Good idea, needs revision

I am referring to this post about low vaccination rates by Ms. Nicole Fisher.  The errors detract from the main point.  Original text in italics.

  1. For example, the conventional model for dispensing vaccines includes: four DTap, three polio, one MMR, three Hib, three Hep B, one varicella, and four PCV (4:3:1:3:3:1:4), for a total of 19 antigens being administered. ”  The confusion here is injections vs antigens.  19 = number of injections.  The number of antigens = 4 (DTap) + 1 (polio) + 3 (MMR) + 1  (Hib) + 1 (Hep B) + 1 (varicella) + 1 (PCV) = 12.
  2. But I miscounted.  The polio vaccine has 3 polio types (I, II, and III), so there are 3 antigens  PCV has 13  antigens(if we referring to current Prevnar).  So total antigens is 26 (12 + 3 + 13 – 2 for doublecounting).
  3. This begs the question, why don’t doctors use combination vaccines?  . . .  The sad answer is that doctors are not financially incentivized to.”  This is way more complicated than just negative financial incentives.  Directions for vaccine administration are part of the label.  MDs are free to administer their own way, but why should they?  Any bad sequelae and the MD will be responsible.
  4. Maybe there would interference after vaccines are combined.  It is possible.
  5. Low reimbursements mean doctors’ lives have more difficulty making ends meet  . . .”  Really confusing sentence.
  6. ” It’s time to recognize the significant and detrimental role monovalent shots are having . . .” 2 of 8 vaccines mentioned are multivalent.

Perhaps Communism deserve an environmental award

“But there’s another way to help the climate. A recent study from Lund University in Sweden shows that the biggest way to reduce climate change is to have fewer children.”  (Per NPR article).

Communism killed millions (The Black Book of Communism: Crimes, Terror, Repression).  I believe the total is 100,000,000.  That means a lot of children were never born.

So perhaps the co-authors could present an award to Communism.

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-.

Take Greyhound

HuffPost is going on a listening tour of America by bus.

  1. they will visit 23 cities.  If they want to learn about America, it should be divided into 11 cities and 12 non-cities.
  2. “We will travel the old-fashioned way — via bus”.  But they will be “converting a tour bus into a mobile video studio”.  So it is not really traveling with the public, but inside a comfortable bubble.
  3. Forget the converted tour bus and take Greyhound.