On Yaz, Bayer Believes "a Multiple of a Rare Event Is Still a Rare Event"

The mainstream media has finally woken up to Bayer's problems on its Yaz contraceptive brands. The New York Times published a story over the weekend about the 74 lawsuits against the company alleging that the pills cause potentially fatal embolisms in users. A close look at recent events at Bayer indicate that the company seems to see the world one way, even though everyone else sees it another.

BNET readers have known since June that Yaz was the focus of concerns that it causes more blood clots in users than older safer pills. Reuters reported another death Friday.

There are three quotes in the Times piece that crystallize what's going on with Bayer and Yaz. The first is from Dr. David A. Grimes, a professor of obstetrics and gynecology at the University of North Carolina medical school, and a paid consultant to Bayer:

My dictum is that a multiple of a rare event is still a rare event.
The second is from Dr. Frits R. Rosendaal, a professor of clinical epidemiology at Leiden University Medical Center and an author of a study that noted increased risk with Yaz:
Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?
The third came from Michael A. Santoro, an associate professor at the Rutgers Business School:
It tells me ... that it [Bayer] is not understanding the business that it is in, that it is not understanding the health risks that it is posing to the public or the financial risk that it is creating for its shareholders.
Note that Grimes and Rosendaal's worldviews cannot be reconciled. A "multiple of a rare event" may indeed remain rare -- until the point that the multiples are so high that they're no longer rare. Either clots are so rare as to be nonsignificant, or there are measurable risks for each brand (and in this scenario Yaz is more risky than others). How Bayer understands these risks, as Santoro put it, will be a key issue in the upcoming litigation.

Also on display in those trials will be manufacturing standards at the Bayer plant that makes the ingredients of Yaz. The FDA cited Bayer back in August for a German factory that did not meet FDA standards. It's worth a read because this theme -- that Bayer "understands" the Yaz universe one way, while everyone else sees it another -- came up again in the FDA's assessment. Basically, the FDA failed the factory twice because it found Bayer using the wrong tests to measure standards. The company was averaging the results of multiple tests -- some of which were graded "out of specification" -- because the average produced a passing grade even though individual results within that average indicated failing grades. (Emphasis added):

We disagree with your rationale and conclusion. An assay test is used to determine potency, not method variability. The validation of your analytical method should address robustness or variability, while system suitability is designed to address instrument variation performance, which was met in each of these instances. We believe that these results were true ODS values and that these batches should not have been released for distribution.

Your firm prepares two to three separate samples, which are assayed individually. We expect you to treat each of these results independently, and not to average an OOS result with a passing individual result. The hiding of an OOS result in the average is an unacceptable practice.

It looks complicated, but the takeaway here is that the FDA is literally accusing Bayer of manipulating its statistics in order to hide problems at its factory. Some of those problems are complicated (such as the measurement of test results, above) and some are simple: The equipment that makes ethinylestradiol was dirty even though a Bayer inspector had labeled it clean.

This is why Bayer's history on Yaz is so worrying. It appears that the company sees no risk where others see more risk; that it sees passing grades where others see failing grades; and that it sees clean equipment where others see dirty equipment.

Time will tell whose worldview is more accurate.