Pharma shenanigans; alliance between healthcare industry & big pharma

This is the official website for the FDA's drug approval process. It includes very imformative and direct information about the drug approval process itself using user-friendly interactive diagrams.

Heidi M. Blanck PhD, Laura K. Khan PhD, Mary K. Serdula MD; Preventative Medicine; 39 (6); 1243-1248; (December 2004)

This article gives a brief overview of the drug approval process in general. It Breaks down the drug approval process in to different phases and explains the necessary steps that must be mastered to continue. It gives statistics of the withdrawal rates for drugs in each phase and cites the issues that cause such a small number of drugs to actually get approved.

This article explains why Fen-Phen has caused serious pulmonary and heart problems. It explains that the both drugs were approved by the FDA for uses but the combination therapy was not. This article goes into the specifics of the neurology and pharmacology of the drug, explaining why the combination has the effects that it does.

After European studies presented suspicious results of pulmonary hypertension this North American study was conducted. This study started with a different approach, instead of targeting Fen- Phen, first the researchers identified development of primary pulmonary hypertension then narrowed down circumstances then those who were unexplained drug histories were taken to show Fen-Phen. This study explores other possible explanations but later concludes that with extended uses the risk increases for development of pulmonary hypertension.

This study was initiated immediately after Fen-Phen was taken off the market. This study is designed to examine the rates and factors that are thought o be associated with increased rate of valvular problems. Many aspects of demographic information was presented in this study to pinpoint those who increase risk factors.

This preliminary report connects Fen-Phen with seizures. This is a small study that conducted on five patients with either a history of seizure currently in remission or new onset seizures due to this diet drug. Not only were the seizures present while taking the drug they persisted after treatment had ended.

This is an investigational study that sought to determine the effect of Fen-Phen and the association with valvual heart disease. This study sought to prove that the early reports were based on too small numbers and limited data that is unsupportive of valvual heart disease. The study concluded that Phen-fen therapy is associated with a low prevalence of significant valvular problems and valvular problems in our subjects may reflect age.