According to the Institute of Medicine, “in any given month, an estimated 48 percent of Americans take at least one prescription drug. Prescription drugs are crucial for preventing and treating diseases and improving the public’s health, but they can also have unintended harmful effects. Often, their benefits and risks cannot be fully identified until after a drug has been used by a large, diverse group of patients over time, mainly because clinical trials conducted before approval may be too small or too short to detect all possible risks.”
New drugs are an important part of modern medicine. However, recent controversies leading to the recall of certain prescription drugs have fueled concerns about the nation’s drug approval process. Unfortunately, even the most rigorously designed and controlled clinical study might not identify every possible side effect of a new drug before it is approved for use. More often than we would like, problems may not appear until after a medication is taken by thousands or even millions of patients.
The FDA’s responsibilities for protecting the health of Americans are far-reaching. The FDA protects our nation’s food supply through regulatory activities designed to cover 80 percent of the food consumed in this country. It also regulates all drugs, human vaccines and medical devices, and hence plays a critical role in ensuring the appropriate safety and effectiveness of rapidly emerging medical products. The FDA monitors more than $1 trillion worth of products, representing about 25 cents of every $1.00 spent annually by American consumers.
For approximately every 5,000 to 10,000 compounds that enter preclinical testing, only one is actually approved for marketing. According to the FDA’s own data, only 8 percent of all drugs progressing to human trials after demonstration of safety in animal studies will gain approval. Only about 15 percent of trials for new drugs and treatments are funded by the government. The private pharmaceutical industry funds 85 percent.
The FDA approved 69 drugs in 2007, a 26 percent drop from 93 approvals in 2006. The approval rate of new drugs dropped below 60 percent in 2007, down from 76 percent the year before. This is the lowest approval rate since 1994.
Under fire on several fronts recently, the beleaguered FDA is facing particular scrutiny regarding the safety of drugs it approves for human use. Recent high-profile drug safety failures such as Trasylol, Pergolide, Zelnorm, Ketek and Avandia add to a litany of dangerous drugs, many still prominent in the public’s memory, including Vioxx, FenPhen, Propulsid, Rezulin, Seldane and Accutane.
About half of clinical-trial drug failures are due to undetected toxicities (poisoning), and about half of the small percentage of approved drugs will later be taken off the market or receive black-box warnings for the same reason.
In spite of all this effort, even marketed drugs do not work for most patients. More than 90 percent of these drugs only work in a minority of patients, and rates of effectiveness are as low as 25 percent for cancer treatments and 30 percent for Alzheimer’s disease products. Something is clearly amiss with preclinical drug testing when only 4 in 100 drugs entering clinical trials are truly safe and effective, and that effectiveness means that only a minority of patients will benefit.
It is generally agreed that tens of thousands of people die every year from adverse effects of the medicines they are taking. It is estimated that 7,000 people die yearly from medication errors (as defined in this testimony) alone. One U.S. study showed that 10 percent of drugs approved between 1975 and 1999 had serious safety warnings added after approval, and 3 percent were withdrawn from the market.
New knowledge comes from diversity. The more diversity you have, the more likely you are to find scientific discoveries. A study published online in the journal Medicine suggested the legacy of Tuskegee partly explained a deep distrust of doctors. Among medical patients surveyed in Maryland, the study found 58 percent of Blacks believed doctors prescribe medicine to experiment on people without consent, compared with 25 percent of whites. And 25 percent of the Blacks — but only 15 percent of whites — thought their doctor would ask them to take part in a study that would hurt them.
The FDA focuses its inspections on domestic companies, with about 1,200 inspections conducted annually in the United States. Meanwhile, only about 300 foreign facilities are inspected each year. The latter number amounts to only about 10 percent of the firms shipping prescription drugs or their ingredients into the U.S.
The FDA says itself that it is understaffed and underfunded and needs more regulation authority to deal with the growing international outsourcing for the manufacturing of pharmaceuticals.
A scathing report for the Institute of Medicine in September 2006 states, “The public would benefit from more information about how drugs are studied before FDA approval, how drugs’ risks and benefits are assessed, and what FDA review entails. Patients also need timely information about emerging safety concerns or about a drug’s effectiveness in order to make better decisions in collaboration with their health care providers. FDA does not have an adequate mechanism for seeking and receiving specific scientific and patient/consumer advice on communication matters.”
The FDA must no longer be comfortable with a failed drug-testing process that puts the public health at risk. What’s needed is a major overhaul of America’s drug approval process, including research ethics. We need to devise a new means of either funding all studies being relied upon in approving medications, or guaranteeing independent oversight of the study process.
Here are a few questions to ask if you are considering being in a clinical trial for a new drug or medical device:
What is a clinical trial, and why is it important to me? Who is sponsoring this trial?
How will my health and safety be protected? Will this benefit me directly? Where can I get more information?
Remember, I’m not a doctor just sound like one. Take good care of yourself and live the best life possible.
The information included in this column is for educational purposes only. It is not intended or implied to be a substitute for professional medical advice.
Glenn Ellis is a health advocacy communications specialist. He is the author of “Which Doctor?” and is a health columnist and radio commentator who lectures, and is an active media contributor nationally and internationally on health related topics. His second book, “Information is the Best Medicine,” was released in January 2012. For more good health information, visit: www.glennellis.com.