I wonder…who is getting paid a kickback at the FDA?
This is a rhetorical question, actually.
A reprint of a ” the savvy investor’s website SeekingAlpha.com” October 26, 2013 report in The Fix (awesome commentary for those who are interested prevention, recovery, social conscience in the pharmaceutical sector) slams the FDA for a recent decision to approve:”
The FDA defied its own experts to approve a new prescription narcotic in a form almost certain to cause addiction and death from overdoses. The Fix investigates…
With ‘expert’ knowledge at their disposal, why on earth would the FDA approved this product and permit the pharmaceutical manufacturer to bring it to market?
“…Zohydro ER, which only the previous day had been approved for sale by the U.S. Food and Drug Administration despite consistent warnings – including from the FDA’s official advisory panel – that Z is potentially more addictive and dangerous than its sister opiate drug, the original and deadly OxyContin…”
By what set of standards does the FDA decide to approve/deny ‘pain medications’, in this case opioids scientifically established to be akin to heroin and known to be abused on the street?
Oh, and not in the inner-city street any longer either: Distributed and abused in the suburbs by our cheerleading and football-playing high school teenagers, in our corporations by our white and pink collar workers? Who does the oversight on the FDA? Are they unaware that such narcotics have sparked a pandemic in the American population within the middle class? Or is that a people-group that no longer counts in American politics or economics, or society?
I wonder exactly what ARE the values by which the FDA sets it standards? Is the proprietary drug manufacturing sector that large and influential that their bottom line/shareholder earnings are considerably more important than the lives of citizens who have become poisoned/addicted by their products (so that more is sold)?
If the question of intent is not raised on a public health/policy level, the FDA will have no incentive to look squarely at their behavior toward the public they serve as a responsible bureaucratic agency.
Perhaps litigation is in order, more specifically a class action suit by those Families Against Narcotics (www.familiesagainstnarcotics.org), a fledgling non-profit grass roots organization of regular folks who have lost children, loved ones due to the pandemic opioid->heroin plague that has hit Detroit’s suburbs. Public awareness and advocacy is high on their mission statement.
While the FDA continues to be influenced by bullish investors:
“…said Seeking Alpha [the original reporter]: “Many bullish investors believe that [Zohydro] will be a huge commercial success. Ironically, their arguments hinged on the thesis that ‘many drug addicts would be willing to pay through the nose for Zohydro.’”
The FDA’s decision-making processes should be under close scrutiny. This could well be considered a consumer advocacy issue, a public health issue, a human exploitation issue.
In any case it is grist for a hearty discussion at the next FAN meeting in chapters around the state of Michigan. To the tune of $3.5 billion industry booster shot, you can count on 85% it at least will be in the black market. And who pays for that clean up job?
You guessed it, the middle class.
- 28 States Ask FDA to Rethink Painkiller Approval – ABC News (abcnews.go.com)
- Zohydro approval protested by 28 attorneys general (utsandiego.com)
- AG Gansler urges FDA to reconsider Zohydro ER decision (baltimorenewsjournal.com)
- State AGs urge FDA to rethink approval of painkiller Zohydro (trust.org)
- Attorneys General Want FDA to Reconsider Zohydro (americannewsreport.com)
- 28 states ask FDA to rethink painkiller approval (seattlepi.com)
- Letter to the FDA: Regulate E-Cigs Lightly for the Sake of Public Health (ecigarettereviewed.com)
- Attorneys general fear drug abuse epidemic, wants FDA to reconsider its approval of painkiller Zohydro (medcitynews.com)