Corrupt Medical Research Only the Tip of the Iceberg

Alan Cassels, University of Victoria

WE TRUST strongly in our medical system because, metaphorically speaking, we largely don’t mix church and state. For the most part, the medical care we receive from our hospitals and doctors is supported by public funds and delivered on the basis of human goodness, charity and justice. Examples that show how strenuous we are in ensuring that commerce doesn’t taint our medical care include:

• We don’t let doctors sell drugs; pharmacists do that.
• We don’t let drug companies run medical schools; universities do that.
• We don’t let drug manufacturers write prescribing guidelines for physicians; independent experts do that.
• And we don’t let people selling drugs or medical devices write medical journal articles; academic physicians do that.

Or, at least, that’s what I thought.

April was a particularly hard month for rude awakenings. Cracks in the crumbling edifice between commerce and medicine were revealed and new research unveiled gross, sometimes shocking, levels of conflicts of interest in our medical system. We are finding evidence of academic doctors selling themselves to the highest bidders, medical journals allowing themselves to be prostituted by drug companies and medical schools allowing doctors in residence to be bribed with drug company trinkets. I would argue that of all the factors threatening to undermine our trust in medicine, financial conflicts of interest top the list.

Don’t believe me? Then believe the data: In April, four separate research studies published in four diverse areas showed the widespread and rampant nature of conflicts of interest in medicine. One derives from the world of cancer research. One is from psychiatry. One is from medical education and the last is from the world of medical journals. As you absorb these examples, try to decide for yourself if we are doing enough as a society to eliminate the conflicts of interest infecting medicine.

What do I mean by conflict of interest? Wikipedia generally defines it as “any situation in which an individual or corporation (either private or governmental) is in a position to exploit a professional or official capacity in some way for their personal or corporate benefit.”

One study from the cancer world examined the frequency and impact of conflicts of interest as they related to high-impact, published, clinical cancer research. It basically asked the question: “Are researchers who publish in cancer journals conflicted?” (For instance, do they own shares or have stock in or otherwise benefit financially from their association with a drug manufacturer or do they work for the drug company whose drug they are studying?) The reviewers looked at cancer research published in eight major journals in 2006 to see if conflicts of interest were reported and, if so, who funded the research? They also wanted to discern if there is a real association between the research funders and what the research concludes (i.e. do the industry-sponsored researchers have more positive things to say about their sponsor’s drug than the researchers not on industry’s payroll?)

Their results? Out of 1,534 original oncology studies, almost a third (29 percent) of the researchers had a conflict of interest, including industry funding, yet only 17 percent declared they had received such funding. Studies paid for by industry funding were twice as likely to focus on treatments (as opposed to other aspects of cancer care) and randomized trials that assessed survival were more likely to report positive survival outcomes when there was an obvious conflict of interest. In other words, the drug is shown to “work” better if there is company money involved.

The authors concluded there are indeed conflicts of interest in the clinical cancer research published in high-impact journals; often, those conflicts are not disclosed and the conflicts result in a more positive spin being put on the results of the trial.

The next example comes from the world of mental illness. A report by Boston researchers found that 90 percent of the authors of three American Psychiatric Association (APA) clinical practice guidelines in psychiatry had financial ties to companies that manufacture drugs mentioned in those guidelines. Worse yet, the authors had financial connections, including owning equity in the companies that made the recommended medications, being a consultant or corporate board member, or receiving honoraria. None of these conflicts were disclosed in the guideline.

Translation: The academics who wrote the major guidelines for American physicians on treating serious mental illness – schizophrenia, bipolar disorder and major depression – were basically all funded by the drug companies. If you thought only well meaning psychiatrists, interested in the welfare of patients, provided the guidelines, you’d be wrong. The picture looks even darker when you narrow in on the conflicts of interest of the authors of the guidelines for only bipolar disorder and schizophrenia: Here, 100 percent of the authors had such conflicts. Most people would consider these findings very worrisome, including Tufts University professor Sheldon Krimsky, one of the co-authors of this report. Tufts published a 2006 study examining conflicts of interest of the creators of psychiatry’s “Bible,” the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders).

In a telephone interview with Krimsky from his office in Boston, he told me we should be worried about conflicts of interest because they can lead to a “distortion of the scientific record” and that industry-funded activities may lead to an “interpretation of the science in a direction that may not be defensible.”

While he’d like to see these guidelines do a much better job of disclosing conflicts of interests among the authors, such disclosure is only an intermediate step towards erecting a solid firewall between drug companies and guidelines for physicians. “The innovators must be separate from the evaluators,” he notes. That’s right, a separation of church and state.

No doubt guideline committees, such as those sponsored by the APA, need to come clean about their financial conflicts, but they must go further to avoid them in the first place. At the very least, groups like the APA should admit they’ve got a huge potential PR liability on their hands, and if they don’t prevent drug companies from putting their own people on guideline committees, the APA shouldn’t be surprised when our doctors scorn or ignore their guidance.

What about smaller things than prescribing guidelines? What about trinkets – do they influence what our physicians think about drug companies? A recent study conducted in two medical schools in the US found that exposure to even small pharmaceutical items affected a doctor’s treatment preferences.

You might find this hard to believe. Most physicians I know scorn the idea that they could be “bought” with trinkets. (We’re talking drug company pens, free drug samples and other logo-laden paraphernalia.) Most physicians are adamant that these small, promotional items are unlikely to influence prescribing behaviour. Yet, in this study, the researchers measured whether exposure to these items result in doctors looking more favourably on drug companies and whether or not the medical schools with more restrictive policies towards pharmaceutical marketing produce doctors with different attitudes.

Researchers conducted a randomized, controlled experiment with more than 300 senior level medical students at two US medical schools. One of the schools (University of Miami) allowed the students to be exposed to small, branded promotional items for the cholesterol-lowering drug Lipitor (atorvastatin). The control group was comprised of students at the University of Pennsylvania School of Medicine where restrictive policies are in place to limit pharmaceutical marketing.

What did they find? The Miami students exposed to the Lipitor swag were obviously more enamoured with the drug compared to the control group in Pennsylvania. On a “skepticism” scale, the Miami students held more favourable attitudes toward pharmaceutical marketing compared with the other group of students where the opposite effect was observed. Basically, those students not marinating in drug company promotion were less swayed by promotional items related to the drug.

The authors concluded “subtle exposure to small, pharmaceutical, promotional items influences implicit attitudes toward marketed products among medical students.”

A study published in April by Sergio Sismondo at Queens University in Kingston looked at the relationship between drug companies and medical journals and asked, “Are medical researchers and medical journals too close to the pharmaceutical industry for comfort – or patient safety?”

We’ve all heard of the phenomenon of “ghostwriting” where big, important names in medical academia are asked to put their names to papers written by others (often drug company hacks). But Sismondo pushes the concept a bit further referring to the “ghost management” of pharmaceutical research and publication where cradle-to-grave medical publishing is “managed” every step of the way by pharma funders. He notes there has always been a problem with plagiarism and the misallocation of credit (like the prof who puts his own name on the hard work of his graduate students), but those scenarios are only the tip of the iceberg.

A more serious problem in medical publishing is the pharmaceutical industry using “willing participants” in the form of researchers seeking fame, glory and money associated with huge, multimillion-dollar studies. These people, known in the marketing world as KOLs (Key Opinion Leaders), are luminaries who put their names to the body of academic published research and serve as speakers and de facto promoters of the company’s products. They put their names to studies that are published according to the objectives of the funders (usually the drug companies). The published studies are then reprinted and distributed to the offices of physicians and anyone else who influences drug formularies.

As Sismondo says, “Those articles may look like independent confirmation of the reps’ pitches [and] plagiarizing KOLs lend their good names to the pitches.”

If you were to ask me if conflicts of interest are a problem in medicine, I’d say, “Ask the data and then decide for yourself.”

Alan Cassels is a drug policy researcher at the University of Victoria, British Columbia and the co-author of the bestselling Selling Sickness. He does not work for the pharmaceutical industry.

cassels@uivic.ca www.alancassels.com

From: http://elderadvocates.ca/request-for-public-inquiry/

HAND DELIVERED

The Honourable Mr. Ron Stevens, QC
Minister of Justice and Attorney General
Room # 208, Legislature Building
10800 – 97 Avenue, Edmonton, AB T5K 2B6

Dear Mr. Minister:

Request for a Public Inquiry to Address the Following:

A physician, has a powerful quasi-judicial position in society by virtue of the reliance on his assessments by the judicial system, in that his assessment can lead to the detaining of lawful citizens behind locked doors, and removal of property and human rights.

The current standards required for a physician in the performance of his assessment are not well defined. We believe that if the judiciary is to rely on a physician’s assessment, specific standards and criteria must be developed for the exercise and documentation of a physician’s assessment. These should include cross examination of the physician or documentation/ affidavit testimony which outlines the process which was followed as well as practical avenues for the appeal and review of that assessment.

Many seniors are being abused through the process that declares them incompetent to look after their finances and personal decisions.

Therefore we ask your government to hold a Public Inquiry to:

1. allow hearings across the province of persons who have been victimized by a process that has no safe, definitive guidelines to ensure a fair, ethical assessment. The hearings should include those Alberta citizens who are detained behind locked doors who wish to be heard
2. establish legislated criteria and standards to govern the assessment protocol, that recognizes constitutional rights and the Charter of Rights and Freedoms
3. establish practical avenues of accessible, appeal protocol.
4. establish penalties for those who are in breach of legislation.
5. a definitive time line in regard to these undertakings.

Thank you.
Respectfully submitted,
Elder Advocates of Alberta Society

In response to proposed changes to legislation and regulations pertaining to adult guardianship laws in British Columbia, Canada.

Submitted:  December 15, 2008

1. There appears to be no legal or procedural mechanism in the province of British Columbia (BC)  to review a doctor’s opinion when a finding of incapability is questioned. Nor does there appear to be any such mechanism to review the determination of incapability made by any designated health care professional, even when there is credible and concrete evidence of error and harm to the person, and opposing medical opinions.There is no means for resolving a dispute between health care professionals, even when there is evidence of impropriety on the part of the person making the finding of incapability. There is no recourse provided in BC legislation to hold health care practitioners accountable for their opinions; the only alternative is to sue the health care practitioners, and that is not a meaningful or achievable avenue for many, many people, especially seniors.It is unreasonable to assume that there is no possibility that a medical doctor or any other designated health care professional would never, or could never, make an error in rendering their opinions. There are many, many examples across Canada of medical practitioners who have been found to have committed errors and/or abused their positions of authority on a routine basis without any meaningful oversight, and sometimes with the complicit knowledge of superiors. To cite just a few in the past year:
   • The doctors and health authorities in Newfoundland & Labrador, and in New Brunswick who willfully neglected to provide cancer patients with appropriate tests, results notification, and/or treatment,
   • The children’s coroner in Ontario who, for several decades, made erroneous judgments regarding the deaths of children which ensured many innocent people, mostly parents, were charged and imprisoned when they should not have been, and
   • The 10 doctors in BC last year who were found by the BC College of Physicians and Surgeons to have committed acts of sexual assault on their patients.

   Appealing to the College of Physicians and Surgeons, or the colleges of any of the other designated health care professionals is not, in any way, a part of the Guardianship Act. As such, this represents a major flaw in the Guardianship Act, and it leaves seniors vulnerable to error and abuse, and without adequate protection.

   The effects of an error or abuse of authority on a person whose rights have been removed by any health care professional are enormous and devastating.

2. The draft legislation gives too much discretion to, and provides no oversight of, the health care professional(s) who conduct assessments and make decisions regarding incapability. It is folly to rely on professional bodies to regulate themselves, especially in regard to their performance in enacting a legal statute. Health care professionals do not have legal credentials.Moreover the notion of “self-regulating professionals” is rapidly becoming an oxymoron; even so-called “regulated professionals” such as those in the financial industry are hard pressed to ensure proper oversight. Surely, in a matter so profoundly fundamental to the well-being of a person as the declaration of incapacity, it is incumbent upon us to ensure vulnerable individuals are protected from errors and abuse. At very least, there should be two separate declarations of incompetence required, independent of one another, rather than coupled, as specified in section 6. (1) (b). Independence is a critical factor in the medical arena, where “group think” often results in mis-diagnoses, errors and omissions. A fresh, challenging perspective is essential to ensure that a person is not inadvertently mis-diagnosed.Health care professionals, particularly in long-term care settings, often prefer to deal with only one member of a patient’s family, and preferably a compliant one. There are numerous studies and evidence to attest to this phenomenon. This will only increase as the cost of, and demand for, long-term care increases. A facility’s costs are reduced when its clientele (and their family) are subdued and acquiescent. This is a common scenario, and one that can easily result in a health care provider “taking sides” in favour of compliant family members, often to the detriment of the patient.

   In addition, there is no requirement for health care professionals (including medical practitioners) to provide evidence of and justification for their opinions. The “opinions” of medical doctors or psychiatrists are usually comprised of nothing more than vague phrases, and pronouncements of diseases or “disorders” which are simply theories for which there is no scientific proof. Despite the appearance of validity by virtue of the DSM, there is often a marked confusion or contradiction of terminology used by doctors when decreeing a person to be incapable. In fact, the DSM is routinely debunked, and even privately mocked in medical and other circles. In short, there are no objective means used in BC to determine whether a person is incapable; the doctor’s opinions are entirely subjective. As such, they are wide open to error and abuse.

3. The prevalence of powerful antipsychotic and other drugs routinely, and increasingly, prescribed by doctors, are well-known and plainly documented by Health Canada, the US Food and Drug Agency and the pharmaceutical companies themselves to cognitively impair a patient. Therefore it is a fundamental conflict of interest for a doctor who is prescribing drugs that are acknowledged to impair cognitive function to render an opinion of incapability with respect to that patient. This should be firmly reflected in the legislation and/or regulations.
4. Furthermore, seniors (who will be the largest group affected by this legislation) are routinely over-medicated, particularly in long-term care facilities, often for non-medical reasons. This over-medication by powerful drugs is very relevant to the Adult Guardianship Act. See attached a copy of a report of an All-Parliamentary Committee of the British government dated April 2008, entitled Always a Last Resort: Inquiry into the prescription of antipsychotic drugs to people with dementia living in care homes. This phenomenon is reaching epidemic proportions in the western world. There are many studies to show similar or worse results in Canada; I provide this report because it is a rare display of all-party unanimity, as well as a frank depiction of the dangers, the ubiquitousness and the urgency of the situation. Over-medication of our seniors is an epidemic, the dirty secret of our affluent drug-based health “care” systems.Many pharmaceutical drugs, not just antipsychotic or mood altering drugs, have serious debilitating side effects. Chief among them is cognitive impairment. Health care providers (including medical practitioners) rarely consider the possibility that a senior’s cognitive impairment could be caused by the pharmaceutical drugs being given to the senior. Furthermore, there is no recognition or allowance made for the fact that in many case, this cognitive impairment will improve, even disappear upon the cessation of the drug(s) being administered.The attached article appeared in mid-November as one of a series of eight articles published in the Toronto Star: The journalist, Judy Steed, undertook “a one-year project to document the most pressing policy implications of our aging society as part of the 2008 Atkinson Fellowship in Public Policy.?She has visited dozens of nursing homes and interviewed hundreds of health-care workers, policy-makers and seniors to present this weeklong portrait.”

   Her article (“Drugged out seniors: a recipe for disaster”) depicts a common scenario in long-term care facilities across Canada. I would also urge you to read the five pages of readers’ comments following the article. Although these comments are not hard data, I believe it is important to consider the actual experiences of people who have encountered egregious behaviour on the part of health care professionals in their treatment of seniors. I think you will note a pattern of disrespect shown by health care providers towards patients and families, disturbingly questionable medical practices, and a common thread of helplessness on the part of family members who seek comfort and care for their loved ones.

   It has become increasingly evident since the introduction of the current regional health care authority model in BC that health care professionals and facility staff and administrators can, and do, operate with impunity. They do so for one simple reason: there is no meaningful, effective oversight of their actions and decisions. When no one is watching, care standards are meaningless, and the situation is ripe for abuse.

5. The power of doctors in particular, and other health care professionals, is great. There is no real independent oversight of their actions and effects, save the Court. However, even that is a moot point. Quite simply, judges defer to doctors in legal matters, taking the affidavit of a doctor to be beyond reproach. That defies the laws of human nature: doctors can err, can operate with motives other than the well-being of the patient, and so on. In essence, this places the doctor above the law, beyond the reach even of judges. Who judges the doctors in the matter of asserting incapability? No one. Even the Public Guardian and Trustee, the public body who ostensibly plays a major role in overseeing the guardianship of others, routinely defers to doctors. [Making a complaint to the College of Physicians and Surgeons is something that would be done outside of the Adult Guardianship Act and is therefore not oversight per se, and the investigation of a complaint to the College would also have no bearing whatsoever on the legal result of declaring a person to be incapable. This is another very serious flaw in the law. Meaningful oversight or opportunity for independent review of doctor and health care provider “opinions” is critical, both in law and in regulations.

It is essential if we are to be a civilized society, that we ensure appropriate safeguards against the potential for error and abuse in this, the most serious of legal harm that can come to a person, that of stripping them of their personhood.

More Can Be Done to Protect Residents from Abuse

Results in Brief

Allegations of physical and sexual abuse of nursing home residents frequently are not reported promptly. Local law enforcement officials indicated that they are seldom summoned to nursing homes to immediately investigate allegations of physical or sexual abuse. Some of these officials indicated that they often receive such reports after evidence has been compromised. Although abuse allegations should be reported to state survey agencies immediately, they often are not. For example, our review of state survey agencies’ physical and sexual abuse case files indicated that about 50 percent of the notifications from nursing homes were submitted 2 or more days after the nursing homes learned of the alleged abuse. These delays compromise the quality of available evidence and hinder investigations. In addition, some residents or family members may be reluctant to report abuse for fear of retribution while others may be uncertain about where to report abuse. Although state survey agencies in the three states we visited had designated telephone numbers for reporting abuse, we found it difficult to identify these numbers in the government and consumer pages of local telephone books for some of the major and mid-size cities in these states. However, we did find a wide variety of other organizations that, by their name, appeared to be able to address abuse complaints, but, in fact, had no authority to do so. Although CMS requires nursing homes to post these numbers, it is not clear that this ensures that residents and family members have access to this information when it is needed. In recognition of the need to better inform residents and family members about abuse reporting, the agency initiated an educational campaign in 1998. The campaign included development of a new poster with removable information cards containing appropriate numbers for reporting abuse. Although a pilot test was conducted, the poster has not been approved for distribution nationwide.

Few allegations of abuse are ultimately prosecuted. The state survey agencies we visited followed different policies when determining whether to refer allegations of abuse to law enforcement. As a result, law enforcement agencies were sometimes either not apprised of incidents or received referrals only after long delays. When referrals were made, criminal investigations and, thus, prosecutions were sometimes hampered because witnesses to the alleged abuse were unable or unwilling to testify. Delays in investigations, as well as in trials, reduced the likelihood of successful prosecutions because the memory of witnesses often deteriorated.

Safeguards to protect residents from potentially abusive individuals are insufficient at both the federal and state level. There is no federal statute requiring criminal background checks of nursing home employees nor does CMS require them. Although the three states we visited required background checks to screen potential nursing home employees, they do not necessarily include all nursing home employees nor are they always completed before an individual begins working. They also focus on individuals’ criminal records within the state where they are seeking employment. Safeguards at the state level are also insufficient. While nursing homes are responsible for protecting residents from abuse, survey agencies in the states we visited rarely recommended that certain sanctions-such as civil monetary penalties or terminations from federal programs-be imposed. Twenty-six homes were cited for deficiencies related to abuse from the 158 case files we reviewed. The survey agencies recommended a civil monetary penalty for 1 home, while the remaining 25 nursing homes faced less punitive sanctions such as a requirement to develop corrective action plans. State survey agencies also play a role in preventing homes from hiring potentially abusive caregivers through the states’ nurse aide registries. These registries, among other things, identify aides that have previously abused residents. A finding of abuse should prevent a home from hiring an aide. However, delays in making these determinations can limit the usefulness of these registries as a protective safeguard. In addition, findings of abuse for several nurse aides could not be found in one state’s Web-based registry, compromising its protective value. As a result, aides who the state survey agency had already determined had abused residents could have been hired by unsuspecting nursing homes. Finally, none of the three states we visited had a safeguard in place-similar to a nurse aide registry-to professionally discipline those nursing home employees who do not need certifications or licenses to perform their duties, such as maintenance or housekeeping personnel.

Delays in Reporting Abuse Preclude Immediate Response by Law Enforcement or Survey Authorities

Most of the local police departments in the three states we visited told us that they were seldom summoned to a nursing home following an alleged instance of abuse. Several police officials indicated that, when they were called, it was sometimes after others had begun investigating, potentially hindering law enforcement’s ability to conduct a thorough investigation. Instead, state survey agencies were typically notified of allegations of abuse. However, these notifications were frequently delayed. Allegations of abuse may not be reported immediately for a variety of factors, including reluctance to report abuse on the part of residents, family members, nursing home employees, and administrators. In addition, individuals who are unaware that state survey agencies have designated special telephone numbers as complaint intake lines may have difficulty identifying these numbers in telephone directories, which could also result in delays.

Police Not Immediately Notified of Abuse or Routinely Involved in Survey Agency Investigations

Victims of crimes ordinarily call the police to report instances of physical and sexual abuse, but when the victim is a nursing home resident, the police appear to be notified infrequently. Residents and family members are not required to notify local police of abusive incidents. Several police officials told us that, like any crime, police should be summoned as soon as the incident is discovered. However, police told us that when they do learn of an allegation of abuse involving a nursing home resident, it is sometimes after another entity, such as the state survey agency, has begun to investigate, thus hampering law enforcement’s evidence collection and limiting their investigations. Most of the police departments also indicated that they did not track reports of abuse allegations involving nursing home residents and thus did not have data on the number of such reports.

When residents and family members do report allegations of abuse, they may complain directly to the nursing home administrator rather than contact police. According to one long-term care ombudsman, resident and family members do not always view the abuse as a criminal matter. Nursing homes are usually not compelled to notify local law enforcement when they learn of such reports. There is no federal requirement that they contact police, although some states-including Pennsylvania-have instituted such a requirement. According to an Illinois state survey agency official, a similar requirement will go into effect in that state in March 2002.

Our discussions with officials from 19 local law enforcement agencies indicate that police are rarely called to investigate allegations of the abuse of nursing home residents. Besides infrequent contact from residents, family members, and nursing homes, officials from 15 of the 19 police departments we visited told us that they had little or no contact with survey agencies. Officials from several of these departments reported that they were unaware of the role state survey agencies play in investigating instances of resident abuse.

Abuse Allegations Not Immediately Reported to State Survey Agencies

Our review of 158 case files-mostly from 1999 and 2000-indicated state survey agencies were often not promptly notified of abuse allegations.14 While individuals filing complaints are not compelled to report allegations within a prescribed time frame, nursing homes in the states we visited are required to notify the state survey agency of abuse allegations the day they learn of the allegation or the following day. We found that both complaints from individuals and notifications from nursing homes are frequently submitted to survey agencies days, and sometimes weeks, after the abuse has taken place.

20 of the 31 complaint cases we could assess for promptness of submission contained allegations that were reported to the state survey agency 2 days or more after the abuse took place. Further, eight were reported more than 2 weeks after the alleged abuse occurred.

There were comparable delays in facilities’ notifications of alleged abuse to the state survey agencies. The three states we visited require that nursing homes notify them of instances of alleged abuse immediately- interpreted by survey agency officials in all three of the states to mean the day the facility learns of the abuse or the next day. As table 2 shows, however, only about half of the 111 nursing home notifications we could assess for promptness were submitted within the prescribed time frame. Delays in notifying survey agencies of abuse prevent the agencies from promptly investigating and ensuring that nursing homes are taking appropriate steps to protect residents. Residents may remain vulnerable to abuse until corrective action is taken.

Untimely Reporting Attributable to Multiple Factors

Allegations of abuse of nursing home residents may not be reported promptly for a variety of reasons. For example, a recent study found that nursing home staff may be skeptical that abuse occurred.15 Residents may also be afraid to report abuse because of fear of retribution, according to another study and two long-term care ombudsmen we met with.16 According to one law enforcement official, family members are sometimes fearful that the resident will be asked to leave the home and are troubled by the prospect of finding a new place for the resident to live. In addition, nursing home staff and management do not always report abuse promptly, despite requirements to do so. According to law enforcement and state survey agency officials, staff fear losing their jobs or facing recrimination from co-workers and nursing home management. Similarly, they also said that nursing home management is sometimes reluctant to risk adverse publicity or sanctions from the state.

We saw evidence of delayed reporting by family members, staff, and management in our file reviews, as illustrated by the following examples:

¹⁵Ann W. Burgess, Elizabeth B. Dowdell, and Robert A. Prentky, “Sexual Abuse of Nursing Home Residents,” Journal of Psychosocial Nursing, 38, no. 6 (June 2000).

¹⁶Paul D. Hodges, “National Law Enforcement Programs to Prevent, Detect, Investigate, and Prosecute Elder Abuse and Neglect in Health Care Facilities,” Journal of Elder Abuse and Neglect (1998).

We saw evidence of delayed reporting by family members, staff, and management in our file reviews, as illustrated by the following examples:

• A resident reported to a licensed practical nurse that she had been raped in the nursing home. Although the nurse recorded this information in the resident’s chart, she did not notify nursing home management. She also allegedly discouraged the resident from telling anyone else. Two months later the resident was admitted to a hospital for unrelated reasons and told hospital officials that she had been raped. It was not until hospital officials notified police of the resident’s complaint that an investigation was conducted. Investigators then discovered that the resident had also informed her daughter of the incident, but the daughter, apparently not believing her mother, had dismissed it. The resident later told police that she did not report the incident to other staff at the nursing home because she did not want to cause trouble. The case was closed because the resident could not describe the alleged perpetrator. However, the nurse was counseled about the need to immediately report such incidents.
• An aide, angry with a resident for soiling his bed, threw a pitcher of cold water on him and refused to clean him. Another aide witnessed the incident. Instead of informing management, the witness confided in a third employee, who reported the incident to the nursing home administrator 5 days after the abuse took place. The abusive aide was fired, and a finding of abuse was recorded in her nurse aide registry file.
• One nursing home employee witnessed an aide slap a resident; two other employees heard the incident. The aide denied the allegation, yet the resident developed redness, swelling, and bruising around her eye. The witnesses reported the matter to nursing home management, which investigated the situation and suspended the aide the next day. The aide was subsequently fired. However, the state survey agency was not notified of the incident by the home until 11 days after the abuse took place.

During our work we discovered that nursing home residents and family members who are prepared to report abuse to the state survey agency could encounter difficulty in identifying where to report a complaint of abuse, which can further delay reporting. For example, telephone books for Chicago and Peoria, Illinois, and Athens and Augusta, Georgia, did not include complaint telephone numbers. Although telephone books in Philadelphia and Pittsburgh, Pennsylvania, contained the correct numbers for the state survey agency’s offices, they did not identify the designated complaint number, making it difficult for an individual unfamiliar with the agency to recognize its telephone number as an appropriate place to report suspected abuse.

Individuals who are not already familiar with the state survey agency’s role and its complaint telephone line may encounter a confusing array of numbers both public and private in their local telephone directory. In the three states we visited we reviewed the government and consumer pages in nine telephone books and identified a wide variety of organizations, which, by their names, appeared capable of addressing complaints. However, many did not have the authority to do so. In this review, we identified 42 entities that appeared to be organizations where abuse could be reported and were not affiliated with the state survey agencies. Only six of these entities represented organizations-such as long-term care ombudsmen-that are capable of pursuing abuse allegations. The remaining 36 entities either could not be reached or could not accept complaints, despite having listings such as the “Senior Helpline.” Sometimes these entities attempted to refer us to a more appropriate organization, but with mixed success. For example, our calls in Georgia resulted in four correct referrals to the state survey agency’s designated complaint telephone line but also led to five incorrect referrals. Five other Georgia entities offered us no referrals.

To facilitate reporting, nursing homes are required to post the telephone numbers of complaint lines in a prominent location within the facility. State survey agencies are expected to verify that these numbers are properly displayed when they conduct their annual inspections and have the option of citing homes with deficiencies if they fail to do so. However, deficiency data compiled by CMS do not specifically identify the number of homes cited for failure to display these numbers, and so it is not readily apparent how often nursing homes do not comply with this specific requirement.

Despite its requirement that nursing homes post the complaint telephone numbers, CMS recognized that a greater awareness of how to report abuse was warranted and so, in 1998, it initiated an educational campaign regarding abuse prevention and detection in nursing homes. Because publicizing the appropriate telephone numbers for reporting abuse is critical, a key component of the campaign was the development of a poster to be used by nursing homes nationwide. According to a CMS official, the poster will identify several options for reporting abuse, including notifying nursing home management, local law enforcement, complaint telephone numbers, and CMS.17 In addition to displaying these numbers, the posters will feature removable cards-which individuals may retain-listing the organizations and telephone numbers contained on the poster. A pilot test of the poster was conducted in 1999. Based on feedback received from the pilot test, the poster was revised, but it has not been approved for distribution.

Abusive Nursing Home Staff Difficult to Prosecute

Relatively few prosecutions result from allegations of physical and sexual abuse of nursing home residents. We identified two impediments to the successful prosecution of employees who abuse nursing home residents. First, allegations of abuse were not always referred to local law enforcement or MFCUs. When referrals were made it was often days or weeks after the incident occurred, compromising the integrity of what limited evidence might have still been available. Second, a lack of witnesses to instances of abuse made prosecutions difficult and convictions unlikely.

Lack of Witnesses Reduce Likelihood of Successful Prosecutions

The lack of compelling evidence often precludes prosecution of those who have abused nursing home residents. MFCU and local law enforcement officials indicated that nursing home residents are often unwilling or unable to provide testimony. The state survey agency and law enforcement officials we spoke to agreed with this determination. Our file reviews confirmed that residents were reluctant or unable to provide evidence against an accused abuser in 32 of the 158 cases we reviewed, thus making it difficult to pursue a criminal investigation. Our work also indicated that resident testimony could be limited by mental impairments or an inability to communicate. We noted several instances in which residents sustained unexplained black eyes, lacerations, and fractures. However, despite the existence of serious injuries, investigators could neither rule out accidental injuries nor identify a perpetrator.

Prosecutions of individuals accused of abusing nursing home residents are often weakened by the time lapse between the incident and the trial. Law enforcement officials and prosecutors told us that the amount of time that elapses between an incident and a trial could ruin an otherwise successful case because witnesses do not always remember important details about the incident. Although it is not uncommon for the memories of witnesses in criminal cases to fade, impaired recall is even more prevalent among nursing home residents. Our review showed that nursing home residents may become incapable of testifying months after they were abused. For example, in one case, a victim’s roommate witnessed the abuse and positively identified the abuser during the investigation. However, by the time of the trial-nearly 5 months later-she could no longer identify the suspect in the courtroom, prompting the judge to dismiss the charges. Moreover, given the age and medical condition of many nursing home residents, many might not survive long enough to participate in a trial. One recent study of 20 sexually abused nursing home residents revealed that 11 died within 1 year of the abuse.20 Law enforcement officials told us that, without testimony from either a victim or a witness, conviction is unlikely.

Measures to Safeguard Residents from Abusive Employees Are Ineffective

The safeguards available to states do not sufficiently protect residents from abusive employees. CMS’s requirements preclude facilities from employing an individual convicted of abusing nursing home residents but permit the hiring of those convicted of other abusive acts, such as child abuse. Although some states have established more stringent requirements, criminal background checks typically do not identify individuals who have committed a crime in another state. Nursing homes can be cited for deficiencies if they fail to adequately protect residents from abuse, but these deficiencies rarely result in the imposition of sanctions, such as civil monetary penalties, by state survey agencies. State survey agencies, which also oversee the operation of state nurse aide registries, do not adequately ensure that residents will be protected from aides who previously abused residents. Finally, states are unable to take professional disciplinary actions against other employees, such as security guards or housekeeping staff, who may have abused residents but who are neither licensed nor certified to care for residents.

Employment Requirements and Background Checks Do Not Ensure Resident Protection

While nursing homes are required to establish policies that prevent the hiring of individuals who have been convicted of abusing nursing home residents, this requirement does not include offenses committed against individuals outside the nursing home setting, nor does it specify that states conduct background checks on all prospective employees. This requirement does not preclude individuals with similar convictions-such as assault, battery, and child abuse-from obtaining nursing home employment.

The three states we visited all apply a broader list of offenses that prohibit employment in a nursing home. Each state’s prohibition of employees includes those convicted of offenses such as kidnapping, murder, assault, battery, or forgery and is not limited to offenses against nursing home residents. However, the three states vary in their application of these prohibitions. For example, Illinois’s prohibition does not apply to employees who are not directly involved in providing care to residents and allows nurse aides who have been convicted of such offenses to apply for a waiver. Waivers may be granted if there are mitigating circumstances and allow these aides to work in nursing homes. Pennsylvania’s prohibition applies to all nursing home employees, not just those involved in patient care. Georgia’s prohibition, enacted in 2001, also applies to all nursing home employees, but only if they were convicted of abuse-related crimes within the preceding 10 years.

Criminal background checks do not adequately protect residents, in part, because, as in Illinois, they may not apply to all nursing home employees.21 More importantly, the background checks that are performed by state and local law enforcement officials in the three states we visited are typically only statewide. Consequently, individuals who have committed disqualifying crimes in one state may be able to obtain employment at a nursing home in another state.

Nationwide background checks on prospective nursing home employees can be performed by the Federal Bureau of Investigation (FBI) if nursing homes request them. These checks could identify offenses committed elsewhere, but not all states take advantage of this option. According to an FBI official, 21 states have requirements that subject some health care employees to these checks, but state requirements vary and do not always apply to prospective nursing home employees. This official told us that most of the requests the FBI receives on health care personnel are from these 21 states. He told us that, of the remaining states, only nursing homes in North Carolina and Ohio request such background checks regularly.22 Of the three states we visited, only Pennsylvania submits background check requests to the FBI. However, these are limited to those individuals who have lived outside the state during the 2 years prior to applying for nursing home employment.

Two of the states we visited allow employees to report for duty before background checks are completed. Pennsylvania23 and Illinois permit new employees to report to work before criminal background checks are completed, for up to 30 days and 3 months, respectively. However, Georgia survey agency officials told us that nursing homes could be cited with a deficiency if new employees assume their duties before the nursing home receives the results of the background checks. Georgia requires that these checks be completed within 3 days of the request.

CMS does not require that the results of criminal background checks be included in nurse aide registries. Of the three states we visited, only Illinois requires that the results be reported to the state survey agency by the nursing home.24 If the check reveals a disqualifying criminal history, it will be included in the Illinois registry. Therefore Illinois nursing homes are able to identify some aides with disqualifying convictions before offers of employment are made and criminal background checks are initiated. Officials in Georgia and Pennsylvania explained that they verify the completion of background checks for new employees, including nurse aides, as they conduct their periodic nursing home surveys. As a result, they told us that they do not believe that the results of these checks need to be added to their registries.

Nursing Homes Rarely Sanctioned for Improperly Responding to Abuse

For the states that we reviewed, sanctions were rarely imposed against nursing homes for deficiencies associated with their handling of instances of abuse. Deficiencies considered the most severe-those resulting in actual harm or immediate jeopardy to resident health or safety-could result in an immediate sanction, such as a civil monetary penalty. Deficiencies not resulting in actual harm or immediate jeopardy usually resulted in nursing homes being required to submit a plan of corrective action. Nursing homes that submit corrective action plans may also face other sanctions.

The Georgia, Illinois, and Pennsylvania survey agencies eventually cited 26 nursing homes-from the 158 cases we reviewed-for abuse-related deficiencies such as failing to report allegations of abuse in a timely manner or failing to properly investigate them, as well as inadequately screening employees for criminal backgrounds. The state survey agencies rarely recommended to CMS that civil monetary penalties be imposed against nursing homes for abuse-related deficiencies, primarily because most of the deficiencies cited for these 26 nursing homes were not categorized as placing residents’ health or safety in immediate jeopardy or resulting in actual harm to residents. Only 1 of these 26 facilities-in Illinois-was assessed a civil monetary penalty. However, the penalty was reduced on appeal. State survey agencies did not recommend other sanctions on the 25 remaining nursing homes.

Nursing Home Employees May Not Be Disciplined

Although nurse aides compose the largest proportion of nursing home employees, other employees, such as laundry aides, security guards, and maintenance workers have also been alleged to have abused residents. While survey agencies can prevent abusive aides from working in nursing homes and can refer licensed personnel, such as nurses and therapists, to state licensing boards for disciplinary action, they have no similar recourse against other abusive employees, who may continue to work in nursing homes. Survey agencies can, however, cite facilities for deficiencies if appropriate actions-such as reporting and investigating the allegations-are not taken.

Of the 158 cases of alleged physical and sexual abuse that we reviewed, 10 suspected perpetrators were employees who were not subject to licensing or certification requirements. None of the facilities in these cases were cited for deficiencies. Although there is no administrative process to enable the state to take actions against such employees, these employees could be criminally prosecuted. Of these 10 cases, 4 involved allegations that proved unfounded or for which evidence was inconsistent. One of the 10 employees ultimately pled guilty in court. Three others were investigated by law enforcement but were not prosecuted.29 The remaining 2 employees were terminated by their nursing homes but were not the subject of criminal investigations.30

Conclusions

Nursing homes are entrusted with the well-being and safety of their residents yet considerable attention has recently been focused on the inadequacies of care provided to many nursing home residents. Along with receiving quality care, residents are entitled to be protected from those who would harm them. Residents who are abused need to be assured that their allegations will be immediately referred to the proper authorities and investigated expeditiously. In addition, law enforcement authorities need to ensure that abusive individuals are prosecuted when appropriate, and survey agencies should recommend to CMS that available administrative sanctions be imposed against known abusers.

Our work shows that nursing home residents need both stronger and more immediate protections. Law enforcement agencies, such as state MFCUs or local police departments, are not involved as often or as soon as they should be, especially when there are indications of potential criminal activity. Additionally, determining where to report complaints of alleged abuse can be confusing. Prompt reporting is especially crucial given the often-limited evidence available.

CMS is taking important steps that may better protect residents. For example, its feasibility study on the development of a national abuse registry could lead to enhanced resident safety. However, other efforts have fallen short. For example, an important tool could be the agency’s educational campaign using a new poster in nursing homes nationwide to better inform residents and family members about how to report abuse. However, the poster has been under development for more than 3 years.

More should be done to protect nursing home residents. CMS’s requirement that nursing homes not employ individuals convicted of abusing residents does not sufficiently prevent the hiring of potentially abusive individuals. Those who have committed similar offenses, such as child abuse, are eligible to work in nursing homes unless states impose a more stringent requirement. While CMS does not require criminal background checks, some states have instituted them. However, they may not be required for all prospective employees and may not identify offenses committed in other states. In addition, CMS’s definition of abuse is not sufficiently detailed to ensure that all states report every incident that CMS would consider abusive. Affording due process to nurse aides who have allegedly abused residents is important and necessary. However, determinations that nurse aides have been abusive can be time-consuming, leaving residents at risk if these aides continue to work in nursing homes. Finally, nurse aide registries may have incorrect information, allowing nursing homes to hire aides previously found abusive.

Target: Our State and National Legislators and Obama Administration
Sponsored by: Elder Abuse Victims Advocates – Houston, Texas

We are calling for national efforts to confront the abuse and financial exploitation of our elderly and vulnerable citizens and for real change to end the abuse and address problems in adult guardianships.

Elder abuse is on the rise and the guardianship systems in our state courts and protective agencies intended to protect the vulnerable, all too often, fail to do so. cases can ultimately cost a vulnerable person, and their family, tens, if not hundreds, of thousands of dollars.

The opportunity to get rich quick is tempting for perpetrators who know how to play the game. Professionals and court petitioners who abuse the system give a bad name to those who are trying to do the right thing.

Strangers are often appointed to take over the person’s life and family members, who end up separated from their own loved ones, dare not speak out for fear of losing the right to even visit them at a time when they are most vulnerable.

In the meantime these dear citizens can lose all of their civil rights and could end up with fewer rights than a prisoner on death row. There is simply no excuse for the enormous cost and abuse that can be doled out (by perpetrators that include unethical attorneys, unprofessional guardians and uncaring judges in this dysfunctional system in our courts) to family members who truly care and are desperately trying to help someone dear to them who is in need.

We need a Family Member’s Bill of Rights so we can have a voice to help our loved ones when they get old and vulnerable! We need national oversight, legislation and checks and balances that work! We need nation reform that ensures justice and reduces the cost of giving a helping hand!

We need change and together we can make it happen! Yes we can! Please sign our petition for change!

“It was once said that the moral test of government is how that government treats those who are in the dawn of life, the children; those who are in the twilight of life, the elderly; and those who are in the shadows of life, the sick, the needy and the handicapped.”Hubert H. Humphrey

Contact us at stopguardianshipabuse@gmail.com if you are willing to join our cause or to leave feedback on what you think can be done to help advocate the changes we need to fix this terrible problem.

Send a letter to your representatives at: www.change.org/actions/view/stop_elder_abuse_guardianship_system_abuse_-_petition_to_our_leaders

Due to complaints that this site in not properly allowing signatures, here is an Alternate Petition Site if your signature does not show up below: www.ipetitions.com/petition/STOPELDERABUSE