The Johnson & Johnson cancer drug scandal that encapsulates corruption in health care – Statnews


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.

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.

After learning of Henke’s study and Goldberg’s revela­tion that there were others with similar results, the Food and Drug Administration in May 2004 called a public hearing of cancer experts. During the meeting, a top J&J research executive was forced to admit publicly for the first time that the company had undertaken at least five studies that had to be stopped because pa­tients getting EPO died more often than those getting a placebo. J&J executives dismissed the results of all these studies as uninterpretable or confusing.

There are many moments in the history of American health care that are difficult to explain in retrospect. One is the worsening opioid disaster after the risks of these dangerous medicines became clear. But just as inexplicable was the growth in EPO prescriptions after the FDA advisory committee made the drug’s dangers plain.

In the EPO case, prosecutors and investigators later expressed shock at how thoroughly corruption infected almost every major in­stitution involved in cancer care. While J&J was never charged in connection with the marketing of EPO, its partner in making and selling EPO, Amgen, was. The companies were also fierce competitors that sued each other repeatedly over vari­ous aspects of their EPO relationship, and J&J executives have said that it is unfair to suggest that they were in any way complicit in Amgen’s crimes, for which Amgen eventually pleaded guilty. Still, various investigations revealed how J&J incentivized doctors and hospitals to expand the use of Procrit.

Lying to Medicare

The federal Medicare program began in 1965, and for most of its history it generally paid for hospital care but not routine drug pre­scriptions. Since cancer treatments were usually administered in hos­pitals by infusion, the drugs were considered part of hospital care, so Medicare paid the bill.

Drug companies were supposed to report the average wholesale prices, or AWP, of drugs. This was the amount the government reim­bursed the hospitals. But companies routinely charged hospitals less than the price reported to the government. The larger the gap between the actual price that hospitals paid and the fictitious AWP that drug companies reported to the government, the bigger the amount of money that hospitals could pocket as profit. Oncologists soon opened infusion clinics outside of hospitals so they could capture more of these profits themselves instead of sharing them with hospitals. Given this, drug companies figured out they could boost sales of medicines simply by widening the gap between the real price and the fake AWP price.

In 2005, to crack down on some of this fraud, the Medicare pro­gram changed its reimbursement formula to something called the average sales price, or ASP. But the games and the gaps between real and reported prices continue, and as cancer medicine prices soared, the drug markups got bigger and bigger. Again and again over the years, cancer doctors have tended to favor drugs that gave them the most money, whether those drugs worked better than other drugs or not.

Although the vast majority of oncologists are honest and caring, financial incentives can unconsciously nudge even the most honest doctors to change their prescribing habits, studies show. Many pa­tients pay a portion of those costs out of their own pockets. So, as doctors enrich themselves, some also bankrupt their patients and — because their prescribing decisions are based on profits instead of effectiveness — undermine their patients’ health. Again, much of this — in some cases, maybe all of it — may be done unconsciously, given the many incentives dangled in front of oncologists. But con­scious or unconscious, the results are the same.

This, in a nutshell, is the story of EPO. It is also the grim reality of cancer care in the United States and is among the chief reasons why Americans who get cancer tend to die earlier and poorer than their European counterparts.

At roughly $1,000 a dose during the height of its use, EPO was and remains expensive. Doctors and hospitals often pocket nearly a third of that price themselves — or about $300 per dose in the 2000s. Many patients get dozens of doses.

Nurses don’t spill that much

According to secret grand jury files, J&J sales reps admitted that they, with the full knowledge and support of top J&J executives, even gave doctors free Procrit vials, for which the reps helped them seek full-price reimbursements from Medicare and private insurers. Johnson & Johnson added about 10 percent more medicine to EPO vials than listed on the containers. The company justified the practice by saying the extra product was meant to compensate for spillage. But infusion nurses don’t spill expensive cancer drugs. The extra was just another way to give free product to doctors and hospi­tals, for which they would then bill the government and private in­surers as if they had paid full freight. The profits involved were so huge that some hospitals hired compounding pharmacies to repack­age EPO into smaller vials.

Other sales representatives told investigators, according to grand jury files, that J&J encouraged almost every oncologist in the country to bill Medicare for medicine they got for free. Such widespread fraud created huge financial incentives for doctors to use enormous quantities of EPO, resulting in an estimated doubling of oncologists’ take-home pay — from about $300,000 a year to about $600,000.

A practice manager in Washington state in 2007 was so appalled by the payments that he gave the Times financial statements showing that doctors in the practice pocketed $2.7 million after prescribing $9 mil­lion worth of J&J’s EPO over the course of a year. Looking at a different set of records, reporters at the Wall Street Journal reported the very next day that cancer doctors got back $237,885 for every $1 million of Pro­crit they prescribed.

The EPO disaster in many ways exceeds that of prescrip­tion opioids. The two have cost a similar number of lives, but opioid makers never ensnared as many doctors and revered medical institu­tions into participating in such blatant and systematized greed. Opioids relieve pain in ways no other drugs can match, so patients can benefit from treatment. By contrast, since simple blood transfusions are far safer and more effective than EPO, the drug’s only offering for cancer patients is injury and death. And because EPO is so much more expensive than any opioid, the scale of the theft of tax, insurance, and patient dollars has been vastly greater.

By the end of 2007, eight large studies would convincingly dem­onstrate that EPO increased the risks of heart attacks, strokes, and tumor growth. The FDA put a black box warning, its strongest, on EPO drugs, saying doctors should use the lowest possible dose to help patients avoid blood transfusions. It added a note that Procrit should not be given to patients “when the anticipated outcome is cure.”

It is difficult to explain the ongoing widespread use of EPO ever since. The only approved use of EPO in cancer is for patients who become anemic as a result of other chemotherapeutics. But cancer patients rarely take such toxic chemo unless they’re seeking a cure, a situation for which the FDA said they shouldn’t be given EPO. The drug has not been proven to improve patients’ quality of life and so is not appro­priate for hospice patients, either.

Small-town doctoring

Doctors who continue to prescribe EPO say that it’s helpful for their patients, many of whom are going to die anyway. But such pre­scriptions undermine almost everything oncologists say they stand for, since the drug can actually shorten life, and leave the victim’s family impoverished financially as well as emotionally.

Doctors who still prescribe EPO for many of their patients are invariably located in small towns and cities where care tends to be poorer. In 2018, the oncologist in the United States who used the most EPO was located in New Hartford, New York, a town of about 22,000 located halfway between Albany and Syracuse. The second biggest user was a nephrologist in Roseburg, Oregon. The third and fifth biggest users were oncologists in Little Rock, Arkansas, and the fourth was in Atlantis, Florida.

Not one of the five is affiliated with a major academic medical center where their EPO prescriptions would likely garner scrutiny. But for these oncologists in small towns, small markets, and small cities, prescribing EPO brings considerable extra income, helping them fight against many of the trends in medicine that might other­wise lead them to flee to bigger cities or cost them their ability to fund second homes.

Perhaps not coincidentally, these are the kind of places that voted decisively for Trump and where Kennedy’s claims of corruption in health care resonate so powerfully.

Adapted from the book “No More Tears: The Dark Secrets of Johnson & Johnson” by Gardiner Harris. Copyright © 2025 by Gardiner Harris. Published on April 8, 2025, by Random House, an imprint and division of Penguin Random House LLC. All rights reserved.

Gardiner Harris was the lead pharmaceutical reporter at the Wall Street Journal and the New York Times. He then became a Times foreign, White House, and diplomatic correspondent. He lives in San Diego.

Source: https://www.statnews.com/2025/04/03/erythropoietin-epo-scandal-cancer-drug-johnson-and-johnson-no-more-tears-excerpt/


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