Diabetic writes about his clinical trials
This is my site Written by Alex on April 13, 2009 – 10:26 am   

Shar Porier, from the Bisbee Daily Review/Sierra Vista Herald did a nice piece on the book:

Local diabetic writes about his clinical trials

Type 1 patient enjoyed brief ‘cure’ a while ago

By Shar Porier

BISBEE — “The year I was cured, I knew how normal people felt.”

Alex O’Meara reflected on his 30-odd years as a person with Type 1 diabetes and the short-term “cure” he found as a participant in a clinical trial done a few years ago at the University of Virginia.

In Type 1 diabetes, the islet cells in the pancreas fail to produce enough insulin to properly regulate blood sugar, he explained Sunday at his Bisbee home. In addition to diabetes, he was diagnosed with hypoglycemic unawareness after he passed out a few times.

“It wasn’t that hard on me, I was unconscious. The people around me were more affected by the shaking and sweating than I was. But, I got tired of waking up in ambulances and in the emergency room. I lost a job because of that,” he said. 

Bisbee resident Alex O’Meara talks about his book about medical clinical trials in his home Sunday. (Vera Davis•Herald/Review)

Hypoglycemic unawareness is a result of low blood sugar, he explained. People with the condition may not know what’s happening to them until it’s too late.

He has accepted his illness and has done most everything he wanted. He even runs in marathons. But, the idea of ending all those pin pricks to check his blood glucose level and the self-injected insulin shots was a lure he could not ignore.

In the two-year evaluation process prior to starting the trial, a lung growth was discovered which nearly cost him his spot in the trial. He opted to remove the growth so he could be considered for the trial.

Upon selection for the study, he would undergo a transplant of islet cells from a cadaver, whose tissue was matched to his blood type. These cells were expected to take hold in his system relieving the symptoms of the disease. He would also have to take immunosuppressent drugs to prevent his immune system from waging an all-out attack on the transplanted cells. That immunosuppressent medication would be paid for through his insurance, since the study did not cover them. One prescription alone cost $900 a month.

“I wasn’t really looking for a cure,” he said about the extreme measure he went through. “You never get a day off from diabetes. It’s every day. I had been on the defense all my life and this gave me the chance to go offensive.”

O’Meara was fortunate. Since he stayed on top of his illness, he did not have the serious complications that can come with diabetes — his kidneys and circulatory system did not suffer. That was to his benefit and ended up being one of the the reasons he was selected as a guinea pig for a research laboratory at the University of Virginia. Though only the second person to try the cell infusion, he remained optimistic.

After his first transplant in May 2006, he gradually began showing a 50 percent improvement and his insulin dosage was reduced. He reasoned that if one transplant worked halfway, maybe two would give him total relief. So, in August, he had another and it worked. For one year he lived like a normal person.

“I liked feeling normal. I still took my medications, but I just didn’t have that constant worry,” he said.

Then the islet cells started failing gradually. While it wasn’t the total cure he was seeking, the remaining cells are continuing to affect his insulin production which remains sharply reduced. The researchers will continue to monitor him for the rest of his life or until he gets dropped from the trial.

“I’m a realist. I knew the odds were small,” he admitted.

Being an inquisitive, reporter-type person, O’Meara wondered about the whole business of clinical trials and launched into a project that produced his first published book, “Chasing Medical Miracles: the Promises and Perils of Clinical Trials” that is due to come out June 16. He includes two chapters on his own experiences with diabetes and the research study that offers a personal and objective look into the world of medical science through his eyes. He calls it a “tour through the history, horror and headaches” of the industry.

His research shed light on an industry that involves the lives of 20 million Americans while pulling in $24 billion a year.

“This is a major business and I thought it would make an interesting book,” he added.

He found that over the past 10 years, the clinical trial industry had grown 300 percent. And it’s not the big pharmaceutical powerhouses that perform the trials. They just hire a private research corporation to hire research labs to do the actual studies.

“There is a huge business that is done by the clinical research corporations. The drug manufacturers hire these firms to do the testing,” O’Meara explained.

Using his skills as a reporter, (he once worked for Newsday, the Baltimore Sun in Washington, D.C., and the Bisbee Daily Review), he began researching the industry as a whole. He soon discovered that this industry is global and can set up in just about any country.

“All they have to do is meet the country’s standards for the testing process,” O’Meara said. “Some countries have no standards.”

He traveled to Uganda to find out what clinical trials were being offered there. There are times when the research companies go to a foreign country where things are less expensive and regulations are lax. Though tuberculosis and malaria were the big health concerns in Uganda and other African nations, the clinical study was being done on HIV-AIDS, he added.

“Malaria and tuberculosis no longer exist in the western world. There’s no money to be made in those diseases in the West. Instead, they do studies on HIV-AIDS,” he said.

He goes into it deeper on his Web site: “For years people in third world countries agreed to be subjects in clinical trials when researchers from the United States came with promises of money rather than detailed information about the effects of the tests they were conducting. Such ‘cooperation’ sent a lot researchers knocking on a lot of doors in Nigeria, Russia, China, and other countries with high rates of poverty.

“In 1996, 86 percent of clinical trials took place in the United States. In 2006 that number was 57 percent. Drug companies from the West are already committed to spending millions of dollars in overseas projects … With billions worth of drug patents set to expire in the next six years, U.S. companies have been aggressively developing new medicines more often in the third world countries. One Indiana-based pharmaceutical company, for instance, is spending $300 million to run clinical trials in China.”

One of the important things he discovered in this research is that even though the study may be about HIV-AIDS or some other illness unrelated to the communities where the research is being done, the poor people of the country do get access to medical care. Infections, diseases and other maladies end up being diagnosed in the process, which can improve health. The clinics and hospitals also come out ahead with new equipment and medicines. It’s a trade-off, he says.

His book received a positive review from Publisher’s Weekly prior to going on sale. If his book sells well, he could go on the talk show circuit to promote it. He is planning a book signing in Bisbee at some point in the future.

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