Human Guinea Pig: Are clinical trials the answer to your prayers?

I was browsing Facebook when an ad caught my eye: “Crohn’s Study – Diagnosed Volunteers Needed.” Crohn’s Disease is incurable, and it can make a patient’s life a living hell. I have it. I was intrigued, so I clicked on the link.

The link took me to the site, which is a patchwork quilt of promises, each highlighted in a color block with handy links to allow visitors to apply online. I was tempted by the promise of remission dangling in front of my very eyes … for free!

But what kind of help is really being offered here? That is unclear. Anyone can go to and do a search for available trials, so why register through a third-party site? The advantage may lie more to the drug companies than with the patients. According to Fortune magazine, the cost to develop and gain FDA approval for a new drug today is more than $2.5 billion. Driving much of that cost are human clinical trials, and from a regulatory standpoint, they’re essential; but not enough people are enrolling in them right now. Only between 3% and 5% of adult patients are under clinical trial care. It seems that the enticing advertising of recruitment sites is a major factor in luring patients to enroll. Why aren’t more patients jumping at the chance for free, groundbreaking treatments? It may have to do with the odds.

If you are a terminally or chronically ill patient, these trials offer you hope, but unfortunately, hope is the only promise the trials can be certain of keeping. Many drug trials are very much like the lottery – your chances of getting the actual medication or procedure is a crap shoot. The result variation between a new drug and a placebo is what controlled studies are all about. And if you do get the real treatment? These are trials, remember? There’s a reason you sign a consent form before starting. There may be unpleasant side effects or no results, which are some of the things studies hope to discover.

I asked my friend Dr. H what he thought of drug trials. He made it clear that he didn’t want to promote, publicize or endorse them in any way. Dr. H is not a fan of the pharmaceutical industry in general. “Their drug reps lie, they extort exorbitant amounts of money from the healthcare system and patients, and they purchase most of their breakthrough products after some small start-up has done all the innovation and discovery. I think most of the ads you are seeing are from doctors who get paid a good amount to do the trials; they are helping the manufacturer sell their product. These particular trials are almost certainly not done in academic centers,” he said.

So, are there any advantages to participating? Well, there is a chance you may receive a new treatment before it is widely available to the public. You might also help provide researchers with the information they need to develop new procedures and treatment methods. Your treatment costs may be decreased, or free, because many of the tests and exams are paid for by the company sponsoring the study. But your insurance may or may not pay for medication after the trial.

What is the downside? Obviously, because the drug or device is new, the exact risks are not known. There may be damaging side effects along with possible benefits. Most treatments do have potentially unpleasant effects. And then there is the uncertainty. In many cases, you have no way of knowing whether you are receiving the groundbreaking drug, a traditional treatment, or a placebo.

Are clinical drug trials for you? That is for you to decide. But that decision should not be based on the cajolery of recruiting sites. Once you enroll, it is your own health on the line and you have no idea what will happen. However, for a patient who has run out of options and is grasping at a last straw, drug trials can be one last beacon of hope in a very bleak world.

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