Heparin: Costs and Deadly Side Effects
Heparin is a blood thinner, prescribed by physicians and surgeons for kidney-dialysis and post surgical patients to prevent blood clots. One of the key ingredients in Heparin is derived from the mucous membranes of pig intestines; pigs naturally produce proteins used in pharmaceutical products.
Baxter International, a very large multinational health care company based in Deerfield, Illinois, whose sales totaled $11.26 billion in 2007, partnered with Scientific Protein Laboratories (SPL) to provide Baxter with the key ingredient for Heparin. SPL was started in 1976 by Oscar Meyer Company in Waunakee, Wisconsin.
In 2007, a team of quality control specialists from Baxter International visited a facility in the Zhejiang Province, which is located in a remote area north of Shanghai, China. This facility is owned by its partner, SPL. The quality control team found nothing unusual and gave the facility a “clean bill of health.”
Approximately a month and a half later, after using Heparin for two months while on dialysis, an American woman, Bonnie Hubley, died on December 19. She had been rushed to the hospital two days prior with various complications, such as diarrhea, vomiting, as well as substantial pains in her chest and abdominal areas. Within two days of admittance into intensive care, she slipped into unconsciousness and was placed on a breathing tube, deteriorating rapidly. The doctors at the Toledo, Ohio hospital were stunned and had to inform her husband and family that there was no hope, and she would not recover.
Approximately three weeks later, her son Randy Hubley, who also suffered from the same ailments, and was also using the same drug, suffered similar, if not exact same symptoms as his mother, Bonnie Hubley. Mother and son were buried side by side within a month of each other.
In addition to, there are also a number of other products that have either injured or killed people around the world, such as tainted baby milk One additive ingredient in the infant formula is melamine. This industrial grade additive is used to mask the dilution of protein, which in this case is a popular baby formula in China. Approximately 53,000 small children in China have developed issues with kidney stones and other kidney related issues and approximately four have died. The product has been recalled around the world by eleven countries, which includes the U.S. The list of recalled products from China includes seven instant coffee as well as milk-tea products, pet foods, all of which were made in Taiwan using tainted Chinese milk. The company that is responsible for the manufacture and distribution of these tainted milk products is Sanlu Group, based in Hebei Province in central China, and is owned by the Chinese government.
China has emerged as an economic powerhouse over the last two decades, with most of the world’s common products originating in Chinese factories. Pharmaceuticals are no exception. With this surge of economic growth, and increasingly intense competition within, the Chinese government apparently has little to no oversight or regulation, and what regulatory authorities it has may be corrupt. Various sources cited within the investigation into the Heparin debacle have alluded and stated that the Chinese government’s “regulation” is haphazard at the very best, and sometimes nonexistent. The competition in the country is based solely on cost, and profits are achieved by undermining competition at all costs. In the case of the Heparin issue, the investigation proved that there is little to no oversight.
The way heparin is made starts with pigs on farms. Nearly half the pigs in the world are located in China. The conditions in which these pigs live are deplorable. Farmers that raise the animals are not held to U. S. standards, and are not held accountable for the health of the animals. When the animals are slaughtered, the intestines are harvested for such purposes as creating raw heparin. SPL purchased the raw heparin from two sources, Changzhou Techpool and Ruihua Biomedical Products Co. SPL then refines it and sells it to companies such as Baxter International for distribution to hospitals and pharmacies. According to the FDA investigation, it appears that the contamination in the heparin was intentional, and has been called “economic fraud, “by deputy FDA administrator, Janet Woodcock. As previously outlined, the Chinese undercut each other in order to maximize profits, and they did to achieve this is substitute a chemical known as oversulfated chrondroitin sulfate (OSCS), which is derived from animal cartilage and only used in dietary supplements. This chemical mimics heparin, but does not have the medicinal values of the real thing. This chemical costs $20 per kg, instead of $2000 for crude heparin. The investigation concluded that the fake heparin was still sold for the same price as the authentic heparin, and the difference in was pocketed by the conspirators. This difference was approximately $1,980 per kg sold.
Baxter International and the FDA devised a test that identifies any OSCS in heparin. The FDA is scheduled to have eight full time staffers in China, which include four inspectors and a senior technical expert in food, medicines and medical equipment. The FDA, while working with its Chinese counterpart in Beijing, will be able to conduct more timely inspections, and in 2008 did only 30 inspections in China.
U.S. government agencies have little control or authority in foreign nations; however, approximately 60 personal injury lawsuits have been filed against Baxter and SPL in federal court. None of the involved companies have admitted any wrong doing. SPL states their heparin met Chinese standards, which apparently are murky at best. The Rihua Biomedical facility refused to allow inspections of it’s processing labs, and refused to provide a list of crude heparin suppliers. Prior to the heparin scandal, SPL’s Chinese facility was never inspected by Bejing’s drug-safety agency simply because the agency thought the facility was a chemical plant.
The only company throughout the entire issue that seemed to have any conscience and ethics is Baxter International. When this was discovered, they pulled all the heparin off the shelves, have cooperated with the FDA, and appear to be eager to resolve the deficiencies within the supply chain.
In summation, it appears that there are a number of entities at fault: First, the American and Chinese governments for not mandating stiffer laws, regulations, guidelines and fines for companies that staunchly import products from foreign companies and countries with little to no oversight, and allow harm to befall the public. Second, the companies in question put profits above the health and welfare of the consumer, and have turned an unseeing eye and a deaf ear to the origination of the materials they purchase for manufacture, until issues like the heparin scandal arise, and then they scramble to do damage control. Third: the populace for not demanding sanctions and embargos against the Chinese government and companies such as SPL, and Baxter International if they are deemed responsible. With regard to heparin and milk products specifically, there is no reason why U.S. companies should have to rely on animals half way around the world to supply American markets with milk and key ingredients for heparin. Additional controls that need to be implemented and streamlined for milk and heparin’s raw materials, to ensure a quality supply chain, are: Inspection of raw and finished ingredients and products that must meet FDA guidelines no matter where originating or manufactured; production process monitoring; close field work supervision, internal control supervision/scrutiny, and extremely stiff penalties for falsifying ingredients, documents, or committing fraud of any kind. The FDA has the authority to fine and or close any U.S. company that is not in compliance with U.S. regulations and standards. Therefore, any American company found in collusion with outside vendors, or at fault for unwittingly harming the public when said company should have performed due diligence to ensure the publics’ trust would not be betrayed. These companies employ experts that hold the publics’ welfare in the palms of their collective hands. These professionals are held to a higher standard due to their education and expertise in the medical or pharmaceutical fields.
Since money appears to be the driving force behind the heparin scandal, it would be safe to say that the only way to prevent other companies from attempting similar tactics with other products, be it food or pharmaceuticals, is to take the money away from said companies in the form of exorbitant fines and penalties. In short, whatever profits they made selling tainted goods, should be seized and given to the victims or their families. Furthermore, American and European companies should, in good faith, close their Chinese facilities and move their bases of operation back to their home countries, thus ensuring oversight and proper regulation. By ostracizing the Chinese and their products, will in effect, cripple their economy, destroy their reputation and position as an economic powerhouse, and thus prevent their unethical business practices from infecting the rest of the world and destroying more lives.
The operations management terms that can be utilized to describe this article are efficiency, which means doing something at the lowest possible cost. The companies in question felt the only way to obtain efficiency was to falsify key ingredients thus endangering lives of the consumers. For the greater part of a decade, these companies went for the most part unchecked. They utilized standard ingredients and practices to create their product, and maintained sustainability. However, at some point, a decision was reached to change the ingredients, and use cheaper and ineffective materials to fraudulently triple or quadruple their bottom line. The difference in price for the key ingredient in heparin and OSCS is $1,980, all of which was pocketed by the manufacturers. Eventually the sustainability of this scheme was destroyed when the consumers of this product became sick and died, and investigations were launched and concluded. While these companies focused solely on profits and exceeded their original expectations for their bottom line, in the long term, their profits and sustainability have been diminished, if not destroyed due to their lack of ethics and zeal for greed.