Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.
University of Science and Technology (ISU), a detailed admission by the Respondent, and additional analysis conducted by ORI, ORI and ISU found that Dr. Dong-Pyou Han, former Research Assistant Professor, Department of Biomedical Services, ISU, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants P01 AI074286, R33 AI076083, and U19 AI091031.
Bradac said in a phone interview Monday that Han apparently added human blood components to the rabbit blood to skew the results. The human blood came from people whose bodies had produced antibodies to HIV, the virus that causes AIDS, Bradac said. The presence of these antibodies in the rabbits’ blood made it appear that the vaccine was spurring the animals to build defenses against HIV. “This positive result was striking, and it caught everybody’s attention,” Bradac said.
Drug companies have turned into marketing machines. They’ve kind of lost sight of the fact that they’re actually doing something which involves your health,” Marciniak says. “You’ve got to take away the key components of the trials from drug companies.
As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed, and clinical guidelines, medical practice, and healthcare expenditure decisions are biased
The charges included experimenting with human beings as well falsifying parental authorizations so babies could participate in the vaccine-trials conducted by the laboratory from 2007 to 2008
Minimizing the COIs in vaccine safety research could reduce research bias and restore greater trust in the vaccine program
We have identified a potential source of publication bias among several medical journals
Corruption in the pharmaceutical sector occurs throughout all stages of the medicines chain, from research and development to dispensing and promotion
Overall, studies funded by a company were four times more likely to have results favourable to the company than studies funded from other sources. In the case of the five studies that looked at economic evaluations, the results were favourable to the sponsoring company in every case. The evidence is strong that companies are getting the results they want...