Anemia Drug Made Billions but at What Cost?
August 22, 2012
By Dr. Mercola
Three anemia drugs – Epogen, Procrit and Aranesp – have been among the best-selling prescription drugs in the United States for years, generating more than $8 billion a year for their makers, Amgen and Johnson & Johnson.
They were blockbuster drugs that stimulate your body to produce new red blood cells, which supposedly helped boost kidney and cancer patients' energy and, ultimately, enhanced their lives.
But now, after millions of people have taken these drugs, it's come out that the benefits were "wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked."1
Worse still, the Washington Post has uncovered a series of unsettling events that show just how far drug makers were willing to go to get rich…
Doctors Earned Profits of Up to 30 Percent Just for Prescribing the Drugs
And this was one of the first problems. Drug makers lobbied Congress in order to put a system into place so that doctors and hospitals would be reimbursed more for the drugs they prescribed to Medicare patients than what they actually paid for them. The markup could be as high as 30 percent, and the higher the dose prescribed, the more money they made.
According to Charles Bennett, endowed chair at the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina, in the Washington Post:
"It was just so easy to do – you put this stuff in the patient's arm, and you made thousands of dollars… 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."
Higher Doses Pushed to a Growing Number of Patients
Initially, patients with kidney disease, who often suffer from anemia, were the key target market for the drugs. If anemia is severe enough, blood transfusions are required to boost red blood cell counts. Epogen, Procrit, and, later, Aranesp, were able to accomplish the same boost in blood cells without the need for transfusions.
The Washington Post reported:
"The trouble would arise as the drugmakers won FDA approval for vastly expanded uses, pushing it in larger doses, for milder anemia and for patients with a wider array of illnesses. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. The size of average doses would more than triple. And over the next five years, the FDA would approve it to treat anemia in patients with cancer and AIDS, as well as those getting hip and knee surgery.
The key to their marketing was the claim that the drugs at higher doses could make patients feel better. By 1994, the drug's label, approved by the FDA, advertised a range of benefits: 'statistically significant improvements for... health, sex life, well-being, psychological effect, life satisfaction, and happiness.'"
These claims, however, were based on a series of incomplete and never-published research, some of which were drawn out over a decade or more only to show inconclusive results. One safety study on cancer patients that was supposed to be finished in 2008 is still not complete, and won't be until 2017, according to Amgen, which will be nearly 25 years after the drugs were approved for cancer patients.
And as it turns out, the claims that the drugs lead to improved quality of life have since been withdrawn because they don't meet the U.S. Food and Drug Administration's (FDA) standards of proof.
Higher Doses Increased Patients' Risk of Dying – Study Results Missing Key Data
In 1998, the Normal Hematocrit Trial was published, which explored giving higher doses of drugs to dialysis patients in order to boost their red blood cell count above those generally achieved with transfusion.2 The study did, in fact, find that patients receiving the higher drug dose were dying or having heart attacks at a higher rate than those receiving the lower dose; the trial was actually halted because of this.
However, rather than sounding an alarm bell, when the study was published the authors downplayed the danger, calling the increased death and heart attack rate "not significant." And while no difference was found in quality of life between patients receiving the higher or lower dose, this was not noted in the published study. (Four of the study's eight authors were employed by Amgen, and two have served as consultants.)
As the years went by, health care providers and the drug companies continued to profit from the ever-rising doses of these drugs being prescribed – despite continued studies coming out questioning their safety. It wasn't until years later, in 2011, that the FDA put out a safety announcement calling for more conservative dosing of the drugs "because of data showing increased risks of cardiovascular events."3
The Washington Post reported:
"For years, a small Bethesda-based nonprofit think tank, the Medical Technology and Practice Patterns Institute, had been publishing studies that challenged the conventional enthusiasm for the drug and the government policies that it said promoted their overuse.
Then in November 2006, a study published in the New England Journal of Medicine reported that kidney patients targeted for higher doses were linked to higher risks of hospitalization, strokes and death. In December, a group of Danish researchers said that it had stopped a trial of Aranesp in cancer patients because of an increase in deaths and tumor growths. And that was just the beginning of the bad news…"
The FDA Finally Cracks Down
The Danish research seemed to be the breaking point for the anemia drug trio.
"'Then the FDA cracked down,' The Washington Post reported. 'The drugs' use was ruled out in cancer patients considered curable, it was ruled out in patients considered just slightly anemic, maximum recommended doses were lowered, and the agency told doctors in many cases to use the smallest amount possible to avoid a blood transfusion.
The agency also began to look askance at the alleged benefits, for which the evidence, in retrospect, seemed flimsy. There was no solid proof, under revised FDA guidelines for such measures, that use of the drugs leads to 'statistically significant' improvements in happiness and other benefits, the agency said. Those quality-of-life claims, once so critical to the drug's adoption, were removed from the label.
…Last year, nearly two decades after the Office of the Inspector General first suggested it, the economic incentives to use more of the drugs on patients in dialysis disappeared."
No major class-action suits have so far been filed against the drugs' makers; it is often difficult to prove the drugs were the cause of death, particularly because patients who received them were typically already facing chronic health problems. Still, Amgen has put aside a reported $780 million to settle various claims, including some for alleged illegal sales tactics – a paltry compensation to those who have lost loved ones. This is, unfortunately, just the latest drug scandal to be brought to the public's attention… and it surely won't be the last.
Pharma Giant Pfizer Fined for Bribing Officials in Eastern Europe and China
Earlier this month, it was revealed that U.S. pharmaceutical giant Pfizer and its subsidiary Wyeth have been charged with paying off officials, doctors and healthcare professionals in Eastern Europe and China to secure approval and registration of the companies' products.
The company allegedly paid millions of dollars in bribes from 2001 to 2007. The bribery was so blatant and entwined in the sales practices that they even offered points and bonus programs to improperly reward foreign officials who proved to be the best customers, according to the head of the SEC's Foreign Corrupt Practices Act Unit. Obviously, such corrupt pay-offs puts honest companies at a disadvantage, James McJunkin, assistant director of the Washington field office of the Federal Bureau of Investigation pointed out.4
And that is the over-riding theme we see again and again – these companies are typically NOT honest, yet we trust them with the most sacred possession we have, our health. For punishment, Pfizer will be paying various fines ranging from $15 million to $26 million – barely a slap on the wrist for a company that makes billions of dollars a year.
Big Pharma's Lack of Ethics, Regard for Patient Safety Seemingly Knows No Bounds
If it seems like the number of lawsuits that Big Pharma is settling – many of them out of court without going to trial – are rising, they are. From Merck's $950-million Vioxx deal to the latest announcement that Pfizer has made an $896-million settlement with Prempro victims, the deals show no signs of stopping. Most of the lawsuits are being filed in conjunction with, or aided by, the U.S. Department of Justice, many of them originating from former employees-turned-whistleblowers who divulged marketing misdoings by their employers.
The litigation and settlements are starting to rattle the drug industry, which is becoming no stranger to billion-dollar settlements. Most likely near the end of 2012, Johnson & Johnson reportedly will settle for as much $2.2 billion for its fraudulent marketing of the antipsychotic drug Risperdal.
That amount rivals what was the largest health care fraud settlement to date – $2.3 billion paid by Pfizer in 2009, also for illegally promoting uses of four of its drugs. However, now it's come out that GlaxoSmithKline has agreed to a whopping $3-billion settlement – the largest in U.S. history for health care fraud – with the U.S. government, again for advertising drugs for unapproved uses, along with using gifts to persuade doctors to prescribe the drugs.5
Unfortunately, Americans are disproportionally supporting this behemoth of an industry. Americans, including children, are the most drugged people in the entire world, with the average adult taking 11 prescription drugs – each of which comes with an average of 70 different potential side effects that are then typically addressed with even more drugs...
The situation has gotten out of hand, especially since there's a mountain of evidence supporting the use of alternatives, and there's very strong evidence that some "alternative" treatments, such as diet and exercise, are FAR more effective, not to mention safer, than any of the drugs currently in use. My site is chock full of free comprehensive recommendations that can serve as an excellent starting point to break free from this fatally flawed paradigm. The tools I provide on this site will help you to reduce your reliance on the broken health care system, including its overuse of drugs, and provide you with the tools and resources to Take Control of Your Health.