Drug giant profits from human suffering

Just two days after the Philadelphia-based pharmaceutical giant Merck & Co. Inc. reported that first quarter 2008 earnings had soared on a special $2.2 billion pretax gain from a limited partnership with AstraZeneca, federal inspectors reported finding 49 “areas of concern” involving contamination of Merck’s products, including children’s vaccines.

The U.S. Food and Drug Administration, which spent 30 days at the company’s plants between November 2007 and January 2008, issued a 21-page report suggesting the problems “could be a symptom of Merck’s cost cutting in the face of rapid growth of its vaccine business.”

The FDA report, however, has not been published. Unlike the hew and cry when Chinese drug manufacturing plants were accused of making tainted heparin and heparin-related products, there seems to be no outpouring of condemnation by U.S. media against this U.S.-based firm. However, the Philadelphia Inquirer did obtain details of the report through a Freedom of Information Act request.

In 2007 Merck & Co. Inc. revenues were $24.2 billion. Merck is a well-known name in vaccine production, which accounted for an increase in company sales from $1.1 billion in 2005 to $4.3 billion in 2007.

The federal investigation cited instances of unwanted “fibers” on the stoppers of MMR (measles, mumps and rubella) vaccine vials at the company’s vast plant in Montgomery County outside Philadelphia. This same plant was the source of a chemical spill that contaminated a nearby recreation area and closed water-intake pipes on the Schuylkill River in 2006. Merck paid out $20 million for that incident.

Consumers are not the only ones negatively impacted by Merck’s “cost-cutting” measures. By 2007 Merck had cut about 6,000 jobs and plans to eliminate 7,000 more in 2008.

Inspectors also found instances of contaminated children’s vaccines and uninvestigated complaints at Merck’s West Point plant. Samuel Young, a retired FDA deputy director, told the Philadelphia Inquirer, “Vaccine-makers were supposed to investigate vaccine lots if their use was associated with a death or a life-threatening event.” (April 24, 2008)

The FDA report noted that Merck had failed to investigate two such cases. In 2005 a patient treated with Merck’s pneumococcal vaccine Pneumovax developed a half-dollar-size abscess and required intravenous antibiotics to contain the infection.

Another extremely serious problem is its vaccine Gardasil to prevent Human Papilloma Virus (HPV) infection, which causes 70 percent of all cervical cancer cases. FDA documents indicate Gardasil may have been responsible for at least eight deaths in a number of countries. Since its approval, there have been more than 3,400 complaints of adverse reactions to the drug.

Other quality control problems at Merck’s West Point plant resulted in the shutdown of bulk production of varicella-related vaccine for chicken pox and disruption of the supply of Vaqta for hepatitis A.

In December 2007, the company voluntarily withdrew 1.2 million doses of the childhood vaccines PedvaxHIB and Comvax because it could not guarantee the products’ sterility. FDA inspectors criticized Merck for making a manufacturing change involving the withdrawn vaccines in mid-2006 and then later reversing course and claiming that the change was the reason for the withdrawal.

Merck recently announced it would pay $4.85 billion to settle tens of thousands of lawsuits stemming from its painkiller Vioxx, which it pulled from the market in 2004.

While it appears that the FDA may take no action where Merck is concerned, China’s State Food and Drug Administration, after the safety of raw materials came under fire, issued a directive to the makers of heparin and heparin-related products to strengthen quality control standards, even though there was no concrete evidence that drugs manufactured in Chinese plants were the cause of 21 reportedly heparin-related deaths in the U.S.

U.S. corporate media and anti-China bloggers were quick to turn the heparin-related deaths into the latest “don’t buy products made in China” campaign, following similar scares around alleged “exploding cellphone batteries,” “children swallowing magnets” and “anti-freeze in toothpaste,” to name a few.

The motivation behind these anti-China campaigns, however, may have a lot more to do with China’s rise as an economic power at a time when U.S. economic influence is declining, than concern over the health and safety of consumer products.

These attacks are also useful in diverting attention away from the serious underfunding of U.S. product safety monitoring agencies like the Food and Drug Administration. It has experienced a multimillion-dollar funding cutback that has resulted in serious understaffing at the same time Bush and Congress are spending $341.4 million per day on war.