Other methods to lower cholesterol may be just as effective as statins in also reducing cardiovascular events. Researchers recently analyzed 49 trials involving more than 300,000 people that looked at different ways of lowering cholesterol. The trials were sorted into 4 groups: Those that examined statins; nonstatin treatments that work to lower LDL “bad” cholesterol levels such as diet and the drug Zetia (ezetimibe); fibrates and niacin; and the newest class of cholesterol-lowering drugs known as PCSK9 inhibitors. Statins and nonstatin interventions had similar reductions in the risk of a heart attack, stroke or need for a stent, according to the study, published in JAMA. Fibrates and niacin also worked to mitigate the risk, though the reduction was not as great as with statins and nonstatin treatments. The PCSK9 inhibitors also showed some benefit, but there have been few studies conducted to determine their long-term benefit. Published September 27, 2016. Via JAMA.
A large percentage of FDA drug reviewers who leave the agency end up working for pharmaceutical companies, according to a new study that documents the long-suspected trend. Of 55 medical reviewers who examined applications for hematology-oncology drugs between 2001 and 2010, 15 of them — or 27% — left the agency for a career either with a biopharmaceutical company or as a consultant to one, according to the research published in The BMJ. About half of those 55 have remained at the FDA. Overall, 26 reviewers left the FDA. The findings are concerning as some critics have argued that the allure of a job in industry may unduly influence FDA staff when reviewing a drug. However, the study did not insinuate this. In addition, the study did not examine whether the reviewers worked for the drug industry prior to the FDA. Reviewers are also required to declare potential conflicts of interest. Posted September 27, 2016. Via BMJ.
The FDA has approved a biosimilar version of the inflammatory disease treatment Humira (adalimumab) called Amjevita. The approval is only the third time the agency has approved a biosimilar — in essence, a generic version — of a biologic based drug, which can cost tens of thousands of dollars per year. In late August, the FDA approved Erelzi, the first biosimilar of an inflammatory disease treatment. Amjevita is approved to treat various conditions, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Like Humira, Amjevita will have a “black box” warning on the increased risk of serious infections leading to hospitalization or death. Posted September 23, 2016. Via FDA.