Up yours FDA

I cannot imagine which parent would force--and I use the word force here literally, their own infant into medically-related pharmaceutical studies. What goes through a mother's mind when she essentially signs away her own child's life to the medical industry?

A very recent study examines the repercussion of drug, Paracetamol, in infants whom have been given precautionary vaccinations for fever. Paracetemol, a fever reducer, is an NSAID, which are non-steroidal anti-inflammatory agents/analgesics. It has been studied to cause liver failure in certain types of mammals, and to do serious damage on kidneys, even in low dosages, on humans. All this, and its more harmful effects are, by law, written in the print of the study contracts and thereafter provided to patients (in this cause the legal guardian of the patient) for their understanding prior to accordance of admission. What I am trying to say is that mothers are fully aware of the damaging possibilities their child may experience while being involved in such a study.

With a trial group of over 400 babies, of each who partook in vaccines against pneumococcal disease, Haemophilus influenzae type b, diphtheria, tetanus, whooping cough, hep B, polio, and rotavirus, were then provided with three "therapeutically relative" doses of this NSAID every 6 to 8 hours. It was found that these babies developed a WEAKER immune system with decreased amount of antibodies as a result of the said drug, alongside mild damages to infant kidneys.

BABIES DO NOT HAVE THE CAPACITY TO MAKE ARTICULATE DECISIONS, let alone moderately simple ones. It is therefore the task of the caretaker to make the most informed decisions for their child. I feel that there needs to be a greater amount of regulation and education for such cases. It seems striking to me that infants can bear horrible results from experiences in their life they did not have control over, especially in sitations that CAN AND SHOULD be easily regulated by the government. Why is the governmental health agency even allowing production of such research studies on infants? Especially when it is that that humans of this age group are most susceptible to disease and infection? The more and more I advance in my medical school education, the more and more I become disgusted with the process and influence the pharmaceutical industry has on my future career and on the future of global health. Research is crucial. However, I do not feel that drugs should make its way through the green light on FDA's horribly regulated roads without having successive POSITIVE tests in ALL directions on in vitro trials.

FDA fails to reduce accessibility of paracetamol despite 450 deaths a year. Confidential documents from the US Food and Drug Administration suggest that the agency has avoided a debate on tough new measures to reduce overdoses from painkillersto avoid offending the pharmaceutical industry. FDA fails to reduce accessibility of paracetamol despite 450 deaths a year. Confidential documents from the US Food and Drug Administration suggest that the agency has avoided a debate on tough new measures to reduce overdoses from painkillersto avoid offending the pharmaceutical industry.

In the United States paracetamol is associated with more than 100000 calls a year to poison control centres, as well as 56000 visits to emergency departments, 26000 hospitalisations, and
450 deaths.

According to one FDA insider, [decisions to black label this drug] were dropped because senior FDA managers saw them as too offensive to Johnson & Johnson. Asked about this alleged corporate influence within the FDA, Dr Cantilena smiled and said he did not want to speculate.

Of course.

Up yours FDA.