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Doctors Group Sues FDA, Saying|Drug Does More Harm Than Good

LOS ANGELES (CN) - A physicians group sued the U.S. FDA, seeking revocation of FDA approval of roflumilast, a drug used to treat chronic obstructive pulmonary disease.

The drug, whose trade name is Daliresp, may do more harm than good, Physicians for Integrity in Medical Research says in its federal complaint against Food and Drug Administration Commissioner Margaret Hamburg.

The FDA approved roflumilast on Feb. 28, 2011, to treat severe chronic COPD.

Roflumilast "does not work as stated" and "does more harm than good to patients with COPD," according to a petition the nonprofit group sent to the FDA in 2011, which is included as an exhibit to the lawsuit.

Patients with COPD suffer from cough, sputum and shortness of breath and may need to be treated with oral and inhaled medications, including steroids and theophylline. But because of its "low efficacy and high incidence of side effects," theophylline is not recommended unless other treatment options are not effective or available, according to the complaint.

Roflumilast works in a similar manner as theophylline: both have anti-inflammatory actions and a similar side effect profile, according to the complaint.

Despite their similarities, "there have been no clinical studies comparing roflumilast to theophylline. The clinical effects of roflumilast appear identical to those of theophylline except that roflumilast appears to have more frequent and more severe side effects than theophylline," according to the complaint.

Because "theophylline has already been discredited in the treatment of COPD, roflumilast has no place in treatment of COPD," the doctors say in the complaint.

Side effects include an increase in suicide, cancer and acute pancreatitis, among other things, the doctors say.

Clinical studies of roflumilast showed either no benefit or only a small but statistically significant benefit on moderately exacerbated COPD, and no benefit was seen for the rate of severe exacerbations or overall mortality. The best-case scenario showed that roflumilast reduced the number of exacerbations by one episode a year for every five patients treated, according to the physicians.

Furthermore, the drug was only compared to a placebo, and not to standard drug regime, so the clinical trials "do not replicate the way this drug will be used in practice," the doctors say.

An FDA Advisory Committee voted on April 7, 2010 that efficacy and safety data did not support the approval of roflumilast for maintenance treatment of COPD and the FDA denied approval on May 17, 2010. However, without any further clinical studies, the FDA approved the drug on Feb. 28, 2011 in an "arbitrary and capricious" decision, according to the complaint.

The physicians group filed a petition with the FDA requesting revocation of the approval, which the FDA rejected on Nov. 5, 2012, stating that the approval was based on a narrowed indication for the drug's use, provided by a new sponsor.

"FDA approved roflumilast because the sponsor demonstrated that it is safe and effective for its stated indication and met other requirements for approval," the FDA said in a letter to the physicians group, also attached as an exhibit.

The FDA stated that "the risk-benefit assessment of roflumilast favored approval" and that "roflumilast potentially benefits patients who have severe COPD associated with chronic bronchitis and a history of exacerbations by reducing the risk of exacerbations."

The physicians group responded to the FDA that the indication changes were "merely cosmetic and did not change the risk/benefit analysis of roflumilast."

The group told the FDA that, among other things, the regulator ignored the "statistically significant increase in incidents of prostate and lung cancer in patients taking roflumilast."

In studies, the drug also showed an "increase in suicides, acute pancreatitis, severe weight loss and gastroenteritis severe enough to require hospitalization. Each individual side effect was not statistically significant but all of them combined show a profound side-effect profile of roflumilast," according to the lawsuit.

The group asks the court to order the FDA to revoke its approval of roflumilast.

It is represented by Steve Gupta in La Canada.

The FDA did not immediately return a request for comment.

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