Saturday, January 17, 2009

Lily must pay up: pharma and illegal drug promotion

I first came to understand the link between the responsibility of pharma to closely follow FDA marketed drug regulations and related pharmaceutical company lawsuits with the landmark Merck settlements. The Vioxx claims of increased cardiac events in patients and the cover-up of data implicating these conditions reminded me of the power pharmaceutical companies have affect the lives of millions of people. For me, that opened up a whole world of knowledge of the area of pharmaceutical litigations, especially with the rising number of lawsuits dealing with illegal drug promotions. Bristol-Myers Squibb had to pay $389 million for illegal promotion of the use of Abilify (aripiprazole) to children. Purdue Frederick had to pay $700 million in connection with the resolution of charges on the promoting of the opioid analgesic, OxyContin, which opium-related side effects were not delved. And now Lily must pay over $1.4 billion across various states in the US, the highest sum for any case perpetuated by a whistle-blower, for the illegal promotion and the use of schemes to increase the number of prescriptions of the drug Zyprexa to vulnerable populations.

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Saturday, December 27, 2008

Efficacy and Safety of Incretin in Type 2 Diabetes

Currently available hypoglycemic agents are not able to successfully lower the hemoglobin A1C (HbA1C) level to less than 7% in the majority of type 3 diabetes. If not from ineffective usage, the lack of efficacy is majorly due to a dease in pancreatic beta cell function. Efficacy is also limited by adverse effects such as weight gain, edema, hypoglycemia, or lack of targeting of postprandial hyperglycemia. New treatment options aside from the conventional antidiabetic agents are being considered for nonpregnant adults with type 2 diabetes.

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Tuesday, October 14, 2008

Drug discovery: forward or reverse pharmacology?

Drug discovery is a very complex process which entails discovering new agents for the treatment or prevention of diseases and disorders. Despite the high level of advances in the understanding of the human body, from basic human physiology to the smallest level of the human genome, a potential agent still takes an upward of 15 years from pre-clinical study in the lab to the patient lying in a hospital. Only in understanding the various strategies that have been implemented for the development of clinically successful agents can one find the best approach for effective drug discovery. Recently, new terms have been coined to describe two approaches to the
study of the interaction between organisms and chemical molecules used to alter the biochemical function of molecular targets: forward and reverse pharmacology.

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