Contents

  Freedom of Information Conference 2000

Jean Hoffman-Anuta

The benefits to the public of access to primary research: a personal journey

I would like to start out with a quote. "For everyone who keeps on asking, receives, and he who keeps on seeking, finds, and to him who keeps on knocking, the door will be opened." These words were recorded about two thousand years ago and throughout time people have sought answers to questions that have perplexed mankind. I, like my ancestors, have had some very perplexing questions. I kept asking, I found answers, and the door has been opened to me. Although how I found my answers is very different to how someone might have found an answer two thousand years ago - or for that matter even twenty years ago. But the basic tenant remains the same: ask, seek, find. Today I want to tell you how I found answers to some very complex medical problems by seeking medical information that was available but not accessible. I had to knock on many doors.

My journey seeking medical information started when I was in college during a class on drug therapy. My teacher discovered two of his previous lectures were outdated by new medical research. In frustration he threw up his hands and said he would never be able to teach us everything we needed to know and that the only thing we could do to prepare for the future was to learn how to access information. The class began the next week in the library where we learnt to find information for our future careers. I did not realise it then but that week I gained some of the most important skills of my life.

The first thing I learned was there was so much information available that no one could learn it all or even keep up with it. The second thing was how to search medical literature. This was over twenty years ago and the process of accessing information was very different to how it is today. After being in the real world for a few years I enrolled in Graduate School and wow, things had changed in a few years. I was introduced to search engines I could use on my own. I did not have to rely on a librarian to search for me.

Miscarriages - need information to find the reason

Meanwhile my husband and I had a child in 1989 without a great deal of difficulty and planned to have a second. It came as big shock that we would start having miscarriages. After the fifth miscarriage we started searching medical literature, first to find how common the problem was and then to look for causes. We used a search engine called Grateful Med from our home PC to access Medline and were able to get abstracts of articles. We then spent many nights and weekends in medical libraries getting copies of articles. At the same time we searched medical literature to shed more light on our problem.

I was also referred to a specialist and we can call him Specialist number One. He could not find reasons for our miscarriages and said we were just unlucky. He tried several therapies but none worked. We had no answers and were emotionally drained; so we moved onto Specialist number Two. He isolated a small hormonal problem, treated it, and we became pregnant. We thought all our problems were solved until a routine sonogram could not pick up the foetal heartbeat. Miscarriage number six. Lab results showed a genetically normal little boy. We were devastated once again.

Emotionally bankrupt and financially stinging - these therapies are not cheap - we thought we would try one more time before we closed the door. With our last and final attempt we wanted to make sure no stone was left unturned. We did not want to find out later that there was information available that could have helped us. We found researching the literature therapeutic; it was something we could control when our lives were very much out of control. Searches of Medline turned up several articles and luckily one of them was written by a Physician at a nearby medical institution - we'll call him Specialist number Three.

He was able to identify another problem and gave us four treatment options. We had some idea of the pros and cons of each but were bewildered by the choice. Back to the medical literature we went. As luck would have it a researcher in our area, Specialist number Four, had published preliminary results of a study that showed one of the therapies to be promising for us. Unfortunately it was also very expensive. We went to see this specialist who performed more tests that further identified the problem. She told us that only one of the options was likely to work and it was the most expensive. The charges were not for any of her services but for the drug. We sent a pre-determined benefits to our managed healthcare plan and, not surprisingly, they promptly denied coverage. I spent several days getting research articles supporting the use of the treatment and forwarded them to an insurance company in hope that we could get our manage care plan to cover the treatment. In the meantime it appeared we had become infertile as we were no longer able to get pregnant.

A well-known physician in the area - number Five - has a radio program that discusses latest advances in medicine. He had recently addressed a situation such as ours on his program and was able to treat us with antibiotics. Surprisingly, very surprisingly, shortly thereafter I was pregnant. However, we still faced almost certain loss without continuing treatment. We needed the medication recommended by Specialist number Four. Our insurance was still denying payment for the treatment.

Specialist number Four did a sonogram and laboratory tests but before the results were back I started to miscarry. We saw her on an emergency basis and there was still a strong heartbeat on the sonogram. She got my test results, which did not look good, and gave us the option of getting an emergency dose of the medication needed to sustain the pregnancy. We still did not have insurance coverage but elected to go ahead and save our last pregnancy. The medication was infused that day and I went home to rest. If everything remained stable for a week we had reason to hope. A week later there was still a strong heartbeat and the foetus had grown.

Careful monitoring and continued drug therapy from Specialist number Five got us past the critical twelve weeks. I was then referred back to my regular clinic for routine follow up. The first visit, however, foretold a potential disaster. The miscarriages had weakened my cervix and I might go into labour before my baby could survive. Back to Medline. We found a local medical institution had published several articles on surgical treatments for the problem. The next morning I asked Specialist number Four if I should be evaluated by the local institution and she agreed. The institution's high-risk specialist recommended monitoring and if I got past twenty-two weeks our chances of having a full term pregnancy would be excellent. If there was a problem the high-risk specialist would try to stitch the cervix shut to prolong the pregnancy.

To make matters worse

Meanwhile the insurance company was still denying coverage for the therapy that seemed to be saving our baby. Mike, my husband, requested a review of our denial and put together an appeal with copies of research articles. I just want to mention that my husband is a Systems Engineer, he has no medical background, but he was still able to write a very good appeal. In this small window of time before what would become the second of three medical emergencies, my father passed away. We flew to the mid-West for the funeral and to spend some time with my mother. When my husband returned from the funeral he found good news waiting. His appeal had been successful and we would get coverage.

After my father's funeral life settled down a little. The monitoring of the pregnancy was going fine and we were starting to relax and prepare for the birth of our second child. At what was to become one of the final visits to the radiologist to check the integrity of the cervix it appeared the cervix had shortened a great deal. The radiologist made me lie on the table, feet up, while he called my regular clinic. I was to go right home, put my feet up, head down, drink lots of water, and be at the hospital to see the high-risk specialist first thing in the morning.

I was a very compliant patient that night but I got little sleep. First from worry and then from trying to sleep with my feet up in the air. Because I could not sleep I spent a lot of time searching Medline with my portable PC on my stomach. It gave me comfort to go through the articles and see the positive outcome that could come from this surgery. The news from the high-risk specialist the next day was bad. I was essentially going into labour at twenty weeks and the only way to try not to lose the pregnancy would be to stitch the cervix shut. At twenty weeks of pregnancy the foetus was not viable. The foetus had to make it to at least twenty-four to have any chance of survival.

Asked from God

The surgery was difficult. I spent a few days in the hospital and was sent home on bed rest with the hope that I could make it at least another month. Every week I made it past twenty-four weeks made things look brighter. I had close monitoring was allowed to go for weekly sonograms. Then at thirty-two and a half weeks I went into a labour that could not be stopped. I had an emergency c-section and delivered a healthy 4lb 8oz boy. We named him Samuel, which means Asked From God. After a short stay in the hospital he came home and the person who performed the c-section said if I wanted to have another baby to let him know and he would leave obstetrics and become a dermatologist!

Since the birth of Sam, using the medical literature has become even easier. With the ability to search Medline free on the internet, a large barrier to accessing medical information has been overcome. Speaking of barriers I would like to relate to you how we and other parents have used primary research information found using the internet. My oldest son suffers from migraines. He also has a speech and language disability, which when you combine the two is a recipe for disaster. He is also very bright. If any of the physicists are here that spoke yesterday, he has a learning profile that looks something like Einstein - a problem with language but a very high IQ. We have used the medical literature to find appropriate help for our older son both medically and educationally and he is doing just fine.

Other parents who have used primary research information have contacted me. I have heard from parents of children with asthma, autism, physical disabilities, emotional disorders and learning disabilities. To become good advocates for their children these parents have become internet savvy. First in medical educational and legal lingo with no formal training or background. Many of these parents have no more than a high school diploma. Many of these parents have been forced to go to the courts to obtain appropriate accommodation for their children's disabilities. Many of these cases have or will set precedence in state and district courts. The parents of the disabled children I have just mentioned have asked me to speak on their behalf.

One only has to turn to the National Council in Disabilities January 2000 report to find that, although there are laws to protect disabled children, they are not being enforced by federal agencies. This report also underscores that every state in the union is grossly out of compliance and therefore the only option for these parents is the use the court. These parents, armed with good research information, are the most powerful advocates for their children. These parents need and want accessible research information so they can open the doors that have been shut for their children. As one parent so aptly said, "I don't understand why my tax dollars fund research and I cannot have easy access to the research findings. What good does it do if I don't know about them?"

In closing I want to mention that I am constantly amazed by people like the parents of the disabled children I have just mentioned who have no prior medical or computer background. Who, with just the desire to help a loved one or are sick themselves, become knowledgeable about a medical condition. They, like our generations before, need to ask the questions, keep on seeking answers, and knocking on doors and, eventually, they hope a door will be open to them.

Questions from the floor

Question 1: Did you have any difficulty distinguishing between good and bad scientific data in your research?

Jean Hoffman-Anuta: I am a clinical pharmacist. The biggest problem was convincing the managed care plan that it was good science. More so than being able to distinguish that myself.

Question 2: What advice do you have for the laymen without your background on going onto the web to find medical information? How would you tell them to distinguish between the good and the bad?

Jean Hoffman-Anuta: You know, frankly, I think that is an area where there are many business opportunities. I worked with women with infertility problems, parents with just high school diplomas, who in a very short period of time can sort out the weak from the strong data. They can get some rudimentary background information on what is a good study and what is not a good study. Most of the parents that I work with have gone right to Medline. Granted that not everything on Medline is 100% reliable, but more so than a lot of things on the web. They also go to things like expert panel reports and get some of their studies out of expert panel reports. They don't just rely on one study. Many of these also take the studies to their physicians to open up the dialogue and the physicians are often helping them in terms of dealing with schools and other barriers that parents have.

Question 3: Jean, can I just ask. If you were to say one or two things you think would make life easier for people in your position, what would they be?

Jean Hoffman-Anuta: What I tell people is to first go to their public library and get a general book written for lay people on whatever disorder it is so they become familiar with the anatomy, the words, the terminology. Then if they have any questions to try and access the librarians, any other books, and then go to searching on line.

Question 4: But are there things about searching on-line that you can imagine would make life easier? The way it is structured, the way it is presented?

Jean Hoffman-Anuta: I think there could be some form of education for people searching literature on review article versus primary research versus peer-reviewed. Often I recommend people to start with review articles so they get an idea of what is out there and then go to studies. It depends on the background of the person attempting the research. There are a lot of groups out there with smart people, infertility groups who are putting primary research on the web. I don't know if it is legal or how they are doing it, but they have got frustrated because they cannot find the information and they are just putting it there themselves, on their own websites.