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New York Times

EpiPen Shows, It’s Good to Be the King

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By Henry Ehrlich

EpiPen rules the autoinjector market

“It’s good to be the king,” says Mel Brooks, playing Louis XVI in The History of the World, Part 1 while leering at the decolletage of a willing lady of the court. This came to mind as EpiPen picked up where it left off last season infuriating patients, parents, and legislators for the privileges that attach to its near-monopoly status. Rules of the marketplace that have affected a long line of competitors don’t seem to apply to EpiPen.

Last week, the New York Times reported that the Food and Drug Administration accused Pfizer, which manufactures EpiPen for Mylan, “of failing to properly investigate reports of malfunctioning EpiPens, including incidents when patients died or became severely ill after the device failed to work.”

Pfizer spokeswoman, Kim Bencker, responded that the company was confident in the safety and efficacy of the 30 million EpiPens sold since 2015.

A few comments:
1) Without sympathy for Mylan, I would like to see some substantiation of those deaths. Fatal anaphylaxis is rare enough, and food allergy is the rarest cause. Most of those fatalities result from delayed use of epinephrine, but some happen with timely use. Maybe some of those can be attributed to misfiring EpiPens, but there’s nothing in the news coverage to indicate that’s the case.

2) It is irksome to Auvi-Q fans that their favored product was completely withdrawn because of a putative manufacturing flaw and they were compelled to return to EpiPen for two years. By comparison, the Times says that Pfizer and Mylan recalled 13 lots of EpiPen this year only after the F.D.A. inspected the suspect manufacturing facility, but production and sales continued. When Auvi-Q went away, EpiPen was a “safe” reserve. What do people do now when EpiPen’s safety is called into question? The newly revived Auvi-Q is showering the market with affordable injectors, but do they have the capacity to replace EpiPen while Mylan gets its act together?

3) My third complaint derives from an additional comment by the Pfizer spokesperson, Kim Bencker. “It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals.” Way to go–blame the customer. In light of those complaints, shouldn’t EpiPen undertake much wider efforts to instruct patients and caregivers in the proper use of the device?

Fast forward a week and we have another nasty report on EpiPen, unconnected to the FDA story, this one from STAT as part of an article about big pharma tactics to maintain monopoly status as their patents wind down. That is the point where generics and competition theoretically come into play. (We have covered this before on this website as it pertains to antihistamines.)

STAT tells us, “EpiPen falls under a category called complex generics, which covers a host of products including drug-device combinations. Mylan, EpiPen’s manufacturer, has spent years tinkering with its injector pen to make it easier to safer and easier to use. And because each change is duly patented, the net effect is a product with virtual immortality.”

The drawback for competitors is that with complex generics, “…in order for the FDA to consider a competitor to be truly interchangeable, a patient must be able to use it without additional training. This creates a paradox: How do you make something that works exactly like an EpiPen but doesn’t infringe any of EpiPen’s patents?” Sneaky.

Two scandals, one mechanical, one legal, with no apparent connection? Maybe not. Maybe all that tap dancing to stay one step ahead of patent expiration is also outpacing their ability to manufacture a consistently dependable product. Perhaps it is time to put more money into mechanical engineering and less into legal engineering.

The ideal, of course, would be a new autoinjector with Auvi-Q’s cool but at a much lower cost. The current competitive environment favors EpiPen, with its massive market share. It reminds me of the old AT&T, which tolerated only as much competition as it needed to keep it out of the clutches of antitrust enforcement. Or the old IBM, which chose to concentrate on building personal computers and outsourced building the operating system to Bill Gates. We need some disruption in the autoinjector market. Everyone hates EpiPen, but they often have to keep it with them at all times. If something really new (and cheap) arrives, monopoly EpiPen will age faster than the face of Dorian Gray.

Dupilumab—Breakthrough Therapy Gets Breakthrough Price

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By Henry Ehrlich

The other day, I had a dermatologist appointment. The first thing I said was, “it’s a big day for you!” He said, “You read about the approval.” Yes, indeed. This was clearly a big day in skin health.

Dupixent—the brand name for dupilumab, the first biologic for moderate-to-severe atopic dermatitis—has been approved by the FDA, and as we predicted the price is a stunner. In fact, this breakthrough therapy for a truly miserable disease is even higher than we speculated last year–$37,000 list price, for what looks like forever. We have to ask, what do we mean by affordable health care when one drug is priced like this?

Don’t get me wrong! This is a drug that will restore quality of life for millions of patients. I’ve been following it avidly for several years since I watched Dr. Emma Guttman-Yassky speak to the New York Allergy and Asthma Society over roast chicken and salad. The “before” slides she put up on the screen looked like napalm victims. Dr. Peter Lio described the misery of these patients for us when he wrote about the drug last year: “The relentless itch, continual skin breakdown, poor sleep, cracked and painful skin that can become infected: All of these are part of daily life for those with more severe eczema. The quality of life indices for this disease show that day-to-day suffering exceeds that of many other chronic conditions considered much more dangerous.”

The plight of these patients often begins in early childhood, and is a precursor to asthma and food allergies. As I wrote a couple of years ago, “People will go to great lengths to achieve some relief, even at the expense of their own long-term health. While most people are wary of steroids and will avoid their use even when it’s really bad for them, which happens often with asthma, AD patients will use them too much.”

How much will it really cost? The New York Times, which had an explosion of drug-price reporting last year because of the Mylan fiasco, did some excellent reporting on the new biologic.

Among the highlights, “Regeneron Pharmaceuticals and Sanofi took the unusual step of directly negotiating with insurers over the price and other details ahead of time….They also often must demonstrate that other, cheaper drugs did not work before an insurer will cover more expensive drugs. Regeneron has said it also negotiated a more streamlined approval process, although patients will still have to try other drugs first. It also said it had a patient assistance program to help people who have troubling paying.”

The Times also cited Dr. Steve Miller, chief medical officer at Express Scripts, the big pharmacy benefits manager, to the effect that the drug makers held all the chips because the drug works well and has no real competition. Also if it’s any consolation, the Times says that Humira and Enbrel, also for skin diseases, run about $50,000 list.

So what will they pay and when will they pay it? I asked Dr. Paul Ehrlich who said, “Since it’s only approved for patients 18 and up, it’s not going to be an issue for me since most of my patients are children.” For them, it’s wet wraps, topical steroids, and if all else fails referral to Dr. Xiu-Min Li. He did note that trials for younger patients are on their way, probably for ages 12-17 to start.

Our contributor, Dr. Purvi Parikh, who occupies the adjacent office to Dr. Ehrlich at Asthma and Allergy Associates of Murray Hill, adds, “This is a great non-steroidal alternative we can offer our severe eczema patients. Often eczema takes a toll on quality of life as well as self-esteem. It is nice to have another agent especially for those who have been reliant on steroids for many years with no avail.”

Promising though this treatment is, it won’t take patients by storm. Because of the expense, the criteria will include exhausting all other methods and then throwing them on the mercy of their insurance companies. I asked my dermatologist if he had any likely patients. “We’ll have to see.”

Peanut Envy–Real World Consequence of New Guidelines

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By Dr. Paul Ehrlich

New guidelines for introducing peanut into the infant diet made it onto the front page of the New York Times. This is the culmination of two years of coverage of the LEAP study, which we have been following all along. The article quotes Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) on the front page who calls it “game changing.” After the jump, the chief voice is Dr. Matthew Greenhawt, chairman of the American College of Allergy, Asthma and Immunology’s food allergy committee, and an author of the new guidelines. He concludes, “This won’t outright prevent every single case of peanut allergy – there will still be some cases – but the number could be significantly reduced by tens of thousands. In the best-case scenario, every allergist across the U.S. could be seeing fewer cases of peanut allergy — and that’s a good problem to have.”

I have nothing new to add to the news of the day, except that as a practitioner I have been coping with it for two years since Dr. Gideon Lack and Dr. George DuToit shook the food allergy world with their finding announced at the 2015 AAAAI meeting (analyzed here), which reversed years of conventional wisdom on withholding allergens from kids’ diets.

Such radical reversals do have consequences in the real world of clinical practice. Just this week I met with a mother and her infant son. Months ago, we determined that he fell within the early parameters for risk and we introduced peanut into his diet. So far so good.

Except that his older brother, who is allergic, has been watching the mother give the baby peanut, and he is good and mad. He wants it, too.

Click here for practical advice on implementing these guidelines, the American College of Allergy, Asthma & Immunology.

EpiPen and the Publicity Boom

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By Henry Ehrlich

Turning $1 worth of medicine into $600 worth of gold
Turning $1 worth of medicine into $600

Sometimes numbers tell a story that words can’t. Sunday morning I opened my New York Times and there were two new stories about Mylan’s adventures in pricing. That made three in the previous 24 hours. According to the search engine on the website, there had been 71 over 12 months. But that’s when the numbers started getting interesting. Sixty-six of those 71 were from the last 30 days, 24 of them in the previous seven. Clearly the story has caught fire. However, the most important thing is how the saga has gone from a price-gouging story to a symbol of so much that is rotten about our healthcare system.

The most interesting of the Sunday stories — “Old Drug, Pricey New Package” — was by Elizabeth Rosenthal, who used to be a Times writer and now works for the Kaiser Foundation, and author of the forthcoming book, An American Sickness: How Healthcare Became Big Business and How to Take It Back. If this piece is any indication, I can’t wait for her book.

“Old Drug…” begins where I suspect much of the new wave of Epi journalism does–from personal experience, although in Ms. Rosenthal’s case, it was to relieve acute asthma attacks back in the 1960s and it was given by syringe by her summer camp nurse. Then she recounts the alchemy of technology, lobbying, and law by which a dollar’s worth of medicine changes into a $600-a-hit medical necessity for millions.

Rosenthal says that this price spike may lead to some remedies for a broader crisis in American medicine, of which the current one is just a symptom. She cites Dr. Aaron Kesselheim from Harvard who suggests, “(T)he government could regard extreme prices as it does drug shortages, allowing for emergency imports of cheaper products. The United States patent office and the F.D.A. could be stingier in handing out market exclusivity for patents on drugs and delivery devices that offer little or no benefit. A national body could set price ceilings for essential medicines (as occurs in other countries), or review rate increases levied on products that are unchanged.”

But she also warns that other fiascoes like this will undoubtedly take place as consultants, lawyers, and various other trolls lurk on the road ahead. Bankers whom I used to write for always warned that reforms undertaken in a time of crisis always laid the groundwork for the next crisis. Of course that didn’t stop them from creating new crises when those reforms were rolled back. I wouldn’t mind seeing some of the current profiteers take a hit for now. And for more comprehensive reforms, I eagerly await Rosenthal’s book. Let’s hope the embarrassment of Mylan doesn’t turn out to be another news boom that goes bust.

aac-thumbnaillogoe-mail me with your questions and comments at:
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EpiPen and the Invisible Hand

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Adam_SmithBy Henry Ehrlich

Mylan today announced that it will offer a generic version of the EpiPen. It will be available in a matter of weeks and identical to the brand name version, but at a consumer cost of only three times the 2007 product instead of six times. Company stock is up 2.5% in early trading. Some version of previous pricing and discounting for the original will remain in place. Both will be manufactured by Pfizer. This is a familiar dynamic for anyone who shops. Best Yet Spicy Brown Mustard, the store brand around the corner from me, is identical in every way to Guilden’s except for the name on the label.

Avarice has done for Mylan what competition could not. Reputation risk can occasionally be as potent as the marketplace.

Why was Mylan able to compete against itself so quickly? You can bet these plans have been in the works for some time. After all, they didn’t know for sure that Auvi-Q would have manufacturing problems (although some in the food allergy community believe otherwise). They couldn’t know for certain that Teva’s generic would get hung up by the FDA (unless…..). Regardless of whether you believe conspiracy theories or not it’s safe to say that any organization savvy enough to build a brand as potent as EpiPen had a contingency to combat something as mundane as pricing competition. They are both lucky and smart.

So what’s a patient or parent to do? Do you buy the store brand, or wait for a coupon for the brand name? What does your doctor do? The New York Times coverage suggests that Mylan is counting on the stupidity of physicians for a certain amount of profit. “The term EpiPen is Portnoy_s_Complaintso familiar that many doctors write prescriptions for it rather than for a generic epinephrine auto-injector. Pharmacists in many states will be able to substitute the generic version but in some cases they may not, leaving Mylan with higher revenue than if it had cut the price across the board.”

When a dominant company competes against itself, the invisible hand is not that of Adam Smith, but that of Alexander Portnoy, as economist Robert J. Samuelson said in a different context. Mylan still has a firm grip on the market.

aac-thumbnaillogoe-mail me with your questions and comments at:
henry@asthmaallergieschildren.com
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EpiPen Pricing—The Scandal is What’s Legal

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By Henry Ehrlich

Frog_and_saucepanToday the New York Times published two articles on the outrageous price rises for life-saving EpiPen, and threw in an editorial to boot. The editorial drew attention to a wider problem of drug manufacturers playing the pricing game according to the rules of Monopoly, in which you invest in houses and hotels and raise the price every time your opponents land on them. EpiPen has become Boardwalk and Park Place for Mylan. We have harped on related issues for years—my cousin complains that going back many years even before Mylan bought the property, the EpiPen reps would ignore his practice except during those Brigadoon moments when a competitor would appear. I noted back in 2011 on this website that there must be a new entry on the horizon because Mylan had started advertising, and sure enough in 2012 Auvi-Q showed up. I have continued to draw attention to this corporate behavior ever since, all the while acknowledging that they do save lives.

The main Times article today observed that Mylan was following an established pattern of raising prices faster in the run-up to an expiring patent or the expected introduction of a generic version. Thus, semi-annual 10% hikes after 2007 were followed by three years at 15% instead. This profiteering was enabled by the withdrawal of Auvi-Q, which proved much more popular with users but had manufacturing problems, and the FDA’s failure to approve a generic from Teva. Whoopee! Let’s raise prices.

Management consultants I used to work with enunciated something called the “boiled frog” principle. To wit, if you put a frog in boiling water it would try to get out, but if you put it in room temperature water and raised it slowly, little Hoppy would stay until it was too late. Mylan got too frisky and now the fecal matter has hit the rotating blades. The story has everything. It pits one Senator’s daughter, Mylan CEO Heather Bresch, (father Senator Joseph Manchin of West Virginia) vs. the EpiPen-carrying daughter of Amy Klobuchar of Minnesota. Looking back at another article I did about Mylan and West Virginia last year, it’s clear that the Mountain State has had a very cozy relationship with the company.

Mylan is doing damage control while waiting for the subpoenas to arrive by making EpiPen “more affordable” but this begs the question, why didn’t they think of this already instead of squeezing patients till the water reached the boiling point? Too little too late.

Personally, I think that the problem is structural. Every time this comes up, whether with epinephrine or asthma medicine, I urge people to write to their Congresspersons and ask for restoration of vigorous anti-trust enforcement. I also believe there should be ways to weight the tax system so that scientific innovation is rewarded instead of financial innovation, Mylan having transferred its headquarters to the Netherlands from the United States to avoid paying US taxes (called “inversion”). Way to go, daughter of a US Senator from a coal-producing state. In addition to being known as the Mountain State, West Virginia’s terrain has earned it another nickname: “the Switzerland of America.” With all these financial machinations, that might be more appropriate in this case.

aac-thumbnaillogoe-mail me with your questions and comments at:
henry@asthmaallergieschildren.com
or fill-out the contact form in
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Epinephrine Access Slogs State by State, While Overdose Treatment is Fast-Tracked

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By Dr. Paul Ehrlich

Only yesterday, food allergy advocates spent hours testifying before a California legislative committee on behalf of an access-to-epinephrine bill for school children. It is a scene that has been repeated in state after state, with favorable legislative results and even more notable health outcomes. I have nothing against this process, which seems to be a rare instance of widespread bi-partisanship at the state level, in the wake of President Barack Obama’s endorsement of the principle and his announcement that one of his children is allergic to peanuts.

naloxone jq 1Still, I was somewhat surprised to see in this morning’s New York Times that the FDA is moving at lightning speed (for a federal agency) to approve access to a device to rescue addicts who are overdosing.

“The hand-held device, called Evzio, delivers a single dose of naloxone, a medication that reverses the effects of an overdose, and will be used on those who have stopped breathing or lost consciousness from an opioid drug overdose. Naloxone is the standard treatment in such circumstances, but until now, has been available mostly in hospitals and other medical settings, when it is often used too late to save the patient.”

The device is even compared to an EpiPen autoinjector, although the report describes EpiPens as used for insect stings and omits food allergies.

I did most of my medical training at Bellevue Hospital in the 1970s. I know what it’s like to treat a heroin overdose. It didn’t take the death of Philip Seymour Hoffman to alert me to the tragedy of opioid abuse, either heroin or prescription drugs that flow all-too-freely into the hands of addicts, which now account for half of overdoses. I was struck by the statistics in the Times article: “Deaths from opioids have quadrupled in 10 years to more than 16,500 in 2010, according to federal data.”

As a matter of public health, however, fast-tracking life-saving medication shouldn’t depend on body counts. Epinephrine auto-injectors are safe, effective, and convenient. They should be in all schools and teachers should be trained in their use (and by the way schools should let children carry their own asthma medicine, too). Putting them there shouldn’t depend on grinding it out in state capital after state capital.

The High Cost of Treating Severe Asthma

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Medical gold mine?
Medical gold mine?

By Dr. Paul Ehrlich

Great timing. An article on the front page of the Sunday New York Times on colonoscopies happened to coincide with the fact that I finally received an answer to a question eight weeks after I asked it. The Times piece was about colonoscopies and the part they play in our inflated national health care bill. Funny, I always thought doctors were looking for signs of cancer during this undignified procedure. It turns out they were also looking for gold.

A procedure that costs a few hundred bucks in other developed countries, runs anywhere from about $2800 in Cleveland, Milwaukee, and Salt Lake City to about $8500 in New York City. The gastroenterologist who’s responsible for actually looking for signs of disease actually makes less than the anesthesiologist who either administers general anesthesia—a largely unnecessary excess—propofol, which renders you unconscious just for the length of the scoping, or a bit of Valium. (Take note, music fans—propofol was the drug that allegedly did in Michael Jackson.) But don’t cry for the gastroenterologist. He may be a partner in the venue itself, which, like a hospital, can charge a whopping “facility fee.” These colonoscopy centers can provide a 100% return on investment in less than two years.

So, what does this have to do with allergies? One word: Xolair (or maybe two words, since the generic name for Xolair is omalizumab). Allergists use Xolair, also known as the anti-IgE antibody, to treat very severe cases of asthma. Xolair must be injected slowly, it is often painful for patients, has side effects and therefore requires observation, and is also incredibly expensive—upwards of $1200 per shot. After my staff gets through with the elaborate coding, arguing with insurance companies, and so forth, I end up giving it practically at cost.

With this in mind, when I was approached by hospitals I am affiliated with to take my Xolair patients for their injections, it made sense. They would assume the entire paperwork burden and I wouldn’t lose space in my waiting room for observation, or indeed my own precious capacity for paying attention to patients who are receiving a powerful drug. But then I asked the question, “What do you charge to give one of these shots?” Eight weeks later, I got the answer: $5500.

I’m not doing it. Certainly the red tape is extraordinary. But these are my patients, and I don’t want to lose the continuity of treatment and observation while they report to another facility even if I don’t get paid. Would I like to split the difference between what I charge and what the hospital charges? Sure. And if the insurance companies had any sense they would find a happy median. I even know where they can find the money–they can just make up the additional payments to me out of their savings in other medications and emergency treatment. Regardless, no more referrals from me.

Doctors Are from Mars, Patients Are from Venus

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By Dr. Paul Ehrlich

A recent article in the New York Times “Afraid to Speak Up in the Doctor’s Office” by Pauline W. Chen, MD, a transplant surgeon, gave the following account of a phone conversation with a friend about a recent medical episode:

“[W]hen I suggested she speak with her primary care doctor and perhaps a neurologist, her end of the line went silent. I wondered if my cellphone had dropped the connection or, for a single harrowing second, if my friend was having another strokelike event. When she finally spoke again, her once-confident voice sounded nearly childlike. “I don’t really feel comfortable bringing it up,” she said. While her doctor was generally warm and caring, “he seems too busy and uninterested in what I feel or want to say.”

“I don’t want him to think I’m questioning his judgment,” she added. “I don’t want to upset him or make him angry at me!”

What is it about doctors and patients these days? Are we physicians really that forbidding? Are patients really so scared of us? Does a prolonged stay in the waiting room set a mental alarm clock in a patient’s head that cautions against asking a nagging question or mentioning some additional symptom that might lead to more time, tests, co-pays, and prescriptions or other bad news? You don’t have to be as cynical as Dr. House (“everybody lies”) to think that patients (and doctors) don’t always tell the truth, the whole truth, and nothing but the truth.

We certainly get a taste of the communication gap at Asthma Allergies Children world headquarters as we monitor various discussions on the web. We like the idea of peer exchange. It arms patients and patients’ parents with knowledge to share with their doctors, which makes the doctors better at what they do. Now and then, however, we see threads that beg the question, “where are the doctors?” Why are people pursuing lines of thinking that an MD could clear up in a moment? When it comes to feeding a food-allergy family, the average parent after a while probably knows much more than the average allergist, and peer-to-peer communication helps more than the doctor. But that board certification in allergy and immunology carries some weight, too. Yet, it is clear from the back-and-forth that consulting the doctor is a last resort. This does a disservice to both sides. It may not be easy to get an appointment with your allergist, but when you get there don’t worry about wasting her time, or his. There are no trivial questions.

Unnecessary Tests and Treatments? New York Times Editorial Hits Home

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By Dr. Paul Ehrlich

This morning, the Monday after Easter, I was jolted to attention on the way to the office by my regular Starbucks and by an editorial that began: “If health care costs are ever to be brought under control, the nation’s doctors will have to play a leading role in eliminating unnecessary treatments. By some estimates, hundreds of billions of dollars are wasted this way every year. So it is highly encouraging that nine major physicians’ groups have identified 45 tests and procedures (five for each specialty) that are commonly used but have no proven benefit for many patients and sometimes cause more harm than good.”

A couple of clicks on the online version brought me to this list, compiled by the AAAAI (first alphabetically on the roster of specialties):

1. Don’t perform unproven diagnostic tests, such as immunoglobulin G (IgG) testing or an indiscriminate battery of immunoglobulin E (IgE) tests, in the evaluation of allergy. Appropriate diagnosis and treatment of allergies requires specific IgE testing (either skin or blood tests) based on the patient’s clinical history. The use of other tests or methods to diagnose allergies is unproven and can lead to inappropriate diagnosis and treatment. Appropriate diagnosis and treatment is both cost effective and essential for optimal patient care.

2. Don’t order sinus computed tomography (CT) or indiscriminately prescribe antibiotics for uncomplicated acute rhinosinusitis. Viral infections cause the majority of acute rhinosinusitis and only 0.5 percent to 2 percent progress to bacterial infections. Most acute rhinosinusitis resolves without treatment in two weeks. Uncomplicated acute rhinosinusitis is generally diagnosed clinically and does not require a sinus CT scan or other imaging. Antibiotics are not recommended for patients with uncomplicated acute rhinosinusitis who have mild illness and assurance of follow-up. If a decision is made to treat, amoxicillin should be first-line antibiotic treatment for most acute rhinosinsutis.

3. Don’t routinely do diagnostic testing in patients with chronic urticaria. In the overwhelming majority of patients with chronic urticaria, a definite etiology is not identified. Limited laboratory testing may be warranted to exclude underlying causes. Targeted laboratory testing based on clinical suspicion is appropriate. Routine extensive testing is neither cost effective nor associated with improved clinical outcomes. Skin or serum-specific IgE testing for inhalants or foods is not indicated, unless there is a clear history implicating an allergen as a provoking or perpetuating factor for urticaria.

4. Don’t recommend replacement immunoglobulin therapy for recurrent infections unless impaired antibody responses to vaccines are demonstrated.Immunoglobulin (gammaglobulin) replacement is expensive and does not improve outcomes unless there is impairment of antigen-specific IgG antibody responses to vaccine immunizations or natural infections. Low levels of immunoglobulins (isotypes or subclasses), without impaired antigen-specific IgG antibody responses, do not indicate a need for immunoglobulin replacement therapy. Exceptions include IgG levels <150mg/dl and genetically defined/suspected disorders. Measurement of IgG subclasses is not routinely useful in determining the need for immunoglobulin therapy. Selective IgA deficiency is not an indication for administration of immunoglobulin. 5. Don’t diagnose or manage asthma without spirometry. Clinicians often rely solely upon symptoms when diagnosing and managing asthma, but these symptoms may be misleading and be from alternate causes. Therefore spirometry is essential to confirm the diagnosis in those patients who can perform this procedure. Recent guidelines highlight spirometry’s value in stratifying disease severity and monitoring control. History and physical exam alone may over- or under-estimate asthma control. Beyond the increased costs of care, repercussions of misdiagnosing asthma include delaying a correct diagnosis and treatment.

I can’t argue with this list. Item number one—those unproven IgG tests and indiscriminate use of IgE tests are right up there for me. I provided allergy services to a large group practice in one of New York’s fair boroughs for some time until the practice controller noticed that I wasn’t routinely ordering the full panel of 60 tests that insurance ordinarily covered. Decades of clinical practice had taught me to winnow the long lists based on a good history. This emphasis on the bottom line made that a bad fit for me. In addition, there is the problem of over-diagnosing food allergies based on test results, which results in unwarranted worry and food avoidance.

As for inappropriate use of antibiotics for most rhinosinusitis, “this too shall pass” is the height of medical wisdom. When patients demand “results” in the form of a prescription, we should resist. And so on for items three through five.

We are faced with these and other issues every day in practice. Another big one for me is when to recommend immunotherapy, and what kind. Patients with mold allergies may be desperate for relief, but I counsel against it unless it is combined with other allergens because it’s not all that effective, and not worth the weekly or monthly shot on its own. Spending the money to ventilate or seal the basement or fix the roof is a much better idea. Many allergists have jumped on the bandwagon for sub-lingual immunotherapy—SLIT as it’s called—which is easier than shots, particularly for small children. Yes, but it is also not proven for a broad range of allergens and for the one where it is somewhat effective, it is less effective than shots.

The value of any doctor lies both in knowledge and in wisdom. We should not prescribe tests just, as some suggest we do, to cover our behinds in a litigious society. Neither should we prescribe tests and treatment just to cover our expenses. Treating patients means saying no as well as yes.

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