Caregivers Increasingly Targeted in AD Drug Trials, Marketing

by Matt Mahady

In recent marketing efforts--particularly for drugs to treat Alzheimer's disease--the pharmaceutical industry has focused special attention on caregivers. Companies such as Janssen, Novartis, and Pfizer are stating that acetylcholinesterase inhibitors, currently used to mitigate the progression of mild-to-moderate AD symptoms, may also decrease caregiver burden. Clinical trials of agents such as donepezil, rivastigmine, and galantamine are beginning to include caregiver burden-related endpoints.^1-3

Although the focus of this article is on drugs for Alzheimer's disease, it is relevant to note that caregiver-burden reduction is also an advertised feature of several treatments for cancer, Parkinson's disease, and schizophrenia.

Regardless of disease state, is it valid to tout the impact of a drug upon a person who is not even undergoing therapy? Or, is all the noise concerning caregiver burden little more than a marketing technique?

Data Support Claims

Recent studies seem to lend support to pharmaceutical company claims that appropriate drug therapy may exert a positive effect on caregiver burden. These include:

• A study that linked the functional and cognitive benefits of galantamine with beneficial effects on caregiver burden. The researchers found that, compared with placebo, galantamine reduced the time that caregivers needed to spend supervising and assisting patients with routine daily activities by up to 61 minutes per day.¹
• A self-administered, nationwide survey of AD caregivers, conducted by the Institute for the Study of Aging, that compared caregivers of patients treated with donepezil to caregivers of patients not treated with donepezil. Caregivers of donepezil-treated patients reported significantly lower "difficulty of caregiving" scores.²
• A randomized trial evaluating rivastigmine that demonstrated a beneficial effect on caregiver burden.³

Denis J. Keohone, MD, Medical Director of Pfizer's Alzheimer's Disease Management Team in New York City, said in an interview that "Alzheimer's disease therapies can absolutely be said to have a positive impact on caregiver burden. Clinical trials have demonstrated that [drug therapy] can increase the time that caregivers have to take care of themselves and take a break. Time saved represents an alleviation of part of their daily workload."

Dr. Keohone added that other soon-to-be released, Pfizer-funded studies will provide more evidence linking the alleviation of caregiver burden with decreased rates of institutionalization (Note: Other companies that produce Alzheimer's drugs, as well as the trade association, PhRMA, were contacted but declined to comment for this article).

High Costs of Caregiving

Caring Editorial Board member Eric Tangalos, MD, CMD, Professor of Medicine and Chair of the Division of Community Internal Medicine at Mayo Clinic in Rochester, MN, noted in the January issue of Caring that caregiving families are "the invisible long-term care system," providing $196 billion of unpaid care per year.⁴ In addition, at least one-third all caregiver expenditures are AD related.

Alzheimer's Association numbers place the average lifetime cost of caring for an AD patient at approximately $174,000. A recent Alzheimer's Association report stated that, on an annual basis, caregiver burden accounts for $36.5 billion in lost productivity, absenteeism, and replacement costs (see www.alz.org).

The financial toll of is only one component of caregiving's cost. Patients with AD require substantial investments of caregiver time,⁵ make more physician visits, use more prescription drugs and are two to three times more likely to report symptoms of depression than the general population.⁶

Cautious Optimism

Gary J. Kennedy, MD, President of the American Association of Geriatric Psychiatrists in Bethesda, MD, observed that "drug therapy can be effectively employed to alleviate caregiver burden," adding that caregivers often act as catalysts to initiate drug therapy. "More often than not, it is the family who is requesting help because the AD patient simply does not have the insight to detect the fact that he or she could benefit from therapy."

The benefits of therapy need not be substantial for detectable relief of caregiver burden to take place, Dr. Kennedy noted. "Even the subtle effects of acetylcholinesterase inhibitor therapy may be beneficial. Even if the only thing that happens after the patient takes the medication is that the patient is more alert, that small gain is a serious plus for the family. The patient is more engaged. If the patient resides in a long-term care facility, he or she will likely get better care due to the fact the patient's enhanced alertness is likely to garner the attention of staff members.

"There are those who argue that the effects of acetylcholinesterase inhibitors are so minimal and insubstantial that, as a class, they are not worth prescribing. I don't think the data support that," Dr. Kennedy continued. "There are ample data that show that caregivers [of treated patients] are spending less time supervising patients. When caregivers don't have to spend so much time supervising, they have more time for companionship." In addition, said Dr. Kennedy, "certain people lack enthusiasm for AD medication [because] the patient does not get better. However, the patient does not get any worse either. Not getting worse is a win. Stabilization of symptoms is a win."

He cautioned against unrealistic expectations on the part of caregivers, however. Acetylcholinesterase inhibitors may, in some instances, be able to temporarily slow the progression of AD. But there is no evidence that the drugs alter the course of the underlying dementia process. "One danger would be to oversell these medications. The benefits are modest at best. If the caregiver thinks the problem behaviors will go away because the patient is taking an acetylcholinesterase inhibitor, they will be disappointed. The patient will be more tolerable but behavioral problems will not completely disappear."

Other experts also reacted with cautious optimism when queried about the relationship of patient therapy to caregiver relief. Bonnie Lawrence, Communications Manager of the Family Caregiver Alliance in San Francisco, noted that "any therapy that is likely to help the patient is likely to help the caregiver. That statement holds true not just in the case of AD therapy, but for any therapy for any serious, chronic disease that requires the constant presence of a caregiver."

The utility of acetylcholinesterase inhibitors is limited to instances in which the disease is diagnosed and treated relatively early, Ms. Lawrence continued. Thus, patients with advanced, severe AD are not likely to benefit from pharmacologic therapy. Family members of long-term care residents with AD should explore all options, she said, but should maintain a realistic outlook about the limits of therapy.

More Data Needed

Jennie Ward-Robinson, PhD, Director of Medical and Scientific Affairs at the Alzheimer's Association in Chicago, expressed a wait-and-see attitude, noting that the jury is still out on the impact of drug therapy on caregivers. "There are several camps and several opinions that I have heard concerning this issue. It depends on who you ask. The pharmaceutical industry says yes. Many respected physicians are saying yes. We're certainly hearing a great deal of anecdotal evidence from families that patients became more manageable once they were diagnosed with AD and treated." Nevertheless, much more study is needed before a definitive conclusion can be reached.

"We do not have a lot of literature that evaluates caregiver response to patients on therapy. In fact, we are still trying to quantify what caregiver burden is. The Alzheimer's Association is currently working with social and behavioral scientists to define caregiver burden and objectify factors associated with it. Hopefully, this will lead to constructs that will enable us to effectively measure specific aspects of caregiver burden."

What is clear, however, is that "informal caregiving over the course of [the disease] leaves a lot of families bankrupt, emotionally, physically, psychologically, and financially. At this point, institutionalization may be necessary," Dr. Robinson continued. "There is no clear-cut rule. It depends on caregiver capacity and capability to meet patient demands. Institutionalization usually occurs in late stage AD, but can easily happen earlier if the patient is aggressive and uncontrollable."

As AD incidence swells, resources of the long-term care industry will likely be stretched thin unless the value of informal caregiving is leveraged in an efficient manner, the experts agreed. Appropriate pharmaceutical and non-drug therapies (see box above) may help to maximize the utility and capacity of AD caregivers, and thereby reduce some of the strain on long-term care facilities.

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