Q. COVID-19 is an unprecedented public health emergency. Why can't we go faster in developing drugs for it that are effective and safe?
A. That's what we all want: fast, effective, safe. But we can't usually have all three, so we settle for effective and safe.
In the United States, the FDA approves drugs to treat specific diseases. To prove to the FDA that a drug is effective and safe, doctors need time. A large number of patients need to be recruited and followed to see whether the drug has worked and whether it has produced dangerous side effects — and that all takes time. If doctors cut corners, they can draw the wrong conclusions about whether the drug is effective and safe.
Sometimes rare but serious side effects don't show up until a lot of people have taken the drug for a long time. For example, the arthritis drug rofecoxib (Vioxx) was studied on thousands of patients, judged to be safe, and approved for use. But when hundreds of thousands of people started taking the drug, it became apparent that the drug increased the risk of severe high blood pressure and heart attacks. The drug was taken off the market.
To develop a drug for a new viral disease, like COVID-19, you have to learn how the virus is built, because it might have a weak spot that you can attack with a drug. You have to learn how the virus attaches to and then enters into a person's cells, and how it multiplies once it's inside the cells — so that you can create or find a drug that blocks those steps.
Now and then, an old drug for an old disease can also be effective against a new disease. We have ways of rapidly testing whether thousands of drugs already approved to treat other diseases might also treat a new disease. When that happens, it greatly speeds things up, since the approved drugs have established records for safety and are already being manufactured. For example, two drugs that appear to be effective in treating COVID-19 — remdesivir (Veklury) and dexamethasone (Decadron) — were developed for other conditions. Developing a brand-new drug is a much slower process.
Many people ask why the FDA's approval process is so slow. Actually, the FDA process is faster than those of many other developed nations. But it also is careful and deliberate, and that has saved suffering and lives. For example, in the early 1960s, FDA testing spotted a dangerous side effect of the drug thalidomide and kept it off the U.S. market, saving thousands of American children from birth defects.
Today, many drugs and vaccines — old and new — are being carefully tested against COVID-19 — more than previously were tested for any other new disease. That's grounds for optimism.
Author by Dr. A. Komaroff