In American urban centers, where homelessness is abundant and the working class slips into poverty, it is not difficult to find people willing to test experimental drugs in exchange for a little cash. Here in Chicago, ads for pharmaceutical studies can be found on CTA trains and buses; in Philadelphia, they are advertised in local newspapers, and recruiters often visit shelters. Dangerous drug lawyers at Pintas & Mullins take a closer look into how Big Pharma is testing medications on the homeless, and getting away with it.
Carl Elliott, writing for Medium, recently published an extremely troubling but illuminating article on this topic. The studies discussed in his piece can be for pharmaceutical companies, medical schools, or drug testing companies, who pay volunteers to take new, experimental drugs, and monitor their reactions.
Many programs request volunteers who are already addicts, or depressed, but most are to test the risks and side effects of psychiatric drugs, such as stimulants (Adderall, Vyvanse), anxiety drugs (Valium, Xanax), antipsychotics (Risperdal, Seroquel), and antidepressants (Paxil, Zoloft). Aside from homeless shelters, research organizations often recruit subjects from facilities where mentally ill residents are provided shelter and meals.
Most people simply do not think about how pharmaceuticals are approved for market - or they think the research is highly controlled in medical centers. In reality, Big Pharma contracts the research out to private research organizations, which can run clinical trials quicker and cheaper than medical schools. Today, the contract research industry generates annual income of more than $100 billion.
Is This Legal?
Not too long ago, when clinical trials were run by government programs, this type of payment-for-treatment was considered unethical. Experts believed that paying a subject placed vulnerable, uninsured people to serious health risks. As mentioned above, clinical trials moved into the private sector, and ethics were sidestepped.
In the federal guidelines for drug research are instructions to avoid coercion and undue influence in recruiting volunteers. The problems with this language are obvious: Elliott compares using addicts and the homeless for drug trials with children working in sweatshops. No one is coercing or threatening these people to do this (that would make it illegal), but it is an ethically wrong to exploit desperate people and take advantage of them by offering money.
The more dangerous and lengthy the program, the more it pays; many trials offer more than $6,000 for inpatient drug studies, and subjects no longer have to be in good health. Volunteers are accepted with wide ranges of ailments, from liver disease to schizophrenia. Researchers freely admit that 85 to 90 percent of subjects volunteer for the money.
The drug trial business is just that: a business. Currently, there are about ten different types of atypical antispychotics on market, and many more that were tested but never approved for market. When the patent on these drugs expire, rival companies will need to test their own versions to sell. This a business like any other - drug companies need mentally ill people to test their drugs on, and there is a steady supply of this demographic in halfway houses and homeless shelters.
Homeless subjects that take part in in-patient studies told Medium reporters that they are treated well - meals are ordered in several days a week, access to TV, DVDs, XBOX, birthday parties - comforts that we take for granted. Many feel that the side effects are worth it, most of the time, and take volunteer for dozens of trials.
Another Medium profile of drug trials, written by Peter Aldous, details how the doctors running these trials are often themselves abusing drugs. In fact, it is not uncommon for disgraced doctors to find high-profile jobs in the drug industry. Aldous found dozens of doctors working on clinical trials who have had disciplinary action taken against them by state medical boards. Making matters worse, the FDA rarely inspects trial sites.
Many argue that doctors should be held to higher standards for clinical research than for regular practice. These doctors are responsible for the welfare of dozens, if not hundreds of patients who rely on them for advice. They should be at the top of their game, not bottoming out.
Side Effects, Deaths, and Lawsuits
Antipsychotics are booming in the U.S., often prescribed in nursing homes, prisons, and to children, however, they cause dangerous and permanent side effects. Among the most popular antipsychotic drugs include Abilify, Seroquel, Risperdal, and Zyprexa.
Side note: Prescribing these drugs to elderly residents of nursing homes can be considered nursing home abuse, as the FDA has added warnings to antipsychotic labels regarding the risk of early death in patients with dementia.
Medical malpractice lawsuits can also result from negligently performed or poorly monitored drug trials. The children of Walter Jordan recently sued the research firm CRI Lifetree for his wrongful death. Jordan was a veteran, widower with three children, and paranoid schizophrenic surviving on disability benefits. He was offered around $2,000 to take part in an antipsychotic drug trial, where he would spend about two months in-patient.
It was a Phase I trial, so he would remain on the drug and monitored for new and changing side effects as doctors steadily increased his doses. Staff would monitor his heart rate, rhythm and blood pressure, as antipsychotics can cause dangerous heart conditions. Eight days into the trial, Jordan felt discomfort in his chest and was short of breath. Doctors told Jordan he was having a panic attack and prescribed an anxiety drug; by noon, he had been given a second dose of the anxiety drug, started shaking, the fell unconscious. At 12:35, he was pronounced dead. His autopsy lists heart attack as his cause of death.
His family sued CRI for failing to properly monitor Jordan and refusing to medically intervene to save his life. There was an emergency department right around the corner from the CRI clinic he was staying in, and doctors were well aware of the drugs' cardiac risks. The case ended in a sealed settlement.
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