Boehringer Ingelheim Supports Undocumented Immigrants & Sides with Latino TV vs. Donald Trump. Bravo!

Click on image for an enlarged, uglier view.

Two stories caught my attention yesterday:

One involved drug company Boehringer Ingelheim and Spanish-language television network Telemundo.

The other involved Donald Trump and another Spanish-language television network - Univision.

In the first case, a major (non-US) pharma company has the courage to support “illegal” Mexican immigrants and at the same time raise awareness of diabetes among the U.S. Latino public, whether they are illegal or not (read the press release here).

In the second case, Donald Trump evades questions about his Mexican deportation plans from Univision Spanish-language news anchor Jorge Ramos and kicks him out of a press conference with the words “Go Back To Univision” (read the story here).

How does Boehringer support “illegal” Mexicans in this country?

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Off-Label Uses Promoted in DTC Ads for Diabetes Drugs

Print and TV DTC ad for Farxiga
(click on image for an enlarged view)

Public Citizen, a consumer advocacy group with more than 350,000 members and supporters nationwide, sent FDA’s OPDP Director Tom Abrams a letter on March 31, 2015, urging him “to stop the apparently violative off-label promotional statements in the direct-to-consumer (DTC) advertisements of five prescription drugs approved for the treatment of Type 2 diabetes. The drugs are Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide) and Bydureon (extended-release eventide).”

Usually, pharmaceutical companies are accused of promoting drugs “off-label” to physicians, which is understandable because it is perfectly legal for physicians to prescribe drugs for so-called off-label use.

The FDA rarely cites off-label or “unapproved use” claims made in DTC ads. None of the letters issued by FDA in 2014 mentioned that violation. Historically (between 2004 and 2013), only 4% of violations cited in FDA letters were concerned with off-label/unapproved use promotion and no TV ad received such a letter (see here).

Public Citizen includes a Farxiga ad that “touts” weight loss and blood pressure reduction as potential benefits although the drug has not been approved for those indications (see the ad in the above figure; also included is a screen from the TV ad).

“These five drugs have been approved solely to lower hemoglobin A1C levels in patients with Type 2 diabetes,” says Public Citizen, “but the advertisements presented in this letter clearly convey the false perception to patients and doctors that the drugs have been deemed safe and effective for weight loss and/or reducing blood pressure.”

Public Citizen wonders if the FDA approved the ads and asks a couple of interesting questions in light of the recent paucity of warning letters issued by the FDA (read “Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions”).

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Look Ma! No Bong! Afrezza Inhaled Insulin Device is a Cool Gadget

UPDATE (1/5/2016): Sanofi terminated its license agreement related to the development and commercialisation of MannKind's inhaled insulin therapy Afrezza, MannKind said today (here). MannKind noted that the deal will be terminated no later than six months from the effective date of Sanofi's notice or July 4. MannKind added that it "is reviewing its strategic options for Afrezza as a result of the termination."

In the post below I noted the exuberance of the diabetes community for this device and I gave Sanofi kudos for engaging this community via social media. I guess not even the best efforts to mobilize patients via social media in support of a product is guaranteed to be successful.

Also, Sanofi attributed the lower-than-expected sales of Afrezza to the FDA's requirement that patients undergo lung tests before starting treatment and while using the therapy as well as the broader need to raise awareness about the product (see "Sales of Afrezza Inhaled Insulin Stymied by FDA Says Sanofi").

 ------------ORIGINAL POST FOLLOWS--------------

Sanofi and MannKind Corporation announced today that Afrezza® (insulin human) Inhalation Powder, the only inhaled insulin, is now available by prescription in U.S. retail pharmacies nationwide. Afrezza is approved by the U.S. Food and Drug Administration to control high blood sugar in adults with type 1 and type 2 diabetes.

Afrezza is a drug–device combination product that consists of a dry formulation of human insulin delivered from a small and portable inhaler to help patients achieve blood sugar control. Afrezza is rapidly absorbed and has a short duration of action. It is administered at the beginning of a meal.

This is a vast improvement over the Exubera "Bong" that Pfizer attempted to launch back in 2007. In June of that year, Amy Tenderich, author behind award-winning blog Diabetes Mine, wrote:

"Because for any PWD [person with diabetes] with an actual social life, Exubera inhaled insulin is looking like a bomb. As I told the reps at the ADA conference frankly, the science behind it IS revolutionary, and we PWDs are grateful for strides in alternative insulin delivery, of course! But the Exubera Inhaler Device really is as bad as it looks in pictures. Worse, because the bulky 'white' plastic portions are not white at all, but that hospital-grade biege that reminds you of walkers and bedpans. An aesthetic nightmare, in the age of cool gadgetry" (see "Are you happy to see me, or is that just your Exubera Bong?").

The Afrezza device is definitely a cool bit of gadgetry! This may be the first time that a drug/device was designed based on fostering relations with patients via social media, something that Pfizer may have learned too late. How so?

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