Melissa Palmer, MD is available to the pharmaceutical and biotech industries for DILI Consulting– Drug-Induced Liver Injury Consulting
Melissa Palmer, MD has been a member of AASLD for more than 27 years. She inaugurated and lead the hepatotoxicity safety team at 2 pharmaceutical companies. In addition, Melissa Palmer, MD recently coauthored consensus guidelines for detection and assessment of DILI in clinical trials of NASH. Dr. Palmer has numerous additional publications pending on DILI for other liver diseases–such as PBC, PSC alcoholic hepatitis HBV and cirrhosis.
Melissa Palmer, MD would welcome the opportunity to consult with any pharmaceutical or biotech company on any drug-induced liver injury (DILI) issues.
SOME FACTS ABOUT DRUG-RELATED LIVER INJURY (DILI)
Liver failure, cirrhosis hepatitis and other types of liver injury can occur due to prescription drugs as well as over-the counter vitamins, herbs and other supplements
DILI is the frequently cited reason for withdrawal of medications from the market
The annual incidence DILI is 10 -15 per 10,000 – 100,000 persons exposed to prescription medications
DILI is the most common cause of acute liver failure in US
DILI accounts for 3-10% of all adverse events (AEs) reported to the FDA
DILI may not be detected prior to drug approval, because most new drugs are tested in< 3000 subjects. As a result, cases of DILI with an incidence of 1 in 10,000 may be missed.
For every 10 cases of ALT elevation (>10 x ULN) in a clinical trial, there will be 1 case of more severe liver injury that develops post-approval
10% of DILI incidents overall progress to death or liver transplant
17% of initial DILI events progress to chronic liver injury
Up to 5% of DILI patients suffer Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis, with 36% mortality
It is nearly impossible to predict which new drugs will cause hepatotoxicity and who will be susceptible to DILI. This is due in large part to the idiosyncratic nature of DILI and the lack of animal models for most drugs where mechanisms of liver injury and susceptibility factors can be uncovered.
Contact DILI Consultant — Drug-Induced Liver Injury Consultant– Melissa Palmer, MD