MadInAmerica.Com recently reported on Abbott Laboratory’s $500 million sentence as a result of pleading guilty to illegal off-label marketing of Depakote and this caused me to root around on the federal courts’ electronic filing database to see what I could find out about details not reported in the media. Included among the 725 pages comprising the plea agreement (55 megabytes), was an Agreed Statement of Facts. It is a primer on many of the fraudulent and illegal ways in which drug companies boost their sales.
The above links take you to the source documents, which PsychRights has posted on its website for convenience, and I will discuss some of the items to which Abbott admitted in the Agreed Statement of Facts.
To start with, Abbott admitted that Depakote has never been approved by the Food and Drug Administration (FDA) as safe and effective for agitation and aggression in patients with dementia or for the treatment of schizophrenia.
Illegal Promotion of Depakote for Use on the Elderly in Nursing Homes
In 1999, a study of the use of Depakote in the elderly was terminated because of serious adverse events. In spite of there being no scientific justification for its use, from 1998 through 2006, Abbott illegally promoted the use of Depakote on the elderly to control agitation and aggression. If a doctor asked about the terminated study, Abbott trained its sales force to minimize these safety concerns by saying the dosages used in the study were too high.
Abbott also trained its long term care sales force to promote Depakote as safe and effective for this unapproved use, including that it didn’t have the same side effects as neuroleptics. Abbott paid bonuses to its sales force for garnering sales of Depakote for this unapproved use. Abbott also funded a prescribing “guide” from a supposedly legitimate source that promoted the use of Depakote in the elderly, with Doctors being able to earn continuing medical education (CME) credit by taking a test at the end of the guide. Abbott paid millions of dollars in rebates to Long Term Care Pharmacy Providers based on increases in the use of Depakote to their nursing home patients.
Illegal Promotion of the Use of Depakote on People Diagnosed with Schizophrenia
The “MD99-010 Study” was conducted to show the safety and effectiveness of Depakote together with neuroleptics to treat patients with “acute exacerbations of the symptoms of schizophrenia,” but it did not result in significant improvement after 28 days as compared to the use of neuroleptics alone. A consultant then told Abbott that while the study “does not support combination use (as defined strictly the combination being superior to each [neuroleptic] alone), we could still argue for [the study's] applicability to add on” therapy. Maybe this is some medical language I don’t understand, and I am just a bush lawyer, but to me it is completely gobbledy gook. I guess they couldn’t say it was okay for “combination” therapy, but could for “add on” therapy. Maybe that is because there isn’t a definition for “add on” therapy.
There was another study, “M02-547″ that also did not show a statistically significant treatment difference when Depakote was combined with a neuroleptic, but did show that somnolence, weight gain, and urinary incontinence were significantly higher for patients receiving Depakote ER combined with a neuroleptic than those treated with a neuroleptic alone. Following the completion of this second study, one of Abbott’s vice president, after stating there were no systematic problems with the study, concluded that “there is not an obvious benefit of adding Depakote to [neuroleptics] in acute schizophrenia.”
In spite of these negative studies Abbott promoted the use of Depakote as a treatment for schizophrenia. Doctors were paid $2,500 to attend a “Depakote Psychosis Speaker/Facility Development Meeting,” in which the M99-010 Study was portrayed as positive, and presentation slides given to the doctors. Abbott also organized programs at an American Psychiatric Association (APA) meeting to provide the M99-010 Study data to promote Depakote for the treatment of schizophrenia. Abbott did not present any information about the M02-547 Study.
When Abbott conducted a survey about the effectiveness of these illegal off-label promotion activities, it found a majority of surveyed providers recalled that, during their most recent visit with an Abbott sales representative, the sales representative had discussed the off-label use of Depakote as combination therapy for the treatment of schizophrenia.
Abbott funded and organized “Psychiatry Consultant Meetings,” which were used to provide information about the results of the M99-010 Study to healthcare providers. Abbott paid a $500 “honorarium” and travel expenses for each psychiatrist’s attendance. Abbott continued to present a false impression of the M99-010 Study in its promotional activities, while not presenting any information about the M02-547 Study.
Government Enforcement Actions Against the Drug Companies Are Ineffective
From my PsychRights work it is my observation that the use of Depakote in combination with one or more neuroleptics has become ubiquitous. Clearly, Abbott’s illegal promotion of Depakote was successful from a profit perspective. Depakote is an anti-seizure drug that would normally have a very limited market, yet from 1998 to 2008 Abbott’s gross sales of Depakote were approximately $13.8 Billion. The $500 million paid by Abbott as a fine for its criminal activity in promoting Depakote for use in the elderly and for schizophrenia was a small price to pay — just a cost of doing business.
Does anyone expect that the use of Depakote on the elderly, and people diagnosed with schizophrenia will plummet? I don’t. Why haven’t the past revelations of drug company fraudulent marketing causing tremendous harm to millions of patients without benefiting them resulted in any meaningful change in prescribing practices? I would suggest that the Agreed Statement of Facts should be required reading before any doctor prescribes Depakote for one of these uses. Fundamentally, the psychiatrists prescribing these drugs in this way have breached the trust that society has placed in them in exchange for granting them monopoly power over legal access to these drugs, i.e., prescribing privileges.
There is the further question of why the Government continues to pay for these off-label prescriptions, when neither Medicaid nor Medicare properly cover such uses? As succinctly stated by the court in US ex rel Rost v. Pfizer, 253 F.R.D. 11, 13-14 (D.Mass. 2008):
Medicaid can only pay for drugs that are used for a "medically accepted indication," meaning one that is either approved by the FDA or"supported by citations" in oneof three drug compendia, including DRUGDEX.
In a May, 2011 report, the Inspector General of the Department of Health and Human Services confirmed that Medicare has the same restriction:
Medicare requires that drugs be used for medically accepted indications supported by one or more of three compendia to be eligible forreimbursement.
The big fines paid by the drug companies are not effective, yet the government is ignoring the simple solution of enforcing Medicaid and Medicare’s restrictions to drugs that are prescribed for medically accepted indications. It is hard to take seriously the government’s stated commitment to rooting out fraud when this massive fraud is consciously allowed to continue. I know it is consciously allowing the fraud to continue because the government has been antagonistic to our whistleblower cases raising this point. Massive harm is not enough to cause government action. Massive fraud when the government is drowning in red ink is not enough either. What is it going to take?