A new post by an apparently well-informed Pfizer drug sales rep seems to lend credibility to a report last July that the Exubera insulin inhaler had some quality control issues.

The disturbing revelation on Cafe Pharma’s drug sales team message boards is that one reason for the diabetes drug’s delayed launch was that:

[Pfizer] recall[ed] the inhalers because they aren’t working right.

That’s exactly what another apparent Pfizer sales rep. suggested on the message board last July 25th, shortly after the drug company’s sales reps had a national sales meeting on how to pitch the drug.

The anonymous post cited two reasons for Exubera’s delayed launch. Each one sounded like a serious safety risk:

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

Were there genuine quality control issues with the Exubera inhaler and the drug’s insulin blisters?
These sound like important safety reasons for why Pfizer may have delayed Exubera sales from last summer to January 2007.

The FDA just issued an important recall notice and safety alert for diabetics using Lifescan, Inc.’s One Touch blood glucose test strips. Lifescan is owned by Johnson & Johnson (NYSE:JNJ).

Although this information is unrelated to Pfizer’s Exubera inhaled insulin, this blog believes this recall notice is too important for our readers to miss. Why? According to the FDA:

The counterfeit test strips potentially could give incorrect blood glucose values–either too high or too low–which might result in a patient taking either too much or too little insulin and lead to serious injury or death.

Identifying the Counterfeit One Touch Blood Glucose Test Strips

Diabetics who use One Touch glucose strips need to check the lot numbers and packaging of their supplies. The FDA says that the ounterfeit test strips are:

• One Touch Basic®/Profile® (lot #272894A, 2619932, 2606340, and 2615211 (new)) test strips; and,
• One Touch Ultra® (lot #2691191 and 2691261 (new)) test strips.

According to the FDA, the following characteristics may help to identify the counterfeit test strips:

Counterfeit One Touch Basic/Profile Test Strips, lot numbers 272894A, 2619932, and 2606340

• The lot number 272894A, 2619932, or 2606340 appears on the outer carton and on the inner container (vial).
• The outer carton is written in multiple languages including English, Greek and Portuguese.
• The outer carton is labeled as 50-Count One Touch (Basic/Profile) Test Strip packages
• The bottom of the outer carton does not include an NDC number.

Counterfeit One Touch Basic/Profile Test Strips, lot number 2615211

• The lot number 2615211 appears on the outer carton and on the inner container (vial).
• The outer carton is written in English.
• The outer carton is labeled as 50-Count One Touch (Basic/Profile) Test Strip packages.
• A picture of a hand appears on the test strip displayed on the outer carton.
• The inner container is labeled as “plasma-calibrated”.

Counterfeit One Touch Ultra Test Strips, lot numbers 2691191 and 2691261

• The lot number 2691191 or 2691261 appears on the outer carton and on the inner container (vial).
• The outer carton and the inside container (vial) are written in both English and French.
• The outer carton is labeled as 50-Count One Touch Ultra Test Strip packages.
• The bottom of the outer carton does not include an NDC number.

You can get more information from Lifescan’s website here:

http://www.lifescan.com/company/about/press/counterfeit/

You can also:

1. Contact Lifescan at 1-800-227-8862 to speak to a representative
2. E-mail Lifescan at: CustomerService@lifescan.com,
3. Call the FDA’s MedWatch program; or
4. Call the FDA at: 1-800-FDA-1088

Remedies for Diabetics and Lost Opportunities for Lifescan

Will Lifescan replace any counterfeit One Touch blood sugar test strips with new ones? Nope. Here’s what the company had to say about that subject:

Please be aware that LifeScan will not issue credit for counterfeit products. For restitution, you will need to contact your original source of supply for these test strips.

While counterfeiting is a huge crime (think about all those bootlet DVDs, Gucci bags, and fake Viagra), this blog thinks that Lifescan is passing up a huge marketing opportunity to make a bad situation for diabetics better.

Lifescan makes money on the blood glucose strips. They pretty much give the meters away just so that diabetics can become dependent on One Touch strips.

Think about how much new revenue they could make by replacing counterfeit strips with legitimate ones, and then using that as a marketing vehicle to let diabetics know how they can purchase legitimate One Touch strips directly from the manufacturer and authorized dealers.