In 2004, a Texas urologist named James Vestal was shown to have violated the rules for FDA drug-trials numerous times in his studies for Eligard, a prostate cancer drug. Over the next three years, Vestal continued to perform drug trials until he received a letter from the FDA starting disciplinary action. Even so, Vestal was still not forced to stop running trials, although he voluntarily stopped while in negotiations with the FDA.
Vestal’s violations included using an unqualified and unconfident study coordinator, Jennifer Lawton, whose prior experience was limited to drawing blood and working as a lab technician. Ms. Lawton explained to Vestal repeatedly that she did not feel comfortable carrying out the duties assigned to her and she spoke to a supervisor and even went to the drug company itself and spoke to representatives. However, her concerns went unrecognized and she eventually just left her position. In Vestal’s lab, investigators found frozen, unlabeled vials of urine and two-week old samples that were supposed to be sent out on a daily basis. One of the FDA investigators said that Vestal’s lab was “the worst mess” she had seen in her 12 years as a researcher.
What many people, myself included, are wondering is why does it take the FDA so long to prevent doctors from performing further drug trials blatant violations of policy are discovered? As the article states, “the clinical drug trial industry is poorly regulated and riddled with conflicts of interest, Bloomberg News reported in 2005.” Even our dear friend Arthur Caplan was appalled at the Vestal case and said that the time he was allowed to continue researching was far too long. Although the FDA is trying to speed up the disciplinary process, no one really has a good idea of how many researchers who are being investigated by the FDA are still doing drug trials.
Even after Vestal was demoted to the position of sub-investigator, the FDA still failed to follow up on him and make sure that he was following the rules. This situation screams to me that the current system of drug-trials regulations is heinously overdue for an update. The FDA needs to revamp its evaluation and investigation process immediately. The sheer number of drug trials that are being carried out unsupervised is unconscionable and allows drugs that are potentially unsafe to be marketed on the basis of unreliable trial results.
Source: http://www.bloomberg.com/apps/news?pid=20601109&sid=a3iFD.rCBpA8&refer=home
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I completely agree with your disgust at the FDA’s lack of response to Vestal’s violations of the rules determined for drug-trials. However, I would not limit the cause of this atrocity to the fault of only the FDA. I believe that in general, not enough attention, both from the media and from political figures, is paid to the issue of discipline with regards to the FDA. The lack of attention in turn, causes a lack of funding to the FDA. Without sufficient resources, the FDA would not be able to stop researchers such as Vestal from carrying out trials even if they redesigned their methods by which to critique researchers.
Additionally, the underlying issue of lack of funding for the FDA affects more that the medications being produced from internal research. The lack of FDA funding is also affecting the “foreign inspection budget” (http://www.washingtonpost.com/wp-dyn/content/article/2007/10/31/AR2007103102669.html). But what does this mean exactly? It means that drug manufacturing companies that are based in other countries and import drugs into the United States are not subject to rigorous quality control tests. In China, there are over 700 drug manufacturing companies, and in a given year only approximately 20 of them undergo inspection. Even then, because the inspectors require translators and guides, companies are often notified of inspections far in advance, giving them time to prepare for the examination. This lack of quality control presents a central risk to any patient that consumes drugs manufactured outside of the country. Therefore not only is the lack of funding to the FDA causing a lack of discipline in research within the country, but with other aspects of health care as well, such as the manufacturing of drugs.
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