Confidentiality Certificates: A False Sense of Security?

First, for those who don't know what a Confidentiality Certificate is (and if you didn't, why would you be reading this?), let me just briefly explain. A Confidentiality Certificate is issued by the federal government to researchers who ask for it and who are conducting research involving information about participants which, if disclosed, could put the research participant at risk financially, socially, criminally, or otherwise. For example, just knowing someone was enrolled in a study of a sexually transmitted disease, such as syphilis, would potentially be harmful to a participant. For this reason, and to enable researchers to enroll otherwise unwilling participants, all information collected during the research covered by a Confidentiality Certificate is protected from disclosure. That means the investigators can withhold the information, even if a court orders its release.

For years, researchers in psychiatric disorders, substance and behavioral addiction, and other fields have relied on the protection afforded by Confidentiality Certificates to offer participants assurance that information collected about them would not be shared. Researchers at Duke University have just published a paper in Science suggesting that this reliance may be far from secure.

In the case described in the November 14 Science article, the authors describe how, when they objected and Duke appealed a judge's order that information about a research participant be released in a criminal case, it became apparent that the judge was not even aware of the protections afforded by Confidentiality Certificates. Further, even when he was made aware, he ultimately ordered the information be released, under seal, to those involved in the case over which he was presiding. The information never actually saw the light of day only because it was ultimately deemed irrelevant to the case.

Laura Beskow and her colleagues at Duke, Lauren Dame and E Jane Costello, have done the biomedical and social science community a great service by bringing their experience in this matter to the public's attention and by highlighting the need for research into the incidence of breaches of confidentiality. Meanwhile, researchers and clinical trial participants alike should be aware that information collected during a clinical trial, while maintained as confidential under normal circumstances, may be exposed in a court of law.

-Joe

Putting Alternative Medicine to the Test

Alternative, or complementary, medicine encompasses all of the therapeutic and preventive strategies which enjoy a measure of success, despite not having been developed based on solid scientific principles. They include everything from herbal remedies to acupuncture, yoga and mindful thinking. Practitioners and patients alike swear by the effectiveness of particular healing methods, even where there may not be a scientific explanation of how they work or even empirical evidence that they do really work.

That alternative medicine has been taken seriously of late is evidenced by the establishment of one of the newest units of the National Institutes of Health - the National Center for Complementary and Alternative Medicine. The web site http://nccam.nih.gov/ lists a large number of clinical trials in this arena, involving the use of such interesting therapies as magnetic brain stimulation, broccoli sprout tea, moxibustion, polarity therapy, and expressive writing.

Criticism of research on alternative medicine arises on occasion, and when it does, is met with fierce opposition from advocates. The discussion customarily goes something like this:

"Alternative medicine is baloney."

"But many patients feel they've been helped by it."

"The science that is being done to prove whether or not these things work is pretty lame and, where it's been done properly, there's not much evidence of any real clinical effects."

"But many patients feel they've been helped by it."

"Patients aren't helped by the therapy at all - it's just the placebo effect at work."

"But many patients feel they've been helped by it."

I believe rigorously conducted clinical trials can make significant contributions to the conversation about alternative and complementary medicine.

First, clinical research on particular therapy or preventive measures could demonstrate their safety and weed out those that are actually harmful to patients.

Second, clinical research could demonstrate whether or not a particular therapy had a particular effect on patients, irrespective of whether or not the patient felt better. This would provide solid scientific information useful both inside and outside the alternative medicine debate.

Third, clinical research could quantify how much better patients felt as a result of a therapy, or by how much the incidence of a particular condition was lowered in a patient population as a result of a preventive measure.

I'm not sure there needs to be a determination, using clinical trials, of which alternative and complementary approaches should or should not be allowed, except in the case where significant health safety issues are raised. Rather, clinical trials can show whether or not a particular approach can be moved out of the "Alternative" realm and be accepted by the medical establishment and the communities it serves as a scientifically proven approach. And in the meantime, those approaches that have yet to be proven to have a measurable physiological explanation or effect can continue to benefit those patients who believe in them.

-Joe

Related Topics:

• Natural Medicine is Based on Science, Too!
• What Are The Major Types Of Complementary And Alternative Medicine?

Technorati Tags: alternative medicine, complementary medicine, integrative medicine, clinical trials, NIH

Who Owns Your Blood? (continued)

Photo Credit: Shen Shi'an

The U.S. Supreme Court recently weighed in on a case involving a university researcher, Dr. William Catalona, who claimed that the tissue samples collected under clinical trials he conducted while at Washington University in St Louis belonged to him and he could therefore take the samples with him when he transferred to Northwestern University in Chicago. Not surprisingly, the university objected, and the case made its way up the through the courts. Ultimately, the Supreme Court in effect upheld an earlier ruling that the samples belonged to the university and not to the researcher.

Throughout the process, the researcher was supported by a number of the research participants. In their minds, they felt the researcher deserved ownership of the samples because he designed and conducted the research, collected the samples, and had plans for continued research involving the samples. To them, the university was simply the institution at which the research was conducted, an impersonal entity compared to the individual they knew and associated with the research.

California's Supreme Court ruled that John Moore did not own the cell line developed from his bone marrow. Mr. Moore was a leukemia patient and participant in clinical research at UCLA conducted by Dr. David Golde who was also Moore's physician. Dr. Golde and the university licensed the rights to the cell line and products derived from it to Genetics Institute and Sandoz for several hundred thousand dollars. Mr. Moore claimed rights to the cell line, but was denied those rights by the court.

Bottom Line: When you participate in clinical research, you are probably giving up any property rights you have in your blood, tissues, saliva, urine, organs, and everything else.

-Joe

Related Topics:

• Who Owns Your Blood?
• Fact or Fiction? Take the Clinical Trials Quiz

Technorati Tags: clincial trials, courts, health and wellness

Who Owns Your Blood?

As a participant in a clinical trial, it would not be unusual for your blood to be drawn as part of the research protocol. Once a sample has been taken, to whom does it belong? You? The researcher conducting the clinical trial? The university, hospital or research institution hosting the clinical trial? Who cares?

In most cases, the blood sample would belong to the institution, to be used by the researcher as described in the Informed Consent document you were given. And, in fact, you probably wouldn't think twice about who owned the sample from that point on. If you were donating blood or an organ, for example, your donation would ultimately belong to the individual into whom the blood was transfused or the organ transplanted.

Now for some what ifs...

What if questions arose about the ownership of the blood, or saliva, or tissue, or urine sample collected from you as part of a clinical trial? What if the researcher transferred from the original institution hosting the clinical trial to another and wanted to claim ownership of the sample, but the original institution wanted to retain ownership and didn't want to allow the sample (your sample) to be transferred? Would you care then?

Or what if the sample turned out to be valuable? Suppose your blood contained a hormone that had never been seen before. Maybe the hormone controls the spread of cancer or reduces pain. Certainly the researcher and her institution would be keenly interested in studying the new hormone. And if turned out to be safe and effective, then the institution would license the hormone's use to a pharmaceutical company which would manufacture and market it in large batches. The institution and researcher would receive royalties from the company for the discovery - which wouldn't have been made if you hadn't volunteered your blood for the clinical trial in the first place! Have you started caring yet?

Even if you accept the fact that you agreed to donate your blood to the study and gave up your ownership of it at that time, what about the hormone found in your blood? If it was unique to you, would you feel some rights of ownership then?

Next time... a couple of real life examples of these circumstances.

-Joe

Related Topics:

• Concerns for Women, Children, and Genetic Privacy in Clinical Trials
• Living with an Organ Transplant

Technorati Tags: clinical trials, health and wellness

Don't Give Your Child Cold Medicine

Update: This information has been updated by new FDA guidelines. Please see our WebMD article here.

Last week the Food and Drug Administration (FDA) issued a warning to parents: don't give infants and toddlers over-the-counter (OTC) medications for colds. Why not? Because those medications, many of which have been pulled off the shelves by their manufacturers over the past few months, may do more harm than good, overall.

Of course, it's a little more complicated than that.

First of all, we're talking about medications that have been marketed for infants and toddlers - 0 to 2 years of age.

Consider the possibility that an infant or toddler could be given more than the dose prescribed on the label. This might happen when they are given more than one medication (to treat more than one symptom, say a cough and sneezing), each of which contains the same active ingredient. It could also happen when they are unwittingly given multiple doses by multiple caregivers (say a day care staff member, dad, and grandma). Either way, the result is unintentional overdose.

While such overdoses and other adverse reactions may be the exception, they are not rare. Add to that the fact that many of these medications have not been demonstrated to be effective in infants and toddlers, and there is just no reason to expose these children to the risks for no proven benefit.

Let's take a step back and ask a couple of questions.

If the medications in question have not been shown to be effective in children, then why are they being marketed for children in the first place? It's not that they have been proven ineffective. Rather, it's that they have not actually been tested in clinical trials in children. Many have only been tested in adults - that's how they received FDA approval. In those tests, they were shown to be safe and effective at relieving symptoms - in adults. It was just assumed, then, that they would be safe and effective in children - in lower doses. But, in fact, they have never been shown to relieve symptoms in children.

How is it the medications were never tested in children? Probably because of the risk and expense of testing them in children. What if something goes wrong? As I described in a blog posted here two years ago this month, it is not uncommon for a new drug to be tested in adults, but not children (or pregnant women), for fear of harming the research participants.

As a result, we are now at a point where we'll need to await the results of clinical trials of cold medications in infants and toddlers before these products can reappear on the pharmacy shelves. That is, if the manufacturers believe the cost of conducting the clinical trials is worth the potential market.

Something to remember - cold medications do not "cure" a cold, anyway. They only treat the symptoms of a cold, making the person, child or adult, temporarily feel better.

-Joe

Related Topics:

• WebMD Video: Treating Baby's Cold
• Infant Cold Medicine Recall: It's Back to Chicken Soup

Technorati Tags: infants colds, medications, clinical trials