Tag Archives: Allergies

Peanut.

New peanut allergy treatment ready for FDA review. It’s based on peanuts

A peanut a day… keeps peanut allergies at bay? New research says yes.

Peanut.

Image credits Nicole Köhler.

A new study presented today at the American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting reports that it’s possible to protect yourself against peanut allergies by building a tolerance to the food over time.

Peanut vs peanut

“We’re excited about the potential to help children and adolescents with peanut allergy protect themselves against accidentally eating a food with peanut in it,” says co-author Stephen Tilles, MD. “Our hope when we started the study was that by treating patients with the equivalent of one peanut per day, many would tolerate as much as two peanuts.”

Spoiler alert, they hoped right.

The team worked with participants ranging from 4 to 55 years old (most between 4 to 17 years old), all of whom were allergic to peanuts. One-third of the participants were assigned to the control (placebo) group, and the remainder were given daily doses of protein powder. This powder was administered in increasing amounts until reaching the “maintenance dose”, which remained unchanged for the rest of the study. This daily dose was roughly equivalent to one peanut.

All participants received the peanut powder as part of an oral food challenge (OFC). A person in an OFC is given a very small oral dose of the food under the supervision of a board-certified allergist to test for a severe reaction. OFCs are considered the gold standard for testing food allergy.

“We were pleased to find that two thirds of the people in the study were able to tolerate the equivalent of two peanuts per day after nine to 12 months of treatment, and half the patients tolerated the equivalent of four peanuts.”

By the end of the study, the patient’s “reactions from the [OFCs] were much milder than prior to treatment,” Dr. Tilles adds. On average, each participant was able to tolerate exposure to a 100-fold higher dose of peanut after the study compared to the initial result. Even better, their reaction to this 100-fold dose at the end of the study was milder than their reaction to the initial dose at the beginning of the study.

The approach was also met with fewer side effects than the team anticipated. Only six percent of participants dropped out of the study due to such complications. One-third of patients completed the study without experiencing anything more than mild side effects along the way.

All in all, the results are quite promising. Again, this isn’t meant as a be-all-end-all solution to peanut allergies; it’s simply meant to protect patients against life-threatening reactions (anaphylactic shock) when they unknowingly come into contact with a small dose of peanut. The team also reports that once a patient stops treatment, the protective effect wears off.

Should this treatment be approved by the FDA, it will provide the first treatment option for peanut allergies. It will be available by prescription, and patients will need to remain on it to stay protected against accidental consumption.

The paper “AR101 Oral Immunotherapy for Peanut Allergy” has been published in the New England Journal of Medicine.

pacifier

Sucking on your baby’s pacifier may protect them from allergies

Many parents clean their baby’s pacifier by sucking on the silicone nipple. As it turns out, this may actually be a very helpful practice that boosts the child’s immune system and offers protection against allergies.

pacifier

Credit: Pixabay.

Researchers at Henry Ford Health System tracked levels of a protein linked to allergies, the IgE antibody, in 74 infants whose mothers reported giving them pacifiers to use. Fathers were not included in this study.

Some mothers said they sterilized the pacifiers in boiling water or cleaned them with soap and water, while others said they simply sucked on them. Researchers compared the babies’ IgE levels at birth, six months, and 18 months for each cleaning method.

The babies whose parents sucked on their pacifier to clean it had lower levels of this antibody, which theoretically makes them less susceptible to allergies and asthma. It’s possible that the protective effects may be due to parents passing on healthy oral bacteria in their saliva, which could strengthen the child’s immune system. The conclusion seems to be supported by a previous study published in 2013 by Swedish researchers, who likewise found an association between parents sucking on their baby’s pacifiers and a reduced risk of allergy development.

“Although we can’t say there’s a cause and effect relationship, we can say the microbes a child is exposed to early on in life will affect their immune system development,” said Eliane Abou-Jaoude, the study’s lead author.

“From our data, we can tell that the children whose pacifiers were cleaned by their parents sucking on the pacifier, those children had lower IgE levels around 10 months of age through 18 months of age.”

[panel style=”panel-warning” title=”Allergies” footer=””]An allergy is the response of the body’s immune system to normally harmless substances, such as pollen, foods, or house dust mite. This hypersensitivity causes the body to overreact by producing a disproportionate immune response when contacting an allergen. In some cases, the response can be so strong that the body enters anaphylactic shock — with potentially fatal consequences.

It’s not clear what causes allergies or why some people are more predisposed than others. Studies so far have linked both genetic and environmental factors to allergies. What’s certain, it seems, is that allergies are on the rise regardless of gender or ethnic background. According to findings presented at the American College of Allergy, Asthma, and Immunology conference, the incidence of shellfish allergy has grown by 7 percent, tree nuts by 18 percent, and peanuts by 21 percent. Shellfish and peanuts are also among the most common food allergies overall. The results are based on a survey of 53,575 U.S. adults.[/panel]

Because the study did not establish a causal relationship, but merely a correlation, parents should take these findings with a grain of salt. That being said, sucking your baby’s pacifier to clean it might not necessarily lower the child’s risk of developing allergies. It could be that other factors are at work. For instance, the same parents might let their children play outside in the dirt more or may live in less sanitized households. Previously, research showed that people who live near livestock, those who avoid dishwashers, and even babies born through the microbe-filled vaginal canal (and not a C-section) are less likely to develop allergies. Children who grow up with pets also tend to have a lower allergy risk.

More research will have to be carried out in order to tease out the correlation between pacifiers and baby’s risk of developing allergies.

Taking fish oil and probiotics during pregnancy may reduce food allergies

Taking a fish oil capsule daily during pregnancy and the first few months of breastfeeding can reduce your baby’s risk of egg allergy by 30%, a new study has found.

Via Pixabay/PublicDomainPictures

Researchers from the department of medicine at Imperial College London say that omega-3, a polyunsaturated fatty acid found in fish oil, has positive, anti-inflammatory effects.

According to a 2014 study, the lifetime self-reported prevalence of common food allergies in Europe ranged from 0.1 to 6.0%. In the UK, one in 20 children suffers from food allergies, such as nut, egg, milk or wheat allergies. Food allergies are caused by chaotic functioning of the immune system, that overreacts to some types of foods. Common symptoms of food allergies include rashes, swelling, vomiting, and wheezing.

For the study we’re discussing today, the team looked at data collected from 19 trials of fish oil supplements taken during pregnancy, involving a total of 15,000 participants. They report that the reduction in allergy risk equated to 31 fewer cases of egg allergy per 1,000 children. Afterward, they also analyzed the effect of probiotic supplements taken during pregnancy and discovered a 22% reduction in the risk of eczema development in children up to the age of three.

“Our research suggests probiotic and fish oil supplements may reduce a child’s risk of developing an allergic condition, and these findings need to be considered when guidelines for pregnant women are updated,” says Dr. Robert Boyle, lead author of the research.

The NHS advises that it’s better to eat fish than take fish oil supplements, fish being an excellent source of nutrients that are good for pregnant women‘s health and for their unborn baby’s development. The main reason for this is that eating liver and liver products such as liver pâté, liver sausage or fish liver oil supplements such as cod liver oil may contain too much vitamin A, and that can harm unborn babies. The NHS also recommends that tuna and oily fish consumption should be limited, while some types of fish should be avoided completely, such as shark. Also, don’t eat raw shellfish when pregnant, as it can cause food poisoning.

Avoiding foods such as nuts, dairy, and eggs during pregnancy made no difference to a child’s allergy risk. Also, fruit, vegetables, and vitamins seemed to have no repercussion on allergy risk either, the study published in the journal PLOS Medicine showed.

Understanding Allergies: What they are and how they work

Allergies, you can’t live with them… and would gladly live without them. Unlike standard illnesses, rather than involving a shortcoming of the immune system, allergies actually happen when it becomes too reactive.

Yes, you have allergies because your immune system loves its job and is working overtime — it is called a hypersensitivity reaction. These reactions include autoimmune disorders as well as organ and graft rejections. But, here, I’ll give you the crash course on Type I hypersensitivity reactions, a.k.a allergies.

What causes allergies?

To answer this question we need to go down to the cellular level and take a look at our immune system. This system consists of many parts but what we’re mostly concerned with here are white blood cells — lymphocytes and granulocytes. Our cells are well trained to respond to threats and, like with a national military, we leave it up to their discretion and expertise to determine which foreign molecules (antigens) pose a threat. T lymphocytes, our generals, make these calls. Let’s meet these high-ranking members of the army.

Most of us have heard of antibodies, if only from watching cartoons. These defensive molecules are produced by our B lymphocytes — high ranking special forces who answer only to T cells. Polymorphonuclear cells (PMNs), named for their unusually shaped nuclei, are our soldiers and are the immune cells found in greatest numbers at sites of infection. They are also called granulocytes for the granules observed in their cytoplasm, which serve different functions for each cell type. Along with mast cells, these cells respond to lymphocyte orders to release granules.

“Sir, yes, sir!” 3D renderings of PMNs. From left: a basophil, eosinophil and neutrophil. Image credits: Blausen.com staff (2014). “Medical gallery of Blausen Medical 2014”. WikiJournal of Medicine 1 (2). DOI:10.15347/wjm/2014.010. ISSN 2002-4436.

Macrophages are our all-rounders – scouts, marksmen and information specialists. They are usually the first to identify strange foreign substances which they consume, break apart and then present segments (like snapshots) of them to the T cells. Now, the generals must decide if these strangers are worth waging war. T helper cells (TH, CD4+) give out orders and our cytotoxic T cells (CD8+) personally attack problem cells, like cancer cells.  Sometimes, unfortunately, they get it wrong. This is when you experience a hypersensitivity reaction.

Okay. So what is an allergy?

With the introductions out of the way, we can learn about the anaphylactic response. ‘Ana’ means ‘away from’ and ‘phylaxis’ means ‘protection’. Seasonal allergies, severe allergies, and rashes are typical type I (anaphylactic) reactions. Interestingly, this is the reaction you will have, not the first time, but the second time you are exposed to the same ‘threat’ – and every time after that. Our immune system is a learning system, this is the reasoning behind vaccination and why chickenpox won’t affect you the same way twice. Once threatened, your army remembers their enemy so they can mount a faster, stronger defense the next time.

“A new challenger appears!” False color electron micrograph of various pollen grains, a common allergy trigger. Image credits: Dartmouth College Electron Microscope Facility.

In our first response, our T cells send in our B cells to attack. Once activated they become bigger, scarier, plasma cells. Their weapon of choice is, of course, antibodies but particularly immunoglobulin E (IgE). The first time our body encounters a strange antigen, be it pollen, dust, animal dander etc., there is a chance we will produce IgE. Some of these attach themselves to mast cells, which behave the first time around. The second time, however, they hold nothing back. And so we get back to the anaphylactic response, characterized by vasodilation and bronchoconstriction – essentially, your blood vessels expand and your air passages close up.

The T cell signals, which tell your blood vessels to expand, are to allow cells like PMNs and mast cells to move more quickly to the site of the challenge. Unfortunately, in the case of allergies this is usually your respiratory tract and skin. Once the PMNs and mast cells see their enemy, all hell breaks loose. The IgE antibodies on the mast cells identify the evil pollen and trigger the cells to degranulate, along with the attacking basophils.

Diagram showing a mast cell with attached IgE (A) and its degranulation (B) once the deadly pollen grain antigen binds to it. Image credits: Zoe Gordon, ZME Science.

From these granules, among other pre-formed mediators, histamines come out. A bit like grenades, they do their job very well but create a mess while they’re at it. They are excellent vasodilators and help your army enter the area quickly, unfortunately, they also make those areas leak. Essentially, histamines help to cause your red, runny nose and watery eyes. In fact, histamines are also stimulating your nerves and making you sneeze and itch. This is the reason why the medication we take to unclog our poor sinuses and de-rash our skin are antihistamines.

  • Early phase reaction: Within 15 minutes

The reaction that occurs — swelling of the area, redness, inrush of cells — is a standard inflammation reaction. And we see this on our skin in the form of itchy rashes or hives. The redness is because the blood vessels have expanded. But what about bronchoconstriction? As it turns out, within ten minutes after exposure, other mediators (e.g. prostaglandins) in those granules trigger tightening of the smooth muscle in the respiratory tract. This is allergy induced asthma and can become life-threatening anaphylaxis.

  • Late phase reaction: 4-6 hrs later

The war is over, but those cells just don’t seem to want to go away. In fact, some reinforcements are still arriving. The acute symptoms are gone but the effects of their presence remains. Rashes and hives can last for weeks or even months. The bronchoconstriction is even more troublesome, usually peaking at 30 minutes and fading but sometimes recurring after a few hours.

  • Anaphylaxis

Anaphylaxis is a different situation than your standard type I reaction. It’s potentially life-threatening and often comes with some combination of these symptoms: visible inflammation, trouble breathing, a worrisome drop in blood pressure, gastrointestinal distress.  When the person’s face swells up and they can’t breathe, what they need is a shot of adrenaline!

The most well-known brand of portable epinephrine shots. Image credits: Intropin/ Wikimedia Commons.

Epinephrine shots are your go-to for anaphylaxis – the sooner the better. Why? Because adrenaline essentially causes the exact opposite effect of inflammation. It’s our fight or flight hormone. It makes us breathe better, pushes up our heart rate and constricts our veins to increase blood pressure and flow. Allergies only become more severe with repeated exposure, so if you have experienced anaphylaxis, ensure you walk with your shots and that there is a way for people to know.

Now you know

All in all, your pollen allergy is essentially equivalent to a stray beach ball rolling across the battlefield and immediately getting focus fired by every soldier on hand – because it looked funny. And it doesn’t seem to matter how many times they try to harmlessly roll by. In fact, over time, the soldiers get joined by an extra platoon, then tanks, and then the air force because those beach balls have got to go! And over a few bits of pollen, soldiers and bystanders have been lost.

Yes, it’s very strange to imagine, but a lot of the symptoms we associate with allergies and illness aren’t things that the invader is doing to your body, but things that your body is doing to you – fever, runny nose, itchy eyes, shortness of breath, rashes, and hives. Your body is making you miserable… in an attempt to protect you. But, remember, when it’s not an allergy, to appreciate that. It’s doing the best it can.

 

 

peanut allergy

A surprising number of people develop food allergies in adulthood

If you made it through childhood without developing an allergy that doesn’t mean you’re home free. According to a new study, 45 percent of adults develop an intolerance to a foodstuff after they got older.

peanut allergy

This picture is enough to make some people swell. Credit: Pixabay.

An allergy is the response of the body’s immune system to normally harmless substances, such as pollen, foods, or house dust mite. This hypersensitivity causes the body to overreact by producing a disproportionate immune response when contacting an allergen. In some cases, the response can be so strong that the body enters anaphylactic shock, with potentially fatal consequences.

It’s not clear what causes allergies or why some people are more predisposed than others. Studies so far have linked both genetic and environmental factors to allergies. What’s certain, it seems, is that allergies are on the rise regardless of gender or ethnic background. According to findings presented at the American College of Allergy, Asthma, and Immunology conference, the incidence of shellfish allergy has grown by 7 percent, tree nuts by 18 percent, and peanuts by 21 percent. Shellfish and peanuts are also among the most common food allergies overall. The results are based on a survey of 53,575 U.S. adults.

The survey also shows that adults are far more susceptible to developing allergies than previously thought. Another surprising finding was that ethnic minorities are more predisposed to developing allergies in adulthood. According to co-author Christopher Warren, among black, Asian, and Hispanic adults, the risk of developing a food allergy to certain foods is higher than for whites.

There are two likely candidates that can explain the upward trend in allergies across the US. One deals with hygiene — too much of it, to be precise. Children nowadays are too locked up at home for their own good. Since their bodies haven’t accustomed to various substances, the immune system simply doesn’t have enough experience to differentiate between harmless and potentially dangerous substances, or so the theory goes. Secondly, misuse of antibiotics is throwing the immune system out of wack, besides generating antibiotic resistance, which is a way worse problem. Vitamin D deficiency (not enough sunlight) and obesity have also been linked to allergies.

EpiPen still expensive and critics should go “copulate with themselves,” Mylan chairman thinks

Oh boy, do I have a treat for you guys today. The kind that makes you breathe deeper, gets you feeling all hot and bothered inside, the kind of treat that really gets the blood boiling. Hope I didn’t give it away yet. You ready?

It’s corporate greed and gross indifference towards human suffering, of course! How quaint. Naturally, Mylan is the centerpiece of the show. So let’s dive right into it.

But first:

Meet Robert Coury. He’s a firm believer in self-love. You’ll see.
Image via YouTube.

 

A short recap

A while ago we fired a few shots at Mylan and its CEO Heather Bresch for the ludicrous price increases of the company’s signature EpiPen. She found herself in the ignominious position of testifying in front of Congress with the same credibility of a schoolgirl blaming the dog for eating her homework, then not being able to recall what the homework was.

The short of it is that Bresch wasn’t able to remotely justify the product’s 500% price increase since 2007 when Mylan acquired its patent rights. It also became apparent that the company strong-armed schools into effectively banning lower-cost alternatives from their nurse offices via the EpiPen4Schools program, all adding up to something which Rep. Tammy Duckworth rightfully called a “monopoly”.

To add a little Godfather (Godmother?) twist into the whole thing, schools were “strongly encouraged” or downright required to have anti-anaphylactic meds on hand following an unprecedented push by the National Association of State Boards of Education (NASBE) — which was headed since 2012 by Gayle Manchin, Bresch’s mother. Naturally, the schools weren’t informed of the blood ties between NASBE and Mylan when they were signing the deals.

“Eleven states drafted laws requiring epinephrine auto-injectors. Nearly every other state recommended schools stock them after what the White House called the “EpiPen Law” in 2013 gave funding preference to those that did,” USA Today reported on the issue.

Altogether, Congress had a lot of ‘slippery’ during the hearing and almost no hard answers — if you’ve missed it, here it is again, so you can give it a read. Because you’re going to need all the warm-up you can get for this next bit.

Anatomically incorrect

As you can probably tell, the whole thing basically pissed everyone off, except the shareholders. Mylan has had to deal with a very harsh backlash from customers, advocates, federal investigators, lawmakers, all the works, but the price of EpiPen is still not dropping. Which is puzzling, to say the least — what Mylan is doing is the economic equivalent of putting on the noose and handing the rope to the same people whose kids, friends, and relatives are dying to a peanut because they can’t shell out $609 on a pack of life-saving medicine. The parents, family, and friends of some 15 million of Americans.

It’s all terribly puzzling until you factor in that Mylan has, for all intents and purposes, a near monopoly on a vital product and/or hear about their creative take on marketing strategy. It’s all courtesy of The New York Times’ , who sat down with 10 of the company’s former mid-level executives and also talked with CEO Heather Bresch to pick their brains on the matter.

According to these former executives (all of whom asked to remain anonymous citing nondisclosure agreements and potential retaliation from Mylan), the company’s top brass fully expected a public outrage over its price hiking and planned to simply ignore it. These former execs say they’ve repeatedly raised concerns that the hiking amounts to “unethical profiteering” on the backs of patients with no other alternative, all the way back since 2014. And here’s where it gets really good:

“Over the next 16 months, those internal warnings were repeatedly aired. At one gathering, executives shared their concerns with Mylan’s chairman, Robert Coury,” Duhigg writes. “Mr. Coury replied that he was untroubled.”

“He raised both his middle fingers and explained, using colorful language, that anyone criticizing Mylan, including its employees, ought to go copulate with themselves. Critics in Congress and on Wall Street, he said, should do the same. And regulators at the Food and Drug Administration? They, too, deserved a round of anatomically challenging self-fulfillment.”

“When the executives conveyed their anxieties to other leaders, including the chief executive, Heather Bresch, these, too, were brushed off, they told me.”

I can only tip my hat to Mr. Duhigg’s impressive word taming skills. The point makes its way across nicely. Though I warmly invite Mr. Coury to show us all how it’s done.

Unethical is putting it mildly

EpiPen.

I’d suggest he start with one of these. Considering the price they’re going for it’s guaranteed to increase his self-worth.

You may be surprised to find that despite receiving around $160 million in compensation last year from Mylan, Mr. Coury declined to comment on the matter — who would have thought, right? Bresch luckily didn’t, and it’s from her we learn that Mylan is, in fact, “a pretty rare and unconventional company,” wholly dedicated to the consumer, delivering low-cost meds, snooze, snooze, snooze. It’s the broken healthcare system that’s bringing the company down, bringing prices up, and causing all this hardship for the people in need.

To back her words, she mentions the generic version of EpiPen, which Mylan released after their meltdown of a Congress hearing. A two-pack of these will take you back less than the brand-name two pack, but as always, there’s a caveat.

“When I asked my pharmacist for the generic EpiPen,” Duhigg recounts, “he told me that I would have to wait 90 minutes, until he could get my doctor on the phone to authorize the substitution. Then, he charged me $370 for the generics.”

A far cry from the $100-a-two-pack price the pens were sold for before Mylan got in on the business — and an inexcusable leap from the $35 EpiPencil Four Thieves Vinegar proved you can make at home. Even if that price was excusable, how many of us would be willing to wait for an hour and a half to get the cheaper pen when your kid can’t breathe back home? How enjoyable will that wait be when the generic kind is all you can afford, even if it means no food today, tomorrow, the whole week — maybe the week after that? Unethical profiteering seems too small a term when seen from this light, doesn’t it?

In the end, Mylan made some $1.1 billion in revenue every year from the EpiPen alone. And its CEOs are the highest paid in the industry. Shame and loathe be onto them. But I think it’s clear that left to their own devices, Mylan’s top brass won’t change. They don’t see any reason to. Change has to come from outside — affordable alternatives to the EpiPen (pills and auto-injectors) are slowly becoming available, and doctors need to start prescribing those (as well as other competing products) in place of what Mylan has to offer. Pharmacists, too, should guide customers to non-Mylan alternatives.

Because if they have an alternative to the EpiPen, all those hands holding the noose will have not only a motive but also a means to pull on the rope.

Epinephrine pill might break the EpiPen scandal and give patients their first valid alternative

An alternative to the EpiPen might soon make it to a pharmacy near you. An epinephrine tablet that dissolves under the tongue comes to shake auto-injectors’ monopoly on the market.

epipenLast month, Heather Bresch as CEO of Mylan went through a pretty harsh Congressional hearing to explain the skyrocketing prices of the EpiPen, Mylan’s signature product. The price increases have left many without access to epinephrine, vital for people with allergies going into anaphylactic shock. During the hearing, representatives voiced concerns that Mylan has control over the market as competitors have a hard time going past EpiPen’s patented design — so most offered alternatives, which relied on other types of auto-injectors, never got approved (you can be a pirate and make your own — but be warned if done incorrectly this may be fatal).

A small team of researchers including Mutasem Rawas-Qalaji, a pharmaceutical researcher at Nova Southeastern University in Florida, thinks they’ve found a way to solve this problem. They propose delivering the substance through a pill.

Working a bit like an ordinary orally disintegrating tablet (ODT), the treatment is designed to be administered under the tongue. That’s because delivering epinephrine through the stomach is pointless — the hormone breaks down before finding its way to the liver or blood. ODTs are meant to dissolve on the tongue and provide an alternative to liquid drugs or standard pills for patients who have trouble swallowing. They’re also used to bypass the digestive system altogether when delivering a drug. Rawas-Qalaji plans to have the pill dissolve in the blood-rich area of the under-tongue — so the epinephrine gets directly into the bloodstream.

He also spent the last few years tweaking the pill, making the epinephrine crystals it contains smaller and smaller to make sure that it will dissolve and be absorbed in seconds — there’s no time to wait during an anaphylactic shock. Still, it’s a much more inefficient way of doing things than just injecting the epi into muscle because a lot of the hormone gets lost in the mouth. While a pen holds roughly 0.3 mg of epi, the latest version of the tablet holds some 20 mg just to deliver an equivalent dose.

Dr. Mutasem Rawas-Qalaji and his epi tablets. Image credits Mutasem Rawas-Qalaji.

Dr. Mutasem Rawas-Qalaji and his epi tablets.
Image credits Mutasem Rawas-Qalaji.

But an EpiPen has flaws of its own apart from the cost, however. A Texas Uni study published last year found that only 16% of patients use the devices correctly. Most people don’t jam them with enough force into the leg or don’t hold it in place for the recommended ten seconds. They’re also bulky making them inconvenient to carry around, and they expire after about a year.

If approved, the tablets could solve a lot of EpiPen’s problems — it would be cheaper, simpler to use, smaller, more portable, and more stable. Rawas-Qalaji believes they could last up to seven years on shelf.

“So if you don’t use them you don’t have to go and buy another one,” he said.

As far as price is concerned, he couldn’t give an exact figure — it would depend on the manufacturer. He’s confident that the tablets can be sold “at a price that’s affordable and makes sense […] to fill a gap and meet the needs of the patients.”

Still a while to go

But there’s still a lot of work to be done before anyone’s putting these pills anywhere near their tongue.

“It’s a good idea. We’d love to have it. Patients would love to have it. There’s a lot of appeal,” says Robert Wood, an allergist at Johns Hopkins.

“But the risk of it not working is that people die.”

Wood says that the only way to make sure the pills work is to test them on people actually going through anaphylaxis — that means finding patients with severe allergies and asking them to expose to a potentially deadly allergen to test a drug that should work. Which, unsurprisingly, isn’t something that would fly with your average review board.

Rawas-Qalaji agrees that it isn’t ethical or feasible to do things that way, so he’s doing the best he can to make the pills as efficient as possible without endangering anyone. So far, he’s tested the tablet on rabbits. In the future, he plans to give the tab to healthy volunteers, then measure the epi concentration in their blood. If it’s equivalent to those from people given the EpiPen, the pills should work in stopping anaphylaxis. Wood also pointed out that the swollen mouth of a patient in shock might react differently to epinephrine than a healthy mouth.

“The swelling and other related unanswered questions have been discussed with FDA,” Rawas-Qalaji said for Popular Science.

“We had a good agreement of what can be tested and what [can]not.”

With input from the FDA, and help from specialists in allergies, Rawas-Qalaji and his team hope to start clinical trials sometime in the next few years. He also wants to get FDA approval for the tablets well before Mylan’s patents are up in 2025.