J&J’s Gorsky Should Be Forced to Testify in Suit, U.S. Says
Reuters
By Margaret Cronin Fisk
Apr 13, 2012
Johnson & Johnson’s recently named Chief Executive Officer Alex Gorsky should be ordered to give sworn testimony in a lawsuit claiming the company paid kickbacks to influence sales of the antipsychotic drug Risperdal to nursing home patients, government lawyers said. The U.S. sued J&J and two units in January 2010, claiming they paid millions of dollars to induce Omnicare Inc. [OCR] to buy and recommend J&J drugs including Risperdal. Justice Department lawyers asked U.S. District Judge Richard Stearns in Boston to compel Gorsky to appear for a deposition for the suit.Gorsky was named in February to take over April 26 as J&J’s CEO, succeeding Bill Weldon. Gorsky, who had been vice president of sales and later president of J&J’s Janssen unit, has “relevant knowledge” concerning the division’s marketing to Omnicare, attorneys for the U.S. said in court papers April 11. This includes “knowledge about various allegedly illegal payments that J&J made to induce Omnicare to purchase and recommend Risperdal,” the U.S. said. The company said it wouldn’t make Gorsky available for a deposition, calling the request “nothing more than a fishing expedition,” according to a March 26 letter sent to the Justice Department. J&J has argued that payments to Omnicare were allowable rebates and not illegal kickbacks.
“Mr. Gorsky has no reasonable connection to the subject matter of the government’s complaint and was not involved with the facts underlying this case,” attorney Robert D. Keeling, of Sidley & Austin, said in the letter. The request for Gorsky’s testimony “unnecessarily targets – and thus would unduly harass – J&J’s top executive.” While with Janssen, Gorsky “was in a position to know why J&J chose not to inform Omnicare [or members of Janssen’s own sales staff] that, in January 1999, the Food and Drug Administration had warned J&J that marketing Risperdal as safe and effective in the elderly would be false and misleading,” the U.S. said in the April 11 filing. The company declined to comment because it is pending litigation, Bill Price, a J&J spokesman, said in an e-mail today…
Once again, Johnson & Johnson and the federal government are locking horns. The latest instance is an attempt by the feds to compel Alex Gorsky, who is about to succeed the embattled Bill Weldon as ceo of the health care giant, to provide a deposition in a widely publicized kickback case involving the Omnicare nursing home pharmacy. For those who may not recall, J&J is denying claims in a whistleblower lawsuit, which was joined by the US government, that charges Omnicare received kickbacks – in the form of rebates, educational grants and payments for marketing data – so the Risperdal antipsychotic would be prescribed more often. The lawsuit also alleged J&J’s Janssen unit hid the payments from Medicaid to avoid reporting a ‘best price’ that would have triggered rebates to the agency…So the feds want to quiz Gorsky about his dealings with Omnicare and his knowledge of how J&J marketed Risperdal to the nursing home pharmacy, starting in the late 1990′s. And the feds contend that, unlike the lawyers who had difficulty recalling certain key details and interactions, Gorksy should know a thing or two. J&J argues that Gorsky “has no reasonable connection to the subject matter of the government’s complaint and was not involved in the facts underlying this case.” But the feds point out that he was the go-to guy when it came to Omnicare and Risperdal, and no one else possesses the same level of knowledge.
From October 1998 to October 2001, Gorsky was Janssen’s vp of marketing, and from October 2001 to early 2003 he was the Janssen president, the feds note in court papers. During that time, he was responsible for selling Risperdal, and Omnicare was the biggest Risperdal customer. Moreover, according to his resume, Gorsky instituted a Janssen compliance program for regulatory and legal issues. He also regularly received monthly reports on J&J’s Long Term Care Group, including reports which had details about Omnicare efforts to promote Risperdal prescribing of Risperdal. And Gorsky met repeatedly with senior Omnicare execs to discuss those efforts.
And this is the crucial part: “As vice president of marketing, and having previously worked closely with J&J’s Medical Development group [which was responsible for developing clinical trial data for Risperdal], he was in a position to know why J&J chose not to inform Omnicare [or members of Janssen’s own sales staff] that, in January 1999, the Food & Drug Administration had warned J&J that marketing Risperdal as safe and effective in the elderly would be false and misleading because the drug had not been adequately studied in that population,” the feds write. “Likewise, he was in a position to know why J&J did not disclose to Omnicare executives that, in 1999, the FDA had rejected J&J’s attempt to get approval to market Risperdal for treatment of psychotic and behavioral disturbances in dementia [by far, the most prevalent use of Risperdal in Omnicare-served nursing facilities] because of inadequate safety data” [here is the motion filed by the feds to depose Gorsky]…
Justice, J&J duel over Gorsky’s contribution to kickback case
Fierce Pharma
By Ryan McBride
April 16, 2012
Alex Gorsky’s name has surfaced in the U.S. government’s Risperdal marketing lawsuit just weeks before he is supposed to step into the role of CEO at the healthcare giant Johnson & Johnson. The Department of Justice wants Gorsky to answer questions in its civil suit against J&J, and the company has been stymieing the effort in a struggle to keep its next chief executive out of the matter…The government’s request to talk to Gorsky follows its civil lawsuit against J&J for shelling out millions of dollars in alleged kickbacks to Omnicare ($OCR) to get the pharmacy services provider to push for use of J&J drugs such as Risperdal with its nursing home customers, The Wall Street Journal reported. New Brunswick, NJ-based J&J has maintained its innocence in the case. Omnicare forked over $98 million to resolve its part in the kickback controversy, doing so without admitting guilt.
What does Gorsky know? The way Justice officials figure, he was in leadership positions at J&J and the company’s Janssen unit, which sells Risperdal, at the same time alleged marketing misdeeds were committed during the late 1990s and 2000s. And he had a role in marketing activities at the company, according to the WSJ piece. "Mr. Gorsky did have personal involvement in some of the transactions at issue, and likely has knowledge of others – and so the United States should be permitted to depose Mr. Gorsky," Justice wrote in its request to U.S. District Judge Richard Stearns, as quoted by the WSJ.
Q. Let me hand you what’s been marked previously as Exhibit 224. I’ll represent to you this is an e-mail string, the subject of which is your visit to the Janssen home office.
A. Yes.
Q. The bottom half of the e-mail, the sentence that begins, "Dr. Shon is a very influential KOL in the public sector" psychia – "psychiatry arena." Have you ever heard the term KOL?
A. No.
Q. It says in the sentence right before that, "It is critical that we support and maintain a strategic alliance with Dr. Shon for the following reasons." Do you see that?
A. Yes.
Q. And it talks about you being an influential KOL. Did anyone from Janssen tell you that they were interested in supporting and maintaining a strategic alliance with you?
A. That was not discussed, no.
Q. So it says there down there at the bottom, "To provide some flexibility for attendees, Dr. Shon has agreed to make two presentations. The first presentation will run from 10:00 to 12:00 in Alex Gorsky’s" — "Alex Gorsky’s conference room," right?
A. Yes.
Q. And Mr. Gorsky was, at the time, either a very senior executive or – or the chief executive officer at Janssen, was he not?
A. I knew he was an executive. I wasn’t sure how high up he was.
Q. "He will conduct the second presentation from 1:00 to 3:00 in a meeting room to be determined. The content of both presentations will be the same." And I believe you told us earlier, Dr. Shon, that the content of the presentations was your overview of – of both the history and the current developments in TMAP.
A. That’s correct.
Q. Did you do this trip on the State of Texas’s time or comp time or vacation?
A. I don’t recall. I don’t recall. It was probably State of Texas time, I think, but I could be wrong.
Q. And Janssen promised to reimburse you for all your costs associated with that?
A. Yes.
Q. And are you familiar that the Texas Penal Code in Section 3607 prohibits a public servant like yourself from soliciting, accepting or agreeing to accept any honorarium in consideration for doing any services that the public servant would not have been requested to provide but for that person’s official position or duties?
A. Yes.
Q. If you were being asked to speak because of your title or position, it was prohibited by law and by policy of the TDMHMR to accept honoraria?
A. Yes.
Salesmen having such a huge influence on who gets medicated with what drugs and doing it wholesale is preposterous. Taking down a CEO might help, but as long as a pharma company can give their shareholders huge dividends the occasional ruin of an individual isn’t going to accomplish much.
Wiley,
I think otherwise [though my understanding of business is in the negative numbers]. My theory is that if a big guy goes down, the next big guy will think twice because it’s his life that’s at risk. If it’s a little guy, he’s going to rat out the big guy to save his neck – the latter being the way they go after organized crime [apt analogy]. When the economy tanked in 2008 and Joseph Cassano, AIG-FP CEO who had managed the derivative sales walked away rich instead of on his way to jail, it left a space for the next guy. I’m thinking that busting actual people might do the trick, or at least help. I’d even be pleased for some of those “big guys” to be psychiatrists who sold out to Pharma. I might be wrong about this, but I’d sure like to see it tried…
Oh, it’s definitely worth a shot! Fraud does need to be treated like the crime that it is. Gorsky marketed drugs under false pretenses for profit, and took advantage of a particularly vulnerable population to do so. That is fraud— white collar crime— but it’s not medical malpractice.
A doctor should know the difference between a sales pitch and a scientific study and the difference between a single study and one that’s been replicated. I’m crossing my fingers for making all studies publicly available. I was very angry with a state psychiatrist who seemed to know very little, until I saw how much journals cost. It seems there should be a public, digital library that all prescribing mental health care professionals can have access to. Mental illness is a public health issue.
Money, money, money.
“We are a nation of laws, not of men.” – John Adams
I thought this story might interest you
http://www.propublica.org/article/gone-without-a-case-suspicious-elder-deaths-rarely-investigated
Wiley:
Your point about all physicians having access to the research literature is one which applies across all science and health professions disciplines. The Public Library of Science (PLOS) journals use a different funding mechanism in order to provide open access. There is an effort to boycott publishers such as Elsevier for making the costs of access even for individual studies out of reach for users. Science blogger, Bora Zivkovic, at Scientific American, as well as the NYT’s Carl Zimmer, are 2 leaders in science reporting who follow this issue. (Both have Twitter accounts and use them judiciously, BTW)
Notably, in psychiatry, there are very few open access journals, almost none with high impact factors, and several “junk” journals which are nothing more than pharma fronts. I believe that physicians refer to them as wastebasket journals.
Yeah. I keep finding psychiatric articles on-line, many of them don’t even offer an abstract. You want to read it, you have to buy it. I can see how this would lead to studies being read by name recognition, which gives shills a leg up.
PubMed has all the abstracts. If the whole article is available on-line, it will say so [in red] like Free PMC Article. The links to the free full text articles is under LinkOut at the bottom under the abstract. It takes a bit to learn to search [under Advanced Search]…
Thank you, Mickey.
I don’t think I’ll ever truly master searching on PubMed, but it’s worth it to keep slogging. It occurred to me that Wiley might be trying to find editorials, letters and commentary in journals. Those most often don’t have abstracts, and many journals don’t even include the 1st 100 words or so. Other than the citations, that content is pretty much hidden.
Pubmed’s search function is primitive — it’s a dumb free text search, you have to search on all the synonyms you can think of — but the e-mail alerts system is useful.
I was looking at stuff like this:
http://psychiatryonline.org/searchresults.aspx?q=multiple%20sclerosis&t=J*&p=1&s=1&c=0
There appears to be a lot of studies being done on MS and psychiatric problems right now. It being interesting makes it all more bearable.
Pharma has bailed on developing psychiatric drugs and is more interested now in true neurological disorders.
Altostrata, that might lead to some breakthroughs. Right now, for instance, my neurologist can’t say that the new lesions in my corpus callosum are or are not related to my first psychotic break. It could just be a coincidence; but the fact that people with MS are almost twice as likely as the general population to have bipolar disorders, the fact that anti-epileptic drugs can be efficacious for bipolar disorder, and the role of the corpus callosum in epilepsy makes me suspect that some forms of mental illness are rooted in physiological dysfunction that is far more specific than the “chemical imbalance” theory, therefore the study of mental illness as a neurological phenomenon might be more likely to lead to more effective drug treatments and perhaps even prevention for some “disorders”.
Being told that you have a disease that is like “diabetes” and psychiatric drugs are like “insulin” is bull if they can’t tell you what the pancreas of the brain is. The drugs aren’t a complete treatment either and it’s perfectly possible to be fine without the drugs.
Being told what your disease actually IS would be therapeutic in its own right.
This is not to dismiss the formative power of environment, for those who are particularly vulnerable to stress and living in a stressed environment, or are normal in a pathologically stressed environment, addressing and relieving the stress and learning skills to help to better deal with it is important. as is social support.
The fact that a drug is being developed for a neurological disorder doesn’t mean that it can’t be explored as a treatment for the conditions that we have come to think of as “mental disorders”. Which comes around to the topic here— what are scientists in psychiatric drug research trying to treat? Peddling a drug for a population without testing it on a sample of that population that has been reliably demonstrated to be suffering from whatever the drug in question is supposed to treat is using people as unwitting guinea pigs, producing substandard research, and making suckers of us all. Medicare and Medicaid pay for the lion’s share of the anti-psychotics that were given to elderly patients. This is fraud on so many levels that it stinks on ice, and I suspect that if these companies did get out of psychiatric research, that they would simply find another Medicaid/Medicare cash cow with which to exploit relatively powerless demographics— the elderly and children.
Uh…. I wouldn’t be surprised if pharma’s secret agenda includes somehow repurposing (maybe off-label) any drugs found effective for “true” (but rare) neurological conditions for the more fanciful (and common) psychiatric indications.
Mickey, I wonder if you can get the raw data & break this study down for everyone…this reads like an “Insel” NIMH sales speech.. talk about completely irresponsible reporting on a known target market for depression drugs…Teens…based on Rat Behavior they are touting a usable blood test for depression (only in Teens)….I would be actually laughing my arse off, if the consequences were not dire…
http://www.foxnews.com/health/2012/04/17/scientists-develop-first-blood-test-to-diagnose-depression/
Speaking of the news media hype teen depression blood test:
http://www.thestar.com/news/canada/article/1162636–blood-tests-could-diagnose-teen-depression-study-says?bn=1
“Researchers, including Dalhousie University’s Kathleen Pajer, tested the blood of 28 teens from Ohio aged 15 to 19. Half had been diagnosed as depressed but not treated; the others weren’t depressed.”
Diagnose depression study based out of Dalhousie?(Canada) Does Stan Kutcher, co-author PAXIL 329 ring a bell?
http://psychiatry.medicine.dal.ca/people/faculty/kutcher.htm
Professor, Dalhousie University
Department of Psychiatry
Staff Psychiatrist, IWK Health Centre
Sunlife Financial Chair in Adolescent Mental Health
Director, WHO Collaborating Centre
Maritime Outpatient Psychiatry
Kind of interesting being that Kutcher pressured and succeeded the retraction of a news article in the Coast featuring Alison Bass, referencing Kutcher’s part in the PAXIL 329. The Coast did retract the article. Now look at what he is in charge of, and I dare say teens are being targeted once again, via a study tested on only 28 people. It just makes me wonder if people like Kutcher care at all about their past, with something like PAXIL 329 as part of it. They just keep on going,, pushing their agenda no matter who it harms.