Study outcome won't sway company on eye drug

(AP) -- What does a company do when there's anecdotal evidence that two of its drugs are equally effective in treating a leading cause of blindness in the elderly, one costing patients $60 per treatment and the other $2,000? In the case of Genentech Inc., nothing.

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• Shirley - Aug 31, 2008
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  In all of the discussions surrounding Lucentis vs. Avastin, nowhere is anybody talking about the inherent risk using a compounded medication. The reason we have the FDA-approval process is to provide an assurance that a drug has gone through rigorous testing for safety and efficacy and in the case of an injection like Lucentis, sterility is always of concern.
  
  Using compounded drugs because they are cheaper is NOT the reason a compounded drug should ever be used. Rather a compounded drug should be used only because there is no other commercially available option for the patient. If we want cheap, why not get rid of the FDA approval process? That%u2019s essentially what we are doing when we promote compounded drugs over FDA approved drugs because of costs.
  
  The only group benefitting from this move towards cheaper and not safer drugs is the pharmacy compounders who are successfully creating a %u2018second%u2019 tier pharmaceutical industry - one that is self-regulated and doesn%u2019t have to conform to any federal regulations regarding the safety, efficacy or sterility of their drugs.
  
  Physicians who choose to prescribe the cheaper unapproved drug must, in plain English, explain to their patients they have decided to administer them a drug that is NOT FDA-approved for safety, efficacy or sterility for WMD and why they are doing so.
  
  For patients on Medicare and other insurance, the FDA-approved drug, Lucentis, is covered, as it should be, and physicians place patients at unnecessary risk when using a compounded avastin instead. Recently, Britain%u2019s National Institute of Health and Clinical Excellence recommended Lucentis be available to U.K. residents.
  
  We should all be greatly concerned that our government, led by these physicians, is creating a precedent where insurers are being encouraged to NOT reimburse for an FDA-approved drug because a compounding pharmacy can make something cheaper, even though they cannot guarantee the safety, efficacy or sterility of every product they make.
  
  Headlines in 2007 from Oregon where three patients died from a 'mistake' made in a compounding pharmacy begs the question, "How do we justify increased risk using unapproved drugs to save money as being 'best for the patient?"
  
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