Friday, September 09, 2005

Just Ignore The Coughing, Listen For The Cha-Ching

Here's an interesting little case study in whose interests the media serve when they report on pharmaceutical developments.

Say you read CNN for news of a morning. Here's what CNN Health has to say about the endorsement by an FDA advisory panel of an inhalable form of insulin called Exubera, manufactured by Pfizer, Sanofi-Aventis and Nektar Therapeutics:
Federal health advisers on Thursday recommended government approval of the first inhaled form of insulin, offering some diabetics an alternative to many of their daily injections.

The recommendation by a Food and Drug Administration advisory panel came despite questions about use of the drug in people who have lung disease or were exposed to secondhand smoke.
During drug trials, researchers found that inhaled insulin was generally as effective as injections in controlling blood sugar levels. However, some patients who took inhaled insulin complained of coughing and a small decrease in breathing capacity.
OK, new drug, 'questions about [its] use' in people with compromised pulmonary health. 'Some patients' had a 'small decrease in breathing capacity'. Doesn't sound too bad. All drugs have limitations, right?

Now read MedPage Today, a news service targeted at health professionals, and you get a somewhat different story (free reg. required):
Exubera, an inhaled insulin, won endorsement today from an FDA advisory panel despite concerns about the agent's pulmonary toxicity.
Inhaled insulins have been in the works for more than a decade. In clinical trials they have been demonstrated to have efficacy similar to that of short-acting insulins, but without the needle stick required for subcutaneous injection. This for some patients is a barrier to better glucose control.

But a host of concerns regarding Exubera have cropped up, including worries about pulmonary toxicities, and questions about its ability to get glycosylated hemoglobin (HbA1c) levels -- a measure of glucose control over time -- down below 7%, the gold standard set by the landmark Diabetes Control and Complications Trial (DCCT).

At the 2005 meeting of the American Diabetes Association in San Diego last June, researchers from Quebec reported that in a 226-patient safety study, Exubera was associated with an early decline in pulmonary function that appears to peak by week two and then declines but doesn't completely disappear.

Additionally, use of the inhaled insulin was associated with a decline in carbon monoxide diffusing capacity, a measure of the ability of the lungs to deliver oxygen to the blood.
Also at the ADA, William Cefalu, M.D., of Louisiana State University in Baton Rouge presented results from three two-year studies of Exubera for treatment of type 2 diabetes. The investigators found that in the more than 500 Exubera-treated patients, there was a slight decrease in pulmonary function as measured by a drop in FEV1 of about 0.07%, and a similar decrease in oxygen exchange.
'A host of concerns'. 'Pulmonary toxicity'. That's hardly comparable to CNN Health's 'questions' about its use in a limited, compromised subpopulation. Even allowing for the scare-value of medical jargon, there's more cause for concern here than CNN allows when it obligingly translates for the lay reader.

On the other hand, say you get your morning news from CNN Money. You learn that '[a] panel of experts advising the FDA voted Thursday in favor of Exubera, the first form of inhalable insulin, a step that could lead to approval by the regulatory agency.' You get an enthusiastic quote from the Pfizer executive in charge of the drug development team, and a handy little primer on diabetes and how it's
seen as a promising area for the drug industry because it is so common in the United States and Europe. There are 18.2 million diabetics in America, including an estimated 5.2 million who have not been diagnosed yet, according to the American Diabetes Association.

An additional 1.3 million diabetics are diagnosed every year. And another 41 million Americans have "pre-diabetes," or high blood-sugar levels, and are at risk for developing adult onset type 2 diabetes. Type 2, sometimes coined "diabesity," is expected to become more prevalent among the aging baby boomer population.
Well, talk about turning misfortune into fortune. Nation getting fatter and sicker? Now that's what I call Opportunity!

Some excited hyping of the drug's profit potential:
Many analysts see Exubera as a potential blockbuster. Andrew Forman, analyst for WR Hambrecht, and David Steinberg of Deutsche Bank both project that Exubera sales will total $1 billion by 2008. Bernstein analysts project $1 billion by 2011. David Moskowitz of Friedman, Billings, Ramsey & Co. projects $1.3 billion by 2008.
But then, at last, a note of caution intrudes: 'But not everybody is bullish on Exubera.' Ah, here we go. Now we'll get the pulmonary toxicity results, right? Yeah, right.
Albert Rauch, analyst for A.G. Edwards, believes that Exubera won't be as convenient as some people believe and sales will be paltry, not even reaching $1 million.
Oh, heartbreaking. Less convenient than people believe! Paltry sales! Caveat investor, it would appear.

Just in case you had perhaps been lulled into thinking that the media exists to give you information that safeguards or benefits you. Caveat lector.

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