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The discipline of strategic thinking in healthcare
Published in Robert Jones, Fiona Jenkins, Managing and Leading in the Allied Health Professions, 2021
In 1972, when Glaxo heard about Dr Black’s discovery, they decided to improve on Tagamet. In 1978 they began clinical trials in 20 countries and in 1981 they launched Zantac. When Glaxo’s research revealed that physicians saw Zantac as a ‘me too’ drug with no added medical benefit, the marketing decisions makers wanted to follow the assumptions underlying the prevailing theory of the industry — if it is an inferior product then price it 10% below Tagamet’s daily treatment cost. The CEO of Glaxo agreed that Zantac added no medical outcomes benefit, but the simplified once-a-day dosage regime and the lack of side effects made the drug far more convenient and safe. The CEO insisted on charging a 75% higher price. Based on published studies, they positioned their drug as having superior effectiveness with the tag line: ‘faster, simpler, and safer’. Finally, Glaxo had a much stronger international sales force, by creating co-marketing strategic alliances with companies in Japan, Germany and France.
Ethics in research
Published in Voo Teck Chuan, Richard Huxtable, Nicola Peart, Healthcare Ethics, Law and Professionalism, 2018
Possibly the strongest and most sustained criticism of the post-trial access obligation appears in two publications that were the outcome of a conference whose participants were a group of bioethicists and researchers.22 They argue not only that a scheme to ensure ‘fair benefits’ to developing countries need not include provision of the products of research but also that the requirement for post-trial access is flawed in other ways.23 The authors advance several arguments, the first of which is that the requirement guarantees a benefit that may not be a fair benefit. They say, for example, ‘research in which the subjects would be exposed to great risks or the sponsors stand to benefit enormously … may be inadequate and unfair’.24 This is surely an odd criticism, because research regulations and guidelines all require that risks be ‘reasonable’ in light of anticipated benefits. Very few clinical trials involve ‘great’ risks to participants. Especially in research where there is no prospect of direct benefit to participants, it is hard to imagine a research ethics committee approving a study that exposes subjects to ‘great risks’. As for the enormous benefits to sponsors, that is already the case in much industry-sponsored research. It is especially true of what Campbell refers to as ‘me too’ drug studies, in which a company conducts a clinical trial of its own copy-cat ‘blockbuster’ drug hoping to lure significant market share away from its competitor.
The marketing of drugs: how drug companies manipulate the prescribing habits of doctors
Published in Norman J. Temple, Andrew Thompson, Excessive Medical Spending, 2018
Audrey Balay-Karperien, Norman J. Temple, Joel Lexchin
One of these drugs is Crestor®, a member of a drug family known as statins. A doctor who decides to prescribe a statin has several to choose from. Some of these have been tested in long-term clinical trials and been shown to reduce the risk of heart disease. These are reviewed in Chapter 8. But Crestor is a “me-too drug;” it is a slight variation around the chemical structure of the other statins. While it has been shown in short-term trials to lower blood cholesterol, its effect on risk of heart disease has never been tested in a long-term clinical trial. This also means that we cannot say for sure how its safety profile compares with other statins. Despite this, and costing 50% more than generic statins, it has achieved tenth spot in Canada for all drugs, based on value of sales. The drug achieved this status thanks to heavy advertising, including frequent DTCA on American TV (which is often seen by viewers in Canada). The TV adverts do mention that the drug has not actually been shown to prevent heart disease, but the point is unlikely to be noticed by most members of the target audience. The Lancet, the British medical journal, ran an editorial in which it demanded that AstraZeneca, the manufacturer, should: “desist from this unprincipled campaign.”47
The Exploitation of Professional “Guinea Pigs” in the Gig Economy: The Difficult Road From Consent to Justice
Published in The American Journal of Bioethics, 2019
While Millum and Garnett are not explicitly considering professional guinea pigs in their recommendations, this framework could easily be adapted to their situation. It’s worth considering acceptable alternatives—but there might not be any, regarding the participation of professional guinea pigs in phase I trial research. That’s the point of conducting phase I trials in the first place. While some have recommended computerized modeling to move from preclinical studies to later phases of drug development, where the drugs would be tested for safety and efficacy, this does not seem feasible. We have suggested lowering the number of phase I me-too drug trials, which would limit risks for participants while ensuring potential outcomes and would also eliminate professionalization by relying on altruistic participation for a reduced number of potentially lifesaving drugs. The powerful pharmaceutical lobby would no doubt fight to the teeth any restriction or incentive to limit me-too drug trials (Angell 2004). And while for bioethicists the altruistically motivated might constitute the preferred subject group, as they would be simultaneously informed, rational, and oriented toward the social good, we know that blood and organ donation and other instances of altruism do not fare well beyond the limited windows of an emergency or a particular mobilizing event.
Multimedia Aided Consent for Alzheimer’s Disease Research
Published in Clinical Gerontologist, 2018
Barton W. Palmer, Alexandrea L. Harmell, Laura B. Dunn, Scott Y. Kim, Luz L. Pinto, Shahrokh Golshan, Dilip V. Jeste
Subjects were randomly assigned to the consent process for either of two clinical trials: (a) a Phase 3 trial of an investigational cholinomimetic drug (lower risk protocol), or (b) a Phase 2 trial of an AD (anti-amyloid) immunotherapy (higher risk protocol). These trials were selected to foster ecological validity and to permit comparison of two protocols with varied information about risks and benefits. Four of the five currently FDA-approved medications for AD are cholinesterase inhibitors, and all five are symptom management focused rather than disease modifying. Thus, we designed the Phase 3 trial as a prototypic “me-too” drug study, with the likely risks being unpleasant but not disabling or irreversible. In contrast, immunotherapy and other disease modifying intervention trials are growing in prevalence, yet currently tend to be in earlier phases (Phase 1 or Phase 2), and thus have less certain or well-established risk:benefit (safety/efficacy) profiles (Cummings, Morstorf, & Zhong, 2014; Lemere, 2013); some of the early immunotherapy trials included incidents of participant death. Thus, some of the risks for the Phase 2 trial were described as less well established, but including possible severe/irreversible risks, even if unlikely. Further details of these protocols are available in Palmer et al. (2017).
Helicase-primase inhibitors from Medshine Discovery Inc. (WO2018/127207 and WO2020/007355) for the treatment of herpes simplex virus infections – structure proposal for Phaeno Therapeutics drug candidate HN0037
Published in Expert Opinion on Therapeutic Patents, 2022
Christian Gege, Gerald Kleymann
The structure of HN0037 is very similar to pritelivir, namely containing the 2-pyridyl and primary sulfonamide moiety. It has been shown that a fluorinated phenyl moiety exhibits a higher antiviral activity compared to a 2-pyridyl moiety [12]. Such analogues haven’t been exemplified in the first Medshine application and would be expected to reduce physicochemical properties (i.e. TPSA [27]) to a range, where sufficient exposure in ganglia – the neuronal tissue where HSV persists for life in a latent state – is more likely. By retaining the primary sulfonamide group, the carbonic anhydrase activity will likely be similarly high as in pritelivir [10]. This off-target activity may induce rodent-specific bladder hyperplasia during safety studies [28,29]. So, the me-too drug candidate HN0037 may run into the same challenges as frontrunner pritelivir, and the treatable diseases may be restricted to oral and topical application. Remarkably, Aicuris has already abandoned its Alzheimer’s disease application WO2014/124978 [30]. At least Phaeno will have with their crystalline mesylate salt and free base-form similar options as Aicuris, which later also claimed the free base forms [23,25] and even new crystalline salt forms (e.g. maleate [31]) in an attempt to extend the patent lifetime of pritelivir [32,33]. Finally, future development will show which profile regarding potency, efficacy, off-target activity and CNS exposure of the discussed helicase primase inhibitors will prove efficacious in treating herpes simplex disease such as herpes genitalis or labialis, latent herpes infections, herpes encephalitis or more speculative Alzheimer’s disease [34].