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Drug company withholds important safety data to allow increased sales

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The medical profession in the US trusts the information on drugs that the pharmaceutical companies provide. In breaking news on July 23, 2014, the British Medical Journal (BMJ) released a report strongly criticizing information withheld during the approval of Pradaxa, a new blood thinning product.

The report and the BMJ comments were documented in an article by Crystal Phend, senior staff writer for MedPage Today, titled Monitoring, Dose Adjustment for Pradaxa. The article asserts that Boehringer Ingelheim (BI), the maker of Pradaxa, withheld information that increasing the dosage of Pradaxa would make it more effective in preventing strokes. The maximum effective dose to reduce strokes also required monitoring by drawing blood to determine the risk of internal bleeding.

The primary competitive drug with similar effects is warfarin, which is sold under the brand name Coumadin. BI claims that it is unnecessary to get routine blood testing to monitor the effect of Pradaxa for internal bleeding risks. Coumadin requires a blood draw to allow periodic review and adjustment of the dosage if necessary. You can read the full article by Crystal Phend for further discussions of the issues found in the BMJ report.

Avoiding the blood draws and the cost of the monitoring visits are a big advantage for patients, if it were true. The internal discussions at BI of the manufacturer’s own data provides an insight into the importance of money over patient safety to Boehringer Ingelheim. The BMJ report criticized BI for not making the data public at the time of approval in the EU.

Blood level monitoring and dose adjustment for dabigatran (Pradaxa) could reduce major bleeding risk by 40% compared with well-controlled warfarin, according to company documents allegedly hidden from physicians and regulators.

The bottom line on all of this is in the conclusion of Phend’s article for MedPage Today.

Boehringer Ingelheim determined optimal plasma levels to minimize bleeding risk that would have little or no impact on effectiveness in cutting risk of ischemic stroke, but didn't share that data in a bid to boost dabigatran's commercial success.

Thomas Moore of the Institute for Safe Medication Practices made the statement regarding Boehringer Ingelheim’s approach to marketing Pradaxa.

However, the point is not whether there's a net benefit (from Pradaxa versus warfarin) when used unmonitored and untitrated -- it's that the net benefit wasn't maximized, which would have saved lives.

Boehringer Ingelheim is continuing to insist the blood monitoring is unnecessary. The trade-off that is not readily apparent is the following. If you take the most effective dosage of Pradaxa, you have to have blood monitoring to make sure you are not at risk for significant internal bleeding. If you take the dosage suggested by Boehringer Ingelheim that does not require blood monitoring, you are at a higher risk of having a stroke. The TV ads advise you that you can't stop taking Pradaxa or any of the blood thinners without increasing your risk of strokes. Once you are on these drugs, you stay on them.

The medical professionals in the US are thoroughly educated to accept the literature on drug effects and dosing provided by the manufacturers. This is a clear example of why this trust is often misdirected. When combined with the extreme specialization of doctors, the side effects of drugs that help in one area are ignored in another part of the body.

Statins help reduce cholesterol risks according to cardiologists and lipidologists. The FDA has forced statin manufacturers to warn patients that statins can have rare side effects that destroy the liver. There is a recent requirement to inform patients that statins also increase blood sugar leading to diabetes.

In the case of Pradaxa, there was a clear effort to withhold information to the FDA and the European Union with regard to the improvement of mortality and morbidity when dosages were adjusted for each patient, and when blood monitoring was done to determine risks for internal bleeding.

You can read an article by Joey Rosenberg that describes the approval of Eliquis that is filed under the category Dangerous Drugs. The article is titled Blood thinners Pradaxa, Xarelto Have New Competitor in Eliquis. The article discusses the lengthy process in getting Eliquis approved, and comparisons of the risks of warfarin, and these competing drugs.

There are several natural supplements that have proven over thousands of years of usage in Oriental and Ayurvedic medicine to reduce the risk of strokes without the severe adverse effects of warfarin and the new warfarin substitutes. Ginseng, ginkgo biloba, and vitamin E all have blood thinning attributes without the risks of warfarin, Pradaxa, Eliquis and Xarelto. The natural alternatives may not work as quickly as these pharmaceutical products, but they won’t kill you either.

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