Connecticut will receive more than $10 million in one of the largest pharmaceutical fraud settlements in history, as Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., resolve allegations of unlawfully marketing two antipsychotic drugs, including Risperdal, heavily used among nursing-home patients.
Johnson & Johnson has agreed to pay a total of $2.2 billion to states and the federal government to end civil and criminal investigations into off-label marketing of Risperdal and Invega, both antipsychotics, as well as the heart drug Natrecor, for uses not approved by the U.S. Food and Drug Administration. The company allegedly paid kickbacks to physicians and pharmacists to promote the drugs for unapproved uses.
In documents filed Monday, federal officials said that Johnson & Johnson, through Janssen, marketed Risperdal to doctors for use in elderly dementia patients, even though the drug was approved only for schizophrenia. Connecticut’s rate of antipsychotic use in nursing homes remains in the top 20 nationally, but has dropped in recent years, a recent C-HIT analysis found.
Connecticut and other states contend that between 1999 and 2005, the pharmaceutical companies promoted Risperdal for off-label uses; made false and misleading statements about the safety and efficacy of Risperdal; and paid illegal kickbacks to healthcare professionals and long-term care pharmacy providers to induce them to promote and prescribe Risperdal to children, adolescents and elderly patients.
The states also contend that from 2007 to 2009, the companies promoted Invega for off-label uses and made false and misleading statements about the drug’s safety and efficacy.
The portion of the settlement attributable to the state and federal shares of Connecticut’s Medicaid program is $19.5 million, of which $9.6 million represents the net state share. Connecticut will receive an additional $475,000 for prescription drug programs administered by the Department of Social Services.
Improper marketing of drugs “leads to false and fraudulent claims against our Medicaid program, and ultimately puts patients at risk,” Attorney General George Jepsen said in a statement.
Chief State’s Attorney Kevin Kane commended the Medicaid Fraud Control Unit in the Office of the Chief State’s Attorney, the Office of the Attorney General and the Department of Social Services for their continued efforts to recover public resources.
The companies also will enter into a corporate integrity agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will closely monitor the companies’ future marketing practices.
Could it be true that this story concerns more than a record recovery to the public treasury? Anyone following the news would see that the fines to pharma for its dealings with the medical complex comprised of pharmacists, nursing homes…and ((doctors)), have gotten larger and larger. But between the lines one might discern that the story is actually about human suffering, …i.e. damage to quality of life for elders under care, with actual sickness, pain, and death resulting. I can think of a few things that the state and federal government could do with the these monies, but mostly it should be, (and won’t be) used to benefit elders in nursing homes, who are scarcely mentioned, and it is not going to prevent the conditions that led to the problem in the first place.
So maybe the money could be used to bolster the legal rights of nursing home residents and their families. Is there actually such a thing as informed consent in the nursing home system? Senator Blumenthal attempted to sponsor a bill in the Senate which would have required that family members be sought out for informed consent when psychopharmeceuticals are utilized, but it failed. He called the off label drugging with psychopharmceuticals – “elder abuse.” What would it take to have such a bill pass this state’s legislature? Unfortunately, it may often be the case that a physician can prescribe a med to a patient sight unseen by phone based upon a nursing request. A former Director of Center for Medicare Services which federally administers Nursing Home regulation was quoted in a Boston Globe article of a few years ago stating that she feared that the homes would just switch to an off label use of anti-depressants which carry side effects and dangers as well. Is that being addressed? A report from the office of the Inspector General of Health and Human Services in February of this year found that Nursing Home Care treatment plans nationwide, which among other things include review of meds, and education of families in quarterly meetings, are frequently not followed, resulting again in multimillions of dollars in charges to the Medicare and Medicaid programs for in the words of the report “substandard care.
What about additional monies for the State Department of Public Health which is the sole arbiter of nursing home regulation and hence patient rights? Connecticut’s Department as a whole recently had an audit which found deficiencies in many areas, but the audit did not include nursing home oversight. If one reads the regulatory action reports it publishes quarterly for nursing homes again and again one finds that elders suffer pressure sores, injuries, infections, and neglect, that occur routinely even in highly rated homes, those covered by regulation, conditions that are deemed avoidable. Off label usage of meds is rarely cited as a violation even though the state has one of the highest rates in the nation and there is regulation against unnecessary meds. The fines and consequences for the homes are negligible, which is perhaps why Connecticut was ranked #36 in the country by a national advocacy group and given D grade for its long term care. By the Department’s own reckoning in a recent report a third of elders in the state’s nursing homes have lost dentures and more than 50% have untreated dental decay. But while the law already requires that residents receive both routine and emergency dental care a top official of the Department described the lack of care provided by the homes as an “oversight.” It is widely recognized that such conditions lead to more serious costly and painful medical conditions.
Since the story appears to be primarily about the money, maybe in my ideal or merely sufficient world, an endowment could be created to support a team of journalists who would report unflinchingly in a “person-centered way” about the issues of significance to elders and their care, who would not only tell us about the statistics or repeat the comments of officials, but provide a human face to clearly draw a picture of what a settlement in “Billions,” capital B means in terms of the human experience. For Connecticut that might mean connecting the dots…that these conditions might be related to the fact that the state has one of the lowest mandated staffing ratios in the nation that has not been updated in over thirty years, or that its fines for the long term care industry are among the lowest in the nation. What this means to individuals at the end of their lives is that their needs are being addressed in a way that does not meet them, but that often produces more suffering. They are over medicated due to a lack of staffing and staff training. Shouldn’t it be that for the money we have we could assure that residents are able to have a call light answered or be able to have help for the bathroom.
So… is this really a story about mega dollars and false advertizing? Could it be that the pharmaceutical companies which are big enough and important that they can continue to feed pharma directly into our social nervous system, with only a slight pause for a bad headline, also have the resources to support the public policy and the candidates that they choose, and are lucrative enough so that these fines amount to little more than just a bad stock market day. The alleged kickbacks to Nursing Home Directors may have been as commonplace as a physician’s lunch sponsored by the pharma salesman, but this settlement as the story describes closes both criminal and civil suits against the companies and there is no criminal prosecution for anyone. If we are not hearing of the consequences for the CEOs and Nursing Home Directors for what has clearly been a massive problem, there is scarcely a mention of the human factor: our fathers, mothers, brothers and sisters occupying these nursing home beds. And aside from a check for the treasury has anything really happened to address or prevent the harm done to elders in the Long Term Care System?