BIG PHARMA … ANGEL OR DEVIL?

Angel:Devil

The term “Big Pharma” is more often than not, a pejorative term used to describe the conglomeration consisting of the largest pharmaceutical companies. The annual earnings from these companies’ number literally in the billions of dollars.

Facts, fiction, myths and legends surround Big Pharma. Some believe that Big Pharma is the devil incarnate focused only on their self-interest by creating customers and not cures. And yet others believe that Big Pharma’s existence has significantly eased the pain and suffering of millions of people and have saved an untold number of lives. Regardless, one thing is certain. Big Pharma possesses billions of dollars in earnings and profits which when used in a collaborative, wise manner has the potential and ability to attain breakthroughs in the identification and treatment of diseases.

Who or What is Big Pharma?

Like the barker at a sporting event repeatedly shouting out “Get your programs! Get your programs here! You don’t know the players without a program!” So too, we must identify the players in “ Big Pharma.”

In general, “Big Pharma” refers to the largest pharmaceutical companies in the world. The ten biggest pharma companies in terms of 2018 revenue production from their pharmaceutical segments alone (not including include sales from consumer health, animal health or crop science) were:

  1. Pfizer – $53.7 Billion
  2. Roche – $45.6 Billion
  3. Johnson & Johnson – $40.7 Billion
  4. Sanofi – $39.3 Billion
  5. Merck & Company – $37.7 Billion
  6. Novartis – $34.9 Billion
  7. Abbvie – $32.8 Billion
  8. Amgen – $23.7 Billion
  9. Glaxo/Smith/Kline – $23 Billion
  10. Bristol-Meyers Squib – $22.6 Billion

In 2018, the total revenue production from pharmaceutical sales alone for these ten companies was $354 Billion. That is $354,000,000,000!

Big Pharma as the Devil on the Shoulder

With stratospheric earnings, come stratospheric power and influence. Deep financial pockets open the door to every state house in the nation as well as Congress. Between 1998 and 2014, pharmaceutical companies were reported to have spent approximately $2.9 Billion on lobbying expenses in our Nation’s Capital alone. Further in 2013 and 2014 alone, these companies reportedly spent $15 billion in campaign contributions.

Spending on marketing and advertising is also prodigious. In 2018, the pharmaceutical industry purportedly spent $6.4 Billion on advertising. One watchdog journal reported that drug companies spend 19 times more on marketing than they do on research and development. Another investigative journal reported that every $1.00 spent on a commercial, billboard, radio, or print ad results in over $4.00 in retail sales. For example, Boehringer Ingelheim spent $464 million in advertising for Pradaxa, its blood thinner, in 2011. In 2011, sales of Pradaxa surpassed $1 billion

Reportedly, American television viewers are subjected to as many as sixteen (16) hours of prescription drug advertising every year.

The television character Alan Shore from the hit series, Boston Legal, summed up the pharmaceutical industry as such:

Alan Shore on Big Pharma

Conspiracy theories abound about the evils being perpetrated by Big Pharma. Some people postulate that there are all-natural cures for serious illnesses including cancer, herpes, arthritis, AIDS, various phobias, depression, obesity, diabetes and other diseases. They opine that these cures are all being deliberately hidden and suppressed from the public by the Food and Drug Administration, the Federal Trade Commission, and the major food and drug companies.

A common claim among proponents of the conspiracy theory is that pharmaceutical companies suppress negative research about their drugs by financially pressuring researchers and journals.

Legal claims, including Medicare and Medicaid fraud, improper off-label promotion and inadequate manufacturing practices, have been successfully prosecuted against the pharmaceutical industry by the Department of Justice. In 2012, GlaxoSmithKline pled guilty to criminal charges of willfully promoting its leading antidepressant drugs, like Paxil and Wellbutrin, to consumers under the age of 18. Neither drug had been approved by the US Food and Drug Administration to be used by minors. As a result, the Department of Justice fined GlaxoSmithKline $3 billion.

In 2012, Johnson & Johnson was hit with a $2.2 billion fine for promoting off-label use of its drugs [i.e., the company was found guilty of encouraging consumers to use the drugs for purposes not condoned by the FDA]. In 2009, Pfizer, paid $2.3 billion for illegally marketing its Bextra drug. The New York Times noted that the fine – a “record sum” at the time – accounted for less than three weeks of Pfizer’s sales.

In October 2019,  a jury in Philadelphia assessed an $8 billion verdict against Janssen Pharmaceuticals, a Johnson & Johnson subsidiary over its marketing of the anti-psychotic drug Risperdal. The plaintiff argued that the health care giant downplayed risks that the drug could lead to breast growth in boys.

In short, reliance on pharmacotherapy bears known and obvious risks for patients and medical practitioners.

Big Pharma as the Angel on the Shoulder

In 2012, Boston Children’s Hospital released a statement acknowledging a bold, new frontier with Big Pharma. This statement recognized that partnerships had been created, “… which demonstrated Big Pharma’s recognition that academic medical centers hold many important cards in clinical research: scientific expertise, animal models of disease, patient samples and phenotypic data.”

This statement also reported, “Increasingly, these partnerships involve academic and company researchers developing joint grant proposals in targeted areas, selected (by joint agreement) for company sponsorship. Some, like the Immune Disease Institute’s $25M arrangement with GlaxoSmithKline are specific to one academic institution; others, like Pfizer’s Center for Therapeutic program, provide the same resources under the same deal structure to multiple institutions. Each new deal advances the interaction and understanding between academia and pharma around the common goal of finding new compounds and bringing them to clinic.”

Prior to the 2000s, the autism community had hoped for drugs that target the disorder’s hallmark social and communicative deficits. Similar to eating disorders, the U.S. Food and Drug Administration had only approved two compounds to treat autism. In the case of autism, it was the antipsychotics risperidone and aripiprazole which were utilized to alleviate secondary symptoms, such as irritability and aggression.

Like eating disorders, there is no known cure for autism. However, research is increasingly indicating that earlier therapy in the form of social and communication coaching can have a disproportionately beneficial effect.

Enter Big Pharma. (Or, those who solely embrace the devil on the shoulder would say that Big Pharma saw an opportunity to increase their profit margins by investing in autism research).

In 2011 industry giant Pfizer  launched an “Autism Research Unit,”, the first in Big Pharma dedicated to autism. The autism group is part of Pfizer’s neuroscience unit, which also investigates schizophrenia and Alzheimer’s disease.

Beginning in 2012, a $38.7 million research project spearheaded by Autism Speaks, King’s College London and Swiss pharmaceutical giant Roche concluded in March 2018. This project, called EU-AIMS, focused on developing a framework for drug discovery. Its leaders sought to validate biomarkers for autism and to work with regulators on establishing the best ways to run clinical trials. The researchers also made advances in understanding how brain development, anatomy and function relate to autism features. Other participating companies included Eli Lilly, Servier, Janssen Pharmaceuticals, Pfizer and Vifor Pharma.

In 2018, a new international research collaboration was formalized and funded. With more than 113 million euros (about $132 million) in funding, it is the biggest project to date in autism research. Launched in June, the Autism Innovative Medicine Studies-2-Trials,  or AIMS-2-Trials brought together 48 partners from 14 nations, including academic institutions, pharmaceutical giants and charities. One of its aims was to establish a clinical-trial network of more than 15 centers across the European Union.

Declan Murphy, a professor of psychiatry and brain maturation at King’s College London and the academic lead on the project stated, “Because autism may take vastly different forms, the ultimate goal is to tailor therapies to an individual’s biological profile.”

The AIMS-2 researchers also plan to look for risk factors that render autistic people particularly susceptible to other conditions, such as anxiety and epilepsy. Professor Murphy also stated, “These co-occurring conditions add a “significant burden” on top of autism. The plan is to explore the connection between autism and these conditions, quantify their impact and investigate ways to treat and prevent them.”

In March 2019, a study was released indicating a new autism drug had successfully improved sufferers’ social skills in both adults and children, scientists revealed.

Experts are hailing the outcomes of the drug trials despite the fact that so far, licensed medication for Autism Spectrum Disorder (ASD) does not address core symptoms, such as problems with social communication and repetitive behaviors. But, that is one of the many goals toward which this collaboration is working.

Finally, in September 2019 President Donald Trump  signed into law, the Autism Collaboration, Accountability, Research, Education and Support Act. This Act allocates $1.8 billion in funding over the next five years to help people with autism  spectrum disorder and their families.

So, what does one get for that investment in autism? Generally accepted treatment standards.

Consensus Guidelines in the UK

Practice Guidelines in India

Guidelines for Children with ASD

As for eating disorders?

Big Pharma and Eating Disorders

In Texas, we have a somewhat colorful expression for “fait accompli,” that is, “the horse done left the barn.” With regard to Big Pharma and the treatment of eating disorders, not only has “the horse done left the barn,” but it galloped down the lane, mated with the neighbor’s prized brood mare and is currently eating apples off the trees in Aunt Bessie’s orchard three counties over.

The United States Food and Drug Administration has approved only two drugs to treat eating disorders.  Vyvanse is the first FDA-approved drug to treat binge eating disorder in adults. It’s also used to treat ADHD. It is not clear how the drug works in binge eating, but it is thought to control the impulsive behavior that can lead to bingeing. In studies, patients who took the medicine had fewer episodes of binge eating.

The FDA also approved the use of Prozac (Fluoxetine) for Bulimia Nervosa.

No medication has been FDA-approved for the treatment of Anorexia Nervosa. Despite this, clinical doctors have been known to prescribe an aggressive medication regiment to treat eating disorders. Remeron, which has not even been studied in trials with Anorexia Nervosa, is nonetheless often used in patients with Anorexia Nervosa (especially if there is co-occurring depression or anxiety) due to its ability to help with sleep and increase appetite, thereby potentially increasing weight gain.

In order to treat the symptoms of eating disorders and the co-current conditions, doctors often prescribe a plethora of drugs not specifically approved to treat the disease. This is called “off-label” prescribing.

The following drugs have been utilized to treat eating disorders and its many co-occurring conditions:

  1. Fluvoxamine;
  2. Ambien;
  3. Lithium;
  4. Potassium;
  5. Vayarin;
  6. Fluoxetine HCL;
  7. Buspirone HCL;
  8. Gabapentin;
  9. Mirtazapine;
  10. Latuda;
  11. Metronidazole;
  12. Vitamin B-1;
  13. Divalproex;
  14. Doxepin;
  15. Zolpidem;
  16. Mag Oxide;
  17. Cymbalta;
  18. Hydroxyzine Pamoate;
  19. Trazadone;
  20. Mynocycline;
  21. Baclofen;
  22. Topiramate;
  23. Thiamine HCL;
  24. Ondansetron ODT;
  25. Prazosin;
  26. Sulfamethoxazole;
  27. Citracal Plus D3;
  28. Omeprazole;
  29. Spironolactone;
  30. Ferrous Gluc;
  31. Venlafaxine;
  32. Lamotrigine;
  33. Ranitidine;
  34. Trifluoperazine;
  35. Olanzapine;
  36. Vancomycin;
  37. Oxcarbazepin;
  38. Risperidone;
  39. Naltrexone;
  40. Neurontin;
  41. Vistaril;
  42. Trileptal;
  43. Klonopin

Some doctors who treat eating disorders have begun to utilize ketamine to treat certain aspects of eating disorder symptoms. They swear to its effectiveness and report they have seen vast improvement in patients using ketamine as part of their therapy regiment.

The cold, harsh reality is that Big Pharma is already firmly embedded in the eating disorder industry and is not going away. And so, we are left with the issue of how do we handle this dilemma going forward. Do we acknowledge the reality that Big Pharma has a permanent presence in the industry and find meaningful ways of collaborating? Or do we figuratively tightly shut our eyes, place our index fingers in our ears, loudly stamp our feet, hold our breath until our faces turn blue and hope Big Pharma goes away?

To date, in the realm of the treatment of eating disorders, research scientists, university based doctors and professionals historically have not only not embraced the reality of pharmacotherapy, but have routinely shunned its presence.

With hundreds of billions of dollars in annual sales, Big Pharma has the ability to partner with doctors and organizations and pour their formidable financial resources into whatever cause, disease treatment or prevention it chooses. Or, through being shunned and rejected by an industry, diseases remain understudied and research into them is undertaken in a piecemeal fashion with little or no collaboration. And all the while, our loved ones continue to suffer.

In 2018, of that $354 billion in pharma sales, how much was spent on lobbying for eating disorder research based bills or bills that would establish centers of excellence so that research could be conducted in a collaborative manner? ZERO. NADA. NONE.

It is incumbent upon the industry to recognize that reality and find proactive, productive ways to collaborate and make use of the tremendous financial resources available to Big Pharma.

For far too long, the eating disorder industry has recognized the “evil” of Big Pharma and shunned the “good” of Big Pharma. The eating disorder community pushes legislative bills that do not address any funding for research and which stand very little chance of passing. Our research scientists are operating in silos believing that very little funding exists for their studies. With that mindset of isolationism and turning away legitimate sources of funding, our loved ones continue to pay the price for that lack of vision.

And whether it is one person dies every 62 minutes, or one person who dies every 167 minutes, that is one person too many.

 

 

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