Big Pharma shows off its big gall with risky products and dubious practices

dsuvia-300x225Big Pharma is a broad commercial sector with many diverse enterprises large and small, but they keep showing they’re united in their giant gall when it comes to their unacceptable products and practices, as timely news reports demonstrate.

Just consider:

  • As the nation grapples with an overdose epidemic that kills tens of thousands of Americans annually, why would the firm AcelRx race to market — and why would federal regulators approve — a new opioid painkiller? Experts warn the drug is incredibly powerful and so tiny and easy to use that it fast will be much abused and lethal. The new pill, Dsuvia, is just 3 millimeters in diameter — the size of a big grain of sand. Placed under the tongue, it delivers its dose almost as soon as it dissolves. It is said to pack 10 times the potency of an already deadly synthetic painkiller: fentanyl, which is up to 100 times more potent than morphine and many times that of heroin.
  • Why is Amarin Corp. continuing to promote Vascepa, its purified fish oil drug, as a boon in reducing deaths related to heart attacks, strokes and other conditions — and, doing so, while only promising to produce the scientific data that supports this eyebrow-raising claim? Vascepa isn’t a new product, but the company is seeking to reposition it in a major and highly profitable way, including with claims that it is superior to other fish oil products. How? Why aren’t regulators cracking down on drug companies hyping products first, especially to investors with dollar signs dancing in their eyes, before presenting rigorous evidence of the bona fides of their claims — not only to the medical community but also to agencies that are supposed to oversee the drug industry and approve its products?
  • Why isn’t there even greater shaming and blaming of Merck & Co. for yanking itself out of its long-term agreement to provide a reasonably priced and effective vaccine to millions of children in West Africa — where 200,000 babies and kids die of rotavirus, the disease the inoculation protects against. The drug giant is pulling its limited supplies of RotaTeq, preferring instead to get a higher price for the vaccine in China, which also suffers with rotavirus deaths but can pay much more for protections.

In my practice, I see not only the harms that patients suffer while seeking medical services but also their struggles to access and afford safe, efficient, and excellent medical care, especially at a time when prescription medication prices keep skyrocketing and too many drugs prove to be outright dangerous.

The opioid crisis exploded when regulators, lawmakers, doctors, hospitals, and insurers slumbered, and abetted Big Pharma’s relentless profiteering, pushing drugs that patients didn’t need with unfounded claims until tens of thousands were hooked, suffering and dying. AcelRx says its new opioid holds promise for treating dire battlefield injuries, and it has pledged to keep supplies under lock and key. The federal Food and Drug Administration already is hemming and hawing about its approval of Dsuvia, for which the agency has been ripped by experts and lawmakers. Does this all sound familiar?

As for Amarin and Vascepa, the FDA may be cowering in the face of the company’s hard and thus far unjustified sell due to a 2016 court case, Stat, an online health and medical news site reported. The agency settled a lawsuit by the drug maker, and “the FDA permitted Amarin to market Vascepa to audiences for whom it hasn’t been specifically approved — so long as the company doesn’t say anything untrue about the drug.” OK, when will Amarin prove its now fishy assertions and how long will regulators allow them not to? The company insists it will start to show its evidence at the annual cardiologists’ meetings later this month.

For Merck and its shareholders the question may just be: How well do you sleep at night, even with the cushion of pennies, dimes, and dollars stuffed in an already overflowing mattress? For West Africans, there may be alternative supplies of vaccines — these will be slow to ramp up, may cost more and may not be as effective.

But, then, the developing world may look to the United States to see a negative model in which Big Pharma profits matter most and the democratic processes that are supposed to keep untrammeled capitalism in check sputter. We have much work to do.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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