Just like allergy sufferers. And they are on the rise. For many people allergies can range from sniffling and sneezing to skin rashes to gastrointestinal issues. A certain percentage, however, have more than these uncomfortable symptoms to deal with. Anaphylaxis, a serious life-threatening reaction, causes approximately 1,500 deaths a year in the United States alone. Clearly, allergies are nothing to sneeze at!
Articles for Advocacy
Big Pharma, get your act together! Since 2017, Epi-Pens© have been in short supply, causing much concern in the allergy community. Pfizer, which manufactures the product for Mylan, says their production is improving but supplies will continue to be tight. The problem began in 2017 when inspectors noticed chips in the glass cartridges and bent or broken needles. Fortunately there are now alternatives to Mylan’s Epi-Pen that you can read about in the article below. Teva, for example, reports they have a good supply, and Mylan Customer Service says they will help anyone find a pharmacy to fill their prescription. You can read all the details of this unfortunate situation below.
What’s Behind the Persistent Shortage of Lifesaving Epi-Pens©?
By Bloomberg News
August 23, 2019
Mylan and Pfizer are still struggling with manufacturing issues for the EpiPen anti-allergy injector as the critical back-to-school season gets underway and a rival generic product hits the market.
Epi-Pens, which can help stop a severe or life-threatening allergic reaction, have been hard to get since at least May 2018, when the U.S. Food and Drug Administration said the device was in short supply. Former and current employees of Pfizer's Meridian Medical Technologies Inc., which makes the product for Mylan, said supply has been unsteady since at least 2017, when inspectors began noticing defects.
Pfizer spokeswoman Amy Rose said the drug maker is committed to resolving the supply problem.
"Our production output is improving," Rose said. "However, we anticipate supply to be tight as we enter the peak demand season."
As noted in the previous article, whenever a company owns 90% of a product’s market share, it can create havoc when there are quality issues causing supplies to dwindle. Sanofi was a competitor of Mylan’s EpiPen, and lost so much money due to Mylan’s alleged unfair selling practices that they turned the rights back to Kaléo in 2016. Now Sanofi is suing Mylan for erecting barriers such as not allowing insurers and pharmacies to get rebates if they offered reimbursement for Sanofi’s product, Auvi-Q. Fortunately, Kaléo re-introduced Auvi-Q to the market in 2017.
You can read the whole sordid story below.
Sanofi Seeking Billions from Mylan in Epi-Pen© Anti-trust Suit
By Dave Bloom
August 13, 2019
Prompt administration of epinephrine can mean the difference between life and death for a food allergy sufferer experiencing anaphylaxis, a severe, sometimes fatal reaction to an allergen. That’s why those that have been diagnosed with an allergy to specific foods are encouraged to carry two epinephrine auto-injectors with them at all times, wherever they go.
Back in 2015, there were three epinephrine auto-injectors approved for the US market: EpiPen by Mylan — by far the dominant product with a 90% market share — Adrenaclick by Impax, and Auvi-Q, a relatively new entrant at the time manufactured and marketed by Sanofi.
There is yet another approach to desensitizing those who are allergic to peanuts. Instead of having patients ingest peanut protein as in oral immune therapy, doctors using Sublingual immunotherapy (SLIT) place a small amount of peanut protein under patients’ tongues. Because the peanut protein goes immediately to the blood stream and avoids digestion, patients can be given much smaller amounts that will hopefully avoid serious side effects.
New Peanut Allergy Treatment Shows Effectiveness and Safety
Source: University of North Carolina Health Care
Date: September 4, 2019
Sublingual immunotherapy (SLIT) trial participants tolerated between 10 and 20 times more peanut protein than it would take for someone to get sick. Researchers say SLIT provides a good cushion of protection with an easy mechanism (tiny bit of liquid under the tongue) and a strong safety signal.
People allergic to peanuts may have a new way to protect themselves from severe allergic reactions to accidental peanut exposure. It's called sublingual immunotherapy — or SLIT — and it involves putting a miniscule amount of liquefied peanut protein under the tongue, where it is absorbed immediately into the blood stream to desensitize the immune system to larger amounts of peanut protein.