Human Subject: An Investigational Memoir

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21. Like Pulling Teeth

“L'esprit a naturellement des tendances systématiques, et c'est pour cela que l'on cherche à s'accorder plutôt sur les mots que sur les choses.”

During my brief sojourn among the dental students, I started thinking about the dentistry study I had volunteered for about a dozen years earlier. As I recalled it, the investigators were testing a substance that was put in the gaps around silver fillings (which are technically known as “amalgam restorations”) to extend the life of the filling. I thought that they had used this technique on a couple of my teeth, after identifying a couple of others as controls. Lucky for them, my mouth had been the site of much drilling when I was a child (one day my mother gave me a dollar for lunch, and I spent it all on 10-cent candy bars).

I remembered going back to the dental school a few times for follow-up visits, but only for about a year after the procedure was done, so I wondered how they had managed to gather any useful data about the effectiveness of their method. Because my memory was so hazy, and because I was in the midst of studying researchers anyway, I decided to see what I could learn about the outcome of that study.

If the research had ever been published, the article would have appeared in a dentistry journal, perhaps Caries Research or Dental Materials. (Probably not Revista Cubana de Estomatologia, although I vaguely recalled that one of the investigators was Hispanic.) I started searching in online databases for articles by Big U dentists that described the research as I remembered it. I had no luck finding a write-up of that particular experiment, but I found some articles on related topics by a dentist with a Hispanic name, and I ascertained that he was still at Big U. He frequently collaborated with another faculty member whose name looked familiar, but none of the articles written by either or both of them seemed to be about the restoration-preservation study that I’d been in. So I decided to send them both an email.

Breaking one of the first rules of effective email communication, I addressed my message to both dentists. You’re never supposed to send a request to more than one person, because then none of the recipients will take responsibility for handling the request. The correct procedure is to address the message to one person, with copies to anyone else who should be in the loop. It’s a phenomenon similar to the bystander effect described in chapter 10: The more people you address your message to, the less likely it is that you’ll get any response, because everyone thinks someone else is handling it. I made the risky decision not to single out either dentist, because I didn’t know for sure that either of them was involved in the study.

I’ll never know whether this lapse in email protocol is the reason why neither dentist ever responded to me. In the message, I gave a clumsy description of the research as I remembered it, and I asked them to send me either (1) a citation to the paper that reported the results or (2) a copy of the records pertaining to my participation in the study.

Ten days after attempting to contact the dentists, I got a message with the subject line “public records request #07-10648.” It was from the generic email address for InfoGuard. Following the precedent set by InvestiGuard, the sender did not identify itself. Here is the entire text of the message:

In the process of collecting records responsive to your request a question has arisen: would your participation in the study have been under the name Janice Keller, or a different last name?

I don’t know about you, but I learned in school that a proper business letter has certain required elements, including a salutation, a closing, and a signature. They probably don’t teach letter-writing in school anymore, and I’ll bet they haven’t replaced that unit with lessons on proper email writing. Still, I find that almost all my business correspondents use at least a salutation and a signature. Maybe the people in some Big U offices are just so busy that they don’t have time for the niceties. Or maybe it was part of some official Big U policy, designed to protect staffers from irate customers who might try to track them down in order to bully them into releasing government secrets.

I immediately wrote back, saying that I hadn’t submitted a request and that I didn’t know what study they were referring to, but that I had indeed been known at one time as Janice Jones. The unidentified public servant wrote back that it was responding to the request I had submitted to the two dentists.

A few hours later I got the day’s mail, which included a postcard from InfoGuard acknowledging my request, just like the postcard it had sent when I requested the oxycodone protocol. So then I sent a second email, asking how my personal health records could be considered public records. I thought about adding, “And please identify yourself in your reply.” Even without that officious request, the message went unanswered.

Comparing the two postcards I’d received, I saw that they were addressed in the same handwriting. Then I remembered that I hadn’t given any mailing address to the dentists. Apparently an InfoGuard employee had recognized my name and said, “Aha! It’s that troublemaker again.” Either they don’t get many requests for public records, I thought, or I’m a bigger pain than I thought I was.

The postcard said they would let me know if the request would take longer than 15 business days. After 18 business days, I sent an email inquiry and got another response from an unidentified public servant:.

The InfoGuard staff is now reviewing your documents. We hope to have the records mailed to you this week.

That was a surprise. Last time I’d had to pay for the documents before they would release them. I’ve always loved getting mail, especially when I don’t have to pay for it, so I looked forward with eager anticipation to receiving my documents. When they arrived a week later, sure enough, there was no charge for photocopying the stack of about 100 pages.

This time the cover letter was from the director of InfoGuard, rather than from a legal assistant. The letter stated that the dentists’ research had never been published, because, according to the PI, the data assessment had never been completed. I had forgotten the name of the PI, but had guessed right about who the other investigator was. I had also remembered the purpose and procedures of the study pretty well: “to evaluate the effectiveness of a surface preparation technique for sealing the broken-down margins” of amalgam restorations. Since the research had never been written up, I could have spent the rest of my life looking in vain for the published results. I was glad I had finally asked.

The packet included copies of various InvestiGuard forms and correspondence, plus a lot of dental-school documents. Here is some of the extraneous information in those documents that I found of incidental interest:

On the consent form for the study, in a section called “Risks, Stress or Discomfort,” there was a lot of discussion of how much radiation a person might be exposed to during the taking of X-rays, but no other major risks were described. Liars! I distinctly recalled feeling like I might asphyxiate during a procedure that involved keeping a “tongue blade” in my mouth (for four minutes, according to the protocol) in order to get impressions of my teeth. The placement of the blade caused me to gag uncontrollably. “My mom also has a strong gag reflex,” the young dentist said, making me feel elderly and frail at 41. Once the blade was in, those four minutes were among the most uncomfortable and stressful I can recall, and the procedure was repeated several times .

In the application for funding, the researchers stated that the problem being investigated had significance in terms of public policy. I wasn’t sure what that meant, but they went on to hint that the cost of repairing the margins could be more attractive to insurance companies than the cost of replacing a filling. They also suggested as a subject for further study the question of whether there was a higher risk of mercury poisoning from removing and replacing the failing fillings or from extending their lives and therefore leaving them in the mouth longer. I don’t know if anyone has definitively answered that question, but one article I found said that amalgam repair, as opposed to replacement, is considered by many to be “patchwork dentistry.”

The Human Subjects section of the application stated that the knowledge to be gained from the study far outweighed the minimal risks to subjects. And yet the researchers never even finished analyzing the data. I suspect this was because the results weren’t as good as the investigators had hoped: According to the brief status reports I saw, much of the sealant material washed out of the margins, especially in the less defective restorations. This study took place before the push for mandatory registration of clinical trials, and even today the Journal of the American Dental Association only recommends that trials reported in its pages be registered, unlike JAMA and other medical journals, which require registration. So no one outside the dental school need ever have known that the study was never completed.

I was quite disconcerted to find, in this packet of so-called public information, my personal record of participation in the study. This included a medical history (I had checked “No” next to “Venereal disease”—ah, those innocent, pre-diagnosis days!) and a copy of the consent form I had signed. The form clearly stated: “Only team members and support personnel of the Clinical Research Center will have access to your records.” So what business did they have sending my personal health information to InfoGuard?

I fired off an email to the privacy officer at Big U’s medical center, as well as to a couple of the administrative people in the dental school, asking if/how I could/should complain about this infraction. OK, “fired off” isn’t quite accurate. First I spent about an hour trying to find out what recourse people have when their privacy rights are violated. There’s a lot of information on Big U’s Web site about what information is protected and whose job it is to protect it, but absolutely nothing about what you can do when you find out it hasn’t been protected at all.

The next morning a concerned staff member at the dental school wrote to me, saying she would be happy to look into the issue for me. After I explained the situation to her, i.e., that I’d gotten my own medical record from InfoGuard instead of directly from the dental school, I didn’t hear back from her.

Later that day I got a call from the recruiter at the company where I’d interviewed. I hadn’t gotten either of the two jobs the department had open. It’s entirely possible, given my interviewing ineptitude, that they had only three candidates, or even that they had only two candidates and decided to leave one position unfilled rather than hire me. That sort of thing does happen. For instance, I recently heard a story (true, I think) about someone who came in third in a contest, when she was the only entrant.

The department that didn’t want me had suggested to the recruiter that I might be a good candidate for a position in one of the other departments, so we arranged another interview for the following week. I was glad to have at least one more week of home-based swabbing before returning to the workforce, and after that there would be just one more week before my participation in the UniVir study would be complete.


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