Are You Using Hospira Humalog® Without Knowing It?

On Monday, I posted that some brand-name insulin manufacturers have been deceiving patients by slapping their brand-names on insulin made by third-party manufacturers. Since 2003 at least, Lilly has had FDA approval to sell Humulin® R (and apparently, Humalog®, too) made by Hospira, Inc.'s "One 2 One Contract Manufacturing Services" (known previously as Abbott Laboratories' One2One Global Pharmaceutical Services which was spun-off as an independent company in 2004).

Do you know this company? Well, if you use Eli Lilly and Company's Humulin R or Humalog, perhaps you should. The fact is that Lilly has been contracting the manufacture of vials of Humulin R and Humalog to Hospira, Inc. (which is headquartered in Lake Forest, IL), but has an FDA-approved manufacturing plant for protein in McPherson, KS. If you don't believe me, try reading what's printed on the insert in your next package of insulin. Below, I have included a relevant excerpt from the current, FDA-mandated vial insert for Humalog, taken directly from Lilly's website which highlights the third-party manufacturing relationship:



Perhaps the packages should also be updated (I took some Photoshop liberty on a package for Humulin R here):



Of course, this does explain how Lilly was able to shelve plans last year for a new insulin manufacturing plant in Manassas, Virginia. Apparently, it's far cheaper and easier to let someone else make it, and simply slap their label on the product. But a commenter suggested that brand-name manufacturers had higher standards than generics companies.

Gimme a break.

When it comes to recombinant DNA manufacturing, the FDA has outlined standards that all companies must follow, generic or brand-name alike. But thanks to lobbying from the brand-name insulin manufacturers, quality controls are strictly voluntary, not mandated by the FDA, according to a 1998 change in policy entitled "Removal of Regulations Regarding Certification of Drugs Composed Wh..." which effectively exempts synthetic insulin manufacturers from batch testing -- the sort which vaccine manufacturers are obliged by FDA policy (and U.S. law) to conduct at regular, periodic intervals. (Note: the FDA's "Good Manufacturing Practices" still apply, but are so general they also govern the manufacture of Band-Aids) Insulin manufacturers may indeed do this batch testing voluntarily, but why isn't this mandated policy, or more specifically, if it's so important to patient safety for vaccines and other biopharmaceuticals, why was the rule discontinued for insulin?

I responded to the comment by noting that although Lilly is presently approved to sell Hospira insulin made in Kansas, there is no reason why the company cannot contract with another manufacturer. According to FDA documents, India's Biocon, Ltd. has had the FDA seal of approval since January 27, 2004 to manufacture human insulin in bulk at the company's facility in Bangalore. In addition, since February 5, 2001, another company based in the Netherlands known as Organon BioSciences, NV, which as of November 19, 2007, is now part of the American pharmaceutical company Schering-Plough. Shering-Plough also owns Diosynth, another large bulk insulin supplier also based in the Netherlands. Schering-Plough was recently implicated for holding back information about the pivotal, failed clinical trial called Enhance which compared Vytorin (a combination of Zetia and Zocor) with Zocor alone and showed no difference. The company's president, Carrie Cox, is now being investigated for insider trading of stock options by selling her stock before the study results were released to investors. Once again, big pharma and ethics displayed at its finest!

A fair number of people I've met on various diabetes social networks and message boards feel adamantly that drugs coming from India are inherently lower quality. Initially, I shared these concerns, but today, I'm no longer so sure. With the outright deception and greed that has been going on in big pharma, and the clearly unethical management such as at Schering-Plough and others, it makes me honestly wonder if outsourcing to an Indian company is really any worse? I'm starting to think otherwise! After all, Indian companies already have a significantly lower-cost of scientists, manufacturing and intellectual capital, so they have nothing to gain by delivering a low-quality product. In fact, they are trying to establish themselves as viable, global players, so they may be more likely than the big guys to adhere to the letter of the regulations, while big pharma routinely tries to weasel their way out of them with lobbyists and other shady maneuvers. Think about that!

Link to this original post:
http://sstrumello.blogspot.com/2008/02/big-pharma-deception.html