[step-list-wrapper title=”” time=””] [step-item number=”1. ” image_url=”” title=”Don’t give up on medical research.” ]“Never before have we had so many scientific advances that need to be evaluated,” says John Gallin, MD, director of the National Institutes of Health Clinical Center in Bethesda, Maryland. But there’s a serious shortage of volunteers to help test the potential breakthroughs in the more than 50,000 clinical trials currently under way around the world. Some studies do come with risks; others don’t. Many volunteers say they see enrolling in a clinical trial as a kind of civic duty — with the potential to do good for all mankind.[/step-item]
[step-item number=”2. ” image_url=”” title=”Be wary of new drugs.” ]All medicines come with risks. When a doctor prescribes one, he’s making a judgment call that its benefits outweigh its dangers. But with newly approved drugs, the risks are not always well understood at first. That’s why Drummond Rennie, MD, of the University of California, San Francisco, advises sticking to meds that have been on the market for at least four or five years: “I never, ever take a new drug. I want to see reports on the toxic effects after many thousands of people have taken it.” The exception: A patient with a life-threatening condition may be more willing to accept risks. Check your meds at medlineplus.gov.[/step-item]
[step-item number=”3. ” image_url=”” title=”Report your side effects.” ] As a consumer, you can (and should) report adverse reactions to drugs and medical devices directly to the FDA. You can submit a form online at www.fda.gov/medwatch or call 800-FDA-1088.[/step-item]
[step-item number=”4. ” image_url=”” title=”Pony up.” ] Urge your representatives to support increased funding for the FDA. Visit strengthenfda.org to find contact information and to learn what the Alliance for a Stronger FDA (with more than 100 nonprofit, consumer and industry groups, as well as former FDA commissioners and Secretaries of Health) is doing to improve the agency that is entrusted with America’s health.[/step-item][/step-list-wrapper]
The birth of a new drug takes about 15 years.
STAGE 1 — 6 to 7 Years
Scientists toil away in their laboratories, studying thousands of chemical compounds in the hope of finding one that can fight a particular disease. If one looks promising, it’s tested on animals to see how effective and safe it might be for humans. But it’s survival of the fittest at this stage: Only 5 out of every 10,000 compounds tested, on average, will do well enough to qualify for human trials.
STAGE 2 — 6-7 Years
To test a drug on people, drug companies must perform three levels of clinical trials to see if the drug is:
• Safe: Side effects and dosages are studied in 20 to 100 healthy volunteers.
• Sound: A group of 100 to 500 people with the targeted disease try the drug to see if it actually works.
• Superior: A drug is usually tested on 600 to 3,000 people to see how well it works compared with other treatments or placebo. Just one out of every five drugs will score passing marks during this stage.
STAGE 3 — 6-12 Months
The FDA reviews the scientific data and decides if the drug will be approved. (Most drugs take ten months, fast-tracked drugs about six months.) Once approved, the drug soon hits store or pharmacy shelves.
STAGE 4 — 18 Months
In this phase, the FDA can now require drug companies to review the drug’s safety in the general population after it goes on the market.