Pique the Geek 20111113: I was Right. Twice

(9 pm. – promoted by ek hornbeck)

First of all, I am back from taking vacation from writing for the past week.  I needed to get my thoughts organized and also to recharge a bit.  There are also some other things going on that are significant that I mentioned yesterday in a post.  But this is Pique the Geek, and we shall try to stay on topic.

Now, I hope that I have been right in this series more than twice, but these two instances are significant.  Those of you who read this series regularly know that I often write on health issues.  I have made recommendations here from time to time, and in these two occasions the Food and Drug administration (FDA) actually has, presumably independently, has adopted one of them outright and the other at least partially.

After doing more research, I have to say that my statement in the paragraph just above is not quite accurate.  FDA actually did something BEFORE I recommended it, but it got almost zero coverage and I just today found the information.  I shall clarify this as we go.

Around two and a half years ago I wrote about the dangers of acetaminophen, the common over the counter (OTC) fever reducer and pain reliever.  At the time I stated that because of the dangers associated with this drug, it should be by prescription only.  Here is the entire piece, written by invitation for a series called Health Care Change Night, which no longer seems to be active on Kos.

FDA did not go quite so far as to make acetaminophen prescription only, but it did require the pharmaceutical manufacturers to reduce the maximum amount of the drug in prescription pain medication.  The drug is often combined with opiates in combination ingredient pain medication (in general I am not a big fan of combination ingredient products with some exceptions) to potentiate the effects of the narcotics without adding to the dose of potentially addicting drugs.

Interestingly, less than two weeks after I posted that piece, FDA came out on its website with Acetaminophen and Liver Injury: Q & A for Consumers (updated 20110909) that included many of the statements that I had made, but did not call for the end of OTC sales.  However, it later went further and promulgated guidelines for the maximum amount of the drug per dose that could be blended into heavy duty narcotic pain relievers.

The new limit for acetaminophen is now 325 mg per dosage unit (tablet, capsule, or measured amount of liquid).  Here is a consumer update from FDA posted on its site 20110113.  At the time, according to FDA here, there were (if my count is accurate) 70 narcotic preparations that had acetaminophen in them, and 38 of them contained more than the new guidelines.  Some of them contained 750 mg per dosage unit, over twice the new guidelines.

Although I wish that FDA had gone further, this is a good start.  In addition, there are now black boxed warnings on all prescription acetaminophen products.  Those get your attention, IF you happen to have the original container from the pharmaceutical manufacturer.  They do not appear on the amber, plastic bottles that the pharmacy fills that the consumer ultimately gets in most cases.  Instead, FDA did require warnings on the consumer label, but people do not pay much attention to those from my experience.

Another flaw in the approach is that the new requirements are to be phased in over THREE YEARS beginning in January of this year.  FDA also states in one of the links that I provided that

OTC Products Already Require Warnings

Over-the-counter pain and fever medications, such as Tylenol, that contain acetaminophen are already required to change the dosage labeling to include information about the potential for safety risks, including liver injury.

Go get your bottle of acetaminophen and look at the label.  It does indeed contain some information about that, but FDA has caved to the pharmaceutical lobby about warnings for this drug for years.  Here is the list of warnings for Tylenol, taken directly from the McNeil (the manufacturer) website.  Take a look at the forth bullet point.

Severe liver damage may occur if adult has 3 or more alcoholic drinks every day while using this product

OK, that is well enough.  However, the official site for Advil has essentially the same warning but does not mention liver damage.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you have 3 or more alcoholic drinks every day while using this product

The three drink rule applies to all OTC pain and fever products, regardless of the active ingredients.  While I do not have any direct evidence to support this hypothesis, I believe that the acetaminophen interests pressured FDA to force all OTC pain relievers to carry the three drink warning to level the playing field so that acetaminophen is not at a competitive disadvantage.

I stand by my original thesis:  acetaminophen is a dangerous drug and should be available by prescription only.  There are other drugs that are as effective or more effective that are much safer than acetaminophen.  In a few rare individuals there may be conditions present that contraindicate any other pain reliever than acetaminophen, but those individuals probably should be under the care of a physician in the first place.

The second thing that I got right is more recent.  Back in August I wrote about the human papilloma virus (HPV).  Here is the link.

A summary of my piece is that HPV causes more disease then cervical cancer in women.  The bad strains of HPV are also known to cause rectal cancer, penile cancer, throat cancer, and several other cancers.  My recommendation was that not only girls be vaccinated before beginning sexual activity, but boys as well.  It makes sense to me to vaccinate both sexes to reduce the amount of virus in the population as much as possible.  Even if men were not affected negatively by HPV infection, and the ARE, elimination men from the reservoir pool would reduce the number of women infected, since most transmission is sexual.  My thesis is even stronger since men DO suffer from cancers caused by HPV infection.

I must say that it was I that missed the boat in this one, because FDA had already approved Gardasil for boys and young men, but only a few months before and it got almost zero publicity.  I had to root around a long time before I started to find links to this approval, and evidently my sources back in August had not been updated by the time that I wrote the original piece.  In any event, my piece was written with dated information but based on the evidence that I had available I made the right call.  But there is more, and so I was not completely out of date.

The other HPV vaccine, Cervarix, has NOT been approved for boys, even though data indicate that it is the more effective vaccine for HPV Types 16 and 18, the ones that are responsible for most cancers associated with HPV.  Evidence is available that indicates that Cervarix produces a stronger immune reaction than Gardasil, and that it may last longer.  There are probably a couple of reasons for that.

First, Gardaisil  protects against Types 6 and 11 in addition to Types 16 and 18, and males are just as apt to get genital warts as women (most warts are caused by Types 6 and 11).  Thus, there is a more tangible benefit for males for the use of Gardasil in that respect.  But it seems to me that it is logical to want the best protection possible from the deadly types.  I am a bit conflicted on that one, but I have a suggestion.

Why not produce a vaccine that protects only against Types 6 and 11?  That way the evidently more effective Cervarix could be used to protect against the deadly strains (Cervarix also seem to have some effect against Types 31 and 45, also deadly strains and this has not been shown to be the case for Gardasil), and then another vaccine could be used for the strains that only cause warts.  Perhaps this might be the answer.

Well, you have done it again!  You have wasted many more einsteins of perfectly good photons reading this self congratulatory piece.  And even though Michelle Bachmann realizes that it is unseemly to whine about not getting enough questions at the last Republican debate when she reads me say it, I always learn much more than I could possibly hope to teach by writing this series, so keep those comments, questions, corrections, and other feedback coming.  I shall hang around tonight as long as comments warrant, and shall return at about the same time tomorrow for Review Time for late comments.

Wednesday at 9:00 Eastern we shall continue with My Little Town with some recollections about the house in which I grew up, and Friday we start a short (three of four part) history of The Who in Popular Culture.  Please join in there!  I have not yet settled on a topic for next Sunday for this series, but I shall come up with something that I think that you will find interesting.

Warmest regards,

Doc, aka Dr. David W. Smith

Crossposted at The Stars Hollow Gazette,

Daily Kos, and

firefly-dreaming