Baxter CEO Says Heparin Purposely Tainted

Yesterday on Capitol Hill, a house subcommittee heard testimony on the recent issue of contaminated Heparin. Robert Parkinson, CEO of Baxter testified that the company believes the heparin was deliberately tainted.

Most heart wrenching, was when the family’s victims told their stories on how the tainted Heparin has destroyed their lives.

Leroy Hubely, was in tears as he explained how his wife Bonney died in December 2007 and then a month later his son, Randy died under the same circumstances. Only after the recall of Heparin, did he learn from his local dialysis center that tainted heparin, and not some cruel twist of fate, led to both of their deaths.

His daughter-in-law Collen Hubely, a dialysis nurse, testified: “As a nurse, I thought that I would be there to save my husband from any errors, but I guess I was naive. I never thought the life saving medication we were relying on might be contaminated. If citizens are truly going to ever to feel safe in this country going to the hospital, a doctor, taking your daily medication; we have a responsibility to be make sure that everything that is given is free from contamination.”

Families demanded more stringent policies and testing to protect consumers from dangerous materials hidden in our medications.

WHO Combats Malaria

The World Health Organization has declared tomorrow, April 25, 2008 as World Malaria Day.

A day dedicated to education and understanding this dreaded disease. Malaria is preventable and curable with the right medication. Sadly however, the most common medications are also highly counterfeited, with a rate as high as 85% in some countries, such as Nigeria. Patients are left with what was to be their hope now becoming their downfall.

Even more tragic, those most vulnerable to the disease are young children and pregnant mothers. More than a million die each year.

WHO has declared war and has vowed to eliminate Malaria. Please take a moment to reflect on their accomplishments in this humanitarian effort.

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.


Please click the Play button

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.

Human Error Eliminated?

Pharmaceutical authentication is ever evolving to meet users’ needs and at the top of their wish list is the desire to eliminate as much human entry errors as possible. This is why the new scanning feature on the XT250 System is so exciting.

Using the product barcode already on the pharmaceutical in question, an operator scans the container; thereby, automatically selecting the drug name, manufacturer, NDC code, dosage, and quantity. The XT250 will use this information to locate the medicine’s signature standard and compare along side the sample. The results will display as “passed” or “failed”.

Simple authentication with this new feature enables the entire process to run smoother, quicker and more efficiently by eliminating entry error.

Opinion: Heparin Deaths Just the Start

Unfortunately the recent FDA announcement of over 100 deaths due to contaminated Heparin, is just the start of a health care epidemic within the United States.

As with other consumable products that are now produced globally, the United States Pharmaceutical Supply Chain is now more vulnerable than ever.

In 2008 nearly every pharmaceutical manufacturer has doubled their overseas production. Additionally over 80% of all raw materials used in the production of pharmaceutical products is produced overseas

We here in the United States have been relatively protected from exposure to contaminated, adulterated and counterfeit medications that has been a scourge for the rest of the world for many years.

In 2006 it was estimated that the US Pharmaceutical Supply Chain had only 1% of its channel impacted by contaminated, adulterated or counterfeit medications. This still meant that one in nine citizens had at least one of its prescriptions filled with bogus medication.

Globally this statistic in 2006 was that nearly 10% of medications or one in ten within the Global Pharmaceutical Supply Chain were fake and potentially lethal.

* Expect the percentage of the United States Supply Chain of fake medications to rapidly grow in 2008 with the rise of more Heparin-like incidents. Most likely the United State's Pharmaceutical Supply Chain will begin to mirror the Global Supply Chain statisically.
* Expect to hear stories in the media with dozens, hundreds or even thousands in the Untied States made ill or even die because there are no effective measures in place to authenticate the validity of the medications within the Supply Chain. No longer will the stories of hundreds of people dying because of contaminated or fake medications be exclusive to underdeveloped areas of Africa and Asia.

Even though the technology is currently proven and readily available to authenticate the molecular structure of medications within a sealed bottle, the regulatory, manufacturing, distribution and dispensing members of the Pharmaceutical Supply Chain are hesitant or unwilling to deploy effective measures and appropriate technology to protect the United States consumer.

Fortunately the solution and technology is available today to prevent these impending health care disasters due to fake and contaminated medications. Now all we have to do is convince the members of the supply chain and the regulatory agencies to put it in place.

Just check out our website at www.xstreamsystems.net to see the solution.

FDA Links 100 Deaths to Heparin Since 2007

Late yesterday, the FDA announced publicly that over 100 patients within the United States have died while taking the blood thinning medication Heparin since January 2007.

The FDA found that over 62 of the deaths are the result of allergic reactions to contaminated batches of Heparin, which is significantly higher than their previous estimate of 19 deaths. Many of these deaths were not reported when they occurred, but are only now being reported to the FDA.

Allergic reactions to heparin are rare with only 3 deaths reported in 2006. However these increased in 2007, jumping dramatically to 8 in November, 12 in December, 16 in January, and 11 in February. FDA has posted the month to month mortality statistics on their website.

The presumed cause of the increased reactions is the adulterated compound the FDA discovered in the recalled products, whose ingredients were imported from China (See: Chemically Altered Chondroitin-Sulfate Found in Recalled Heparin).

China is a major supplier of raw heparin, which is derived from pig intestines. Recent decreases in swine population, due to blue ear disease, have caused Chinese plants to turn to smaller wholesalers for their own supply. Chondroitin-Sulfate is less expensive than its genuine heparin counterpart, which may explain why it was incorporated in the raw heparin.

In answer to this major threat, recalls have expanded to seven countries: U.S., Germany, Japan, Denmark, France, Italy, and Australia. Furthermore, the FDA has upgraded the pharmaceutical testing of imported Heparin.

Where, Oh Where Did My Medicine Come From?

You may think you know where your medicine originated. It came from Pfizer, or Merck, or Bayer, or some other big name pharmaceutical manufacturer. The question is where did they get it?

Many of our modern day medications are complex. They might be synthesized from chemicals or use biological agents and all have some kind of filler, bulking agent, or suspension liquid. So where do all those ingredients come from and why can’t you tell where your medication was made?

Almost 80% of the active ingredients come from overseas and many of the companies that supply the fillers or chemicals are not inspected by the FDA because the product is not considered pharmaceutical. Even to inspect only the active ingredients, the FDA has stated it would take them over 13 years to inspect each plant.

What’s more – pharmaceutical companies are only required to list active ingredients not the raw material or fillers that make up the medicine.

It’s like a giant puzzle; but what if you could zoom out and see the whole picture, match it against the picture on the box and know if something didn’t fit? That might be just around the corner with EDXRD technology. A new product, the XT250 System, uses this technology to build an industry standard of a compound and then use it when comparing a sample. The software will even do the thinking for you to determine if it is or is not a match – no scientific knowledge required. It’s like a pharmaceutical lie detector to stand guard at our gates.

It would give consumers the peace of mind to know “what they see is what they get” because after all, isn’t that what really counts?

Law and Order: Criminal Intent - Fiction Takes a Clue from Real Life

Many of us enjoy the episodes of Law and Order: Criminal Intent, and while those cases may be fictional, many do not realize that the facts are often only TOO real. “Smile”, which first aired October 18, 2007 (Season 7 Episode 136), depicts the murder case of a dentist and the mysterious death of four young patients. As the case unravels, the young children’s deaths are tied to counterfeit mouthwash manufactured in China.

Law & Order - Counterfeit Mouthwash

As we return to the REAL world, we discover that counterfeit mouthwash and counterfeit toothpaste were discovered in Panama and claimed hundreds of lives in May of 2007. This particular news made national headlines, but many do not understand that it also hits much closer to home here in the U.S.

Also in 2007, counterfeit tubes of Colgate toothpaste were discovered in Dollar Plus Stores. The packaging was for distribution in Africa and was not Colgate’s packaging, but a fair imitation. The real life clincher is the owner commented that the tubes couldn’t be counterfeit because he had purchased them from a big company, but the toothpaste was found to contain Diethylene Glycol, the same ingredient that was depicted in the Law & Order story and the same ingredient that caused so many deaths.

Unfortunately, sometimes real life can be as unbelievable as those fictional stories we watch.

Which leads us to wonder – “Do you know where your toothpaste has been?”