Seroquel Documents: AZ Issues 2002 Warning In Japan, But Insists All Is Well In The US

Bloomberg reported yesterday that after being ordered to warn doctors in Japan about Seroquel in 2002, AstraZeneca continued to insist in the US market that there was no link to diabetes.

"The London-based drugmaker issued a letter to Japanese physicians in November 2002 that said AstraZeneca had received 12 reports that Seroquel users were diagnosed with high blood-sugar levels over a 21-month period, according to company documents unsealed last week in connection with litigation over the drug.

"'Since February 2001 when Seroquel started to be marketed [in Japan, US marketing began in 1997], 12 serious cases (including 1 death) of hyperglycaemia, diabetic ketoacidosis and diabetic coma where causality with the drug could not be ruled out have been reported,' AstraZeneca officials said in the letter."

And yet in 2005 company marketing officials continued to inform sales reps by company voice mail that weight gain on the drug was low and that there was no link to diabetes.

You can read the letter to doctors in Japan here. The voice mail in question can be read here.

This situation is similar to what I reported two years ago regarding Lilly and Zyprexa. In April 2002, Japanese regulators required Lilly to advise doctors in that country of diabetes, hyperglycemia and other issues connected to Zyprexa and yet, two months later, in June 2002, Lilly rolled out a Zyprexa marketing campaign aimed at PCPs. As Lilly noted in relation to the Japanese label change, "This does not change the status of Zyprexa as a safe, effective and cost effective agent in the US market."

In the Seroquel instance, AZ spokesman Tony Jewell told Bloomberg:

"'Every country has a different regulatory administration with different regulatory standards and requirements,' Tony Jewell, an AstraZeneca spokesman, said in an e-mailed statement. 'AstraZeneca marketing companies are required to comply with the rules and regulations of the regulatory authorities in the country in which they operate....'

"Jewell noted that under U.S. law, drug company salespeople are required to use information from 'the label approved by the FDA.' AstraZeneca officials contend that Seroquel’s warning label provided 'adequate and appropriate information' about possible diabetes-related side effects."

While I don't doubt Jewell on what the FDA requires, it's completely bizarre for a situation to exist where AZ (and Lilly) can act as if health effects experienced in other countries wouldn't have some applicability in the US. Human beings aren't that different.

Either way, this sort of arrangement deprives doctors and patients of appropriate information about the risks of taking a drug.

Maybe what ought to be required here is that the FDA change its regulations so that any company that is ordered to deliver a warning about a drug in country X would have to inform doctors and the public that they've had to issue a warning overseas. Hell, maybe the FDA could do something smart and realize that if there's a safety signal popping up in another country, then maybe it might apply in the US and the agency ought to look into the matter.

Crazy idea, I know.

As I noted yesterday, I'm still a couple of days out from writing much about the Seroquel documents because I took the drug, experienced problems on it, and would like to have some distance between my personal aggravations and the documents before holding forth more formally.