Medical fraud

AU the medical records of the subject should be available for comparison with the data recorded in the case report form (CRF). In the past, physicians have not allowed medical records to be available for the so-called source verification by non-physicians since they felt that this broke the strict confidentiality of the study subject s medical records. However, frequent mistakes in transferring important clinical data to the CRF, the recruitment of subjects who do not meet the inclusion and exclusion criteria and the occasional blatant fraud has led to an insistence by sponsors and regulatory agencies for sponsor s review of study documentation. Indeed, verification of source data cannot take place without access to the medical records of the study subject by the sponsor s staff. 

Lock S, ed. Fraud and Misconduct in Medical Research, 2nd edn. London BMJ Publishing, 1996. 

The introduction of GCP has accelerated the need for quality control and quality assurance, particularly in the field of clinical research. Quality control is carried out by the staff who are responsible for the particular activity, working to SOPs that cover all the tasks under scrutiny. SOPs not only need to be written but must also be updated regularly. Quality assurance is the process which seeks to confirm that SOPs have been observed this is accomplished by the process of auditing. Internal audit departments should be under a separate management from the medical department. Regular audits can not only assure external bodies, such as regulatory authorities, that proper procedures have been followed, but also serve to deter those rare attempts at fraud on the part of clinical investigators, which occasionally become evident. ... 

In response to these wild claims and harmful side effects, medical societies called for regulation of patent medicines. The dean of the Harvard Medical School, Oliver Wendell Holmes, Sr., said in 1860 before the Massachusetts Medical Society that if all available drugs could be sunk to the bottom of the sea, it would be better for mankind, and all the worse for the fishes. 4 An expose of the patent drug industry called The Great American Fraud by Samuel Hopkins Adams appeared in Collier s Weekly in 1905. Hopkins accused the industry of relying on fake testimonials and fraud to poison the public. 

The Spitzer suit claimed, GSK has engaged in repeated and persistent fraud by misrepresenting, concealing and otherwise failing to disclose to physicians information in its control concerning the safety and effectiveness of its antidepressant medication paroxetine... in treating children and adolescents with Major Depressive Disorder. ... 

We mentioned earlier that science is coming full circle to that which was taught in the ancient mystery schools. Even modern medical science is beginning to recognize man s subtle energy substructure such as the acupuncture meridians. Practical alchemy has labored under a bad reputation, branded fraud or at best pseudo-science by those with no practical experience in the matter at all. 

Similarly, billing Medicare or Medicaid for medications fhaf were obtained as free samples or trial supplies from manufacturers would also be considered as fraud under the False Claims Act. Furthermore, pharmacies that receive medication samples and bills for them also violate the PDMA. The pharmacist must track the disposition of free samples and frial supplies and assure that they are not fraudulently billed for. 

We in medical research have also been unconscionably apathetic. We have allowed the most extreme animal-rights protesters to seize the initiative and frame the issue as one of animal fraud. We have been complacent in our belief that a knowledgeable public would sense the importance of animal research to the public health. Perhaps we have been mistaken in not responding to the emotional tone of the argument created by those sad posters of animals by waving equally sad posters of children dying of leukemia or cystic fibrosis. 

The principle medical body in France established a group of experts in 1999, the Delegation a l Integrite Scientifique, to focus on both the prevention of research fraud and the sanctions to be taken against individuals or institutions, although there have been few official reports of fraud. There are detailed sequential procedures to be followed, and much use has been made of the experiences of other countries. 

The system for dealing with doctors suspected of research crime in the United Kingdom revolves around the GMC, which stated in 1992 that their disciplinary committee would take a very serious view of proven clinical research fraud. Since 1990, 26 doctors accused of research fraud have been reported to the GMC, all but 1 being found guilty. The penalties imposed ranged from erasure from the Medical Register, to admonishment and limitation of future research. The GMC can only investigate suspected fraud or misconduct after a formal... 

Research fraud is a reality, but in the past, healthcare professionals and academia have sometimes chosen to turn a blind eye, and pharmaceutical companies tacitly condoned it by choosing not to investigate fully and to bring prosecutions. The climate now is changing, driven by all those parties, but medical research is still vulnerable in the absence of any effective mechanism to combat and detect fraud. 

Ankier S. 2004. Misconduct and fraud in clinical research. In Medical Law and Research. Ankier Associates. 

Lastly, the ethical component to modeling cannot be overemphasized. Many models are complex and it is easy to deceive a reader on model development, modeling results, and interpretation. Patients who are prescribed medication rely on the integrity of the pharmaceutical scientists involved in their medication s development. A breach of that trust may lead to deleterious consequences for the patient, the scientist involved, and for the company should any fraud be discovered afterwards. Beyond financial and safety reasons, ethical modeling leads to greater trust in the methodology and advances the profession. 

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