A recent article by New York Times reporter Stephanie Sual highlights a widely known practice by drug reps, including Pfizer’s sales team: giving doctors free breakfasts and/or lunches to get them to ‘write scrip’ for a pharmaceutical company’s drugs.

Pfizer’s sales team is probably trying to push initial sales of Exubera this way during the next three months, following the announcement last week of the inhaled insulin’s market push-back to September 2006.
One alleged Pfizer rep described the drugmaker’s initial strategy for getting docs to write scrip for Exubera as a:

Phased launch with initial focus only on key high prescribing physicians for early experience. Additional physicians added throughout the year with complete launch mode beginning in 2007  (Source: Cafe Pharma message boards)

Take, for example, the Exubera scrip that doctors at North Shore Diabetes and Endocrine Associates are likely to write for their patients.  This New York practice on Long Island
has 7 full-time endocrinologists, a host of other doctors, diabetes educators, and other medical professionals.  They claim to see some 15,000 patients a year (not all of whom are diabetics).  Imagine the volume of scrip that these endocrinologists write for their diabetics!

Would it surprise you to learn that the NSDEA either already has or will participate in Exubera clinical research studies?

Will Pfizer lunches get these suburban New York doctors to be ‘key high presribing physicians’ for Exubera?  My guess is that they probably won’t hurt.

One supposedly anonymous Pfizer sales rep disclosed two (2) apparent big reasons behind the drug company’s 3-month delay for bringing Exubera inhaled insulin to market. If true, they sound like genuine quality control issues with the inhaled insulin.

Each problem sounds like a serious safety risk:

“[There are p]roblem[s] with high quality control failure in the inhaler and issues with 1 mg blisters.”

When added to the list of the insulin’s currently known and suspected dangers, the reasons cited by the poster on Cafe Pharma’s message boards seem like major drug quality control problems.

Some of Pfizer’s Exubera drug sales reps cite an inherent contradiction they face selling the drugmaker’s inhaled insulin in the South.

On the one hand, a southern sales rep says that in his/her region, “[e]veryone is a diabetic, everyone needs insulin, so our quotas will be thru [sic] the roof.”

But according to the same rep, southern Exubera sales must be weighed against the fact that in North Carolina “everyone smokes! Are they really going to give up smoking just to take insulin??”
Uh, no!

According to a study done by Pfizer and Sanofi-Aventis (whose rights to the inhaled insulin Pfizer bought for ) the drug companies and FDA already know that smoking diabetics on Exubera put themselves at a huge risk for hypoglemcia. That’s because the study found inhaled insulin is far more concentrated in smokers’ blood than in non-smoking diabetics. Hypoglycemia, if untreated, can kill.

The Pfizer reps on Cafe Pharma’s message boards are keen to this problem. One rep asks:

“Are they really going to give up smoking just to take inusulin???”

That’s the same question asked by one U.K. nurse, representing the U.K. Association of Diabetes Nurses, in her comments to Britain’s health watchdog NICE about why England’s national heath service shouldn’t approve Exubera:

Smoking has been suggested as a contraindication for inhaled insulin. Significant numbers of people with diabetes smoke and some do not admit to smoking in routine consultations. This could cause problems as absorption has been shown to be faster in smokers. Similar concerns for people with asthma.

So there you have it: it appears that some Pfizer drug reps and diabetes professionals are keenly aware of the risk that smoking diabetics may try to lie in order to get a prescription for Exubera. That’s of little benefit if they end up killing themselves from hypoglycemia.
Another poster on the Pfizer Exubera sales team boards offers a candid agreement with the U.K. nurse, predicting that smoking diabetics will simply lie to their doctors in order to get the inhaled insulin:

Then they will get into all kinds of trouble with the product. Then the product will become “tainted” with issues and we will have another vioxx/zyprexa on our hands.

The product liablity lawyers are probably drooling over a potential for multi-million dollar verdicts if that turns out to be true.

A Pfizer spokeswoman disclosed that the cost of its Exubera inhaled insulin should be about $3.75 to $5 a day. But without more information, that cost estimate seems hard to decipher.

How would this estimate compare to the cost of a 10 ml vial of an injectable insulin analog, like Lilly’s Humalog, or NovoNordisk’s NovoLog? How much insulin does Pfizer estimate Type 1 and Type 2 diabetics would have to inhale to get that Exubera cost estimate? That’s unclear.
Exubera would seem to be more expensive when compared to buying a vial of Humalog. Walking into a U.S. pharmacy, you can buy a vial of Humalog for roughly $30.00. Then you need to estimate the number of units a diabetic would take each day before breakfast, lunch, and dinner, as well as an occasional bolus for being sick or to correct an unreasonably high blood sugar. For arguments sake, lets say that a diabetic would be taking anywhere between 30 - 45 units of Humalog a day, at 100units/1ml.

That means a diabetic would theoretically use up to one and a half (1 1/2) bottles of Humalog a month (1.5 x $30 per bottle = $45), and need roughly one (1) box of 100 insulin syringes a month to administer the dose. BD syringes can cost anyhere from $20 - $35 for a box of 100.

Anyway you inject it, that seems to be much cheaper than Exubera. That’s the conlusion that U.K.’s NICE committee of doctors, medical professionals, and health care policy analysts came up with when the decided against recommending Pfizer’s inhaled insulin for health insurance coverage under the Britain’s national health insurance program.

Apparently one Pfizer sales rep is being cautious about predicting sales of Exubera, the drugmaker’s new FDA-approved inhaled insulin.  “I don’t think we, or anyone else, can adequately gauge the level of the demand,” the rep said Saturday on CafePharma’s message boards. “It will be patient-driven.”

Tellingly, the drug rep predicts that if Pfizer “handle[s] it right (and future product improvements arrive before competitors) it could be a major blockbuster.”

Pfizer and Nektar announced last week that the insulin would not be available until September 2006. What could the drug salesperson be referring to when talking about ‘future product improvements?”  Could such improvements include improving pulmonary function?  Use by children and smokers?