Summary of issues presented
Heparin, one of the most widely used blood thinners, has been linked to the deaths of several patients in the recent past. This has prompted the Food and Drug Administration (FDA) to launch an inquiry into the allegations. In examining the allegations, it has been determined that all of the Heparin which was linked to the deaths of the patients consisted of active ingredients which were obtained from a Chinese plant. The Chinese plant which manufactured the Heparin was found to have “potential deficiencies.” The specific nature of the deficiencies was not indicated, however, the number of incidents involving Heparin has drastically increased in the weeks following the first indication of a problem.
One of the most significant issues with regards to deaths and injuries associated with Heparin is one that involves a blatant oversight on the part of the FDA. The FDA is duty-bound to inspect any plant-providing ingredients or products that are approved by the FDA. The FDA has admitted that its officials have neglected to inspect, Changzhou SPL, the Chinese plant which provided the heparin utilized by Baxter International, the maker of the heparin in question. The implications of this are such that the failure on the part of the FDA to do its job can be cited for the resulting deaths of what is now estimated to be approximately seventeen (17).
Another related issue is the notion that one is unclear as to whether the individuals who died did so as a direct result of the heparin they were provided with. There can be no direct causal relationship in that many of the individuals who were provided with heparin had significant and life-threatening illnesses. These illnesses may have indeed caused their deaths and the issuance of heparin may not have been to blame. Essentially, any link which exists between the deaths of these individuals and heparin is esoteric and inconclusive at best.
Description of parties involved
The approval of drugs and their regulation follows a complicated scheme. The parties involved in this paradigm include the individual manufacturers, their suppliers, the regulatory agencies both within the United States and abroad as well as the individual consumers and the organizations which provide the individuals with the drugs in question. The individual manufacturers owe a duty to the product consumers to assure that their products meet the guidelines provided by the regulatory agencies and will not do any harm to the consumers.
The suppliers of the raw materials which are utilized by the manufacturers owe the same duty to the individual consumers. Additionally, they have to assure that they are in compliance with the necessary regulations. An inspection of their facility by the FDA is one of those measures which have to be complied with. The regulatory agencies, on the other hand, have to assure that compliance with their measures is facilitated. This compliance involves actual attempts to inspect a facility and a final determination of its suitability. In the case in question, this was not done and as such, the agency did not live up to its obligation to assure that no consumers were harmed as a direct result of the utility of certain drugs.
Finally, the organization which provides the drug is involved in that it actually administers the drugs to the individuals. The administration of the drugs does come with certain responsibilities. These responsibilities include the competent administration as well as assuring that there are no issues involving the drug which can be detrimental to the health of the patient other than those indicated under the potential side effects.
Potential resolutions
One of the most fundamental resolutions with regards to the heparin which has been linked to the deaths of the patients is that of a recall issued by either the drug manufacturer or the regulatory agency. In this case, a complete recall was issued by Baxter International. This was the responsible course of action and I’m happy to see that Baxter International did take this action.
Another potential resolution was one that was motioned in the article. That resolution involves the utility of heparin manufactured by other manufacturers who did not utilize crude heparin from the Chinese plant in question. In so doing, one has to assure that all of the inspections and the necessary compliance measures have been undertaken.
Yet another potential resolution to this issue is one which involves accountability on the part of the FDA. It is prudent that the FDA conduct the necessary inspection(s) in order to assure compliance on both the part of the manufacturing plant and that of the plant providing the crude heparin. Such an inspection would assure that the quality of the heparin produced is one that is aligned with the guidelines as created by the regulatory agencies.
Open questions
After reading this article, there are several areas that can be made clearer and as such, some questions have arisen. These questions are as follows:
- What is at the root of the problem seen in the heparin which was produced using crude heparin from Changzhou SPL?
- Under what conditions will Baxter International be able to produce heparin assuming that the FDA will grant such permission?
- Will the officials of the FDA who were charged with the responsibility of inspecting the Chinese plant face any punitive measures?
- Is there a system of checks and balances within the FDA which allows for the detection of compliance measures that have been overlooked?
- Will the FDA implement any proactive measures to assure that such a tragedy does not occur in the future?
Reference
Bogdanich, Walt (2008). Blood Thinner Might Be Tied to More Deaths. The New York Times (online).