Clinical trials and new drug approval

George Curry Media

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

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.”

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 to admit, 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. The FDA 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 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. Private pharmaceutical industry funds 85 percent.

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 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 acknowledges 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 find more information?

DISCLAIMER:

The information included in this column is for educational purposes only. It is not intended nor implied to be a substitute for professional medical advice. The reader should always consult his or her health care provider to determine the appropriateness of the information for their own situation or if they have any questions regarding a medical condition or treatment plan.

Advertisement

Be the first to comment

Leave a Reply

Your email address will not be published.


*