Hey! Food & Drug Administration, Are You Listening?

Hey!  Food & Drug Administration, Are You Listening?

We can’t get away from it: one study after another indicates a need for more accountability from the FDA and pharmaceutical companies manufacturing and distribution of addictive prescription medication in America.    Isn’t it odd that one arm of the federal government announces findings of  research on medication overdoses to be a leading cause of fatal injury in the United States, but the responsible arm of government as a watchdog for drugs distributed to the marketplace appears deaf to it?  I certainly haven’t heard any statements from the FDA.  Have you?

Now, how can that possibly be?

“Poisonings, mostly from drug overdoses, are the leading cause of accidental death among working-age adults in the United States, a new report shows.”(from healthfinder.gov – Overdoses, Cellphone-Linked Car Crashes Among Top Causes of Fatal Injury in U.S..)

I haven’t heard a peep from the Surgeon General either:  Certainly not from the former, Regina M. Benjamin whose term ended 2013. Meanwhile, opioid substance deaths spiked the four years under her watch, at least in Michigan.  Don’t be naive, though.  It’s everywhere.

 Opioid-Related Hospitalizations in Michigan, 2000-2011

Nor does it appear the White House deems fatal overdoses important enough a topic for the Surgeon General.  If anything, President Obama is tentative “lest-we-suffer-embarrassment” backpedaling about nominating Vivek Murthy as the new SG, but for a rather peculiar reason.  Mr. Murphy, of all things, is outspoken on gun control!  Why, that kind of talk might get the Republicans all upset and filibuster the Senate again.  Well, POTUS certainly can’t have that. [http://www.usatoday.com/story/news/politics/2014/03/15/obama-surgeon-general-nominee-trouble/6457575/]

Whoever in their right mind, I wonder, would think the Surgeon General’s jurisdiction is more appropriately over gun control than the health of the general population due to the high rate of abuse of OxyContin, Vicodin, or into possible collusion, bribery, corruption pharmaceutical companies’ profit making strategies perhaps with the Food and Drug Administration turning a blind-eye on releasing highly dangerous and addictive pain medications to the public?

Yeah, I know.  That is a heavy allegation.

No, I am not an investigative reporter, but, boy, I sure wish I were.  I hope someone has the guts to look into it.  More and more the politics of government is clearly more important than civil service.  And the comfort of civil servants is more and more important than the safety and and protection of the citizenry to whom the government is accountable.

I and my like-minded colleagues are still asking the Food and Drug Administration what is it as a governing/watchdog body doing to protect healthcare consumers from profit hungry pharmaceutical manufacturing and marketing firms?  How is it that the latter still continue to flood the ethical (and I use that term reluctantly) drug market vis a vis coupon redemption marketing and other ‘incentives’ so that avaricious physicians may be rewarded for rampantly dispensing substances holding DEA Schedule III and DEA Schedule II (that is, pretty extreme) risk for dependency among their patients?

Times must be hard if the only way to make a buck is to make the product highly addictive.  Reminds me of the tobacco companies and cancer in the 80’s.  Hey, thanks for letting me rant.


When the FDA and Zogenix push poison…

push back!

Following our December 2013 post, the audacity and brazen push to release Zogenix’ uber-opioid pain-killer Zohydro ER, in spite of its known high potential to cause fatal overdose, is given the FDA blessing.  

Wait, what?

Manufactured by Zogenix, presented to the FDA in October 2010, Zohydro ER is highly addictive and, as an opioid is akin to heroin, derived from the opium poppy plant.  The not-so-underlying message in this headline is the money-grab.  But hey,who cares if pill addicts running to this stuff OD and croak?  Junkies choose the lifestyle, don’t they?  Well, then they deserve what they get!’  Right?

The question in the wake of my December 2013 blog post, namely, ‘who watches the watchdog?’ is now made obsolete and trumped by a few new ones, now that it seems the FDA is sticking to its green light determination for Zohydro ER and Zogenix.

Has anyone in legal at Zogenix, or for that matter on the taxpayer’s payroll at the FDA done a respectable due diligence on this product?  Who, if anyone, has thought to inform our ivory tower, holier-than-patient medical community of the behavioral health, law enforcement and collateral repercussions when this med is stolen from acute pain patients in assisted living communities?  Who is going to pay for the additional rehab beds, emergency room stomach pumps, and mental health treatments for the bereaved families after the swarm of fatal overdoses start pressing hard on our suburban communities?  And who will pay for the training required and the staffing, and the parity-driven 25% – 40% pay raises to substance abuse counseling personnel when they have to clean up the mess after Rx  Zohydro ER is raided from granddad’s medicine cabinet?  Who pays for increased narcs to find and collar the unscrupulous Drs. Feelgood who’ve been Swiss banking their quadrupled script sales revenues?

Not your problem?  Just wait till your little Tabitha or Jessica gets hold of this stuff.  

killer pain killer


A quick thanks to NEWSER and Arden Dier, who posted the following on February 28, 2014. It bears repeating in entirety for the red flag it raises.

Zohydro, which the FDA gave the green light in October against the advice of its advisory panel, will serve as a powerful pain pill for those who can’t get relief from what’s already out there. It contains the same basic ingredient (hydrocodone) as Vicodin, but it has 5 to 10 times the power, Forbes notes, and without the added acetaminophen. As an expert on the advisory board who voted “no” tells NBC News, that acetaminophen deters savvy addicts from loading up on Vicodin for fear of liver damage. Like OxyContin, Zohydro is a “pure narcotic”; but unlike OxyContin, the Zohydro set to be released isn’t tamper resistant, and can easily be crushed, then snorted or injected.
“In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” some 40 experts wrote to the FDA in a call for Zohydro’s reevaluation. “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule. It will kill people as soon as it’s released,” says one of those experts. But one doctor points out that “it all depends on how doctors monitor it. It could be lifesaving. But if used the wrong way, like any medication, it can cause trouble.” On that front, Forbes reports that experts say someone unaccustomed to opioids could overdose with as little as two pills, and that a single pill could kill a child.

I am curious how a compound such as Zohydro ER in 2014 could have progressed so far to release to market when so many health risks to the public have been cited.  The recovery community, schools, law enforcement, judicial system, politicians, the medical community needs to be aware that if this product actually does reach the public, be prepared to put the coroner, clergy and funeral parlors on speed dial.

Ask any suburban hockey mom if the market is not already glutted with opioids; presenting ‘unforeseen consequences’ with abuses on the street by adolescents and other vulnerable populations ~ a veritable turbo-charged gateway to heroin use, addiction and death.  Wayne and Monroe counties in Michigan alone have enough first hand experience with the current opioid/heroin transfer, with deadly results bordering on the pandemic, they certainly need Zohydro ER like a hole in the head.

I visited and read the warning label to the medical profession on the Zogenix website.  You tell me; is it enough to deter suicide prone Generations Y and Z to refrain from playing with these pills at their next slumber party?

Zohydro ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.  Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions.
Serious, life-threatening, or fatal respiratory depression may occur.  Monitor closely, especially upon initiation or following a dose increase.  Instruct patients to swallow Zohydro ER whole to avoid exposure to a potentially fatal dose of hydrocodone.
Accidental consumption of Zohydro ER, especially in children, can result in fatal overdose of hydrocodone.
For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome.  Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome.
Instruct patients not to consume alcohol or any products containing alcohol while taking Zohydro ER because co-ingestion can result in fatal plasma hydrocodone levels.

Who is going to call first for an independent investigation of Zogenix’ executive leadership, marketing, R&D and head counsel inquiring who signed off on this product?

Who is going to start knocking on the door of FDA with microphones, subpoenas for bank records and search warrants?

Seriously, I want to know.   That legislator will have my vote.  If the congressional oversight committee is successful and smokes out the criminally uninformed and callously capitalistic negotiators of this deal with enough evidence to put them behind bars,  I will personally work on their re-election campaigns.  UN~believable



By John Fauber of the Journal Sentinel, Kristina Fiore of MedPage Today 

Oct. 28, 2013

Zogenix Stockholders Facing World of Pain?  By David Phillips February 25, 2014 The Motley Fool  http://www.fool.com/investing/general/2014/02/25/zogenix-stockholders-facing-world-of-pain.aspx

Zogenix product information:   http://www.zogenix.com/content/products/zohydro.htm

<img style=’width:240px;border-width:0px;’ alt=” src=’http://img1-cdn.newser.com/square-image/183072-20140228163608/painkiller-will-kill-people-as-soon-as-its-released.jpeg’> 

Who Watches the Fed’s Watchdog Agency?

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.


Hazardous waste deep injection well construction ~ at Lake Huron

English: Map of Lake Huron. Category:Michigan maps

English: Map of Lake Huron. Category:Michigan maps (Photo credit: Wikipedia)

Faulty, Corrupt Nuclear-Waste Deposit Well Deal between Romulus, Michigan & Canada

OK, I’m pretty mad that we have to find out about this stuff milling around online when we’re supposed to be doing homework. Why is this message under-reported in the mass media?   Continue reading

Nowadays, everybody knows somebody who’s…

…been effected by prescription drug addiction or some other form of addiction.  One way or another, everywhere in society we have been touched by the chaos.  Urban, suburban or rural areas have been touched; across class lines, ethnic lines…whether directly or indirectly, abuse of narcotics has cost us dearly.  In lives, quality of life, the effects of ancillary crime, health implications, relationships – be it in a friend or family member, a neighbor, colleague, team-mate…

Conservatively, Alcoholics Anonymous‘ worldwide membership alone, has leveled off to more than two million, taking into account the turnstile effect of recidivism and the steady stream of newcomers.  The recovering community at large, inclusive of individuals grappling with other substances and process addictions, has exploded in size.  Then, consider as well those others who struggle with aspects of the disease seeking alternative measures to manage its symptoms or its systemic effects.

Advocates, family members, employers, service providers, lawmakers, faith communities are joining people in recovery to speak up and call out the real barriers to stopping the loss of life, productivity, order and safety Americans need to thrive.  There is a huge pink elephant in our town squares that until now NO ONE wanted to talk about.  The fact that as a people we have been unable or unwilling to objectively, effectively discuss ramifications of untreated mental illness is in itself PART of the illness!  And, frankly, substance abuse is simply a subset of the mental health issue.  The endemic attitudes, exploitation, corruption, that distorts public policy, politics, economics and social conduct is both the tail end and the beginning of the vicious cycle.

To get a better understanding of what Families Against Narcotics (FAN)  is about, click the link  <<<===  and watch the video on YouTube. Real live, fine, upstanding regular people are coming together to address the whole ‘ball of wax’.   In the video, I’m the lady that sits beside Richard Sands, the man who shares about the loss of his adorable granddaughter to a drug overdose.  Richard is chairman of the Downriver (Detroit) Chapter of Families Against Narcotics, formed in April 2013.

You’ll see, it’s going to get better, but we all have to do our part.As one lovely member clarified at one of the early local FAN meetings,

“We do not need a War on Drugs anymore!  What we need is a War on Addiction!”

This topic is going blow your mind, but you have to first open your heart.  One thing is for certain; the more you learn about the exact nature of the drug problem in the United States, the more you will find there IS yet to learn of the scope and depth of devastation it has done to our nation as a whole.  America and Americans are worth saving.  Each and every human being effected by the epidemic has a right to be rescued and restored to live a happy, joyous and free life.  There is much more I will share with you on this topic.  We have a lot to hope for, and much to expect from and for the American way of life, should we choose to care for and nurture it.

Repost: Senator Hopgood Warns of Grave Risks of Underground Nuclear Waste Repository

The Great Lakes as seen from space. The Great ...

The Great Lakes as seen from space. The Great Lakes are the largest glacial lakes in the world. (Photo credit: Wikipedia)

Initiative to build underground Nuclear Waste Repository less than one mile away from Lake Huron shore in Michigan. Great Lakes to dispose of ‘rags’ belonging to Canada has been ‘gifted’ for $36,000,000 to raise local support. What!? Michigan Senator Hopgood’s warning is shocking and timely:

Senator Hopgood speaks on ‘unthinkable’ risks of proposed underground nuclear waste repository in Canada, less than a mile off the shores of Lake Huron.

Detroit’s Cleaning Up ~ And it is More Than Just Litter!

Flag of the United States of America

Flag of the United States of America (Photo credit: Wikipedia)

Detroit is secretly a beautiful city!  One must LOOK BENEATH ITS SURFACE and recall how it has been disparaged in every way for 46 years.  But, it is a valley being raised up, just as the mountains of corruption are being torn down. Abolitionists speak up, so:  Listen up, USA!