New Geography

Author: Paul Ehrlich M.D.

  • Primatene And The War on (Asthma) Drugs

    On December 31, 2011, Primatene Mist, the only over-the-counter asthma inhaler still available, will be taken off the market. The ban is being pointed to as an example of regulatory overreach by the Obama administration. As a physician and asthma specialist, I have been observing the Primatene controversy for — without exaggeration — decades, and have concluded that there’s blame enough to share between both the pro and con government regulation camps, as well as the pharmaceutical and financial industries.

    The official reason for the ban is the danger Primatene poses to the environment. I have always thought that extending the ban on chlorofluorocarbon propellants (CFCs) to medication was an example of regulatory overkill, because medication is such a small part of the problem. However, it does help to look at the context. Back in 1987, when Ronald Reagan was President and the Montreal Protocol was written, there was international consensus that we needed to do something about depletion of the ozone layer high in the atmosphere, which was causing problems for us here on earth. For many of the products releasing these gasses into the atmosphere — car air-conditioners, hairspray, and deodorant, for example — alternatives could plausibly be found. I wish we could find a way to relieve asthma attacks with a roll-on, but we can’t.

    Medical aerosols were given more time than other products, and, frankly, I don’t think we’ve done a very good job of replacing them. The new inhalers don’t deliver medication as efficiently as Primatene delivers its active ingredient. Still, anyone who looks at the timeline for the upcoming restriction can see that the key decisions were made in 2006 and in 2008. The current administration is following the timetable set by its predecessors.

    The charges of over-regulation have been accompanied by newly expressed sympathies for the plight of poor people with asthma. I think the greater disservice was done recently when stronger air-quality regulations were postponed. The best way to treat asthma is to reduce its incidence, and air quality is one of the biggest factors. It’s unfair to generalize, but I have a feeling that some of the people looking to demonize Big Government for regulating Primatene were also calling tighter air-quality regulations “job-killers” a few weeks ago.

    The best argument against Primatene falls outside of the environmental realm, and that is the medical case. The active agent is epinephrine, which is pharmaceutical adrenaline. This has the ability to relieve the airway tightness produced by an asthma attack, also known as bronchoconstriction. In this, it resembles the action of the preferred asthma-relief medicine known generically as albuterol. However, epinephrine also stimulates the heart. This makes it unsuitable for large numbers of asthmatics who also have heart problems. Most of the people who rely on Primatene are poor, and often overweight and hypertensive. These regular jolts to the heart are not doing them any good.

    In addition, it does nothing to control asthmatic inflammation, which is best accomplished with systematic, daily doses of inhaled corticosteroids, a very different kind of drug. Asthmatic lungs are what British doctors called “twitchy,” i.e., they are chronically inflamed and primed for any asthma trigger, such as diesel fumes, airborne allergens, or viruses, to touch off an attack. Primatene treats symptoms, not causes, and I have no doubt that users miss a lot of work or school and are sub-par performers when they do go. Uncontrolled inflammation is remodeling their airways, costing them lung capacity for the long haul.

    Many who decry the passing of Primatene believe the ban was contrived to squeeze more money out of those who can least afford it. They probably have a point. I would love to see the FDA memos and transcripts from 2006 when the Primatene decision was made, or from 2008 when the fuse was lit, not to mention those of the current owners when they decided to acquire the drug. Even without access to these secrets, we know that drug makers like to tweak existing medicines and bring them back on the market at higher prices than they command over the counter, and that investors sometimes buy up the rights to older drugs with exactly this in mind.

    It doesn’t always work. The next generation drugs are sometimes no improvement over the previous ones. Last year I wrote a post commemorating a landmark: Never before in over 30 years of practice had an entire month passed in which I hadn’t written a prescription for an oral antihistamine. The OTC versions were good, and the new drugs weren’t so much better that they justified prescribing.

    When it comes to asthma, I believe in active intervention. The economics of good asthma care have proven themselves again and again. Want to do something for poor people with uncontrolled asthma? Pay for systematic care. Want to lower the nation’s emergency room bills? Help people control inflammation in their airways through daily use of medication and reducing exposure to triggers. Treating asthma symptoms, whether with Primatene or albuterol, is not asthma treatment, any more than a ride in an ambulance is health care.

    Dr. Paul Ehrlich is co-author with Dr. Larry Chiaramonte and Henry Ehrlich of Asthma Allergies Children: A Parent’s Guide (Third Avenue Books), available only from Amazon.com and from Barnes & Noble. He is co-founder of the website www.asthmaallergieschildren.com, and president of the New York Allergy and Asthma Society. He has been featured as one of the top pediatric allergy and immunology specialists in New York Magazine for the last 10 years.

    Photo by eo was taken: Asthma Map

  • Asthma: The Geography of Wheezing

    Are you familiar with the Hygiene Hypothesis? The HH — or, as some of us call it, the “pound of dirt theory” — is grabbing attention again. A minor medical press feeding frenzy followed the publication in the New England Journal of Medicine of a study based on data from Europe. The summary?

    “Children living on farms were exposed to a wider range of microbes than were children in the reference group, and this exposure explains a substantial fraction of the inverse relation between asthma and growing up on a farm.”

    This is the Hygiene Hypothesis incarnate. The HH posits that part of our immune system produces an antigen called IgE, which evolved to fight parasites in unhygienic conditions that have prevailed for most of human history, and since we are now cleaner, these antigens attack otherwise harmless proteins in some of us, making us sick, in the form of allergies. Instead of attacking, say, hookworms, the antigen goes after that just-chomped peanut butter sandwich.

    Proponents of the HH compare the prevalence of allergies in East and West Germany before and after unification. East Germany had more children growing up on farms and in larger families than West Germany, and much lower rates of allergies and asthma. Now, with its more westernized culture, East German rates of allergies and asthma have nearly caught up with West Germany.

    It makes a great story. The whole farm-city thing resonates deep in the American mind. It evokes the mythic hold that farm life has over our national psyche. Farms good; cities bad. Wholesome Jeffersonian America is good for our children not only morally, but physically. The implication is that if we all grew up on farms, asthma wouldn’t be at the epidemic levels we now have. The trouble is that in medical science there are too many variables to draw sweeping conclusions from one set of data, and anyone who would do so is not a serious scientist, or is driven by an agenda (or both).

    A case in point is a Forbes blogger who took a pot shot at mold-inspired litigation against landlords, interpreting the study to mean that mold is good for us. The Forbes blogger mentioned the case of Bianca Jagger, who sued her landlord about mold growing in her Park Avenue apartment. Erin Brockovich, Michael Jordan, and Ed McMahon are other celebrities who have coped with mold contamination, along with countless sufferers whose names are not familiar to us.

    Some mold is, undoubtedly, good. Without it, we wouldn’t have penicillin or blue cheese. But some mold can kill, particularly stachybotrys chartarum – a toxic black mold – which is often found in buildings with water damage. Other molds, while not immediately life threatening, are still potent allergens, including the ones you find in the woods behind the back 40, in Central Park, and in virtually any basement anywhere. In fairness, it’s not as easy for landlords to decide which molds to allow in their properties as it is, say, to choose between Stilton or Roquefort. As for that wet laundry you left in the washing machine for two days, it may not make you sneeze, let alone kill you, but it does stink.

    As objectionable as I find enlisting a specious inference in service of an ideological argument against the American tort bar, there are medical considerations to look at before we let the kids run barefoot through the barnyard as immunotherapy against asthma.

    First, these were European farms under study. The European farm population may or may not be a fairly homogeneous group compared to city dwellers, and genetics make a large difference in who develops asthma. It stands to reason that generations of working the family farm may have bred a hearty cohort of kids who can breathe the local air without wheezing.

    Second, there may be something about European farming practices that makes their farm/city dynamic different from ours. European farms are regulated very differently from our own, in part because of the health fears of the European commissioners. For example, genetically modified food is much more tightly restricted in Europe, if it is legal at all. This means that Europeans use different fertilizers and pesticides than the ones we use here, which undoubtedly affects the rural health picture.

    And European farm asthma may just be lagging behind ours. Typical farms are rampant with chemicals. Add to that the effects of weather on the pollen count and the aromatic plumes from manure lagoons, and no wonder rural America is suffering from an asthma epidemic that rivals the one we’re seeing in urban America.

    CDC researcher Dr. Teresa Morrison, medical epidemiologist in the Air Pollution and Respiratory Health Branch, was lead author of an article in the Journal of Asthma which concluded that “Asthma prevalence is as high in rural as in urban areas.” The goal of their research is “… to document patterns of asthma symptoms among rural residents in Midwestern states, and learn more about possible environmental exposures that potentially lead to asthma attacks.”

    David Van Sickle, who has worked with Morrison, holds a doctorate from the University of Wisconsin, and is founder of a Madison-based company called Reciprocal Sciences. In a guest editorial for www.asthmaallergieschildren.com in November, he wrote that studies of farm workers in California showed that exposures to agricultural dusts were associated with the development of persistent wheeze, exposure to pesticides was associated with the development of asthma in women, and that community exposures to airborne waste from large scale animal agriculture might also be associated with exacerbations of asthma. As he also pointed out, this may have remained hidden because it’s hard to study, but that is changing, in no small part because Van Sickle has developed an iPhone app called Asthmopolis, which can transmit information to doctors every time the patient—say a farmer—toots on his inhaler.

    No one who has studied immunology, as I have, can ignore the contribution farms have made to the treatment of the human immune system. As every biology student should know, vaccination began because Edward Jenner noticed that milk maids exposed to cow pox gained immunity from small pox. I have my doubts that a similar benefit can be derived with asthma.

    The country — where the air is full of all kinds of pollen and chemicals — is probably not the ideal choice for a Fresh Air Fund-style migration of wheezing children. But who knows? Maybe some of those farm microbes do have a salutary effect on kids’ immune systems. I wouldn’t recommend sending the kids to the city, either (check out some of the reasons a Bronx neighborhood has the nation’s highest asthma rates). If I sound equivocal, it’s because I am. Maybe sneezing, wheezing, and itching are the price we — that’s an urban and rural “us” — pay for “progress.”

    Dr. Paul Ehrlich is co-author with Dr. Larry Chiaramonte and Henry Ehrlich of Asthma Allergies Children: A Parent’s Guide (Third Avenue Books), available only from Amazon.com and from Barnes & Noble. He is co-founder of asthmaallergieschildren. He is a fellow of the American Academy of Pediatrics, the American Academy of Allergy, Asthma & Immunology, and the American College of Allergy, Asthma & Immunology, as well as a clinical assistant professor of pediatrics at New York University School of Medicine, and an attending physician at Beth Israel Medical Center and at the New York Eye & Ear Infirmary. He has been featured as one of the top pediatric allergy and immunology specialists in New York Magazine for the last 10 years and counting.

    Photo by Nathan T. Baker: “I might have to get a cooler style for this asthma inhaler.”