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Amgen's Sharer sees light at end of tunnel
Amgen has had a rough couple of years. The world's biggest biotech saw sales of its blockbuster anemia drugs Aranesp and Epogen take a major hit last year when they garnered black box warnings for heart and vascular problems at high doses. And when Medicare--the drugs' biggest buyer--cut reimbursement rates for the drugs, Amgen suffered. The biotech cut 2,600 jobs in 2007 as part of a widespread restructuring aimed at slicing out a billion dollars in expenses.
But in an interview with the Wall Street Journal, CEO Kevin Sharer (photo) says the company's tough times are in the past. "...Amgen is poised to be 'among the top three in revenue growth and earnings growth' in the biopharmaceutical industry over the next five years, a period when many large drug companies will face added pressure because of patent expirations," the WSJ reports.
Key to Amgen's turn-around is the osteoporosis treatment Denosumab. The drug has already been submitted for FDA review and, if approved, could bring in $2 billion to $3 billion in sales a year.
- read the Wall Street Journal article
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Comments
The addition of a black box warning has virtually no effect on a doctors prescribing habits. The reason being all doctors practice an ART. The principles of practice may be based on scientific fact, however, when you get down to the nitty gritty, since no two patients are alike, each prescription is an EXPERIMENT because there is no way to know how the treatment or drug will work until it is tried. THE PATIENT TRIES IT TO DETERMINE IF THE TREATMENT WORKS OR NOT OR ONLY SLIGHTLY. Adjustments commonly have to be made in dose due to ineffectiveness or extreme side effects of the original dose, or selection of a different drug because the patient is allergic to the original one, or medication may cause drowsiness, medication may be incompatible with other drugs the patient is taking requiring treatment to be adjusted or changed or many other reasons.
Therefore, any doctor could maintain he/she used this on many patients and it always worked. He/she discovered a new treatment for this condition that was more effective and less expensive than anything else that is available. The doctor could maintain he/she was going to prepare an article to send to the New England Journal of Medicine to share this with colleagues so that everybody who needed it could enjoy the benefits of this new discovery at no cost. I discovered it by accident. The story is no different than the discovery of Viagra. They were looking at a new drug for cardiology use and came up with a drug for a completely different purpose. This happens rarely but it happens. When it happens on a few patients it takes a long time before there are enough patients on this therapy to get statistics that demonstrate how effective this treatment is. As long as medicine is an ART NOT A SCIENCE and insurance companies settle out of court there will never be too much concern about black boxes. Doctors know if the drug was really bad it would be recalled by FDA. They have confidence in FDA and their insurance.






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