Monday, 11 March 2019

Now most people with egg allergies can get a flu shot

When a person with a life-threatening allergy is exposed to his or her “kryptonite” (be it peanuts, bee stings, latex, or something else) the result is an intense immune response called anaphylaxis. The throat tightens, the tongue swells, blood pressure can crash, and it can become hard, maybe even impossible, to breathe. Rapid treatment is critical. “If a reaction is that severe, epinephrine basically saves a person’s life until she or he can get definitive healthcare,” says Dr. Susan Farrell, emergency room physician and assistant professor at Harvard Medical School.

Epinephrine is cheap — about $5 per milligram. The problem is that for people at risk for anaphylaxis, epinephrine needs to be handy and given quickly when an allergy exposure occurs. That’s the “beauty” of the EpiPen. The device makes it easy to keep an emergency dose available and simple to administer correctly. The dose delivered by the adult EpiPen is an inexpensive 0.3 mg. The medication is not costly; it’s the injector that’s expensive. But the high cost of EpiPens is not news. For a person with a high deductible insurance plan (or no health insurance at all), an EpiPen Two-Pak costs $622.09 at Walgreens. It is not much cheaper at other pharmacies and can still cost as much as $400, even with coupons and insurance combined.
Why are EpiPens so expensive?

A lack of competition is one of the reasons that Mylan, the company that makes EpiPens, can continue to increase the price. A similar product called Auvi-Q was pulled off the market due to concerns that the device did not deliver the right dose of medicine, according to Dr. Ana Broyles, allergist and immunologist at Boston Children’s Hospital. Other alternatives have not been that much more successful. Adrenaclick, for example, is significantly cheaper than the EpiPen ($188 at Walmart’s pharmacy) but Dr. Broyles finds it harder to use. It is rarely prescribed. Other companies have been trying to develop generic (and thus cheaper) versions of the EpiPen, but none have received FDA approval yet.
A proposed solution that won’t actually bring down the cost — and has the potential to influence “independent” recommendations

Most people who need this device don’t buy just one. They have them all over the place — the car, the office or school, a pocket or a purse. That’s why it hit consumers especially hard when they were forced to pay upwards of $500 for two EpiPens. Surprisingly, it was Mylan that proposed a solution to the soaring cost. It recently asked the U.S. Preventive Services Task Force (USPSTF) to place the EpiPen on its list of preventive medical services. That would make it completely covered by all insurances, including the Affordable Care Act and private insurance companies. There would be no co-pay, which sounds great.

But the mission of the USPSTF is to evaluate strategies to maintain health and prevent illness. Epinephrine is not preventive. It is not something you inject before you’ve been exposed to an allergen. It’s not something you take regularly to prevent a reaction. It’s a medication you inject after you’ve had a reaction. So, should the USPSTF make recommendations on EpiPens at all? Just yesterday, an opinion piece in the Annals of Internal Medicine argues that EpiPens are not only not a preventive service but in order for the USPSTF to remain completely unbiased and evidence-based, its recommendations should not determine insurance coverage at all.

Even if EpiPens did land on the list of preventive medical services, it probably wouldn’t benefit consumers in the long run. Mylan could continue to raise prices with little backlash from the public and would have no incentive to keep prices competitive or reasonable. While you wouldn’t be paying for your EpiPen out of pocket, your employer or your insurance company would. And those costs could simply circle back to you in the form of increased premiums or other lost benefits.

With so many children and adults at risk for severe allergic reactions, this discussion is important. Developing generic versions of the same medication and an equivalent delivery device creates competition. Those with allergies need better options, including improved access at lower cost — and transparency. Several contemporary clinical trials have shown that cholesterol-lowering statin drugs reduce the risk of heart attacks in patients with coronary artery disease. This compelling body of evidence has led to the question of whether other drugs that lower cholesterol also reduce heart attacks. Older studies had certainly shown this, though these studies were from an era prior to widespread statin use. A recent study showed that in patients with a mild heart attack, adding ezetimibe — a drug that interferes with cholesterol absorption from the intestines — to a statin reduced cardiovascular risk compared with a statin alone.

Now, a carefully done meta-analysis synthesizes all the studies to date and provides some new insights. A meta-analysis is a way of combining data from many studies over several years and analyzing the data to provide a bottom-line message. This particular meta-analysis consisted of data drawn from 49 studies of a total of 312,175 patients, a staggering number. The authors included only randomized clinical trials — the most rigorous type of study — and went back all the way to 1966 in their search for relevant trials.

The degree of benefit provided by statin and certain non-statin approaches that work predominantly by increasing the number of receptors in the body to clear out LDL cholesterol was roughly similar. The non-statin approaches included diet, bile acid sequestrants, ezetimibe, and ileal bypass surgery. Additional non-statin drugs assessed included niacin and fibrates. Both types of drugs offered cardiovascular risk reduction as well, though a major caveat regarding the data supporting use of these non-statin drugs was that the trials were not done on top of statins, or did not show clear benefits when added to statins.

Another important observation in this analysis was that lower levels of achieved LDL cholesterol were associated with even lower rates of major coronary events. This held true both for secondary prevention (that is, in patients with known atherosclerosis) as well as for primary prevention (that is, in patients with elevated cholesterol and cardiovascular risk, but without apparent atherosclerosis). The data drawn from the recent studies of the potent injectable PCSK9 inhibitor drugs also seem to support the relationship of lower cholesterol levels being more beneficial. However, it should be noted that large cardiovascular outcome trials are ongoing with these expensive injectable agents, to see if in fact they do decrease heart attack rates to the extent predicted from the large reductions in cholesterol they produce.

Thus, it appears that a variety of methods to lower cholesterol — several drugs and also diet — lower cardiovascular events, such as the chances of developing a heart attack. For patients at high cardiovascular risk, in addition to a healthy diet, statins remain the first-line drug therapy. For patients who cannot tolerate statins, non-statin drugs, including some of the older drugs, may provide a reasonable degree of benefit. The answer to whether even lower degrees of cholesterol reduction achieved by PCSK9 inhibitors further decrease cardiovascular risk is eagerly awaited. There are hundreds of viruses that can cause respiratory illnesses; influenza (the “flu”) is just one group of viruses which can cause mild to severe illness, and sometimes even death. Certain people — such as the very young or the very old, pregnant women, or those with chronic medical conditions like asthma, diabetes, or heart disease — are at greater risk for serious complications from the flu. Though the numbers fluctuate, the flu leads to hundreds of thousands of hospitalizations and anywhere from 3,000 to 49,000 deaths every year in the U.S., based on the numbers from the last few decades. How bad the flu season is depends a lot on the circulating flu viruses and whether the flu vaccine is well-matched, both of which usually change from year to year.

Typical flu symptoms come on quickly and include high fever, chills, headache, body aches, non-productive cough, and sometimes sore throat and stuffy or runny nose. Getting the flu vaccine at the beginning of the flu season (around October) is one of the best ways to protect yourself from this miserable illness. The CDC recommends routine yearly vaccination for everyone six months and older, unless they have had a previous serious allergic reaction to the influenza vaccine.
What if you have an egg allergy?

Because most influenza vaccine products are made with a small amount of egg protein, previous guidelines advised against using these vaccines in those with a severe egg allergy. This year, the Advisory Committee on Immunization Practices (ACIP) now states that people with egg allergies can receive influenza vaccines as long as they have never had a serious allergic reaction to the actual influenza vaccine or its other ingredients in the past. Specifically:

    People with a hives-only allergy to eggs can receive any licensed, recommended, age-appropriate vaccine.
    Those who report serious reactions to eggs other than hives (even anaphylaxis, a severe life-threatening allergic reaction) may receive any licensed, recommended, age-appropriate vaccine, but it should be administered in a medical setting (such as a clinic or hospital) by someone who can recognize and treat severe allergic reactions.
    Prior recommendation to monitor for 30 minutes after receiving the flu vaccine was removed, but the ACIP has a general suggestion to observe patients for 15 minutes after all types of vaccines, though this would not catch delayed serious reactions that happen much later.
    Another option for people 18 years and older is the egg-free recombinant influenza vaccine (RIV) Flublok.

Why this change?

Supercharge your cold and flu defenses!

27 surprising secrets, smart strategies, and simple steps to keep your immune system at its cold-and-flu-fighting best

It turns out that anaphylaxis as a result of the flu shot is quite rare. Ten cases of anaphylaxis were reported among the 7.4 million trivalent inactivated influenza vaccines — vaccines that use killed viruses to protect against three strains (types) of flu — that were given alone, corresponding to a rate of 1.35 events per one million shots. These reactions may have been due to ingredients other than the very small amount of egg protein in the vaccine. Rare cases of anaphylaxis following the flu vaccine in patients with egg allergies have been reported. However, there are several studies of children and adults with egg allergies, including one review of over 4,000 patients, who were given trivalent flu shots and none developed anaphylaxis. Studies with live-attenuated influenza vaccine (FluMist) showed similar findings (though the FluMist is not recommended this year because of concerns of lower effectiveness).
Get your flu shot

So the good news is that if you have been avoiding the flu shot in the past because of an egg allergy, studies suggest that a severe allergic reaction to the flu vaccine is quite rare. So if you have never had a bad reaction to the flu shot itself, try to protect yourself this year by getting a flu shot now. Go to your doctor or hospital to get vaccinated. This way you can get prompt treatment in the unlikely event that you have an immediate severe reaction.

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