Wednesday, March 26, 2008

Memes and the Business of Diabetes

Beth tagged me for yet another meme, but since I was tied up with work stuff earlier this week, I'm only now getting around to responding. I must admit that these things drive me crazy, and this one is harder than usual, but here it goes:

Six Word Memoir Rules:

1. Write your own 6 word memoir
2. Post it on your blog and include a visual illustration if you'd like
3. Link to the person that tagged you in your post and to this original post if possible so we can track it as it travels across the blogosphere
4. Tag 5 more blogs with links
5. And don't forget to leave a comment on the tagged blogs with an invitation to play!

And my answer, which is really just 6 words than describe my mood and/or thoughts at the moment:

Introspective, curious, investigative, progressive yet reserved.

OK, since most of the Diabetes OC has already been tagged, let me just extend the invitation to anyone who wants to participate.

The Business of Diabetes

Now, onto the business of diabetes. First, Eli Lilly & Co. and the state of Alaska announced early Wednesday a $15 million settlement for a lawsuit brought by the state against the company over the marketing of its Zyprexa drug. Eli Lilly was sued by Alaska and at least 9 other states for illegally marketing Zyprexa for unapproved uses and concealing the drug's side effects, one of which is that the drug leads to obesity and has been responsible for causing type 2 diabetes in patients who use it.

There is a growing body of evidence to support this claim. Recently, researchers from the University of Alberta's School of Public Health in Canada published in Diabetes Research & Clinical Practice after studying the medical history of 2,400 people who were diagnosed with depression and were also taking antidepressants and found that the risk of diabetes almost doubled for patients who were using two types of therapies at the same time, tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). The lawsuits, however, do not focus on the link between the medicines and diabetes, rather they argue that Lilly knowingly chose to promote the drug for off-label use, which is in violation of the drug's FDA-approved use.

The Indianapolis-based pharmaceutical company said that the Alaska settlement will include payment by Lilly of $15 million plus a term that will ensure that Alaska is treated as favorably as any other state that may settle with the company in the future over similar claims. But Lilly also said the settlement involves no admission of wrongdoing on the company's part.

"While we had a strong defense, we agreed with the State that the best result for everyone is an amicable resolution," Robert A. Armitage, Lilly's senior VP and general counsel said in a statement.

That's the real rub here. Apparently, the company was concerned that the Alaska case was not going the company's way, and since 9 other states are also suing the company over the very same issue, the company did not want Alaska to set a legal precedent which the other states could use in their own cases. Some of the other states suing the company are much larger states as far as population is concerned, so while the Alaska case does not set a legal precedent against the company, it also does not eliminate the legal liability for the company. But Lilly certainly does not have cash-flow problems, but whether the other states will be as quick to settle remains to be seen.

In other diabusiness news, it appears that Sanofi Aventis was pretty close to buying one of the last few independent insulin producers late last year: Argentina's Laboratorios Beta. The deal was announced in October 2007, which did not sit well with the locals for several reasons. First, Beta controls 48% of the local market. Second, although multinationals including Eli Lilly, Novo Nordisk and Sanofi Aventis sell insulin in Argentina, those same companies virtually abandoned the country during the currency crisis that occurred in the 1990's, forcing many people with diabetes to pay a king's ransom just for insulin. Fortunately, Brazil's Biobrás was able to sell affordable insulin in that market until local entrepreneurs expanded Laboratorios Beta to include insulin production during the early 1990's.

In 2004, Novo Nordisk acquired Biobrás, which became the company's largest manufacturing facility in North or South America. Subsequently, the company has worked to migrate patients to more expensive, patent-protected insulin analogs and costly pen devices. Needless to say, prices increased.

Sanofi Aventis dropped its plans to acquire Laboratorios Beta in December, apparently because of the difficulty in getting regulatory approval, complaints from doctor groups, and also because many of the company's own shareholders are complaining that the company has yet to even digest the acquisitions its already made. Apparently, the integration of Sanofi-Synthélabo and Aventis has (so far) been in name only.

It's never a dull day in the business of diabetes, is it? I'm there is much more to come, but these were a few noteworthy or late-breaking news items worth reporting. No doubt, there will be more to come!

3 comments:

Jenny said...

Scott,

Fifteen mil? That's a parking ticket when you look at Lilly's bottom line.

How many millions did they earn from the off-label prescribing each year?

How many of the people they GAVE diabetes to are now buying Byetta and Humalog from them?

Companies do this kind of thing because they know they will earn far more from this kind of practice than they will ever have to pay in fines.

And knowing they are ruining people's health.

Scott said...

I certainly agree, which is why the Alaska settlement is troubling. This is why it is urgent we do not allow the FDA to loosen its restrictions on off-label marketing. There's still time to respond -- see here for details on that. The scary part is the bigger issue, which is that this move solidifies what critics like Dr. Sidney M. Wolfe, the Director of the Public Citizen Health Research Group in Washington, DC have been saying for some time: that the FDA now sees itself as serving the pharmaceutical industry, not as servants there to protect the public health.

Anonymous said...

Perhaps letters to our Senators & Representative are in order, demanding that they more carefully monitor the FDA . . . and if the mission of the agency is devolving into one of industry advocacy & propaganda dissemination--the agency should be terminated. As society has become more complex, perhaps we need a FOOD SAFETY Administration, a DRUG SAFETY Administration, and a Drug Approval/Evaluation Agency. Industry already has a loud voice in the form of well-paid lobbyists; our representatives must be encouraged to SPEAK FOR US.

--Melody