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Three seemingly unrelated issues in the news that touch marginally or not at all on drug safety nevertheless carry important lessons for those of us who do pharmacovigilance for a living.

1- Meningitis from injectable steroid preparations made by a compounding pharmacy.  As of this writing, over 20 people have died apparently from fungal meningitis attributed to vials of drug produced by a Boston area compounding pharmacy.  The FDA has released a list of some 2900 medical centers and individual health care providers who may have received and used the products.  The compounding pharmacy has done a voluntary recall of all of its hundreds of products.  Lawsuits have already been filed.  A google search using the three key words: “meningitis steroids lawyer” produced 729,000 hits and at least two firms had paid aids seeking patients for a free consultation on this issue.  Patients are showing up at ERs concerned with and without symptoms.  Anyone who received a steroid injection during the critical time period is concerned or scared. Diagnosis will be hard and may take a long time.

The finger pointing has begun with disputes over jurisdiction (FDA vs state governments), good manufacturing practice (GMP) oversight, whether some group or groups obstructed the FDA investigations and more.
2- The NY Times reported on October 22, 2012 that “Five people may have died over the past three years after drinking Monster Energy, a popular energy drink that is high in caffeine, according to incident reports recently released by the Food and Drug Administration.” The Times correctly notes that “these reports do not prove a link between Monster Energy and the deaths or other health problems.” Nonetheless, lawsuits have been filed; the company is ““unaware of any fatality anywhere that has been caused by its drinks” and the stock price has dropped.

This will now wend its way for years through the courts, the media, interest groups and the internet.  Where the truth lies and when it will come out remains to be seen.
3- In Italy, six prominent engineers and scientists and an ex-government official on a scientific committee were convicted of multiple manslaughter for having provided “inaccurate, incomplete and contradictory” information about the danger of the tremors felt ahead of a 2009 earthquake in L’Aquila Italy that killed 309 people according to the BBC (https://www.bbc.co.uk/news/world-europe-20039769).  The committee had said that a major quake was not impossible but not likely.  They were sentenced to six years in prison.  The scientific community and media are aghast and appalled. One prominent physicist said he would not now take such a job.

They clearly got it wrong, tragically wrong.  Evidently predicting earthquakes is about as easy as predicting….well…. adverse events.

So how does this tie into drug safety and what lessons can we learn?

Well, item number one, the contaminated steroids really is a drug safety issue though it is somewhat more than that.  Some as of yet unanswered questions:

So now the fingers are pointing; everyone is lawyering up; there are embarrassed government officials in Washington and the state capitals running for cover; there will probably be Congressional investigations and surely a new law putting these companies under FDA oversight equal to that of drug companies.

This is tragic for those who died and a catastrophe for those who may go months now wondering if they will have fungal meningitis or some other injection related problem.  Many will undergo tests that, hopefully, will not hurt them too much to see if they have meningitis.  For those in the industry, there will be job losses, bankruptcy, suffering, lawsuits, perhaps prison, more bad publicity and more.

This is, in fact, a rather standard drug safety story that we have seen happen after many other products.  All of these stories are messy and ugly and will get messier and uglier.

Item number 2 is not a drug (apparently) but rather a supplement.  The labeling for supplements generally lists the contents and amounts (which here include caffeine).  The company and the American Beverage Association note that “the ingredients and labeling comply with all US FDA requirements.” (https://www.fox23.com/webmd/story/FDA-5-Death-Reports-for-Monster-Energy-Drink/Z6p2tWDfSkai6jW0IcNf5Q.cspx).

So here we have beverage that evidently complies will all FDA requirements but which has been associated with deaths.  Causality has not been established and it looks like it will be the courts (and perhaps health agencies) that will decide.  One would not be surprised if lots more cases now pop up as the publicity will increase awareness.  How the company and FDA will handle these remains to be seen also.

Item 3 is clearly the “one that doesn’t belong in this group”.   Italian earthquakes and drug safety?  The issue here is that predicting earthquakes is evidently as easy (read: very hard) as is predicting drug side effects.  Evidently even tremors before the quake are not necessarily predictive.  Sound familiar?  Do all elevations of liver function tests predict subsequent severe liver toxicity? (No).  Yet well-intentioned, senior scientists got it wrong and are now being sent to jail.

What conclusions do we draw about drug safety?:

So what should you do (in my opinion):

And finally, to repeat, always do the right thing (After you figure out what the right thing is – it may not be so easy).

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