Dangerous Drugs for the Elderly and Alzheimer's
- Published on Thursday, 22 May 2008 21:45
- Written by Stanton O. Berg
Note: I do not make specific or individual recommendations on treatments nor drug usage in any specific case. If you find the contents of this page applicable to your situation or your loved ones situation, make your decision based on a discussion with your own doctor or a competent doctor in the field of Geriatrics and Internal Medicine!
There are NO FDA approved drugs for the treatment of behavioral and psychiatric symptoms in elderly Alzheimer's dementia victims
Many doctors are prescribing atypical antipsychotic drugs for elderly Alzheimer's/dementia patients who have behavioral and psychiatric symptoms or problems. This is in spite of the practice being condemned by all leading medical authorities and the FDA. Most increase the chance of death by 100%.
Most authorities recommend that the use of medications or drugs to treat behavioral and psychiatric symptoms be considered with "extreme caution" and to be reserved as a treatment of "last resort". Unfortunately it is frequently the first option considered. Many times it is used for the convenience of the medical or nursing staff. Most authorities also agree that the chances of success by using such drugs are low while a risk of death of a loved one looms on the horizon. They are odds that no gambler would accept.
“Agitated behaviors in dementia are generally “about” something rather than simply a behavioral manifestation of that disease. To the extent that we can identify what a patient wants and needs we can modify his or her behaviors." (Dr. Jeffrey Nichols, Vice President for Medical Services of the Cabrini Eldercare Consortium, New York - February 2011. AMDA's "Caring for the Ages".
The cause of the behavioral and psychiatric symptoms should be carefully analyzed in an effort to determine the underlying cause. They may be caused by the:
(1.) Side effects of other drugs being used by the patient or victim.
a. Delirious from medications - b. Electrolyte imbalance
(2.) Underlying medical problems. -
a. Pain management - b. Urinary Tract Infections - c. Other untreated infections - d. Comfort concerns - e. Severely constipated - f. Nauseated - g. Hunger -
(3.) Environmental conditions.
a. Moving to new residence, b. changes in the caregiver, c. changes in the environment, d. negative noise stimulation, e. perceived threats - fear of strangers etc.
Mayo Clinic recently (26 July 2012) discussedthe importance of seeing "challenging behaviors as symptoms instead of problems." They also talked of "negative behaviors" as being demonstratons of "Unmet Needs". Mayo recommends that "to better manage "behavior symptoms" in a person with dementia, we need to uncover and address the real source of the problem." Mayo suggests that the caregiver take on the role of a detective to uncover the real source of the behavioral problems..."the result will be fewer unmet needs and consequently fewer behaviors that challenge and wear down caregivers." Mayo suggests that the "unmet needs" causing behavioral problems may fall into three general categories: 1. Physical Health, 2. Physical Environment and 3. Social Environment...They then go on to discuss problems of physical health that may be triggering the challenging behavior. Examples given were: fatigue due to poor sleep, presence of infections such as UTI, Clinical depression, Vision loss (missing eyeglasses), hearing loss (hearing aid malfunction), constipation, dehydration, need to urinate and hunger. Mayo points out that if a person with Alzheimer's or some form of dementia "is fatigued, hungry or in pain and is unable to articulate or take care of the need independently, that they would express anger, agitation or even aggression."...Mayo also links such behavioral symptoms to the victim's physical environment. They stress that physical environment can be a powerful factor in triggering behavioral symptoms. Stress may result from factors and changes of or in "physical space, daily routine and sensory stimulation." (Noise levels and such things as sight, sound, taste and smell.)
The Nursing Home Reform Act of 1987 (Federal Law) states among other things that:
"The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms "
A chemical restraint is a reduction of the individual's ability to think and act independently by means of a powerful antipsychotic drug - Such a drug should never be used unless the reasons and parameters are specified in the care plan.
This federal law establishes the civil right to be free of chemical restraints...I think the law should go further and make such use a crime of assault and abuse with federal penalties...the fact that the FDA does not approve such use is an indictment of itself...
(1.) The New York Times published an article June 24th 2008 “Doctors Say Medication Is Overused in Dementia” “The use of antipsychotic drugs to tamp down the agitation, combative behavior and outbursts of dementia patients has soared, especially in the elderly. Sales of newer antipsychotics like Risperdal, Seroquel and Zyprexa totaled $13.1 billion in 2007, up from 4 billion in 2000...about a third of all nursing home patients have been given antipsychotic drugs. The increases continue despite a drumbeat of bad publicity.
A 2006 study of Alzheimer’s patients found that for most patients, antipsychotics provided no significant improvement over placebos in treating aggression and delusions....misuse of the drugs is widespread. “These antipsychotics can be overused and abused,” said Dr. Jonny Matson, a professor of psychology at Louisiana State University. “And there’s a lot of abuse going on in a lot of these places....Dr. William D. Smucker, a member of the American Medical Directors Association,...”.prescribe antipsychotics only as a last resort”, he said, “many physicians are absent without leave in the nursing home and don’t take an active role in the assessment of the patient.”
(2.) The St. Petersburg Times (Florida) ran an article on 18 November 2007 exposing this practice. "Dementia relief, with a huge side effect". The off-label use of some drugs is helping elderly patients, but may be killing thousands." Kris Hundley, Times Staff Writer.
The following is quoted from this article:
"Two years ago, federal regulators sounded a dire warning: Elderly people with dementia who take drugs like Seroquel, Risperdal and Zyprexa could suffer the ultimate side effect.. They could die.
Yet today, about one in four nursing home residents still take these antipsychotic drugs. Sales to the elderly continued to rise, generating a total of $13-billion in revenues for their manufacturers this year.
The disconnect between government warnings about the increased risk of death and physician prescribing practices led to a prominent Food and Drug Administration safety expert to make a stunning estimate
Dr. David Graham, who had blown the whistle on the dangers of Vioxx, was back before a congressional panel in February. He testified that Zyprexa and other antipsychotics kill about 15,000 nursing home residents each year."
Dr. Graham was quoted: "I would pay careful attention to antipsychotic medications....The problem with these drugs are that we know that they are being used extensively off label in nursing homes to sedate elderly patients with dementia and other types of disorders.....But the fact is, is that it increased mortality perhaps by 100 percent. It doubles mortality. So I did a back of the envelope calculation on this and you have probably got 15,000 elderly people in nursing homes dying each year from the off label use of antipsychotic medications....With every pill that gets dispensed in a nursing home, the drug company is laughing all the way to the bank."
He talked about the FDA's Black Box Warning. "So named because of the black border that surrounds it on the drug label. It's the FDA required disclosure that a drug can have serious or life threatening side effect. What drugs got black box warnings? Abilify, Zyprexa, Seroquel, Risperdal, Clozaril, Geodon and Symbyax."
Note: As of June2008, the older antipsychotic drugs have also been added to the list of those requiring the black box warning. "The U.S. Food and Drug Administration on Monday cautioned doctors that certain types of antipsychotic drugs can raise the risk o death in some elderly people with dementia. The older conventional antispychotic drugs include Haldol (Johnson & Johnson), Moban (Endo Pharmaceutical Holdings Inc.) and Navane (Pfizer Inc.), according to a database on the FDA's website. In year 2005, a similar warning was issued for newer or "atypical" anti-psychotics, including Abilify, Zyprexa and Risperdal. The FDA official said that from now on old class of antipsychotic drugs will include a strong "blackbox" warning, cautioning physicians of the danger. Antipsychotic drugs are used now and then by physicians to help treat behavioral problems in dementia patients." (The MedGuru June 17, 2008) (Also included as subjet to the black box warnings are antipsychotics Compazine, Loxitane, Mellaril, Orap, Prolixin, Stelazine, Thorazine and Tilafon.)
(3.) The U. S. Department of Health's CMS (Centers for Medicare and Medicaid Services) has issued a revised Surveyor Guidance for Unnecessary Medications (F329) that contains a very alarming statement: (`12/18/2006)
"Report (2001) Fifty –eight (58) percent of 693,000 residents who received antipsychotics either
- Lacked appropriate indications for use or
- Received doses exceeding maximum recommended dosage levels including duplicative therapy"
(4.) The Minneapolis Star-Tribune recently ran a story much like the St. Petersburg Times story. The article appeared in the March 9th, 2008 issue of the Star-Tribune. "People with dementia getting drugged rather than helped." The following is quoted from this article:
"using powerful antipsychotic drugs to quiet disruptive people with dementia – at times a step that's easier and cheaper than taking staff time to fix the problem. The practice is alarming Medicaid officials enough that last year they ordered stare nursing home inspectors to start cracking down on it.
Of the state's 398 nursing homes, 38 percent were cited last year for using such medications inappropriately, up from 27 percent in 2006. So dangerous are the drugs that the Food and Drug Administration requires some to carry a "black box warning" that they heighten risk of death for older patients, a warning that might extend to all antipsychotic drugs. They also increase the risk of confusion and falling.
Dr. Robert Sonntag stated: "You don't use antipsychotics just for Alzheimer's and you never, ever drug a patient to just make life easier for the staff or the family."
Note: One of the drugs described in the above articles is "Seroquel". This is the antipsychotic drug that my mother Ellen F. (Nedland) Silbaugh was on when she died suddenly. My mother was an elderly Alzheimer's patient in a small town nursing home in Barron, Wisconsin. (100 miles from my home.) My mother died of one of the two causes (heart) associated with the use of Seroquel. My mother who had never had a heart condition, and had the blood pressure of a teenager, died suddenly of a heart attack. There is no question in my mind but that a negligent medical establishment caused my mother's early death. I share responsibility for my mother's early death due to the use of this inappropriate drug. I should have investigated the drugs that the nursing home was administering to my mother at an earlier date. My wife June was in late stages of Alzheimer's at the same time. I was distracted from my mother who did not appear to be as far advanced with the disease as did June. It was only about a month before mother's death that I started making inquiries and challenging the Nursing Home's use of the antipsychotic drugs. Inquiries were in to the doctor when Mother rather suddenly passed on. I am thankful that I had just spent the day with mother before she died. When I left late that afternoon to drive back to Minneapolis, I had no hint that Mother would pass on that night. I filed complaints with the Governor of the State of Wisconsin who launched an investigation. Citations were issued against the nursing home but it was too late to save my mother. I carry a burden of guilt for my mother's death.
(Photo below right is my mother Ellen F. (Nedland) Silbaugh taken in 1994 before her Alzheimer's.)
(5.) The Wall Street Journal in their "Technology & Health Section for Friday January 9, 2009 has a story by Shirley S. Wang entitled: "Antipsychotics Can Spur Alzheimer's Deaths."
This story reports the results of a clinical trial in the UK and documented in the British Medical Journal Lancet Neurology. These findings support the previous indications of doubling the mortality of Azlheimer's patients who are placed on the antipsychotic drugs as described above.
"The long term use of antipsychotic medications in patients with Alzheimer's disease appears to nearly double their rate of death after one year. ...."Patients who remained on antipsychotic drugs were significantly more likely to die after one year or longer than those who were swithched to a placebo."....After three years, patients in the placebo group had a two thirds chance of still being alive while those in the antipsychotic treatment gorup had only on third chance..."
(6.) The AMDA publication (Official publication of the Medical Directors Association) "Caring for the Ages" discusses medication problems with the elderly in almost every issue. The October 2007 issue has an article "The Challenge of Cutting Medications in LTC." It discusses the use of "Atypical Antipsychotics" as used on my mother the article concludes: "The relative risk of death goes up and the chance that you are going to help the patient is small."
Literally every issue of the AMDA publication referenced above decry's the dismal practice of using off label atypical antipsychotics for behavior problems of the elderly and dementia symptom residents. In fact the January 2008 issue has three such articles. The front page article starts out telling how such use is effective less than 20% of the time. The second article same issue talks about the use benefit as being "uncertain, even dangerous." The third article refers to "unapproved medicines whose harm can outweigh their benefits", etc. etc.
My mother exhibited additional signs and symptoms of an ADR (adverse drug reaction) called Tardive Dyskinesia that is associated with the use of Seroquel and other antipsychotics. (Abnormal involuntary movements of the jaw. Repetitive chewing motions or movements.) It is a muscular disorder. These motions were almost continuous over a period of a few months. My inquiry of the nursing home staff revealed no answers as to the cause. It is when I researched Seroquel (post mortem) that I found the answer. It was not something that my mother would do on occasion but was almost continuous while awake. This should have been a wake up call for the entire medical staff. The Alzheimer's Society in March 2004 had the following to say about this ADR associated with antipsychotic drugs. "Tardive Dyskinesia, which is recognized by persistent involuntary chewing movements...This may be irreversible, but is more likely to disappear if it is recognized early and the medication causing the problem stopped."
* emphasis added.
Below is a copy of the actual FDA Black Box warning that is packaged with every prescription of Seroquel. This warning was first issued by the FDA on April 11th, 2005 as an FDA Public Health Advisory. Similar FDA Black Box warnings are used with all of the other antipsychotic drugs mentioned above!.
(7.) Wall Street Journal on January 15th, 2008 -"Study Confirms Antipsychotics Pose Heart Risk." - by Robert Tomsho. The study was just released in the New England Journal of Medicine.
The latest and by far the largest study of the use of antipsychotics by the medical profession. "Patients taking the latest generation of antipsychotic drugs are twice as likely to suffer sudden cardiac failure and death as nonusers, according to a new study that found such medicines are no safer than the older ones.....the study...was one of the largest to date, and it found dangers for younger adults, too."
"researchers at Vanderbilt University in Nashville, Tenn. reviewed the medical records of about 277,000 Tennessee Medicaid enrollees for the years 1990 to 2005. Of them, about 46,000 were taking atypical antipsychotic drugs and 44,000 were taking typical antipsychotic drugs. Patients ranged in aged from 30 to 74 years; the average age was about 46.
The death rate from cardiac arrest were double the rate for the antipsychotic drug users compared to the non users. (The atypical drugs in the study were Seroquel, Zyprexa, Risperdal and Clozaril. The typical antipsychotic drugs used for comparison were Haloperidol and Thioridazine.
An editorial accompany the new study said the use of such drugs should be "reduced sharply" among children and elderly patients.
This study is a further condemnation and indictment of the medical profession and it's many doctors who go their own way for the sake of expediency and convenience. This danger has been well known since 2005 and ignored by doctors and the medical profession. The sale of antipsychotic drugs in the US has increased EVERY year since 2003 including 2008.
(Connecticut, Arkansas and other states were reported to have sued various drug makers, alleging that they marketed such drugs for uses not authorized by the FDA and didn't adequately disclose potential side effects...)
(8.) Article in the Minneapolis Star-Tribune (Ira Rosofsky - Psychologist) 27 March 2009 entitled: "Enough With The Drugging of Old People." Sub title reads: "We spend billions on this practice. Does it make living with dementia any easier? for us, maybe, Not for them."
"A survey released in 2002 by the Kaiser Foundation found that the staffs in a typical nursing home spend about two hours and 20 minutes a day with each resident. For the remaining 21 hours and 40 minutes, residents are left to their own (mostly medicated) devices. Where is the comfort in that? Dementia sufferers in nursing homes are not only taking donepezil and memantine but other similarly questionable drugs for depression, anxiety, psychosis or simply being ornery. It is easier to medicate than to engage. And when the chemical restraints don't work, nursing homes use physical restraints...why not admit the failure of medication and instead spend some of that money on more staff to hold the hands of both patients and their families?" Beyond nurturance, the savings could be deiverted to research that might yield not only statistically significant but meaninful and large improvements. Or maybe even a cure."
(9.) Article in the AMDA "Caring For The Ages", June 2009 issue verifies that the use of antispsychotic's for behavioral problems continues to be used in large amounts and continues to be a failure. When will doctors discontinue this outrageous practice and conduct. FDA's warnings and lack of approval seems to fall on deaf ears. "Residents of 670 nursing facilities in New York state were studied. All had a...diagnosis of dementia or Alzheimer's disease...One third of the residents with dementia was taking an antipsychotic at admission and most continued to do so for nearly a year. Another 16% were started on an antipsychotic within 3-6 months of admission, and nearly half of these patients continued on the meds of up to a year. Overall, the average time on antispychotic therapy was 15 months...Residents receiving antipsychotics at the time of admission and then removed frm the meds showed the greatest improvment in behaviors...The researchers also found that residents taking antipsychotics were 24% more likely to fall and more likely to experience functional decline over time than those not taking antipsychotics...Speaking of leaders at one facility..."They were worried that if they took everyone off these meds they'd go crazy. Instead, people actually came alive. They were more alert and more commuicative."
(10.) AMDA "Caring for the Ages" November 2009 - article on "Sublingual Antipsychotic Coming to Market".
This article discusses a new FDA approved drug in August 2009. The drug is Asenapine marketed as Saphris by Schering-Plough Corp. (An atypical antipsychotic for bipolar I disorder and schizophrenia in adults.) The Editor's Note in this article however contains the following clarification on usage.
"Risperidone, Aripiprazole, and Rolanzapine are all currently available orally dispersing tablet formulations of atypical antipsychotics that exist in regular oral forms. Atypical antipsychotics Ziprasidone and Paliperidone are at our disposal, as well as Clozapine and a host of traditional antipsychotics. These drugs carry significant risks, especially in our LTC population and none is indicated for dementia with agitation. This new drug may be welcome but probably will have limited use in LTC.- Karl Steinberg, MD, CMD, Editor in Chief."
(11.) Article in the AMDA "Caring For the Ages" - December 2009 - "Overused Antipsychotics’ Remain an LTC Challenge".
Article cites evidence that the improper doctor's use of Antipsychotic drugs continues at a high level but with a few areas reporting success in eliminating their use. They reference a recent article in the Chicago Tribune headlined: "Nursing Home Doctors Untouched Even as Facilities Are Cited."..."nursing home inspection reports found 1,200 violations concerning psychotropic drugs in Illinois since 2001...physicians have been prescribing the powerful medications inappropriately and without retribution." "AMDA past president Dr. David Smith was quoted: :"when he refused to prescribe an antipsychotic that staff at an nursing facility wanted for a combative resident...the family changed to another physician who would write the prescription. The resident became a Zombie, and they considered that an improvement." ...Dr. Smith also stressed that many behaviors in residents, although they can be odd, are not harmful and don't call for medications." Research by a Dr. Teigland found that "residents in for profit facilities were 20% more likely to be on antipsychotics." There are a number of facilities nationwide that are successfully reducing antipsychotic drug use...one such example is Finger Lakes Center for Living in Auburn, N.Y. "After a year, the facility celebrated the elimination of antipsychotic use for all dementia patients."
(12.) Doctors in the United Kingdom also deplore the use of antipsychotic drugs in Alzheimer's - dementia treatments. The British "Sky News" TV Channel - (Thursday January 8, 2009.)
"Drugs Prescribed to Thousands of Alzheimer's Suffers could Double their risk of Dying, Scientists have Warned." The story by correpondent Thomas Moore continued: "New research shows antipsychotic drugs, which are used to control aggression and behavioural problems are linked to significantly higher death rates...Researchers at King's College London monitored 128 patients who were prescribed antipsychotic drugs or dummy placebo pills...after three years the difference between the groups was dramatic, with twice as many people dying in those given the antipsychotic medication."
"Too often these dangerous drugs are used as a substitute for good quality dementia care" is a quote from the British Alzheimer's Society, Neil Hunt - Chief Executive. "The drugs increase the risk of stroke, as well as causing unpleasant side effects such as sedation." "This distressing new evidence highlights the desperate need to stop people with dementia being over prescribed antipsychotics," he said. The Alzheimer's Society believes up to 105,000 patients are being inappropriately prescribed antipsychotics.
(13.) AMDA's publication, "Caring for the Ages" April 2010, "Teamwork Can Reduce Psychoactive Drugs." by Sherry Boschert.
This is an interesting article on efforts to reduce the use of Antipsychotic Drugs in Nursing homes -"Using interdisciplinary teams in a systematic way can help nursing homes...stop excessive use of psychoactive medications in residents."...this came from information reported at the "Long Term Care Medicine - 2010, AMDA's annual symposium. They referenced Federal Health Regulations for Long Term Care Facilities rule 329 (F-Tag 329) which mandates that "each resident's medication regimen must be free from unnecessary drugs"..."At a 230 bed long term care facility in San Antonio, an interdisciplinary team approach reduced antipsychotic use by 74%, anxiolytic use by 23% and stimulant use by 13% within 6 months"...At a 150 bed skilled nursing facility in Hendersonville, NC, 6 months of an interdisciplinary team approach reduced use of antipsychotics by 54%, reduced the use of hypnotics more than twice a week by 64% and decreased psychiatric discharges to hospitals by 72%"...The incidence of untreated depression dropped by 47% and the proportion of residents experiencing increased symptoms of depression or anxiety fell by 10%. Rates of pressure ulcers declined by 66%, falls...reduced by 25%."
(14.) U.S News and World Report, October 2010 article: “Overmedication: Are Americans Taking Too Many Drugs?” by Deborah Kotz.
“Overmedication is a big problem for half of all seniors today who take three or more medications a day. “The drug-drug interactions can be worse than the disease.”
John Morley, director of geriatric medicine at the St. Louis VA Medical Center says Doctors sometimes suspend common sense when prescribing a treatment plan. “For example, they prescribe Aricept for Alzheimer’s patients and then treat a frequent side effect, urinary incontinence, with anticholinergic (an inhibitor of nerves responsible for involuntary movements) like Enablex or Ditropan whose side effects include delirium, confusion and memory loss.
Kotz reports that some nursing home residents were given antipsychotics to treat anxiety, confusion and irritability, which were triggered by other medications. “Using antipsychotics for this inappropriate purpose has led to fatalities,” says Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.”
Aging is a natural and sometimes painful process that occurs to all physical living things. Overmedication can exacerbate the natural problems brought on by aging. Some doctors recommend at least two or three different medical opinions in order to avoid over medication.
(15.) Minneapolis Star – Tribune Sunday December 5th, 2010, ran the following article: “Some Nursing Homes Seek End to Stupor”.
This article points out that: “Powerful antipsychotic drugs shave been used or years to reduce agitation, hallucinations…among people with mental illnesses. They also are widely used “off label” to quell disruptive behavior among people with Alzheimer’s disease and other forms of dementia.”
The dangers in their use were also described. “Several studies have concluded that more than half are prescribed inappropriately. The drugs are especially hazardous to older people, raising the risk of strokes, pneumonia, confusion, falls, diabetes and hospitalization”….”There’s a bunch of problems, not the least of which is those drugs can kill you.” Said Dr. Mark Kunik of Baylor College of Medicine in Houston…”Instead of looking for causes of disruptive behavior among dementia patients, doctors typically prescribe drugs to mask the symptoms” he said, because “It’s the easy thing to do”…That’s true in hospitals, in clinics and in nursing homes.”…
”Whether you have Alzheimer’s or not, there’s a reason people get frustrated or upset – pain, urinary tract infections, hunger, fear of strangers or loud noises or strange settings, maybe drug interaction”, Kunik said. “If you figure that out, you likely can find a safer, non-pharmacologic treatment.”
Eva Lanigan a nurse and resident care coordinator at Sunrise Home in Two Harbors, MN developed a new system of care that may become a model tor the nation. “Working with a psychiatrist and a pharmacist, Lanigan started a project last year to find other ways to ease the yelling, moaning, crying, spitting, biting and other disruptive behavior that sometimes accompany dementia. They wanted to replace drugs with aromatherapy, massage, games, exercise, personal attention, better pain control and other techniques. The entire staff was trained and encouraged to interact with residents with dementia. Within six months, they eliminated antipsychotic drugs and cut the use of antidepressants by half. The result, Lanigan said: “The chaos level is down, but the noise is up – the noise of people laughing, talking, much more engaged with life. It’s amazing. Now the home’s operator, Shoreview based Ecumen, has started a project called “Awakenings” throughout its 15 long term care nursing homes. It’s based on Lanigan’s work….”We saw what Eva was doing – something everybody in the industry talks about – and we were impressed,” said Mick Finn, an Ecumen vice President. :”We said, hey, this is real. Can we all do this?”
The nation’s nursing homes should all start their own programs of “Awakenings”. They all need a wake up call to stop injuring, killing and drugging into stupor, the nation’s Alzheimer’s and dementia residents who are already in a daily and deadly struggle with this terrible disease.
(16.) AstraZeneca Plc (AZN) (10 March 2010) agreed to pay $68.5 million to 37 U.S. states and the District of Columbia to settle lawsuits alleging that the company deceptively marketed its anti-psychotic drug Seroquel.
The settlement, announced today, is separate from an in addition to a $520 million agreement London-based AstraZeneca reached with the U.S. last year over the marketing of Seroquel, said Tony Jewell, a company spokesman.The company marketed Seroquel for uses that weren’t approved by the U.S. Food and Drug Administration, FDA, the federal and state governments alleged. AstraZeneca promoted the drug, approved for schizophrenia and bipolar disorder, for dementia, depression and anxiety in violation of federal drug (FDA) rules, according to the states. While doctors can prescribe medicines for other diseases, companies aren’t allowed to market drugs beyond FDA approved uses.
Editorial Note: While this settlement will not bring back my mother Ellen Silbaugh who died as a result of this drug, I am sure that if she is looking on in Heaven, she has a smile on her face.
(17.) Caring for the Ages (AMDA) May 2011. “The Ethics of Antipsychotics in Alzheimer’s” Dr. Jonathan Evans, MD, MPH, CMD, Charlottesville, VA.
“There are many ethical and philosophical issues surrounding the use of medication to control behavior, particularly in patients who are unable to give informed consent…the obligations to do no harm…medications given over patient’s objections…”
“These drugs are harmful, they are ineffective in treating behavior…The use of antipsychotic drugs in elderly patients is discouraged by the Food and Drug Administration and other regulators. Many consumer groups are strongly opposed to their use as well. Antipsychotic drugs have no FDA approved indication for treatment of patients with dementia. On the contrary, each carries a “black box” warning against their use in elderly patients with dementia. In 2005, the FDA issued a warning of increased risk of death in elderly patients receiving antipsychotic drugs. That risk emerges even after a very short period taking such drugs.”
“Antipsychotics slow brain functioning in patients whose brain function is already diminished by dementia…the best evidence indicates that antipsychotics are ineffective at treating behavior in dementia…significantly more adverse effects, including confusion and sedation than did placebo (CATIE-AD large double blind study)…”
“The widespread use of antipsychotics drugs to control behavior…often represents either a fundamental misunderstanding of behavior in dementia, if not a fundamental misunderstanding of the disease itself, or an unwillingness or inability to change the environment, alter one’s approach to the patient,…while providers are ill trained to understand, interpret, and respond to behavior. Their culture tends to blame the patient….behavior is communication. Behavior itself is not a disease. In people whose ability to communicate with words is limited (such as patients with dementia), communication tends to be more nonverbal (i.e., behavioral)….”
“Many of the behaviors that are common in patients with dementia and that are often labeled as difficult, challenging, or bad – such as agitation, wandering, yelling, inappropriate urination, and hitting – are typically reactive, almost reflexive behaviors that occur in response to a perceived threat or other misunderstanding. These people by definition of their underlying illness have an impaired ability to understand.”
“Moreover, all of the challenging behaviors exhibited by confused elderly patients in health care settings across the country every day are identical to behaviors by normal, healthy, very young children in day care centers and preschools. While the behaviors are often the same, the expectations and responses are often quite different….what is this person trying to say…Identifying factors such as pain, anxiety, and loss of a familiar object, person, or place may be invaluable to the caregiver in developing an appropriate response…it may be as simple as changing our approach to prevent and minimize distress…The fundamental basis of health care is caring for others. The fundamental basis of caring is love and acceptance.’
(18.) “Government Reports Wide Misuse of Antipsychotics” – AMDA’s “Caring for the Ages” June 2011.
“Health and Human Services Inspector General Daniel Levinson urged drug manufacturers to heed federal laws regarding the promotion of off-label use of drugs following the release of a report that found a high rate of inappropriate use of atypical antipsychotics among nursing home residents receiving Medicare benefits.”
“…88% of the Medicare claims for atypical antipsychotics were for patients with dementia. Labeling for the eight drugs in the atypical antipsychotic class contains a black box warning stating that elderly patients with dementia related psychosis. They are approved to treat schizophrenia and bipolar disorder.”
“Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there’s ample evidence that some drug companies aggressively market their products towards such populations putting profits before safety.”
“A series of lawsui8tes and settlements that (Health and Human Services) helped bring about suggests that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years.”
A review of Medicare claims for atypical antipsychotics reveals: 83% were associated with off-label uses. 88% were for claims of patients with dementia. 51% of claims were erroneous, meaning they were not used for medically acceptable indications as approved by the FDA…”22% were given in excessive doses or for excessive durations.”
(19.) “Atypical Antipsychotics and LTC Liability” AMDA’s “Caring for the Ages” August 2011.
This article talks about a Federal Case where the Department of Health and Human Services upheld a finding of noncompliance at the “immediate jeopardy” level when a resident received excessive doses of the atypical antipsychotic Risperidone (Risperdal) …A 68 years old woman with dementia…who suffered cardiac arrest and died...there had been no diagnosis documented in the chart to indicate an order for Risperidone. The CMS requires that service provided or arranged by the facility meet professional standards of quality, that pharmacists question every irregular medication order, and that residents be free from unnecessary drugs…there was no diagnostic indication for Risperidone…the resident was also receiving Lorazepam (Ativan), and Sertraline (Zoloft) which can potentiate the effects of Risperidone and should have raised an additional red flag.
The article further discussed two lawsuits in Florida and Illinois alleging improper usage of Risperidone. The article also discussed the off label usage of such drugs as for agitation in elderly dementia and the FDA's black box warnings against atypical Antipsychotics usage…increases risk of mortality…reference made to the latest “OIG report that many elderly nursing home residents with dementia continue to receive atypical antipsychotics for off label uses and often for indications that either are not medically acceptable or don’t exist.
This issue also discussed a meeting of the US House Ways and Means Committee addressing concerns about prescriptions for antipsychotic drugs…need for behavior management…assessing why the behavior is occurring and what may be done to address/’remove the cause of the behavior and the implementation of a comprehensive multidisciplinary care plan.
Editorial Note: The Criminal Negligence (Involuntary Manslaughter) trial of Michael Jackson’s personal physician Conrad Murray revealed the coroner’s finding that Jackson died of “acute Propofol (hospital anesthetic) intoxication aggravated by the effects of Lorazepam (Ativan).an anti-anxiety drug. (3 November 2011) It should be noted that the drug Lorazepam is frequently prescribed for Alzheimer’s patients despite the fact that it is not approved for such use by the FDA.....In addition below are the listed side effects of this drug:
Ativan is noted for the side effects of "addiction, depression, and cognitive impairment;.."Lorazepam (Ativan) appears to have more profound adverse effects on memory than other benzodiazepines; Lorazepam (Ativan) impairs both explicit memory and implicit memory. In the elderly, falls may occur as a result of benzodiazepines. Adverse effects are more common in the elderly, and they appear at lower doses than in younger patients. Benzodiazepines can also cause or worsen depression.
(20.) Antipsychotics, Dementia, Dilemma. Dr. Jeffrey Nichols. AMDA’s “Caring for the Ages” September 2011.
“Using Antipsychotics to treat the behavioral complications of dementia is like hitting the television set on the side to improve the pictures….I meant that it was a common activity based on frustration rather than any understanding of the complex mechanisms that are producing the problem.”
Antipsychotics are used to treat unsafe behaviors in nursing home patients because they sometimes work and other options may be very limited. For many dementia residents, the real black box is not the FDA warning but rather the mind, whose inner workings are a complete mystery...There is no scientific basis for administering medications that decrease neurotransmitter levels in the brains of patients already suffering from decreased neurotransmitters.”…The most successful studies of antipsychotics demonstrate efficacy rates of about 40% at 3 months…Unfortunately, the highest risk period for cardiac events or sudden death is in the first month or two of use..”
Dementia experts are well aware that dementia behaviors are “about something” and not simply involuntary, random behaviors, the treatment of choice is to deal with the underlying problem. This requires extensive time from multiple staff members, (interdisciplinary team**) for which insurers don’t want to pay.
“The agitated dementia resident who is refusing care and striking out at staff members might be in (1.) pain or (2.) severely constipated or (3.) nauseated; have (4.) untreated infection, be (5.) delirious from medications or (6.) electrolyte imbalance or simply be (7.) confused and frightened. Ideal treatments might be as varied as (a.) analgesics, (b.) laxatives, (c.) medication withdrawal, (d.) antacids, (e.) cholinesterase inhibitors, (f.) antibiotics, (g.) music therapy, a (h.) stuffed animal , or (i.) specialized activity program for diversion”.
** Interdisciplinary team = Psychiatrist, Pharmacist, social worker, Nurse etc.
(21.) AMDA’s Caring for the Ages, January 2012 carried a story on the Senate Special Committee on Aging and the Hearings on “The Human and Taxpayers Cost of Antipsychotics in Nursing Homes”. This story was headlined “AMDA Testifies on Antipsychotics”
“Behavior is not a disease. Behavior is communication.” Was the message from AMDA Vice President Dr. Jonathan Evans. “The hearing examined the increased prescribing of antipsychotic medications to nursing home residents with dementia, despite those drugs carrying a Food and Drug Administration “black box” warning…He also noted that few health care professionals, including physicians, receive any training on how to respond to dementia related behaviors by any means other than medication…few physicians today receive any meaningful training in nursing homes and other long term care settings during medical school or residency training….increased dementia training for nursing home surveyors and all members of facilities’ interdisciplinary teams was a common theme at the hearing…This is all about improving the quality of care for seniors across the continuum. I hope to shed some light on improved drug prescribing in the elderly and the promotion of patient centered care…focusing on understanding behaviors in dementia so that we can understand what patients are trying to communicate and get them what they need.”
22. British Medical Journal study now adds Blood Clots to Antipsychotic Risks (BMJ, Online First, Sept. 22, 2010, C Parker.)
In the newly published study, researchers analyzed data from a nationwide medical registry that included 11 million patients attending more than 500 general practices throughout the U.K. The study revealed that: “Use of antipsychotic drugs during the previous two years was associated with a 32% increase in blood clot risk.” “Use of antipsychotic drugs over the previous three months was associated with a 56% increase in risk.” “Starting antipsychotic drugs within the past three months was associated with a two-fold increase in risk” “The risk was highest for new users of the drugs and for patients prescribed atypical antipsychotics, which include Seroquel (Quetiapine), Risperdal (Risperidone) and Zyprexa (Olanzapine).” Compared to patients who did not take antipsychotic drugs, users of atypical antipsychotics were 73% more likely to develop the dangerous blood clots. Seroquel use was associated with a nearly threefold adjusted increase in risk among the study population.”
Note: The WebMD article reporting on the above study, also referenced the long time FDA warning that the use is associated with an “increased risk of death among the elderly with dementia related psychosis and that the “warning includes both atypical antidepressants and conventional antidepressants like Thorazine (Chlorpromazine) and Haldol (Haloperidol)”.
23. Antipsychotic Risperdal Slapped with $2 Billion Dementia Penalty…11 November 2013…
“Washington – Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nations largest long term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with federal government and states totaling $1.72 billion.”
“In a criminal investigation filed today in the Eastern District of Pennsylvania, the government charged that from March 3, 2002, through Dec. 31, 2003, Janssen Pharmaceuticals Inc., a J&J subsidiary, introduced the antipsychotic drug Risperdal into interstate commerce for an unapproved use, rendering the product misbranded. For most of this time period, Risperdal was approved only to treat schizophrenia. The information alleges that Janssen’s sales representatives promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. The information alleges that the company created written sales aids for use by Janssen’s Elder Care sales force that emphasized symptoms and minimized any mention of the FDA approved use, treatment of schizophrenia...”
Note: Risperdal is one of several FDA “Black Box” labeled antipsychotic drugs with a warning against such use by elderly dementia type patients.
24. Geriatric Psychiatry…Antipsychotics’ risk in dementia revised upward…Clinical Psychiatry News Digital Network...8 April 2014...
ORLANDO – The mortality risk associated with prescription of antipsychotics or valproic acid for behavioral disturbances in patients with dementia is considerably greater than previously estimated, according to a massive national study.
This retrospective study included 45,669 matched pairs of Veterans Affairs patients over age 65 with dementia diagnosed during 1998-2009….
Rebecca Moore - Florida - (5 December 2010): “Just wanted to Thank You so very much for this website. My Mom has 'Alzheimer’s' and I have been caring for her the past three years. All the usual tries with every herb and supplement that we thought might help, then Aricept and Namenda. Hospice has stepped in, with anti-psychotics and heavy sleep meds, causing more falls and instability, less talk...good grief, and she's never been worse...The drugs had horrible side effects, and I've taken her off everything except her anti-seizure med. Guess what, she can walk around and putter in the yard, talk 50% sentences that are understood (Wow) and is much happier. We are in our 7th year since diagnosis...so, I feel extremely lucky that she is still in pretty fair shape...Since I've found your site all our lives are greatly improved. It's made me so much more confident that I am making the right decisions for her, now that I know the truth.”
Editorial Note: The drugs discontinued by Ms. Moore in achieving this fine result are the following: (1.) Clonazepam (Klonopin, (2.) Lexapro, (3.) Ativan (Lorazepam), (4.) Restoril (Temazepam), (5.) Haloperidol (Haldol), and (6.) Seroquel. Ms. Moore retained the drug Keppra (Levetiracetam) which is an anticonvulsive or anti-seizure drug. (The discontinued drugs are a group of drugs used for treating anxiety, depression, antipsychotics, anticonvulsive and sleep disorders. Three have cautions by FDA for use with the elderly and 2 are Black Box labeled.)
Gill Denman - Essex, United Kingdom - (12 November 2013): "This subject hits a very raw nerve with me, all anyone does over here is recommend anti-psychotics for mum. I ask for memory clinics or someone to work with her to stimulate her mind (which is still there although spluttering like a vetran car on the Brighton Run), she needs to be socialised in the right sort of way, not just being put with other dementia sufferers so she can see where she is going, she needs something that gets a grip on the now. I hate these drugs, I know that our local hospital gives them to inpatients when they get even slightly challenging, mum was covered in bruises which matched hands/fingers holding her down hard, a consultant told me I had "unrealistic expectations" of mum's capacity. After they broke her arm, I was told that it wasn't worth giving her physio with her mental state, she would lose the use of her arm. When we got her home and off the drugs, she not only regained a lot of capacity but has also taught herself to use the arm again. When we had a discharge meeting at our home, a professional who had made judgements about mum was visibly suprised when I said mum wasn't taking any mood controlling drugs. It all puts an enormous pressure on me as well, I am left to cope in a way that I feel best, I am positive that, had I left it to the 'professionals' that mum would now be a cabbage or dead."
Maura BuddyBear - Dublin, Ireland - (17 November 2013): "My Mother was on Seroquel when I read the side effects, I voiced my concerns with Professor Swanick , he told me it was a double edged sword. The Seroquel worked for my mother but like all medications there were side effects. About a year and a half ago the Seroquel was stopped because my mother was always very quiet and never ever was she violent. I was relieved that she no longer needed medication for alzheimhers, my mother had TIA'S but I think that was a progression of the disease and not the medication...my mother has a stuffed monkey and a doll, in the early days my mother carried her monkey around all day and would talk to it and kiss its head, as if it were her baby."
See the companion essay on the inappropriate and dangerous use of anti-depression drugs in the treatment of Alzheimer's and dementia victims:
Stan Berg updated (11/11/2013)