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There are 6 ways to get fired from Johnson & Johnson: (1) theft, (2) sexual harassment, (3) running an experiment without a control group, (4) keeping a gambling addict away from the casino, (5) chapter 11 bankruptcy proceedings, and (6) not covering up records of side effects of a drug you’re marketing to kids

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Paul Alper writes:

Gorsky, it seems to me, dwarfs the villains you often write about.

Here’s the background, from New York Times columnist Nicholas Kristof:

Risperdal is a billion-dollar antipsychotic medicine with real benefits — and a few unfortunate side effects.

It can cause strokes among the elderly. And it can cause boys to grow large, pendulous breasts; one boy developed a 46DD bust.

Yet Johnson & Johnson marketed Risperdal aggressively to the elderly and to boys while allegedly manipulating and hiding the data about breast development. J&J got caught, pleaded guilty to a crime and has paid more than $2 billion in penalties and settlements. But that pales next to some $30 billion in sales of Risperdal around the world.

Kristof’s conclusion:

In short, crime pays, if you’re a major corporation.

But there’s more:

Oh, and the person who was in charge of marketing the drug in these ways? He is Alex Gorsky, who was rewarded by being elevated to C.E.O. of J&J. He earned $25 million last year.

How did this happen?

J&J’s previous antipsychotic medicine ended its patent life, so sales plunged as generics gained market share. In 1994, J&J released Risperdal as a successor, but the Food and Drug Administration said it wasn’t necessarily better than the previous version and in any case was effective primarily for schizophrenia in adults. That’s a small market, and J&J was more ambitious. It wanted a blockbuster with annual revenues of at least $1 billion.

So J&J reinvented Risperdal as a drug for a broad range of problems, targeting everyone from seniors with dementia to children with autism. . . . Even though Risperdal wasn’t approved for the elderly, J&J formed a sales force, called ElderCare, with 136 people to market it to seniors. . . . The company began peddling the drug to pediatricians, so that by 2000, more than one-fifth of Risperdal was going to children and adolescents. . . . In 2003, the company had a “back to school” marketing campaign for Risperdal, and a manager discussed including “lollipops and small toys” in sample packages . . .

One challenge was that a J&J study had found that Risperdal led 5.5 percent of boys to develop large breasts, a condition known as gynecomastia. J&J covered this up . . .

Kristof reports:

Last week the Appeal of Conscience Foundation, an interfaith organization, announced it would honor Gorsky with an award as a “man of integrity” and a “corporate leader with a sense of social responsibility.”

I guess Mark Hauser and Dr. Anil Potti were unavailable.

2 sides to the story?

OK, so here’s my question. Is there another side to this story? Kristof writes, “Risperdal is a good drug that helps people. But it was marketed too broadly, and the system failed to protect consumers.” It seems that Gorsky did behave unethically, and people have certainly been fired for much less—at the very least, he might want to veer clear of the Stockton Police Department. But here’s my question: Has Risperdal been an overall net benefit to seniors and kids? That is, do the pluses when Riseprdal has worked outweigh the minuses of the strokes it’s caused among some elders and the body distortions it’s caused among some kids?

I have no idea; it just seems like the logical question to ask.

That said, even if Riseprdal has net benefits, that’s no excuse for burying the data. If it causes problems but is still good on balance, that’s fine, but then make the case: admit the problems and explain why the positives still win. Assuming the facts of the story as conveyed by Kristof (based on reporting by Steven Brill) are correct, the ethical violations seem clear and they seem large, and it seems ridiculous for this guy to be getting a 25 million dollar job—or, should I say, for our tax dollars to go to a company that’s paying this guy and, indirectly, encouraging future data-hiding. Moral hazard and all that. This is even worse than the American Statistical Association giving its Founders Award to a multiple plagiarist, or Columbia University Teachers College and the New York City Department of Education hiring a liar, cheat, and thief as principal of a new school.

But, all this aside, I’d be interested in seeing an analysis of the total costs and benefits here.

P.S. If you’re wondering where the title of this post came from, see here and here.

P.P.S. Johnson & Johnson is popular! At least, it used to be. In a Pew survey from a few years ago, 95% of respondents expressed a favorable view of that company (among those willing to give a rating).

43 Comments

  1. Paul Alper says:

    The above photo of Alex Gorsky indicates that he is handsome, rich and has a full head of hair. You would be very well rewarded if you watch another male with an impressive head of hair: Ben Goldacre:
    https://vimeo.com/17889555
    https://www.ted.com/talks/ben_goldacre_battling_bad_science?language=en
    https://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe?language=en
    But do read Brill’s lengthy presentation:
    http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/

  2. Anonymous says:

    Throughout your post there is an implicit assumption this drug actually works: “Risperdal is a billion-dollar antipsychotic medicine with real benefits…Risperdal is a good drug that helps people…pluses when Riseprdal has worked”

    For what it’s worth (not that I vouch for this analysis…):
    “For positive and negative symptoms, there is mixed evidence about whether risperidone is superior to placebo.”
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3385413/

  3. zbicyclist says:

    IMO, J&J is a company that used to be ethical, but now has sold its soul. Consider, for example, the botched manufacture of Tylenol. This wasn’t a simple case of an isolated manufacturing problem.

    http://www.nydailynews.com/life-style/health/cvs-won-stock-tylenol-stores-article-1.1240622
    (in 2013) “Since 2009, faulty manufacturing has prompted J&J’s McNeil unit to recall millions of bottles and packages of Tylenol, Benadryl, Motrin and other over-the-counter medicines.”

    http://money.cnn.com/2011/03/10/news/companies/johnson_mcneil_fda_action/
    (in 2011) “The government is taking over three Tylenol plants following a blizzard of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.

    The FDA and the Justice Department on Thursday took action against McNeil PPC and two of its executives — its vice president of quality and its vice president of operations for over-the-counter products — for failing to comply with federally-mandated manufacturing practice.”

  4. Martha says:

    Andrew said: “admit the problems and explain why the positives still win”

    I say caution beyond this is needed: the positives might “win” on average, but they might not in some cases. Maybe such a cost-benefit analysis might be appropriate for approval, but it is still important to consider approval only with certain limitations (e.g., only for adults, not for seniors). And it is important 1) to be transparent about what went into the cost-benefit analysis, 2) to be transparent about possible side effects, and 3) to educate physicians and the public about side effects (since once a drug is FDA approved, it can legally be prescribed “off-label” by physicians).

  5. Kristof is too sanguine about the benefits of Risperdal. For a very interesting discussion of antipsychotic drugs, see Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America, by Robert Whitaker. Briefly, Whitaker argues that psychiatric drugs can actually worsen the outcome of mental disorders. For a shorter treatment, see Mind drugs may hinder recovery, also by Whitaker.

    • Jon says:

      There is a cottage industry of fighting the usage of medicines in treating mental illnesses; having seen some of the studies and know people helped by the controversial medicines, I would say those fighting the usage of medicines to treat mental problems are highly misguided.

      And why has ‘mental illness’ diagnoses risen so much? For one thing, because we can now provide relief, it is useful to diagnose the conditions. Secondly, the greater importance of mental work vs physical work makes various mental deficits and mood disorders a greater obstacle. If your job was to make widgets in a factory or plow the farm, it did not matter too much whether you were depressed. Fewer people have those kinds of jobs.

      • Anoneuoid says:

        >”There is a cottage industry of fighting the usage of medicines in treating mental illnesses; having seen some of the studies and know people helped by the controversial medicines, I would say those fighting the usage of medicines to treat mental problems are highly misguided.”

        Can you give an example of a study (or collection of them) that convinced you?

        • Jon says:

          For one thing the FDA and other regulatory bodies all require proof of safety and efficacy to approve the medicines.

          Most of the medicines work only in some patients.

          While there are plenty of flaws in the current system of testing and marketting and approving drugs.

          Most of the major illnesses that we try to treat can last years and be due to or influenced by multiple different mechanicisms. This means that getting the perfect proof of efficacy is near difficult to impossible. The current solution is that the practitioner keeps trying different drugs until one works.

          The critics would have us deny patients the chance that one of the drugs would help him or her while they reject the high likelihood that one will work while waiting for the perfect answer.

      • My interest in psychotropic drugs dates back to the mid-90s when I used to work on the central nervous system team of a major pharmaceutical company. I have no doubt that lots of people feel better after they take psychotropic drugs. I’ve heard it in focus groups both from the prescribing psychiatrists and the patients themselves. So it’s a bit simplistic to ask whether “people [are] helped by the controversial medicines.” The interesting questions are more nuanced: When these drugs do work, what fraction of the improvement is attributable to some direct neurophysiological effect, vs. the placebo effect? What non-drug treatments are available, and how do they compare in their effectiveness and side-effects? What are short-term side-effects of these drugs, and what side-effects arise from long-term use? What is the optimal dose, and what diagnoses can best benefit from the use of these drugs? Can we trust the clinical trials that are cited as evidence of the effectiveness? How are the long-term outcomes affected when patients take psychotropic drugs, as compared to non-drug treatments?

        What’s interesting about psychiatry is that it’s characterized by the repeated rise (and eventual fall) of various “miracle cures”. It wasn’t that long ago that António Egas Moniz won the Nobel prize for popularizing lobotomies as a “cure” for psychiatric illness. I remember the hype that was associated with the release of Prozac in the late 1980s. I think that even supporters of the drug would agree that the exuberance was not justified.

        My own view is that some psychiatric drugs have their uses, but they’re vastly over-prescribed – and non-drug treatments are often unfairly bypassed (due to time pressures, Big Pharma influence, etc.). The drugs also have harmful side-effects that are much more serious than commonly believed, particularly when the drugs are used over the long term. And, ironically, some of those side-effects actually worsen the underlying condition that the drugs are ostensibly treating.

  6. Jon says:

    For costs and benefits to be meaningful, we need to pick a reference standard. I’d suggest, for Risperdal, the best available alternative treatment for each patient, and for J&J/Gorsky’s actions, their impact relative to a scenario with Risperdal marketed in a responsible fashion. I’m not clear if it’s what you meant, but implicitly comparing Risperdal to no treatment at all would be setting the bar very low in either case.

  7. Llew says:

    In NZ, like most countries in the world, we used to simply accept these ‘advances’ in science and believed that companies like J&J were doing ‘good’. Risperidone (Risperdal) was embraced here medically as a new generation medication for schizophrenia. Pharmac, who are our QUANGO that manages and purchases medication internationally for the maximum benefit of all our citizens, were I recall slow to be as warm as physicians. Pharmac’s presience has remained to the extent that US drug companies actively lobbied for years to have it abolished, trying to trade its existence against other trade deals with the US. Watchdogs for public good seemed to be anathema to these companies, it seems, for reasons we all suspected. Because, in NZ, we have in major part publicly funded medical care, unlike most of the rest of developed countries, we do not have the competing interests of patient (individual benefit ) versus (patient, meaning population maximised benefit for minimised cost) issues to the same extent. It is my strong view that too much ‘research’ focuses on population samples and group epidemiological benefits. Where mental health issues, such as psychotic disorders, afflict relatively a small proportion of the population (with base rate issues amongst many others arising) and where there is yet to be had a neurobehavioral consensus on classification, causation and treatment, it is more a case that we seek to alleviate suffering for all those afflicted, not just as many as possible. Human compassion over Jeremy Bentham’s cost-benefit philosophy. In that spirit, not to have the full facts about side effects has been iniquitous in this particular instance. In many of our hospital settings, patients on this medication ballooned, triggering a host of other medical risk factors. Who knows how many might better have been managed on ‘older’ medication? And it is my strong suspicion, based on observation, not data, that implicitly patients indeed at some point were much more cautiously put on Risperdal, even though those profiting from it never disclosed that intuition was in reality the science we had not seen.

  8. Chris G says:

    > Last week the Appeal of Conscience Foundation, an interfaith organization, announced it would honor Gorsky with an award as a “man of integrity” and a “corporate leader with a sense of social responsibility.”

    So my curiosity gets the best of me and I Google “Appeal of Conscience Foundation”. The Wikipedia entry lists their World Statesman of the Year awardees… Let’s just say the recipients are a pretty sketchy cast of characters. (For example, search “John Negroponte war crimes”. Inquiring minds would also like to know whether Ms. Fiorina received her award because she ran H-P into the ground and laid off 30000 people or in spite of doing so.)

  9. Steve Sailer says:

    “I guess Mark Hauser and Dr. Anil Potti were unavailable.”

    By the way, the 2015 Tom Stoppard play “The Hard Problem” has a plot twist involving the Replication Crisis in psychology. I was wondering which scandal Stoppard might have had in mind and the Hauser monkey business came to mind.

  10. Jon says:

    Dementia is a fatal illness that kills slowly and painfully. Often patients with dementia suffer delusions that cause a lot of distress and makes it hard for others to care for them. Is not a calmer last few years of life worth some risk of a stroke?

    • Peter says:

      Jon, drug regulators like the FDA, when deciding on a marketing licence for a drug, evaluate its efficacy and safety for a given medical condition. Moreover, they will also take into account the availability or lack thereof of other treatments for that same condition. That means, a drug may gain approval even with a not so favorable efficacy/side effects profile if there is a dearth of treatment alternatives.

      Your question “Is not a calmer last few years of life worth some risk of a stroke?” makes two assumptions: That there were no other licensed treatments that could calm down agitated elder patients without incurring an increased stroke risk or other risks of comparable severity, and that the serious negative side effects of Risperdal were limited to an increased stroke risk.

      Regarding the latter Brill writes in chapter 2 of his exposé on Risperdal that “[Johnson & Johnson] was also not allowed to promote it to treat the elderly except for the most serious psychotic disorders; it was thought to cause strokes, diabetes and other ailments in that population.”
      And in ch.2 he writes: “For Risperdal the risks were substantial. Even in the earliest trials, the data showed significant rates of side effects. These included involuntary twitches, somnolence, diabetes and, most frequently, significant weight gain. In the elderly there was a particularly high risk of strokes and other heart-related diseases.”

      What is wrong with the current regulatory regime is not that the FDA (as opposed to individual consumers) decides how to make trade-offs between safety and efficacy. The problem is that the system is totally distorted by conflicts of interest. In most cases patients cannot be reasonably confident that they get the best treatment because medical science has been very much corrupted by big pharma. I’m talking about large-scale scientific fraud as it has been documented for the general public by medical researchers like Ben Goldacre, Peter Gøtzsche and David Healy.

      • Jon says:

        Should getting diabetes be a worry for a patient whose dementia had advanced to the point of psychosis? The dementia is apt to kill them well before any diabetes or weight gain will.

        Often companies don’t bother to seek approval for off label usages of drugs; this does not mean the usage is not legit.

        • Peter says:

          In the Risperdal case, Johnson & Johnson did try to get FDA approval for its use in the elderly and in children – without success. If you read Brill’s essay you will learn that widespread off-label use of Risperdal was brought about through corruption (paying prescribers kickbacks) and scientific fraud. It was not a case where doctors on their own discovered that this drug was relatively safe and effective for certain off-label uses.

          In fact, and this is the heart of the matter, for most drugs it is impossible for doctors to make such a determination (without deceiving themselves) based on their clinical experience. If you doubt this I recommend reading:
          Druin Burch: Taking the medicine: A short history of medicine’s beautiful idea, and our difficulty swallowing it. 2009
          http://www.amazon.com/Taking-Medicine-Medicines-Difficulty-Swallowing/dp/1845951506
          Testing treatments. 2nd ed., 2011
          free download here: http://www.testingtreatments.org/book/about/the-book/download-the-book/?nabe=4876413604724736:0
          David Colquhoun: Blogpost: Placebo effects are weak: regression to the mean is the main reason ineffective treatments appear to work. Dec.2015
          http://www.dcscience.net/2015/12/11/placebo-effects-are-weak-regression-to-the-mean-is-the-main-reason-ineffective-treatments-appear-to-work/

          Without a legal ban on off-label promotion the FDA could not fulfill its mandate of assuring that marketed drugs are reasonably effective and safe. Big Pharma defends off-label promotion on the grounds that it is inadmissible that its right to free speech be restricted (see Brill ch.2). But there are situations where speech should be restricted to achieve other goals. Should you have the right to yell “Fire, Fire” in a crowded theater when there is no fire (at the risk of setting of a stampede)?
          The alternative would be to allow off-label promotion and then let judicial courts decide which of the manufacturers’ claims about their products are deceptive advertising and which are truthful. How would courts have the scientific expertise to decide this? How would consumers have the financial resources to litigate such claims?

          Responding to your question “Should getting diabetes be a worry for a patient whose dementia had advanced to the point of psychosis?”
          My answer is: a drug may gain approval even with a not so favorable efficacy/side effects profile if there is a dearth of treatment alternatives.

        • Martha says:

          @Jon

          Several problems with what you’ve said:

          1) “Off-label use” doesn’t mean there is any diagnosis of psychosis, or even of severe dementia — it might be used, for example, to “treat” a patient who is confused, dazed, or angry at being confined to a nursing home — i.e. to keep them quiet and compliant.

          2) Patients may receive a misdiagnosis (e.g., of dementia or of psychosis), perhaps for convenience (to justify using the medication for off-label uses) or perhaps because of diagnosis by someone who is not well qualified to give the diagnosis.

          Part of my reason for saying this is my mother’s nursing home experience. It turned out that the home was owned by a physician who declared that he (or perhaps also a couple of cronies) was the only physician authorized to treat people in the home. Unfortunately, she needed post-hospital skilled nursing care for physical reasons, and that was the only skilled nursing facility in the area that had beds available. There she was given Haldol, an antipsychotic. She did have a credible diagnosis of “some possible left frontal lobe vascular dementia,” but that did not warrant anti-psychotic medication. She eventually was able to get into a better facility, and her mental condition improved considerably there. She lived about five years after first entering a nursing home, which would be long enough for side effects such as diabetes to develop.

          I suspect this type of situation is quite common.

          • Peter says:

            Another issue is that if you manage dementia with a drug that causes diabetes you will have to treat the diabetes as well. You may end up in a situation where a patient takes 5 or 6 or 7 drugs (polypharmacy, actually quite common in the elderly) and nobody has any idea how these drugs interact in the body. This is potentially dangerous.

            • Jon says:

              People abuse all sorts technologies and there are lousy doctors who over prescribe all types of drugs, including antibiotics, which few dispute have valid usage. The fact is there are people with dementia who suffer from psychosis and it would be cruel to them and their care givers to deny them access to treatment.

      • Anonymous says:

        “For Risperdal the risks were substantial. Even in the earliest trials, the data showed significant rates of side effects. These included involuntary twitches, somnolence, diabetes and, most frequently, significant weight gain. In the elderly there was a particularly high risk of strokes and other heart-related diseases.”

        In what sense is “significant” being used here? I worry that author has confused statistical with practical significance. How common and severe are each of these side effects?

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