June 18, 2013

What can patients do about the levoxyl recall?

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In response to Pfizer’s voluntary recall of  levoxyl, I have received many comments from young adult cancer patients and others living with thyroid health issues. Many have asked what patients can do to urge the company and FDA to resume production of levoxyl prior to the target date of 2014.  I believe patient pressure on Pfizer and the FDA will have no impact; unfortunately we must instead experiment with other thyroid replacement hormones, like synthroid, and manage the burden of their potential side effects.  Here’s why:

King Pharmaceuticals manufactured levoxyl in their Bristol, TN plant until 2010 when they were purchased by Pfizer for $3.6 billion.  In August 2011, after conducting studies of its “Logistics and Plant Network Strategies”, Pfizer Global Supply announced it would close their Bristol plant by 2014, relocating elsewhere the production of levoxyl, among other drugs.  It is simply more profitable for the company to abandon levoxyl production at the Bristol plant and make the drug at another location.  On May 29, 2013, the Baltimore Business Journal reported on the acquisition of the Bristol plant by UPM, a Baltimore based company.  UPM will continue to manufacture some of Pfizer’s drugs at that plant for two more years, but  Pfizer has clearly stated that levoxyl will be manufactured elsewhere sometime in 2014.

Coinciding with Pfizer’s new cost-saving manufacturing plan for levoxyl is their voluntary recall of the drug.  A first voluntary recall of levoxyl, announced in March, was based on what Pfizer says were patient and pharmaceutical reports of a strange odor.  Pfizer’s website states: “Pfizer conducted a careful health assessment of the situation and concluded that this odor is not likely to cause any adverse health consequences.”

The FDA recommends a company take a series of actions in response to voluntary recalls, such as creating a plan for remedying the situation and reporting back to the FDA every two to four weeks with updates.  However, in recalls where no adverse health consequences exist, these actions are merely suggestions from the FDA and not enforceable regulations.

At the end of April, just weeks after the initial recall,  Pfizer announced a second voluntary recall when three batches of levoxyl,  made using a previous formulation, showed a potency level slightly below Pfizer’s standards.  Upon this second recall, Pfizer notified doctors that levoxyl production would cease until an undesignated date in 2014.  Because the variation was based on Pfizer’s own standards and not the FDA’s, government oversite does not play a role in this recall either.

Lauren Starr, a spokesperson for Pfizer, indicated to the Wall Street Journal on May 10 that the supply disruption of levoxyl until mid-2014 would not affect the company’s projected earnings for 2013.  (Pfizer is the largest pharmaceutical manufacturer in the world.  Their revenue for 2012 was $59 billion.)

Pfizer has no monetary incentive to rapidly resume production of levoxyl, nor does the FDA require them to do so.   Pfizer’s obligation is to company shareholders, not to patients’ demands.  This is legal and a perfect example of why a healthcare system based on the free market economy and weak government regulations does not benefit patients.

Do you agree or disagree that patient pressure on Pfizer and the FDA will not expedite the production of levoxyl?  Why?

Read Everything Changes: The Insider’s Guide to Cancer in Your 20s and 30s to learn more about the US health system and its impact on your care.

 

 

 

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