FDA clears dangerous blood thinner drug despite faulty clinical trials

Thursday, October 20, 2016 by: J. D. Heyes
Tags: FDA, blood thinner, clinical trials

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(NaturalNews) Once again an agency of our overly bureaucratic federal government has demonstrated that its incompetence is only surpassed by its willingness to defer to political donors and special corporate interests.

As reported by Reuters, the Food and Drug Administration recently determined that Xarelto, a widely-used blood thinner, was safe and effective for patients with atrial fibrillation – a chronic heart arrhythmia – despite serious doubts arising over the major study that was used to gain its approval.

Chemically known as rivaroxaban, Xarelto won approval from the FDA in 2011 after it was allegedly demonstrated to be safe and effective as an alternative to warfarin in a study of 14,000 people with A-fib, as it is called in the cardiology world. Warfarin was used in the same role for decades to treat A-fib, which can contribute to strokes. Without treatment for the irregular heartbeat, sufferers of A-fib are five times more vulnerable to having a stroke.

In a study that was nicknamed Rocket-AF, therapy using warfarin was monitored via the Alere Inc INRatio device that has been recalled due to its potential to produce inaccurate results. That has cast a pall over the value of the large, and ultimately pivotal, clinical trial.

"The FDA has completed a variety of analyses to assess the impact that this faulty monitoring device had on the Rocket-AF study results," said the agency in a statement posted on its web site and cited by Reuters. "The Agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal."

Big Pharma always looking for the next cash cow

Minimal?

Reuters further noted that Xarelto is a multi-billion-dollar product manufactured by Bayer AG overseas and by Johnson and Johnson in the United States – which helps explain why such clinical trial deficiencies were very likely overlooked. The drug is the market leader for a new and popular class of medicines whose goal is to replace warfarin, which has been problematic because it requires a special diet and routine monitoring in order to ensure that dosing remains correct. Warfarin doses must be within a therapeutic range that is neither too low, which boosts risk of stroke, or too high, which boosts the risk of serious bleeding.

And while there may be some legitimate problems and hurdles with warfarin, there is also this: Since it has been around for a long time and now comes in generic forms, it is very inexpensive - and, you know, Big Pharma is always looking for the next cash cow.

One of them happens to be Xarelto, and now the FDA has indicated which side the agency is on – and as usual, it's not the side of the American people.

But this isn't the only example of chicanery committed by the agency. In April we reported that the way in which the agency utilizes scientific studies is also subject to fraud.

Nutritional supplements cannot be sold with medical claims but drugs with faulty clinical studies can be

Understand that the FDA itself does not conduct any scientific studies on drugs, food or products it is asked to approve, first and foremost. Rather, the agency relies on the companies pushing the products to conduct their own research – and of course, companies have a vested financial interest in seeing that their products get approved, right?

And the process is hypocritical as well, because the FDA virtually shuns the food and vitamin supplement industry while favoring Big Pharma, even though drugs and medicines kill more than 100,000 people a year, while supplements kill no one (unless they happen to choke on a tablet, capsule or pill!) [1].

That said, many claimed that drugs are heavily regulated, but supplements are not regulated at all. That is completely false. If you're selling a supplement that hasn't been approved by bureaucratic masters at the FDA, and you make a medical claim about that supplement, then your company will be held liable by the government – financially and otherwise – and you'll be lucky if you survive bankruptcy court.

But, as the agency has proven with Xarelto, it's willing to look the other way when actual clinical trials are tainted with faulty data.

Sources:

Philly.com

NaturalNews.com

[1] Null, G. Ph.D. et al. (2011) Death by Medicine: Praktikos Books. Link here.