Consumers outraged by EpiPen price increases

By ThinkReliability Staff

Outrage over rampant increases in drug prices is nothing new. But it seems to have reached a new high with the rising cost of the EpiPen, an auto-injection device that delivers epinephrine to severe allergy sufferers who are at risk of their throat closing shut due to anaphylaxis. Disgust with the increase is at such levels that Martin Shkreli, the CEO of Turing, who, in 2015, raised the price of Daraprim, a malaria-HIV drug 5,000% (from $13.50 to $750 a tablet) has asked “What drives this company’s moral compass?” and referred to Mylan (the manufacturer of the EpiPen®) as “vultures”. (See our previous blog on the price increase of Daraprim.)

The EpiPen has been in use since 1977 (so research and development costs have long since been recouped). It was bought by Mylan in 2007, when the cost of an EpiPen was less than $60 and revenue from the product was about $2 million a year, with a profit margin of 9%.   Fast forward to 2016, when the cost of an EpiPen 2-pack (the only way they are sold) is more than $600, with a profit margin of 55%. Last year, the revenue from EpiPen was $1.2 billion, accounting for 40% of Mylan’s profits. Over that time, the compensation for Mylan’s CEO increased from $2.5 million to $18.9 million. Profits are rising rapidly along with the EpiPen costs.   (As a comparison, the cost of two EpiPens in France is about $85.)

The US Senate has demanded information related to the cost increase. It’s not based on the cost of raw materials (the amount of epinephrine in an EpiPen costs less than a dollar).   Mylan claims that it’s due to an improved product, but provides no specifics, and there doesn’t appear to be anything noticeably different to users. Many claim that the price increase is simply because Mylan can. Senator Amy Klobuchar, the ranking member of the Senate Judiciary Committee, says “This outrageous increase in the price of EpiPens is occurring at the same time that Mylan Pharmaceutical is exploiting a monopoly market advantage that has fallen into its lap.”

Mylan currently has an effective monopoly on the EpiPen. There is no generic alternative.   EpiPen has a monopoly in the US via patent until 2025. Another manufacturer’s application to the US Food and Drug Administration (FDA) was rejected for “major deficiencies”. It does not expect its product to be brought to market until 2017 at the earliest. Three alternatives to the EpiPen have been removed from the market since 2012 although one, Adrenaclick, is back on the market. However, Adrenaclick is not considered pharmaceutically equivalent, so it has to be prescribed by a doctor, which is unlikely due to the name recognition of EpiPen (thanks to its massive marketing campaign and free giveaways). It’s also considered more difficult to use, somewhat expensive on its own, and not covered by many insurance plans.

Mylan says that “In 2015, nearly 80% of commercially insured patients using the My EpiPen Savings Card received EpiPen Auto-Injector for $0.” That leaves nearly 20% of insured patients (and nearly all uninsured patients) paying out-of-pocket costs that have been reported at more than $1,000 for a two-pack (the only way EpiPens are currently sold – many times two doses are needed). To add insult to injury, an EpiPen is usually good for a year or less because epinephrine is extremely unstable and a full dose is needed in the case of a reaction.

Unfortunately, there aren’t many good alternatives to paying for the EpiPen. Going without, or using an expired EpiPen, could be extremely dangerous. While epinephrine can be injected via a normal syringe without the EpiPen functionality, that in itself carries risk and should only be performed by a trained professional. (Many governments are providing epinephrine, syringes and training to emergency medical responders to avoid the cost of multiple EpiPens.)

Most of the general public will just have to wait: for a generic to be introduced, for Adrenaclick to be covered by insurance, or for the Senate to quash the price gouging.

To view a one-page PDF showing the cause-and-effect relationships associated with the EpiPen price increases, click “Download PDF” above. Or, click here to read more.

Sewage Leak Kills Two Mechanics

By ThinkReliability Staff

Two workers were overwhelmed by hydrogen sulfide and later died of their injuries after attempting to fix a sewage leak at a waste water treatment plant in Wichita Falls, Texas on July 2, 2016. The city has released its internal investigation findings into the incident. In order to fully understand the issues associated with the incident, we can capture the information within a Cause Map, or visual form of root cause analysis.

The first step in the Cause Mapping process is to capture the what, when and why of an incident, as well as the impacts to the goals. In this case, the injuries that caused the deaths occurred July 2 in Wichita Falls waste water treatment plant’s basement #2 while the two employees were attempting to repair a valve causing a wastewater leak. Capturing the task being performed at the time of the incident can provide useful information related to the incident.

The deaths of the two employees are an impact to the safety goal. The high levels of hydrogen sulfide are an impact to the environmental goal, while the need for a valve repair is an impact to the property goal. The emergency response and external incident investigation impact the labor goal. The investigation begins with one of the impacted goals as the first “effect” of a cause-and-effect relationship. Additional causes are added by asking “why” questions. Capturing all relevant cause-and-effect relationships offers the highest number of potential solutions, which can act on any cause to reduce the risk of a problem recurring.

The employee fatalities resulted from exposure to high levels of hydrogen sulfide. The high levels of hydrogen sulfide resulted from the leak of sewage with high levels of sulfur. While problems with ventilation can result in high gas levels, the intake and outgoing ventilation were both found to be functioning properly and the door to the building was left open. The sewage was contained in the pipes (as it was a waste water treatment plant) and leaked from a failed valve. However, the investigation found that the sulfur levels were higher than expected and set out to find the cause of the elevated sulfur. Industrial users of the waste water system have been interviewed and did not indicate any sulfur-using production processes or discharges with elevated sulfur. Although the investigation continues, the source of the elevated sulfur may never be determined. The proposed solution – installing permanent detectors in the basement and other areas of risk – will mitigate the risk of potential personnel injury due to high gas levels, regardless of the cause.

The exposure to high levels of hydrogen sulfide also resulted from the employees (both mechanics) being in the basement with the elevated hydrogen sulfide levels without self-containing breathing apparatuses (SCBAs). The employees were in the basement repairing the leak and initially entered wearing SCBAs, having been warned that the area smelled “gassy”. However, for reasons that are unclear the employees did not take air quality measurements or complete initial checklists for using SCBAs. A proposed solution is to require employees to carry gas detectors (which would provide immediate feedback as to whether an additional oxygen source was required) in areas where gas could be present. The investigation found that the training provided to these and other employees regarding the use of SCBAs was adequate and no changes to the program were recommended.

These potential solutions, which would provide real-time feedback as to gas exposure hazards, would increase the likelihood that employees would wear SCBAs or other personal protective equipment, thus reducing the risk of exposure to high levels of gas, when present. To view the outline, initial Cause Map and proposed solutions, please click on download PDF above. Or, click here to learn more.

Put down the cookie dough

By ThinkReliability Staff

Almost everybody knows that there are potential risks with eating raw cookie dough (or any other raw batter).  However, much of that risk was thought to be due to the potential of salmonella from raw eggs and so, if the plan was to eat, rather than cook, the dough, the eggs could just be left out.  No more! say health experts.  Turns out that just removing the eggs and eating the raw dough may protect you from salmonella, but it still leaves you at risk for E. coli.

A Cause Map, or visual form of root cause analysis, can help demonstrate the risks (or potential impacts) associated with an issue, as well as the causes that lead to those risks.  The process begins by capturing the what, when and where of an incident, as well as the impact to the goals in an Outline.  In this case, the problems being addressed are risk of illness from eating raw cookie dough, as well as a recall associated with contaminated flour.  The when and where are just about everywhere that dough or batter is being made (or eaten).  The safety risks most commonly associated with eating raw cookie dough are salmonella and now E. coli.  The environmental goal is impacted because flour is contaminated with E. coli and the property goal is impacted because of 45 million pounds of flour that have been recalled by the current recall.

Once the impacted goals are captured, they become the first “effects” in the cause-and-effect relationships.  The Cause Map is created by capturing all the causes that led to an effect.  In this case, the risk of contracting salmonella from eating raw cookie dough results from eggs being exposed to salmonella, and the salmonella not being effectively destroyed (by the heat of baking).  The risk of contracting E. coli results from a similar issue.

Cookie dough contains raw flour.  The cooking process kills E. coli (as well as salmonella), meaning cookies and other baked goods are safe to eat, but dough is not.  Distributed raw (uncooked) flour was found to be contaminated with E. coli (leading to the impacted environmental goal and the recall).  The flour was likely contaminated with E. coli while it was still wheat in the field.  Birds and other animals do their business just about wherever they want, and it’s got some bacteria in it, meaning that excrement that falls on wheat fields can deliver contamination to pre-flour.  (Quick side note: we frequently get asked when to stop asking “why” questions.  When you get to an answer that is completely outside your control, like why birds poop in wheat fields, for example, this is a good place to end the cause-and-effect reasoning.)

While flour is processed, the process isn’t designed to completely kill pathogens (unlike pasteurization, for example) and according to Martin Wiedmann, food safety professor at Cornell University, “There’s no treatment to effectively make sure there’s no bacteria in the flour.”  Flour is not designed to be a ready-to-eat product.

Once the causes related to an issue have been developed, the next step is to brainstorm and select solutions.  Unfortunately, health professionals have been clear that they’re not getting far on keeping birds from pooping in fields, nor is there some sort of miracle treatment that will ensure raw flour is safe from disease.  (Scientists underscore that flour isn’t less safe, it’s just that we are becoming more aware of the risks.  Says Wiedmann, “Our food is getting safer, but also our ability to detect problems is getting better.”)  The only way to reduce your risk of getting sick from raw cookie dough is . . . not to eat it at all.  Also, wash your hands whenever you handle flour. (This is of course after you’ve thrown out the floor involved in the recall, which you can find by clicking here.)

To view the Cause Map of the problems associated with raw cookie dough, please click on “Download PDF” above.