“Ghost managed research does not merely shape academic cultures and the knowledge they produce but makes them unnecessary except to provide authority…Ghost-managed “science” has been crafted to help sell drugs”.
Ghost-Managed Medicine:Big Pharma’s Invisible Hands by Dr. Sergio Sismondo is a detailed study of how the pharmaceutical industry has taken control over “medical knowledge” to secure and sustain the market for its products. Other authors who have focused on the corrupted science of a specific drug, class of drugs, a vaccine, or a device, left the impression that the problem involved a few “bad apples”. Dr. Sismondo examines the industry-wide modus operandi that enabled Pharma to capture and control the science, and by extension, to control he practice of medicine.
In the chapter that describes Purdue’s marketing of OxyContin, he emphasizes that this case is not unique, but rather, “an extended example that includes almost all of the elements of the rest of this book.
For the most part, it is a very ordinary tale of drug marketing, except for the inherent dangers of the particular drugs and the scale of the disaster they created. The number of drug overdose deaths in the US and Canada has been increasing by approximately 20% per year since the year 2000.45 In that period, more than 200,000 North Americans have died from prescription opioids.46 Prescription opioid abuse has cost the affected economies billions of dollars.”
He shows how the medical establishment, its academic and professional institutions, and its leadership succumbed to Pharma’s financial incentives and collaborated with the demolition of an honest medical knowledge base. The medical establishment ceded professional integrity to the pharmaceutical industry which now controls and ghost-manages every facet in the production of medical research and its dissemination prior to launching a new product and throughout its patent life.
The book describes in detail how this industry has gained control over the “spectral elements of the production, distribution, and consumption of medical information” and how each of these functions are performed by an intricate unidentified network of individuals, corporate, and academic collaborators; each of who served a particular function within industry’s marketing campaign. These shadows are rarely identified, or credited for the functions they perform to further Pharma’s commercial marketing goals.
The “ghostly” network of high paid professionals includes contract research organizations (CROs), prestigious key academic opinion leaders (KOLs), academic institutions, medical schools and ghost-managed providers of continuing medical education (CMEs), professional associations, and the gatekeepers of the scientific literature, prestigious medical journals. These “authoritative” sources provide the mantle of credibility to Pharma’s commercial marketing agenda. The corporate-controlled media serves both as a vehicle for advertising new products; and, more importantly, it serves as a conduit for shaping and reinforcing public opinion, and influencing public policy. Advertising expenditure is an investment, providing leverage expanding a company’s influence in the media and medical journals.
Medical science is dominated by the pharmaceutical industry which funds half of all clinical trials. Industry sponsors most of the new trials each year. Most important, is how industry has gained control over the all-important randomized, controlled trials (RCTs) which are designed to serve multiple commercial purposes. RCTs are used to identify potential markets and serve as the entry requirement for market licensure, and for permission to advertise. RCTs are used to convince doctors to prescribe the product, and to convince insurers to pay for it.
“A trial can help create a buzz around a product, through reports on it placed in medical journals and the popular media. A trial can suggest new, unapproved uses for a drug. A trial can put a drug in the hands of physician-investigators, who will then prescribe it more frequently. A trial can establish relationships with investigators, who can later be called upon to speak on behalf of the studied drug and others. A trial can enroll patients, who may continue to use the studied drug after the trial is over. An ongoing or future trial can serve to delay answers to questions about a drug. Every single one of these uses of trials contributes to marketing drugs.”
RCTs are mostly conducted by contract research organizations (CROs) whom industry pays to plan and run its clinical trials for the purpose of getting new drugs approved and/or to provide data for the use of existing drugs for other than the approved indication. CROs recruit doctors, who, in turn, recruit patients to serve as human subjects; their tissues, fluids and observable effects are transformed into data.
“CROs are the first of the phantoms in the drug industry, feeding on trial subjects’ bodies, but mostly staying out of sight in the medical research world. CROs make no claim on the data they produce; they simply turn it over to the companies that hire them to use as they want.”
Pharma companies implement an elaborate marketing protocol, using multiple strategies, and an intricate network of stealth agents and collaborators. These collaborators produce the data, manage, select, shape it for publication, disseminate, and publicize the “science-based medical knowledge” that is of highest commercial value to the companies that hires them. Dr. Sismondo notes that the pharmaceutical industry is secretive about how their products are tested, what they choose to report to obtain market licensure, how they have gained control of the scientific literature promote their products, and when needed to refute safety many things; they have much to hide about their widely used products.
“The pharmaceutical industry is immensely fond of invisible hands, they try to maintain a ghostly status so that they cannot easily be seen, or cannot be seen for what they are. For pharmaceutical marketing to work best, it has to look like disinterested, unbiased, impartial medical knowledge. As a result, many of the hands doing the companies’ marketing work need either to be invisible or to look as though they’re doing something else.
Whereas other critics had to rely on the information contained in documents that had become publicly available through lawsuits, Dr. Sismondo managed to penetrate pharmaceutical conferences and networking meetings at which information was exchanged candidly among collaborating participants. These meetings helped shed light on how this industry manages and controls the knowledge base of numerous fields of medicine from the shadows.
CRO’s are industry’s trusted handmaidens for a significant percentage of drug trials, providing data that other ghosts interpret favorably for the sponsor’s product. Those favorable “findings,” are then ghostwritten in published reports in the major, “high impact” medical journals.
“In the more prestigious medical journals, as many as 40% of the articles on recently approved drugs have been ghost-managed for companies. Some of the key ghosts are called publication planners, who design publication strategies, create teams of professionals to shape and write articles, select the journals they will be submitted to and choose KOLs to serve as the putative authors of these articles.
As a result of the work of CROs and publication planners, medical science is shaped to serve marketing goals. The drug companies’ interests can be expected to influence any number of choices in the design, implementation, analysis, description, and publication of clinical trials. We can reasonably expect – and there is abundant evidence – that the companies make choices to support their commercial interests.”
Chapter 7 highlights the important leveraging role played by patient advocacy organizations (PAOs) – as few others have done. PAOs serve as “perfect phantom hands for the industry”. They are important “nodes in the shadowy marketing of drugs [and vaccines]. Not only are they industry–supported allies; they represent key stakeholders who are recognized as stakeholders by government regulators and insurers as independent advocates when in fact, they have been bought:
“Two-thirds of PAOs in the US receive industry funding, and the organizations within that group receive 45% of their funding from pharmaceutical, medical device and biotechnical companies.17 Some 93% of PAOs that make presentations before or participate in discussions within the US Food and Drug Administration (FDA) receive industry funding.18 The situation is similar in other high-income countries such as the UK.
In extreme cases, PAOs are creatures of the industry. They are fully funded by one or more companies, staffed by professionals, and find patients to be members after the fact. They, like many other funded PAOs, serve as lobbyists and do public relations work, promoting drugs and diseases and defending pharma against negative publicity. They are sirens for the industry, singing passionately about better futures with better drugs. And as for pharma’s other phantoms, invisible hands are busy manipulating other actors, working diligently to disguise motives and interests.
Overall, then, pharma companies rely on systematic pressure on the circulation of scientific knowledge and the resulting medical practices. This is a system of influence made more effective by being shadowy and spectral.”
The book is freely available from the publisher online at:
https://www.matteringpress.org/wp-content/uploads/2018/07/Sismondo-Ghost-managed-Medicine-2018-1.
Chapters
- Power and Knowledge in Drug Marketing
- Data Extraction at the Margins of Health
- Ghosts in the Machine: Publication Planning
- Hosts and Guests in the Haunted House
- Possession: Making and Managing Key Opinion Leaders
- Draining and Constraining Agency
- Sirens of Hope, Trolls of Fury and Other Vocal Creatures
- Conclusion: The Haunted Pharmakon