Drug Safety Responsibility– For whom does the finger point?

The recent heparin recalls have left consumers fuming and pointing fingers at those who were supposedly protecting them from harm. With a difficult past year in both tainted food and medical products – this was the last straw.

But in reality, most in the industry knew the FDA was woefully understaffed and unequipped to cope with the expansion of global inspections required to guarantee the safety of our food and drug supply. Finally this week in answer to Pennsylvania Senator Arlen Spector’s request, FDA commission Andrew C. von Eschenbach asked congress for $275 million as an immediate budget submission. Increased funds will be use to increase inspections, modernize their science and staff, and upgrade their laboratory facilities.

Julie Zawisza, an F.D.A. spokeswoman said “These resources will accelerate the changes required for F.D.A. to protect and promote the health of all Americans in a rapidly changing world that poses new, emerging threats to the safety of food and medical product.”

One might asked, how could we let it get to this point? How indeed! The pharmaceutical industry has a history of relying of reactive testing, specific to the particular contaminant or variance they are guarding against. However, modern day protection requires a more proactive approach – a verification of the whole and an assurance against those criminal minds that can fool testing with traces of authentic material mixed in with the altered substance.

To further this point, we must have testing down the chain as well. As the saying goes, “Test Often, and Test Late!” The closer to consumer that authenticity testing is done, the more you are sure the consumer is receiving the “True Goods”. Too often each company points to the other on whose responsibility it is too safeguard the product.

Now it is the consumer who is doing the pointing and he or she is pointing at us all!

Heparin Contaminant found in 11 Countries!

China is continuing to deny their part in the contamination of the Heparin supply and the related deaths. They have even gone so far as to imply that the contamination could have occurred in a US plant. There is no denying on their part now, as the countries affected have climbed to 11 including: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.

With this latest revelation, China has at least accepted responsibility for the contaminant (oversulfated condroitin sulfate, or OSCS), but denies this resulted in the over 800 adverse reactions and the 81 deaths the FDA has attributed to it in the U.S. alone. FDA has conducted testing which has linked the OSCS to the adverse reactions observed. Additionally, The FDA has traced the lots in question to 12 Chinese companies involved in the heparin’s manufacturing.

Worldwide, the heparin recalls have expanded to include recalls from numerous companies that use heparin in a variety of medicinal products: Baxter (heparin); B.Braun (heparin solutions); Covidien (pre-filled syringes); American Health Packaging (heparin sodium vials); Hospira (heparin syringes, vials, and bags); AstraZeneca (heparinized saline); Sanofi-Aventis (Clexane drug); Rotexmedica (heparin products); Opocrin (heparin API); Sierra Pre-Filled Inc.(heparin lock and normal saline flushes); G. Bichsel AG (heparin products); and Arseus NV -Fagron (heparin).

The FDA has updated their testing to include two screening tests and is currently working with US Pharmacopeia, a non-profit organization dedicated to safety in the pharmaceutical industry on further testing.

Clearly, the magnitude of these recalls echo the need for more encompassing and rapid screening tests in the pharmaceutical arena. As the saga continues, manufacturers and suppliers should ask the question – Am I doing everything possible to ensure my supply is secure?

As the number of deaths stemming from the Heparin tragedy increases, so must our vigilance to make sure this does not happen again.

The Secret of CSI: Miami’s Lab

CSI:Miami draws its viewers to the edge of their seats by spinning out scenarios which catch a criminal and all involved during a day’s work. But how do they do it week after week?

First - you start with a crime lab that would make most real-life crime scene investigators green with envy. The lab boasts modern day tools like mass spectrometry and DNA analysis. The equipment portrayed on the series is very real, but at a cost prohibitive price for most crime labs’ budgets.

Add to the superior equipment, the almost super hero ability to complete tests before the end of day and sometimes within hours. One of these super technicians is Eva LaRue, who plays DNA expert Natalia Boa Vista on the show. She can even extract a single drop of perspiration from a leaf and tell you who was at the crime scene.


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The reality is lab tests are not completed instantaneously. Once a sample is submitted, it could take weeks for the results to be returned. It is for this reason, screening tests are helpful. These are generally less expensive than outsourcing to an analytical lab and less time consuming.

One industry looking for more efficient screening methods is the pharmaceutical industry. Guarding itself against counterfeits and adulterated medicine is an ever increasing task. They use a variety of security measures currently, but most are focused on the packaging rather than the material itself; such as holograms or special inks.

A viable material screening solution is the XT250 System, which can identify the crystalline structure of a substance by matching it against its standard. By rapidly testing products such as pharmaceuticals in their sealed packages, wholesalers can quickly determine what “passes” and what “fails” industry standards.

CSI: Miami may have the best equipment on T.V., but in real life, the XT250 System is as close as we get to rapid drug authentication.