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The Truth Seeps Out

Big Pharma Has A Rare Week

by MARTHA ROSENBERG

The sound you hear is Pharma swinging from the rafters. Two news stories this week may reinfuse revenue streams in an industry whose blockbuster pill “bubble” has burst.  As Lipitor, Seroquel, Zyprexa, Singulair, Concerta and several other drugs have lost patent protection, Pharma is shedding both employees and ad campaigns. WebMD, the voice of Pharma on the Web, announced it would cut 250 positions in December and medical journals like the Journal of the American Medical Association (JAMA) and New England Journal of Medicine are noticeably thinner without the Pharma ads that have leavened them for years.

Vitamin D and calcium will not protect older women from fractures, a government task force reported this week, in the Annals of Internal Medicine. The U.S. Preventive Services Task Force “recommends against daily supplementation with 400 IU or less of vitamin D3 and 1000 mg or less of calcium for the primary prevention of fractures” and  also recommends that older women, and younger ones with risk factors, be screened for osteoporosis.

While the report does not recommend expensive drugs or seem to be penned by Pharma consultants, its message is still good news for Pharma whose anti-osteoporosis drugs carried it through the 2000s.  “Don’t rely on just Vitamin D and calcium” and “get a bone scan!” were the marketing messages of the bone drugs Boniva, Fosamax and Actonel.

According to published reports, Merck, who launched the bone drug category with its Fosamax, single handedly initiated the “bone scan” craze foisted on middle aged and older women, including setting up a bone “institute” to secure Medicare reimbursement for the scans which were driving Fosamax sales.

Pharma even created the term “osteopenia”–at risk of osteoporosis–to sell the now discredited bone drugs, which are linked to esophageal cancer, osteonecrosis of the jaw, irregular heart beat, pain and actually causing fractures. Subsequent medical reports found the heavily marketed bone scans only benefit 10 percent of women who get them.

In more good news for Pharma this week, Genentech’s drug for allergic asthma, Xolair, co-marketed with Novartis, was trumpeted as having a new possible indication of treating patients with chronic hives or chronic idiopathic urticaria, reported the New York Times. 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. Ka-ching.

Genetically engineered drugs like Xolair (called monoclonal antibodies) cost as much as $20,000 a year and cause TB, cancers and super infections according to their labels because they suppress the immune system. 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.

Some of the clinical tests to determine Xolair’s safety were conducted at Vivra which was investigated twice by the FDA for procedural irregularities. Trials of Xolair and at least seven other drugs were corrupted by protocol violations and outright falsifications, according to a former clinical research subinvestigator who worked at the facility. San Mateo, Calif.-based Vivra Asthma & Allergy was the nation’s largest respiratory disease physician practices until a merger with Lakewood, Colo.-based Gambro in 1997 and with El Segundo, Calif.-based DaVita in 2005.

There is even a genetically engineered monoclonal antibody drug called Prolia to treat osteoporosis that costs $1,650 a year now that we know Vitamin D and calcium don’t work.

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).