Expert Says New FDA-Approved Painkiller “Will Kill People”

The FDA has approved Zohydro, a new extended-release painkiller that is 5 to 10 times more powerful than the amount of hydrocodone found in Vicodin. Critics are warning only two pills of this chillingly potent medication can kill. Why has the FDA, an agency entrusted to safeguard public health, allowed this drug on the market?

Needless to say, the green light given to Zohydro has ignited a furor among groups gravely concerned about its safety. Headlines from news organizations from across the country blare the alarm felt by many who are calling the pill ‘truly frightening’ and ‘deadly dangerous.’

Opposition to FDA Decision Is Widespread and Vehement

Public opposition of the drug’s approval is sweeping. In fact, in a strongly worded letter to the FDA, more than 40 experts urged the FDA to reverse its decision. “In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the coalition wrote. One person who signed the letter, Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing, bluntly predicted Zohydro “will kill people as soon as it’s released.”

Government entities are requesting the FDA to reconsider as well. Twenty-nine state attorneys general sent the FDA a similar letter in December, while members of congress asked the agency last November to review its approval ruling. The FDA’s decision even goes against the recommendation of its own advisory panel, who voted 11 to 2 for refusal of the new drug application for Zohydro.

What’s All the Fuss About?

Like OxyContin, Zohydro is a highly addictive opioid and a pure narcotic. But, unlike OxyContin, Zohydro isn’t tamper resistant, and can easily be crushed, a factor that would allow it to be snorted or injected.

The Centers for Disease Prevention and Control reports deaths from prescription opioids have quadrupled in recent years, skyrocketing from 4,030 in the year 1999 to 16,651 in 2010. Experts fear Zohydro’s potency and abuse potential will cause a quick rise in these grim overdose statistics.

Successful Clinical Trials or Cheating?

The clinical trials on Zohydro used a controversial method called enriched enrollment, a process that lets drug companies avoid testing a product on patients who don’t respond well to a medication or who are unable to tolerate its use. This approach is criticized because it is a way of making a drug seem more effective and enhances its chances of approval. Some call this method cheating, and rightly so, as it doesn’t accurately represent the drug’s effect on the general population.

Something Smells Fishy

Why did the FDA make such a seemingly insupportable decision to approve such a drug? Allegations have arisen over a possible conflict of interest between the federal agency and Elan Corp, Zohydro’s original manufacturer. In response to a Freedom of Information Act request, last fall several emails were made public that cast doubt on the presumed integrity of the FDA’s ruling. The emails indicated professors from the University of Rochester Medical Center arranged private meetings between FDA officials and pharmaceutical companies who manufacture pain medication.

This raises red flags because the drug firms paid the professors $20,000 to $35,000 to attend the meetings, and one of the companies present was Elan Corp. Zogenix, the current manufacturer of Zohydro wasn’t in the picture yet, but the company later partnered with Elan.

Kolodny tells NPR News that the revelation of these emails produced “a sense of ah-ha” among opponents of the drug’s approval. Senators David Vitter and Joe Manchin are seeking the answer to why the drug companies paid these sums. FDA officials who are involved in the approval process for prescription painkillers should not be receiving large amounts of money from drug firms, Vitter said. “If these allegations are true, there is a clear, illegal conflict of interest between the FDA and these pharmaceutical companies that puts consumer safety at risk,” he adds.

Sources:

http://www.usatoday.com/story/news/nation/2014/02/28/newser-painkiller-zohydro-fda/5893749/

http://www.cnn.com/2014/02/26/health/zohydro-approval/

http://www.newyorker.com/online/blogs/currency/2013/12/zohydro-why-did-the-fda-approve-a-new-pain-drug.html

http://www.wbur.org/npr/282836473/critics-question-fdas-approval-of-zohydro

http://www.vitter.senate.gov/newsroom/press/vitter-manchin-want-answers-on-fda-pay-to-play-deals-with-pharmaceutical-cos

http://www.jsonline.com/watchdog/watchdogreports/senators-seek-answers-on-meetings-between-drugmakers-fda-officials-b99214969z1-247591111.html

http://www.medpagetoday.com/PainManagement/PainManagement/42510

Mary West is a natural health enthusiast, as she believes this area can profoundly enhance wellness. She is the creator of a natural healing website where she focuses on solutions to health problems that work without side effects. You can visit her site and learn more at http://www.alternativemedicinetruth.com. Ms. West is also the author of Fight Cancer Through Powerful Natural Strategies.