Dear Colleagues! This is Asrar Qureshi’s Blog Post #724 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to email@example.com for publishing your contributions here.
This series of blogposts is based on multiple sources, links to some of which appear at the end.
Three pharmaceutical companies and their involvement has been discussed in detail already. However, such instances are complex matters. Lot of work was done to understand commercial, social, ecological, legal, and policy matters which contributed to the spread of this epidemic. We shall briefly look at these points to strengthen our understanding. Our situation in Pakistan is not much different. We do not have oxycodone available here. In fact, I remember I had contacted Mallinckrodt to get their oxycodone for Pakistan market around 2005-6 from the platform of the company I was working with at that time. The opioid epidemic had not been recognized yet; rather opioid use was at its height at that time. Fortunately for us, Mallinckrodt did not entertain our request. In hindsight, I can understand they were too busy with their own market.
On February 2, 2022, Stanford-Lancet Commission on the North American Opioid Crisis published its report. They said that a major conclusion was that the crisis represented a multisystem failure of regulation. In the first place, the approval of OxyContin from Purdue Pharma should have been done after greater review. It transpired later that the firm had presented a fraudulent description of the drug being less addictive. Secondly, there was no regulatory check on what the company was telling the physicians who were given the same information. And the firm went for all out marketing to entice large number of customers, particularly those who were willing to work through mutual obligations. Thirdly, the donations to politicians influenced the policy making. Fourthly, several officials of government regulatory agencies, such as Drug Enforcement Agency, leave their government job to join pharmaceutical companies with little or no gap. It is a clear conflict of interest. The biggest example was of Scott Gottlieb, head of USFDA, who left to join Pfizer Board in 2019, just after 83 days of leaving. One may connect dots with quick approvals of Pfizer COVID vaccines in all age groups in 2020.
US Congressional Budget Office – CBO Report on the subject of opioid crisis published in September 2022, cites a rise in opioid prescribing, changes in illegal opioid markets, and greater demand for opioids due to worsening economic and social conditions for certain populations as the key contributing factors. COVID pandemic caused another steep rise in the misuse of opioids and deaths due to overdose.
Continuing Education for Healthcare Professionals Site, A Train, has designed a course for physicians to understand the factors, the epidemic, and the alternative strategies. They tell us that pain was added as the fifth vital sign by the American Pain Society in 1995, by the Veteran’s Health Administration in 1999, and by the Joint Commission in 2001. (The four universally accepted vital signs are pulse rate, breathing rate, blood pressure, and body temperature). Recognition of pain was emphasized as a quantifiable measure, so that it was measured and treated. The perception that pain was not given the importance it deserved, led to the increase in the use of opioids, first for cancer-related pain, and then for pain generally. The use was further encouraged by the promotional claims of pharma companies about little or no risk of addiction, which was later found to be false and intentionally deceptive. For many years however, the doctors under promotional pressure of pharma companies, and the relief that patients were describing, kept issuing more and more prescriptions for all types of pain, even after the harms associated with their use started becoming apparent.
The role of pharma companies cannot be understated. In late 1990s, Purdue Pharma started aggressive marketing of their OxyContin for chronic pain, unrelated to cancer. They used academic detailing and education sessions (CMEs) for physicians. Purdue provided financial support to the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, The Joint Commission, pain patient group, and other such organizations who could indirectly support the use of their opioid analgesic. The other pharma companies followed suit. The pharma industry not just influenced prescribing physicians; they also influenced the organizations which issued guidelines for treating pain.
The process is all too familiar, particularly for drugs that are to be used for long term; chronic care drugs like for diabetes, neuro-psychiatric illnesses, cardiovascular diseases, and autoimmune disorders. It starts from clinical trials which are designed in ways to deliver intended results, which are further disseminated through interpretations from respected physicians. The target doctors are primed through early information, talks at medical conferences, and teasers at the exhibitions. An MNC started priming physicians two years before launching their blood pressure drug in Pakistan. They hired a team of doctors/pharmacists who would just go and talk about some new aspect of the coming drug. Some of these target physicians were flown to international medical conferences abroad where clinical experience about this product was shared. By the time, the product was launched here, the doctors were all too eager to prescribe it. Another MNC took a group of senior physicians to USA and ‘trained’ them on the use of parenteral nutrition. One of them mentioned to me that he had developed new understanding about parenteral nutrition which he did not have previously. Apparently, he was quite impressed.
USFDA may also be implicated because they allowed Purdue Pharma labeling on OxyContin which read that iatrogenic (a complication caused by the doctor) addiction was ‘very rare’, and that the delayed absorption of OxyContin reduced the abuse liability of the drug. The FDA asked to remove these unsubstantiated claims in 2001, but by then the impression in the minds of physicians had settled. Moreover, the firm was constantly pushing the concept in marketing campaigns, pain management conferences, and speaker programs.
Finally, many clinicians and researchers failed to disclose the sources of funding and support while issuing guidelines or sharing experiences. For example, one cancer researcher did not disclose millions of dollars in payments. Conflict of Interest must be stated clearly in all scientific studies reports, and it is done regularly. You will find at the beginning or the end that this study was funded by XYZ company, or it was not funded by any related commercial organization. The major pharma companies, manufacturing and marketing opioid drugs, were financially supporting (bribing?) all levels of prescribers/researchers/regulators, and many of them failed to disclose the Conflict of Interest.
In the next post, we shall look at the other contributing factors such as social, ethnic, change in trends, and issues with medical insurance.
To be Continued……
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