Funded by Amgen, the Normal Hematocrit Trial sought to explore the possibilities of raising the treatment target. It drew in more than 1,200 patients who were on dialysis and had a history of heart trouble. It was one of the largest trials to have been done on the drugs at the time.
About half the patients received enough Epogen to boost their hematocrit up to normal levels of about 42 percent; the other half received only enough to get them to 30 percent, the level typically achieved with transfusion.
Three years after the study began, the trial was halted. Patients in the “normal” higher-dose group were dying or having heart attacks at a higher rate than those in the lower-dose, lower-hematocrit group.
It was an indication that the drugs could be deadly. But what could have been a clear warning turned murky as it was presented to the public.
After the termination of the trial, the FDA added a summary of the results to the Epogen label, but it didn’t limit the recommended dosing levels, which the agency had recently expanded.
The reason for the “increased mortality” at the higher doses “is unknown,” the label said.
There have been ongoing studies on EPO for 25 years and they are still not sure of the actual benefits because the studies are still "ongoing." Studies do suggest...it makes people feel better....so, dosages have been doubled and tripled over time..... The drug co's have said...No comment. Why? For what appears to be HUGE PROFITS, or maybe just their caring concerns for patients. We are talking about 2x - 3x dosages and the label says an increase may cause: INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, TUMORS....etc... Death? Yet its sells very well now doesn't it.
See Amgen's EPOGEN and/or Aranesp prescribing info on the web.
AMGN was Shearson's #1 biotech stock pick around 1989 and there was HEAVY lobbying to get this drug on the market and has cost taxpayers BILLIONS and BILLIONS every year -- it's even one of Medicare's leading expense. Have dosage practices been abused for profits?
If you dig further you will see that the drug has received 15 relabels too over the years. FIFTEEN.
Like ARNA's Lorcaserins (rat tumor scare by the BEAR camp in 2011) the multi-billion dollar drug mkt has shown us that drugs or drug candidates with a sketchy past can be repositioned and re-branded IMO. Lorcaserine is now called BELVIQ. Who would buy a drug that caused TUMORS in rats people asked? Well, the name has changed to cover the old tracks a bit for those who didnt follow that BEAR RAID campaign and controversy. I did and ARNA was $1.25 in 2011....which later shot to the $13's. Even AF at TheStreet received a cease and desist from an atty to stop slamming the company (on behalf of the HF's buying maybe??) FWIW. AF was slamming my VVUS too at $9 - $10and well, one fine day...BANG it opened at $20 then traveled up to $30, currently back in today at the $10 level. HaHa.
Keep digging and you will see that if there's money to be made, a drug can be brought back on the market just like Tylenol...if consumers are protected and it is used properly.