Heparin: Purposeful Poisoning or Accidental?

Was the latest heparin blood thinner debacle purposeful or an accident?

Usually conservative in opinion, the FDA commissioner told a Senate subcommittee that the heparin contamination was an economic fraud. The heparin contaminant of oversulfated chondroitin sulfate costs $9 a pound compared with $900 a pound for the active ingredient heparin.

Contaminated heparin-induced 81 deaths is being compared to cyanide laced Tylenol. However, with the blood thinner heparin there were far more deaths including a 60ish man in Ohio who lost both his wife and his son because they both suffered from the same genetic kidney disease that required constant dialysis.

The FDA has identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. Chinese officials dispute the FDA that the contaminant caused injuries and death.

The FDA failed to inspect the plant as did Changzhou SPL. The FDA claims they don't have the budget to properly inspect all the foreign drug inspections.

Nobody wants to get tapped on the shoulder with heparin death blame. So what else is new? Who's minding the store?

Heparin Debaucle and the FDA

When there is a drug or food blunder in another country, that country reacts and immediately recalls the offensive product. The same cannot be said about the FDA and the United States. The FDA doesn't have the power to do so but can only recommend a recall or black box warning label which usually takes months to implement.

In the meantime more people are seriously and fatally affected.

Like in the case of the blood thinner heparin -- In the Heparin debacle, the FDA reported that since the end of 2007, it received over 700 reports of adverse side effects associated with Baxter’s multiple-dose injectable Heparin; 40 percent of these reports were deemed serious.
There were inadequate FDA inspections of overseeing the active ingredients obtained from unregulated factories in China.

In the meantime, the FDA executives are giving themselves huge pay raises while there is no money in the budget to effectively monitor and investigate imports from other countries or hire more employees.

Heparin Testing Goes Awry?

Did flawed heparin tests lead to the recall?

If the primary purpose of heparin it is to make life better for those who take it why did the drug turn out to be so dangerous? Wouldn't the manufacturer, Baxter, realize that releasing a dangerous drug into the marketplace would cause so many problems? Honestly, Baxter did not release purposefully release a dangerous drug in the marketplace. However, the release of the drug heparin was seriously flawed due to improper lab testing. This places a great deal of negligence on Baxter's shoulders.

Let's look at the situation more closely…

When numerous adverse side effects started to display themselves in patients who had been taking heparin, the FDA conducted an examination of the drug to ascertain the problem. As it turned out, the drug contained a dangerous contaminant. It was this contaminant that was the reason a great many people were suffering serious adverse side effects. And, needless to say, this was the reason the drug was pulled off the market. Proper testing of the product would have revealed this contaminant, but the tests conducted were weak. Now, while it was not Baxter's intention to release a dangerous product to the public this is exactly what the company did. Of course, this is also why the company is being held liable for the damages that have resulted in the aftermath of the release.

It is the responsibility of all pharmaceutical companies to make sure that any products that are released to the marketplace are safe for consumers. Often, consumers rely on these products for their very lives. This is why it is important that the product itself does not threaten the life of the person taking it. Yet, this is exactly the problem with heparin. Baxter was responsible for properly conducting tests to make sure this was a safe drug. Obviously, this is not the procedure the company followed and this is why Baxter is in the position it finds itself in right now.

Safer Synthetic Alternative to Contaminated Heparin

The main source for heparin is the intestines of foreign livestock.

Disgusting!

The intestines of foreign livestock creates a condition that is wide open for mass contamination which recently happened in the latest China heparin catastrophe.

A team at the University of North Carolina developed synthetic heparin in 2006 and has worked since that time to fine tune a safer and better version of the blood thinner heparin. Oddly, the backbone for the new heparin comes from the bacteria found in e.coli which is easier to produce.

Through a proprietary scientific process it will probably take around five years to produce the demand required and go through clinical trials.

Better living with chemistry.

Good news, bad news, raw material, heparin

In a global economy, there is both good news and bad news.

The good news is the possibility to increase economies of scale as well as breaking down barriers allowing companies to benefit from the largest and cheapest workforces, raw materials, and technology.

That's also the bad news.

Where's the quality control? Who's minding the store and the regulatory problems?

A perfect example is heparin.

The active ingredient is made in China without any regulatory oversight. The US Federal Drug Administration (FDA) doesn't have a handle on it and neither does its Chinese equivalent.

More than 50 percent of drug active ingredients are produced in China and India. Who's paying attention?

In regard to heparin, the FDA admitted to insufficient inspection of an American-owned production facility in China, prior to approving the drug for market.

On the good news side, a permanent FDA office is scheduled to open in China by October 2008 and pharmaceutical manufacturers there will be subjected to stricter scrutiny.

What about India?

Unfortunately, it's too late for the people who have already died from heparin.

Heparin – Class Action or Go It Alone?

Is a class action heparin suit better than a "solo" suit?

If you have suffered as a result of taking heparin, you may be thinking of taking legal action. This is understandable because may of the severe consequences of taking this drug are the result of negligence on the part of the manufacturer. The manufacturer, Baxter, truly did not properly test and produce this potentially hazardous blood thinner. This is why there are a number of suits pending against Baxter. Those currently looking to file suit, however, many not be sure of what type of suit to file

That is, they may not know whether or not to file an action on their own or to take part in a class action lawsuit. For those not familiar with the term, a class action lawsuit is essentially a collective action were the multitude of people act as the plaintiffs in the suit. If a heparin settlement or judgment is arrived the monetary award would be the split among the various plaintiffs.

This, of course, brings about the question as to what would be the best course of action to take, filing a solo or class action suit. Honestly, this is not a question that can be answered with absolutism because each litigant's situation is different. Different needs and personal situations will dictate the proper course of action to take. So, in order to arrive at a decision, it would be best to consult with an attorney. In such a meeting, the various positives and negatives of class action vs. solo suits can be discussed.

They may be better served with an individual suit. Ultimately, the client needs to realize what would be the right action to take and careful deliberation with an attorney will aid in this regard.

FDA questions labeling of blood drug therapy

Tainted Heparin, a blood thinner medication, manufactured by Baxter International has been directly linked to the deaths of three people as reported previously on this Baxter heparin recall blog.

Most recently, the FDA criticized Baxter International for misleading doctors about FEIBA VH's safety. FEIBA VH is a bleeding treatment drug therapy for people with hemophilia.

The FDA criticized the statement:

"FEIBA is well tolerated in 96%-100% of infusions with a low thrombotic event incidence (0.008%)"

According to the FDA, this is exaggerated.

The FDA requested that Baxter immediately cease the dissemination of the offending email letter as well as any same as or similar violative promotional materials for FEIBA VH.