Donald A. MacGillis

Kickbackers’ motto: ‘Do no harm’ (to profits)

By Donald A. MacGillis
January 26, 2010

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TALK ABOUT death panels. The US attorney in Boston recently filed suit against the world’s largest maker of health products, Johnson & Johnson, for using kickbacks to get more nursing home patients onto its drugs, including one that was later found to be so lethal to the elderly it had to carry a black-box warning. The government’s complaint leaves little doubt that the drug company acted in a predatory way to increase sales and market share for its products, especially Risperdal, an antipsychotic often used to keep Alzheimer’s and dementia patients under control.

Risperdal is used principally for the treatment of schizophrenia and bipolar disorder. Doping the elderly into placidity is an off-label use of the drug, one that the Food and Drug Administration finally cautioned against in 2005. The reason for the black box warning the FDA required? Too many of the elderly who got the drug were dying.

There is one other reason to thank the federal government for going after the suspect payments Johnson & Johnson made to the middleman to juice up sales of its drugs: Since Medicaid covers most of the nursing home patients, the taxpayer ends up paying much of the bill.

The middleman between Johnson & Johnson and the nursing homes is Omnicare, the country’s largest pharmacy for nursing homes. Last November, it agreed, without “any finding of wrongdoing’’ or “any admission of liability,’’ to a $98 million settlement with the government for its role in helping Johnson & Johnson boost sales to nursing homes. The government says that between 1999 and 2004 Omnicare received tens of millions of dollars in the form of escalating rebates based on greater market share for Johnson & Johnson drugs and in payments ostensibly made by Johnson & Johnson for “data’’ from Omnicare, much of which Omnicare never provided. Other kickbacks, the government says, came in the form of “grants’’ and “educational funding.’’

Omnicare is not just a supplier of drugs. It also provides nursing homes with the consulting pharmacists who check over patients’ medications and make recommendations to the doctors who visit the nursing homes periodically and check through patient charts. In more than 80 percent of cases, according to a Johnson & Johnson document, doctors follow the pharmacists’ recommendations on prescriptions. In a memo, the company viewed Omnicare’s consulting pharmacists as an “extension of (Johnson & Johnson’s) sales force.’’

New Jersey, recognizing the potential for abuse, requires that the consulting pharmacists be independent of both the nursing home and the supplying pharmacy. Massachusetts should do the same, and Congress should make it a national requirement.

Underlying the government’s suit is a deeper problem - inadequate staffing at nursing homes and the overuse of antipsychotics as a “chemical restraint’’ for unruly dementia patients. As long ago as 1986, the Institute of Medicine found that understaffed nursing homes “may make excessive use of antipsychotic drugs to substitute for inadequate numbers of nursing staff.’’ In 1987, Congress mandated that nursing homes protect the rights of their residents to be free from “chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms.’’

But that did not keep Johnson & Johnson and Omnicare from making a special push for Risperdal. In the period covered by the suit, Omnicare’s purchase of Johnson & Johnson drugs rose from $100 million annually to more than $280 million, with Risperdal alone generating $100 million. According to the complaint, “Omnicare provided its pharmacists with suggested oral statements and written comments to use to encourage physicians to prescribe Risperdal, sometimes regardless of whether a given patient was already stabilized on another antipsychotic.’’

A court will have to decide whether the payments to Omnicare were illegal kickbacks, but the suit has kicked over a rock that hid corporate greed, the failure of nursing homes to provide sufficient staff, and indifference to the well-being of the elderly. Changing this will require, first, vigorous enforcement of the suit against Johnson & Johnson, which says its conduct was “lawful and appropriate.’’ As US attorney in Massachusetts Carmen Ortiz said, “Kickbacks in the nursing home pharmacy context are particularly nefarious because they can result in excessive prescribing of strong drugs to patients who have little or no control over the medical care they are receiving.’’ But lawmakers on Beacon Hill and in Washington should also act to break the link between drug maker and drug supplier by mandating that all consulting pharmacists be truly independent - and not an extension of a pharmaceutical company’s sales force.

Donald A. MacGillis is a Globe editorial writer.

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