Are patient groups actually representing the interests of patients?
DRUG BUST by Alan Cassels
• Who says “near death” experiences don’t pay?
Welcome to the crazy world of ‘emergency capitalism’ where a rare – but sometimes life threatening – condition is turned into a very lucrative market with the help of skilful fearmongering, the co-opting of patient groups and the buying of experts.
I’m talking about food allergies, the life-threatening type, given we seem to be living in an increasingly allergic world. Food allergies are particularly worrisome because, well, we are surrounded by the stuff. Most of the serious allergies are related to peanuts and tree nuts, milk, eggs, fish, shellfish, soy and wheat. A hyper-allergic reaction, known as anaphylaxis, is where your body goes on a major offensive in response to an allergen. It can often involve multiple body systems – including gastrointestinal, skin, breathing – and it sometimes leads to respiratory and cardiac failure and death. Some people only need a whiff of an allergen to send them over the edge.
Thankfully, for those at risk of an anaphylactic reaction, the drug epinephrine, also known as adrenaline, is packaged as a self-administered emergency medicine. It can basically save your life long enough for you to get to a hospital. As a “use only when required” drug, it is most commonly injected through a self-administered auto-injector into thigh muscles. The two kinds available in Canada are Allerject by Sanofi and Epipen, a Mylan product distributed by Pfizer.
Commercial drug makers are always driven to increase sales and market share, but how do they expand the patient population of those at risk of a life-threatening allergic reaction? Maybe they do the easy stuff first: take a product costing pennies to make, package it in a fancy auto-injector, stamp a one-year expiry on it – most of you would blow a gasket if you knew about the fraudulent use of medication expiry dates – charge $120 for it and get parents, school boards and others to stock it. Above all, push the fear because we all know fear sells.
How common is an anaphylaxis death in Canada? An Ontario study found 80 anaphylactic deaths over a 25-year period. Extrapolating those Ontario numbers across Canada, it would mean about eight deaths per year in Canada. So, not big numbers, but let’s face it, the fear factor hovers large especially if your kid is one peanut away from possible death. What this results in is a strong cohort of hyper-vigilant, internet-savvy mothers (and fathers) who work hard volunteering to raise awareness about life-threatening allergies. The fact that there are so few deaths due to anaphylaxis in Canada is likely due to the work of those parents.
But, as I’ve seen in other patient groups, where there is a high degree of consumer involvement in a disease, there’s also a high degree of interest from companies wishing to tap into this ‘patient engagement.’ Sold as a harmonious alignment of interests between the momma bears – bent on protecting their cubs against any allergens – and the companies selling allergy-related drugs and paraphernalia, it’s easy to forget how much money is at stake. We’re talking billion-dollar industries, not just for epinephrine injectors, but for skin prick tests, inhalers, steroids, specialty foods, antihistamines, oral immunotherapy and so on.
One of those moms very focussed on this issue is Chantelle Olsson. She became involved in the world of life-threatening food allergies when her two-year-old daughter was diagnosed with a peanut allergy. She remembers people asking, “Why aren’t you doing more to prevent this?” Reflecting on this, she thought, “Yeah, why aren’t we doing more?”
In an interview from her home in Langley, BC, she told me she’s most interested in prevention and working to reduce the numbers of children affected by allergies. Her group, Families for Anaphylaxis Education, is different than many other groups working in this area in one important way: they don’t take money from the pharmaceutical or food industries.
In the allergy world, pervasive conflicts of interest exist. For example, Food Allergy Canada (formerly Anaphylaxis Canada) gets some of its money from ‘corporate partners,’ which are mostly food companies and the makers of the epinephrine auto-injectors.
Whether a patient group takes corporate money or not almost always determines their priorities. So why has there been such a rise in food allergies in recent years – maybe as high as one in 13 school-age kids? Could it be due to the way foods are grown or processed or because of the numbers or contents of vaccines, which have changed enormously over the last 20 years? Are kids being exposed to allergens too early, or too late? Should we care that a company making widely used childhood vaccines also makes one of the most popular epinephrine injectors? Who funds research looking at possible links between drugs or vaccines and the rising numbers of allergy-affected kids?
These uncomfortable questions are sometimes bandied about in a rich internet-based world, on parent forums and discussion groups. Parents of children who could suffer anaphylactic reactions have a lot in common and they are adept at using social media to make the allergy-infested world safer for their kids. Like in other disease areas when the industry-supported patient groups put their own spokesparents and trolls on social media parent forums, they are deciding what is or isn’t a legitimate discussion topic.
I’ve scrutinized the public relations world and Big Pharma for 20 years so I find it fairly simple to spot the ‘astroturf activists’ – the ones who are coached by a company’s PR department and who use slick talking points and send out attack trolls to rebuke criticisms of the industry. Question Big Pharma’s involvement, priorities or tactics on a Facebook allergy forum and you’ll likely get bitten by a troll or even booted off the forum.
Another popular tactic is the care and feeding of the ‘good mommies.’ Google “Mylan’s Food Allergy Blogger Summit” and you’ll see the story of 13 well-behaved mommy activists sent to Disneyland on the Mylan payroll, openly declaring their thanks to the company paying for their astroturf adventure with Mickey Mouse.
There seems to be a revolving door between the drug industry and the food allergy charity world. For example, allergist and immunologist Dr. James Baker was appointed last year as the new CEO of FARE (Food Allergy Research Education), a large American industry food allergy charity. The former senior vice-president of Merck’s Global Vaccine Division made his priorities clear when he took over the helm at FARE: “I’d like to make sure that we continue to work for access and, very importantly, for appropriate care for patients with food allergy.” In other words, our priority is moving product. No sense in focusing on prevention.
Chantelle Olsson is correct when she tells me “prevention is a four-letter word.” And concerned that no one’s taking prevention seriously, she adds, “The market for epinephrine injectors and allergy products is limitless and, unless we take action, we might easily see 50% of Canadian children with life-threatening food allergies within five years.”
With such little energy devoted to learning what is causing the spike in allergies in the first place, and tons to be made in pumping out grossly inflated $120 auto-injectors of epinephrine – needing annual replacement – the prevention message seems to be a low priority. Especially when it’s controlled by drug companies.
I’ve often written about the problems of conflicted patient groups – irritating people who contact me to defend their actions. I think most of these people are hardworking, dedicated volunteers working to make the world a safer place for their children. But, at the same time, they may be unable to see how their funders bias them and their priorities.
Many patient groups do honest, important, public-interest work without industry support. They may be poorer, but they can be authentic and able to avoid the massive delusions that come with being tools of industry.
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Alan Cassels is a drug policy researcher at the University of Victoria. He writes about medical screening and drugs, consults with unions on drug benefits plans and is helping research tools to make deprescribing easier for physicians. You can read more of his writings at www.alancassels.com or follow him on twitter @akecassels
Can you tell us more about this? I’d like to find out more details.
Since this article went live there have been two deaths impacting young adults in North America: Simon Katz (Denver, CO), aged 16, and Andrea Mariano (Queen’s University, Kingston, ON), aged 18. Also reported ER visits for anaphylaxis have nearly doubled over a period of seven years according to the Canadian Institute for Health Information. As Mr. Cassels states, life-threatening allergy to food is particularly bothersome because food is everywhere: as interwoven into the human experience as air and water.
IOM/FDA/CDC doctors: Food proteins present in vaccines cause the development of food allergies
Nobel Laureate Charles Richet discovered over a hundred years ago that
injecting proteins into mammals can cause them to develop an allergy to
that protein.
http://www.nobelprize.org/nobel_prizes/medicine/laureates/1913/richet-lecture.html
The US Dept. of Health and Human Services (HHS) charged the Institute of
Medicine (IOM) with providing a thorough review of the current medical
and scientific evidence on vaccines and vaccine adverse events.
The IOM has concluded in its 2011 report that:
FOOD PROTEINS PRESENT IN VACCINES CAUSE THE DEVELOPMENT OF FOOD ALLERGIES.
https://iom.nationalacademies.org/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx
Document Pg. 65 (pdf pg. 94 ):
“Adverse events on our list thought to be due to IgE-mediated
hypersensitivity reactions
Antigens in the vaccines that the committee is charged with reviewing do
not typically elicit an immediate hypersensitivity reaction (e.g.,
hepatitis B surface antigen, toxoids, gelatin, ovalbumin, casamino acids).
However, as will be discussed in subsequent chapters, the
above-mentioned antigens do occasionally induce IgE-mediated
sensitization in some individuals and subsequent hypersensitivity
reactions, including anaphylaxis.”
For those who may not be familiar, here are the basics of allergy – a
two step process:
Sensitization: When exposure to an allergen (food protein) occurs for
the first time, there are no symptoms. Over a period of a few weeks, the
immune system develops antibodies specific to the allergen. The person
is now sensitized. In other words, the person has developed allergy to
the specific food item. “IgE-mediated sensitization”, is the technical
description for development of allergy.
Elicitation: When a sensitized person is exposed to the same allergen
again, they develop an immediate reaction (usually within minutes). Also
called hypersensitivity reaction. This is called elicitation. A severe,
life-threatening case of elicitation is known as anaphylaxis.
So in simple English, the IOM committee has concluded that food proteins
such as gelatin, egg (ovalbumin) and milk (casamino acid is derived from
milk) that are present in vaccines, cause healthy non-allergic people to
develop allergies to those food items upon receiving the vaccine.
In 2002, the doctors from the CDC and FDA warned that gelatin-containing
vaccines can cause gelatin allergy based on similar findings in Japan.
“Nonetheless, our cases with anti-gelatin IgE required some previous
exposure to gelatin to become sensitized, and this may have come through
ingestion of gelatin-containing food or injection of gelatin-containing
vaccines.”
They wrote: “Efforts should continue to identify less allergenic
substitutes for gelatin currently used by vaccine manufacturers.”.
Authors:
Vitali Pool, MD, CDC, M. Miles Braun, MD, MPH, FDA, John M. Kelso, MD,
Naval Medical Center, Gina Mootrey, DO, MPH, CDC, Robert T. Chen, MD,
MA, CDC, John W. Yunginger, MD, Robert M. Jacobson, MD, Mayo Clinic,
Paul M. Gargiullo, PhD, CD.
Prevalence of Anti-Gelatin IgE Antibodies in People With Anaphylaxis
After Measles-Mumps-Rubella Vaccine in the United States
http://pediatrics.aappublications.org/content/110/6/e71.long
Yet today, the CDC table here lists numerous food proteins contained in
vaccines, including gelatin, egg, milk (casamino acid), soy, seaweed (agar) and vegetable oils
(in Polysorbate 80, sorbitol).
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
The result – the food allergy epidemic.
And gelatin in vaccines is still making kids sick today:
http://acaai.org/resources/connect/ask-allergist/Vaccines
Japan removed gelatin from their vaccines in 2000.
Kuno-Sakai H, Kimura M. Removal of gelatin from live vaccines and DTaP-an ultimate solution for vaccine-related gelatin allergy.Biologicals 2003;31:245-9
My son developed multiple life-threatening food allergies from these
food protein contaminated vaccines.
How can this situation ever be justified?
Vaccines are among the greatest achievements of modern medicine.
Food protein contaminated vaccines causing food allergy, is one of the worst blunders of modern medicine.
I feel very sorry for people who spend their energy on the type of negativity promoted in this article. Epinephrine is a life-saving medication. Maybe it costs too much but that just means the drug companies want to make money (big surprise, they are corporations) — not that they are part of some shadowy conspiracy trying to give people food allergies (!!) And our mom-bloggers are not corporate shills: they are posting mostly recipes and advice to help kids at school, for God’s sake!!! Same for our advocacy organizations. Shame on him for trying to tie them in with some big evil plot. The author doesn’t even have food allergies: as if he knows anything about what our lives are like anyway. Boo.
Brilliant article, thank you so much Alan Cassels. We need more voices like yours in this country.
Well written and researched article-with good points. Although, in my food allergy circles and community here in the US, prevention is the focus. I personally would like to see the movement push even stronger towards a cure and therapies. Prevention is simply a critical band-aid to a growing national health concern.
This is disease effects every within the sphere of the allergic person. I do not like asking strangers to become my health partner in helping keep my food allergic children safe. I am sure the others around my child were not planning on becoming a health partner. This disease is unfair to schools and communities.
The death stats may be un-accurate due the lack of proper coding since a person does not die of anaphylaxis–which is a symptom, they die of cardiac arrest, brain damage, etc. Also, Emergency rooms need to be updated on how to code for food allergic deaths. NorthWestern University is working on a food allergy registry to study food allergic reactions and their severity.
Back to your points–which are good. We all need to ask ourselves about our roles, our boundaries and involvement. I fully support the wide spread use and understanding of epinephrine auto-injectors and any other devices that are in the pipeline (pre-measured syringe, etc.). Too many people are suffering the health and mental damages of near death food allergic experiences, in addition to death. Once you have spoken to someone who has lost their child due to delayed or limited access to life saving epinephrine. Your perspective changes. The drug companies do benefit from the foot soldiers who love their products, just as the wonderful natural product and allergen free companies enjoy our conversations and product loving recipes that thrill our families. Thanks again for a well written piece that brings good food for thought. Disclaimer: I am a well behaved mommy activist.
Caroline,
“On point, we all need to ask ourselves about our roles, our boundaries and involvement.” I wonder how it feels to see Mylan’s discussions with BloombergBusiness? Their recent statement explaining how we are their “captive audience” while elaborating on their ability to charge us whatever price, since they are part of raising awareness for our community. How does it feel to realize that you were part of a successful marketing campaign that turned the company around and helped them to successfully hike the price of their product by 32%? http://www.bloomberg.com/news/articles/2015-09-23/how-marketing-turned-the-epipen-into-a-billion-dollar-business
We have an epidemic of autism, brain damage, 1 in 60, and the word cause can’t be mentioned. We all have to pretend it’s a big mystery, coincidence while no one looks for the cause. If anyone is having any success with recovery methods they are full on attacked, labelled “quacks” etc. The serious allergies also out of control and yet the word prevention can’t be mentioned. There is nothing worse that a foundation or group formed because of a medical issue who end up doing more harm than good. Remember Lorenzo’s oil, the foundation for that disease literally tried to prevent him from finding the cure. They were a prevention instead of a help. Once they take money from the Drug Industry and the “slick” reps come by – then that is the end of the good work and they will get nowhere. The goal being that they put a few band-aids on it. The drug industry loves these people, they do all that good sincere work for free and at the same time sell their products. Its like getting the neighbors to canvas in their own neighborhoods, its effective. The multi=billion dollar drug industry is controlling the science, the information, the bully tactics, and the internet with thousands of trolls.
Think of vaccines that prevent no disease but cause many previously uncommon illnesses, including allergies.