FDA Approves a New Narcotic Painkiller…Is This a Mistake??

Prescription painkillers have been identified as one of the major causes of overdoses, as well as drug addiction. For the past few years, the U.S. Food and Drug Administration (FDA) has recommended tighter controls on narcotic painkillers, following record numbers of addiction rates and deaths associated with accidental overdoses.

In a recent article, Dr. Sanjay Gupta discussed conflicts of interests, which may have influenced the FDA to approve a new narcotic painkiller, Zohydro ER (Zogenix).

This new drug is the first drug containing pure hydrocodone, which some critics call ‘synthetic heroine.’ All other hydrocodone-containing painkillers currently on the market are mixed with other non-addictive ingredients. Zohydro ER was approved for patients needing continuous pain relief, and contains an opioid dose five to ten times greater than anything else on the market.

Dr. Gupta noted that when FDA Commissioner Margaret Hamburg was criticized for the agency’s approval of this new drug, she stating that “100 million Americans” suffer from severe chronic pain warranting use of the drug. It has actually been reported that the correct figure amounts to about 40 percent of the US adult population.

Investigators have reported that nine of the 19 experts on the IOM (Institute of Medicine) panel that produced that report had connections to companies that manufacture narcotic painkillers at the time or in the three years prior to their work on the report.

However, the IOM did not disclose any of these financial conflicts of interest when the report was published.

Dr. Gupta stated, “Past Journal Sentinel/Med Page Today investigations found that the boom in narcotic painkillers has been fueled in part by an aggressive push from drug companies that funded nonprofit groups which advocated for greater use of opioids…” Pharmaceutical companies (including the maker of Zohydro) paid up to $35,000 to attend private meetings with FDA and NIH staff to discuss new pain treatments.

The current chairman of the IOM’s pain panel was formerly the dean of Stanford Medical School. Not even a year before the pain panel met, Stanford received a $3 million medical education grant from Pfizer, a big pharmaceutical company. Athough Stanford denies any conditions attached to the grant, Pfizer does manufacture several painkillers. Other drug companies selling pain relievers also contributed money to the school.

Another pain panel member co-founded a group called IMMPACT, which is one of two groups that received $35,000 per drug company attendee at private FDA/NIH meetings to discuss pain treatment. He also served as a consultant and has received research grants from drug companies that make painkillers.

IOM’s new president, Victor Dzau, serves on the board of three companies as well as chancellor for health affairs at Duke University. In a 2010 Lancet paper Dzau said that his vision for global “health science” is driven by a “public-private financial partnership” between academic institutions and governments. Today, large US universities with close ties to Big Pharma are now increasingly creating very lucrative “public-private partnerships” with government, creating a major conflict of interest.

It seems quite clear that our government is more concerned with profit than protecting Americans. Big Pharma manipulates the government in order to get their drugs to market so they can make big profits. On one hand the FDA was cracking down on the over-use of painkillers, as it became an epidemic, and now gives approval for a new painkiller, which is ten times more potent than any other painkillers previously approved. How hypocritical is that?

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