With the costs of name-brand drugs rising exponentially over the past 20 years and higher premiums and co-pays, US citizens have, to a large extent, been able to count on lower-priced generics, which have always been assumed to be the same as their name-brand equivalents. This is not the case anymore as Teva Pharmaceuticals, based in Israel, has been swallowing up many of the leading generic drug manufactures over the past few years, making them the sole producer of many important generics that so many of us count on for a myriad of medical conditions. The fact that Teva is buying up the competition is not the focus here–though corporate monopolies are never good for consumers. It is the fact that so many of Teva’s generics are poorly produced in third-world countries and are not the same as their brand-name equivalents. While the chemical components of their drugs are the same, or bio-equivalent,  as the main chemical compound of the name-brand, it is the low-quality precursor chemicals, inferior manufacturing facilities and lack of production oversight that is causing adverse reactions in consumers that have begun taking generics produced under the Teva Umbrella.

Teva takes over

Teva was officially created in 1976 after the merger of three pharmaceutical companies created in Israel by European Immigrants. In 1982, the FDA approved its main manufacturing plant — and so began the path to market domination.

Teva is not solely interested in generics as they have produced some very effective and useful proprietary drugs such as Copaxone and Azilect. Despite their own research and development, Teva’s meteoric rise atop the pharmaceutical food chain has come through buying and merging with other large drug manufacturers. Most recently, the acquisition of Barr Pharmaceuticals in 2008 for over 7 billion dollars has further entrenched them in generic manufacturing.

Barr had been the largest generic manufacturer in the world when they were acquired by Teva. This, in and of itself, is not necessarily earth-shattering information — big company acquires other big company, making bigger company; the way of capitalism. The relevance of the Barr acquisition lies in the history of Barr–a history of corruption and inferior production standards. Teva, as far as pharmaceutical giants go, has typically been considered a quality developer and producer of proprietary drugs up until the past few years. It is their acquisitions over the past ten years — Barr in particular — and their quest to cheaply produce generics to make even more money that has brought their quality standards under scrutiny.

Lowering the Barr

Barr was an outsider looking in for many years, trying desperately to get FDA approval for its generics. But this quest was deterred by the FDA, who was approving generics and other drugs for the highest bidder.

The company earned notoriety during the late 1980s, when its founder testified before a congressional committee about bribes between generic drug producers and U.S. Food & Drug Administration officials. Funding Universe

This testimony would actually set Barr back a bit throughout the 80s and into the early 90s as the FDA, in possible retaliation, stonewalled the approval for many of Barr’s bio-equivalent manufacturing requests. This would change in the mid 90s when Barr became more aggressive in its approach. With a team of highly paid attorneys, Barr set out to find loopholes in the patents of many popular name-brand drugs. One of the more notable patent challenges came against Eli Lilly’s Prozac in 1996.

Challenging existing patents with a “dream team” of patent layers would become Barr’s main focus in the late 90s and throughout this decade. Considering Barr had smoothed over relations with the FDA in the 90s, getting bio-equivalency approval after winning patent challenges in court was a quick and easy process — unlike the 80s which led Barr to testify against the FDA in the first place. Now Barr was in the driver’s seat. Barr swallowed up other generic manufacturers and continued to win patent suits and gain first rights to bio-equivalency claims of expiring patents.

When Barr was acquired by Teva in 2008, a string of voluntary re-calls would soon follow. Despite Barr’s unscrupulous business history, quality-control of their drugs was never a big issue. With Teva’s acquisition and control of Barr and its wide scope of generic manufacturing, the quest to make their drugs at the cheapest price possible has resulted in the use of low-quality precursor chemicals and a complete lack of manufacturing oversight. Just nine months ago, Barr’s generic Adderall was re-called because they were distributing batches at four to five times the listed dosage. Considering Adderall is a blend of amphetamines, this resulted in an array of cardiovascular and psychological problems for those unfortunate enough to take these potent Adderall pills.

While I’m on the subject of Adderall, it is of importance to note the complacency of many of the major brand-name drug manufacturers in allowing their proprietary formulas to be produced in a manner inconsistent with their own production standards. Shire pharmaceuticals, the original producer of Adderall, has recently granted Barr/Teva the right to be the sole manufacturer of Extended Release Adderall, which is still under patent. The reason for this is of course profit. Shire has a large stake in the growing ADHD market, and are pushing their new ADHD drug Vyvanse as the be all and end all of ADHS medication. Essentially, they have given up any concern over the quality perceptions of the very popular and widely used Adderall to push Vyvanse which is simply Dextro-Amphetamine (Dexidrine) with lysine bonded to it, supposedly creating a less abusable prodrug of something that has been around for over a hundred years. I’ll save my critique of the ineffectiveness of Vyvanse for another time as that would involve delving into some complicated bio-chemistry.

In addition to the Adderall recalls, there have been others just in the past two years since Barr was acquired by Teva. Obviously, recalls and mistakes happen, but Teva seems to make more mistakes than what one would consider acceptable when dealing with drugs that are used to treat life-threatening illnesses. The pharmaceutical industry as a whole, has historically shown indifference to their actual consumers for the sake of generating more profit. With Teva taking over such a large portion of the generic drug market, this could be a scary proposition for those of us who depend on affordable drugs for treating our medical conditions. The FDA, the federal administration responsible for overseeing the safety and effectiveness of these medications has continued to turn a blind eye to the issues of Teva. Considering the FDA’s history of corruption and the fact that it is made up largely of former pharmaceutical executives and representatives, their apathy toward consumers in favor of these corporations should come as no surprise.

Update 05.28.2010: Here’s a nice story written in the USA Today about the FDA warning many drug manufacturers about their shoddy production methods; Teva at the forefront. Let’s hope the FDA does more than just warn them.