Hello everyone,
A drug that figured prominently in the up and down history of AstraZeneca’s Delaware operations was back in the news over the weekend.
The Washington Post (paywall) wrote a lengthy piece on Seroquel (Quetiapine) and the issue of off-label uses that can come with potentially serious side effects.
Seroquel was a mainstay at AZ ’s labs near Wilmington, gaining approval for treating schizophrenia, bipolar disorder, and major depressive disorder.
The issue of off-label use emerged with the rising use of what some viewed as a wonder drug for those coping with severe mental illness.
Thousands of lawsuits resulted. AZ went on to settle the suits without admitting liability. One agreement with the feds amounted to more than a half a billion dollars.
But as the Post noted, there are limits to the ability of regulators to govern uses of drugs. Physicians have a great deal of latitude in using drugs and salespeople have a right to free speech.
Seroquel went on to be used to help some people get a good night’s sleep or calm down people with anxiety attacks. The problem comes with side effects that can include weight gain and diabetes among other things.
Meanwhile, another Seroquel story was playing out that would have a big impact on the Delaware economy.
The drug was heading to the patent cliff, a period when generics jump in and drastically reduce prices and revenue.
An extended release version gave AstraZeneca some breathing room, but nonetheless, Seroquel sales plummeted from nearly $5 billion in 2009 to $332 million in 2017.
Long ago, research work was halted on neurological drugs that would replace Seroquel and that made the Delaware site expendable. The labs that at one point were working on a replacement for the drug were razed.
Other Delaware jobs were cut and AZ’s total employment, which once soared to around 4,000, is now down to 1,500 or less.
AstraZeneca, under new CEO Pascal Soriot, remains out of the mental health drug space and narrowed its focus to areas such as cancer and respiratory drugs.
Seroquel and its generic equivalents are still used, and one would guess the issue of off-label uses has not gone away.
Here’s to a good Monday. Our newsletter returns tomorrow. – Doug Rainey, publisher.
