Sitting in the lap of Big Pharma

by TheEditor

Categories: Investigative, Medicine, Mental Health

Following a recent BBC documentary on antidepressants(2023), I was set on a path of deeper inquiry about psychotropic medications and the relationship of Big Pharma to psychiatrists as a group. Then my colleague S.D. got me reading: The Empire of Pain: The Secret History of the Sackler Dynasty. I was driven to do some digging about Big Pharma’s ‘offences’ in general and then sieved the list down to psychotropic medications. Note our disclaimers. This information is gathered from the public domain and may have some inaccuracies. However, one ought to focus on the ‘big picture’, not the brush strokes.

General list – offences and fines

Promotion of drugs for unapproved uses and failing to report safety data:

  • GlaxoSmithKline (2012) – $3 billion
  • Pfizer (2009) – $2.3 billion
  • Johnson & Johnson (2013) – $2.2 billion
  • Abbott Laboratories (2012) – $1.5 billion
  • Eli Lilly (2009) – $1.4 billion
  • Amgen (2012) – $762 million
  • AstraZeneca (2010) – $520 million

Illegal promotion and kickbacks to doctors: Johnson & Johnson (2013) – $2.2 billion

Manufacturing and selling adulterated drug products: GlaxoSmithKline (2010) – $750 million

Overcharging Medicaid: Pfizer (2016) – $784.6 million

Federal probe into Suboxone Film: Reckitt Benckiser (2019) – $1.4 billion

Causing often-fatal bleeding episodes in patients: Johnson & Johnson, Bayer (2019) – $775 million

Blocking generic competition through forced switching: Allergan (2019) – $750 millionUsing a “purportedly independent” patient foundation as a conduit to bump up scripts: Actelion (2018) – $360 million

Delaying cheaper generics as the patent protection ran out: Teva, Endo, Teikoku Seiyaku (2018) – $270 million

Opioid case: Purdue (2019) – $270 million

Fraudulently increasing the wholesale prices of their drugs: Pfizer, GlaxoSmithKline, Johnson & Johnson, others (2019) – $248 million

Federal probe into opioid marketing: Insys (2019) – $225 million

Publishing inflated average wholesale prices that went into calculating Medicaid reimbursement rates: Teva (2019) – $135 million

Paying for subscriptions to boost sales of their drugs: Astellas, Amgen (2019) – $125 million

Big settlements

Any medication

This is a list largest pharmaceutical settlements from 2013 to 2023:

  1. GlaxoSmithKline (2012): $3 billion for misbranding Paxil and Illbutrin and failing to disclose safety data about Avandia, among other allegations.
  2. Pfizer (2009): $2.3 billion for misbranding Bextra and other allegations.
  3. Johnson & Johnson (2013): $2.2 billion for misbranding Risperdal, Invega, and Natrecor and paying kickbacks to promote these drugs.
  4. Abbott Laboratories (2012): $1.5 billion for misbranding Depakote.
  5. Eli Lilly (2009): $1.42 billion for misbranding Zyprexa.
  6. Reckitt Benckiser (2019): $1.4 billion for a federal probe into Indivior’s Suboxone Film.
  7. Johnson & Johnson and Bayer (2019): $775 million for claims that Xarelto caused fatal bleeding episodes in patients.
  8. Allergan (2019): $750 million for blocking generic competition to Alzheimer’s drug Namenda.
  9. Actelion (2018): $360 million for Medicare fraud related to pulmonary arterial hypertension drugs.
  10. Teva, Endo, Teikoku Seiyaku (2018): $270 million for pay-for-delay deals related to Lidoderm.
  11. Purdue (2019): $270 million for public nuisance related to OxyContin.
  12. Pfizer, GlaxoSmithKline, Johnson & Johnson, and others (2019): $248 million for Medicaid fraud related to various drugs.
  13. Insys (2019): $225 million for mail fraud and False Claims Act violations related to Subsys.
  14. Teva (2019): $135 million for Medicaid fraud related to various drugs.
  15. Astellas and Amgen (2019): $125 million for patient kickbacks related to Xtandi and Sensipar.

By psychotropic medication

  1. Eli Lilly (2005): $690 million to settle claims related to Zyprexa (Olanzapine) causing diabetes or high blood sugar.
  2. Bristol-Myers Squibb (2007): $515 million for illegal promotion of Abilify (Aripiprazole), among other allegations.
  3. Pfizer (2009): $2.3 billion for misbranding Geodon (Ziprasidone), among other allegations.
  4. Johnson & Johnson (2013): $2.2 billion for misbranding Risperdal (Risperidone) and Invega (Paliperidone).
  5. Eli Lilly (2009): $1.42 billion for misbranding Zyprexa (Olanzapine).
  6. AstraZeneca (2010): $520 million for misbranding Seroquel (Quetiapine).
  7. GlaxoSmithKline (2012): $3 billion for misbranding Paxil (Paroxetine) and Illbutrin (Bupropion), among other allegations.

Total of fines (2005 to 2023)

The estimated sum total of all fines and payments from 2005 to 2023 is approximately $19.6 billion based on the following trawl. Note that this is a rough estimate and the actual total could be higher or lower depending on other settlements not included in this list.

  1. GlaxoSmithKline (2012): $3 billion
  2. Pfizer (2009): $2.3 billion
  3. Johnson & Johnson (2013): $2.2 billion
  4. Abbott Laboratories (2012): $1.5 billion
  5. Eli Lilly (2009): $1.42 billion
  6. Reckitt Benckiser (2019): $1.4 billion
  7. Johnson & Johnson, Bayer (2019): $775 million
  8. Allergan (2019): $750 million
  9. Actelion (2018): $360 million
  10. Teva, Endo, Teikoku Seiyaku (2018): $270 million
  11. Purdue (2019): $270 million
  12. Pfizer, GlaxoSmithKline, Johnson & Johnson, others (2019): $248 million
  13. Insys (2019): $225 million
  14. Teva (2019): $135 million
  15. Astellas, Amgen (2019): $125 million
  16. AstraZeneca (2010): $520 million
  17. Bristol-Myers Squibb (2007): $515 million
  18. Pfizer (2016): $486 million
  19. Eli Lilly (2005): $690 million
  20. Merck & Co. (2011): $950 million
  21. Amgen (2012): $762 million
  22. Takeda Pharmaceutical (2015): $2.37 billion

Why psychotropic medications?

Reasons

The concentration of legal cases surrounding psychotropic medications can be attributed to several factors. The most commonly theorised reasons:

  1. Off-label use: Psychotropic medications are often used off-label, meaning they are prescribed for conditions other than those for which they have been approved by regulatory authorities. This can lead to legal issues if pharmaceutical companies are found to be promoting off-label use.
  2. High demand and profitability: Psychotropic medications are in high demand due to the prevalence of mental health disorders. This high demand can lead to high profitability, which may incentivise unethical practices such as fraudulent marketing or kickbacks.
  3. Complexity of mental health disorders: Mental health disorders are complex and not fully understood. This complexity can make it easier for pharmaceutical companies to misrepresent the efficacy or safety of their products.
  4. Vulnerability of patients: Patients with mental health disorders can be particularly vulnerable and may be more likely to be exploited by unethical practices. This vulnerability can also lead to higher damages in lawsuits, as courts seek to compensate for the harm caused to these patients.
  5. Regulatory issues: The regulation of psychotropic medications is a complex and evolving field. Regulatory loopholes or inconsistencies can be exploited by pharmaceutical companies, leading to legal issues.
  6. Scientific uncertainty: The effects of psychotropic medications can be difficult to predict, and there is often scientific uncertainty about their long-term effects. This uncertainty can lead to legal issues if pharmaceutical companies are found to be downplaying or misrepresenting the risks associated with their products.

Manipulation

The manipulation of psychiatrists and other healthcare professionals by pharmaceutical companies can occur in several ways:

  1. Marketing and promotion: Pharmaceutical companies invest heavily in marketing and promotional activities. This can include advertising, sponsored educational events, and promotional materials that highlight the benefits of a drug while downplaying its risks. These activities can create a biased view of a drug’s efficacy and safety.
  2. Financial incentives: Some pharmaceutical companies have been known to offer financial incentives to healthcare professionals, such as payments for speaking engagements or consulting fees. These incentives can create a conflict of interest and influence prescribing behaviour.
  3. Provision of information: Pharmaceutical companies often provide healthcare professionals with information about their drugs. However, this information can be biased or incomplete, leading healthcare professionals to make decisions based on inaccurate or misleading information.
  4. Sample provision: Pharmaceutical companies often provide free samples of their drugs to healthcare professionals. These samples can encourage healthcare professionals to prescribe these drugs and can create a sense of obligation.
  5. Relationship building: Pharmaceutical representatives often build relationships with healthcare professionals through regular visits, meals, and gifts. These relationships can influence prescribing behaviour, even if healthcare professionals are not consciously aware of it.
  6. Sponsored research: Pharmaceutical companies often fund research into their own drugs. This can create a conflict of interest and can lead to biased research findings.

It is important to note that many healthcare professionals are aware of these potential sources of bias and take steps to mitigate their impact. However, the influence of pharmaceutical companies can be subtle and pervasive, and it can be difficult to completely eliminate their impact on prescribing behaviour.

Why psychiatrists?

The field of psychiatry does indeed have certain unique characteristics that might make it more susceptible to influence from pharmaceutical companies. Here are a few potential reasons:

  1. Subjectivity of diagnosis and treatment: Unlike many other fields of medicine, psychiatry relies heavily on subjective assessments. Diagnosis and treatment decisions often depend on the interpretation of reported symptoms rather than objective measures such as blood tests or imaging studies. This subjectivity can make it easier for pharmaceutical companies to influence perceptions of the efficacy and appropriateness of their drugs.
  2. Limited therapeutic options: For many psychiatric conditions, there are limited therapeutic options available, and many patients do not respond adequately to first-line treatments. This can create a demand for new treatments and make psychiatrists more receptive to information about new drugs.
  3. High unmet need: Many psychiatric conditions are chronic, debilitating, and inadequately treated, creating a high unmet need for effective treatments. This can make psychiatrists more willing to try new treatments in the hope of helping their patients.
  4. Stigma and misunderstanding: Mental health conditions are often stigmatised and misunderstood, which can make psychiatrists more reliant on pharmaceutical companies for information and support.
  5. Pharmaceutical innovation: The field of psychiatry has been a major focus of pharmaceutical innovation, with many new drugs being developed and marketed for psychiatric conditions. This can increase the exposure of psychiatrists to pharmaceutical marketing.
  6. Off-label use: Off-label use of medications is particularly common in psychiatry, due to the complex and individual nature of mental health disorders. Pharmaceutical companies may exploit this by promoting off-label uses of their drugs.

It is important to note that these factors do not mean that psychiatrists are less capable or ethical than other medical professionals. Rather, they highlight the complex challenges that psychiatrists face in providing the best possible care for their patients in a rapidly evolving field.

Big questions

So this exploration leaves me with very big questions that I find hard to articulate. We’re talking about huge sums of compensations for a range of misbehaviours that have been categorised. Why is this happening at all? I mean Big Pharma is supposed to be helping professionals to make sound decisions to help unwell people. My concerns reflect a broader societal discourse about the role and responsibilities of pharmaceutical companies. The pharmaceutical industry plays a crucial role in healthcare, developing and producing medications that can save lives and improve the quality of life for millions of people. However, like any industry Big Pharma is about business, and businesses aim to make profits.

Several factors seem to contribute to the issues :

  1. Financial incentives: The potential profits from pharmaceutical sales, especially for blockbuster drugs, can be enormous. This can create incentives for companies to push the boundaries of legal and ethical marketing practices.
  2. Regulatory complexity: The regulations governing the approval and marketing of pharmaceuticals are complex and vary from country to country. Sometimes, companies may interpret these regulations differently from regulators, leading to disputes and legal action.
  3. Scientific uncertainty: The science of medicine is complex and constantly evolving. A drug that is believed to be safe and effective based on the best available evidence can later be found to have serious side effects or to be less effective than initially thought.
  4. Information asymmetry: Pharmaceutical companies have access to more and better information about their products than anyone else. This can create opportunities for companies to misrepresent or selectively present information about their products.
  5. Competitive pressure: The pharmaceutical industry is highly competitive. Companies are under constant pressure to develop new drugs and get them to market as quickly as possible. This can lead to corners being cut and mistakes being made.
  6. Insufficient oversight and penalties: While regulatory bodies like the FDA in the U.S. or the MHRA in the U.K. work to oversee the industry, they often lack the resources to fully monitor every aspect of every company’s operations. Additionally, the penalties for misconduct, while often seeming large in absolute terms, can be seen by companies as a cost of doing business.

These factors, among others, contribute to the ongoing challenges in ensuring that pharmaceutical companies act in the best interests of patients at all times. It is a complex issue with no easy solutions, and it is the subject of ongoing debate among policymakers, healthcare professionals, and society at large.

Reflections and summary

This exploration delved into the complex and often controversial world of pharmaceutical companies and their legal entanglements. I began by examining the major scandals among big pharmaceutical organisations associated with product misrepresentation, focusing on those that led to significant lawsuits and compensations.

I discovered that several of the largest fines and settlements involved drugs with psychotropic properties, used to treat mental health problems. This led me to question why there was such a concentration of cases surrounding these particular medications. Theories proposed included the high profitability of these drugs, the vulnerability of the patient population, and the relative ease of manipulating diagnostic formulations and subjective assessments in psychiatry.

I also found that perhaps many psychiatrists, who do most of the prescribing of these medications, were manipulated through tactics such as biased continuing medical education (CME/CPD) courses, misleading presentations by pharmaceutical representatives, and the use of key opinion leaders who subtly promote off-label uses of medications.

I then updated a list of major pharmaceutical settlements to include more recent cases, from 2005 to 2023. This revealed a continued pattern of large settlements, often involving the same companies as before. The estimated total sum was USD$ 19.6 billion.

Upon categorising these cases, I found that they often involved issues such as the promotion of drugs for unapproved uses, illegal promotion and kickbacks to doctors, manufacturing and selling adulterated drug products, overcharging Medicaid, and more.

Finally, I explored the broader implications of these findings. The pharmaceutical industry, while playing a crucial role in healthcare, is also a business which aims to maximise profits. This can create incentives for companies to push the boundaries of legal and ethical marketing practices. The complexity of regulations, scientific uncertainty, information asymmetry, competitive pressure, and insufficient oversight and penalties all contribute to the ongoing challenges in ensuring that pharmaceutical companies act in the best interests of patients at all times.

In conclusion, my exploration has highlighted the need for continued vigilance, robust regulation, and ethical business practices in the pharmaceutical industry. It has also underscored the importance of informed and discerning healthcare professionals who can navigate the complex landscape of pharmaceutical products and their marketing.


Other posts that may interest you...

Polypharmacy

Polypharmacy is the use of multiple medications by a patient, particularly when too many forms of medication are used by a patient, when more medications are prescribed than are clinically ...

Read more

Off-label and off-licence prescribing

In the UK, the terms “off-label” and “off-licence” prescribing are often used interchangeably, but they refer to slightly different concepts. The General Medical Council uses the term ‘unlicenced prescribing’ to ...

Read more

Paragraph 98 and remote consultations

This blog has considered a number of issues relevant to prescribing of medications. Paragraph 98 is one of the most powerful. It is squarley designed to protect patients. You are ...

Read more