and patients the choice of nothing, or…..cough cough, something. But we don’t know the level of truth. We have no stats. Just because a drug company takes me golfing doesn’t mean I go from Mother Teresa to Hitler. Its wrong, make no doubt, but this story is about setting the level of penalty and that involves complexity. We have no info. This is a story, but there is more story here.

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