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The Heparin DisasterFriday, June 27, 2008 The United States Pharmacopeia Announces Revised Heparin MonographsIn response to the heparin contamination and resulting deaths, the FDA asked the United States Pharmacopeia (USP) on March 19, 2008 to assist in re-assessing current tests and developing new methods for detecting contaminants, such as over-sulfated chondroitin sulfate, in heparin. (See 04/14/08 USP Press Release.) The USP is an independent, science-based public health organization that sets the official public standards for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. (To learn what a “pharmacopeia” is, click here. To learn more about the USP itself, click here.) Among other functions, the USP plays a critical role in developing “monographs” for drug substances, drug products, or “excipients,” (substances that act as a vehicle for a drug). A monograph is a written standard that describes the medical drug, device or product and provides a public standard by which to judge its quality or to test it in order to produce a high-quality and consistent product. (See July 2004 USP Monograph Backgrounder for more information.) These monographs may be updated. For example, heparin, which has been sold in the United States since the 1940s, has had a USP monograph since 1950 that has been updated several times. (04/14/08 USP Press Release.) Monographs are published in the National Formulary (USP-NF), which was originally created in 1888 and contains more than 4,000 monographs for prescription and over-the-counter products, dietary supplements, medical devices and other health care products. (Feb. 2005 USP Program, “What is a Pharmacopeia?”) When a standard is published in the USP-NF, federal and state government agencies, such as the FDA, can recognize and enforce those standards to ensure product compliance and quality. Currently, there are monographs for two heparin drug substances in the USP-NF. (04/11/08 USP Heparin Statement.) In April of 2008, the USP started working to develop more sensitive methods for detecting contaminants found in heparin. (04/14/08 USP Press Release.) This work was divided into two stages. Stage one would include revisions to the heparin monographs, and was “intended to address rapidly the immediate public health crisis associated with the drug and help ensure an unadulterated supply of heparin.” (06/23/08 USP Press Release.) The second stage would seek additional methods to test for over-sulfated chondroitin and other potential contaminants in heparin. The USP conducted a “heparin web meeting with the industry” on April 11, 2008. (To view the power point presentation for that meeting, click here.) On April 25, 2008, the USP’s Heparin Advisory Panel provided written recommendations for the revision of the heparin sodium monograph. (To view these recommendations, click here.) An open microphone meeting regarding the recommendations was then held on June 11, 2008. (To view the agenda for this meeting click here. To view the presentation given at this meeting click here.) As a result of these meetings and recommendations, on June 23, 2008, the USP announced that stage one had been completed and that the monographs for heparin sodium and heparin calcium had been revised and are now available on the USP Web site. (06/23/08 USP Press Release.) The two heparin monographs are posted on the USP Web site at http://www.usp.org/hottopics/heparin.html?hlc. These revised monographs are accompanied by new and updated official USP Reference Standards, that all drug manufacturers who market heparin in the United States are required to meet. (For additional information, see USP “Heparin Monograph Revision Frequently Asked Questions.”) The USP indicates that it will now turn to “the second stage of revision,” which involves seeking out additional methods to test for over-sulfated chondroitin and other potential contaminants in heparin. (06/23/08 USP Press Release.) Although these revisions are important and the USP should be thanked for its hard work, as recognized by the USP itself, they are only “one of a series of safety nets that work to assure that U.S. patients and practitioners have access to good quality medicines.” (Statement of USP executive vice president and CEO, Roger L. Williams, M.D., in the 06/23/08 USP Press Release.) These other critical safety nets must also include “dedicated and trusted drug ingredient and product manufacturers who follow good manufacturing practices (GMPs) and sound sampling protocols in support of batch release testing,” and “oversight from the FDA...” (04/14/08 USP Press Release.) As we have unfortunately now learned from the heparin disaster, when these other safety nets are not in place, the ramifications can be devastating. Companies who do not use good manufacturing practices or purchase product from companies who do not use good manufacturing practices, and do not adequately test their drugs, should be held accountable when those defective drugs cause death and injury. At the same time, the FDA must be given the resources and power it needs to enforce compliance by powerful and wealthy drug companies, including those who want to save money by purchasing product from uninspected and substandard plants in foreign countries. Labels: Baxter, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, MDL; Multi-District Litigation, Monograph, National Formulary, nightline, OSCS, oversulfated chondroitin sulfate, Pharmacopeia, SPL, USP
Thursday, June 26, 2008 Who owns Scientific Protein Labs?
The information in this post is based on information in the public domain.
We have written earlier about Scientific Protein Labs (SPL) and the role they played in providing Baxter with the heparin that had been cut with oversulfated chondroitin sulfate. But unlike Baxter, which is a publicly traded company, the stock in SPL is privately held. 89% of SPL was purchased about 2 years ago for the price of $135 million. The purchaser was American Capital Strategies, Ltd., ("ACAS") a private equity firm headquartered in Bethesda, Maryland, which is publicly traded under the symbol ACAS. Area biotech sold again: Helps make heparin Complete Article ACAS had placed a fair value of $176M on SPL as of 12/31/2007. The total asset value of ACAS is about $11 Billion. Thus SPL represents about 1.6% of ACAS total assets. According to the New York Times story published earlier this week: NYT Story May 23, 2008 An article today posted on The Street.com titled "Valuations Haunt American Capital" contains this information: The ACAS public financials do not disclose what amount of money SPL made from the CZ-SPL and China imports. SPL continues to make heparin from domestic sources as well as some other products. But the FDA has blocked any imports of heparin from SPL's wholly owned subsidiary CZ-SPL. Labels: ACAS, American Capital Strategis, Heparin, heparin attorney, heparin lawyer, LTD, nightline, Scientific Protein Labs, SPL
Tuesday, June 24, 2008 Why Didn’t the Contaminated Heparin Affect Everyone Receiving It?Much is yet to be learned regarding the contaminate found in the recalled heparin, oversulfated chondroitin sulfate (“OSCS”). However, the first and only study published to date since the January 2008 heparin recall does shed some light on the relationship between the contaminate and the severe reactions, sometimes fatal, experienced by many Americans. (“Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System,” N. Engl. J. Med. 358:23, pgs. 2457-2467, June 5, 2008, available for a charge on the New England Journal of Medicine Website.) One of the issues addressed in this article is a question that we are often asked by our clients, why weren’t all patients who received tainted heparin from a particular lot affected? In order to investigate this and related issues concerning the biologic link between the contaminant and the reported reactions, the researchers conducted animal testing. (6/5/08 N. Engl. J. Med. article, pg. 2464.) Pigs were chosen because unlike rabbits, horses and rats, only the pig plasma supported an appropriate level of response to the OSCS contaminated heparin, but not the uncontaminated control heparin. (This also may explain why early attempts by Baxter to provoke an allergic response with suspect lots of heparin failed. See Baxter 03/19/08 Press Update and 6/5/08 N. Engl. J. Med. article, pg. 2464.) The pigs were given a single intravenous dose (5 mg per kilogram) of OSCS-contaminated heparin, uncontaminated heparin, or other substances. (06/05/08 N. Engl. J. Med. article, pg. 2466.) They were then monitored for 60 minutes. Two of six pigs treated with OSCS-contaminated heparin had at least a 30% drop in blood pressure over the first 30 minutes after infusion. One animal remained in a hypotensive state for more than 15 minutes. In contrast, none of the four animals treated with uncontaminated heparin showed any substantive changes in blood pressure. (Additionally, three pigs were given pure synthetic OSCS. All three of these pigs “showed a profound drop in blood pressure [maximal decrease, 45 to 59%] and a concurrent increase in heart rate within minutes after infusion.”) Interestingly, while not all pigs who received OSCS-contaminated heparin exhibited clinical signs, the researchers found that “induction of kallikrein activity [kallikrein is an enzyme present in blood plasma and other body fluids which can lead to the generation of bradykinin that in turn, impacts the blood vessels leading to hypotension and other symptoms] was evident in all animals that received OSCS-contaminated heparin, even when no substantive changes in blood pressure were observed.” (06/05/08 N. Engl. J. Med. article, pg. 2466, with explanation and emphasis added by Zoll, Kranz & Borgess, LLC.) Based on these findings, the researchers concluded as follows: “These findings suggest that activation of kallikrein does not always manifest as clinical symptoms, perhaps because of individual variations in control mechanism that regulate bradykinin activity…. The finding that hypotension did not develop in all animals treated with OSCS-contaminated heparin, even at a relatively high dose, is consistent with the observation that the majority of patients who received contaminated heparin did not experience an adverse event. However, it is important to note that all animals treated with OSCS-contaminated heparin showed evidence of kallikrein activation in vivo, even in the absence of clinical signs. Patients undergoing dialysis who are also receiving heparin therapy are already at high risk for hypotension because of their exposure to the dialysis membrane, which can also activate the contact system, and their treatment with angiotensin-converting-enzyme inhibitors, which inhibit bradykinin degradation. Exposure to OSCS-contaminated heparin may further increase the risk and could potentially trigger an adverse event.” (06/05/08 N. Engl. J. Med. article, pg. 2467.) Thus, the scientific evidence to date suggests that while some patients may not exhibit clinical signs after receiving OSCS, this does not necessarily lead to the conclusion that those patients were “unaffected” by the OSCS, particularly those patients, including dialysis patients, who are already at greater risk. Hopefully, researchers will continue to investigate the relationship between OSCS and the reported reactions, so that the families of those who have lost loved ones can understand how and why this happened, and continue to hope that it can and will be prevented in the future. Labels: Baxter, China, dialysis, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, MDL, nightline, OSCS, oversulfated chondroitin sulfate, SPL
Saturday, June 21, 2008 Sherrod Brown Challenges the FDA
This week Ohio Senator Sherrod Brown sent a letter to the FDA challenging them to evaluate the level of outsourcing by U.S. Pharmaceutical companies, and the impact of that outsourcing on Drug Safety. He also asked Pfizer, who admitted outsourcing 17% of their API ("Active Pharmaceutical Ingredient"), to make public how much money they save by doing so. Sherrod Brown Press release and letters.
Now the FDA has announced that it will spend taxpayer money to set up inspection offices in China and India. (Three offices in China this year, followed by offices in India. Story here.) It seems to me that the drug companies that profit from overseas operations and the lax or total absence of controls and inspections should pay for these offices and the cost of inspecting the foreign operations. Senator Brown is absolutely right to dig into this issue that is so critical to the health and safety of our citizens. As he stated to Janet Woodcock, head of the FDA: I seriously doubt that the current FDA will hold drug companies accountable. But they must do so. And those injured by the failure of the drug companies to perform their duties must be able to obtain full and fair compensation from the drug companies that have failed to provide products that are safe and effective. Thank you Senator Brown. Please keep challenging the FDA, Pfizer, and the rest of the phamaceutical industry to do their duty. And please give those persons and families who are injured and killed the ability to seek full compensation. It is ridiculous to protect these companies from liability on the basis that the FDA is doing its job. As we have seen in the Heparin Disaster, and as I pointed out in my blog yesterday, the Chinese operations, subcontractors and joint ventures of these drug companies are flying under the radar of the FDA. Even when the FDA tries to inspect these companies they cannot do so. Labels: FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawyer, nightline, Pfizer, Sherrod Brown
Friday, June 20, 2008 The FDA China Inspections
The US FDA inspected, or rather attempted to inspect, three heparin manufacturing facilities between February 20th and February 29, 2008. The first facility was that of Changzhous SPL Company, Ltd., ("CZ-SPL") a wholly owned subsidiary of SPL. All of the CZ-SPL product was shipped to Baxter.
This inspection lasted 6 days. This was the first time the FDA had ever inspected the facility, in violation of FDA policy. The inspection found that the process validation for the purification of Heparin Crude was inadequate . It further found a number of other deficiences, including:
The second inspection began February 27, 2008. This inspection was of a facility located right next door to CZ-SPL. The neighboring factory is known as Changzhou Techpool Pharmaceutical Co. Ltd. ("CT"). CT is 45% owned by CZ-SPL. All of the product made by CT is sold to CZ - SPL. Importantly, the plant is not registered with the Chinese FDA because it does not make product for consumption in China. Nor is it registered with or inspected by the US FDA. The inspection lasted only 2 days. On both days the company refused to give the FDA copies of basic documents, including raw material crude specification, test methods, cards, certificates of analysis, blend records, and inventory records. The FDA did take photographs, which we are seeking to obtain. The third inspection was even less successful. This inspection began the afternoon of February 28th and ended the next day when the FDA inspection team was refused reentry into the facility. This facility was located in Hangzhou, China. The name of the firm was Hangzhou Ruihua Biochemical Products Co. Ltd. This firm was a manufacturer and tester of crude heparin that was sold to CZ-SPL for further processing. A photograph of Dr. Wang, the general manager of CZ-SPL and an officer of SPL hung in the entryway of the facility. The firm refused to provide copies of any records and no samples were collected. The firm is not regulated or inspected by the Chinese FDA or the US FDA. The owner of the firm, Mr. Ruihua, admitted that the firm had been unable to meet the needs of CZ-SPL because there was not enough heparin available. He indicated that CZ-SPL was his sole customer. Ruiha collects raw heparin from the countryside and nearby provinces. The workshops are all on a list provided by CZ-SPL. However Mr. Ruiha refused to provide any documents, refused to permit the FDA to inspect the laboratory, refused to provide a list of the workshops from which they get the raw heparin, and would not even state the Provinces in which the workshops were located. On April 21, 2008 the FDA issued a warning letter, which held that the deficiencies and deviations from current good manufacturing processes were so severe that CZ-SPL was barred from shipping product into the United States. Labels: Baxter, Changzhou, China, Chinese, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, OSCS, Scientific Protein, Scientific Protein Labs, SPL
Thursday, June 19, 2008 FDA revises information on Heparin
The FDA has updated its website FDA Questions and Answers on Heparin
The latest version contains new questions and answers about Heparin and its uses, further details on the FDA investigation, and describes the contaminant, oversulfated chondroitin sulfate (OSCS) and its effect on the human body. For example, the new article adds the following question and answer: 18. Why does the contaminant cause serious adverse events? (new question and answer added 6/18/2008) The contaminant activates chemicals in the body called enzymes. These enzymes cause the body to make inflammatory mediators (chemicals that are released by immune cells). Inflammatory mediators can lead to some of the symptoms such as low blood pressure, abdominal symptoms and shortness of breath. This mechanism can explain many of the serious adverse events that occurred immediately after patients were given the contaminated heparin. Tomorrow I will write about the FDA inspections of the Chinese facilities. Labels: Baxter, Changzhou, Chinese, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, nightline, NMR, OSCS, over sulfated chondroitin sulfate, oversulfated chondroitin sulfate, Scientific Protein Labs, SPL
Tuesday, June 17, 2008 Heparin Death Reports Nearly DoubleThe FDA issued an updated report yeseterday on the number of deaths reported after heparin administration that occurred and were submitted to the FDA from January 1, 2007 through May 31, 2008. (See FDA 06/17/08 “Information on Adverse Event Reports and Heparin.”) According to the FDA, as of May 31, 2008, there have been 246 reports of death in patients receiving heparin since January 1, 2007. Out of the 246 reported deaths, 149 of the reports included one or more allergic symptoms or symptoms of hypotension. This report is nearly double the FDA's earlier report in April 2008, which advised of 131 reported deaths, with 81 of those reports including one or more allergic symptoms or symptoms of hypotension. The FDA's Center for Devices and Radiological Health (CDRH) has also recently reported 11 deaths and 86 injuries since January 1, 2008, which have been linked to use of medical devices containing heparin. (06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.") The heparin in the majority of these medical devices was found to be contaminated with OSCS. Labels: Baxter, CDRH, China, Chinese, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, MDL, nightline, OSCS, over sulfated chondroitin sulfate, Scientific Protein Labs
Friday, June 13, 2008 Draft Bill Regarding Preemption To Be Introduced
On February 20, 2008, the United States Supreme Court severely curbed the rights of injured victims in the case of Riegel v. Medtronic, which held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA. (The problems with preemption have been discussed previously on this blog including, “The Preemption Problem” and “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”)
However, as reported in the 6/10/08 FDA news Device Daily Bulletin, prominent lawmakers are now seeking to introduce a bill in the next few weeks that would render this harsh U.S. Supreme Court decision moot. (FDAnews Device Daily Bulletin, Vol 5 No. 113, “Device Preemption Ruling Threatened by Draft Bill.”) This important bill would add a subsection to the FDCA stating, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.” The draft bill is sponsored by Congressmen Pallone and Waxman and is available at: www.fdanews.com/ext/files/FinalBill.pdf. As this legislation is critical to ensuring the accountability of medical drug and device manufacturers for the safety of their products, we support this new bill. Labels: Baxter, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, Pallone, preemption, Scientific Protein, Scientific Protein Labs, SPL, Waxman
Wednesday, June 11, 2008 Heparin Timeline with Web-Links Now Available
Zoll, Kranz & Borgess, LLC has just posted a detailed timeline relevant to the Heparin recall and subsequent litigation. This timeline created solely by Zoll, Kranz & Borgess, also features web-links to almost a hundred articles, videos, and other documents, including public documents from Baxter, SPL and the FDA. Please visit this timeline by clicking here.
Labels: Baxter, Changzhou, China, Chinese, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Heparin Timeline, MDL, MDL; Multi-District Litigation, nightline, OSCS, Scientific Protein, SPL
Monday, June 9, 2008 Additional U.S. Deaths from Heparin Medical DevicesOn June 3, 2008, the FDA announced that there have been 11 deaths and 86 cases of harmful side effects since January 1, 2008 that have been linked to use of medical devices containing heparin. (See 06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.") The heparin in the majority of these medical devices was found to have the same contaminate, oversulfated chondroitin sulfate (OSCS), as found in Baxter heparin multiple-dose vials often used in dialysis and other medical procedures. Products coated with, containing or manufactured with heparin include:
A list of other medical devices and diagnostic products that may contain or be coated with heparin can be found by clicking here. This list also includes the manufacturer or distributor. In a media interview, the FDA said that these 11 deaths involving heparin medical devices are ``probably in addition'' to the 81 deaths stemming from Baxter heparin multiple-dose vials, though some of the reports to the FDA are ``very sketchy'' and there could be ``some minor overlap.'' (See 6/5/08 Blooomberg News, "Heparin in Medical Devices Linked to 11 U.S. Deaths.") The majority of reports of death and injury from medical devices containing heparin were associated with use of heparin lock flush solutions in vials and solutions in pre-filled syringes, although reports have also been received for other medical devices listed above. (See 06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.") This contamination can also lead to inaccurate test results from diagnostic diagnostic devices that monitor heparin or use it as part of the device itself. (See 06/03/08 FDA web update: "Questions and Answers on Heparin, Medical Devices and In-vitro Diagnostic Assays.") Heparin and medical devices containing heparin have been recalled by Baxter (01/25/08 Baxter recall notice and 02/28/08 Baxter recall notice), American Health Packaging (03/20/08 Am. Health Pkg recall notice), B. Braun (03/21/08 B. Braun recall notice), Covidien (03/28/08 Covidien recall notice), and Medtronic (05/14/08 Medtronic recall notice). Labels: American Health Packaging, B. Braun, Baxter, Covidien, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, heparin medical device, Medtronic, nightline, over sulfated chondroitin sulfate, Scientific Protein Labs
Friday, June 6, 2008 Heparin MDL Sent to Toledo, OhioOn May 29, 2008, Zoll, Kranz & Borgess, LLC argued before the United States Judicial Panel on Multi-District Litigation that the Heparin Products Liability Litigation be transferred to the Northern District of Ohio, before the Honorable Chief Judge James G. Carr. Other districts, including the Southern District of Illinois, District of New Jersey, Southern District of Florida, the District of Puerto Rico, and the Northern District of California, were suggested by Baxter Healthcare Corp., Scientific Protein Laboratories, LLC, and other parties. Today the United States Judicial Panel on Multi-District Litigation issued a transfer order, transferring the Heparin Multi-District Litigation MDL No. 1953 to the Northern District of Ohio, before the Honorable Chief Judge James G. Carr. A copy of the decision is available by clicking here. Any inquiry regarding this or any other Heparin matter may be directed to either David Zoll or Pamela Borgess at (419) 841-9623. We have invited all Plaintiff attorneys from across the nation to meet with us and organize for this important litigation. We are committed to working for the common benefit of all Plaintiffs in this action. Update: Link to story in Toledo Blade Labels: Baxter, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, OSCS, over sulfated chondroitin sulfate
Wednesday, June 4, 2008 The Preemption ProblemBaxter, along with other drug manufacturers, continues to advocate for complete immunity from the majority of suits involving unsafe medical drugs under a legal concept called “federal preemption.” (See Baxter’s “Response to Preemption Discussion to Quaid’s Lawsuit.” See also testimony of Dennis and Kimberly Quaid at the Committee on Oversight and Government Reform’s 5/14/08 hearing, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” The full transcript and video of this hearing is available by clicking here.) Baxter and other drug manufacturers argue that regardless of misconduct or failures on their part, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA. This argument is not only legally and ethically problematic, but is based on the flawed assumption that the FDA has the resources, authority, and capability to ensure product safety. Unfortunately, as the heparin debacle as reminded us, such is not the case. Since the contaminated heparin recall, the significant shortcomings in the FDA’s ability to protect this county against unsafe drugs and medical devices, has been on the forefront of the news media, as well as the agenda of Congress. Reports exposing the depth of the problem continue. This week USA Today published an article entitled “Drug Companies Drain Scientific Brains from FDA,” which reports that the FDA continues to lose its most experienced scientific minds to major drug companies with more financial resources. This has led to staffing problems for the agency, which has a turnover rate twice that of other agencies. A previous study conducted by USA Today and reported in an article entitled “FDA Advisers Tied to Industry,” found that “more than half of the experts hired to advise the government on the safety and effectiveness of medicine had financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions.” With their undeniable influence at this and other levels of our government, it is no wonder that drug companies have gained support for federal preemption of medical drug and device lawsuits. It is also no wonder that Americans continue to die from unsafe drugs and medical devices. Yet, our constitution gives every-day Americans injured through no fault of their own, a powerful weapon against corporate corruption and greed, the right to a jury trial. In a United States court of law, a regular American can hold even the wealthiest and most powerful corporation accountable. Attempts by Baxter and others to sacrifice that constitutional right for protection of its corporate profits, should be not be permitted. Labels: Baxter, China, Dennis Quaid, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, House Committee on Oversight and Government Reform, MDL, MDL; Multi-District Litigation, nightline, OSCS, over sulfated chondroitin sulfate, preemption, Scientific Protein Labs
Monday, June 2, 2008 SPL story in Wisconsin State Journal
The Saturday, May 31, 2008 edition of the Wisconsin State Journal ran a story on Scientific Protein Labs, the supplier of the contaminated heparin to Baxter. (SPL was formerly a division of Oscar Mayer, the hot dog company.) The story is worth reading for several reasons. First, it describes the process involved in processing pig intestines into the raw sugar powder used to make heparin. This powder is called the api, or active pharmaceutical ingredient. Here in the United States, SPL controls its supply by actually processing the pig intestines. One 22 ton semi load of pig guts is processed down into just six pounds of heparin powder. In China, SPL - Changzhou (SPL-CZL), an SPL joint venture, bought processed pig guts, rather than act as the parent company and purchase the raw pig guts. SPL-CZL purchased the material after some processing had been done. SPL - CZL then shipped the heparin powder in bags from China to Wisconsin. SPL did not even open the bags in Wisconsin, but simply forwarded them to Baxter's Cherry Hill, New Jersey plant. These bags contained material that had been "cut" with a counterfeit product that mimicked heparin. Up to 30% or more of the material was actually oversulfated chondroitin sulfate (OSCS). What is new in this article is the admission that Baxter bought all of its raw heparin only from the China operation. The raw heparin that is made by SPL from domestic pigs is all sold to Sanofi Aventis, another drug company. All of SPL's heparin was made in the United States until 2004, when it acquired the China operations. In China SPL purchases its raw materials from two different companies, and each of them obtain the processed raw |
