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Ouch or Ouchless?

Apr 8, 2008

Exubera gets pulled from the market, Lilly discontinues AIR. Why is this happening. Why would patients want Ouch over Ouch less? Richard Dolinar, MD, Senior Fellow Healthcare Policy, Heartland Institute, thinks he knows what happened. Click here to find out what he figured out.

Richard O. Dolinar, MDOuch or Ouchless?

Richard Dolinar, MD, Senior Fellow  Healthcare Polic, Heartland Institute,

In Practice columnist discusses the patient preference of injectable over inhaled insulin.

Strange market forces must be at hand when a painless insulin product can make a multi-billion dollar pharmaceutical company say “ouch.” That is exactly what has happened with Exubera, an inhaled insulin product developed by Pfizer that was recently removed from the marketplace after roughly a year of dismal sales.

Who would have thought that injectable insulins would prevail over inhaled painless insulin? Do patients actually prefer “ouch” over “ahh?” Should other companies currently developing inhaled insulin products discontinue further development before they lose millions or even billions of dollars?

When it comes to market forces and human nature, history has shown that people prefer ease and convenience in the products they use. As consumers, they expect progress, improvements, the next best thing.

Consider the way we communicate.

We have Alexander Graham Bell to thank for the telephone — the wonderful invention that enabled us to establish immediate contact with another person regardless of the distance. True, sometimes you must dial other numbers to finally track someone down and both parties need to be on the phone at the same time to communicate unless they resort to playing phone tag. And, unless you tape record your conversations, you have no record of what the other person has said. Once you hang up, that conversation is gone.

Enter e-mail; we can type and send messages anytime, day or night, simply click and send. Miraculously, the message goes out into the world and finds the recipient. E-mails can be read by the recipient at a convenient time – perhaps while the sender sleeps three time zones away. E-mails leave a trail of information that can be reviewed at a later date or forwarded to a third party.

What would have happened if Bill Gates had been born before Alexander Graham Bell, and we had the internet and e-mails before the telephone? If people had grown up on e-mails, would they consider it to be worth the hassle to communicate verbally on the phone? Probably not. Consider teenagers today who text message on their phones rather than dialing and speaking to the other person directly.

What if, when insulin was first discovered, there was only an inhaled form? Then today, more than 80 years later, Pfizer introduces injectable insulin to the marketplace. How hard would it be to convince patients to switch from inhaling insulin to injecting it? Probably impossible. The reps would be laughed right out of the office, and the product would likely fail.

Yet, this was not the case with Exubera. Injectable insulin came first, and inhaled insulin certainly seems to be an improved product for those who use it. Why didn’t consumers embrace this more convenient, easier to use product?

Certainly, the timing of a product’s entry into the marketplace can be critical. More importantly, and quite often forgotten, is that it is the consumer who decides what to buy. The consumer, who is at the core of the marketplace, determines which products will be successful and which will not. Pfizer is facing this reality now as it takes a “$2.8 billion pretax hit on the product – one of the drug industry’s costliest failures ever.” (Johnson, Avery. “Insulin Fiasco Costs Pfizer $2.8 Billion”. Wall Street Journal; Oct. 19, 2007.) Exubera was launched in July 2006 and was gone by October 2007. General Motors is facing a similar problem and losing sales as consumers opt to buy cars produced by foreign competitors.

As large as these companies are, they do not have the power to force consumers to buy their products. It is the consumer who is supreme in the marketplace. In health care, however, the dynamics of the marketplace are more complicated because the consumer (the patient) and the payer (the insurance company or government) are separate. And sometimes, third party payers restrict access to drugs. Could the hurdles that third party payers placed in the way have caused the collapse of the market for this drug?

It’s possible other factors could have contributed to the demise of Exubera. Perhaps the drug failed because physicians were concerned about the potential effects of inhaled insulin on lung tissue. Pfizer monitored this very closely and found no significant adverse effects. Perhaps failure could be attributed to the need for patients to do pulmonary testing prior to initiation of therapy. However, in many offices the testing was done at the time initiation of therapy was considered. Some think the size of the device used to administer the inhaled insulin was excessively large. Yet when you compare it to the glucometers that first came out over 20 years ago the device was smaller and lighter than them.

There are a number of patients in my endocrine practice who absolutely refuse to take injections even though control of their diabetes has not been possible on oral agents. No matter how small and sharp the insulin needles are, no matter how much they have improved over the years, it is a pain some patients simply refuse to bear.

What really happened to cause Exubera’s demise? Only time will tell, after extensive research is done. Once identified, hopefully adjustments and modifications will be possible and inhaled or other types of painless insulins will enter the marketplace. I just hope it doesn’t take too long — especially for that small group of patients who, whenever they think of insulin, can only think “ouch!”

Richard Dolinar, MD, is a Senior Fellow in Healthcare Policy at the Heartland Institute, Chicago, a Clinical Endocrinologist in Private Practice, Phoenix, AZ, and is a member of the Endocrine Today Editorial Board.