Author

Kurt Niland

5154 posts

Kurt Niland has been a professional editor and writer for 15 years. He is the author of four books and a number of articles for trade journals, newspapers, magazines, and web blogs. He attended New Mexico State University, the University of New Mexico, and Auburn University Montgomery, where he graduated summa cum laude with a degree in English. His lifelong interests in geography, anthropology, political science, literature, and religion fuel his writing and inspire him to travel at every opportunity. Originally from Connecticut, Kurt has resided in Montgomery, Alabama since 1991.

FDA warns Bayer about two OTC aspirin products

The Food and Drug Administration sent Bayer Health Care official warnings, stating that the company is marketing and selling two over-the-counter medications that are “illegal,” according to FDA spokeswoman Rita Chappelle. The two aspirin products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, are misbranded, mislabelled, and confusing to consumers, according to the FDA. According to Bayer, its Women’s Low Dose Aspirin fights heart disease and osteoporosis with a combination of 81 mg of aspirin and the equivalent of an 8-oz glass of milk in calcium for possible “lifesaving benefits.” Bayer Heart Advantage combines the same ... Read More

Vytorin loses market strength … again

Clinical trials haven’t been kind to Vytorin, Merck and Schering-Plough’s cholesterol brainchild. The first blow was dealt by the ENHANCE study, which showed Vytorin to be no more effective than much cheaper generic statins. Next came results of the SEAS trial, which indicated a link between Vytorin and risk of cancer and death by cancer. A flurry of disputed interpretations, accusations, and controversy followed in the wake of the trials. Most analysts expected the market for Vytorin to bottom out over the summer after the SEAS results became public — an event that many felt would deal the already wounded ... Read More

New Haven wants to recover Vytorin money

Should municipalities be allowed to reclaim the money it spent on expensive prescriptions if the prescribed drug turns out to be a dud? For the city of New Haven, CT, the answer is yes. According to a report in the New Haven Independent , the city’s top lawyer, John Ward, wants more than $400,000 back from Vytorin manufacturers Merck and Schering-Plough. New Haven City Hall spent more than $400,000 on Vytorin and Zetia (ezetimibe) prescriptions for members of the city’s healthcare plan when it could have spent a fraction of that amount for cheaper generic statins that have proven to ... Read More

Merck speeds trial of new cholesterol drug

Following Vytorin’s recent fall from its blockbuster status, Merck is ratcheting up studies of its new cholesterol fighting drug, The Washington Times reported. MK-0524A, as the new drug is called, is the subject of a study based in Oxford University in England. Merck submitted the drug to the FDA for approval, but it was rejected last April. The FDA wanted results from the study known as THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) before it made another ruling. The study already involves 20,000 people from the UK, Scandinavia, and China who are taking the experimental drug. ... Read More

FDA finds link between Revlimid and skin diseases

The FDA’s post-market safety review has uncovered a link between lenalidomide (marketed as the drug Revlimid) and serious skin reactions, including Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). The FDA approved Celgene Corp.’s Revlimid in December 2005 to treat a bone marrow disorder. It was later approved for use in treatment of multiple myeloma, a type of blood cancer. Earlier this month, Revlimid appeared on a list of approximately twenty drugs under investigation by the FDA for possible safety hazards. No details about the specific concerns were made available at that time. From the drug’s approved use in ... Read More

scientist cautions against dismissing Vytorin-cancer link

Does Vytorin increase the risk of cancer death? The question seems like it would be simple to answer, yet finding the answer requires navigating through a murky labyrinth of botched test results, apparent cover-ups, possible payoffs, and a whorl of conflicting interpretations that sometimes resemble self-interest, sometimes truth, depending on whom you ask. The University of Washington’s Thomas Fleming is one respected statistician and adviser to the FDA who cautions against dismissing Vytorin’s link to cancer as merely an anomaly. Leading researchers involved with the SEAS study, which uncovered a Vytorin-cancer link, maintain that the results were a fluke. In ... Read More

Avandia sales drop hurting GlaxoSmithKline

A UK newspaper reported yesterday that drug giant GlaxoSmithKline (GSK) – the second largest pharmaceutical company in the world – will cut 150 or more scientists and support staff positions. For years, GlaxoSmithKline, the manufacturer of Avandia, enjoyed stellar sales of the diabetes drug. Avandia was GSK’s second-best seller until the results of some studies surfaced that indicated the drug poses serious risks for its users. In February of 2007, a press release issues by GSK announced a link between female users and increased risk of bone fractures, especially of the upper arms, hands, and feet. In June of last ... Read More

UnumProvident federal trial in progress

UnumProvident’s trial has begun in federal court in Boston. The insurance conglomerate has been accused of fraudulently sticking the federal government with several million dollars in disability claims. Some of the allegations made against the UnumProvident include an apparent cost-cutting scheme in which the company directed its claimants to file for Social Security disability insurance benefits first, knowing that they were completely unqualified for such benefits. Claimants who failed to follow this procedure by not filing a claim with Social Security first had their benefits cut. Eligibility for Social Security disability is much more narrowly defined and harder to receive ... Read More

Merck developing possible Fosamax replacement

Back in January we explained how many pharmaceutical companies, following a Hollywood business model, have started to experience an erosion of their profits as patents expire on their “blockbuster” drugs. Aggressive, multi-billion-dollar marketing campaigns lead to multi-billion-dollar drug sales, but when patents expire, so do profits. Merck & Co.’s leading osteoporosis drug Fosamax illustrates the Hollywood paradigm. Its patent protection ran out earlier this year leaving Merck in a struggle to regain its share of the profitable osteoporosis market – a market that it once led, thanks to Fosamax. As Hollywood producers acquire licensing rights for their blockbuster movies, so ... Read More

Gadolinium federal lawsuits move ahead

Injecting a toxic liquid metal such as gadolinium into the bloodstream may seem like a procedure from a sci-fi horror movie, but it is a common, every day occurrence in medical centers throughout the country. When gadolinium is in the bloodstream, medical imaging devices produce clearer, more defined images of the patient’s blood vessels. Since gadolinium is extremely toxic to human tissue, it must first be coated with a benign chemical before being injected into the patient. Over the course of time, the body expels the metal through the kidneys. Patients with poor kidneys, however, experience a buildup of the toxic ... Read More