The EPO disaster in many ways exceeds that of prescription opioids
Erythropoietin — also known as EPO — is mostly remembered as the drug that cyclist Lance Armstrong dishonestly used to win seven Tours de France. The blood thickener’s role in a cancer drug disaster that, by one estimate, cost nearly 500,000 Americans their lives has been forgotten.
That darker tale is one of the defining narratives of American health care. At its center is Johnson & Johnson, the largest health care products conglomerate in the world.
Lies, feckless government oversight, and the participation of nearly every oncologist and cancer hospital in the country are all part of this story. Indeed, EPO’s history demonstrates just how unscrupulous one of America’s most important companies and the nation’s educated elite truly can be, helping to explain why President Donald J. Trump and his health secretary, Robert F. Kennedy Jr., get so much support for their claims that the system is corrupt.
While the story of EPO begins in the 1980s when the drug was first approved and came to market, a crucial moment came in October 2003, when a study in the Lancet medical journal came to the shocking conclusion that EPO may be killing cancer patients, nearly half of whom were being given EPO to prevent or treat anemia that results from many chemotherapy treatments.
A follow-up story in the New York Times quoted several cancer experts who cautioned that the results should not lead cancer patients to stop taking EPO, which J&J sold under the brand name of Procrit. Their implication was that the study was an outlier, an aberration. Since researchers rarely challenge the financial interests of major pharmaceutical companies that largely fund their work, the main author of the study would normally have ratified this view. But not this time.
“[T]he senior author of the study, Dr. Michael Henke of the University of Freiburg in Germany, disagreed, saying he would not recommend administering the anemia drug to patients undergoing treatment meant to cure their cancer, except perhaps in studies,” the Times wrote. For the first time, an EPO researcher refused to play along with this deadly game.
That EPO carried risks to the heart had long been known. That it might encourage the growth of tumors was suspected. The vast majority of oncologists assumed that the drug’s benefits far outweighed its risks, because J&J had for 15 years kept them in the dark about the growing mountain of data showing otherwise.
Days later, Paul Goldberg, the editor of the Cancer Letter, broke the news that Henke’s study was not an outlier. Goldberg uncovered an obscure and easily missed letter that had appeared two months earlier in the Lancet Oncology reporting on a breast cancer trial in 939 patients that found 41 deaths among those who got Procrit versus 16 in the placebo group — a nearly threefold difference. Like in Henke’s study, the Procrit deaths resulted largely because cancers grew.
And then Goldberg had this bomb about major organizations that conduct much of the cancer research in the United States: “In recent weeks, several U.S. cooperative groups suspended clinical trials or made dose adjustments of the J&J epoetin [alfa] after finding an increased risk of thrombosis among patients receiving erythropoietin intended to increase hemoglobin to the normal range.”
By the time of Henke’s study, EPO sales in cancer were bigger than any other drug ever before, with profits flowing not only to J&J but to almost every oncologist and hospital in the United States. But it was now becoming apparent that Henke’s study was part of a pattern, that dozens of researchers working for or on behalf of J&J had participated in trials that had found much the same as Henke. In nearly every case, the results had been kept secret, and none of these researchers had been brave enough to blow the whistle.