Millions of Americans suffer from high cholesterol, which clogs the arteries and reduces life expectancy. A poor diet, lack of exercise and genetic factors can cause high cholesterol. Drugs, along with diet and exercise, as the TV commercials say, can lower it. But Vytorin, an oft-prescribed drug of TV commercial fame, may pose another risk. A study known as SEAS indicates it not only may fail in fighting cholesterol, but also could lead to cancer. The Food and Drug Administration has yet to agree.

So, is this a matter of he said, she said? Not so fast. The New England Journal of Medicine at first insisted that the study linking Vytorin to cancer was likely based on chance. But in an unusual reversal, the Journal’s editors conceded last week that it’s too early to dismiss such cancer concerns. “Physicians and patients are unfortunately left for now with uncertainty about the efficacy and safety of the drug,” the Journal reports.

Selling in the billions of dollars, Vytorin is produced and sold jointly by Merck & Co. and Schering-Plough Corp. Merck is the same pharmaceutical giant which produced the discredited drug Vioxx.

Wonder Blood Thinner Turned Killer Drug

A team of scientists led by MIT professor Sam Sasisekharan on April 24, 2008 formally announced that they had identified the contaminant in the blood-thinning drug Heparin, imported from China. Contaminated batches of the Baxter International-produced blood thinner slipped through a series of safety screens leading to death and injuries to scores of patients in the U.S.

The contaminant is a synthetic compound known as “oversulfated chondroitin sulfate” (OSCS). Based on the findings of two studies conducted by the scientists, the U.S. Food and Drug Administration (FDA) has now put screening methods in place to detect contaminated heparin.

Studies Published in Respected Medical Journals

The results of the two studies conducted by Professor Sasisekharan’s team were published in the British journal Nature and the New England Journal on Medicine. The study published in Nature, reported that heparin is only tested for contaminants such as protein, lipids or DNA. OSCS consists of long, complex chains of repeating sugar molecules that are almost impossible to detect. The MIT scientific team used the latest technology developed for analyzing complex sugars to find a method for detecting OSCS. The study in the New England medical journal revealed that OSCS activates two “inflammatory pathways” in the body: one that triggers blood clotting and dilation of blood vessels, resulting in dangerous blood pressure decreases while the other generates toxins that produce severe, and often deadly, allergic reactions.

U.S. Trade Officials Cite Need for China Reforms

China’s pig industry has a sordid history. Heparin, produced from Chinese pig intestines, is critical to the U.S. health care delivery system because the blood thinner is used by millions of patients during kidney dialysis and heart surgery to prevent blood clotting. U.S. commerce officials are now seriously concerned about health products from China. Reuters reported on April 25, 2008 that Christopher Padilla, U.S. Undersecretary of Commerce for International Trade, told a group of businessmen that Chinese regulators lack both the ability and will to monitor the nation’s pharmaceuticals and chemical industries. Padilla said that China’s State Food and Drug Administration (SFDA) has no authority to regulate the production of pharmaceutical ingredients not considered to be of medicinal use. He added that the Chinese manufacturer of the ingredients imported by Baxter to produce heparin was not registered with SFDA as a maker of active pharmaceuticals.

U.S. Officials to visit China

Padilla is leading a group of healthcare executives to China with hopes of introducing the concept of healthcare reform to the Chinese. Healthcare services and products have become one of the America’s fastest growing exports to China. Foreign investors, especially from America, have now become more cautious about Chinese products as the country continues to produce and export dangerous products. This acknowledgement provided little comfort to American drug consumers, especially since China did not inspect SPL because it was listed as a chemical producing plant, not a pharmaceutical plant.

What’s up with the FDA?

A lot of criticism, that’s what. The consumer watch dog is taking a beating for a process of drug approval that has ended up killing Americans. The FDA failure has attracted harsh attacks from the press. The Boston Globe, USA Today and The Reader’s Digest, among others, have published articles slamming the federal watch dog. The April 2008 edition of The Digest features a scathing assessment of the agency that is supposed to protect Americans from bad drugs, devices and products.

Spreading the bad word

The Reader’s Digest has 38 million U.S. readers and 100 million worldwide. But foreigners are no strangers to media criticism of the FDA. In 2005, The Lancet, a highly respected British medical journal, called the federal agency “ruthless and irresponsible” because it failed to take VIOXX off the market in 2000 despite evidence that long term use of the painkiller was risky for cardiac patients.

Internal critics slam the FDA

In early 2004, the white hot light of publicity caused headlines around the world when an FDA scientist testifying before congress attacked the agency for its handling of VIOXX.   Dr. David Graham, a senior FDA scientist accused it of “ignoring its own safety experts.” Its manufacturer pulled the drugg off the market voluntarily after that. By then, the highly touted drug had been sold in the U. S. for more than five years and experts had linked it to more than 27,000 heart attacks or sudden cardiac deaths nationwide between 1999, when it appeared on the market, through 2003.

Where there is smoke, is there fire?

The Reader’s Digest assessment of the FDA is damning. As the April edition of the magazine reports: “The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy  – and, sniff out any food borne terrorist plot” on the budget of a large school district!  Pressures on the FDA by patients who want to speed up the approval process for life-saving drugs; by drug manufacturers interested in profits, some of whom have hidden evidence of defects from the FDA; and by the FDA’s own sloppy record keeping and sometimes deliberate suppression of evidence that a drug is bad, is a recipe for continuing trouble.

Is the public helpless against killer drugs?

What can the public do? That’s a tough question since defective drugs and devices could be on the market for years before there’s enough evidence to recall them. Meanwhile, a new federal law gives FDA staffers the right to publish critiques of the agency; Congress has “created a new office within the FDA to improve the quality of research” and increased its budget. But lawsuits against drug manufacturers, and the media coverage they generate about the continuing FDA failure to properly regulate drugs, are crucial to protecting the public. VIOXX victims have won millions, keeping the story in the headlines, as crusading lawyers teach this malfunctioning federal agency a well deserved lesson.