New Prescription Drugs: A Major Health Risk With Few Offsetting Advantages
Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options, and have the need to do so.
Few know that systematic reviews of hospital charts found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients are given drugs that cause serious adverse reactions for a total of 2.74 million serious adverse drug reactions. About 128,000 people die from drugs prescribed to them. This makes prescription drugs a major health risk, ranking 4th with stroke as a leading cause of death. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the U.S. and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.
Perhaps this is “the price of progress”? For example, about 170 million Americans take a prescription drug, and many benefit from the drug. For some, drugs save their life or keep them alive. About 80 percent of them are generic; that is to say, drugs whose benefits and risks are better known. If we suppose they all benefit, then 2.7 million severe reactions is only about 1.5 percent.
But as far as we can tell (very little research is funded on prescription drugs as a health risk compared to less deadly risks like diabetes or Alzheimer’s disease), millions who take new, patented drugs experience only modest benefits over established drugs. Only a small percent of new drugs provide significant advantages for patients to offset these risks of harm. Independent reviews over the past 35 years have found that only 11 to 15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. These contribute to the large medicine chest of effective drugs developed over the decades. But the 85 to 89 percent with little or no clinical advantage flood the market. About four-fifths of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad) have been spent on these minor new variations rather than on the really innovative drugs.
In a recent decade, between 2002 and 2011, independent reviews by clinical expert teams in France, Canada, and the Netherlands have concluded that only 8 percent of 946 new products were clinically superior, down from 11 to 15 percent in previous decades (see Figure, below). Only 2 were breakthroughs and another 13 represented a real therapeutic advance.
Spokesmen for the pharmaceutical industry point out that therapeutically similar drugs have advantages. First, physicians need some choice within a therapeutic class because some patients do not respond well to a given drug. This is true, but after about three choices, there is little evidence to justify a 4th, 5th, or 6th drug in a class. Second, a sub-group of patients may benefit from new drugs that seem similar. This may be true or not, and we need to identify that sub-group so the effectiveness of the drug can be tested on them. The point of testing drugs for approval is to identify which patients might benefit and see if they do, not to assume that some patients somewhere might. Third, industry spokespersons argue that every incremental development contributes to larger improvements. This might be true, but most significant clinical advances occur through major discoveries. Yet most major scientific discoveries do not significantly improve patients’ health and some may prove deadly. Silvio Garattini, a leader in pharmacological research told me, “When a major discovery actually helps patients, we feel very lucky.”