I Was a Human Experiment 

Want free treatment for that arthritis or memory loss? You too can sign up to be a human guinea pig.

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I was a human experiment. It sounds a bit morbid in a B-movie sort of way, but by signing up to become part of a test panel to examine the herb ginko bilboa’s effectiveness for memory enhancement, I became a small part of a worldwide effort by drug companies to get their products certified for use by doctors and pharmacists. And all I really wanted was to find my car keys in the morning.

As with most steps into the unknown, my adventure began innocently enough. Reading the newspaper one Sunday in June, I saw an ad seeking adults ages 40 to 60 to be part of a group to determine if ginko actually helped to improve memory. With my 50th birthday right around the corner, I am somewhat pleased with the way the years are treating me. No problems with the ol’ rheumatism or arthritis. No high blood pressure, and my cholesterol counts linger in the normal range. Sure, some people claim that I snore, but since this never bothered me, I don’t see it as that big of a problem.

But that damn memory is another story. Absentmindedness has been my bane. Once, on my way home from Atlantic City, I took a cash-filled envelope out of my pocket to adjust my pants and put it on the roof of my car. Check the oil. Check the tires. Drive off and go. Say goodbye to $500 somewhere on the Garden State Parkway. On another occasion, after searching two days in vain for my car keys, I seriously—and I do mean this—entertained the idea they were dematerialized by space aliens, who then evilly rematerialized the keys where I had last left them as a bookmark.

These are but two examples of a chronic malaise made worse by a shattered confidence. I can be holding a pair of reading glasses in my hands and still think that I have lost them. So when I saw that ad offering free treatment and a couple of hundred bucks to boot, not only did I tear it out, I tore out the entire page. And that’s what brought me to Pharmacological Research Associates in Murray. Trying to call their number proved futile. The constant busy signal indicated there were a lot more people than me seeking help for “the problem.”

Since the address was in a business complex near Fashion Place Mall, I drove down to plead my case in person. I need not have been so anxious. The polite receptionist in the pleasantly decorated office informed me that several hundred participants were needed for the study, and would I please fill out this questionnaire.

It’s been a while since I visited a doctor’s office, but the questions seemed quite standard—no heart disease, no schizophrenia, no diabetes, etc. etc. Following the questionnaire, I was interviewed by a staff psychologist about any special diets I followed. Nutrition-free, I replied. Any past family issues that could affect my stability? Normal dysfunctional, I replied. A thorough medical physical followed, which included blood and urine samples and an EKG. I made it, flying colors.

The dotted line that I signed stipulated I would take two pills a day and report to the center for three subsequent monthly follow-up visits, which would last a day each. For this I would receive $500. Nowhere did I see any mention of heavy lifting. Hey, just gimme a glass of water and pass me the pills. To my résumé I could now add: Human Experiment. I had become part of a $3 billion testing industry that annually utilizes between 50,000 to 100,000 human volunteers.

Human testing isn’t exactly new. In 1900, Army doctor Walter Reed was sent to Cuba to investigate the deadly yellow fever. One theory held that it was transmitted by mosquitoes. A member of his team, bacteriologist Jesse Lazear, allowed himself to be bitten by a mosquito. His subsequent death confirmed the mosquito theory and led to control of the disease.

There are other examples not quite as noble. In fact, some are downright despicable. The Nazis’ medical testing on concentration camp prisoners comes to mind. And the U.S. government is also guilty of infamy. Just ask the Utahns subjected to downwind radioactivity. Or the victims of the Tuskegee syphilis experiment. In 1932, the U.S. Public Health Service and Tuskegee Institute enrolled 400 poor black men with syphilis in Macon County, Ala., in a study to view the long-term effects of the disease. The men were told they were only being tested for “bad blood.” At the start of the program, there was no proven treatment for syphilis. But after 1947, when penicillin shots became standard, treatment was still withheld.

The experiment lasted until 1972, when newspaper reports exposed the program. The NAACP successfully sued for $9 million and free medical care for the men. But it wasn’t until 1997 that President Clinton formally apologized, saying, “what the U.S. government did was shameful.”

Conspiracy theorists may say we are equally uninformed as to what’s going on now, but the smart money realizes drug companies have too much on the line to risk such debacles. Dr. James Ferguson, the head of Pharmacological Research Associates, estimates that only one out of every 10,000 pharmaceutical products that a company considers actually reaches the market. The drug that does make it comes at a huge cost. An article in USA Today reported that it takes an average of 15 years and $800 million to discover, develop and bring a new drug to pharmacy shelves.

Ferguson’s firm has been conducting human studies since 1987. His background since medical studies at Stanford University in the 1960s has been in research. The staff at Pharmacological Research Associates currently has three physicians, a psychologist and two social workers. They are not alone. In the Salt Lake area, there are nearly a dozen other research firms testing drugs in areas such as post-menopause, diabetes, prostate disease, high blood pressure, Alzheimer’s, depression and pre-menstrual stress. But Salt Lake is by no means unique. Ferguson said every urban area in America has such research companies. Even Boise has four of them. They are part of a long investigative chain that determines whether a drug will ever find its way into a little brown bottle available through your pharmacist.

When a pharmaceutical company believes it has a promising product, the first step is to test it on a wide variety of animals. Ferguson explained this is necessary because different species show different anatomical similarities to humans. Birth defects, toxicity and side effects are all closely monitored. Animal testing can take up to two years. If the results look promising, the company can apply to the FDA for permission to test the drug in a three-phase human trial.

The first phase looks at a drug’s safety. Up to 100 healthy volunteers, who are literally professional human experiments, are paid several thousand dollars to spend time at research hospitals being monitored for any adverse reactions. If the drug passes this stage, then a second test of up to two years involves patients who test it for safe dosage levels and effectiveness as compared to other drugs on the market.

If results are still promising, phase three testing administers the drug to several thousand people to see the effects on a wide scale. This is where local testing agencies come into play. Cathy Revere, clinical coordinator for Salt Lake Research, says her firm conducts about 20 studies a year. “We get our clients from both advertising and doctor’s referrals,” she said. “We try to avoid patients who are in it for the money, but instead are here to find out about other treatment options available.”

Revere said the results of the testing are submitted weekly to an independent review board to make sure protocols are being followed. But with that kind of oversight and the FDA auditing results to ensure safety, how did the heart-valve problems from phen-fen occur? “It was a terrible accident,” Ferguson said. He explained the fenfluramine and phentermine were both FDA-approved drugs that a doctor could prescribe for weight loss. What was not approved, he said, was to mix both into a weight-loss “cocktail.”

“Small studies were made, but there simply was not sufficient data,” he said. Regardless of doctors’ prescribing patterns, he said the liability went back to the manufacturing drug firms.

But I was not particularly concerned with malfunctioning heart valves. Ginko has been a part of Chinese herbology for centuries. As an herb, it can be bought over the counter and does not come under FDA regulation. The purpose a Swiss pharmaceutical firm had in testing it on my 120-member panel was to see what benefits or side effects accrued from their more purified version.

Herbs aren’t the only natural substance subjected to research. For Ruth Pansen, it was broccoli. Pansen was part of a panel testing the effectiveness of nutrition and diet supplements to arrest macular degeneration, an eye disease associated with aging. She had to eat steamed or raw broccoli five days a week for three months. “I sure got awfully sick of eating broccoli. I’m only now getting to the point where I can stand it again.” For her participation, Pansen received $425, which included a broccoli stipend.

“The money was nice and the eye tests they did weren’t demanding,” Pansen said. “But the most rewarding part was the educational process. I’ve had cataracts and a detached retina. So I really appreciated learning and putting into practice how to take care of my eyes.”

For Mary, who asked that we not use her last name, the $300 she received for a three-month menopause study enabled her to visit her daughter in Chicago. During this period, she wore a patch on her stomach. “I wasn’t feeling very well and this was a way to try something different. All the doctors and nurses treated me with respect and courtesy. I can’t say that I felt any better, but I didn’t feel any worse, either.”

As for my results, several weeks into the regimen, I felt confident that I knew where I put my hat, keys and wallet. The anxiety over misplaced articles lessened, and as for space aliens, they obviously had other items to dematerialize. On subsequent visits to the clinic, I was tested on a computer for number, word and picture recall. I was also tested for blood pressure and given a fresh bottle of pills for the month.

But what were they? Ah, the placebo effect. Each study member did not know whether they were receiving ginko or a placebo. “It is an incredible medical mystery,” Ferguson said. “If we could understand the placebo effect and the power the mind plays in healing, we could advance medicine by light years.”

In the meantime, drug trials will still be with us. Ferguson said there is intense competition to develop treatments for age-related diseases such as Alzheimer’s and arthritis. Heart disease, diabetes and depression are other areas where pharmaceutical firms are seeking to develop blockbuster projects.

But nothing will come to fruition without the element of human testing. “Everything in life has a risk,” Cathy Revere said. “Persons going into a study need to approach it cautiously, weighing out their options and figuring out what is best for them.”

Would I do it again? Well, I am keeping my eyes out for any test study that promises a miracle cure for snoring.

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About The Author

Allen Sacharov

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