It was a remarkable finding of futility while drugmakers had seen billions in profits over 22 years, much of it from taxpayers, millions of patients had been subjected to dangerous doses that might have had little advantage. But while ads touted the drugs virtues, some at the fda had raised safety concerns. Specter received 7,000 in campaign contributions that election cycle from the amgen political action committee and 2,000 from the johnson & johnson pac.
The sales pitch was that higher hematocrit meant a better quality of life. Analysts at the time asked chief executive kevin sharer why there had not been a prompt disclosure. When the agency first approved the drug, it recommended boosting a patients hematocrit up to 33 percent but no more a few years later, after amgens suggestion, it expanded the target range up to 36 percent.
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. Moreover, in 2006, of the 16 members of the foundations panel that created the new dosing guidelines, 10 reported receiving consulting fees, speaking fees or research funds from amgen or johnson & johnsons subsidiary, ortho biotech. Then a nurse said he needed another dose of anemia drugs.
In the first year of the new policy, sales of epogen, the drug most affected by the rule, dropped 20 percent. The first was supposed to evaluate the drugs safety profile and enrolled 2,100 patients. During a hearing, he angrily questioned nancy-ann min deparle, the director of the health care financing administration, which had implemented the policy.
And that was just the beginning of the bad news, which amgen didnt seem particularly eager to share. Amgen filed a clinical study report with the agency in 1995, and the company says its research commitment was fulfilled then. Amgen scientists agreed that the trial results favored the survival of the placebo group but wrote to the fda that there still wasnt enough information.
In a statement, the company said that as the understanding of the drugs has evolved, the company quickly and responsibly communicated these new findings and updated the product labeling 15 times since its approval. His wife, sherry, thought that seemed odd, because his blood readings had been close to normal, but lenox trusted the doctors. Amgen has been hit with whistleblower lawsuits alleging that the company engaged in illegal sales tactics, including the charge from several states that the company overfilled vials to provide an illegal kickback to doctors and hospitals. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. It is impossible to know with certainty whether these drugs caused or hastened his death, doctors said, but they raised his risks.
But within months, the medicare bureaucrats had not only backed off the restriction but agreed to specters higher limit. The pitch worked the average dose for the drugs more than doubled in the early to mid-90s. In the first year of the new policy, sales of epogen, the drug most affected by the rule, dropped 20 percent. But as medicare researchers would later remark, the patients taking the drugs appeared more likely to die than those taking the placebo. 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.
Democrat in a reference to a 1998 senate hearing at which he questioned a policy limiting medicare coverage for high doses of such drugs. The multibillion-dollar rise and fall of the anemia drugs illustrates how the economic incentives embedded in the u. For years, a trio of anemia drugs known as epogen, procrit and aranesp ranked among the best-selling prescription drugs in the united states, generating more than 8 billion a year for two companies, amgen and johnson & johnson. The companies took more than a decade to fulfill their research commitments. Epogen that doctors could freely prescribe in an average patient, adding a cost of 2,000 or more.
The first was supposed to evaluate the drugs safety profile and enrolled 2,100 patients. The sales pitch was that higher hematocrit meant a better quality of life. But, as it turns out, there was a statistically significant sign of danger at least as the moreover, while the article suggested there were quality-of-life benefits to higher hematocrit levels, it left out the fact that no such difference was detected between patients in the higher-dose and lower-dose groups. Sherry lenoxs husband died hours after taking an anemia drug , although cancer was the official cause. And that was just the beginning of the bad news, which amgen didnt seem particularly eager to share. Amgen declined requests for interviews but responded to questions via e-mail. Last year, medicare researchers issued an 84-page study declaring that among most kidney patients, the original and largest market for the drugs, there was no solid evidence that they made people feel better, improved their survival or had any clinical benefit besides elevating a statistic for red blood cell count. For several years, epogen ranked as the single costliest medicine under medicare u. Amgen scientists agreed that the trial results favored the survival of the placebo group but wrote to the fda that there still wasnt enough information. Anemia arises when the body produces too few red blood cells, which carry oxygen from the lungs to the rest of the body.For most men, the recommended dose is 50 mg. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 ...