Prodisc, an artificial spine disc now made by the Swiss company Synthes, is at the center of a congressional investigation into the close financial ties between doctors and the makers of drugs and medical devices.  Senator Charles Grassley (R-Iowa) sent a letter to Synthe’s American headquarters citing concerns over the possibility of “a dangerous conflict of interest” posed by the financial ties many doctors involved in Prodisc clinical trials had with the company that developed Prodisc.  The Food & Drug Administration (FDA) also received a similar letter from the Senator.

Prodisc was approved by the FDA in 2006.  It had been developed by Spine Solutions, which was eventually sold to Synthes.  According to The New York Times, a New York investment firm, Viscogliosi Brothers, helped found Spine Solutions and financed the  disk’s development and research through a number of investment funds in which many of the clinical trial doctors were also investors. As a result, the very doctors charged with overseeing the clinical trails that would determine its approval had a high stake in the success of Prodisc.   More Prodisc Clinical Trials Scrutinized by Lawmaker

Auction rate preferred shares are the  latest securities to be scrutinized by state regulators.  These investment vehicles were sold by closed-end mutual funds, and lately, many investors have complained they are unable to sell their holdings, which were billed as a short-term investments by the firms that sold them. Once considered safe, auction rate preferred shares are the latest victim in the fallout of the subprime mortgage collapse.

Auction rate preferred shares are long-term corporate bonds, municipal bonds and preferred stock on which the interest rates are reset periodically based on bids submitted through securities firms. Generally, rates are reset every  seven, 14, 28 or 35 days. In the past, auction rate preferred shares have been popular with institutional investors due to their low financing costs and the fact there are usually fewer parties involved in the financing process and no requirements for third-party bank support. More Auction Rate Preferred Shares Leave Investors Short

The makers of Progresso Soup and Hot Pockets are recalling some products because they contain Hallmark/Westland meat.    Earlier this month, the US Department of Agriculture (USDA) announced that the Hallmark/Westland Meat Packing Company recalled 143 million pounds of meat, following a videotape of plant workers treating cattle cruelly and violating federal regulations.  Most meat has likely been consumed; at least 37 million pounds were used for school lunches—the company is a top supplier to that program—and federal nutrition programs.  In the wake of this scandal, two of the world’s largest packaged-food companies—General Mills Inc. of Minneapolis and Nestlé Prepared Foods Company, part of Nestlé SA of Switzerland—said they are also  recalling products.

General Mills said it began a recall of 35,000 cases of its Progresso Italian Wedding soup because it contained beef from a supplier that received meat from Hallmark/Westland.  A company spokeswoman said she couldn’t say whether all of the product had been removed from store shelves yet; each case of soup contains between six and 12 cans.  Nestlé said it recalled some boxes of Hot Pockets sandwiches that contain beef from a vendor that used Hallmark/Westland, including some Philly Steak & Cheese sandwiches and some Croissant Crust Philly Steak & Cheese sandwiches sold in two-pack boxes.  A Nestlé spokeswoman said the recall involves about 49,000 cases of Hot Pockets; each case contains eight boxes.  Nestlé told retailers to remove the product from stores.  Minnesota supermarket chain Supervalu, Inc., said it began removing the Progresso soup and Hot Pockets items, as well as some frozen ground-beef patties linked to the recall.  A spokeswoman for Hormel Foods Corporation said no Hormel products were recalled; however, one of its subsidiaries—Southern California’s Farmer John’s—will recall a “small amount” of hot dogs and cotto salami. More Progresso Soup, Hot Pockets, Other Foods Recalled in Wake of Hallmark/Westland Meat Recall

Hepatitis C and other blood borne diseases now threaten thousands of people in Nevada, thanks to the unsafe way anesthesia was administered at the Endoscopy Center of Southern Nevada in Las Vegas.  At least six people who received treatment at the Endoscopy Center of Southern Nevada have already tested positive for Hepatitis C, but health officials in the state have urged another 40,000 to be tested for the virus, as well as HIV.

Hepatitis C is a blood disorder that is  transmitted through blood-to-blood contact. Hepatitis C for the most part is asymptomatic and often leads to chronic, and long-term infection resulting in approximately 70% of those infected developing liver disease.  Hepatitis C is a risk factor for liver cancer and can lead to the need for a liver transplant. HIV is the virus that causes AIDS, and is  transmitted through the exchange of bodily fluids, including blood-to-blood contact.   More Nevada Hepatitis C Outbreak Tied to Las Vegas Clinic. Thousands Now At Risk for Hepatitis, HIV

Medical device maker Medtronic Inc. said on Tuesday that a proposed bill aimed at curbing inappropriate relationships between companies and physicians should require all device makers to be included, not just big ones.  The proposed “Sunshine Act” was introduced earlier this year by Senators Chuck Grassley and Herb Kohl and would require companies to publicly disclose—via the Internet—certain payments made to physicians for help with product development, research, and training.  Currently, the bill excludes companies with an annual revenue of less than $100 million as well as physician-owned companies, which Medtronic claims accounts for 75 percent of the companies in the medical device industry.  Medtronic said “a level playing field for all companies is appropriate and that these entities should operate under the same disclosure requirements, recognizing that transparency can help alleviate any real or perceived conflicts of interest with these types of companies as well.”

Recently, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this must change.  The team also found that once a device receives Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial.  According to the team, this data would improve health professionals’ awareness of “the potential promise and pitfalls of new technology.” More Medtronic Pushes for Expansion of ‘Sunshine Act’

Prozac, Effexor, and Paxil may only be effective in the most severely depressed patients. In a recent study conducted by British researchers on the effect of some antidepressants, it seems that antidepressant medications may only really be truly effective in the most severely depressed of patients. The study also found that these antidepressant medications actually work no better than placebos in many patients taking them and that the patients fared the same whether on a placebo or on one of the antidepressant medications represented in the study. The research was led by Irving Kirsch of the University of Hull and reviewed a series of studies—both published and unpublished—on four specific antidepressants.

The study examined the question of whether a person’s response to these anti-depressant medications was dependent on how depressed the patients were before they received treatment for their depression. All four medications studied are the so-called selective serotonin reuptake inhibitors—commonly known as SSRIs—and were specifically Eli Lilly and Company’s Prozac, which is also known as fluoxetine; Wyeth’s Effexor, which is also called venlafaxine; GlaxoSmithKline’s Paxil, which goes by both Seroxat and paroxetine; and Bristol-Myers Squibb Company’s drug Serzone, which is also called nefazodone. Bristol-Meyer’s Serzone is no longer marketed in the United States. More Prozac, Paxil, Effexor Don’t Do Much For Most Patients

Tysabri, a controversial drug used to treat Multiple Sclerosis (MS) manufactured by Biogen Idec Inc. and Elan Corp. has been linked to serious liver damage. This liver failure can occur within six days of the first dose of Tysabri. Tysabri, which was removed from the market in 2005 then reintroduced in 2006, has also been tied to a fatal brain infection and may even be associated with the onset of the skin cancer melanoma.

A Food and Drug Administration (FDA) advisory panel had apparently discussed the potential liver risks of Tysabri in late 2007 when considering whether it should be approved for Crohn’s disease. The liver risk was put into the drug’s package insert label in January 2008 when the FDA approved Tysabri for the treatment of moderate to severe Crohn’s disease. More Tysabri Now Linked to Severe Liver Damage

Toys “R” Us has announced plans to enforce a voluntary standard for lead in toys that is more stringent than the mandatory federal standard currently in place. According to a Toys “R” Us press release, “We have instructed all manufacturers who produce items for Toys “R” Us, Inc. that products shipped to the company on or after March 1, 2008 must comply with strict new standards, which include…applying a more stringent standard of 90 ppm for lead in surface coatings versus the current federal standard of 600 ppm for all products manufactured exclusively for Toys “R” Us, Inc.”  Toys “R” Us is also moving to ban phthalates in toys and plans to require all products sold in their stores to be phthalate-free by year-end of 2008.  The new standards also includes toys shipped to Babies “R” Us stores.

Studies have shown that phthalate exposure causes developmental abnormalities, particularly in fetuses and infants.  The European Union and the state of California have announced restrictions on the presence of phthalates in children’s products. Lead is known to cause cancer and reproductive harm and can cause mental and physical retardation and behavioral and other health problems in children.  In adults, lead can damage the nervous system. More Toys “R” Us Announces New Lead Safety Standards

The Food & Drug Administration (FDA) is going to be giving drugs more scrutiny once they are approved and on the market.  The new policy comes as lawmakers,  concerned by the rash of recent drug recalls, have been urging the FDA to step in and implement standards to help alleviate these issues.  Also, as part of a larger safety initiative announced to staffers Tuesday, the FDA will strongly recommend that doctors and patients more closely follow safety guidelines when prescribing and taking medications.  This post-approval initiative was triggered by congressional action last year that broadened the FDA’s drug oversight responsibilities

This influencing of actual drug usage is a change from the FDA’s traditional role as that of monitor, or gatekeeper, for new drugs and medical products.  Up until now, the FDA developed the labels that detail how drugs are meant to be used, but it left the final prescribing decisions to doctors, who are not bound by federal guidelines and can prescribe medications for off-label—uses other than what is FDA approved—uses.   More FDA Announces New Drug Safety Initiative

Epogen, Aranesp and Procrit,  anemia drugs used to treat cancer patients, have been linked to a higher risk of a potentially fatal type of blood clot.  According to a review published in the February 27 issue of the Journal of the American Medical Association, anemia drugs—medications designed to fight fatigue and other symptoms associated with cancer treatment-related anemia—significantly increase the risk of death and serious side effects in cancer patients.  The risk of death is increased by 10 percent when taking ESAs  — erythropoiesis-stimulating agents—and the risk of blood clots—venous thromboembolisms (VTE)—increased by 57 percent.  “What we’ve done here is put together the totality of the evidence and found two things that are concerning:  The increased risk of VTE and the increased risk of mortality,” said the review’s lead author, Dr. Charles Bennett, the A.C. Beuhler professor of geriatric medicine at Northwestern University’s Feinberg School of Medicine.

The U.S. National Institutes of Health explains that ESAs—erythropoietin (Epogen, Procrit) and darbepoetin (Aranesp)—work by stimulating bone marrow to produce new red blood cells.  Epogen, Aranesp and Procrit are used in the treatment of chemotherapy-related anemia and to treat anemia in people with chronic kidney disease who are also on dialysis. More Epogen, Aranesp and Procrit Linked to Potentially Fatal Blood Clots