FDA Kept Deadly Anemia Drug Dangers A Secret To Protect Pharma Profits

That excuse may no longer hold water for the Food and Drug Administration which, according to a recent Washington Post report, could have some liability in covering for a drug that a growing body of research says is dangerous and deadly.

For many years, the report said, three drugs known as Epogen, Procrit and Aranesp were among the top-selling prescription drugs in the U.S., raking in more than $8 billion annually for a pair of Big Pharma corporations – Amgen and Johnson & Johnson. In fact, these two companies were stars among stars; for a number of years, Epogen was the single costliest medicine under Medicare, costing U.S. taxpayers as much as $3 billion a year.

"The trouble, as a growing body of research has shown, is that for about two decades, the benefits of the drug – including 'life satisfaction and happiness' according to the FDA-approved label – were wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked," the Washington Post reported.

Shocking, to say the least, but there's more.

Medicare researches last year said, in an 84-page study, that they found among most kidney patients – the original and largest market for the trio of drugs – no solid evidence the medications made anyone feel better, improved their chances of survival or even had any "clinical benefit" outside of elevating one statistic for red blood cell count.

So while the drug companies had made tens of billions in profits over more than two decades, much of it from unsuspecting taxpayers, millions of patients were given dangerous doses of the medications to no advantage.

How?

Economic incentives, willing participants, congressional liability

"To answer the question, The Washington Post obtained the agreements between the drug makers and the Food and Drug Administration, reviewed thousands of pages of transcripts and company reports, and relied on new academic research, some by doctors who once administered the drugs but now look askance at the drug makers' original claims," the paper reported.

The paper said part of the blame comes from economic incentives built into the U.S. healthcare system, which can lead to inefficiencies and potentially deadly uses for drugs. But there is more here than simply that.

Drug makers cannot and will not manufacture and market drugs at a loss, that much is a given. But the FDA, according to the Post's report, shares as much blame as anyone for this travesty. So, too, does Congress.

The paper said Amgen launched a well-funded research and lobbying campaign that was ultimately successful to win "far-reaching approvals" from the FDA. But both companies held drug trials that obviously missed (or ignored) the dangers while touting benefits that, 22 years later, would be disclosed as unfounded.

They also took more than 10 years to fulfill research commitments to the FDA, which – finally – moved to reign in the largest doses of the drugs. The agency was then stifled in its efforts by a "high-powered lobbying effort" aimed at Congress until lawmakers forced regulators to back off.

'It was just easy to do'

Sound familiar?

The paper also points an accusing finger at doctors and hospitals.

"Americans might like to think that doctors focus on only their health. But physicians and hospitals have to pay the bills, too, and, in some cases, the more they treat a patient, the more they earn. This was especially true in the case of the anemia drugs: The bigger the dose, the more they made," said the Post.

Incentives offered to them by the drug makers to increase doses ultimately worked. By 2007, some 80 percent of 175,000 dialysis patients on Medicare were being given the drugs at levels above what the FDA believes now is safe.

"It was just so easy to do – you put this stuff in the patient's arm, and you made thousands of dollars," Charles Bennett, endowed chair at the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina and a critic of the use of the drugs in cancer patients, told the paper. "An oncologist could make anywhere from $100,000 to $300,000 a year from this alone. And all the while they were told that it was good for the patient."