Alex O’Meara researched and wrote this book after he participated in a risky and ground breaking type-1 diabetes clinical trial. In this book, Alex reveals what every health-conscious person needs to know about how drugs, devices and procedures are tested and approved.
In this segment, we detail how Alex was involved in a clinical trial and his subsequent discovery that clinical trials is not to cure anyone but merely to obtain data. Alex O’Meara, in his own words, “has served as a clinical trial guinea pig.”
In 2004, Alex signed up to take part in a clinical trial (The Pancreas Islet Cell Transplant Study) involving an experimental transplant to cure diabetes. He had been suffering from type 1 diabetes for almost 30 years and had “hypoglycemic unawareness”, a condition where his blood sugar, instead of staying chronically high, would plunge dangerously low which can cause seizures, coma, and in some cases even death.
The experimental procedure which Alex took part, replaces the insulin-producing cells that have died in a diabetic’s pancreas with living, healthy, insulin-producing cells. Because the cells are located in a part of the pancreas called the Isle of Langerhans, the cells are called islet cells. Those islet cells are taken, or harvested, from a recently deceased organ donor and infused through a tube into a person’s portal vein, which leads to the liver. The idea was that once in the liver, the islet cells would nestle in and produce insulin as if they were in a pancreas.
After stringent interviews and tests, Alex was accepted into the experimental procedure at the University of Virginia. Later he found out that he was the only one “selected” at the UVA. This made him realise that he was merely “a test subject, the monkey in the space capsule”. The transplant was really experimental and he had donated his body to science and he wasn’t even dead as yet (page 17).
What shocked Alex more was that, on admission into the UVA hospital (in May 2006), he discovered that his doctor Susan Kirk, MD, an endocrinologist who specialised in diabetes also had type 1 diabetes for also almost 30 years. When Alex asked whether she would consider getting an islet cell transplant, Dr Susan said she wouldn’t…perhaps she might consider it in the future, “once the procedure is perfected.”
This encounter with Dr Susan Kirk prompted Alex to spend some time to chronicle his own personal experience and to research further the promise and perils of the entire industry of clinical trials. The following are the main points of the perils of the risky world of clinical trials: -
a) Clinical trials are conducted to collect data only…however some clinical trials candidates suffering from cancer, diabetes, asthma, and other life-threatening conditions sincerely believe (or led to believe) that clinical trials are a valid medical treatment option (page 49).
b) Subjects often come into clinical research studies believing that their own interests will be met in the same way as if they were receiving ordinary medical treatment (page 49).
c) Terrible things happen in clinical trials because they are the most dangerous part of medical discovery. Very little in medical research, of which clinical trials are only the final phase, goes according to plan (page 21).
d) Clinical trials are the one part of medical discovery where human lives are put directly at risk… in the absence of guidelines and agreed-upon definitions of what is ethical and not ethical, subjects in clinical trials get trampled in the blind pursuit of trying to apply medical breakthrough (page 23).
e) There have also been concerns about whether the FDA allows pharmaceutical companies too much freedom in how they design trials and how they report the results of these trials. Pharmaceutical studies can be designed to falsely increase the likelihood of getting the results the drug companies wants (page 46).
f) ….drug companies may skew the design of clinical trials so their drugs will come out looking more effective or less dangerous than they are. Among the tricks that can be used are testing the drug in a healthier population that will be taking the drug and comparing the new medication to a lower dose of an existing medication so the results look better for the drug being tested (page 75).
g) ….consent forms that the trial subjects signed always overstate the benefits and the risks of the trial are understated (page 88).
h) Because clinical trials are not therapy, because they are by definition research, terminally ill patients who do consent to participate in trials are usually persuaded to do so because of therapeutic misconception or the implication they will receive treatment in the trial (page 90).
Regardless, clinical trials are not designed to provide patients with quality care. Somehow, patient care became part of a process designed to only gather information. The doctor administering the trial might be wearing a stethoscope and a lab coat, but he/she is not there to cure anyone. He/she is there purely to collect information from a subject and learn more about medicine (page 30).
The history of clinical trials shows great swings between significantly helping and dramatically harming people (page 52).
They are, after all “medical experiments” dismissed in the public consciousness as “a fringe medical endeavour along the lines of “Frankenstein cooking up a monster in a lab” (page 3).
So, for cancer patients opting/signing up for clinical trials, remember it is an information gathering exercise only and not a medical treatment at all. And in some trials, a placebo (sugar pill) may be used. If you are a cancer patient, you do not have the luxury of time for some drug companies to experiment with your body. Only the drug companies will benefit…..after you are long gone.
Postscript
Alex’s experiment was not successful. In May 2007, one year after the transplant took place he had to increase his insulin intake and in 2008, he was an insulin-dependent diabetic again. His wife, who could not bear it anymore, filed for divorce. Subsequently, the drug company sponsoring the trials also terminated the protocol….and Alex O’ Meara was back to square one.
FURTHER RELATED REFERENCES
There are a lot of books/references if you have the interest/inclination to read further on the subject of ethics (or lack of it) in clinical research. Below is just a short list.
3. EXPLOITATION AND DEVELOPING COUNTRIES: THE ETHICS OF CLINICAL RESEARCH by Jennifer S. Hawkins (Editor), and Ezekiel J. Emanuel (Editor). The book is an attempt by philosophers and bioethicists to reflect on the meaning of exploitation, to ask whether and when clinical research in developing countries counts as exploitative, and to consider what can be done to minimize the possibility of exploitation in such circumstances. A case in point is clinical research sponsored by developed countries and carried out in developing countries, with participants who are poor and sick, and lack education. Such individuals seem vulnerable to abuse. But does this, by itself, make such research exploitative?
4. RETHINKING THE ETHICS OF CLINICAL RESEARCH: WIDENING THE LENS by Alan Wertheimer, Senior Research Scholar, Department of Bioethics, The National Institutes of Health, and Professor Emeritus, University of Vermont.
Clinical research requires that some people be used and possibly harmed for the benefit of others. What justifies such use of people? This book provides an in-depth philosophical analysis of several crucial issues raised by that question. Much writing on the ethics of research with human subjects assumes that participation in research is a distinctive activity that requires distinctive moral principles. Specifically, read chapter 5, “Exploitation in Clinical Research.”
5. WATCH THE MOVIE….The Constant Gardener, a 2005 drama thriller film directed by Fernando Meirelles. The screenplay by Jeffrey Caine is based on the John le Carré’s novel of the same name. The film follows Justin Quayle, a British diplomat in Kenya, as he tries to solve the murder of his wife Tessa, an Amnesty activist. The story is told using many flashbacks and it is gradually revealed that Tessa was trying to uncover dubious drug tests by a Swiss-Canadian drug company on the local population.
It was filmed on location in Loiyangalani and the slums of Kibera, a section of Nairobi, Kenya. Circumstances in the area affected the cast and crew to the extent that they set up the Constant Gardener Trust in order to provide basic education for these villages. The plot was based on a real-life case in Kano, Nigeria in which a meningitis drug, approved for use on adults were used on children (in Europe, the same drug was never approved for adults or children).
6. VISIT THE WEBSITE OF GUINEA PIG ZERO, a Journal for Human Research Subjects…..www.guineapigzero.com……lots to read. Then you will understand why you should not be a guinea pig
Chasing Medical Miracles has been reviewed in the Wall Street Journal as a “worried portrait” of how more than 20 million Americans are enrolled in clinical trials. Clinical trials have become a $24 billion industry that is reshaping every aspect of healthcare development and delivery in the United States and around the world.
The book, Chasing Medical Miracles: The Promise and Perils of Clinical Trials, and this companion website are the first resources to take an objective, behind-the-scenes look at the complicated world of clinical trials. The site also provides up-to-date information about clinical trials for those curious about the topic and for those taking part as subjects. (read more)
Chasing Medical Miracles and this website are by journalist Alex O’Meara who as a diabetic suffered from life-threatening hypoglycemic unawareness. The book chronicles how he participated in a risky and groundbreaking clinical trial to “cure’ diabetes.The book also reveals how a multi-billion dollar industry of private companies conducting trials with little oversight has taken root and quietly become a major part of the American medical establishment.
Along with regulations and ethics, Chasing Medical Miracles examines the economic impact and the heart-wrenching personal stories behind clinical trials both across the country and overseas. O’Meara reveals what every health-conscious person needs to know—regardless of whether you are considering participating in a clinical trial or trying to make sense of the confusing and sometimes conflicting medical advice that’s based on clinical trials.
Alex is an award-winning journalist who has worked for the City News Bureau of Chicago, the Washington DC bureau of the Baltimore Sun; Newsday; NBC in Tucson; and many other media organizations. He is the author of Chasing Medical Miracles: The Promise and Perils of Clinical Trials (Walker 2009) and the novel Bad Day for the Home Team (Zumaya 2010.) Originally from New York, Alex lives in Bisbee, Arizona.
(Adapted from Chasing Medical Miracles: The Promise and Perils of Clinical Trials. A more comprehensive version is available as an Afterword in the book.)If you’re thinking of volunteering for a clinical trial here is some information you should keep in mind.
Before You Decide to Enroll
1 – Volunteering for a clinical trial is a legitimate option you might wish to consider if you’re seeking a new way to address a medical condition you have. However, clinical trials are not medical treatment. You might benefit from a trial, but that is not the reason the trial is being done. The trial is being conducted to gather data – period, end of story.
2 – Volunteering for a trial to help others and advance medical science is honorable. Many people feel compelled to “give back” or to sign up for a trial exploring new treatments and drugs for a condition a family member or loved one suffers from. If such an option feels like something you want to do, then by all means consider it.
3 – Finding a clinical trial is not difficult. There is a very comprehensive listing of more than 50,000 open trials prepared and maintained by the National Institutes of Health at www.clinicaltrials.gov. Another good listing site is www.centerwatch.com, a for-profit information services company that serves the clinical trials industry.
Consent and Questions
1 – When you first visit the sponsor of the trial, be aware with whom you are speaking. Ask the person you are meeting with to describe to you their role in the trial.
2 – For your first visit (and for visits afterward) take someone with you. This is helpful because you are going to be receiving a lot of information and it’s difficult to just process it all on your own without having someone to review it with you.
3 – Informed consent is crucial to the clinical trials process. It is a federal regulation that you give informed consent before the trial. If you are not offered informed consent along with an informed consent form to review and sign before you take part in the trial, do not take part in the trial. Ask for the opportunity to take the consent form home to study and discuss it with others.
During the Clinical Trial
1 – At any point during the trial you can drop out. This is a guaranteed federal and international right.
2 – Be sincere about your involvement. Keep a diary if it’s required. Go to all appointments you agreed to go to. Take all the tests you agreed to take. Adhere to the guidelines you agreed to when you signed up.
3 – Continue to ask questions. You should ask and expect answers to questions about the clinical trial overall, about your test results, about results thus far from the trial, and side effects, about what to expect in the next step or steps in the trial, and about anything else that you are not clear about or that you are merely curious about as you proceed through the trial.
4 – Ask the research team to copy your primary care physician on all your test results. Let your primary care physician know you are asking this and to expect these test results.
5 – Take an active role in the study. You are a partner in the research and as such you should continue to research the area the trial is studying and the progress of the trial and related studies.
6 – Ask the sponsor or the patient coordinator for the results of the trial as it progresses and when it’s concluded. Knowing exactly what’s happening and what happened is important for your own peace of mind.
One outstanding story related to a patient’s right to their own data is from a Hepatitis C trial in which the subjects were not allowed to receive information on their viral load during the study as a way of discouraging drop outs. However, this in itself seems unethical in that the patient would not know whether the treatment was effective or ineffective and whether their disease was progressing. I hope that Institutional Review Boards would not approve such a procedure for trials involving serious illness. Much of the book looks at the issues with placebo controlled studies and blinding – it raises many questions which are yet to be resolved by medical scientist and bioethicists.
I would recommend this book for anyone involved in clinical research, whether in Pharma, medicine or as a patient.
In this segment, we detail how Alex was involved in a clinical trial and his subsequent discovery that clinical trials is not to cure anyone but merely to obtain data. Alex O’Meara, in his own words, “has served as a clinical trial guinea pig.”
In 2004, Alex signed up to take part in a clinical trial (The Pancreas Islet Cell Transplant Study) involving an experimental transplant to cure diabetes. He had been suffering from type 1 diabetes for almost 30 years and had “hypoglycemic unawareness”, a condition where his blood sugar, instead of staying chronically high, would plunge dangerously low which can cause seizures, coma, and in some cases even death.
The experimental procedure which Alex took part, replaces the insulin-producing cells that have died in a diabetic’s pancreas with living, healthy, insulin-producing cells. Because the cells are located in a part of the pancreas called the Isle of Langerhans, the cells are called islet cells. Those islet cells are taken, or harvested, from a recently deceased organ donor and infused through a tube into a person’s portal vein, which leads to the liver. The idea was that once in the liver, the islet cells would nestle in and produce insulin as if they were in a pancreas.
After stringent interviews and tests, Alex was accepted into the experimental procedure at the University of Virginia. Later he found out that he was the only one “selected” at the UVA. This made him realise that he was merely “a test subject, the monkey in the space capsule”. The transplant was really experimental and he had donated his body to science and he wasn’t even dead as yet (page 17).
What shocked Alex more was that, on admission into the UVA hospital (in May 2006), he discovered that his doctor Susan Kirk, MD, an endocrinologist who specialised in diabetes also had type 1 diabetes for also almost 30 years. When Alex asked whether she would consider getting an islet cell transplant, Dr Susan said she wouldn’t…perhaps she might consider it in the future, “once the procedure is perfected.”
This encounter with Dr Susan Kirk prompted Alex to spend some time to chronicle his own personal experience and to research further the promise and perils of the entire industry of clinical trials. The following are the main points of the perils of the risky world of clinical trials: -
a) Clinical trials are conducted to collect data only…however some clinical trials candidates suffering from cancer, diabetes, asthma, and other life-threatening conditions sincerely believe (or led to believe) that clinical trials are a valid medical treatment option (page 49).
b) Subjects often come into clinical research studies believing that their own interests will be met in the same way as if they were receiving ordinary medical treatment (page 49).
c) Terrible things happen in clinical trials because they are the most dangerous part of medical discovery. Very little in medical research, of which clinical trials are only the final phase, goes according to plan (page 21).
d) Clinical trials are the one part of medical discovery where human lives are put directly at risk… in the absence of guidelines and agreed-upon definitions of what is ethical and not ethical, subjects in clinical trials get trampled in the blind pursuit of trying to apply medical breakthrough (page 23).
e) There have also been concerns about whether the FDA allows pharmaceutical companies too much freedom in how they design trials and how they report the results of these trials. Pharmaceutical studies can be designed to falsely increase the likelihood of getting the results the drug companies wants (page 46).
f) ….drug companies may skew the design of clinical trials so their drugs will come out looking more effective or less dangerous than they are. Among the tricks that can be used are testing the drug in a healthier population that will be taking the drug and comparing the new medication to a lower dose of an existing medication so the results look better for the drug being tested (page 75).
g) ….consent forms that the trial subjects signed always overstate the benefits and the risks of the trial are understated (page 88).
h) Because clinical trials are not therapy, because they are by definition research, terminally ill patients who do consent to participate in trials are usually persuaded to do so because of therapeutic misconception or the implication they will receive treatment in the trial (page 90).
Regardless, clinical trials are not designed to provide patients with quality care. Somehow, patient care became part of a process designed to only gather information. The doctor administering the trial might be wearing a stethoscope and a lab coat, but he/she is not there to cure anyone. He/she is there purely to collect information from a subject and learn more about medicine (page 30).
The history of clinical trials shows great swings between significantly helping and dramatically harming people (page 52).
They are, after all “medical experiments” dismissed in the public consciousness as “a fringe medical endeavour along the lines of “Frankenstein cooking up a monster in a lab” (page 3).
So, for cancer patients opting/signing up for clinical trials, remember it is an information gathering exercise only and not a medical treatment at all. And in some trials, a placebo (sugar pill) may be used. If you are a cancer patient, you do not have the luxury of time for some drug companies to experiment with your body. Only the drug companies will benefit…..after you are long gone.
Postscript
Alex’s experiment was not successful. In May 2007, one year after the transplant took place he had to increase his insulin intake and in 2008, he was an insulin-dependent diabetic again. His wife, who could not bear it anymore, filed for divorce. Subsequently, the drug company sponsoring the trials also terminated the protocol….and Alex O’ Meara was back to square one.
FURTHER RELATED REFERENCES
There are a lot of books/references if you have the interest/inclination to read further on the subject of ethics (or lack of it) in clinical research. Below is just a short list.
1) HE BODY HUNTERS by journalist Sonia Shah. In the book, she shares that: The main business of clinical research is not enhancing or saving lives but acquiring stuff: data. It is an industry, not a social service.The people who sponsor and direct clinical trials do it for the data, not to please patients or help bolster ailing health facilities, although they may point to these side effects to justify their activities.
2. WHITE COAT, BLACK HAT: ADVENTURES ON THE DARK SIDE OF MEDICINE (2010) by Dr Carl Elliott, MD, PhD, Professor in the Center for Bioethics at the University of Minnesota, who says medical trials that were once carried out by medical schools and teaching hospitals have moved to the private sector and drug companies manipulate the research and review boards to get the results they want. After drugs are released they again manipulate the system to get drugs recognized on the market even if the risk to patients outweighs the benefits.3. EXPLOITATION AND DEVELOPING COUNTRIES: THE ETHICS OF CLINICAL RESEARCH by Jennifer S. Hawkins (Editor), and Ezekiel J. Emanuel (Editor). The book is an attempt by philosophers and bioethicists to reflect on the meaning of exploitation, to ask whether and when clinical research in developing countries counts as exploitative, and to consider what can be done to minimize the possibility of exploitation in such circumstances. A case in point is clinical research sponsored by developed countries and carried out in developing countries, with participants who are poor and sick, and lack education. Such individuals seem vulnerable to abuse. But does this, by itself, make such research exploitative?
4. RETHINKING THE ETHICS OF CLINICAL RESEARCH: WIDENING THE LENS by Alan Wertheimer, Senior Research Scholar, Department of Bioethics, The National Institutes of Health, and Professor Emeritus, University of Vermont.
Clinical research requires that some people be used and possibly harmed for the benefit of others. What justifies such use of people? This book provides an in-depth philosophical analysis of several crucial issues raised by that question. Much writing on the ethics of research with human subjects assumes that participation in research is a distinctive activity that requires distinctive moral principles. Specifically, read chapter 5, “Exploitation in Clinical Research.”
5. WATCH THE MOVIE….The Constant Gardener, a 2005 drama thriller film directed by Fernando Meirelles. The screenplay by Jeffrey Caine is based on the John le Carré’s novel of the same name. The film follows Justin Quayle, a British diplomat in Kenya, as he tries to solve the murder of his wife Tessa, an Amnesty activist. The story is told using many flashbacks and it is gradually revealed that Tessa was trying to uncover dubious drug tests by a Swiss-Canadian drug company on the local population.
It was filmed on location in Loiyangalani and the slums of Kibera, a section of Nairobi, Kenya. Circumstances in the area affected the cast and crew to the extent that they set up the Constant Gardener Trust in order to provide basic education for these villages. The plot was based on a real-life case in Kano, Nigeria in which a meningitis drug, approved for use on adults were used on children (in Europe, the same drug was never approved for adults or children).
6. VISIT THE WEBSITE OF GUINEA PIG ZERO, a Journal for Human Research Subjects…..www.guineapigzero.com……lots to read. Then you will understand why you should not be a guinea pig
Chasing Medical Miracles has been reviewed in the Wall Street Journal as a “worried portrait” of how more than 20 million Americans are enrolled in clinical trials. Clinical trials have become a $24 billion industry that is reshaping every aspect of healthcare development and delivery in the United States and around the world.
The book, Chasing Medical Miracles: The Promise and Perils of Clinical Trials, and this companion website are the first resources to take an objective, behind-the-scenes look at the complicated world of clinical trials. The site also provides up-to-date information about clinical trials for those curious about the topic and for those taking part as subjects. (read more)
Chasing Medical Miracles and this website are by journalist Alex O’Meara who as a diabetic suffered from life-threatening hypoglycemic unawareness. The book chronicles how he participated in a risky and groundbreaking clinical trial to “cure’ diabetes.The book also reveals how a multi-billion dollar industry of private companies conducting trials with little oversight has taken root and quietly become a major part of the American medical establishment.
Along with regulations and ethics, Chasing Medical Miracles examines the economic impact and the heart-wrenching personal stories behind clinical trials both across the country and overseas. O’Meara reveals what every health-conscious person needs to know—regardless of whether you are considering participating in a clinical trial or trying to make sense of the confusing and sometimes conflicting medical advice that’s based on clinical trials.
Alex is an award-winning journalist who has worked for the City News Bureau of Chicago, the Washington DC bureau of the Baltimore Sun; Newsday; NBC in Tucson; and many other media organizations. He is the author of Chasing Medical Miracles: The Promise and Perils of Clinical Trials (Walker 2009) and the novel Bad Day for the Home Team (Zumaya 2010.) Originally from New York, Alex lives in Bisbee, Arizona.
Advice for Subjects
(Adapted from Chasing Medical Miracles: The Promise and Perils of Clinical Trials. A more comprehensive version is available as an Afterword in the book.)If you’re thinking of volunteering for a clinical trial here is some information you should keep in mind.Before You Decide to Enroll
1 – Volunteering for a clinical trial is a legitimate option you might wish to consider if you’re seeking a new way to address a medical condition you have. However, clinical trials are not medical treatment. You might benefit from a trial, but that is not the reason the trial is being done. The trial is being conducted to gather data – period, end of story.
2 – Volunteering for a trial to help others and advance medical science is honorable. Many people feel compelled to “give back” or to sign up for a trial exploring new treatments and drugs for a condition a family member or loved one suffers from. If such an option feels like something you want to do, then by all means consider it.
3 – Finding a clinical trial is not difficult. There is a very comprehensive listing of more than 50,000 open trials prepared and maintained by the National Institutes of Health at www.clinicaltrials.gov. Another good listing site is www.centerwatch.com, a for-profit information services company that serves the clinical trials industry.
Consent and Questions
1 – When you first visit the sponsor of the trial, be aware with whom you are speaking. Ask the person you are meeting with to describe to you their role in the trial.
2 – For your first visit (and for visits afterward) take someone with you. This is helpful because you are going to be receiving a lot of information and it’s difficult to just process it all on your own without having someone to review it with you.
3 – Informed consent is crucial to the clinical trials process. It is a federal regulation that you give informed consent before the trial. If you are not offered informed consent along with an informed consent form to review and sign before you take part in the trial, do not take part in the trial. Ask for the opportunity to take the consent form home to study and discuss it with others.
During the Clinical Trial
1 – At any point during the trial you can drop out. This is a guaranteed federal and international right.
2 – Be sincere about your involvement. Keep a diary if it’s required. Go to all appointments you agreed to go to. Take all the tests you agreed to take. Adhere to the guidelines you agreed to when you signed up.
3 – Continue to ask questions. You should ask and expect answers to questions about the clinical trial overall, about your test results, about results thus far from the trial, and side effects, about what to expect in the next step or steps in the trial, and about anything else that you are not clear about or that you are merely curious about as you proceed through the trial.
4 – Ask the research team to copy your primary care physician on all your test results. Let your primary care physician know you are asking this and to expect these test results.
5 – Take an active role in the study. You are a partner in the research and as such you should continue to research the area the trial is studying and the progress of the trial and related studies.
6 – Ask the sponsor or the patient coordinator for the results of the trial as it progresses and when it’s concluded. Knowing exactly what’s happening and what happened is important for your own peace of mind.
What Everyone Needs to Know About Clinical Trials
- More than 20 million people in the U.S. – and 50 million worldwide – are enrolled in clinical trials, an increase of 300 percent in one decade.
- It costs more than $6,000 to have one participant go through a clinical trial from recruitment to completion.
- The U.S. government requires that any American company or person conducting a clinical trial overseas must meet only the ethical and legal standards of the country where the drug is being tested, not US standards.
- Clinical trials are a $24-billion-a-year industry.
- There are more than 1,000 private companies—Clinical Research Organizations—conducting the majority of clinical trials in the U.S., operating with less regulation than colleges and universities conducting clinical trials.
- The pharmaceutical industry has seen the largest, steadiest annual growth of any industry in the United States since the 1940s.
- The pharmaceutical and clinical research organization industries are so large in one part of Pennsylvania that the region is known as “pharm” country.
- The 1954 clinical trials testing the polio vaccine was the largest and most successful in history, involving 1.8 million American children. Mostly forgotten is that 220 children became infected with polio and ten of them died after receiving a bad batch of the vaccine from one supplier.
- Clinical trials are always experimental and should not be seen or presented as offering treatment, although researchers commonly foster that misconception in order to recruit subjects.
- The U.S. Department of Health and Human Services says the FDA inspects less than one percent of all clinical trials. Out of the 350,000 trials sites the FDA had registered from 2000 to 2005, they inspected fewer than 3,000.
- Sponsors of clinical trial can pick and choose which trial results they release. Out of 74 clinical trials for 12 antidepressants between 1987 and 1994, 94% of the drug trials that yielded positive results were published compared to only 14% percent of the unfavorable results.
Review of Chasing Medical Miracles
February 21, 2010
The subtitle of this 2009 book by Alex O’Meara is “The Promise and Perils of Clinical Trials.” O’Meara combines this personal experience of a clinical trial using stem cells for Type I Diabetes. He reviews the risky world of clinical trials beginning with large for-profit research centers who recruit healthy volunteers and stories of the volunteers who participate for a living or to supplement their income. Some questionable situations are noted including the recruitment of low income and alcoholic men in Indianapolis and elsewhere. He details some famous cases of unethical trials which landed in the courts including those involving genetics and conflicts of interest. Fortunately, some of these potential abuses are more carefully scrutinized. He spends two chapters on international clinical trials which have shifted much of the work to developing countries with a real focus on the issues in Uganda as case study. The fact that drug companies provide medical care in addition to clinical trials creates a dilemma for developing countries with small healthcare budgets.One outstanding story related to a patient’s right to their own data is from a Hepatitis C trial in which the subjects were not allowed to receive information on their viral load during the study as a way of discouraging drop outs. However, this in itself seems unethical in that the patient would not know whether the treatment was effective or ineffective and whether their disease was progressing. I hope that Institutional Review Boards would not approve such a procedure for trials involving serious illness. Much of the book looks at the issues with placebo controlled studies and blinding – it raises many questions which are yet to be resolved by medical scientist and bioethicists.
I would recommend this book for anyone involved in clinical research, whether in Pharma, medicine or as a patient.
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