Fight-or-Flight Pharma Lawsuits

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As originally described by Walter Bradford Cannon, “thfight-or-flight response (also called hyperarousal, or the acute stress response) is a physiological reaction that occurs in response to a perceived harmful event, attack, or threat to survival.”

I can’t help but wonder if the recent lawsuits brought against several Big Pharma opioid manufacturers by various states has placed the Pharma in a state of fight-or-flight. Now we can add Ohio to Mississippi’s pending lawsuit in addition to West Virginia who settled out of court, the City of Chicago, and various counties in New York and California all of whom have started litigation for their sweet monetary settlement. But, any judge allowing such nonsense to move forward could culminate, at least in my mind, into harm that sets dangerous precedent to attack, and threaten the survival of several industries in the free world, including not just Pharma, but the tobacco industry, alcohol, and yes, even unhealthy snacks and beverages. I promise – we’ll come back to this!

As highlighted on the American Pharmacists Association (APhA) website, the Wall Street Journal’s recent report, Ohio sues five drug firms, saying they fueled opioid crisis highlights the state of Ohio is next on the list of states to file suit “against five drug companies, accusing them of conducting marketing campaigns that misled doctors and patients about the danger of addiction and overdose. The complaint—filed by Ohio Attorney General Mike DeWine—targets parent companies and various subsidiaries, including Purdue Pharma, Johnson & Johnson, Teva Pharmaceutical Industries, Allergan, and Endo International’s Endo Health Solutions unit.” It went on to say that the companies are accused of being dishonest with prescribers and the general public about opioid analgesic risks. Ohio is seeking monetary damages to curtail the costs associated with the opioid crisis.

I was happy to learn that according to ReutersChris Kening, Janssen spokesman Jessica Castles Smith did not succumb to flight in her emailed statement: “The allegations in this lawsuit are both legally and factually unfounded.” And she went on the say “Janssen has acted responsibly regarding its opioid pain medications, which are approved by the U.S. Food and Drug Administration and carry FDA-mandated warnings on their labels about the drugs’ known risks.” That is quite a statement coming from such a conservative family-orientated company that is owned by Johnson & Johnson.

Purdue Pharma took the comfortable Swiss approach, stating via email “We share the attorney general’s concerns about the opioid crisis and we are committed to working collaboratively to find solutions.” I won’t quite assign Purdue the flight award yet; at least they commented, unlike other Pharma companies named in the suit.

Notwithstanding, like so many others, Kening’s article quotes a common misdirected factoid that “opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the U.S. Centers for Disease Control and Prevention.” 

What this and most articles don’t tell you is that for the last several years, prescription opioids have declined, prescription opioids are not the root cause of overdose deaths in this country, and the majority of addiction does not start in teens that experiment with prescription opioids.  

While opioid deaths have generally risen from 2001 to 2014 according to NIH, from 2010 to 2014, opioid deaths leveled off.  What changed during that time is that heroin use, precipitously increased. All of these are nicely graphed on the NIH website which is easily accessible to media muckrakers that continue to incorrectly correlate and sensationalize prescription opioids as the root cause of the opioid crisis.  Moreover, according to SAMHSA data, non-medical use of opioid analgesics dropped between 2004 and 2005, leveled off from 2005 to 2009, and dropped significantly from 2009 to 2014.

Reuters and the WSJ also fail to acknowledge that there is no separation made in the mortality data between illegally obtained heroin-associated deaths and that of prescription opioids. Furthermore, while prescribed opioids and deaths associated from these have clearly declined, we have seen the worse surge in heroin use than ever before as unmistakably highlighted on the NIH website graphs linked above.   

Three years ago, guest blogger Sarah Fudin Hermalyn pointed out that “Drug companies spent nearly $84 million marketing pharmaceuticals in the District of Columbia in 2011, including an outlay of nearly $19 million for gifts given to physicians, hospitals and other health care providers, according to a report by researchers at the George Washington University School of Public Health and Health Services (SPHHS).”

She went on to say that “before we criticize all that Big Pharma does, perhaps we need to put things in perspective. Her comments below are for all Pharma, not just limited to those that manufacture opioids.

◾In 2011, Big Pharma spent $2.4 billion direct-to-consumer (DTC) television ads, a 23% drop from the $3.1 billion spent in 2007.

◾In 2006, the most recent available data indicates that five of largest cigarette manufacturers spent a total of $12.49 billion – or over $34 million dollars a day for DTC advertising.

◾As of 2012, “the NBA, NHL, MLB, and NFL are worth, combined, more than $12 billion. Furthermore, over the next decade, the value of professional sport teams is going to rise to unpredictable levels.”

“There is greater than 5 times as much spent in direct-to-consumer advertising to encourage people to smoke –public health risk for sure.”  Big Pharma does spend a lot of money in DTC advertising, but those ads are highly regulated by the FDA and do not include advertisements for opioids or opioid-containing products. As Ms. Hermalyn points out in her post, “one can argue that with the current obesity epidemic within the U.S. (a significant public health risk), perhaps the professional sports industry should pay money towards encouraging healthy lifestyles and exercise instead of sitting on a couch, hours on end watching these highly paid athletes.” Hey, maybe states can start suing athletes!

Last year I collaborated on a blog post with Kathleen Nicewicz which we titled, Opportunistic Turds and Opioid Induced Constipation. Here we pointed out that during the Super Bowl, there were multiple beer commercials. So, I ask our readers, why isn’t Ohio and other states suing Anheuser-Busch for the societal costs of drunk driving, alcohol poisoning, liver toxicity, or alcohol neuritis?  When they advertise, I recall a statement like, “drink responsibly”.  I think that’s probably a trivial warning compared to the counseling, patient handout materials, and warning labels prominently displayed on every prescription opioid bottle coupled with FDFA regulation, REMS programs and dedicated educational programs sponsored by Pharma.

Similarly, PepsiCo had multiple ads during the Super Bowl. They make products such as Lays potato chips, Gatorade, Quaker, Tostitos, and Pepsi. Why aren’t states suing PepsiCo for the cost of obesity prevalence in America and associated morbidity and mortality from diabetes that may land a significant portion of victims on costly dialysis?

For the life of me, I can’t understand why Big Pharma isn’t counter-attacking with personal lawsuits against each individual politician that is responsible for rallying their municipalities against Pharma for the purpose of grand-standing and generating revenue. I can tell you from personal experience litigating against the government, creates a very unpleasant environment for the politician(s). Sure, each grand-stander has liability insurance and protection with their respective state, but there will come a time that personal aggravation will trump the desire to unfairly pursue Pharma.  What I learned personally as a victim is that eventually the accused needs to make a decision; take the heat as prey, or reverse your roles and become the predator – creating an unexpected twist for a pompous political figure that now finds him or herself on the defensive. You’d be surprised how fast their legislative allies back away as personal pressure supervenes.

Just imagine what would happen if various states were to win or settle cases for millions of dollars against the Pharma industry. As we continue to see significant decreased federal funding to each state for underprivileged and substance abuse treatment, what’s to stop them from suing the tobacco, alcohol, or food industries for millions of dollars as well?

Big Pharma needs to become the predator instead of the prey and stand up to the villains that are suing for the wrong reasons.  It is high time that Pharma take to fight-not-flight, in an effort to prevent threat to survival. Instead of bowing to large financial settlements, states should be forced to work with Big Pharma to settle in ways that promote a safer opioid environment, such as encouraging Abuse Deterrent Formulations and other means that can help to ensure that legitimate long-term pain patients truly requiring long-term opioid therapy are not caught in the crossfire.

In closing, I suspect there are many here that are dying to post a comment but are precluded from doing so because of their connections to politics and/or the Pharma Industry.  Don’t worry; post your name as anonymous and leave your e-mail address blank. Or, if I see an anonymous come in, I’ll be certain to remove any identifiers. I sure would like to hear from a few attorneys on here. As usual, all are invited to comment, pro and con.

 

 

11 thoughts on “Fight-or-Flight Pharma Lawsuits

  1. I simply cannot even finish reading this article though I know I probably should.

    What really bothers me is that no matter how big pharma advertised their (12 hour release) opioid/s or how they touted it as “safe” … please, do tell me what doctor did not already know that ALL opioids have risks!?? What sort of well educated physician would ever assume any opioid would suddenly not pose the usual risks that have been historically well documented with their use and moreover within populations with predisposing factors! Did they really believe in their hearts and minds that a “special” coating would prevent abuse!??? Oh please. Imho, docs should take responsibility for being so darn naive and eager to skip quality time with their patients as well as reviewing records.

    Now states, with physicians all yelling and rooting them along, are suing big pharma!?? Talk about taking absolute advantage of a situation. I don’t suppose these states plan to share their windfall with families affected by their misuse?? Yes, I doubt it. I suppose they feel entitled to the funds for having spent Medicare dollars on rehabilitation.

    The idea that grown, educated thinkers such as doctors could not see beyond the hype of pharma’s usual used car sales pitch is absolutely amazing to me.

    Where do we go from here? Force every CPP to have a genetic test to prove their need for a particular opioid and dose? Do we continue to deny adequate relief?

    How do we put the genie back in the bottle? Well, I have many ideas but far too long to address here.

    Let’s all just stop looking to blame something or someone. Let’s move forward with love and compassion for addicts and people in chronic pain. Oh, and let’s try to remove the police state from the doctor’s office.

    Jmho.

  2. As a chronic pain patient, I cringe every single time I see a pharmaceutical company blamed for the heroin epidemic. The only statistic we see is the number of deaths where opioids were present. 9 times out of 10, the opioid was heroin, and had been taken with a benzodiazepine or alcohol. If this case does make it to court, I want to hear how many of the heroin overdose victims ever had a prescription for an opioid in the past, as well as what other drugs were found after a toxicology report, and if the victim had valid prescriptions for those drugs as well.
    While I am sure there are some legitimate patients who resorted to heroin after their Dr got arrested, or otherwise could not get a prescription for their pharmaceutical of choice, I am willing to bet that number is quite low. If the opioid responsible for death was a pharmaceutical, even among addicts, I want to know the method of administration as opposed to it’s intended route of administration. Of course someone who decides to inject something that was meant to be taken orally is going to have bad results, but that’s not the pharmaceutical company’s fault.They used a product in a manner it was never meant to be used. Hell, if I decide to use my car as a wheelchair at the mall, that wouldn’t make the car company responsible for the damages.

  3. Thank you Dr. Fudin and several of the comment authors, for brilliantly voicing the many opioid-related issues that anger–and affect–me on a daily basis. I wish we could document how many lives like mine were *saved* by long-term high-dose opioid therapy. Recently I was reminded how it feels to inhabit my sick-for-26-years body without the support of my pain meds; the experience inspired me to make all necessary arrangements to take my own life if I become a victim of the politics, propaganda and sloppy statistics discussed above.
    Recently I complained to a physician friend about the disproportional news coverage of opioid-related deaths, and about the issue discussed above re lack of distinction between patients taking medication prescribed for them and people using illegal drugs at will. He responded with 2015 statistics indicating 90 deaths/day caused by the combination of situations now referred to as “opioid deaths”. Apparently 241 deaths/day were attributed to alcohol! Smoking? 1315 deaths/day. But at least strict controls are in place over alcohol and cigarettes: the purchaser must be at least 21 years old.

      1. Thank you kindly Dr. Fudin. Sure it could’ve been read between the lines, but no one should have to: my potential need for a Final Exit is not suicidal ideation or even depression. My pain specialist is drastically cutting the opioid doses of his patients, and I’ve been sick for so many years and tried so many alternatives…

        You do us great service here.

  4. Brilliant article! And excellent contribution by Sarah Fudin Hermalyn as well! Maybe part of the choice in “fighting or fleeing” by the individual Pharma Co’s, is decided by who still has skin in the game of profits by the manufactured “epidemic” and the players comprised in manufacturing it. It’s clearer to see with each passing day by more and more that this current so-called “War on Drugs” exacerbated by the CDC’s Guidelines and consistent manipulation of data to Congressional and State leaders, cannot possibly be about what’s in the “best interest” of either the addiction community or those Prescribing Opioids for the Chronic Pain Community as neither communities are benefiting – but both are severely being harmed. They know it. They are being consistently told by experts, physicians, associations, patients and their families. And yet, they continue to turn a deaf ear.
    No, this has never been about what’s “Responsible for the Prescribing of Opioids” to help either communities in this manufactured “epidemic” in which restriction, Guideline, state law, and Defense Dept actions have all directly contributed to the escalation of overdose deaths and the heroin/illicit fentanyl demand over the last five years to be certain. This is and always has been about money. Worldwide, “pain” is a multi-trillion dollar industry. And so many players stand to gain – and gain substantially by restructuring of opioids and how they’re “prescribed”. Abuse-deterrent formulations? Absolutely. Big Pharma needs to get their hands on those new patents! Generics started killing them and they needed to do something about that. They also need to get their other top selling meds in the hands of pain patients. Anti-epileptics, anti-depressants, etc. Get them OFF of their EVIL opioids and we’ve got a better cash infusion coming in. Let’s not forget the injections for one of the top, if not THE #1 complaint amongst Baby Boomers – Low Back Pain… now you’ve got your selection of steroids to include to make all the Interventionalists, Neurologists, and Anesthesiologists et al, happier who slightly changed the names of their bread and butter epidural steroid injections to other names that aren’t currently getting a bad wrap in the press and by the FDA. “Come in and get a shot of prednisone like Yule had in your knee or hip”. “Have a selective nerve root block” … And people are completely clueless to the dangers.
    Big Device Manufacturers? Thrilled with selling more neurostimulators! Or should I say – Spinal Cord Stimulators and Infusion Pain Pumps – however, less of those as they might have to use a dreaded “opioid”. And the addiction specialists? PROP & Addiction Treatment Centers? Well, this is the best for them because they’ve convinced the politicians that this will get the vote and it PC – politically correct. Never mind that our nation’s heroes and Veterans are being neglected and dying, millions are suffering unimaginable agony because their lives aren’t as important. The stats are all based on lies manufactured by our governement’s CDC in order to manipulate the media, Congress and legislation. But this isn’t anything new. This started getting legs back in 2005 with the NASPER Act developed by a group of “concerned” physicians (Interventionalists) and has been building ever since. But really got teeth in 2010. Why is that? Isn’t that an interesting timeline.
    Money. Always follow the money.

  5. The search goes on by media pundits and politicians to find a scapegoat and a simplistic explanation for the increasing number of opioid deaths in the U.S. They often point to events that coincide in time with the beginning of the increase in opioid deaths as if the coincidence in time means that one caused the other. But what of other things that occurred in 2001 and the years following? 9/11, the invasion of Afghanistan and Iraq, two downturns in the economy, the election of a Democratic president, and a couple of solar eclipses. Does their mere existence at the same time that opioid deaths increase mean that any one of them was the cause? It’s as logical as saying that opioid deaths increased in a prime number year 2003, therefore years with prime numbers are associated with increased opioid mortality.

    So now the scapegoat is the Pharma Industry. Seems logical. And yes, we know about the illegal actions of Purdue Pharma. There is no excusing that. But did their pushing the sale of OxyContin trigger an international increase in opioid deaths? And even if they did push their sales, remember it was the physicians writing prescriptions and the pharmacies dispensing product that put it in the hands of patients and users (as far as I know their sales reps were not standing on street corners handing out samples). What of their duty, and are they the next scapegoat?

    Other scapegoats have come and gone (it was a letter to the editor in the NEJM in the 1990’s; it was JCAHO pushing the Fifth Vital Sign; it was the FDA..) and more will come in the future. But the solution to this problem is to understand the complexity of substance abuse disorder and addressing all the elements that come together that lead to the increase in addiction in North America, including drug availability, genetic susceptibility to how opioids affect pleasure centers in the midbrain, the scourge and cycle of unemployment, poverty, hopelessness and depression, mental illnesses especially bipolar disease and personality disorders, the existence of chronic pain and the absence of alternative treatments, the availability of both illicit opioids and prescription opioids on the streets, the lack of adequate pain management specialists, and the lack of availability of treatment centers for addiction.

    History is replete of examples of Draconian solutions to problems leading to unintended consequences and even worse problems (World War I, Prohibition, the War in Vietnam, the Iraq War and subprime mortgages come to mind). I fear we will see patients with chronic pain hurt by another Draconian solution to a significant problem but one that is much smaller than other causes of death and suffering in the U.S. that deserve equal or more attention from the media and our government.

    Enough said.

    Thank you for publishing this piece, Dr. Fudin, and thank you Sarah Fudin Hermalyn for your research.

  6. It’s time for Chronic Pain patients to come together in their respective States and find compassionate attorney to begin Class Action lawsuits against their STATES.
    Have no idea how to begin, but maybe here we can do some brainstorming?

  7. I would love to be a wittness for pharma that not only does long term high dose opioid rherapy work but it improves quality of life DRASTICALLY . I will also prove that when forced to reduce the pain is so bad I’m bedridden for days if I do simple exercise.

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