Over the last 20 years, nearly two dozen powerful, immune-suppressing drugs that treat conditions such as psoriasis and rheumatoid arthritis have hit the market leading to booming sales and an unrelenting barrage of TV commercials. While the ads depict happy people with clear skin and “sexy elbows,” or dancing and playing basketball, there is an alarming, darker side to the drugs. Known as biologic medications, or biologics, the drugs and a few others that compete in the same market can provide significant relief of symptoms, or even remission in some cases. But by suppressing the immune system, they expose patients to a greater risk of infection.
An investigation by Milwaukee Journal Sentinel reporters John Fauber and Kevin Crowe found that since 2004 the drugs were linked to reports of more than 34,000 deaths and more than 1 million adverse events, including nearly 500,000 that were deemed serious. Their reporting identified a key flaw in the approval process: The U.S. Food and Drug Administration often allows drug companies to test their products on healthier patients or against inferior treatments. But once on the real-world market, the drugs are used in patients who are more likely to suffer serious side effects or find that the drugs don’t work as well.
On at least 25 occasions, they found, the FDA has issued safety alerts or required drug labels to be updated with information about serious new risks — all after the drugs were approved for use. Indeed, 62% of the drugs now carry the agency’s most stringent “black box” warning. Those warnings include everything from fungal and bacterial infections to tuberculosis; from neurological conditions to liver failure, heart failure, lymphoma and other cancers. Despite the risks, sales of the drugs have reached $40 billion a year.
As with the opioid crisis, the rise in the use of the drugs was fueled by a massive and expensive effort by drug companies that included financial contributions to medical societies; positive papers authored by drug company employees and consultants; and treatment guidelines recommending use the of the drugs written by doctors with financial ties to the drug companies.
How extensive is the drug-company effort? In one case, AbbVie created a “Nurse Ambassador” program that paid nurses around the country to make in-home visits to patients who had been prescribed Humira, its top-selling rheumatoid arthritis and psoriasis drug, according to a lawsuit filed by California regulators. The wrinkle: The nurses were instructed not to mention the risks of the drug such as potentially deadly infections. The stories exposed a cozy relationship between the FDA and Pfizer, which makes an expensive drug that competes in the same market with biologics.
In February 2019, a Pfizer safety trial showed that rheumatoid arthritis patients who got a higher dose of the drug Xeljanz had substantially more blood clots in the lungs and deaths than those who got the lower dose. Unlike European drug regulators, the FDA under Scott Gottlieb did not immediately tell doctors to stop prescribing higher-dose of Xeljanz. Soon after the clots and deaths were discovered, Pfizer asked Gottlieb to join its board of directors. It was not until weeks after a Journal Sentinel story about the FDA’s lack of action — and after Gottlieb had left the agency — that the FDA issued a black box warning for Xeljanz.