CCHR responds to a federal investigation launched against the harmful psychotropic drugging of the elderly in nursing homes. It demands effective oversight and penalties to stop such dangerous mental health practices from continuing.
By CCHR International
Mental Health Industry Watchdog
January 27, 2023
On Wednesday, January 18th the U.S. Department of Health and Human Services’ (HHS) Centers for Medicare and Medicaid Services (CMS) announced that it was launching a targeted crackdown on certain nursing homes that are misdiagnosing seniors with schizophrenia and treating them with dangerous antipsychotic drugs.[1]
HHS Secretary Xavier Becerra is commended for launching the investigation. However, it is imperative that the government act effectively this time on the results of any investigation findings. This is because the kind of abuse being uncovered today has been perpetrated on our seniors for decades, with earlier promises that it would be corrected.
Becerra stated: “The steps we are taking today will help prevent these errors and give families peace of mind.”[2]
Unfortunately, his predecessors have made similar assurances.
The HHS announcement of the commencement of the current investigation notes that in 2012, the federal government began tracking when nursing homes used antipsychotics on residents.[3] Despite this, evidence continued to mount of some facilities administering antipsychotic drugs to sedate them, despite dangerous side effects that could include death.[4]
Assurances were made in 2011 by then-HHS Inspector General Daniel R. Levinson, who exposed the drug abuse of nursing home residents at the time: “Government, taxpayers, nursing home residents, as well as their families and caregivers, should be outraged—and seek solutions. Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there’s ample evidence that some drug companies aggressively marketed their products toward such populations, putting profits before safety.”[5]
During the time the government said it was “monitoring” the toxic assault on seniors, the Food and Drug Administration (FDA) issued two “black box” warnings citing increased risk of death when antipsychotics are used in elderly patients with dementia.[6] (Many of these nursing homes are misdiagnosing dementia as schizophrenia to justify the use of antipsychotics).
As early as 2002 CCHR engaged in personal visits to Congress to alert legislators to this tragedy.
Then, in frightening testimony given to Congress in 2007, then-FDA drug reviewer David Graham said that at least 15,000 residents had died in nursing homes from antipsychotics.[7]
How many seniors died as a result of being drugged in nursing homes since then, especially in light of unscrupulous marketing of antipsychotics?
- In 2009, Eli Lilly, the manufacturer of the antipsychotic olanzapine (Zyprexa), pled guilty and paid $1.4 billion to the federal government for allegedly targeting doctors who worked in nursing homes and assisted living facilities to prescribe olanzapine off-label to elderly patients with dementia.[8] Psychiatrists and doctors chose to prescribe these.
- In 2012, Abbott Laboratories agreed to pay federal and state governments $1.6 billion in criminal and civil fines for illegally promoting unapproved uses of its drug Depakote, including sedating elderly patients in nursing homes. The settlement included an agreement to plead guilty to a criminal misdemeanor.[9]
- Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, Inc., also promoted that its antipsychotic Risperdal be prescribed to children, the elderly, and those with mental disabilities despite both warnings of significant health risks and lack of FDA approval for use in these patient populations. It agreed to pay the state of Virginia $21 million for allegedly defrauding Virginia’s Medicaid program by—among other things—marketing Risperdal and its other antipsychotic Invega for uses not approved by the Food and Drug Administration.[10]
In May 2012, U.S. Senators Chuck Grassley (R-Iowa), Herb Kohl (D-Wisconsin), and Richard Blumenthal (D-Connecticut) filed an amendment to the Food and Drug Administration Safety and Innovation Act seeking to combat the costly, widespread, and inappropriate use of antipsychotics in nursing homes. “This amendment responds to alarming reports about the use of antipsychotic drugs with nursing home residents,” Grassley said.[11]
Following Senator Grassley’s efforts, antipsychotics for nursing home residents dropped to under 20% in recent years, according to federal data. However, the November 2022 report by HHS-OIG revealed that residents were still being wrongly diagnosed with schizophrenia in order to be prescribed antipsychotics—a practice that skyrocketed between 2015 and 2019, with 99 nursing homes in the country claiming that an astonishing 20% or more of their residents had the “disorder.”[12] CMS says facilities may be dodging increased scrutiny around the gratuitous use of antipsychotic drugs by coding residents as having schizophrenia.[13]
Not only is there a lack of oversight, but there is also ineffective accountability and deterrents. What happens to those facilities and prescribers found to have been misdiagnosing and drugging seniors with antipsychotics that can cause death?
Are they fined? Are those responsible for this terror prosecuted? Are there any civil or criminal prosecutions? No, no, and no.
The nursing home gets its wrist slapped.
And we can expect the same wrist slap if civil, financial, and criminal penalties are not enacted. In its recent statement, HHS stopped short of threatening to levy fines against facilities. The agency does not have plans to immediately intervene in the patients’ care directly or notify relatives of residents who have been wrongly coded or given antipsychotics.[14]
The HHS-CMS investigation should not only look but forcefully act. Any investigation needs to determine why oversight has continually failed nursing home residents. If not done, in 10 years’ time, the death toll will have again unforgivably mounted, and no doubt new assurances will be made that this dire situation needs correcting.
We’ve heard it all before.
Accountability now requires substantial civil, financial and criminal penalties to be put in place, including against top prescribers and offending facilities. And for the elderly to be compensated when abused.
Our senior citizens deserve nothing less.
[1] “Nursing Homes Under Investigation for Abuse of Antipsychotics,” Newsmax.com, 18 Jan. 2023, https://www.newsmax.com/health/health-news/nursing-homes-government-federal/2023/01/18/id/1104862/
[2] “Feds to Investigate Nursing Home Abuse of Antipsychotics,” U.S. News, 18 Jan. 2023, https://www.usnews.com/news/health-news/articles/2023-01-18/feds-to-investigate-nursing-home-abuse-of-antipsychotics
[3] https://apnews.com/article/health-nursing-homes-medication-schizophrenia-ad76a524c9e97c5eaf857d89c4119b34
[4] Op. cit., U.S. News, 18 Jan. 2023
[5] https://www.cchrint.org/2011/07/18/1-out-of-every-7-elderly-nursing-home-residents-on-antipsychotics-despite-risk-of-death/, citing: Modern Medicine – July 16, 2011; https://oig.hhs.gov/newsroom/news-releases-articles/overmedication-nursing-home-patients-troubling/
[6] https://www.cchrint.org/2012/05/23/u-s-senators-file-amendment-to-combat-widespread-antipsychotic-drugging-of-elderly-in-nursing-homes/
[7] https://www.cchrint.org/2021/03/16/elderly-should-study-warning-psychotropic-drug-risk-dementia/; Testimony by Dr. David Graham, House Hearing, 110th Congress – The Adequacy of FDA to Assure the Safety of the Nation’s Drug Supply General, 13 Feb. 2007, https://www.govinfo.gov/content/pkg/CHRG-110hhrg35502/pdf/CHRG-110hhrg35502.pdf, p. 66
[8] https://www.cchrint.org/2011/08/15/two-high-ranking-senators-grassley-kohl-question-use-of-psych-drugs-in-nursing-homes/
[9] N.C. Aizenman, “Abbott Laboratories to pay $1.6 billion over illegal marketing of Depakote,” The Washington Post, 7 May 2012, https://www.washingtonpost.com/national/health-science/abbott-laboratories-agrees-to-16-billion-settlement-over-marketing-of-depakote/2012/05/07/gIQAh5098T_story.html
[10] “Cuccinelli recovers $21 million in health care fraud settlements with Johnson & Johnson,” Commonwealth of Virginia Office of the Attorney General, https://www.oag.state.va.us/20-resource/mfcu-archived/289-november-4-cuccinelli-recovers-21-million-in-health-care-fraud-settlements-with-johnson-johnson-archived
[11] https://www.cchrint.org/2012/05/23/u-s-senators-file-amendment-to-combat-widespread-antipsychotic-drugging-of-elderly-in-nursing-homes/
[12] Op. cit., Newsmax.com, 18 Jan. 2023
[13] Ibid.
[14] Ibid.