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Merck and Schering-Plough are not the only Big Pharma players getting hurt by their own actions.

Before Merck and Co. withdrew the painkiller Vioxx in 2004, it was linked to tens of thousands of heart attacks. Now a new study of internal Merck documents alleges the company knew of the dangers years earlier, but falsified statistics to hide them from the FDA.

In the five years it was on the market, Vioxx was a blockbuster for Merck that generated billions of dollars. When it was eventually linked to heart attacks and strokes, the product was pulled from the market. Earlier this year, Merck agreed to almost $5 billion in compensation to the victims of the Vioxx — I hesitate to use it, but there’s just no other word to describe it — scam.

A scam is “a confidence game or other fraudulent scheme, especially for making a quick profit.” A popular synonym is the word “swindle”. And that’s exactly what Merck, a Big Pharma player, worked on its millions of patients, their physicians, and before that, the Food and Drug Administration that approved the drug.

Now Merck is embroiled in another possible scam, this one over its massively profitable — $5.1 billion in 2007 — cholesterol drug Vytorin, a combination of Merck’s Zocor and Schering-Plough Corp.’s newer drug Zetia. An ongoing study shows that Vytorin is no more effective than cheaper, generic versions of the statin drug Zocor at reducing plaque buildup. The report has doctors nationwide reverting to older, cheaper statin drugs. And Congress is investigating whether the two companies withheld the unfavorable study results to boost sales.

In spite of widespread public concerns about the FDA’s effectiveness at protecting us from drug dangers, the agency appears to be stepping up to plate with Merck.

The FDA has rejected Merck’s application to sell the cholesterol drug Mevacor over the counter, and it has begun an investigation into the asthma and allergy drug Singulair, linking it to higher rates of suicide. Merck had already updated the drug’s warning label about side effects including tremors, anxiousness, depression and suicidal behavior, but further investigation may reveal more problems.

Merck shares fell 35 percent in the first quarter, much of the loss due to the Vioxx scandal, according to Wall Street analysts. The company is far from the only Big Pharma player in trouble, as scams, swindles and scandals continue to surface across the playing field. According to Ed Silverman in his Pharmalot blog, Schering-Plough’s share prices have been “ravaged” by the Vytorin controversy, caused “massive layoffs”, and in general “sullied the company’s reputation.”

Well, as the old saying goes, if the shoe fits . . .

There are plenty of laws on the books, at all levels of government, designed to protect the public from scams and swindles. It’s time for our lawmakers to take a very long hard look at how Big Pharma is being regulated and its products are tested and approved. And part of the scrutiny needs to be directed at the FDA itself. A lot of people need reassurance that the scams aren’t getting some help from Big Pharma friends on the inside.

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