You may or may not know by reading the label.

Nearly 20% of the 84,000 chemicals being used commercially in the US—from rust removers to driveway sealants—are being legally kept secret from the public, according to the Environmental Protection Agency.

That gaping problem arose after Congress passed the Toxic Substances Control Act in 1976 to help protect trade secrets but made it rather easy for manufacturers to bypass normal regulatory scrutiny, even when it involves chemicals that could pose harm to humans.

Nearly 95% of the notices for new chemicals received by the Feds in recent years requested the silent treatment. Roughly 700 chemicals are introduced each year to the American market.

Of the nearly 17,000 secret chemicals, most are probably harmless. But chemical producers have disclosed in mandatory reports to the Feds that many pose a “substantial risk” to public health or the environment.

In March, for example, over half of the 65 “substantial risk” reports received by the EPA involved secret chemicals.

151 of the secret chemicals are made in quantities equal to or greater than 1 million tons per year. Ten of them are used in products designed for children, the EPA reports.

Select EPA employees do know the identities of the secret chemicals but they are prohibited from sharing the information with other federal or state officials, emergency responders and the public.

“Even acknowledging what chemical is used or what is made at what facility could convey important information to competitors, and they can start to put the pieces together,” Mike Walls, vice president of the American Chemistry Council told the Washington Post.

The Obama administration wants Congress to make manufacturers prove a chemical should be kept confidential, and wants to allow EPA officials to share that confidential information with state regulators who implement most EPA mandates across the country. Stay tuned.

An expert panel has advised the Food and Drug Administration to green light Crestor, AstraZeneca’s cholesterol-buster, for a wider role in the prevention of cardiovascular disease. FDA acceptance of the panel’s recommendations could markedly increase utilization of Crestor and drugs like it.

The recommendation follows release of data from the so-called Jupiter trial, which was sponsored by AZ. In Jupiter, Crestor reduced the risk of heart attacks in apparently healthy adults with no prior history of cardiac disease and normal cholesterol levels.

Participants in Jupiter did have elevated levels of C-reactive protein (CRP), a non-specific marker for inflammation that identifies people at risk for cardiac events regardless of their cholesterol levels.

Jupiter participants who took Crestor experienced a 54% reduction in the risk of heart attack and a 48% reduction in the risk of stroke. They were 46% less likely to require angioplasty or coronary bypass surgery and had 20% lower mortality from all causes.

In reaching its decision, the expert panel noted that Crestor patients developed diabetes at a higher rate than the placebo group, and experienced more deaths due to GI disease and more episodes of mental confusion. But the panel felt these events were due to chance rather than Crestor itself.

AZ wants the FDA to authorize a discussion of the Jupiter study on Crestor’s label, since this would permit the company to market Crestor to a much wider patient population.

Crestor already generates $3.6 billion in annual revenues for AZ, which is good for 9% of the US market. Pfizer’s Lipitor (27%) and generic statins (49%) have the lion’s share of this market.

Both Lipitor and the generic simvastatin have been shown to lower CRP levels. It is estimated that the label modifications would apply to about 6 million US patients.

Plavix, the clot-busting blockbuster marketed by BMS and Sanofi, is never out of the news for long.

One story that developed legs in the last year for example, was the finding of apparent marked variability in responsiveness to the drug. This begat calls for personalized prescribing of Plavix based on genetic markers, and warnings that Nexium-The Purple Pill—impaired its effectiveness, thus creating an increased risk of vascular complications.

Now it seems, the worm has turned again on this story. Victor Serebruany and colleagues have reported that the issue of Plavix nonresponsiveness may be caused by something rather mundane: non-compliance with the drug.

To reach this conclusion, the scientists obtained blood samples from 422 heart disease patients and 209 poststroke patients that had platelet activity tests performed before and after Plavix use.

They tested these archived blood specimens for a chemically stable, carboxyl metabolite of Plavix, and then defined Plavix noncompliance to be a very low plasma concentration of this inactive metabolite.

They found that 138 patients (22%) were in fact noncompliant. Noncompliance was more frequent in stroke victims (38%) than cardiac disease patients (14%).

“Some of the patients whom we would classically describe as ‘resistant’ to clopidogrel, in that they showed low levels of platelet inhibition, in fact didn’t actually have clopidogrel on board,” Serebruany told Medscape.

“The whole variability issue with clopidogrel (Plavix) is not such a big deal,” Serebruany added. “It has been hyped by the manufacturers of the newer antiplatelet agents. If we did studies with these agents, they would show variability, too.”

“Future antiplatelet trials should recognize noncompliance as a critical confounding factor, and every attempt should be made to minimize and strictly monitor prescribed antiplatelet regimens,” the authors concluded.