Heparin Contamination Was Due To Economic Fraud
8 CommentsBy Ed Silverman // April 16th, 2008 // 8:17 am
That’s what FDA commish Andy von Eschenbach said at Senate hearing, although he didn’t specify who added the contaminant and Baxter International maintains the contamination occurred before the blood thinner reached its supplier, Bloomberg News reports. Some samples of Baxter’s heparin, whose main ingredient was made from pig intestines and imported from China, were contaminated with a cheaper substance derived from animal cartilage.
“It was apparently, we suspect, done by virtue of economic fraud,” von Eschenbach today told a Senate Appropriations subcommittee that oversees FDA spending. Of course, that’s another way of saying the contamination was done intentionally to make money. But after the hearing, Andy backpedaled and said his comments may have gone too far. He told reporters the agency had no evidence the contamination was intentional. “One thing you always wonder about is whether it was done in order to be deceptive,” he said. Thanks for clearing that up, Andy.
Meanwhile, 62 people given heparin died since January 2007 after suffering allergic reactions or low blood pressure, according to the FDA. But the agency hasn’t determined where in the supply chain the tainted material was introduced. Baxter and its supplier of raw heparin, Scientific Protein Laboratories, say the contaminant wasn’t added in their factories, but don’t know how or why it got there. Baxter has been seeking access to consolidators and workshops in China that handled the crude material before it went to Scientific Protein, Bloomberg writes.
The FDA has been under criticism from lawmakers who say regulators haven’t done enough to ensure the safety of food and drugs produced overseas and shipped to the US, but the agency plans to station eight employees in three Chinese cities - Beijing, Guangzhou and Shanghai - to inspect food and drug facilities and assist Chinese regulators, von Eschenbach said at the hearing.
Earlier this year, the FDA admitted that it didn’t inspect a Scientific Protein plant in China that makes the main ingredient in Baxter’s heparin because the agency confused records on that facility and another with a similar name, Bloomberg reminds us. But Andy told the committee that even if an inspection had taken place, the contaminant wouldn’t have been found.
“That inspection would not have detected the contamination of heparin because the contaminant is not detectable by our routine testing methods,” von Eschenbach said. The agency has has since announced new methods that drugmakers should use to test their heparin products. The agency now requires testing of imported raw heparin before it enters the US.
The FDA didn’t request enough funding for next fiscal year to regulate the safety of food and drugs, said Senator Herb Kohl, a Democrat from Wisconsin, who is chairman of the subcommittee that held the hearing, Bloomberg writes. “I find it very hard to believe that this recommendation will achieve anywhere near the goals FDA has set,” Kohl said.
President George W. Bush has proposed increasing the FDA’s budget by 5.7 percent to $2.4 billion for fiscal 2009. The FDA has said von Eschenbach sought more, without saying how much he recommended. Once again, Andy didn’t directly respond when asked how much more funding the agency needs. Asked if the FDA could make use of an additional $100 million, von Eschenbach said yes. More money could be used for safety programs, he told lawmakers.
Source: Bloomberg News
Jack2
The real sadness here is that, most likely, someone(s) with advanced knowledge of synthesis chemistry could have applied that knowledge to help people, but instead intentionally used that knowledge to create a dangerous and ultimately lethal product.
harpy
What I want to know is how they’re going to ensure it doesn’t happen again.
CMC guy
I agree with Jack2 that appears to be smart criminal(s) involvement which frustrates me both as a scientist and a person involved in procurement. Although would seem to have available tests/tools to prevent reoccurence in case of heparin does make one wonder if will be like drug smugglers who readily shift methods/targets to exploit weaknesses. The Chinese authorities, Pharma companies, Suppliers/sub-contractors and FDA all can do more but still think impossible task to 100% assure everything particularly when dealing with greedy intelligent and determined foes.
Jack2
You will never get 100% assurance. In this case it took the FDA and Baxter a while to find out what happened after they knew to look for a problem.
Hopefully, if this turns out to be intentional wrong doing they will catch and prosecute the criminal. Considering China executed the head of their FDA equivalent last year for corruption, and politically China will want to look super-tough on this issue, I expect the penalty will be severe.
Brian
After thousands of years of recorded history, Mankind still hasn’t stopped crime.
However, there is no question that some societies have higher levels of certain types of criminality than others. The reasons are complex and debatable (as is the potential for ’solutions’), but the statistics are facts and are not easily disputed.
Most people familar with the situation would agree that ‘economic fraud’ is especially prevalant in China. We might not always agree on the reasons why, but the facts speak for themselves, and these facts are available to anyone with any role in outsourcing drug APIs.
So, the real question is: do ‘we’ try to ‘fix’ China, or do we leave China to ‘fix’ itself in its own time, and simply buy our critical APIs only where the data demonstrates that it is safe to do so–Even if it costs a bit more?
Considering that the largest expense in most drugs tends to be things like R&D, in large part due to safety concerns, in my opinion it makes NO SENSE WHAT-SO-EVER to spend millions of $$$ to eliminate an additional xx% risk of SAEs (where xx typically tends to be very low). And yet turn around and save pennies importing APIs from a region where the risk of fraud is almost certainly higher than xx.
Frankly, the people who make decisions like this are guilty of economic fraud as well…
CMC guy
Brian your astute comments are very good and this whole issue is complex and debatable not just societial variability. Anyone that does business in China (and India too) must go in with eyes wide open to different rules/culture with greater potential risks. This awareness should trigger more due diligence upfront with robust continuous monitoring that go beyond periodic routine QC of materials purchased. In the case of Heparin looks like Baxter & SPL could have done more in vetting supply chain but still are no guarantees that sabotage can be prevented.
In a Macro sense not sure we could make substantial headway to fix China, particularly in government /regulatory behaviors (not our problem!), and a complete API boycott could possibly create undesired backlash without accomplishing aims. There does need to be constant pressure to insist in a Global economy for implementation of ICH/ISO standards rather than “Chinese GMP” which must be driven by Sponsors and US/FDA. In a Micro sense Sponsors have to closely work with/audit Suppliers/Contractors/Sub-contractors to build and maintain trusting relationships. Chinese companies I have dealt with have had strong willingness to adopt higher standards required unfortunately they do often lack guidance and good examples so is a long and twisty path for both sides (I have also been spoiled to have Chinese Nationals as co-workers/collaborators who knew language and culture in order to cut through to real substanitive issues).
Funny I can’t really understand some of the dichotomies that exist either such as you mention although another is that R&D activities can be comparatively bloated and inefficient (vs other industries) then end up that manufacturing getting stuck with operating overly narrowly (although here too not so much pressure as other industries) so forced to seek cheapest sources. (Note I am not advocating cuts in R&D but do think could do better with what we do have since big part of costs in successful drugs is to cover failures).
Not sure would call it economic fraud as perhaps tracks to significant number of people in charge not understanding science and drug development IMO so all they see are calculations being straightforward where those saved pennies (and likely dollars differential) add up very fast and the quality and/or risk factors which are hard to quantify do get obscured. I also don’t see any tolerance in investors or customers to earn less or pay more to cover these intangibles since focus is on prices and not costs.
Jack2
CMC guy makes a lot of good points.
Drugs are treated as commodoties where one heparin is exactly the same as the other heparin. Baxter probably made pennies on the vials of heparin it sold, which forces them to seek the cheapest ingredient supplier. Wholesalers seek to buy the cheapest drugs possible, and then sell the cheapest drugs to the pharmacy so they don’t lose their contract to another wholesaler. The pharmacist dispenses whatever generic the wholesaler sold them.
The whole system forces the patient to accept the product offered to them at the pharmacy - whereas with other products, like a TV or a car, you might look at the name of the manufacturer to assess the quality of a product the ultimate user of drugs is not afforded that luxury. To a wholesaler an authorized generic or a generic made by a more “reputable” manufacturer commands no higher value in their eyes - and the wholesaler ultimately control which drugs reach the pharmacy.
I’m not saying it should be any different. The cost efficiencies and savings to society are enormous; I have no idea if the cost of the problems like this even approaches a fraction of the total cost savings. Plus, even if it was different, it doesn’t mean that a counterfeit ingredient would always get caught.
I’m just pointing out another one of those delightful nuances of healthcare - where a product user has very little choice in which product (s)he uses.
pataloca
Companies like Baxter supply their heparin in countries such as China because there is a worlwide shortage of heparin. US is by far the largest consumer of heparin (unfractioned heparin and low-molecular heparin) and US facilities that extract heparin from pig intestines do not produce enough heparin. It would take years to increase US heparin production just to satisfy US consumption.
Companies like Sanofi have identified in the 90ties the risk of shortage of heparin and they initiated a program to develop synthetic anticoagulant like fondaparinux (arixtra) which is now considered as a better anticoagulant than heparin-derived drugs.