| "Primum non nocere", or "first do no harm", is the | | | | were long ago replaced by modern inhalers such as |
| physician's creed. On September 25th FDA held a | | | | albuterol precisely because they were more |
| workshop to discuss how to best to let consumers | | | | effective, more selective, longer acting and much |
| know that Primatene Mist inhalers were going to | | | | safer. Epinephrine was left on the OTC market |
| have a new environmentally friendly propellant before | | | | mostly because the government felt it was better to |
| 2012. Yet the real issue is why these products remain | | | | throw the poor a life preserver rather than nothing. |
| in the market at all. Decades-old government | | | | But that gesture is bad medicine. These patients |
| paternalism continues to put the nation's asthmatics | | | | need to be encouraged into the health care system |
| at risk by relegating those who are poor to reliance | | | | rather than left out on their own. Sale of epinephrine |
| on an old rescue drug in lieu of inviting them into | | | | inhalers does more harm than simply offering an |
| mainstream medical care. To begin with asthma is not | | | | outdated alternative, it can also: 1) keep the |
| an OTC condition: not truly self-diagnosable, not truly | | | | consumer outside of the medical system; 2) indirectly |
| self-treatable. On the contrary asthma is chronic, life | | | | deny consumers anti-inflammatory medicines; 3) |
| threatening, and debilitating at times; it demands | | | | expose vulnerable consumers to side effects such as |
| physician management. The OTC sale of outdated, | | | | cardiac arrhythmias; 4) increase ER visits and ER |
| poorly efficacious, and perhaps unsafe epinephrine | | | | dependency; and, 5) increase inhaler dependence. In a |
| bronchodilators, mostly used by the nation's inner city | | | | 1990's survey of consumers Whitehall-Robins |
| population, keeps those most in need outside the | | | | uncovered that about a fifth of users fit at least one |
| system. | | | | criterion for mild-to-moderate disease while 7% went |
| The intent of OTC drug regulation should not be to | | | | to the ER more than 4 times a month. Lastly, only |
| create a market for inferior care. The goal is to | | | | 37% claimed to also use Rx drugs leaving 63% reliant |
| create a free market in products a consumer can use | | | | on OTC inhalers. Clearly this promotes a double |
| largely for safe and effective symptomatic relief of | | | | standard in asthma care. OTC epinephrine inhalers |
| passing conditions. The axiom governing the OTC | | | | should be phased out not protected by FDA. |
| market is self-diagnosis followed by self-treatment. | | | | Here are two quasi-free-market solutions to |
| Asthma does not fit this paradigm. Nevertheless, FDA | | | | encourage OTC users to seek medical supervision: |
| stated "OTC asthma relief products are important to | | | | - Place epinephrine inhalers behind the counter; allow |
| the agency" according to The Tan Sheet (Sept 28, | | | | sale of one unit at a time. For every OTC purchase |
| 2009). Interested parties that oppose OTC sale | | | | through the pharmacist provide an Rx manufacturer's |
| include the American Lung Association. In 1999 the | | | | coupon for a free Rx inhaler(s) convertible with any |
| AMA recommended that FDA re-examine its policy. | | | | later doctor's prescription. Phase out epinephrine |
| The last FDA Advisory Panel review of the OTC | | | | inhalers after 3 years. |
| inhalers occurred in 1994 and resulted in a split vote | | | | - Place epinephrine inhalers behind the counter; allow |
| advocating stronger labeling not removal. | | | | sale of one unit at a time. Begin an FDA-initiated Rx |
| Asthma is fundamentally an inflammatory disease of | | | | OTC switch of albuterol brands to behind the counter |
| the airway. Its evolution can be subtle. its persistence | | | | while leaving a version Rx. The OTC version must be |
| long, and its outcome sometimes catastrophic. | | | | priced greater than the cost of the equivalent Rx |
| Endpoints used to follow its severity may include | | | | co-pay so as to switch the buyer to Rx treatments. |
| number of visits to the ER, frequency of inhaler use, | | | | Offer manufacturer's discount coupons (or trade in's) |
| objective measures of lung function, and mortality. | | | | to all OTC purchasers redeemable for the Rx version. |
| Clinical algorithms require practitioners to move | | | | Phase out epinephrine inhalers after 3 years. Continue |
| patients from casual symptomatic treatment with | | | | sale of higher-priced OTC albuterol inhalers as an |
| bronchodilators to treatments designed to attack the | | | | entry point into the health care system, or phase |
| underlying inflammation, or both, as their disease | | | | them out all together. |
| progresses. Monitoring progress is critical and can only | | | | Obviously there are issues to these concepts |
| really be done within the doctor's office or hospital. | | | | concerning the role of government and industry's |
| Since the disease definition, in part, depends on | | | | profit structure. The second scenario encourages Rx |
| evaluating airway function it is hardly self-diagnosable. | | | | brands to source volume from the OTC side to |
| Since current treatments include a range of drugs, all | | | | maintain or grow its Rx share. Differentiating OTC |
| of which are sold by prescription (with this one | | | | & Rx versions will require some creative thought |
| exception of epinephrine), it is hardly self-manageable. | | | | although the switch of Prilosec OTC suggests it is a |
| According to the label children over 4yro and | | | | solvable problem. |
| teenagers who suffer asthma are free to use | | | | Chronic disease management has perplexed OTC |
| Primatene Mist despite the fact that proper use of | | | | regulators for years. Perhaps the best case study is |
| inhalers requires instruction and epinephrine interacts | | | | P&G's switch of Prilosec that brought a modern, |
| with other drugs. Moreover, asthma itself can induce | | | | far superior treatment of an often chronic, yet more |
| clinical emergencies, such as status asthmaticus. | | | | benign, condition to the consumer marketplace. With |
| Superior technology has increasingly entered the OTC | | | | chronic conditions such as asthma the issue is never |
| market mostly via Rx products with sufficient prior | | | | the drug, it's managing the disease. Asthmatics |
| use that then supersede older OTC treatments. Yet | | | | deserve better. |
| older treatments, such as aspirin for pain, antacids for | | | | [Dr. Riker is a member of the American Academy of |
| reflux, coal tar for dandruff, diphenhydramine for | | | | Allergy, Asthma & Clinical Immunology, the |
| allergies often remain as competitors to these newer | | | | American Society of Pharmacology and Experimental |
| technologies. Nonetheless, in this case while | | | | Therapeutics, the American Society of Clinical |
| stand-alone epinephrine inhalers have been | | | | Pharmacology & Therapeutics, and the last VP |
| transcended by newer Rx technology this technology | | | | R&D & CSO at Chattem, an OTC product |
| has not yet entered the OTC market. | | | | manufacturer. At P&G Dr. |
| Epinephrine inhalers, a $31 MM business in the US, | | | | |