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Summer 2002

Trial(s) and Error: PWC Offers Tips for Participating in Drug Tests
By Michelle Lapuk

It was more than 10 years ago, but I still remember that autumn day well. A friend called to tell me that she had heard about a drug trial taking place at the National Institutes of Health (NIH) in Bethesda , Md. I lived in Connecticut and had very little money, but my friend insisted that I call anyway. To my amazement, NIH offered to pay for all my travel and food needs — and to provide the drug free of charge. I was enthusiastic, excited, a bit intimidated and unsure of what to expect from my first CFIDS drug trial.

That trial was for an anti-viral drug called Acyclovir. Then came hydrocortisone, Inter-leukin 6, Florinef, Ampligen and a host of other trials. Over the past decade, I’ve become a regular participant in trials for CFIDS-related drug treatments. In fact, you could call me a drug trial junkie. In writing this article I hope to share some of my expertise with others who are looking to take part in clinical drug testing.

The question I get asked most often is where I find all these studies. I have seen advertisements on television and newspaper articles. I also search the Internet. Drug companies also have Web sites looking for volunteers. Two of the most helpful sites are http://www.centerwatch.com and http://www.clinicaltrials.gov/. (Editor’s note: The CFIDS Chronicle occasionally posts calls for test subjects in the Bulletin Board section. A list of current drug trials also is available on the Association’s Web site, www.cfids.org.)

It’s important to understand that all drug trials are not alike. Some of them are an attempt to get an experimental drug on the market, some are trying to prove a certain drug can be used for a particular condition and some are looking at dosing changes.

The people who run trials also have different agendas. Some trials are run by drug companies who just want their drug on the market. Some physicians run clinical centers and do studies strictly for the money. Some doctors have a genuine interest in CFIDS research.

You need to ask a lot of questions to find out if a trial fits your needs. Before entering any drug trial, you should receive a consent form. This form should list all possible drug side effects and possible interactions. Read it very carefully. Show it to your primary care physician, and ask for advice.

This is especially important when the drug is truly experimental. If a drug does not have FDA approval, the government has not officially deemed this drug safe. If the consent form indicates that monkeys had heart trouble in previous studies, ask how the monkey heart trouble could translate to human heart problems. Your question may seem silly, but if it eases your mind then it is worthwhile.

By the way, don’t assume that a doctor running your trial now becomes your primary care physician. That’s not the case. You will continue to use your regular doctor for all issues not directly related to the drug trial.

Many of the trials I have participated in used a double-blind placebo format. To someone not familiar with research jargon, this all sounds like gibberish. But it’s not that complicated. A placebo is an inert or innocuous substance used in a controlled experiment to test the efficacy of a drug. A placebo may be a sugar pill or a saline drip or anything that the drug company feels will not have an actual effect on the patient. Some patients get the real drug, while others get the fake, look-alike placebo.

The problem with CFIDS and placebos is that many patients have so many sensitivities. In some cases a placebo may not actually be one. For example, if saline is used as the placebo, and saline may help with orthostatic intolerance, then the study is flawed to begin with.

Double blind means that neither the doctor nor the patient knows what is being administered. I prefer double-blind studies because when the doctor knows what they are administering it is very hard to be objective.

You must always consider your level of commitment before starting a drug trial. In many cases you may have to give up more time than you initially expect. It is not as simple as swallowing a pill and going home. There may be screening questionnaires, depression evaluations, blood work, daily activity logs and an array of various forms to fill out. I urge you to tell the truth. I have seen many patients so desperate for help, that they are not honest on the forms. You may be disqualified, but in the end it probably is for the best. I once got kicked out of a CFIDS study halfway through because they found out I also have a thyroid condition. I should have told them up front.

Only one in 20 people who start trials actually finish them. When you change your mind and drop out, it only hurts those who stay in. It is unfair and slows down the study. It is one thing to drop out because of side effects; it is another to drop out because of lack of commitment. These studies are slow enough. By the time it is unblinded and published it can take years.

One thing I like about studies is that in many cases everything is paid for. You may or may not be paid to participate, but you should be receiving the drug for free. You also may be paid for air or car travel costs. Be extremely cautious of any study where they ask you for money!

I am also on Social Security Disability. I am not sure if it helps, but I always let them know that I am participating in various studies. It shows a continued desire to try to get well.

All in all I really enjoy participating in drug trials. I feel that in a small way I am helping my own fate. I do acknowledge that drug trials are not for everyone. That’s a decision you’ll have to make on your own.

Michelle Lapuk is a former ABC television reporter. She is currently co-president of the Connecticut CFIDS/FM Association, Inc. Michelle lives in Bloomfield, Conn.

Weigh the drawbacks before starting trials

Clinical drug trials are essential in CFIDS research. But be aware of these potential drawbacks before participating: 

• You may need to go off all other medication — even those not related to CFIDS.
• Some drugs cause an initial worsening of CFIDS symptoms. You may need extra help from caregivers at first.
• The drug may not be available for use after the trial. Even if it is available, you may have to pay for it.