COMMENTARY:

Drugmaker Got Kickbacks for Nursing Home Patients

There really should be a special place in hell for pharmaceutical manufacturers who make money by exploiting the weakest and most vulnerable of patients: old people with dementia. I wrote about one such case back in April of last year:

Pharmaceutical giant Eli Lilly recently agreed to pay a record $1.4 billion dollars to settle charges that it illegally marketed the anti-psychotic drug Zyprexa as a treatment for Alzheimer’s and other forms of dementia in elderly patients. This despite the fact that the drug was not only unapproved for this “off-label” use, but had also been shown to cause obesity and diabetes.

Now, $1.4 billion might sound like a tough punishment, until you find out that Lilly’s total sales of Zyprexa have topped $37 billion. And at least some of those sales were thanks to doctors who, with guidance from Lilly drug reps, wrote thousands of prescriptions for patients with virtually no ability to defend themselves.

The steep fine against Lilly apparently didn’t discourage another drugmaker, Johnson & Johnson, from using even sleazier tactics to promote its own lucrative antipsychotic for use on nursing home residents. As the New York Times reported on Friday:

Johnson & Johnson paid kickbacks to the nation’s largest nursing home pharmacy to increase the number of elderly patients taking the antipsychotic Risperdal and several other medications, according to a complaint filed Friday by the office of the United States attorney in Boston.

The payments violated the federal anti-kickback statute and led Omnicare, a pharmacy company specializing in dispensing drugs to nursing home residents, to submit false claims to Medicaid....The complaint charges that Johnson & Johnson and two of its subsidiaries...paid tens of millions of dollars to induce Omnicare to buy and recommend Risperdal for elderly patients as well as the drug maker’s prescription pain relievers Duragesic and Ultram, and the antibiotic Levaquin.

The complaint charges that Omnicare’s pharmacists engaged in intensive efforts to persuade physicians to prescribe the drugs from 1999 to 2004, a period in which the pharmacy’s annual purchase of Johnson & Johnson medications nearly tripled to more than $280 million, from about $100 million. During the same period, the pharmacy’s annual purchase of Risperdal rose to more than $100 million, according to the complaint filed in United States District Court in Massachusetts....

In return for Omnicare’s efforts, the drug maker allegedly paid the pharmacy company kickbacks in the form of rebates based on the market share of some Johnson & Johnson drugs, sponsorship of Omnicare meetings, grants and payments for Omnicare data, like the prescribing habits of doctors, of the kind that Omnicare had previously provided the drug maker for free, the complaint said.

Let’s recall that these are the same pharmaceutical companies who were praised for their cooperativeness last year when they cut a back room deal with the Obama administration to support health care reform. Part of the deal supposedly involved cutting costs for seniors on the Medicare Part D prescription drug program. Of course, it turned out the deal wasn’t all it was cracked up to be–and while it supposedly “gave” to seniors with one hand, Big Pharma kept on ripping them off with the other.

In the Johnson & Johnson case, the Times reports, the company seems to have conspired to circumvent government regulations specifically meant “to protect nursing home residents from medication mismanagement, like being sedated with psychiatric drugs for the purposes of discipline or convenience.” These regulations require an outside consultant pharmacist to review nursing home patients’ medications once a month, and report any irregularities.

But the government’s complaint in the Johnson & Johnson case raises the question of whether some companies have used the consultant pharmacists — the very people entrusted by the government with safeguarding the integrity of nursing home drug prescriptions — for corporate gain. In this case, according to the complaint, Omnicare’s consultant pharmacists worked to increase Risperdal’s market share....

In one company document among the court exhibits, for example, Omnicare said that its efforts generated a record market share high of 55.5 percent for Risperdal in the first quarter of 2000. “This market share represents Omnicare’s ability in persuading physicians to write Risperdal in the areas of behavioral disturbances associated with dementia,” the Omnicare document said.

But Risperdal, which is approved by the Food and Drug Administration to treat schizophrenia and bipolar disorder, is not specifically approved to treat behavioral problems in elderly people with dementia. In fact, in 2005 the F.D.A. required that the labels of certain antipsychotic drugs, including Risperdal, carry a black box label warning that elderly people with dementia-related psychosis treated with such drugs were at an increased risk of death compared with those taking a placebo.

So Johnson & Johnson knew that their drug, used in this way and on these patients, could actually increase the risk of death. But what’s the death of a few old, disoriented, defenseless, forgotten people, compared with the potential for fantastic profits? Not much, apparently. According to the Times article:

In an Omnicare letter to Johnson & Johnson in 2001, an executive wrote that the pharmacy planned to spend about $173 million on Johnson & Johnson products.

The executive wrote in capital letters, “We are selling more high-priced drugs (read Risperdal here) for the pharmaceutical industry!!”