The Spark

the Voice of
The Communist League of Revolutionary Workers–Internationalist

“The emancipation of the working class will only be achieved by the working class itself.”
— Karl Marx

“Legal” Drug Dealers and Their FDA

Jun 17, 2024

Pharmaceutical companies push the Food and Drug Administration (FDA) to have their drugs approved through a quickened approval process. Later, these drugs turn out to be not effective in treating patients. But still companies make billions of dollars before these non-working drugs are taken off the market.

In 2023, the pharmaceutical companies pushed two-thirds of all new drugs to the market through such an “expediting” scheme, as Bloomberg recently reported.

Amylyx Pharmaceuticals Inc.’s drug to treat amyotrophic lateral sclerosis (ALS), a deadly disease, is one such example. After Amylyx completed only one small clinical trial, the FDA approved its drug in 2022. Amylyx priced the treatment at $158,000 a year. Then, the company’s Wall Street stock price surged more than 50%. Nearly a year and a half later, a large clinical trial confirmed that Amylyx’s drug was no better than sweetened water. But the company reaped 400 million dollars in sales from this scheme within this short period.

In another example, the FDA approved Makena in 2011, a drug supposed to reduce premature birth risk. Eight years later, however, results of a large clinical trial showed that this drug did not work. Yet it took another four years for the FDA to force it off the market. Meanwhile, several companies that marketed Makena made over 1.6 billion dollars.

Medical device companies are no different in resorting to quick shortcut approvals. The FDA recently approved Abbott’s cardiac device, trademarked TriClip, even after the FDA’s own staff pointed out that a clinical trial indicated that this device won’t work as intended. Patients treated with TriClip had “numerically higher” mortality and heart failure hospitalization rates during the 12 months after the procedure compared with a control group, according to the FDA staff.

Ten of the advisers who approved this device had previously received payments from Abbott or conducted research Abbott funded, totaling up to about $650,000, according to KFF Health News. As the adage goes, “He who pays the piper calls the tune.”