What does it take for a big pharmaceutical/ device/ biotechnology company to get an ethics award?
Reported by Sheila Kaplan at Stat (but for subscribers only), and first noticed by Carl Elliott and just discussed on his Fear and Loathing in Bioethics blog, it appears that the giant Johnson and Johnson pharma/ device/ biotech company will get an award in "ethical leadership" from and "organization called Fellowships at Auschwitz for the Study of Professional Ethics, or FASPE."
The Stat report, quoted by Dr Elliott, stated:
FASPE Chairman David Goldman, an attorney in New York, said he was aware of the pharma giant’s various ethical tangles, but believes the company has moved beyond them. 'We do think they’ve acknowledged their failures and taken the apropriate steps to resolve them,' he said. 'They know what they’ve done; we talked to them about it and they’ve taken the right action.'
Others disagree, noting that in 2013, J&J and its subsidiaries agreed to pay $2.2 billion to resolve criminal and civil allegations of improperly promoting several prescription drugs, including paying kickbacks to physicians. That was one of the largest health care fraud settlements in US history. The company has also lost recent product liability cases involving allegations of its talcum powder causing ovarian cancer.
If only it were just that.
In fact, we have been writing about the ethical misadventures of Johnson and Johnson for a long time. Our collected posts are here. An updated version of their legal record since 2010 is at the end of this post. Their misadventures go well beyond those listed in the Stat article, and new cases of them have been appearing regularly, most recently this year.
Perusing the list suggests that this giant company (with about $70 billion in yearly revenue) is a poster child for bad behavior by health care organizations. Despite the multitude of allegations leading to settlements, and sometimes findings of guilt, the company has never faced a penalty of significant size, given its revenue. Furthermore, almost no company leaders who enabled, authorized, directed or implemented the various misadventures have suffered any negative consequences, therefore appearing to enjoy impunity.
There are many more examples on this blog of legal settlements, and even episodes involving bribery, fraud, kickbacks, and other crimes that demonstrate the continuing impunity of leaders of large health care organizations. It is likely that such impunity has led to the general concerns that the system is "rigged" in favor of the wealthy, the well-connected, and the insiders.
(And now we have a president-elect who has promised to act against the "rigged system," but seems to be bent on appointing wealthy, well-connected people to run his executive branch, but in any case, as we have said before...)
We once again see the perverse incentives at work that drive bad behavior by health care oragnizational leaders. One can obviously become very rich by directing this bad behavior. Up to now, the likelihood that one would eventually pay any penalty for doing so was tiny. Now it is slightly higher. Whether those up the ladder, who might have authorized the behavior, turned a blind eye to it, or avoided enquiring about anything that could be bad behavior, as long as the money came in, will suffer any negative consequences from these actions or inactions in the future is still unclear.
We will not make any progress reducing current health care dysfunction if we cannot have an honest conversation about what causes it and who profits from it. True health care reform requires ending the anechoic effect, exposing the web of conflicts of interest that entangle health care, publicizing who benefits most from the current dysfunction, and how and why. But it is painfully obvious that the people who have gotten so rich from the current status quo will use every tool at their disposal, paying for them with the money they have extracted from patients and taxpayers, to defend their position. It will take grit, persistence, and courage to persevere in the cause of better health for patients and the public.
Appendix - Johnson and Johnson Legal Record since 2010
- Convictions in two different states for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax
- Guilty pleas to bribery in Europe by Johnson and Johnson's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses (see this link for all of the above)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
- Testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
- Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
- Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post).
- Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this post)
- Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this post).
- Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .
- Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this post for this and above case).
- Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this post).
- Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this post).
- Johnson & Johnson DePuy subsidiary settled Oregan state charges that it marketed the ASR XL metal-on-metal hip joint prosthesis without disclosing its high failure rate (see this post).
- Johnson & Johnson found by jury to have concealed harms of Risperdal.
- Johnson & Johnson Ethicon subsidiary found by jury to have concealed harms of its vaginal mesh device.
- Johnson & Johnson McNeil subsidiary pleaded guilty to marketing adulterated Tylenol. (see this post for three items above.)
- Johnson & Johnson subsidiary Aclarent settled allegations that it sold its Stratus device for unapproved uses. Two former executives of that subsidiary also were found guilty of distributing misbranded and adulterated devices (see this post)
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