It’s no secret that the bloom has fallen off Pharma’s rose. Blockbuster pills like Lipitor, Seroquel, Zyprexa, Singulair and Concerta have gone off patent with nothing in the pipeline to replace them. Medical journals like the Journal of the American Medical Association (JAMA) and New England Journal of Medicine (NEJM) are noticeably thinner without the Pharma ads that have leavened them for years. As ad revenues attenuate, WebMD, the voice of Pharma on the Web, is also withering on the vine and announced it would cut 250 positions in December.
As the blockbuster pill model breaks down, Pharma is pushing vaccines and injectable drugs which cost hundreds per dose, can sometimes be co-marketed through pharmacies and are not as susceptible to generic competition. Especially lucrative to Pharma are genetically modified biologic drugs that suppress the body’s tumor necrosis factor (TNF). TNF-blockers, which cost around $20,000 a year, can be life saving for autoimmune diseases but… life-threatening for diseases which do not warrant them! Nonetheless Pharma is marketing TNF-blockers for arthritis, back pain, skin and digestive disorders, to prevent bone thinning and even for asthma. Ka-ching.
Most of the TNF-blockers are linked to TB, cancers and super infections according to their labels because they suppress the immune system. One such drug, Xolair, was investigated by the FDA for links to heart attack and stroke and 77 people who took Xolair had life-threatening allergic responses in a year and a half, according to FDA reports. Still it is “recommended” for asthma by doctors who are consultants to Pharma. What?
This month, Xolair, marketed by Genentech and Novartis, was trumpeted in the New York Times for having a new possible use of treating patients with chronic hives or chronic idiopathic urticaria. If approved for the new indication, chronic idiopathic urticaria will likely became a major U.S. health problem to be advertised on TV like restless legs syndrome.
Some of the clinical tests to determine Xolair’s safety were conducted at Vivra which was investigated twice by the FDA because of whistleblower reports. Trials of Xolair and at least seven other drugs were corrupted by protocol violations and outright fraud, according to a former clinical research subinvestigator who worked at the facility. Patients were pressured to participate in trials and not warned of the risks, patients’ drug dairies were falsified and insurers were billed for services which were actually enriching the investigator running the trials. San Mateo, Calif.-based Vivra Asthma & Allergy was the nation’s largest respiratory disease practice until a merger with Lakewood, Colo.-based Gambro in 1997 and with El Segundo, Calif.-based DaVita in 2005.
Other TNF-blockers Pharma is pushing are Humira for back pain that ads now suggest might actually be an autoimmune disorder and Prolia to prevent osteoporosis.
Drugs to prevent osteoporosis have not been Pharma’s finest hour. The heavily marketed bone drugs Boniva, Fosamax and Actonel are linked to esophageal cancer, osteonecrosis of the jaw, irregular heart beat, pain and actually causing the fractures they are supposed to prevent. Oops! Fosamax-maker Merck single handedly initiated the “bone scan” craze foisted on middle aged and older women and set up a bone “institute” to secure Medicare reimbursement for scans driving Fosamax sales, according to National Public Radio.
Watch for similar ruses to sell Pharma’s new injectable drugs.