According to the Washington Post, Congress’s investigative agency will release a new report today that is highly critical of the U.S. Food and Drug Administration (’FDA’) for lacking “clear policies for addressing drug safety issues.” Today’s Wall Street Journal highlights the report’s conclusion that the FDA “lacks a clear and effective process for making decisions about, and providing management oversight of” drug safety following a medication’s FDA approval.

The report from the Governmental Accountability Office (’GAO’) was launched after the Vioxx safety debacle in 2004, when Merck pulled the prescription pain relief drug from the market after an increased risk for heart attacks and strokes was found for users of the chronic pain-relieveing drug.
What will this mean for Type I or Type II diabetics who start to use Exubera, Pfizer’s new FDA-approved inhaled insulin? Potentially, quite a lot.
The FDA’s January 27, 2006 approval of Exubera directed Pfizer to conduct a long-term study of 5,000 patients using the new inhaled insulin.  This request reportedly stems from a concern that no sufficiently long-term safety data exists for the drug that could affect a patient’s pulmonary function.  The drug was approved with a list of FDA warnings, including that diabetics who smoke and others at risk for impaired or decreased lung function cannot us the drug.  Signficantly, the FDA did not approve Exubera for use by children with diabetes drug, given safety concerns.

Recently, Exubera-Risks reported what it learned about the Breeze Study seeking to recruit Type II diabetics to participate in a 26-week study for:

“men and women ages 18-80 years old with Type 2 Diabetes to participate in an approximately 26 week research study which will assess the safety and effects of investigational inhaled insulin (Exubera®) on your blood sugar control if you are already taking 2 or more oral medications.”

Will a 26-week study be sufficiently long to assess the drug’s long-term safety? That is a question one wonders whether the FDA and Pfizer have asked and answered.

One of the top diabetes research and advocacy organizations, the Juvenile Diabetes Resarch Foundation (’JDRF’) expressed a note of caution after the FDA’s January 27, 2006 approval of Exubera inhaled insulin:

Exubera was not tested in children and has not been approved for use in children. Finally, there are a number of safety concerns raised during the review process that are still being addressed.

This position is significant. When a well-respected diabetes organization like the JDRF expresses caution about a new diabetes drug, it’s important to hear what the group has to say.

The JDRF emphasized that any exuberance over Exubera “should be tempered with caution,” since it will not replace the need Type 1 diabetics have for daily background injections of long-acting basal insulin. as these concerns are addressed.

A special word of thanks to Scott Strumello for alerting diabetics to the JDRF’s concerns in this post in his blog.

A San Francisco CBS-affiliated television station admitted that its own Emmy-nominated reporter Thuy Vu violated KPIX CBS-5’s own policy and the F.C.C. rules by failing to disclose that her January 27, 2006 broadcast about FDA approval of Exubera inhaled insulin was not all reporting. Instead, the report blended roughly one-half of a Pfizer video news release that was nothing more than a press release spun by Pfizer on the drug’s new approval.

According to the San Francisco Weekly’s Ryan Blitstein (”Irrational Exubera“), the F.C.C. frowns upon the practice because it can deceive viewers about the true source of the information:

Corporations and government agencies have long used video news releases (VNRs) — essentially live-action press releases — to transmit their version of the news to the public. The FCC considers the practice legal as long as the source of the content is disclosed, but it’s ethically hazy.

KPIX rarely includes footage from VNRs in its stories, according to spokesperson Akilah Monifah, and only makes exceptions when “the footage is for background in a story, and it’s footage that we did not possess.” Station policy is to attribute the source of that footage.

In the Exubera report, that didn’t happen. Vu blended her own reporting and interviews at Nektar with product demos, graphics, and even an interview with a “patient” from the MultiVu release. Yet it seemed to viewers as if everything in the segment was produced by KPIX.

Shockingly, Blittstein noted that the reporter edited out nearly 80% of Pfizer’s mention of adverse side effects and risks that Exubera could have for some diabetics. Instead of leaving the full 38 second discussion of these risks intact, she devoted only eight-seconds to Exubera’s potential health risks for diabetics.

This blending of Pfizer’s Exubera press release and the KPIX reporter’s piece on Exubera was first disclosed by the folks at the Center for Media and Democracy, a media watchdog.

A new report, according to today’s Washington Post suggests that gains from inhaled insulin Exubera’s approval were probably driven more by biotech company Nektar, the developer of the airbone drug-delivery system, than by pharmaceutical giant Pfizer that will market the drug after it’s January 2006 FDA approval.

The report, Beyond Borders: The Global Biotechnology Report, was prepared by the consulting firm Ernst & Young.

A key question, however, remains who will bear the risk if there are complications suffered by Type 1 or Type 2 diabetics who use the drug to treat their chronic disease.  From a marketing perspective, it would appear that Pfizer would stand to suffer more if complications were found amongst Exubera users down the road.

Ongoing monitoring by the FDA and EU of any potentially adverse reactions to the drug, reports by endocrinologists and other physicians prescriping Exubera to their patients, and long-term studies could shed light on these questions.

The University of Alabama at Birmingham is seeking people with Type 2 diabetes to participate in a 6-month study of ’safety risks and effects’ of using Exubera inhaled insulin to regulate their blood sugar:

We are looking for men and women ages 18-80 years old with Type 2 Diabetes to participate in an approximately 26 week research study which will assess the safety and effects of investigational inhaled insulin (Exubera®) on your blood sugar control if you are already taking 2 or more oral medications.

More information about this study can be found by contacting Fernando Ovalle or Marianne Vetrano at the University of Alabama at Birmingham, 510 20th St. South, FOT 702, Birmingham, AL 35294, Tel: 205-934-4112.

The real question, however, is where the funding and sponsorship for this study, and others like it, comes from.

This Exubera study appears to be one of many across the U.S. tagged as the “Breeze Study.” The website set up to recruit Type 2 diabetics into being part of this study was created by PraxisDirect, a company that bills itself as “a full-service patient recruitment company” whose clients include pharmaceutical companies looking to get patients to test their drugs.

The language used in the Breeze Study website tries to scare diabetics into thinking that taking injectable insulin a such a horrific experience in taking care of their disease:

Insulin shots, while proven effective in controlling the disease, are often an unwanted treatment option by people with diabetes. In fact, mealtime shots can even be viewed as the worst side effect of diabetes [Emphasis added]. However, right now research is underway to help develop a new investigational treatment for type 2 diabetes — an inhaled insulin. And you may be able to help. To find out if you may qualify, click the link below to find a participating physician near you.

Given that that the marketing language of the website tries to recruit patients for the study as part of a “new investigational treatment for type 2 diabetes - an inhaled insulin,” it appears to be part of a study funded Pfizer before the FDA announced it’s January 2006 approval of Exubera inhaled insulin.

What is significant is that the University of Alabama study specifically states that it is looking for Type 2 diabetics to volunteer themselves to “assess the safety and effects of investigational inhaled insulin (Exubera®).”