‘Conversations’ – 8/14/11.

That’s was partly why when I read in the NYT article that some cancer experts thought a new wave of experimental cancer drugs should be used for treatment before they’re approved I sat stunned. I read the article three times. “Experts” are actually arguing that patients should have increased access to drugs not yet tested and that this should be done on compassionate grounds. This article, by the way, came out a few days before the FDA decided to restrict Avandia, a drug that HAD ALREADY BEEN APPROVED because it increased the likelihood of heart attack

The very first time I saw the words “therapeutic misconception” in the New York Times was just one month ago. In an article by Gina Kolata, What to Tell the Patient After a Trial Goes Awry. “Most patients entering clinical trials believe they are getting a new treatment that may benefit them, Dr. Brody [director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine said]said. Ethicists call that a ‘therapeutic misconception,’ he said, adding, ‘No one should ever assume that in a clinical trial.”

Gosh, ya think?

Like most media outlets, the Times treats trials as another medical option available to patients. This is because patients consider trials a medical option; as if they’re getting to buy wholesale rather than retail. That’s because doctors and researchers encourage patients to think of them as an option so they can recruit subjects to trials. It’s one vast belief but it’s not true. It’s built on statistics: If enough people believe it, eventually it’s true. I used to believe that truth was not statistical, that popularity didn’t make a thing real. And, of course, in an activity as rigorous about process and facts as medical research, truth was surely an inflexible concept. But after reading the NYT article I realized some researchers want the truth to be flexible, based on the whims of doctors and patients. And that’s a great way to make the truth disappear.

Local diabetic writes about his clinical trials

Type 1 patient enjoyed brief ‘cure’ a while ago

By Shar Porier
Herald/Review

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.

Third world countries are used as medical sweatshops to test drugs, devices, and treatments that will be used by citizens in developing nations. Those are the overall findings of a report on the globalization of trials published in the New England Journal of Medicine on February 19. (You can read the article here.) Fixing the problems with the “ethically murky” practice of outsourcing clinical trials, the Duke University researchers who wrote the report say, “will require input from stakeholders in academia, industry, and regulatory agencies around the world.”

Even though the report is welcome, it’s a telling example of how unaware the West is with the horrific acts taking place in the developing world in the name of advancing medical science. Fortunately, people in third world countries are already insisting on ethical treatment in clinical trials and sponsors are finding themselves becoming forced to treat subjects like human beings instead of guinea pigs.

For instance, Charles is a 43-year-old brick maker who lives in Gayaza, a small town on the outskirts of Kampala, Uganda. He, along with one of his daughters, is HIV-positive. His wife and one of his children have already died of AIDS. Once a month Charles walks five miles to a government-run medical clinic to get HIV medication for himself and his daughter. Three times last year drug company representatives from different United States corporations have come to Charles’s home and offered to give him free experimental HIV medication. They said their drugs were better than the ones he was taking. They said they would make repairs to his house. They offered him money. Charles was suspicious and three times he turned them down. “The drugs I am taking are working,” he says. “I have no reason to take their drugs.”

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. GlaxoSmithKline and AstraZeneca, in England, along with Roche and Novartis, both in Switzerland, have invested $100 million in clinical research in China. 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.

The sponsors of clinical trials have become entrenched overseas not only because it’s been much less expensive to conduct trials in underdeveloped countries. It’s also because the regulations on testing drugs, devices, and treatments in foreign countries have traditionally been laughable.

The FDA accepts data from clinical trials conducted in countries outside the U.S. if those trials meet the standards set forth in the Helsinki declaration (a set of ethical guidelines adopted in 1964) or if they meet the regulations established by the host country, whichever are stricter. The Helsinki declaration not only fails to carry the weight of law, it does not mandate overwhelmingly strict regulatory oversight. And regulations governing clinical trials have been almost nonexistent in most host countries located in the developing world.

In the 1990s one man named Ilian Ivanov oversaw the regulations governing clinical trials in Bulgaria. He also moonlighted by recruiting companies to Bulgaria to conduct trials. Ivanov insisted that this apparent professional conflict of interest did not mean he was a pushover who allowed the sponsors of clinical trials to cut corners. To illustrate this point, when he caught two Bulgarian researchers conducting trials without government permission Ivanov slapped them with a ten-dollar fine.

But Ivanov represents the past while in Uganda Charles represents the future. Some countries are starting to regulate trials or to hold sponsors of clinical trials from the West to stricter standards. In Nigeria, after a United States court refused to hear civil and criminal charges that were personally brought against executives at Pfizer after a clinical trial went badly, Nigerian courts decided to move forward with the prosecution in their own courts. China has proposed tougher import and export regulations for medical materials entering and leaving their country. In several African countries people are attending universities in the United States and returning home as bioethicists eager to establish oversight systems similar to those in place at the FDA.

With or without the “input from stakeholders in academia, industry, and regulatory agencies around the world,” sponsors of unethical clinical trials in the third world have worn out their welcome to such a degree that they are already on notice. If they want to continue recruiting subjects in poor countries and developing life-saving drugs, devices, and treatments they’ll need to start offering something other than money and small favors. They’ll need to finally bring people like Charles a valid consent form and tell the truth about the risks of what they’re testing.

How do I know this? I subscribe to a free weekly news alert through Google that flags and sends stories about clinical trials to my e-mail. (If you’re interested in clinical trials, or in anything from East Aleutian boxing to dandelion sculpture, I suggest you go to Google and sign up for an alert. It’s extremely cool.) In previous weeks there were a few stories mentioning that people are turning to trials as a treatment option. The stories piqued my interest because two years ago I interviewed a bioethicist named Paul Appelbaum who coined the term “therapeutic misconception” to describe how subjects and researchers have come to consider clinical trials a valid medical treatment option. It’s a misconception because clinical trials are not treatment. They are research. It looked to me that the economic downturn was putting therapeutic misconception on the fast track to being regarded as the absolute truth.

Then, this week two stories came across my Google alert that went a long way to confirming my suspicions. The first is a story from the NBC station in Dallas-Fort Worth Texas that flat out says, “Clinical Trials Provide Options for Financially Strapped Patients.” The other is a story about how the University of Nebraska Medical Center in Omaha recently opened an office to assist people who are increasingly coming to the university to enroll in clinical trials. The reason more people are showing interest in becoming subjects, the story says, is because unemployment is at a 15-year high.

Allowing medical research to become even more entwined with being regarded as treatment is bad for subjects, bad for patients, bad for medicine, and, ultimately disastrous for medical research. Keep your eye out to see if the trend grows.

Embryonic stem cells mimic the characteristics of human cells they are joined with and therapy with the cells could lead to organ replacement and treatments for diabetes, Alzheimer’s, and many other conditions. The trial will involve infusing stem cells in up to ten people with very recent spinal cord injuries to see if the cells can help heal their paralysis. Embryonic stem cells have long been considered the most promising new frontier of medical science., Now the trial will help decide whether the promise is mostly hype or is genuine reason to hope.

Stay tuned.

“[Researchers] say that their children are reliable subjects, and that they give them access that can allow them to do more in-depth studies,” Belluck says in a video accompanying the article. “Meanwhile, ethicists say that some of these projects are acceptable and even valuable. But they also say that they can raise questions about the impact on the child, on the relationship with the parent, and on the objectivity of the data being collected.”

Readers who wrote in on a comment board tended to be opposed to the concept of using one’s child as a research subject. They were particularly opposed to, as one scientist did, running MRIs on a child. Issues of informed consent, bias, long range physical and emotional effects and other issues were raised in the comments.

Whether you are opposed to the idea or in favor of a practice employed for years by prominent scientists such as Noam Chomsky, one thing is certain: It’s a riveting topic and an article you should definitely check out. 

Click here to read the article and access the video and reader board. (Registration for the NYT online is required, but the site is free.)

I touch on many aspects of the book, including the legal and business perspectives, the personal stories of other subjects, my experience researching the book by volunteering as a “guinea pig,” and advice and resources for people on how to learn more about trials

The interview was conducted on a Saturday morning in November in Tucson. The interviewer was Lisa Marie Morrison.