Carl ElliottJul 27, 2014 · 23 min read

The Best-Selling, Billion-Dollar Pills Tested onHomeless People

How the destitute and the mentally ill are being used as humanlab rats

By Carl Elliott

Photographs by Jeffrey StockbridgeIllustrations by Matt Rota

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Two years ago, on a gray Januaryafternoon, I visited the Ridge Avenuehomeless shelter in Philadelphia. Iwas looking for poor people who hadbeen paid to test experimental drugs.The streets outside the shelter werelined with ruined buildings and razorwire, and a pit bull barked behind achain-link fence. A young guy wasslumped on the curb, glassy-eyedand shaky. My guide, a local mentalhealth activist named Connie

Schuster, asked the guy if he was okay, but he didn’t answer. “My guess is heroin,”she said.

We arrived at the shelter, where a security guard was patting down residents forweapons. It didn’t take long for the shelter employees to confirm that some of thepeople living there were taking part in research studies. They said that the studiesare advertised in local newspapers, and that recruiters visit the shelter. “They’llgive you a sheet this big filled with pills,” a resident in the shelter’s day room toldme the next day, holding up a large notebook. He had volunteered for two studies.He pointed out a stack of business cards on a desk next to us; they had been leftby a local study recruiter. As we spoke, I noticed that an ad for a study of a newADHD drug was running on a television across the room.

If you’re looking for poor people who have been paid to test experimental drugs,Philadelphia is a good place to start. The city is home to five medical schools, andpharmaceutical and drug-testing companies line a corridor that stretches northeastinto New Jersey. It also has one of the most visible homeless populations in thecountry. In Philly, homeless people seem to be everywhere: sleeping in Love Park,slumped on benches in Suburban Station, or gathered along the Benjamin FranklinParkway, waiting for the free meals that a local church gives out on Saturdays.

On another occasion, I met former subjects at Chosen 300, a storefront churchthat serves meals to homeless people. The service had already started by the timeI arrived, and raucous gospel music filled the bleak room. The congregationconsisted of several dozen black men sitting on folding chairs. Many stared at thefloor.

After the service I spoke to a thin young man in a dirty T-shirt who told me he haddone an outpatient study for an anxiety drug. “Some kind of new benzo,” he said,as he devoured a bowl of Cheerios. (Benzodiazepines like Valium, Xanax, andAtivan are often prescribed for anxiety.)

Outside, an older man named Steve told me he was trying to get into a depression

Outside, an older man named Steve told me he was trying to get into a depressionstudy. “They ask you a lot of questions and see if you’re approved for it,” he said.“If you’re approved for it they’ll pick you up wherever you’re at.”

Later I walked round the corner to a shelter, where I talked to an elderly white man.“I’d say the majority of guys here take advantage of that,” he told me, “becausethey get a lot of money and they’re broke as hell.”

Addiction treatment studies are one popular option. Last November, I visited theSunday Breakfast Association shelter, where I met a man named George. He hada wispy goatee and a Letterman-like gap between his front teeth. George talkedwith such familiar, ironic congeniality that I was taken aback when he told me hehad spent time in prison and once tried to commit suicide. “This city is fuckingtough, and it is getting worse,” he said. I mentioned a recruitment flyer I’d seenoutside the shelter asking for subjects with “cocaine dependency.” George nodded.He told me that a lot of people start taking drugs just so they can qualify for thosestudies. “You take that shit two days before to get it into your blood.” He mentionedthat he had recently screened for a trial at a research site running addictionstudies. “There were people in the waiting room high as a kite,” he said. “Theywere incoherent.”

But the studies I heard about most often were for psychiatric drugs: antipsychotics,antidepressants, anxiety drugs, and stimulants. George used to take Risperdal, anantipsychotic. “That drug will turn you into a zombie,” he said. He mimed fallingover sideways in his chair. “I couldn’t sit up without falling asleep.” He gesturedtoward the other shelter residents: “Ninety-five percent of the population here hassome kind of mental problem.”

Most people think of pharmaceuticalresearch as a highly technical activitythat takes place in world-classmedical centers. The reality issomewhat different. This is apparentin a grainy video that I watched a fewyears ago. It had apparently beenrecorded on a cell phone, and thecamerawork started off wobbly. A

camerawork started off wobbly. Atanned man wearing sunglasses anda necklace appeared and wasintroduced as Dr. Johnny Edrozo, apsychiatric researcher. His shirt was

unbuttoned partway down his chest. “The latest stimulant coming out of the marketis Vyvanse, which is a Dexedrine preparation,” Edrozo told the interviewer,pausing occasionally to chew gum. For reasons that were not explained, theinterview took place in a parked car.

This was my introduction to South Coast Clinical Trials, a chain of private researchsites in Southern California that specializes in testing psychiatric drugs.Pharmaceutical companies now typically outsource clinical studies to contractresearch organizations like South Coast, which run trials faster and at lower costthan universities do. Their job is simply to follow the instructions of their sponsors.This formula is working: The contract research industry has grown steadily sincethe early 1990s and may now generate over $100 billion in annual income,according to the Tufts Center for the Study of Drug Development. At the top of theheap are corporations like Quintiles, which has 28,000 employees and operates inabout 100 countries. At the other end are private physicians and small companieslike South Coast, which are often based in strip malls or suburban office parks.

Dan Sfera, the owner of South Coast, has produced scores of web videos like thisone, the ostensible purpose of which is to demystify drug research. (The unstatedpurpose, of course, is to generate business for their psychiatric research facilities.)I visited Sfera and his colleague Don Walters not long after watching the video,and they introduced me to a research subject named Steve, who vouched for thegood intentions of South Coast clinic staffers. “I love this place,” he said. “It’sawesome. They don’t treat you like you have a mental illness.” A middle-aged manwith a short, gray-flecked beard, Steve was starting an outpatient study ofDepakote, a seizure drug that is sometimes prescribed for bipolar disorder. He hadarrived at the clinic wearing red gym shorts and bedroom slippers. Over thesummer, Steve told me, he’d been hospitalized for four weeks and had receivedeight rounds of electroconvulsive therapy. As he spoke, his hands trembled soviolently that he spilled his coffee on the floor. He seemed preoccupied with hisroommate, who he said hadn’t showered for weeks. “The man’s got toenails thislong,” he said, holding his fingers inches apart.

Steve told me he was staying at a room-and-board, an unlicensed facility wherementally ill people are given a room and meals. At Sfera’s suggestion, I visited onethat was home to some South Coast research subjects. It was located in SouthCentral Los Angeles, a bleak neighborhood of chain-link fences and graffiti. Thefurniture in the house was worn, but a vase of flowers had been placed on thecoffee table. Herbert Norman, the house manager, told me that he had 21residents living there, and that many had been in clinical trials. In fact, Norman wasenrolled in a South Coast trial himself. “My diagnosis is bipolar II,” he said,surprising me a little. “Yeah, bipolar with a little bit of schizophrenia.” A brokensmoke alarm chirped in the background.

Soon, a very large man in a black Lakers T-shirt lumbered out of a bedroom, givingme a halfhearted fist bump before easing himself onto the couch. He wasintroduced as Harold. His diagnosis was paranoid schizophrenia, he told me, andhe was enrolled in an outpatient study of Abilify, an antipsychotic drug. As wetalked, an older black woman kept wandering in and out of the room, her lips

smacking and her face twitching. I wanted to find out more about the study Haroldwas in and whether he understood the risks, but he spoke in a nearly inaudiblemumble. “I’m always nervous about taking the pills,” he said. “You kind of feel likea guinea pig all of a sudden.” He said, though, that he had not suffered any sideeffects. When I asked Harold how much he was being paid, he hesitated andlooked around the room, as if he did not want anyone else to hear. Then he askedfor a piece of paper and wrote down the number 65.

To find people like Harold, somecontract research organizations haveemployees visit room-and-boardsand homeless shelters. InPhiladelphia I met a man named EdBurns, who explained to me howthese recruiters work. Burns and hiswife had been on the street for overtwo years when we spoke; he saidthey had trouble getting space inshelters, even though his wife ispregnant and Burns has bipolardisorder and depression. “I was on

Depakote and I almost killed someone out of anger,” he said. “It made me awrecking machine.” Burns was living in a shelter when he got a message sayingthat someone from the Veterans Affairs hospital was waiting outside for him. Butwhen he went outside, he said, he was met by a representative of a researchcompany known as CRI Worldwide.

“I was tired, I was hungry, and half an hour earlier the police had treated us likecrap,” Burns said. “And this woman is saying, ‘Imagine, in 40 days you’ll have$4,000!’ The recruiter made testing drugs sound like a vacation in a five-star hotel,Burns said. “It’s like a resort selling time shares. They talk about all the benefitsfirst, and it sounds great, but then you start to ask: What do I have to do?”

Not long ago, such offers would have been considered unethical. Paying anyvolunteer was seen as problematic, even more so if the subjects were poor,uninsured, and compromised by illness. Payment, it was argued, might temptvulnerable subjects to risk their health. As trials have moved into the private sector,

vulnerable subjects to risk their health. As trials have moved into the private sector,this ethical calculus has changed. First came a hike in the sums that volunteerscould be paid: Many clinical trial sites now offer over $6,000 for an inpatient drugstudy. Eligibility requirements have changed, too. For years, trial sites paid onlyhealthy volunteers, mainly to test new drugs for safety. These days people withasthma, diabetes, kidney disease, liver disease, and other conditions can be paidto take part in trials.

More startling is that recruiters are able to approach patients with serious mentalillnesses, such as bipolar disorder and schizophrenia. “We are looking forindividuals 18 and over who are diagnosed with schizophrenia or schizo affectivedisorder,” read a recent Craigslist ad in St. Louis. “Earn up to $2,800.00.” Aroundthe same time, I saw an ad for a Los Angeles site that was offering three times asmuch for a related trial. South Coast tests experimental schizophrenia drugs, too,but only outpatient trials of drugs that have passed initial safety tests. Volunteersare typically paid $40 to $50 per visit. “The payments are low enough to not becoercive, but they’re enough to supposedly compensate them for the time they’vespent here, and give them an incentive to come back,” Sfera said. Still, Walters,who has since left South Coast, added that money is what motivates mostsubjects. “I’d say at least 85 to 90 percent of clients, that’s why they do studies.”

The main ethical issues here, of course, are the competence and judgment of theprospective subjects. “When you say ‘money,’ everything else goes out thewindow,” said Hanif Jackson, a former program supervisor at the Ridge Avenueshelter in Philadelphia, which recently closed down. I heard the same thing fromHarvey Bass, a chaplain who has worked at the Sunday Breakfast Rescue Missionshelter for 15 years. He said drug study recruiters often park outside the shelterand approach residents on the sidewalk. Although Bass didn’t think it was hisplace to warn residents away from the studies, it was clear that he was not exactlya fan. “These guys have no job, no home, and a habit,” he said. “You have peopleat their lowest state, and they’ll say yes to anything.”

Sherman Howerton was sitting onthe steps of the Station House shelteron North Broad Street when I methim in Philadelphia last year. A polite,well-spoken man in early middle age,he was wearing black pants, a whiteshirt with a large black stripe, andblack-and-white tennis shoes. Helooked like a referee. “I suffer fromschizophrenia,” he told me,

schizophrenia,” he told me,explaining that he used to havememory lapses and hear voices.Howerton did his first antipsychotic

study in 2010, and has taken part in three more since, including an inpatient studyof Abilify. “The medicine helps a heck of a lot,” he said. Yet he was carrying quite alot of excess weight, and I noticed that his mouth twitched every few seconds.

Abilify was the best-selling drug in America in 2013, with sales of $6.5 billion. It isalso the most visible representative of an extraordinarily profitable class of drugs.Antipsychotics have been around since the 1950s, but for the first 40 years of theirexistence they were reserved for patients with serious mental illnesses, such asschizophrenia. (Medical journals advertised them with slogans such as “Reducesneed for shock therapy and lobotomy.”) There was good reason for this caution:Antipsychotics can cause potentially dangerous or disabling side effects, such asmuscle stiffness, tremors, extreme restlessness, and tics. The most notorious istardive dyskinesia, a writhing, twitching motion of the mouth and tongue that canbe permanent.

About 20 years ago, pharmaceutical companies began rolling out new andimproved, or “atypical,” antipsychotics—drugs like Risperdal, Zyprexa, Seroquel,and later Abilify. The atypicals were expensive, but the companies’ marketingmaterials described them as safer and more pleasant to take. By the mid-2000s,physicians were prescribing the new antipsychotics for a dizzyingly broad range ofconditions, including insomnia, depression, anxiety, bipolar disorder, agitation,autism, ADHD, and post-traumatic stress disorder. Prescriptions of antipsychoticsfor conditions other than serious mental illness doubled, and the drugs foundfrequent use in nursing homes, juvenile care facilities, and prisons.

The reputation of the atypicals was so stellar that many psychiatrists were shockedby the publication in 2005 of a large, federally funded trial known as the CATIEstudy. Researchers compared the best-selling atypicals to a 1960s-eraantipsychotic and discovered that, despite the marketing claims, the newer drugswere no more effective than the old ones and still carried some risk of the sameside effects. That same year, the FDA added a warning notice to antipsychoticslabelling, after the drugs were linked to increased mortality in elderly patients withdementia. Soon afterward, British researchers who had tracked patients onatypicals for the course of a year showed that the patients had no better quality oflife than those on older antipsychotics, despite the far greater cost of the atypicals.

Then there were the metabolic problems. Almost from the start, doctors reportedseeing patients on antipsychotics experience sudden weight gains. Somedeveloped diabetes. At the end of the 2000s, it was alleged that the manufacturersof atypicals had used misleading marketing strategies and downplayed the sideeffects. Bristol Myers Squibb settled federal charges over the illegal marketing ofAbilify in 2007. Two years later, Eli Lilly pled guilty to criminal and civil charges thatit had illegally marketed its blockbuster atypical, Zyprexa, and was forced to pay a

$1.4 billion penalty. Soon afterward came large settlements or penalties againstAstraZeneca (for Seroquel), Pfizer (Geodon), and most recently Johnson &Johnson, which paid $2.2 billion this past November for illegally marketingRisperdal.

Still, the drugs remain on the market, and drug companies are continually trying todevelop new versions. In most fields of medicine, healthy volunteers are used forthe initial tests of drugs, where the focus is on side effects. After all, it’s easier tolink side effects to a drug if the patient is healthy. It can be hard otherwise to knowwhether a symptom is the result of the illness itself, or even of another medicationthe subject is taking. There are also ethical reasons for using healthy volunteers.The initial safety studies, known as Phase I trials, are almost pure risk and nobenefit. A sick patient who signed up for such a study might need to stop taking anapproved drug—a drug that might well be helping—in order to test the toxicity ofan experimental treatment.

Yet this is precisely what happens with antipsychotics, which are tested first onmentally ill patients who will often need to stop taking medication in order to join atrial. And these are trials that offer little chance of therapeutic benefit, becausemost drugs fail at some point during testing. One study looked at central nervoussystem drugs that emerged from a company’s own labs and entered human tests;only 8 percent were eventually approved.

If you talk to the researchers who do the testing, they’ll say that this makes sensebecause patients with schizophrenia tolerate antipsychotics better, and at muchhigher doses. “You see different side-effect profiles,” said Charles Bailey, medicaldirector at Accurate Clinical Trials, a trial site in Kissimmee, Florida. “The more illthey are, the more they suck up the drug.” This view is widely shared, but reliabledata on the issue is thin—mainly, small studies of only a few hours’ duration, andlimited to older, generic drugs. A more cynical view is that healthy volunteers willnot take such risky, unpleasant drugs, even if they are paid a lot of money. Even asingle small dose of an antipsychotic will cause some subjects to experience asudden drop in blood pressure and faint. Many people say the drugs make themfeel miserable. Bob Helms, the founder of the now-defunct magazine for clinicaltrial volunteers, Guinea Pig Zero, who was a healthy volunteer on over 80 trials,describes antipsychotic studies as “getting half-retarded in exchange for payment.”

There are 10 different atypical antipsychotic drugs now available in the UnitedStates, each of which had to be tested in humans. Several are available in long-acting or injectable formulations, which require additional human testing. When thepatent on a drug expires, rival companies often release a generic version, whichrequires yet more testing. Add to this all of the experimental antipsychotics thatwere tested on volunteers but never made it to market, and you begin tounderstand the economic forces behind what I saw in Philadelphia. Drug

understand the economic forces behind what I saw in Philadelphia. Drugcompanies need mentally ill research subjects, and homeless shelters are full ofthem.

At a shelter called My Brother’s House, I met a resident I will call Anthony, afriendly man in his late 40s with a cheerful smile and a machine-gun laugh. He toldme he had taken part in more than 20 studies of antipsychotics. “They call me aprofessional,” he said. He spoke so quickly that I could barely keep up. “I only doschizophrenic research studies, even though I’m schizophrenic and bipolar…I triedto do the one for severe patients but they wouldn’t let me in. You have to hearvoices every day of the week, and I only hear once or twice a month.”

“They treat you well,” Anthony said when I asked him how he felt about the studies.“You watch TV. They have DVD, CD, PlayStation, Xbox. They order out mealsthree, four times a week. Chinese food, cheese-steak hoagies, Buffalo wings,pizza. They gave me a birthday party a few years ago. I had to cut the cake. Theysang me ‘Happy Birthday,’ and they were on-key.”

Anthony appeared to suffer from many side effects that you might expect to see insomeone who had taken so many antipsychotics: diabetes, significant weight gain,and limb stiffness, for which he takes a drug called Cogentin. He mostly didn’tattribute these problems to the research studies, however, with the exception of histendency to sometimes spit up. “But,” he said, “that didn’t happen until I did about12 or 13 studies.”

Anthony’s feelings aren’t unusual;other homeless people I met told methey appreciated the comforts of theinpatient research unit. Often the sideeffects are worth it, at least in theshort term. But not always.

On a sunny morning a couple ofyears ago, I visited a research unit atLourdes Medical Center of BurlingtonCounty in Willingboro, New Jersey.The unit was operated by CRI

Worldwide, the same company thatBurns told me he had spoken with. (The company is now known as CRI Lifetree.)Its focus was on inpatient Phase I trials, which often involve gradually increasingthe dose of a drug until subjects begin to feel toxic side effects. Some Phase Istudies also require painful or unpleasant invasive procedures. For these reasons,the payment to subjects in Phase I trials is usually much higher than it would be foran outpatient study.

My first thought about the CRI unit: Its appearance did not exactly suggest clinicalexcellence. Most of the furniture looked as if it had been rescued from a SalvationArmy store. Homemade notices with titles such as “Smoke breaks” and “Moneyrequests” hung on the walls. No studies seemed to be going on, but a few peoplewere wandering around or watching television, presumably waiting to be screenedor assessed.

My tour guide was Steven Glass, a psychiatric researcher in his early 60s who hadbeen with CRI for 12 years. He wore a goatee and a baby blue blazer. Glassreluctantly agreed to show me around the locked unit after I called from the lobby,uninvited and unannounced, explaining that I wanted to see what a Phase Ipsychiatric unit looked like. I was pretty sure that he would not have let me in if Iacknowledged my other reason for visiting, which was to have a firsthand look atthe place where Walter Jorden died.

Jorden had been admitted to the CRI trial unit in April 2007. He was a 47-year-oldveteran, the father of three children, and a widower whose wife had died six yearsearlier. His diagnosis was paranoid schizophrenia. Jorden heard voices that toldhim to commit suicide, and once tried to hang himself. He had been hospitalizedfor depression, substance abuse, and a potential heart problem. At the time of thetrial he had a monthly income of $845 in disability benefits and was living in a run-down recovery house outside Philadelphia called New Desires.

CRI offered Jorden a paycheck to test an antipsychotic drug called ASP2314, anexperimental compound then in development by Astellas Pharma. Exactly howmuch Jorden was being paid is unclear, but if the rates at CRI were comparable tothose at other sites, it was probably somewhere around $2,000. According todocuments from a malpractice lawsuit subsequently filed by Jorden’s family, hewas expected to spend about a month in the unit. During that time he would begiven the drug and monitored for side effects as the dosage was graduallyincreased. In particular, the study called for frequent measurement of Jorden’sheart rate, blood pressure, and heart rhythm, using an EKG machine. Jorden alsohad to wear a Holter monitor, which researchers used to continuously record hiscardiac status.

There was a good reason for this attention to the heart. Antipsychotics can causeheart arrhythmias, including a very dangerous condition called torsade de pointes,which can lead to sudden death. In 1996, an experimental atypical antipsychoticcalled sertindole failed to make it to market in the United States after it wasassociated with 12 sudden, unexplained deaths in clinical trials. Mellaril, a once

associated with 12 sudden, unexplained deaths in clinical trials. Mellaril, a oncefrequently prescribed antipsychotic, now has a black box warning for risk ofarrhythmias and sudden death. For this reason, many Phase I trials ofantipsychotics now include careful monitoring for potential heart problems.

On day eight of the study, shortly after 10 a.m., Jorden told an attendant he washaving chest discomfort. According to the court documents, he was sweaty andshort of breath. Doctors were called, including Glass, the researcher in charge ofthe study. They decided Jorden was having a panic attack and prescribed Ativan,an anxiety drug. An hour or so later Jorden left his room and went to the nurse’sstation, again in distress, where another CRI physician instructed him to breatheinto a bag. At noon Jorden was given a second dose of Ativan; he immediatelystarted to tremble and shake, and then fell backwards, unconscious. The staff triedto resuscitate him, but at 12:35 p.m. Jorden was pronounced dead. According toan autopsy performed later, he died of “myocardial infarction,” or a heart attack.

It appears unlikely that Jorden’s heart attack was caused by the experimental drug.But according to Jeffrey Fierstein, a cardiologist retained as an expert witness byJorden’s family, the physicians involved deviated from expected standards of careby not more seriously considering the possibility that Jorden was having a heartattack. In Fierstein’s opinion, they not only ignored classic signs of a heart attack,but also neglected to perform an EKG and missed the opportunity to give Jordenthe clot-busting drugs that might have saved his life. As Fierstein points out, “Myunderstanding is that it [the emergency department] was around the corner; it wasright there.”

I followed up by phone and email after my visit, but none of the people involvedwere willing to talk. Representatives at PRA, the clinical research organization thatacquired CRI Lifetree last November, did not respond to inquiries. JosephGoldberg, the attorney who represented Steven Glass, would say only that allcharges against his client were withdrawn after the court approved a settlementbetween the other parties in the case. I even tried calling the number of a CRIrecruiter that I found on a business card I picked up at one of the shelters inPhiladelphia. I got through, but the conversation was brief, and the recruiter didn’ttake my subsequent calls.

Many people assume that medical

Many people assume that medicalresearch studies are tightly regulatedto ensure the safety of the subjects,but that’s not the case. In the 1970s,after a series of notorious researchabuses, legislators pushed for acentral federal agency with the powerto protect human research subjects.The medical research establishmentfought this idea, however, and whenthe National Research Act waspassed in 1974 a very differentalternative followed: a patchwork

system of small ethics committees known as Institutional Review Boards. Theboards were originally located in hospitals and medical schools, but clinicalresearch has since moved into the private sector. Many are now for-profitcompanies that review studies in exchange for a fee.

Still, most trials have to be studied by a review board, and that includes studiesthat use homeless people. The boards could take a stand against the practice, andperhaps some do. Finding out is next to impossible, because both the FDA and thefor-profit boards regard many of the records associated with clinical trials ascommercial secrets. Even the name of the board that reviewed a trial isconfidential. This secrecy means that it is hard to determine whether reviewerseven know where trial sites are recruiting their subjects. There’s also a conflict ofinterest to consider: Perhaps review boards don’t ask too many questions,because a board may start losing customers if it gets a reputation for being toostrict.

Federal protection is little better. The FDA’s oversight, for instance, can be porous:One report found that between 2000 and 2005 the agency had only 200 inspectorsto police an estimated 350,000 testing sites. And while there are federal guidelinesthat cover clinical trials, it’s unclear whether recruitment of mentally ill subjectsfrom homeless shelters and recovery houses violates these rules. Thoseguidelines require selection of subjects to be “equitable,” and special protection isrequired for subjects who are “economically disadvantaged” or “mentally disabled,”since these people are “vulnerable to coercion or undue influence.” But theguidelines make no mention of mental illness per se. Nor do they specify whatconstitutes being “economically disadvantaged.” The FDA declined to discuss the

issue with me, but said in a statement that neither federal law nor its ownregulations prohibit people living in homeless shelters from taking part in clinicaltrials.

None of the bioethicists or review board managers I spoke to were willing topublicly defend paying mentally ill homeless subjects to take part in clinical trials,although most did not seem especially surprised to hear that the practice wasoccurring. But some prominent bioethicists do not see homelessness as a barrierto research. When The Wall Street Journal reported in 1996 that thepharmaceutical company Eli Lilly was recruiting homeless alcoholics for researchstudies, Lilly responded by hiring an expert bioethics panel led by TomBeauchamp of Georgetown University. The panel argued that not only was testingdrugs for safety on homeless people reasonable, provided proper procedures werefollowed, but also that “it would be unfair to exclude homeless personscategorically as a group.” Beauchamp and another panelist, Robert Levine of Yale,went on to become paid ethics consultants for Lilly.

The guidelines governing the selection of research subjects also tend to have adeeper conceptual flaw. In the notorious research scandals of the 1960s and ’70s,the common element was exploitation. With the Tuskegee syphilis study it wasexploitation of poor black men in Alabama; with the Willowbrook hepatitis study itwas exploitation of disabled, institutionalized children; with the Holmesburg Prisonexperiments it was exploitation of prisoners. In each case, researchers with powertook advantage of vulnerable populations, getting them to “volunteer” for studiesthat most people would refuse.

Yet you will not see the word “exploitation” in the federal guidelines governingresearch. Nor will you see it in the Declaration of Helsinki, a foundational ethicsdocument first signed in the Finnish capital in 1964, or most other codes ofresearch ethics. What you will see instead are instructions to avoid “coercion” and“undue influence.”

Concepts like “coercion” and “undue influence” are poorly suited for economictransactions, however. Offering desperate people money to take risks to theirhealth may be wrong, but nobody is being coerced. No one is threatening to harmpeople if they refuse to become test subjects. One parallel would be sweatshoplabor. The ethical problem is not that people are coerced into working insweatshops—people are desperate to work there, under horrific conditions, forpennies. The ethical problem is whether it is acceptable to take advantage of theirdesperation.

I saw the same desperation on one visit to the Sunday Breakfast Associationshelter in Philadelphia. I was looking for former research subjects in the day room.It was a large, open space, filled with people slumped over in chairs, eyes glazed,or sitting with their heads down on a table. Many of them seemed sleepy ordrugged. There was no television in the room, no conversation, just silence. Thestench of urine and sweat was overpowering.

As I moved from table to table, people started calling out to me. It wasn’t that theywanted to talk to a reporter. They thought I was a recruiter for clinical trials. “I wantto be in a study,” a young woman in a hoodie yelled, bundled up in a corner. I triedto explain that I wasn’t a recruiter, just somebody looking for information, but itmade no difference. Word spread quickly across the room. People were still callingto me as I went out the door.

This story is the first in a two-part investigative special on problems in the clinicaltrials industry. The second, which asks why disgraced doctors are allowed to testdrugs on human volunteers, is available here.

This first part was written by Carl Elliott, edited by Jim Giles, fact-checked byKyla Jones, and copy-edited by Lawrence Levi. Photography by JeffreyStockbridge. Illustrations by Matt Rota. Aleks Krotoski narrated the audioversion.

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Thanks to Mark Lotto and Lawrence Levi.

Thanks to Mark Lotto and Lawrence Levi.

Homeless Medicine Big Stories Matter

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Carl ElliottMedical muckraking. Author of White Coat, Black Hat and Better than Well:American Medicine Meets the American Dream.

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