The Aging Committee has done the American people a great service today in holding this very important hearing. The IG’s finding that about half of the 1.4 million atypical anti-psychotic drug claims for nursing home residents did not comply with Medicare criteria should be a wake-up call for CMS and for all of us who care about the humane care of our most vulnerable elderly citizens. The IG’s determination of noncompliance is based on the fact that the drugs were not used for medically accepted indications. This means that patients are dying unnecessarily, and American taxpayers are paying for the drugs that are causing these deaths.
There is conclusive research evidence that atypical antipsychotics can kill elderly patients. Sudden death is a “side effect” of the drugs. If an elderly patient is schizophrenic, the benefits of these drugs in helping them function could certainly outweigh the risk of death. This is not true, however, if a dementia patient is given an antipsychotic drug as a chemical restraint to keep them sedated. In that case, there are safer alternatives to help quiet the patient, rather than knocking them out with a potentially fatal drug.
Our Center has been contacted by many family members of elderly patients who were given atypical antipsychotics as casually as you or I would take an aspirin. In some cases, the loved one died from the pills before the family even knew what they were taking. In other cases, family members were told that the antipsychotic pills were necessary and that taking them off the drugs would cause dangerous withdrawal symptoms, creating a classic “Catch-22”: the patient should never have been put on the drug to begin with, no informed consent was provided, but now that he or she was on the drug, family members were told it was too risky to take them off.
It is no accident that these very expensive and very dangerous drugs are widely misused. The Department of Justice has investigated AstraZeneca, Eli Lilly, and Johnson & Johnson for promoting these drugs inappropriately, and in some cases providing kickbacks to nursing homes or pharmacies. The billions of dollars in fines may not be a strong enough disincentive against these practices, because the companies are making billions of dollars on these inappropriate uses.
In their testimony today, CMS states that the widespread use of atypical antipsychotics in nursing homes “may not be appropriate.” That is life-threatening understatement. So far, CMS has done much too little to create incentives for doctors and nursing homes to reduce the unsafe and ineffective use of these drugs. We expect that today’s hearing will give CMS a better understanding of the urgency of this issue, and we will work with public health experts across the country to make sure that CMS follows through. In addition, FDA decision-makers and physicians across the country should be aware of the research findings and the IG’s report, and immediately find ways to reduce the misuse of atypical antipsychotics for children and adults.