A few sobering facts about the drug industry. Only one in 10 products approved by the Food and Drug Administration provides significant benefit over existing remedies. More than 50,000 people are admitted to hospital every week due to harmful drug side effects; 2,400 people die from them. Drug companies spend only 1.3% of revenues (not including taxpayer subsidies) discovering new molecules. They spend about 25% of revenues, or 19 times that, on marketing.
These are just some of the points from a recent paper in the Journal of Law, Medicine and Ethics. Led by Donald Light, from Harvard's Edmond J Safra Center for Ethics, the authors write that drug companies are not nearly as "innovative" as they claim to be:
Millions of patients benefit from the one out of six drugs that are therapeutically significant advances; but most R&D dollars are devoted to developing molecularly different but therapeutically similar drugs, which tends to involve less risk and cost for manufacturers.
Drug companies do produce a lot of new drugs. In fact, the number entering trials, and being approved, has increased steadily. It's just that most are iterations, the authors say, rather than new recipes: "Companies are using patents and other protections from market competition primarily to develop drugs with few if any new therapeutic benefits and to charge inflated prices protected by their strong IP rights."
The FDA may be at least partly to blame. For one, drug companies are allowed to test new drugs against a placebo but aren't required to compare them to effective treatments already on the market. The FDA also allows companies to design trials "in ways that minimize detection and reporting of harms and maximize evidence of benefits"--for example, by excluding people from the trial who might react badly to the drug. More broadly, the authors charge, the FDA has become "institutionally corrupted" by lobbying in Congress and industry-funded “user fees” that pay FDA salaries.
The paper is particularly critical of user fees, which were introduced in 1992. On the one hand, they have allowed the FDA to approve drugs more quickly. On the other, they may be letting through more drugs of dubious benefit, including many with serious side effects. "Industry fees have not increased innovation as measured by clinically superior drugs," the paper says.
The authors want fundamental reform of the FDA, including a new independent testing body, and an end to industry fees. But they also recommend consumers be more cautious about new drugs. Don't take anything that hasn't been on the market for at least seven years, unless you have to, they say. Only then can you understand the real benefits and side-effects of a new treatment. The FDA can't tell you.
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