Seeking to emulate the big hitters

Like Althouse or Derek Lowe. This NPR story on drug expiration dating falls short.  Some facts, some exaggeration, some hand-waving.  Let’s review.

  1. “Gerona, a pharmacist; and Cantrell, a toxicologist, knew that the term “expiration date” was a misnomer. ”  Half-true.  Given that medications may really retain sufficient potency past labeled expiration, then a true statement.  Given that in the pharma world ‘expiration date’ means the last day that company can legally sell with guarantee that product has 90% or more of label claim, the statement is false.
  2. Maybe we could save money by extending expiration dating.  The feds do this.  “For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country.”  But already we have to mitigate the possible savings “Maintaining these stockpiles is expensive. The drugs have to be kept secure and at the proper humidity and temperature so they don’t degrade. “.
  3. “To determine a new drug’s shelf life, its maker zaps it with intense heat and soaks it with moisture to see how it degrades under stress. It also checks how it breaks down over time. The drug company then proposes an expiration date to the FDA, which reviews the data to ensure they support the date and then approves it.”  True, especially when the product is new.  The accelerated testing is to estimate longer term shelf life without waiting x years to find out.  Manufacturers cannot afford to wait for real time stability thanks to patent expiration.
  4. “Once a drug is launched, the makers run tests to ensure it continues to be effective up to its labeled expiration date. ”  Half-true, at least in pharma lingo.  The manufacturers run tests to assess that potency remains at 90% of label claim (sometimes 95%, I think) but that is not the same as ‘effective’.  If potency is OK, then presumably effectiveness is OK, but manufacturers are not running clinical trials on manufactured lots.  Half-true, lack of understanding.
  5. “Pharmacists and researchers say there is no economic “win” for drug companies to investigate further. They ring up more sales when medications are tossed as “expired” by hospitals, retail pharmacies and consumers despite retaining their safety and effectiveness.”  True.
  6. “That being said, it’s an open secret among medical professionals that many drugs maintain their ability to combat ailments well after their labels say they don’t. ”  Akin to ‘many believe’, aka “all of my friends believe this is true, and I want it to be true, so it must be true”.  Journalistic laziness.
  7. “But neither Cantrell nor Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, a nonprofit organization affiliated with the George Washington University Medical Center, had heard of anyone being harmed by any expired drugs. Cantrell says there has been no recorded instance of such harm in medical literature.”  Absence of evidence is not evidence of absence.
  8. “Testing showed 24 of the 40 expired devices contained at least 90 percent of their stated amount of epinephrine, enough to be considered as potent as when they were made. All of them contained at least 80 percent of their labeled concentration of medication. The takeaway? Even EpiPens stored in less than ideal conditions may last longer than their labels say they do, and if there’s no other option, an expired EpiPen may be better than nothing, Cantrell says.”  I read that 40% (16/40) of expired devices had less than 90% potency.  Is 80% potency OK?  this is a drug for emergencies.  Can the manufacturer now apply for a label claim that  is 80% of the former label claim?  Doubtful FDA would approve.  And what if one of the 80% devices failed to rescue subject in distress. Lawsuit anyone?
  9. “For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.”  Likely true.  And how are expiration dates set?  By manufacturers, following FDA guidelines and regulations.  So the article is missing how the current dates are set.

Where I am coming from: I worked in manufacturing section of large pharma many years ago.  I saw some stability testing, not a lot.  But lot expirations were set to by 95% sure that product taken off shelf could still mean label claim on potency.  No one wanted a lot recall by FDA.  The artless tone that manufacturers are shorting expiration dates in order to sell more product poorly serves a complicated issue.

Final grade: B-.

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