FDA's Asthma Drug Warning Comes After Complaints About Testing Facility

(MoneyWatch)  The FDA's new requirement for tighter warnings on a range of asthma drugs will not come as a surprise to Dr. Robert Davidson, a former asthma drug clinical trial researcher who has repeatedly alleged that asthma drugs tests at a facility he once worked at were riddled with patients who did not meet test criteria, unblinded results and unqualified staff.

In the FDA's new guidelines:

The FDA today asked makers of Singulair, Accolate, Zyflo, and Zyflo CR to include a precaution on those drugs' labels about reports of behavior and mood changes.

The AP added:

New labels on popular asthma drugs like Merck's Singulair must highlight language about suicidal behavior, depression and anxiety seen in a small number of patients, federal regulators said Friday.

Several of those drug names popped up in a recent expose of asthma drug testing by freelance journalist Martha Rosenberg. She wrote:

Trials of Singular, Serevent, Foradil, Flovent, Xolair, Accolate, and Xopenex conducted at the Tucson, Ariz., facility of Vivra Asthma & Allergy were corrupted by protocol violations and outright falsifications, says Robert Davidson, M.D., a former clinical research subinvestigator (SI) at the facility.

Two FDA "establishment inspection reports" in 1999 found a number of irregularities at Vivra. (Download the FDA reports on Vivra here.) In the reports, Rosenberg says:

Staff could be seen entering rooms where placebos and real drugs were mixed and unblinded, invalidating entire studies sent to the FDA as data for new drug applications.

The brazen "study buddy" and "crossover" arrangements, as staff referred to them, included churning or serially enrolling patients into clinical trials despite risks to their health and early terminations, coercing unwilling patients to participate, and directly falsifying patient study diaries, say documents filed by Davidson in a federal complaint.

"Three study coordinators stated that they saw diary card blank prior to subject entering exam room with PI for visit 2," reads a report from a May 5 though June 28, 1999, inspection obtained under the Freedom of Information Act. "Five to ten minutes after, the diary had approximately two weeks of diary symptoms and peak flow entered."

At one point, the FDA reported, a majority of the Vivra staff signed a note complaining about "pre-screens done by front office, patients with questionable qualifying criteria being randomized anyway," and lack of informed consent by patients.

Vivra no longer exists, having long ago been taken over by Gambro in 1997, and later El Segundo, Calif.-based DaVita in 2005. They did not respond to Rosenberg's request for comment.

Merck released this statement:

Merck is confident in the efficacy and safety of SINGULAIR, a medicine that has been prescribed to tens of millions of patients with asthma and allergic rhinitis since its approval more than 11 years ago.

The FDA's interest in suicide comes after a 15-year-old in Queensbury, N.Y., hanged himself after starting the drug.