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drugs 54 articles

‘Cheerleaders for Opioids’ Paid by Drug Makers

The top five manufacturers of opioid drugs set the stage for the nation’s epidemic of opioid abuse and addiction by investing millions of dollars into certain advocacy groups that aggressively promoted use of the highly addictive painkillers, a U.S. Senate committee investigation determined. The Senate Homeland Security and Governmental Affairs Committee investigation, spearheaded by Sen. Claire McCaskill (D-Missouri), examined the financial ties between the nation’s leading opioid manufacturers and outside organizations, such as patient advocacy groups, professional medical societies, and pain management awareness associations. Sen. McCaskill concluded that the opioid manufacturers invested more than $10 million into these groups, which ... Read More

New drug information database aims to help consumers understand risks and benefits

Last week, former Wired editor Thomas Goetz and Google engineer Matt Mohebbi introduced health care leaders to their new health information resource, which offers an easy-to-use database of drug information by combining the worlds of technology and health. Their company, called Iodine, seeks to serve the public by offering “better information about thousands of drugs, built from clinical research and real life experience from people like you.” Iodine’s database allows users to enter drugs of interest into a search engine, then presents basic information about the searched drug, its purpose, how it works, reported side effects, warnings, upsides and downsides ... Read More

Some diabetes drugs may be linked to more serious side effects than initially thought

Type 2 diabetes drugs known as DPP-4 inhibitors may be linked to more serious side effects than generally believed, according to an analysis from AdverseEvents. AdverseEvents, a health care informatics company, analyzed data on 11 of the newer type 2 diabetes drugs to conclude which were the safest and which may need closer watch. The drugs included in the study involved GLP-1 receptor agonists, such as Bydureon, Byetta, and Victoza, and DPP-4 inhibitors, such as Janumet, Januvia, Tradjenta and Nesina. AdverseEvents examined data from the Food and Drug Administration’s (FDA) Adverse Event Reporting System, FAERS, and then identified suspect cases ... Read More

Participants sought to test long-term effects of popular type 2 diabetes drugs

Researchers at Washington University School of Medicine in St. Louis are seeking volunteers to participate in a study comparing the long-term risks and benefits of four widely prescribed diabetes drugs. The medications will be given in combination with the widely used metformin. The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study will span five years, during which time researchers will evaluate how the drugs affect blood sugar levels, diabetes complications and quality of life. Each drug’s side effects will also be noted. The research team also aims to examine individual factors associated with better or worse response to ... Read More

Studies reveal not all FDA-approved drugs and medical devices receive adequate testing

According to articles in the Journal of the American Medical Association (JAMA), there can be major discrepancies in the amount of testing medical devices and drugs go through before being approved or given to patients. For example, the Food and Drug Administration (FDA) process used to approve certain heart devices using the assumption that if earlier versions of the product are safe and effective, newer products are, too, according to a recent study. Aaron Kesselheim, an assistant professor at Harvard Medicine School and author of one of the studies, notes that these devices go through rigorous testing to begin with, ... Read More

Rise in obesity rates puts more people at risk of serious health consequences

An estimated one-third of the world’s adult population is overweight or obese and at risk of developing diabetes and other serious health conditions, according to a new study by the Overseas Development Institute (ODI). “The evidence is well established: obesity, together with excessive consumption of fat and salt, is linked to the rising global incidence of non-communicable diseases including some cancers, diabetes, heart disease, and strokes,” the report states. The study found the biggest problem to be in developing countries, where an estimated 900 million are considered overweight – nearly three times as many as 1980. Comparatively, about 550 million ... Read More

Novel trials aim to speed approval of experimental breast cancer drugs

Two experimental breast cancer drugs showed promising results in a closely watched study designed to enable the accelerated approval of medication that addresses unmet medical need in the treatment of serious or life threatening conditions. The drugs include AbbVie Inc’s veliparib, a treatment for an especially aggressive type of breast cancer known as triple negative, for which there are few effective treatments, and Puma Biotechnology Inc.’s neratinib, designed to treat a different type of breast cancer known as Her2-positive. Both drugs were tested in an unconventional mid-stage trial involving patients with confirmed breast cancer whose disease is considered curable but ... Read More

Justice Dept urges court to try whistleblower’s lawsuit against Lance Armstrong

Seven-time Tour de France winner Lance Armstrong, who for years illegally used performance enhancing drugs to give him an edge over competition, says the U.S. Postal Service, his biggest sponsor, should have known about his doping. The dethroned cycling champion is attempting to have a USPS lawsuit against him thrown out by arguing that USPS officials “did nothing” and continued to back him when his Tour de France received widespread media coverage. Last week, the U.S. Justice Department objected to Mr. Armstrong’s assertions, which he presented to the court in July, saying that “the government and the rest of the world” ... Read More

Some type 2 diabetes medications linked to increased risk of heart failure

New studies suggest two type 2 diabetes drugs do not increase the risk of heart attack, but may increase the risk of heart failure. A heart attack occurs when blood flow to part of the heart is blocked for a long enough time to cause damage or death to part of the heart muscle. Heart failure is a condition in which the heart cannot pump enough blood to the rest of the body. Both conditions can be deadly. Cardiovascular risks with diabetes medications have made headlines in recent years since the blockbuster diabetes drug Avandia was linked to fatal heart ... Read More

FDA proposes new rules for food, drug, device recalls

Recalls of food, drugs and medical devices continue to make headlines as the Food and Drug Administration (FDA) works to implement the Food Safety Modernization Act (FSMA) and focus on compliance with current good manufacturing process (CGMP) requirements with all FDA-regulated products. As part of this effort, in January 2013 the FDA proposed a rule that would require manufacturers of food to maintain a recall plan that would evaluate the severity and scope of the recall; notify the FDA, consumers and the public; and secure insurance coverage for potential losses and liabilities. Manufacturers with no experience writing recall plans or ... Read More