Thursday, August 17, 2017

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Respectfully President Obama

obama

Respectfully President Obama, You Can Shut Down America’s Opiate/Opioid Epidemic Tomorrow – Literally!

Last night I could not have been more excited than I was watching President Obama’s State Of The Union Address. In the second paragraph of his opening remarks the president said: "Because it’s an election season, expectations for what we will achieve this year are low." He also added, "I hope we can work together this year on some bipartisan priorities like criminal justice reform, and helping people who are battling prescription drug abuse and heroin abuse. So who knows? We might surprise the cynics again."

 

Regardless of your political views, you have to agree the president nailed it. He correctly separated ‘prescription drug abuse’ and ‘heroin abuse’ giving each their deserved distinction. But mixed in with my excitement was confusion on the scale of cognitive dissonance. What I found perplexing was that this proclamation was coming from the President of the United States of America, one of many men and women in government with the power to end America’s Second Opiate/Opioid Epidemic tomorrow – literally.

The mechanisms necessary to shut down this deadly epidemic are already in place. The apparatus and laws were brought into existence by President Nixon over forty-years. They were used to great effect curbing drug abuse in the last part of the twentieth-century; but then something out-of-view happened. Everyone seems to have a theory, but personally, I don’t think we’ll ever know what really went on behind closed doors. What I do know is that right now we find ourselves being ravaged by an avoidable opiate/opioid epidemic.

This is not the first time opiate/opioid merchants have invaded our lands and attempted to manipulate our free and open society. In the mid to late1800’s morphine had its way with wounded civil war soldiers and veterans. Latter on, heroin was being marketed by Bayer Pharmaceuticals as – among other things – a cure for morphine and opium addiction. You can imagine how well that turned out. By the early 1900s, Americans consumed more opium per capita than the Chinese. Opiates and opioids were so pervasive at the time that our 26th president, Theodore Roosevelt, enlisted the help of Dr. Hamilton Wright – our first drug czar – to rein in America’s First Opiate/Opioid Epidemic. Their efforts lead to the 1914 Harrison Narcotics Tax Act that effectively ended the crisis by gaining control on the importation, manufacturing and distribution of opiates and opioids.

This is historical. It was our first effort – and a very effective one at that – to combat the dangers to American’s health and safety posed by opiates and opioids; but time would prove it would not be our last effort. The 60s saw an increase in heroin abuse leading President Nixon to initiate legislation allowing for methadone clinics and the creation of the DEA through consolidation of related government agencies. The newly formed DEA is a division of the U.S. Department of Justice and subject to Congressional oversight.

Although controversy seems to have surrounded the DEA from its inception, the agency has proven its ability to curb the divergence of pharmaceutical drugs to the streets of America. Mr. Gene Haislip was the last successful head of the Office of Diversion, a position he held for 17 years. One of his primary duties was to keep pharmaceutical narcotics off the streets. Haislip was a smart go-getter who took pride in his job and wasn’t afraid to take a creative approach. He often wrote his own bills that quickly gained support from both the White House and congress. The media also held Haislip in high-regard, constantly seeking him out for comments. Haislip’s efforts lead to the significant reduction in Quaalude abuse in the 80s and Methamphetamine in the 90’s.

But since Mr. Haislip’s retirement in 1997, the position he once held looks more like a slow rendition of musical chairs than the esteemed office it once was back in Haislip’s era. Several have sat in his seat, yet no one has filled his shoes.

It was also around the time of Haislip’s retirement that a privately held company, Perdue Pharma, gained FDA approval (1995) for their new oxycodone pain killer, Oxycontin. It was rolled-out in 1996. Many experts consider this era – the late nineties – to be the genesis of America’s Second Opiate/Opioid Epidimic.

It was also a unique time for the FDA. AIDS was killing Americans by the thousands every year. The FDA did not have the budget to hire the needed staff to catch up on the back-log of potentially lifesaving drugs awaiting approval. There was a ‘drug lag’ in the US. The public blamed the Government and the FDA. Politicians used it as a wedge issue on the campaign trail.

But it was the pharmaceutical industry who seized on the hidden opportunity. With the full support of Big Pharma – who has more lobbyist working for them than there are law makers on the hill – Congress enacted the Prescription Drug User Fee Act 1992 (PDUFA) giving the FDA authority to charge and accept fees up-front from pharmaceutical companies seeking faster drug approval. What could possibly go wrong?!

Big Pharma’s cash contributions to the FDA made for great PR, but an even better strategic move with far more reaching consequences. As I’m sure you already surmised, the FDA has become increasingly dependent on user fees over the years. Estimates vary, but about $2 billion of the FDA’s entire 2015 annual budget – roughly 45% – was generated by Big Pharma new drug application and user fees.

To further complicate the FDA’s charter to protect Americans’ health and safety, the agency – and the DEA for that matter – is allowed to be lobbied by the pharmaceutical industry. However, Big Pharma has taken this liberty to new heights – paying $30,000 per representative for a weekend retreat with FDA department heads. This is just the tip of the lobbying iceberg. Over $382,000,000.00 million dollars were spent by the health industry in 2015 to influence our government officials who were elected to protect us. Four of the top ten biggest spenders on lobbying last year were in the health field. I don’t have enough space in this article to go into the health industry’s PR budget – which is far greater than their lobbying budget – and campaign contributions intended to influence members of congress’ votes.

And you wonder why the cost of prescription medication has gone up so much? All of these expenses – and a lot of others that have nothing to do with researching and developing a new drug – are passed down to you, the consumer.

If I were the CEO of one of these mammoth pharmaceutical companies I’d say that it was money well spent. Production of opiate and opioid pain killers are up nearly 400% from the time of Mr. Haislip, retirement in 1997. The Pharmaceutical Industry raked in an estimated $1.07 trillion dollars in 2015.

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This is quite an incredible achievement – especially when you take into consideration the CDC reports that Americans say they are not experiencing any more pain over the same time period. The pharmaceutical industry couldn’t have achieved such feats solely on their own.

The DEA and FDA determine what opiates and opioids can and cannot be produced and distributed in the U.S. All makers of the pain killers must provide the DEA with an application requesting their next year’s production quota. During the course of this process, the FDA consults with the DEA Office of Diversion – making their recommendation as to what drugs and quantities will be needed in the coming year.

The DEA Office of Diversion has the final say over what opiate and opioid production quotas will be. They have the power to reduce the production quotas for any dangerous drug sold in America. This is the very same mechanism Mr. Haislip used to put an end to Quaalude and Methamphetamine abuse. He pulled the exact same lever that sits in the DEA Office of Diversion today to reduce the production of these dangerous and often deadly drugs, thus stemming off the supply and averting any further crisis. It’s just common sense and it works!

President Roosevelt and Dr. Wright did exactly the same over 100 years ago to end America’s First Opiate/Opioid Epidemic. They cut back the supply of deadly drugs and limited their distribution. It worked!

Prior to and during a debate on the house floor, Representative Francis Burton Harrison of New York – author of the 1914 Harrison Narcotics Tax Act that bares his name – stated that "The purpose of this Bill can hardly be said to raise revenue, because it prohibits the importation of something upon which we have hitherto collected revenue." Later Harrison commented, "We are not attempting to collect revenue, but regulate commerce." House representative Thomas Sisson, Mississippi, added, "The purpose of this bill—and we are all in sympathy with it – is to prevent the use of opium in the United States, destructive as it is to human happiness and human life."

Apparently the 63rd United States Congress’s noble and humanitarian sentiment, their genuine concern for Americans’ health and safety, has been lost on the more recent Congresses that seem adamant to circumvent the protections put in place to avoid another opiate/opioid epidemic on our soil. Since the mid 90s, narcotic pain killer merchants have been professing the safety and efficacy of their wares much like the Bayer Pharmaceutical Company promoted heroin as a safe and effective cure for morphine and opium addiction, over 100 years ago. Have we learned nothing? Congress appears to have bought into what has now been proven to be balderdash and started chipping away at the very laws that provide a barrier between these deadly poisons and the public.

Americans started dying from prescription drug overdoses almost immediately. Coroners and medical examiners didn’t know what to make of it at the time. Alarms were going off in the halls of government – and there were plenty of them. All the loud and flashing signs were there.

In spite of the warning, Congress passed The Drug Addiction Treatment Act 2000 allowing qualified doctors to – as crazy as this may sound – prescribe opioids to a limited number of addicts addicted to opioids. This is in direct contrast to one of the main tenets of the 1914 Harrison Narcotics Tax Act that banned the practice of extending addicts’ addiction by physicians prescribing opiates/opioids from their office. In the same year, nearly 2,000 people lost their lives to prescription pain killers, more than any of the up-trending years before. The bold hand writing was on the wall - where was Congressional oversight?

It would have been better if Congress continued to take its usual position and do nothing – but they didn’t. Congress continued to pass laws that paved the way for greater production and wider distribution of opiate and opioid pain killers – a completely opposite approach to that of President Roosevelt and Dr. Wright’s which lead to the 1914 Harrison Narcotics Tax Act, effectively ending America’s First Opiate/Opioid Epidemic.

Now we find ourselves in the current medical paradigm designed to profit from your disease. Our government’s answer for America’s Second Opiate/Opioid Epidemic is to throw what we’ve learned from ending the first epidemic – and subsequent dust-ups with deadly drugs – into the wind and make even more prescription opiates and opioids available to an already over-served market. It is our elected officials who have made the determination that the best option to end this epidemic is to make Suboxone – a semi-synthetic opioid whose research was funded by the U.S. and laws changed to advance its approval – available to every addict. And our government has the audacity to call this new program, addiction treatment.

Yes it’s true. Your government wants you to believe they are looking out for your best interests – the American public’s health and safety – when they give an addict hooked on opiates and/or opioids a semi-synthetic opioid. This is akin to telling a backwater alcoholic to switch from moonshine to vodka. Someone else will have to cue the applause sound track because I find myself sickened by this twisted logic.

The program does have short-term merit in that Suboxone has a consistent dosage while street heroin does not – but the benefits end there. The program has no credible long-term plan to get addicts off of the semi-synthetic opioid that is just as dangerous as heroin – and comes with the same toxic effects that destroys vital organs in the human body.

All that is being accomplished with this program is addict’s addictions are being extended into perpetuity while pharmaceutical companies make more money in the short and long term. People are going to continue to die avoidable deaths, emergency rooms are going to continue to be flooded with overdoses victims, more babies will be born addicted to Methadone or Suboxone, the untold suffering and tragedy will remain untold and lives, children will be orphaned and families are going to continue to be crushed by this epidemic. Let’s just call this program what it really is – an extension of our opiate/opioid epidemic that provides a watershed for the makers of Suboxone and its variants while boosting the economy.

Respectfully Mr. President and distinguished Members of Congress, if we are to have an open and honest conversation about ending America’s Second Opiate/Opioid Epidemic then we must first agree to put American’s health and safety ahead of commerce. Without this commitment there is no conversation. But if we can agree on this point, I’d suggest the following itinerary.

    First and foremost, adopt President Roosevelt and Dr. Wright’s blue print and reduce opiate and opioid production by 90%. As I’m sure you are aware, Americans consume 80% of the global production of opioid pain killers and 99% of the hydrocodone. A 90% reduction would still keep us above, but more aligned with, the rest of the modern world.

    Rescind the laws that removed the barriers between these deadly pain killers and Americans. They served and protected us well for decades – we want them back and enforced.

    Change the culture at the FDA – it’s the only way we’re going to be able to effect any meaningful change. Here is a few recommendations:

            Fund the FDA – take money out of the equation so the FDA is not beholding to the pharmaceutical industry.

            End the FDA’s secret weekend getaways and luncheons with lobbyists and instead hold open forums accessible to the public.

            More transparency - make all emails and transcripts of meetings between lobbyists and the FDA available online.

            Board up the revolving door between the FDA and DEA and the private sector.

    Help us develop a standard of treatment. Addiction treatment is the only field in medicine that does not have a standard of treatment. A quick Google search will show you that the vast majority of treatment available is solely based in the 12 step program. Science has given us so much more yet these modalities have not been utilized.

    Not everyone responds to treatment the same way – there is no ‘one size fits all’ modality. The holistic approach has shown great promise but has gained little traction because insurance companies are cutting back on modalities they’ll pay for. This needs to change. Research has borne out that the most effective treatment lasts 60 to 90 days – not 30.

    Fund the DEA so that they can be effective at stopping the illegal importation of these deadly narcotics.

With all due respect Mr. President and distinguished Members of Congress, you have the power to end America’s Second Opiate/Opioid Epidemic tomorrow, but you must be prepared to regulate commerce as President Roosevelt and the 63rd United States Congress did in 1914 and the DEA’s Haislip did in the 80s and 90s. You cannot prescribe us out of this epidemic. It’s long past time to put American’s health and safety ahead of commerce.

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