The Cost of Manipulation: The Irresponsible Abuse of Technological Opacity in the Pharmaceutical Industry

Pharmaceutical companies use drug trials as a key strategy in the disruption and manipulation of science. Patients in trials that exhibit positive responses to the medication are handpicked while those with adverse reactions are dismissed (Ausness, 2021). These companies are then selective in their reporting practices, only disclosing reports that produce positive outcomes and disregarding the negative for fear that it may hinder the drug’s approval. (McCarthy 2018, Goldacre, 2014).

The detrimental effects of such exploitation on society are grave. Volunteer patients who willingly subject themselves to the intrusion of clinical trials for the betterment of the community are now being exploited due to ineffective treatment – post-medical trials. Consumers are now forced to medicate with subpar and unduly expensive drugs. The unrelenting pursuit of profits constantly puts lives at risk of avoidable and unnecessary suffering, and unfortunately, this is normalized due to the absence of standard care from pharmaceutical companies, and regulatory bodies as well as the absence of legislation to safeguard against such harms.

Clinical trials are funded by Pharmaceutical companies themselves, giving them the liberty to experiment as they see fit. Thus, they are four times more likely to return favorable results compared to government-funded trials (Lexchin, 2011). The matter is made worse with FDA’s oversight when investigating a drug’s efficacy and safety before its release onto the market. To put this oversight into perspective, If 100 trials were conducted with 98 unsuccessful outcomes, the drug would still be approved solely because of the two successful trials. Despite the overwhelming body of evidence pointing to a harmful effect, unsafe drugs continue to be sold thanks to this generous margin of error allowed to pharmaceutical companies.

In an effort to promote transparency through data reporting, The FDA Modernization Act 1997 mandated companies to register their clinical trials online at ClinicalTrials.gov (Goldacre, 2014). Despite this, companies refused to work in compliance with regulation as reports found that 45% of industry-funded trials still failed to report their findings, rendering the law ineffective (Anderson 2015).

Scientific misrepresentation through ghost-written publications

The manipulation of science persists with ghost-writing, where pharmaceutical companies create publications using the names of renowned academics for product promotion. This practice transgresses numerous ethical standards, and compromises the credibility of medical journals, while also imparting inaccurate perceptions to healthcare professionals, scholars, and the general public regarding the safety and effectiveness of the drug in question (Moffatt and Elliott, 2007).

The use of ghost-writing to manipulate scientific data is emerging as a serious issue in the pharmaceutical industry, as it can lead to harmful consequences for patients. Such risks were evidenced in the VIGOR study in 2000, which was discovered to have been ghost-written and contained false information about the drug Vioxx. The study led to over 140,000 people suffering heart attacks, ultimately resulting in the drug being withdrawn from the market in 2004 (Minasi, 2017).

Similarly, in 2001, GlaxoSmithKline was found to have hired consultants to write an article about the drug paroxetine, used to treat adolescent depression (McHenry and Jureidini, 2008). The publication, authored under the names of 22 medical professionals asserted that the drug was deemed both efficacious and safe. In actual fact, the study was harmful and failed both its primary and secondary trials, causing participants to engage in self-harm and suicidal tendencies. Despite this, the drug continued to be cited as positive in 226 peer-reviewed published articles.

The manipulation of scientific data through ghost-writing can be considered a form of hostile information, which includes various types such as “disinformation”, “misinformation”, and “malinformation” (Grasso, 2022). This topic was explored in an international research project led by Dr. Costantino Grasso, called “Whistling at the Fake: The Crucial Role of Whistleblowers in Countering Disinformation.”

The project, whose findings are available on the Corporate Crime Observatory    (www.corporatecrime.co.uk/whistling-at-the-fake) specifically looked at the implications of these tactics in the pharmaceutical industry and emphasized the importance of whistleblowers and insiders in uncovering these acts and increasing public awareness. In particular in a special episode produced by What Does It Profit? as part of a research project, Dr. Elisabeth Bik and Dr. Ivan Oransky further discussed the challenges faced by reporting doctors and scientists when exposing scientific manipulation and how it can be exposed. Reporting scientists may face personal risks, including job loss, personal information disclosure, and physical retaliation, which may deter them from exposing misinformation. Female whistleblowers may face additional personal attacks on their qualifications and appearance, and groups of individuals who disclose misinformation may face harsher retaliation against women and ethnic minorities (Carpenter, Bik and Oransky, 2022).

Abuse of technology through the misrepresentation of risks

Purdue Pharmaceuticals’ opioid crisis is a classic example of how abuse of technology through the misrepresentation of risk can result in harm to the public. Consequently, to illustrate the challenges related to the misrepresentation of risks related to the use of drugs, it follows a brief analysis of Purdue Pharmaceuticals’ misconduct related to the company’s aggressive marketing campaign of OxyContin, which resulted in it being overprescribed, causing an epidemic of addiction and overdoses. As a matter of fact, the way in which Purdue Pharmaceuticals commercialized OxyContin represents a significant case study exploring the implications of technology abuse and hostile information in the pharmaceutical sector.

OxyContin was a safe and vital form of palliative care when administered properly.  By 2004, it had become the most abused drug in the United States (Van Zee, 2009). Purdue Pharmaceuticals misrepresented and concealed the risk of addiction, and this led to the company’s sales growing from $48 million to $1.1 billion in eight years.

Purdue funded research that determined the drug’s addictiveness, with 8% of patients exhibiting addictive behaviors severe enough to classify as prescription misuse. Instead of using this research to educate the public about its risks, Purdue cited studies praising OxyContin’s safety and efficacy, as seen in Jick and Porter’s letter in The New England Journal of Medicine (Alonso, 2021). Purdue then used this data to devise a conniving marketing strategy, with all published writings, audiotapes, brochures, and videotapes boasting about a low risk of addiction. Sales representatives were trained to persuade the public that the risk of addiction was less than 1% (Van Zee, 2009). Physicians were invited to all-expense-paid conferences where Purdue conducted training sessions on how to speak positively about OxyContin.

This misrepresentation caused prescription rates to skyrocket, with disastrous consequences for the public. Users would frequently visit multiple doctors to obtain multiple prescriptions and numerous instances of robberies and burglaries occurred. As Purdue was profiting from the tragedy, several other pharmaceutical companies saw an opportunity to enter the opioid market and promote their drugs unethically, contributing to the epidemic.

The FDA’s failure to properly utilize its authoritative powers further amplified the opioid crisis (Baumrucker, 2001). Purdue was granted a broad label, allowing OxyContin to be prescribed for common conditions such as back pain or a sprained ankle. Up until 2001, the FDA did not require a black-label warning regarding the risk of addiction, and all marketing campaigns to medical practitioners were halted only in 2018.

The societal repercussions of the opioid epidemic have been substantial, encompassing addiction, homelessness, poverty, and unemployment. The evidence shows that Purdue has failed in its obligation to safeguard the welfare of the public, thereby highlighting yet another misalignment between the interests of the pharmaceutical sector and the interests of the public health domain.

In 2007, Purdue pled guilty to criminal charges regarding the misbranding of OxyContin with a $634 million fine. In 2020, Purdue pled guilty to fraud and kickback conspiracies involving aiding and abetting violations of the Food, Drug, and Cosmetic Act by facilitating the dispensing of its opioid products, including OxyContin, without a legitimate medical purpose, and thus without lawful prescriptions. Under the terms of the plea agreement, Purdue agreed to the imposition of the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture (US Department of Justice, 2020). In 2022, Purdue Pharma reached a separate $6 billion settlement to stop all civil lawsuits (Knauth, Stempel, and Hals, 2022). Pharmaceutical companies across the country commonly pay fines in the event of exploitation. However, it seems evident that these fines have no financial impact on pharmaceutical companies as they continue to generate billions of profits annually, allowing them to continue their unethical practices.

Conclusion

The irresponsible use of technology in the pharmaceutical industry has resulted in significant negative impacts on patients, healthcare professionals, and society as a whole. The article has explored three key areas of concern, including scientific manipulation in drug trials, scientific misrepresentation through ghost-written publications, and the abuse of technology through the misrepresentation of risks. Such practices have led to the approval and sale of inferior or dangerous drugs, misleading information about drug safety and efficacy, and overprescribing of addictive drugs. To address these issues, increased transparency, accountability, and regulation are needed in the pharmaceutical industry. Additionally, whistle-blowers and insiders play a crucial role in uncovering these acts and increasing public awareness. Ultimately, protecting the health and well-being of patients must be the priority for the pharmaceutical industry, and the responsible use of technology can help achieve this goal.

References

Alonso JS, “Purdue Pharma Deceptive Research Misconduct: The Importance        of the Use of Independent, Transparent, Current Research” (Voices in Bioethics), available at: https://journals.library.columbia.edu/index.php/bioethics/article/view/7786

Anderson ML and others, “Compliance with Results Reporting at Clinicaltrials.gov” (2015) 372 New England Journal of Medicine 2370

Ausness RC (2021) 71 Corporate Misconduct in the Pharmaceutical Industry 11

Baumrucker SJ, “OxyContin, the Media, and Law Enforcement” (2001) 18 American Journal of Hospice and Palliative Medicine 154

Carpenter D, Bik E, and Oransky I, ‘What Does It Profit? – Whistling at the Fake – Podcast “The Value of Truth in Science“’ (Corporate Crime Observatory, 09 March 2022), audio recording available at: www.corporatecrime.co.uk/podcast-the-value-of-truth-in-science

Goldacre B, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (Faber and Faber 2014)

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Lexchin J, “Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Trials of Medications” (2011) 18 Science and Engineering Ethics 247

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