Cash-strapped hospitals laying off record number of workers

Employed physicians could see job losses or salary cuts if the recession continues.

By Karen Caffarini, AMNews staff. Posted Jan. 26, 2009.

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Increasing numbers of hospitals nationwide are instituting mass layoffs as they try to stay solvent in what some administrators and consultants have called the most challenging time for the industry in at least 40 years.

Some smaller hospitals have even laid off employed doctors or slashed physician pay, and consultants warn that as the economy gets worse, more hospitals will likely follow.

The U.S. Dept. of Labor's Bureau of Labor Statistics reported that as of Nov. 30, 2008, 107 hospitals had reported mass layoffs, defined as 50 or more unemployment claims filed against one company at one time. That was the highest yearly number since the bureau began keeping these statistics in 1995, surpassing the previous high of 100 mass layoffs during 2003.

There were at least 10 incidents of mass layoffs every month for six months from June 2008 through November 2008. No previously recorded year had more than two straight months with 10 or more layoffs.

These statistics don't include incidents of layoffs of fewer than 50 people at a time. The American Hospital Assn. has no data on that, but a survey it conducted in October 2008 found that 53% of the 736 hospitals responding were considering staff cutbacks due to financial stress.

Hospital administrators say a combination of factors resulting from the recession have caused an economic meltdown unlike any they've seen.

Layoffs throughout the overall business community have swelled the number of uninsured patients at the same time that cash-strapped states have slashed Medicare and Medicaid reimbursements. A bear market has resulted in investment losses straining hospital endowments and reserves. Donations are down. And skittish banks have made it more difficult or more expensive to borrow or have frozen credit altogether.

Senate passes children's health bill

Bill calls for tax hike on tobacco products to generate $32 billion

WASHINGTON - Senate Democrats moved one step closer to handing President Barack Obama an early health care victory Thursday, passing a bill extending government-sponsored health insurance coverage to about 4 million uninsured children.

The bill, which was approved 66-32, authorizes an additional $32.8 billion over the next 4 1/2 years for the State Children's Health Insurance Program. The House plans to take up the same measure next week.

Even with the added spending, an estimated 5 million children still would be without health insurance. During his election campaign, Obama called for requiring all children to have health coverage.

"When President Obama signs this bill, the real victory will belong not to politicians, but to kids," said Sen. Max Baucus, D-Mont.

The bill pays for expanding SCHIP by increasing the federal excise tax on cigarettes from 39 cents to $1 a pack. Opponents argued that the tax would hit the poor the hardest.

The Democratic majority turned back Republican amendments to limit expansion of the program. Among the failed amendments were a prohibition on using federal money to cover children of newly arrived legal immigrants and a stricter income limit in some states for participating families.

Current law requires a five-year waiting period before legal immigrants become eligible for coverage under Medicaid and SCHIP. Democrats said that removing the ban would help children before small health problems became big ones.

"It is likely many of these children are already U.S. citizens and many will become U.S citizens, and their being unhealthy doesn't make sense for that family, and it certainly does not make sense for our nation." said Sen. Richard Durbin, D-Ill.

Support for expanding SCHIP has had bipartisan backing. In 2007, former President George W. Bush twice vetoed bills to expand the program. The Senate voted to override Bush, but the House fell about 15 votes short of an override.

Backing SCHIP
Scores of interest groups have lined up in support of more money for SCHIP, including trade groups representing insurers, hospitals, doctors, unions and the pharmaceutical industry.

Some Republican senators complained that Democrats had worked closely with many of them on SCHIP in the past but had ignored them this year when crafting the bill.

"I think we could have had 95 votes," said Sen. Orrin Hatch, R-Utah. "That would have sent a tremendous, tremendous message that hasn't been sent around here for a long time.

Nine Republicans joined 57 Democrats in voting for the bill. No Democrat voted against it.

More than 7 million children were enrolled in SCHIP at some point in 2008. The program was created more than a decade ago as a way to provide health care to children in families with incomes too high to quality for Medicaid but too low to afford private coverage. Federal funding for SCHIP is set to expire March 31 unless Congress acts.

The House already has approved a bill to expand SCHIP. It's comparable to the Senate bill, except it included a provision opposed by physicians and supported by the influential American Hospital Association. That provision would have prevented new physician-owned hospitals from opening, but it's not part of the Senate bill.

The House will vote on the Senate bill and then send it on to the president for his signature.

Republicans said they are fearful that Democrats are using SCHIP to increase the government's role in providing health care. They said about 2.4 million children who otherwise could get private insurance will get government-sponsored coverage instead.

Democrats responded to those concerns by requiring any state covering families earning more than three times the federal poverty level, or $66,150 for a family of four, to be paid at Medicaid levels rather than the higher SCHIP level.

But the bill allowed an exception for New Jersey and New York. Lawmakers said a family of four in New York could potentially qualify for SCHIP even if the family's income came to about $88,000.

"These are certainly not low-income families," said Sen. Jim Bunning, R-Ky., who unsuccessfully tried to remove the exemption for the two states.

United agrees to pay $350 million, scrap system that undercut fees

The insurer pledged to spend another $50 million to help establish an independent database of prevailing payment rates that would be governed by a nonprofit.

By Emily Berry, AMNews staff. Posted Jan. 26, 2009.

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The way physicians are paid for out-of-network care has the potential to change in their favor thanks to two settlements reached with UnitedHealth Group, which has for the last decade held the master key to the industry's "usual, customary and reasonable" pay rates.

An agreement with New York State Attorney General Andrew Cuomo, announced Jan. 13, requires United to scrap two databases sold by wholly owned subsidiary Ingenix and used by most major insurers to determine the so-called UCR, which is used to determine payment for most out-of-network services.

Cuomo said United and other insurance companies were systematically lowballing the UCR rates and, in the process, shortchanging patients and physicians.

Two days after the deal with Cuomo, United settled a class-action federal lawsuit, filed in 2000 by the Litigation Center of the American Medical Association and State Medical Societies, the Medical Society of the State of New York and the Missouri State Medical Assn., for $350 million. The settlement is to be paid to physicians and patients affected by the out-of-network payment system.

As part of both deals, United pledged to spend $50 million to help establish a new independent database governed by a nonprofit.

Insurers using a flawed database underpaid some New York doctors as much as 28%.

AMA President Nancy H. Nielsen, MD, PhD, an internist from Buffalo, N.Y., said the artificially low UCR figures given to patients meant that they would assume that their physician overcharged them, creating a rift between patient and doctor.

"Now the data will be reliable, people will know what they're getting, and that wedge driven between patient and doctor will go away," she said at a news conference announcing the United settlements in New York.

The new database is meant to be used industrywide and will be open to the public on a Web site so that patients and doctors easily can see the prevailing payment for a given service in their area.

Having a publicly available database of typical charges is a particularly significant development for both physicians and patients, said Steve Clark, president of Clark Benefits Consulting, based in Racine, Wis.

With the creation of the new database and public Web site, he said, "we will take an enormous step toward pricing transparency and consumerism in health care."

Meanwhile, other experts said the deal could give physicians more negotiating power. Health plans had used UCR as a means to ensure that physicians who left their networks could not benefit as well financially from doing so, thus in theory giving doctors less incentive to make such a change.

How rates stayed secret

According to Cuomo's investigation, United and the other insurers fed skewed data into Ingenix's Prevailing Healthcare Charges System and Medical Data Research databases. Then the same insurers paid for access to the information, which was labeled as "independently researched" and "proprietary" research.

Cuomo said the PHCS database was the result of a "closed loop," tainted by a clear conflict of interest. He said United had an incentive to report lower payments and edit out high ones to lower the resulting UCR payment rate health plans would pay out-of-network doctors.

In the course of reviewing more than 1 million bills and the Ingenix databases, Cuomo's office determined that some physicians in New York were underpaid by as much as 28%.

By underpaying for out-of-network services for the last decade, the insurance companies cheated thousands of their members and physicians out of hundreds of millions of dollars, Cuomo said.

When insurers paid less than fair compensation for services, patients were left to pay the remainder -- even though they had paid extra to the insurance company for access to out-of-network doctors.

In many cases, doctors never collected the difference between their bills and the artificially low out-of-network payments, either because they wrote it off or because the patient couldn't afford to pay the unexpectedly high out-of-pocket amount.

United wasn't the only company involved, even though its subsidiary was the central database.

Cuomo said his office intended to pursue agreements from other insurers to use the new database when the Ingenix one is eliminated.

"We're starting with United because they own Ingenix," he said. "Once you change Ingenix, you will change the entire system."

Days after the United settlement, Aetna agreed to stop using Ingenix databases and to contribute $20 million to the nonprofit that will hold the independent data.

United did not officially admit to any wrongdoing at the Jan. 13 news conference. But Mitch Zamoff, general counsel for United Healthcare, said, "We regret that conflicts of interest were inherent in these Ingenix database products."

What's next

The new database has funding commitments of at least $70 million for the next five years. Officially, at press time, its home was undetermined but looked likely to be Syracuse University, mentioned specifically in the litigation settlement with the AMA, or another New York university. Syracuse officials said they would be honored to host the database but could not comment about the situation.

Wherever the information is housed, United and Aetna also have agreed to share claims and billing data to serve as a basis for the new database.

United and Aetna are barred for at least five years from developing any competing database. Ingenix may remain as a company. United spokesman Tyler Mason said the two databases were responsible for less than 2% of Ingenix's revenue. The company also houses consulting and research divisions.

As for the lawsuit settlement, before any physician gets a check in the mail from United, a judge must give the final OK for the AMA litigation settlement, and that could take a few months. Any class member who wishes to opt out also will have a chance to do so.

The AMA is preparing resources for physicians seeking their shares of the settlement.

In addition to translating into some compensation for physicians who were hurt financially by the faulty out-of-network pay rate system, the United settlements signal a change to the health care system as a whole, said Michael Rosenberg, MD, a plastic surgeon from Mount Kisco, N.Y. He also is president of the Medical Society of the State of New York.

In particular, he said, the new Web site with accurate information will shift the balance of power between health plans and doctors during negotiations. "There's certainly a sense of satisfaction in them no longer being able to do the wrong thing and that they'll have to make recompense, but more importantly there's now going to be transparency," Dr. Rosenberg said.

The print version of this content appeared in the Feb. 2, 2009 issue of American Medical News.

How the United settlements might affect your practice

Many of the details are still pending, but the UnitedHealth Group settlements following an investigation by New York Attorney General Andrew Cuomo over how it set rates for out-of-network care, as well as for an 8-year-old lawsuit on the same subject filed by the AMA and others, could mean better payment for doctors.

Margaret Lewin, MD, a primary care physician who works in Manhattan, stopped contracting with health plans in the late 1990s. Her patients, who pay more for policies that allow out-of-network care, have been dependent on their insurance companies to determine what was "reasonable" to pay. Now an independent database will set that figure.

"There's no question my patients will be more comfortable going out-of-network," she said.

Perhaps more important, Dr. Lewin said, a proposed Web site that makes transparent the independently determined prevailing charge will help her determine a fair fee and tell patients what they can expect to pay out-of-pocket.

Michael Rosenberg, MD, a plastic surgeon and president of the Medical Society of the State of New York, said he expects in-network doctors also to benefit from the new Web site with the database of prevailing charges.

"How can [they] not?" he said. "If two sides are negotiating and one side has control over a particular piece of data and refuses to reveal it, how can you negotiate fairly? Whereas now, everyone will have the same information."

Like Dr. Lewin, Seymour Cohen, MD, an oncologist who also works in Manhattan, does not contract with health insurance companies. He was more skeptical about the agreement forcing insurance companies to change their ways.

"They will find another way around this very quickly," he said. "They didn't even have to admit guilt."

RELATED CONTENT  You may also be interested in:
Court OKs Health Net deal over out-of-network pay  Sept. 22/29, 2008
Insurers reach accord on P4P principles; standards still to be worked out  April 21, 2008
Subpoenas issued to insurers in New York rate-setting probe  March 24/31, 2008
New York takes on United over tactics as industry arbiter of physician pay  March 3, 2008

The “Army of Lost Souls”

The VA works with federal, state, and community agencies to ameliorate the homeless veteran problem and some of its causes.

David A. Iverson, MD, Marilyn Cornell, MS, MSW, and Paul Smits, MSW

Editor's note:
Homelessness and untreated health problems among U.S. veterans cause much public unease and, frankly, some embarrassment. Why can't society take proper care of those who risked their lives in our name? Virtual Mentor asked three authors who work with Veterans Administration programs and homeless veterans to explore that question.

Our Duty to Homeless Veterans

David A. Iverson, MD

My pager went off at one o'clock in the morning. I called the number—a group home—and the manager declared urgently, but simply, “They shot Jack. Can you come?” By the time I arrived, the coroner had left with the body. Jack was a homeless veteran with serious mental illness and alcoholism. On this cold night, he had been drunk, and, when told that he'd have to leave the shelter, he had no intention of complying. After Jack brandished a knife the manager judiciously backed away. Thinking the dispute was settled, Jack climbed into one of the beds, not knowing that 9-1-1 had been dialed. When a police officer entered Jack's room, Jack charged him, knife in hand. The officer didn't hesitate; he fired six bullets into Jack's chest, killing him.

Learning Objective Understand the scope of the homeless veteran problem, some of its causes, and how the VA works with federal, state, and community agencies to ameliorate it.

Miraculously, only a few of the other residents were awakened. One was Jack's roommate, also a homeless veteran, who, pressed into the corner of the room, watched the bullets fly by. Still shaking, he said, “There was no way Jack was going out into that cold. Not again. Not tonight. He went out like a soldier.”

We had a decision to make before morning: call a hazmat team to clean up the blood (this would cost thousands), or clean it up ourselves. Having worked with Jack for years, it seemed important that we do it, perhaps as a way of honoring him. At 4 a.m., with bleach in hand, I opened the window, turned Jack's bedside radio on low, and in the cool, quiet morning cleaned up his blood and gathered his few personal belongings for his family.

The work I did with Jack did not occur within the Veterans Administration (VA) but at a local homeless clinic. Tragedies like this one, despite the challenge of enduring them, bind us to our homeless patients and their plight, which continuously recommits us to the work. Not coincidentally, I work for the VA now, and do so with pride.

The public is turning its attention to homeless veterans, partly in response to the Iraq War. Our country makes a promise to those who serve in our Armed Services—a promise derived from the words of Abraham Lincoln's second inaugural address, “To care for him who shall have borne the battle, and for his widow, and his orphan.” Soldiers are the only group of citizens in our society to whom we promise health care for a lifetime. While we simultaneously fight two wars, the public is justified in wanting to know why a vet with serious mental illness must seek shelter in a group home or why a homeless man on a street corner holds a sign reading, “Homeless Vet—Please Help.”

The statistics are impressive and sobering. Veterans are over-represented among the homeless, at approximately one in four, whereas one in 11 Americans is a veteran [1]. The reasons are not yet clear, but that doesn't stop us from asking, “What is the VA doing about it?” For starters, the VA operates the largest health care system in the world, serving a sizable segment of our population. Of the nation's 26 million veterans, nearly three-quarters served during a war or official period of conflict. Approximately one-quarter of the country's population is eligible for VA benefits and services because they are veterans, veterans' family members, or survivors of a deceased veteran.

The VA operates 1,400 sites of care, including 155 medical centers, and VA services designed specifically for homeless veterans are growing. The Healthcare for Homeless Veterans program helps veterans get off the streets and provides them support services. Compensated work therapy supplies structured, supervised work. Assertive community treatment, peer assistance, and an array of substance-abuse services—outpatient to residential—are also available through a nationwide network of programs. The VA operates numerous “domiciliaries” that offer longer-term housing and skills training to help formerly homeless veterans make a successful transition to independent living. The overall success of the VA's national network of care is outlined in Best Care Anywhere [2].

But the VA also represents arguably the second largest bureaucracy in the world (the Department of Defense being first). And, despite the fact that bureaucracies are designed to handle large numbers of people fairly, they are not known for being flexible or maneuverable, which can hamper efforts to meet homeless people where they are. Individuals sometimes become lost in the bureaucracy and do not receive the care intended for them. By way of emphasizing challenges such as this, consider these numbers: in Colorado we manage more than 400 vouchers that secure shelter, protection, and nightly services to homeless veterans—a commendable accomplishment. But the vouchers serve a fraction of the estimated 2,500 homeless veterans in our state. As VA physicians and staff, we want to be able to do much, much more.

Any physician who has cared for homeless people knows that their difficulties are often complicated and entrenched. It is important to recognize that homelessness is really only a partial descriptor—such a person is often jobless, undereducated, without family support, poor, and alone. Indigence—meaning the lack of health insurance—is a problem for the field of medicine to address; homelessness itself is a problem for society as a whole [3]. As physicians, it is important that we seek answers to why the problem persists.

In its list of nine principles, the AMA Code of Medical Ethics compels us to practice with compassion, to respect human dignity, honor the law, and accept responsibility for improving our communities [4]. Working with homeless people can sometimes make physicians doubt whether they are practicing ethically. I believe the contributors to this doubt are the powerlessness and confusion we feel when faced with overwhelming need. Not knowing what actions to take should never be confused with not knowing the right actions to take. Ethically, the choices we must make in providing care for a homeless veteran (or any person who is homeless) are relatively clear—such as whether a homeless person should be admitted to the hospital. Should that admission be involuntary? Does the person need a guardian? Should the family be sought out? Can we devote the time right now for this person's obvious needs? I believe the answers to these questions hinge upon whether our health care system and society as a whole—not just the VA—is ready and willing to provide the full support necessary to create lasting solutions to these complicated issues. Homelessness is seldom cured with one hospitalization. So much more is required.

In his remarkable book, War and the Soul: Healing Our Nation's Veterans from Post-traumatic Stress Disorder, Ed Tick reflects upon 30 years of counseling war veterans [3]. His experience has led him to conclude that posttraumatic stress disorder (PTSD) is not an anxiety disorder, as classified in the DSM IV. Instead, it is the expression of indelible change to one's self and one's soul as a direct result of experiencing war—and a reflection of our culture's failure to honor, accept, and “cleanse” our warriors. Veterans on the streets, possibly thousands of them with PTSD, may represent a literal army of lost souls.

Underscoring the complexity of the problem is a 2004 finding by Mares and Rosenheck that fewer than one-third of homeless veterans identified their military service as the cause of their homelessness [5]. Their article also stated that the average lag time between discharge from the military and the first episode of homelessness was a lengthy 14 years. Veterans who did attribute their homelessness to their military service cited the reasons as being (1) a substance-abuse problem that began during the military, 75 percent; (2) inadequate preparation for civilian employment, 68 percent; and (3) loss of a structured lifestyle, 60 percent. Few of these causes can be interpreted as directly related to military life. We can question, then, whether veterans as a group share risk factors for homelessness beyond combat trauma alone.

Could we have spared Jack his violent death? It's impossible to know for certain. We do know that alcoholism and chronic mental illness cause too many premature deaths and that treatment works when it is made readily available for those who want it. Our goal is to keep striving to help others like Jack. Otherwise, for what purpose are we here? The VA strives to accomplish more each day. Together, we must advocate for a comprehensive public and private health care system that promises care not only to veterans, but for all.

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References

1. Schram M. Vets Under Siege . New York , NY : St. Martin Press; 2008.
2. Longman P. Best Care Anywhere, Why VA Health Care Is Better Than Yours . Sausalito , CA : PoliPointPress; 2007.
3. Baum AS, Burnes DW. A Nation in Denial, The Truth about Homelessness . Boulder , CO : Westview Press; 1993.
4. American Medical Association. Principles of medical ethics. 2001. http://www.ama-assn.org/ama/pub/category/2512.html. Accessed December 4, 2008.
5. Tick E. War and the Soul: Healing Our Nation's Veterans from Post-traumatic Stress Disorder . Wheaton , IL : Quest Books; 2005.
6. Mares AS, Rosenheck RA. Perceived relationship between military service and homelessness among homeless veterans with mental illness. J Nerv Ment Dis . 2004;192(10):715-719.

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David A. Iverson, MD, is a psychiatrist and director of the outpatient mental health services for the Denver VA Medical Center and the Eastern Colorado Health Care System. His interests are veterans affairs, homelessness, mental health law, forensics, and ethics.

Community Response to the Health Care Issues of Homeless Veterans

Marilyn Cornell, MS, MSW

The homeless veteran population persists for many of the same reasons that the homeless nonveteran population does. Some are “situationally homeless” as a result of economic hardship, such as loss of employment or a change in life circumstances—like divorce, death of family members, or domestic violence. Others suffer from untreated mental illnesses, including psychotic disorders, mood disorders, or posttraumatic stress disorder. A significant number of homeless people bear drug and alcohol addiction or failure to integrate into society following military service, incarceration, or long-term hospitalization. Few choose a life of nomadic isolation as a “career track,” but they become accommodated to living on the fringe of society in a self-imposed form of social isolation that prompts many to become numb and resigned to their situation. It takes a Herculean effort to mobilize the internal and external resources, energy, and motivation to move oneself from homelessness to stability without outside assistance. As a result, many remain homeless for months or years, often establishing a pattern of episodic homelessness that repeats throughout their lifetime.

The health consequences of living on the street are dire. Homeless individuals are more likely to contract serious infectious diseases such as tuberculosis, pneumonia, or methicillin-resistant staphylococcus aureus ( MRSA). Long-term drug use places addicts, especially intravenous drug users, at risk for contracting HIV and hepatitis. Another hallmark of chronic or episodic homelessness is lack of dental care. Many veterans suffer from missing or diseased teeth or gum conditions and are unable to chew. Their food options, already restricted by economic hardship, become very limited. As a result, many are malnourished, in pain, and often need antibiotic treatment.

Many community groups have been founded to offer needed services to homeless veterans. Veterans Village of San Diego (VVSD), a residential treatment facility for homeless veterans with substance abuse habits, is one. It provides housing, food, access to medical and dental care, alcohol and drug education, recovery meetings, case management, mental health counseling, employment services (job training and placement), and non-traditional options such as expressive-arts therapy, yoga, acupuncture, and massage.

VVSD was founded in 1981 by five Vietnam veterans who were struggling with PTSD and readjustment after their combat experience. They established the program with a $10,000 grant from the San Diego mayor's office to help find jobs for Vietnam veterans. Their first 44-bed residential treatment center, The Landing Zone, opened in 1984 with the motto, “We leave no veteran behind.” Today the Pacific Highway facility is a 224-bed treatment center, licensed by the state of California for alcohol and drug treatment. Sixty to 70 percent of VVSD's patient population is “co-occurring,” that is, diagnosed with both a substance abuse and a mental health disorder.

In 1988, Stand Down was created by several Vietnam veterans, including Robert Van Keuren, who was executive director of Vietnam Veterans of San Diego, and Jon Nachison, PhD, a psychologist. They sought to address the growing number of homeless veterans in San Diego. For 3 days each summer, billeting tents and service providers congregates for the benefit of homeless veterans and their families from the streets. The local VA Medical Center at La Jolla erects a field hospital to offer a broad range of medical treatment, including alcohol and drug detox, tuberculin skin tests, HIV testing, dental care, optometry, podiatry, psychiatry, pharmacy, and to triage care for other conditions regardless of the participant's eligibility for VA medical benefits. (Veterans who received either a dishonorable or bad conduct discharge from the military or did not serve the requisite number of days or months on active duty are not eligible for benefits.)

In July 2008, 830 participants at Stand Down received care. VVSD typically brings in at least 15 eligible participants from each year's Stand Down as residents of its long-term treatment program [1]. The average VVSD population is 140 male and female residents, a total that will increase to accommodate the rising number of veterans in need.

Upon entry to VVSD, each resident is given a brief medical exam by a physician who screens for problems that need referral and immediate attention. Approximately 85 percent are eligible for VA medical benefits and services and get care from several locations including the VA Medical Center in La Jolla and the VA Regional Office in Mission Valley. Those who do not qualify for VA medical benefits are seen by the mobile medical van which visits VVSD twice a week. The local VA also has several social workers who act as liaisons to VVSD and coordinate medical and psychiatric care. They perform intake interviews with all residents to determine their eligibility for per-diem funding and attend weekly clinical treatment meetings to assist in removing barriers to medical and behavioral care. They also review treatment records and bring staff up-to-date treatment information from the VA if the veteran has signed the appropriate releases.

A health care case manager coordinates all non-VA care through family health centers. Residents who are registered with the California Department of Corrections and Rehabilitation and on parole have access to mental health services and obtain their psychotropic medications through the parolee outpatient clinic.

Veterans can stay in the treatment facility for up to 1 year, with 30-day extensions on a case-by-case basis. They may then live in a transitional sober-living site for an additional 2 years. The 14-bed Mahedy House is for working vets who need a sober environment, and the 44-bed New Resolve Program in North County houses residents who are employed or attending school. The Welcome Home Family program is a 2-year transitional-living program for veterans and their families. Residents in all these programs are offered ongoing mental health treatment to assist them with chronic mental health concerns and readjustment to daily living.

In a perfect world, VVSD would incorporate both a detox center and a full medical clinic as on-site services, but funding remains a challenge for all nonprofit agencies. VVSD receives grants and contributions from federal, state, and local sources, in addition to public donations. The current economic forecast, however, means all organizations like VVSD will have to continue to find creative ways to meet the health care needs and challenges of this population.

The global war on terror, and the conflicts in Iraq and Afghanistan specifically, challenge our ability to meet the medical and psychological needs of our returning military. Recent Rand Corporation research estimated that 300,000 returning military suffer from PTSD, another 300,000 suffer from traumatic brain injury (TBI), and another 100,000 overlap both categories. These numbers will certainly tax the VA and community treatment networks. It is believed that it took Vietnam veterans approximately 10 years to fall through various safety nets of family and community before landing on the streets as homeless veterans. Based on the number of younger combat veterans who are already homeless, we anticipate that the current generation will end up on the streets in half that time.

In fact, some of these young combat veterans are being treated in VVSD. To date, 20 have been served at various sites. Americans now seem to have more respect for the military, have learned the lessons of Vietnam, and are willing to “hate the war, but not the warrior.” Whether or not this translates into funding for medical and mental health treatment remains to be seen. The United States prepared for the war, but not for the returning veterans. Their future health care needs are robust, and it is doubtful they can be properly met. In 3 to 5 years, VVSD projects that 75 percent of its population will be Iraq and Afghanistan combat veterans. As of January 2009, VVSD implemented a new program to meet the specific needs of these veterans, including health, wellness, and other classes specifically for this population.

As part of their intake questionnaire, new physicians and medical students should ask the homeless, “Did you ever serve in the military?” Many veterans do not trust the Veterans Health Administration based upon residual myths and beliefs left over from the Vietnam era. Also, more women are now serving in the military, and many have seen combat, but they traditionally do not access veteran's benefits and do not identify themselves as veterans. Treating all veterans with respect, thanking them for their service, and allowing them to tell their stories will help educate caregivers as to the most appropriate level of care.

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Reference

1. Veterans Village of San Diego. Stand down. 2008. http://www.vvsd.net/standdown.htm. Accessed December 3, 2008.

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Marilyn Cornell, MS, MSW, is a clinical director for Veterans Village of San Diego and serves as adjunct faculty at San Diego State University, teaching courses in counseling and psychology. She has been a licensed marriage and family therapist for nearly 20 years, providing outpatient treatment to veterans and their families. She has also been a volunteer at Stand Down in San Diego for 20 years and serves as the organization's tent leader coordinator.

Veterans' Recovery for the Homeless

Paul Smits, MSW

The issue of homelessness troubles many Americans, particularly when it involves individuals who have made selfless personal sacrifices for our country— U.S. veterans. Although the numbers of homeless veterans have decreased steadily over the last 10 years, it is estimated that there were 154,000 homeless veterans on any night in the United States in 2007 [1]. The decline notwithstanding, the presence of one homeless veteran is unquestionably too many.

A common misperception about homelessness is that it is caused by poverty, lack of affordable housing, or unemployment. Those who have fought to end homelessness know these factors are only part of the story. A majority of homeless people have health conditions that interfere with their ability to become productive citizens. Health care agencies report that homeless patients have high incidences of respiratory infections, trauma, skin ailments, gastrointestinal ailments, and hypertension. Dental problems are common, as are communicable diseases such as HIV and tuberculosis, with HIV being three times as prevalent as in the general population [2, 3]. Most noteworthy is that substance abuse and mental illness are widespread and play a significant role in contributing to chronic homelessness. These contributors are not specific to veteran homeless; nonveteran homeless people suffer from similar health conditions.

The Department of Veterans Affairs (VA) has provided services to homeless veterans for 21 years, during which time it has collected extensive data on homeless veterans through VA's Northeast Program Evaluation Center (NEPEC). NEPEC has been actively involved in the design, implementation, and evaluation of VA's specialized programs for homeless veterans from their beginning. Fifty-eight percent of homeless veterans report health problems. Even more striking is the fact that 66 percent carry diagnoses of alcohol or drug abuse and 51 percent have serious psychiatric diagnoses. Thirty-seven percent have both a substance-abuse diagnosis and serious psychiatric diagnosis [4]. Clearly, this data confirms that health care must play a critical role in addressing homelessness and achieving lasting results in ending it.

The VA programs have been built on the recognition that health care plays a critical role in rehabilitation of homeless veterans. The Veterans Health Administration has more than 330 staff members who reach out to 40,000-plus new veterans annually and offer services to 65,000 veterans through its specialized programs [4]. A detailed assessment of each veteran is conducted almost immediately and produces a comprehensive package of rehabilitative services designed to meet that veteran's housing needs; medical, psychiatric, dental, and substance-abuse treatment needs; case management; vocational and employment needs; and, in many cases, assistance with obtaining benefits for disabilities.

Although the VA is uniquely positioned to provide many of these services, its strategy has been to deliver them in collaboration with nonprofit community and faith-based organizations, state programs, other federal agencies, and Indian tribal governments. These collaborations are critical to meet the complex needs of the homeless veteran and his or her family. Providing one or two services to a homeless person in hopes that it will lift him or her out of homelessness is not realistic and sometimes contributes to yet another failure on the part of the individual to end his or her homelessness. At present, the VA's Homeless Providers Grant and Per Diem Program offers transitional housing with supportive services through 330 community-based programs, with almost 9,000 beds currently available that grant rehabilitative care to more than 15,000 veterans per year [4]. In 2008, the VA initiated a 10,500-unit expansion of the Housing and Urban Development-VA Supportive Housing (HUD-VASH) permanent housing program. Through the endeavor, permanent community housing, subsidized through HUD-housing vouchers and managed by local public housing authorities, is paired with clinical VA staff case-management services.

Health issues prevalent in this population can significantly interfere with the veteran's ability to fully utilize other support services. To ensure that veterans receive these health care services, the Veterans Health Administration has initiated three national performance monitors which measure whether homeless veterans have timely access to primary care, mental health care, and substance-abuse treatment. A fourth monitor measures VA's performance of guaranteeing continuity of care for veterans who depart from those specialized programs.

Many homeless veterans receive care through outreach activities in which social workers and other health care professionals bring services to street missions and other places where homeless people congregate. But homeless veterans also come directly to VA's health care facilities and meet with professionals who are knowledgeable and trained to connect them with services. The VA recently issued a mental health handbook that describes a uniform mental health services package and requirements for care. If a veteran and his or her family come to a VA clinic or hospital, the veteran must be given access to a variety of options that include emergency shelter, placement in a residential treatment setting, and transitional or permanent housing with supportive services in addition to medical, psychiatric, or substance-abuse care.

Deferring care or sending a veteran back to the street is considered unacceptable by the Veterans Health Administration, which has adopted standards that spell out the requirement that services must be made available. All health care professionals and organizations should adopt standards of care that follow the VA's model. Recent instances of health care organizations dumping sick, homeless people on the street in skid row areas are deplorable.

In 2008, 21,000 homeless veterans received rehabilitative care services in VA residential programs [4]. More than $334 million was spent on these specialized programs, and almost $2 billion was spent in overall health care costs for homeless veterans [5]. It is the least that can be done for those who made great sacrifices for our nation.

At this point, the question must be asked, “Does the VA's strategy for delivering comprehensive care via collaborative relationships succeed?” The experience of the VA and its partners is that this approach has produced results—many formerly homeless veterans have been able to end their homelessness. The VA has conducted at least eight studies and followed more than 3,000 veterans for up to 3 years after entry in the VA program in a series of systematic program evaluations. All of these studies showed positive results, consistently estimating that 80 percent of veterans who entered the programs remained housed 1 year after entry, with even higher percentages of housing for those who successfully completed the programs [6-13].

The complexity of the problems of the homeless calls for a comprehensive, coordinated approach that can best be accomplished through partnerships between private and public agencies. Health care services are a critical component of a homeless individual's recovery—the reason the VA has taken a leadership role in coordinating health care and other services for U.S. veterans. With high levels of performance accountability, the efforts have shown results as good as those of any other program. The standard of providing homeless care delineated in VA's mental health uniform-services package is a model that can be emulated by other health care organizations. For the VA, the debt owed to our nation's veterans calls for no less.

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References

1. Kuhn J. CHALENG community homelessness assessment, local education and networking groups. 2008. http://www.nchv.org/ docs/MH%20Conf%207-08.ppt. Accessed November 13, 2008.
2. McMurray-Avila M. Organizing Health Services for Homeless People. Nashville, TN: National Health Care for Homeless Council, Inc; 1997.
3. Allen DM, Lehman JS, Green TA, Lindegren ML, Onorato IM, Forrester W. HIV infection among homeless adults and runaway youth, United States, 1989-1992. Field Services Branch. AIDS. 1994;8(11):1593-1598.
4. Kasprow WJ, Rosenheck RA, DiLella D, Cavallaro L, Harelik N. Health Care for Homeless Veterans Programs. West Haven, CT: Northeast Program Evaluation Center; 2008.
5. U.S. Department of Veterans Affairs. FY2009 budget submission medical programs and information technology programs, Vol. 2 of 4.
6. Cheng AL, Lin H, Kasprow W, Rosenheck RA. Impact of supported housing on clinical outcomes: analysis of a randomized trial using multiple imputation technique. J Nerv Ment Dis. 2007;195(1):83-88.
7. Rosenheck RA, Frisman L, Gallup PG. Effectiveness and cost of specific treatment elements in a program for homeless mentally ill veterans. Psychiatr Serv. 1995;46(11):1131-1139.
8. Leda C, Rosenheck RA. Mental health status and community adjustment after treatment in a residential treatment program for homeless veterans. Am J Psychiatry. 1992;149(9):1219-1224.
9. Rosenheck RA, Dausey DJ, Frisman L, Kasprow W. Outcomes after initial receipt of social security benefits among homeless veterans with mental illness. Psychiatr Serv. 2000;51(12):1549-1554.
10. Rosenheck RA, Kasprow W, Frisman LK, Liu-Mares W. Cost-effectiveness of supported housing for homeless persons with mental illness. Arch Gen Psychiatry. 2003;60(9):940-951.
11. Rosenheck RA, Mares AS. Implementation of supported employment for homeless veterans with psychiatric or addiction disorders: two-year outcomes. Psychiatr Serv. 2007;58(3):325-333.
12. Kasprow W, Rosenheck RA. Outcomes of critical time intervention case management of homeless veterans after psychiatric hospitalization. Psychiatr Serv. 2007;58(7):929-935.
13. Desai RA, Harpaz-Rotem I, Najavits LM, Rosenheck RA. Impact of the seeking safety program on clinical outcomes among homeless female veterans with psychiatric disorders. Psychiatr Serv. 2008;59(9):996-1003.

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Paul Smits, MSW, is associate chief consultant, Homeless and Residential Treatment Programs in the VA central office in washing, D.D. He manages the day-to-day operations of the Veterans Health Administration’s (VHA) Grant and Per Diem Program, the HUD-VA Supported Housing Program, the Domiciliary Care for Homeless Veterans Program, the Healthcare for Re-entry Program (prison outreach), and VHA’s homeless outreach services. He has a master of social work degree from Western Michigan University, is a veteran of the Vietnam War, and was awarded the Bronze Star in 1970. Throughout his 36-year career in the Department of Veterans Affairs, Mr. Smits has been involved in the development of the VA’s homeless program. In 2003, he was awarded the prestigious Olin Teague Award for achieving outstanding results in the rehabilitation of homeless veterans.

Related in VM

Boston HealthCare for the Homeless Program: A Success Story, January 2009

Outpatient Commitment: A Treatment Tool for the Mentally Ill? January 2009

Hospital Resources: A Practical Treatment Plan for Homeless Patients, January 2009

Medical Use of Marijuana Divides AMA Delegates

Mark Moran

Psychiatrists and other physicians said the potential for abuse and the possible unintended consequences of reclassifying marijuana called for further study by the AMA's Council on Science and Public Health.

Should marijuana be made more accessible to researchers and clinicians who seek to use it for treatment of conditions such as chemotherapy-related nausea?

The question was the source of passionate debate at the Interim Meeting of the AMA House of Delegates in November. A resolution brought to the house by the Medical Student Section asked the AMA to seek the reclassification of marijuana under the Controlled Substances Act from a Schedule I drug—under which it is deemed to have high abuse potential and no proven medical uses—to another schedule that would make it more available to researchers and clinicians.

The resolution was not approved; rather, it was referred to the AMA's Council on Science and Public Health (CSPH) for further study, but not before it had consumed nearly two hours in reference committee hearings and house floor debate and had elicited strident testimony from advocates both for and against rescheduling.

Compelling case reports of individuals with serious or life-threatening conditions who benefited from marijuana use clashed with concerns about potential abuse should the drug be made more easily accessible and the social issues associated with a declaration that marijuana is a safe and effective medicine. Adding to the mix of opinion was new information about the physiology of the endocannabinoid system and testimony about the advantages and disadvantages of new cannabinoid-based pharmaceutical products versus use of the crude marijuana plant.

Addiction psychiatrist John Halperin, M.D., a researcher at the McLean Hospital Biological Psychiatry Laboratory, said he cannot do research on the medical uses of marijuana.

"I would love to do research with marijuana, but I will not do it because of the current paradigm being foisted on me [requiring me] to go through unnecessary review by NIDA to request NIDA-sourced marijuana that is of substandard quality," Halperin said. "It is a setup for failed research. I would like to do research where I would have input into the design and growth of marijuana that would be useful to research.... I urge you to pass this resolution so that we can get real research going [on the medical uses of marijuana]."

George Wagoner, M.D., an obstetrician-gynecologist, emotionally testified about his wife's experience with chemotherapy-related nausea, the failure of Marinol to control the nausea (Marinol is a synthetic form of THC, the active ingredient in marijuana, and is known to sometimes cause delusions and hallucinations), and the successful use of inhaled marijuana.

"By the second inhalation, my dear wife experienced sudden and complete relief of her nausea that lasted four to six hours.... The relief was as dramatic and as complete as any I have experienced in medicine."

Melvyn Sterling, M.D., a palliative-care physician from California, echoed those remarks, saying that many end-of-life patients could benefit from the medicinal effects of marijuana and that there was a bountiful body of research on its benefits. "It's time to get our heads out of the sand," he said.

But psychiatrists and other physicians countered that the potential for abuse was significant and that the possible unintended consequences of rescheduling marijuana called for further study by the CSPH.

"I have seen many cases of exacerbations of schizophrenia and bipolar disorder brought on by marijuana use," said psychiatrist Kenneth Certa, M.D., a member of the Section Council on Psychiatry. "Another problem I can see is that the marijuana in the community is often not very pure and is frequently adulterated with PCP [phencyclidine, an hallucinogen], which can also cause problems with psychosis.

"I understand that ideally if we had medical marijuana approved, we would have a purer supply and better control, but it would also send a message to others that marijuana is OK to use," Certa said. "And what's out on the street would not be so easy to control."

Albert Osbahr, M.D., an occupational health physician and a member of the CSPH, agreed that the council needed to revisit the issue; its last report was in 1997. "There has been a lot of research done since then, and we need to update the house," he said. "I think after doing that, we can answer the question of reclassification."

Addiction psychiatrist Stuart Gitlow, M.D., also a member of the CSPH, predicted that approval of medical marijuana would result in an upsurge in addicted patients.

"We don't have any good studies to demonstrate significant value from smoked marijuana," Gitlow said. "That's not to say there is no value, but simply that such value hasn't been demonstrated to the level that we demand of prescribed medication. We have an enormous literature detailing the risks of marijuana use. Such risks are likely not going to be present in an end-of-life treatment scenario. Rather, the risks will be present to the adolescents coming into the home of this scenario and finding marijuana just as easily as they now find opioids and sedatives."

AMA-MSS Lobby Day!!!

Obama may not lift stem cell limits

PHILADELPHIA, Pa. – President-elect Barack Obama signaled Friday that he might not use his executive authority to reverse Bush-era limits on stem cell research, but instead might wait for Congress to change the policy. 

Obama pledged during the campaign to lift the restrictions, and political observers had expected him to move swiftly to reverse President Bush’s 2001 executive order – most likely with his own executive order.

But the president-elect suggested Friday that he would wait for Congress to weigh in on the issue. 

“Well, if we can do something legislative then I usually prefer a legislative process because those are the people's representatives,” Obama said in a CNN interview. “And I think that on embryonic stem cell research, the fact that you have a bipartisan support around that issue, the fact that you have Republicans like Orrin Hatch who are fierce opponents of abortion and yet recognize that there is a moral and ethical mechanism to ensure that people with Parkinson's disease and Alzheimer's can actually find potentially some hope out there, you know, I think that sends a powerful message. 

“So we're still examining what things we'll do through executive order,” Obama continued. “But I like the idea of the American people's representatives expressing their views on an issue like this.” 

Bush barred the National Institutes of Health from funding stem cell research that destroyed embryos – a position favored by anti-abortion groups — but he allowed research to continue on several dozen cell lines in existence when he signed the executive order in August 2001.

Enrollment of Economically Disadvantaged Participants in Clinical Research

Disadvantaged and homeless people should not be ineligible to participate in scientifically and ethically sound medical research on the sole basis of this vulnerable status.

Neal Dickert, MD, PhD

In 1996, the Wall Street Journal ran the following headline: “To screen new drugs for safety, Lilly pays homeless alcoholics” [1]. The article provoked reactions of outrage and disgust. How could researchers use society's most disadvantaged people as guinea pigs to develop drugs that these participants could never afford? Even worse, how could they entice them with offers of money or health care, preying on the very vulnerabilities that are so disconcerting?

Learning Objective Understand the argument that disadvantaged and homeless people should not be ineligible to participate in scientifically and ethically sound medical research on the sole basis of this vulnerable status.

These reactions are understandable, and there may indeed be something wrong with how we enroll homeless and other disadvantaged populations in clinical research. The source of the problem, however, may not be that homeless people with alcoholism are disadvantaged or that incentives are used to recruit them. Evaluating this matter responsibly reveals that these gut reactions are often misdirected.

The Risk and Importance of Research

The central ethical challenge in clinical research is that it exposes people to risks that must be justified by benefits to society or science in the form of medical knowledge. Researchers, institutional review boards (IRBs), and sponsors of research take great pains to minimize risks. And although the risk of every project differs and is difficult to estimate, approved clinical research is heavily scrutinized and appears to be safe, despite what media reports and participant consent forms may suggest.

Participating in research is definitely safer than high-risk occupations such as firefighting, law enforcement, or military service and almost certainly safer than the majority of construction work, manufacturing jobs, or garbage collection—jobs that are important and legitimate despite known risks. Like these occupations, clinical research produces a valuable social good that justifies placing individuals at some level of risk. That said, tragedies do happen, as exemplified by the case of Nicole Wan, a 19-year-old student who died as a result of a fatal reaction to lidocaine administered during a research bronchoscopy [2].

If we accept the imposition of some risk for societal benefit, we must confront the question of which people researchers should expose to it. Despite a tendency to react otherwise, there is no obvious reason to believe that economically disadvantaged people ought not to be exposed to the same levels of research risk as the rest of the population. Provided they participate in studies for which they give a valid informed consent, why for example, should we exclude homeless people [3]? One common view is that the principle of justice dictates that disadvantaged populations ought not to be exposed to risks when they are not likely to be among those who benefit from the research findings. But this view does not always stand up to scrutiny. We never argue that poor people should not collect garbage in wealthy neighborhoods or that a homeless person should not be employed building expensive houses. Similarly, if I want to participate as a healthy individual in a study designed to improve the understanding of Parkinson's disease, my own likelihood of developing the disease (thus potentially benefitting from the study data) seems irrelevant to whether I should be allowed to enroll.

Some have claimed there is no reason to exclude disadvantaged individuals entirely, but that enrolling a disproportionate number of them is a problem. Several leading scholars, for example, assert that enrolling 1 percent homeless participants is justified, but having 100 percent homeless participants is not (assuming that the study is not focused on a problem unique to the homeless) [3]. “Pattern equity” is the term used to describe the distribution of research risks or burdens and, although there is widespread concern over pattern equity, its importance is unclear [4, 5]. I suspect that enrolling very high numbers of homeless people in a study may indeed indicate that the study has potential problems, but it is difficult to argue that the distribution of research burden is itself unjust if the level of risk posed by the study is indeed acceptable and participants feel they have an opportunity for financial gain or health benefit.

Examining the Study

There is an important caveat to the preceding comments: clinical research that enrolls disadvantaged people must be ethically acceptable in the first place. In other words, studies must meet basic standards of ethical acceptability regardless of whom they enroll. As elaborated by Ezekiel Emanuel and colleagues, these standards include: the potential for social value, a scientifically valid methodology, fair participant selection, a favorable risk-benefit ratio (including benefits to society), independent and thorough review, informed consent, and respect for participants [6]. Studies that do not meet these standards should not be approved. Most of the studies cited by Elliott and Abadie as exploitative of disadvantaged populations, for example, are flawed in fundamental ways—either they have not been adequately reviewed, are conducted in unacceptable facilities, or have used compounds that may not have been sufficiently researched [7]. These studies should not be conducted. Ensuring that these basic ethical standards are met may require special measures for certain populations. There may be special challenges regarding informed consent when enrolling homeless participants given the high prevalence of psychiatric disease among this population. Special procedures may be necessary to guarantee that consent is adequate, and exclusion of individual participants is obligatory when this cannot be achieved [3].

It may be that only disadvantaged people without reliable ways to make money or obtain health care will find enrolling in ethically problematic studies attractive. Taking advantage of their vulnerability to circumvent ethical standards of research is fundamentally exploitative and must not be tolerated. Thus, additional safeguards may be needed to monitor and prevent such exploitation, if unethical research is indeed as endemic as Elliott and Abadie suggest [7]. The problem in many of these cases, however, lies in the research studies and the regulatory system and not in the participant population. What we owe these participants is adequate review and oversight and not exclusion or different ethical standards.

Incentives Are Rarely the Problem

Much of what I have argued thus far may not be controversial. Most people would agree that nobody, homeless or not, should be asked to participate in a study that fails to meet criteria for ethical research, and most recognize that some level of risk is inevitable and justifiable. Still, many feel that offering incentives to induce disadvantaged people to participate in otherwise approvable studies remains problematic. These worries are typically cast as concerns about coercion, undue inducement, or exploitation and are largely overstated and misunderstood [7].

To start, coercion is never acceptable in research. Fortunately, true coercion is incredibly rare in research, and no offer of money or health care can coerce anyone unless there is some threat of harm for refusing [5, 8-11]. For a situation to be defined as coercive, a potential participant must be made worse off for refusing to participate than if he or she had never been presented with the option in the first place. For example, it would be coercive to strong-arm a homeless man into participating in a study by threatening to report criminal behavior to his shelter if he does not agree to take part. It would not be coercive, however, to offer him a large amount of money to participate. The money may be very attractive to him, and he will almost certainly agree to participate. But this situation is not coercive because the man would not be worse off for refusing the offer than if he had never been asked.

The more appropriate and complicated concern is that disadvantaged participants may be unduly induced by large amounts of money or health benefits. What counts as “undue inducement” is debated, but most discussion of this issue focuses on the potential for attractive incentives to: (1) undermine participants' ability to give valid informed consent by either compromising the voluntariness of their decisions or causing them to ignore and remain uninformed about study risks, (2) cause people to exercise poor judgment, or (3) lead participants to hide pre-existing conditions, side effects, or other information that might make them ineligible for inclusion [5]. Emanuel, in a provocative and important series of papers, argues that concern for undue inducement is “nonsense on stilts” [12, 13]. There are no data to suggest that people misestimate risks because of payment. Some paid participants have said they care less about risks when the amount of payment is high; others have said they are actually more attuned to risks when payment is high [14, 15]. Even if offers did cause people to underestimate risk, the most appropriate initial solution would be to alter consent practices rather than reduce incentives. More importantly, it is far from clear why decisions made for monetary gain in research would compromise voluntariness when they do not in other contexts. How many of us would want a potential employer to reduce a salary offer in order to make sure our decision to take a job is voluntary?

As Emanuel argues, it is also not clear how enrollment in an appropriately approved study would represent poor judgment. After all, IRBs should only approve studies in which they believe it would be reasonable (and thus not poor judgment) for eligible people to enroll. If enrolling reflects poor judgment, the IRB should not have approved the study, regardless of how much payment is offered [13].

Finally, no good data exist on the extent to which potential participants lie or hide conditions in order to maintain eligibility, though it certainly has occurred. Bernadette Gilchrist, for example, was an NIH nurse who died in a paid sleep-deprivation study most likely as a result of electrolyte abnormalities secondary to bulimia, a condition she failed to disclose to researchers presumably because she thought it would disqualify her from participating [16]. Although there are potential data integrity implications when participants fail to report important information, researchers' responsibilities can only go so far in protecting people from risks that derive from their own intentional misrepresentation of their health.

Undue inducement concerns are largely overestimated, and there is a need for more data on the extent to which they are borne out in practice. I do, however, believe that this concern is relevant when considering incentives to severely disadvantaged people, but only at the end of the spectrum of approvable risk or when research involves asking people to trade off values they hold important. I suggest that real undue inducement occurs when large offers induce people to make choices—that may be entirely informed and voluntary—to do activities to which they have strong objections based on their own values [5]. Examples include a homeless person with deep risk aversion who is induced to participate in a very risky (but approvable) study or a homeless Jehovah's Witness induced to participate in a trial involving a blood transfusion. Because research institutions should not be in the business of making “indecent proposals,” the concern for undue inducement gives us reason to avoid dramatic escalations of payment at the risky end of approvable research and when recruiting from populations known to have significant aversion to specific studies. But values vary greatly. IRBs cannot, and should not attempt to account for the values of all potential populations—otherwise no study would be approvable. As a result, some undue inducement is unavoidable and not the responsibility of researchers or IRBs to prevent entirely.

A crucial reason for avoiding overreaction to the potential for undue inducement is the opposite concern—exploiting severely disadvantaged populations by not paying them enough [7]. Just as disadvantaged people are vulnerable to inducements, they are vulnerable to being taken advantage of by offers that undervalue the service they perform. Consider a phase I study of a new antibiotic in healthy people that involves a several-day inpatient stay, drug infusion, and multiple blood draws. If that study offered participants $50 a day ($150 total), who would participate? Most would expect to be better paid for such a burdensome study. Providing very low payments knowing that there are people poor enough to find this offer attractive is paradigmatic of exploiting their situation in a morally problematic way [5, 7]. Lest this concern seem illegitimate, several interview studies of paid participants—many of whom are poor—illustrate that those participants are more worried about being paid too little than about being paid too much [15-17].

The difficulty of balancing concern for undue inducement against concern for exploitation is one reason to adopt an approach that pays participants based on the nature of the unskilled but valuable work they perform [5]. A relatively consistent and standardized payment strategy that pays participants according to the prevalent wage for similar jobs and allows adjustments for inconvenience, discomfort, and, to some extent, risk, will protect them from undue inducement, largely avoid exploitation, and reward people fairly for the valuable service they perform. This strategy will result in a high number of disadvantaged people participating in research, but there is no reason to exclude them as participants, and it is not clear that the pattern-equity concern is sufficient to make this problem a priority. Research studies still must pass stringent ethical muster on all other grounds, and reductions in payment would simply promote exploitation and restrict income from a viable and socially beneficial work option [18].

Conclusion

While disconcerting initially, the enrollment of highly disadvantaged people in paid research studies is generally acceptable on further analysis. Many frequent participants in paid research rightly view it as a valuable and viable work opportunity; denying this opportunity seems both unnecessary and inconsistent with our views of other occupations, many of which involve greater risks and less social value. Studies that enroll disadvantaged populations must be carefully scrutinized to ensure that they meet adequate conditions for ethical research. Similarly, fair payment for participation in acceptable and approvable research is entirely appropriate, and the fact that payment increases participation among poor participants is a relatively small problem. Underpayment, however, in an attempt to protect vulnerable participants, may result in exploitation and fails to recognize that monetary gain is factored into numerous decisions every day.

It is important to recognize the elephant in the room—the driver of many of the gut reactions to enrollment of disadvantaged populations in paid research. Many of these people are the victims of profound injustice and have been abandoned by much of society. The injustice that constricts their options for making ends meet is presumably one of the chief reasons why participation in paid research is attractive. This recognition should strengthen our resolve to ensure that ethical standards of research are met and, more importantly, address the source of injustices in the first place. It does not mean that we should further restrict their options to participate in improving medical knowledge.

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References

1. Cohen LP. To screen new drugs for safety, Lilly pays homeless alcoholics. The Wall Street Journal. November 14, 1996: A1, A10.
2. Rosenthal E. New York seeks to tighten rules on medical research. New York Times. September 27, 1996: B4.
3. Beauchamp TL, Jennings B, Kinney ED, Levine RJ. Pharmaceutical research involving the homeless. J Med Philos. 2002;27(5):547-564.
4. Wilkinson M, Moore A. Inducements revisited. Bioethics. 1999;13(2):114-130.
5. Dickert N, Grady C. Incentives for participants. In: Emanuel EJ, Crouch R, Grady C, Lie R, Miller FG, Wendler D, eds. The Oxford Textbook on the Ethics of Clinical Research. New York: Oxford University Press; 2008.
6. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? Am J Ophthalmol. 2000;130(3):381.
7. Elliott C, Abadie R. Exploiting a research underclass in phase 1 clinical trials. N Engl J Med. 2008;358(22):2316-2317.
8. Wertheimer A, Miller FG. Payment for research participation: a coercive offer? J Med Ethics. 2008;34(5):389-392.
9. Hawkins JS, Emanuel EJ. Clarifying confusions about coercion. Hastings Cent Rep. 2005;35(5):16-19.
10. Wertheimer A. Coercion. Princeton, NJ: Princeton University Press; 1987.
11. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. 1979. http://ohsr.od.nih.gov/guidelines/belmont.html. Accessed November 16, 2008.
12. Emanuel EJ. Undue inducement: nonsense on stilts? Am J Bioeth. 2005;5(5):9-13.
13. Emanuel EJ. Ending concerns about undue inducement. J Law Med Ethics. 2004;32(1):100-105.
14. Bentley JP, Thacker PG. The influence of risk and monetary payment on the research participation decision making process. J Med Ethics. 2004;30(3):293-298.
15. Slomka J, McCurdy S, Ratliff E, Timson S, Williams ML. Perceptions of financial payment for research participation among African-American drug users in HIV studies. J Gen Intern Med. 2007;22(10):1403-1409.
16. Kolata GB. The death of a research subject. Hastings Cent Rep. 1980;10(4):5-6.
17. Kass NE, Meyers R, Fuchs EJ, Carson KA, Flexner C. Balancing justice and autonomy in clinical research with healthy volunteers. Clin Pharmacol Ther. 2007;82(2):219-227.
18. Dickert N, Grady C. What's the price of a research subject? Approaches to payment for research participation. New Eng J Med. 1999;341(3):198-203.

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Neal Dickert, MD, PhD, is a fellow in cardiology at the Emory University School of Medicine in Atlanta. He received his MD and PhD degrees from the Johns Hopkins University Schools of Medicine and Public Health, where he completed residency training in internal medicine. His interests focus on ethical issues in clinical research, particularly the use of incentives to participants in clinical research and the conduct of research in emergency settings and developing countries.