Markets

Oops! We Forgot to Mention 3,500 Customers Died Using Our Product ...

By Jim Edwards

Updated on: October 6, 2010 / 3:30 PM EDT / MoneyWatch

An FDA warning letter that states Actelion Pharmaceuticals (ATLN.VX) neglected to report the deaths of more than 3,500 patients on two of its drugs for pulmonary arterial hypertension underlines that sometimes drug companies cannot be trusted to handle important patient data properly.

This exact issue -- what counts as a "significant" adverse event report for a drug, and whether companies have duty to disclose them -- will be argued in front of the U.S. Supreme Court soon. Virtually all of the issues in that case (Matrixx v. Siracusano) are writ large in the FDA's Actelion letter. Actelion makes two drugs for PAH, Tracleer and Ventavis. The FDA said:

... at the time of the investigation, over 3,500 reports of death of Tracleer and Ventavis patients had not been sent to the Agency as individual case reports. At least 3,427 of registered Tracleer patient deaths and 118 of Ventavis patient deaths have not been determined by the patient's prescriber or healthcare provider (or by other specific information about the death) to be non-attributable to the drugs, thus creating a reasonable possibility that the drugs caused the deaths.

Actelion was sitting on the reports because it believed the deaths were not significant, given the overall rate of death in patients with PAH. Death occurs frequently among patients who have PAH, which is continuous high blood pressure in the artery that carries blood from the heart to the lungs.

The FDA disagreed with Actelion's definition of "significant," which the company reached after assuming that the 3 percent of doctors who did not respond to its monitoring efforts didn't bother because they weren't alarmed:

Moreover, we do not agree that a determination of a relationship between TracleerÂ® use and death by 3% percent of healthcare providers who did respond to Actelion is insignificant or suggestive that those healthcare providers who did not respond to Actelion did not also believe there was such a relationship in the individual cases about which they were being asked.

The rules require Actelion to record and report deaths when:

...based either on information received or a lack of information to suggest otherwise, there is a "reasonable possibility" that the drug caused the death.

It is not that Actelion is responsible for these deaths. If you have PAH, you're very, very sick. Rather, it's that trustworthy decisions about what's significant about patient deaths can only be made by independent observers of the data, in this case the FDA and the researchers who mine its data. We don't know that Actelion's drugs are innocent because Actelion hid the data. Similarly, we can't yet say that Tracleer and Ventavis are unusually dangerous for the same reason.

Lesson: Failure to open the kimino will lead to credibility problems down the road.

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Image by Flickr user Qole Pejorian, CC.