The FDA limits the information that drug companies can share with doctors and consumers. As many as 100,000 Americans died needlessly from heart disease each year that aspirin makers couldn’t advertise aspirin’s role in its prevention. —Dr. Mary J. Ruwart, Healing Our World
We pay 5 times as much for drugs than we should. Because the FDA is blamed when drugs affect some people adversely, the agency drags out the approval process. Drug development time and cost has increased greatly since the early 1960s without any improvement in either efficacy or safety. The true cost, however, is measured in lives, as tens of thousands of people die waiting for the FDA to approve breakthrough drugs. —Dr. Mary J. Ruwart, Healing Our World
The chemotherapy almost killed Thomas. The Navarros refused further treatments, only to find that the FDA wouldn’t permit Thomas to receive the gentler experimental treatment unless he had radiation too. In frustration, the Navarros went to Congress, as other patients have done, to plead for permission to use new drugs not yet approved by the FDA. After a year and a half of fighting, when Thomas was expected to live for only two more weeks, the FDA finally permitted him to have a “compassionate use” exemption.
By that time, Thomas had developed new tumors, called leptomeningial-sarcoma, from his initial chemotherapy. Nevertheless, the experimental treatment kept Thomas going for several more months. How much longer might Thomas have lived if we had honored his parents’ choice in the earlier stages of his disease?
—Dr. Mary J. Ruwart, Healing Our World
Nobody in the drug industry is going to say anything because if they do the FDA could punish them by dragging their feet on their approvals, which could destroy a company, and it has destroyed many. So no one is going to speak out. —Dr. Mary J. Ruwart