In the second section of our volume, we explore philosophical questions that arise in the distribution and dispensing of pharmaceuticals. In their piece "The Wisdom of Nature: An Evolutionary Heuristic for Human Enhancement," Nick Bostrom and Anders Sandberg further explore the ethics of human enhancement.
Dien Ho ends the anthology with a look at the growing problem of antibiotic-resistant bacteria. They are not only of deep intellectual interest, but raise some fundamental questions about who we are and what we want to be.
Development
Patient-Driven Drug Development
Patient-driven drug development can also compromise the clinical trial system, making it harder for other patients to know if a treatment is working. I then argue that patient-driven development is morally permissible, even if it causes some patients to make risky treatment decisions.
Choosing Treatment, Creating Treatment
Government officials should change existing approval requirements to further reduce the cost of drug development and increase the number of treatments available to all patients – especially patients with rare and emerging diseases. Where regulatory burdens currently discourage drug development and access to experimental drugs, some patients are also taking a more active role in drug development.
Patient-Driven Development
Instead, patients are moving away from the conventional development process and taking drug development into their own hands. The citizen scientist movement began in the 1980s and 1990s at the onset of the AIDS epidemic.
The Risks of Citizen Science
However, concerns about the risks of experimental therapy are not unique to patient-driven development. This argument can be countered on the grounds that lay people are incapable of interpreting complex health data, especially when they are in a vulnerable position (Darrow et al. 2015).
Can Drug Development Make Room for Patients?
Lawmakers, regulators, and manufacturers may consider offering other incentives for patients to participate in clinical trials. Therefore, patients who are desperate for experimental treatments should be allowed to use them even if they qualify for clinical trials.
The Politics of Patient-Driven Development
A related objection to patient-driven development is that it is inefficient because it diverts resources from those who need it most (Salmon 2014). In this way, disease-specific, patient-driven drug development can generate research with multiple applications.
Conclusion
But lack of public funding should not prohibit private philanthropists from drug development. The construction of lay expertise: AIDS activism and the forging of credibility in clinical trial reform.
Companies’ Obligation to Assist
Introduction
As the international community and researchers battle against the re-emergence of Ebola in Africa, the fourth section will explore how lessons from the HIV/AIDS situation can help address what pharmaceutical companies may then owe to patients in the region and how the international community should respond to those ongoing. unequal burden of disease.
Global Disparity in HIV/AIDS
Holding Pharmaceutical Companies Morally Responsible
In balancing equity goals and considerations of economic viability, pharmaceutical companies have a duty to assist LDCs by adopting practices that allow for the widest possible distribution. The generic non-accessible ART market represents only 5% of patients in MOLs (Clinton Health Access Initiative 2014), so patent waiver and differential pricing would not significantly impact industry market share.
Duty to Assist: How Far Can We Go?
In the context of the HIV epidemic in LDCs, this prior relationship contributes to the rescue duty and reinforces the duty of aid of pharmaceutical companies. The acknowledgment of the duty to help as a duty of justice arising from previous relationships helps to inform the discussion about how much (many) pharmaceutical companies should contribute to the global effort to contain the HIV epidemic in LDCs and how multilateral cooperation should to be reshaped. coordinated to ensure proper performance of these tasks.
Lessons for Ebola
This is despite the fact that the virus was first discovered in the region in the mid-1970s and that most of the key discoveries about how the virus spread were first made there. As the epidemic begins to ease, study investigators anticipate that flexibility in trial development and design will be necessary to address the changing nature of the outbreak.
Hegemony of Knowledge and Pharmaceutical Industry Strategy
In addition to secondary sources, the material presented in this chapter is derived from a wide variety of sources within the pharmaceutical industry and its closely related sub-industries and professions. The result is a high-level overview, but built on the perspectives of people working on the ground within or closely linked to the pharmaceutical industry.
The Ghost Management of Pharmaceutical Research and Publication
Two key actors in the process are contract research organizations (CROs) and publication planners. Medical journals have high rejection rates, reaching up to 95% in the case of journals such as the Journal of the American Medical Association and the British Medical Journal.
Industry-Sponsored Dissemination of Medical Knowledge Sales Representatives
For this reason, relationships between businesses and KOLs are ideally, from a business perspective, part of overall "KOL management" (standard phrase) plans. Thus, a speaker's bureau program begins with training to ensure that speakers are well versed in the positive aspects of the product and able to speak about them effectively.
Summary and Conclusion
In this we can see the importance of the hegemony of knowledge achieved through the strategy of the pharmaceutical industry. Ghost Management: How much of the medical literature is shaped behind the scenes by the pharmaceutical industry.
Delinquent Adolescents and Medical Product Companies Like Criminal Enterprises
The moral panic has characterized such once-respected medical product companies as RICO companies to exercise their constitutional privilege with commercial speech to promote off-label product uses. Further removal of health researchers and physicians from medical product development will not stem the decline.
The COI Entrepreneurs’ Argument in a Nutshell
The flow of information has been impeded, the cost of knowledge has increased, the value of disagreement in detecting and correcting errors has been curtailed, all because, at bottom, the health care profession as a whole presumably cannot be trusted to behave as "sophisticated consumers" of medical information. products—which the Supreme Court expects them to be.Neither the COI entrepreneurs nor anyone else has been responsible for proving with data that the combined costs of this moral panic have made doctors or companies more ethical, the public more trusting and safer, or that it has been the whole task "worth it," all things considered.
Conflict of Interest
The Perceptions of a Reasonable Person
Undue Influence
An individual expressing conformity with the reported perceptions of others (eg, that the object moved) serves his self-interest because reporting convergence (regardless of what he may actually perceive and believe) better secures group approval. his interest. An undue influence investigation does not rule out that the influencer and the patient are the same person.
Evidence that Patients Exert Comparatively Irresistible Influence on Physicians Prescribing
Legal Analysis of Undue Influence
Susceptibility: Physician Narcissism
COI Management
Will the discloser's characterization of the importance of his own relationship risks not make him a "judge in his own case." Isn't the whole point of asking for the disclosure a proof that we can't trust the discloser to tell the whole truth or give an unbiased interpretation.
What Do Patients Want to Know About Relationship Risk?
Examples of "important" words are not helpful because no one knows what they mean in an individual case. The authors found that excluding conflicting experts would not have made any difference to the vote.
The COI Cascade
As a theoretical exercise, the Public Citizen Group (Lurie et al. 2006) investigated whether FDA expert panel voting would have changed if conflicted experts had been excluded. The remaining panelists complained that the exclusion of conflicted experts robbed the discussion of intellectual depth and experiential enrichment.
Fair-Balanced Treatment of a Controversial Issue?
When a social environment is seeded with a risk heuristic, like COI, and regularly re-seeded by accessibility entrepreneurs and media-driven corruption stories, a cascade can become a "moral panic." A white-glove inspection of the environment finds dirt everywhere (Stossel and Stell 2011): "you see and hear about it all the time." Preventive, preventive measures are introduced. Yet the social milieu is never purged, never found more ethical, nor forbidden rules ever lifted, never declared an overreaction, a failure.
Medical Product Marketing Unduly Influences Physicians’
Since the mid-1970s, social psychologists and behavioral economists have experimentally demonstrated the mind's susceptibility to availability heuristics—they guide the mind, enable the substitution of easier for harder problems, and give attention to some features of experience while ignoring others.
Prescribing with Patient Harm Resulting
What Evidence Supports These Remarkable Claims?
Delving into known therapeutic options indulges status quo bias (Sunstein 2005) and risks 'clinical inertia' – knowing better but not doing better (Phillips et al. 2002). The authors concluded that medical practice turnover is common and occurs in all types of medical practice (Prasad et al. 2013).
What Are “Negative Results on Clinical Care”?
But a pharmacy's gross profit per prescription is even higher when an authorized generic (AG) competes with the successful first-to-file ANDA during the 180-day period. In 2006, Merck decided to sell Zocor to large managed care companies as an AG, but to be priced lower than the versions marketed by Teva and Ranbaxy under their FDA-granted 180 days of exclusivity under first-to-file ANDA .
A Better Systematic Review of Industry Influence?
However, the evidence for the power of CER to change physician behavior is not encouraging (Timbie et al. 2010). In fact, it is ethically questionable to ask research subjects to participate in studies that have a vanishingly small chance of changing physician behavior, a major rationale for such studies.
Does It Strain Credibility that Industry Marketing May Be associated with Some Positive Patient Outcomes?
Is it implausible to assume that marketing is at least associated with increased prescribing of the products. Clearly, significantly increased patient benefit (reduced cardiovascular mortality) was associated with increased product use.
Physician Industry Consultants Will Put Their Mouths Wherever Their Money Is
It replaces a simpler study (on conflicting relationships) with a more difficult study that would have probed pharmacological nuances. The replacement of a simpler examination by a more difficult examination colored the value of the advisory advice of industry-oriented cardiologists.
Is “Drug Reps Off-Campus” Wise Social-Distancing Policy?
About 2,500 years ago, Plato observed that a physician "practices medicine," but practices an additional art that he himself did not profess—the art of receiving payment. Disclosure of Financial Conflicts of Interest and Voting Patterns at Food and Drug Advisory Committee Meetings.
Health Measurement, Industry, and Science
As critics, including this author, have argued, the methods typically used to establish the psychometric properties of these measures are inherently problematic, e.g. the methods of establishing validity are not in themselves valid (Hunt 1997; In fact, I would argue that by improving the apparent scientific basis for these measures, we can make it more likely that PROMs will show a treatment effect.
Problems with PROMs
While this hardship is in the best interest of the industry, it may not be in the best interest of the public. For example, if I score a 30 on the Beck Depression Inventory (BDI-II), we know I scored in the middle of the scale—the BDI-II has a total score of 63.
Solutions to PROMs
An important difference is that Rasch has a clear mathematical model that provides a measurement interaction representation. Climbing stairs will appear further to one end of the ruler than balanced when sitting down.
Industry
But Rasch does not provide a trait theory that guides us in choosing the content of the scale, i.e. the items or questions. Put another way, there is always an element of uncertainty in the use of scientific evidence.
Dispensing
Patient-Centered Care or Drug-Centered Care: The Influence of Pharmaceutical
Patient-centered care, understood as something substantive, can be defended on at least three ethical grounds—it has been shown to produce superior health outcomes in patients; it better respects the personal dignity and basic rights of patients;. If these ethical goods are to be achieved, we must ask whether drug-centred care promotes or interferes with these outcomes.
Pharmaceutical Industry Marketing
Beyond these practices that can be clearly labeled as marketing, the reach of the marketing department within a pharmaceutical company usually extends even further. Clinical trials of promising drugs were prematurely stopped by the company based on market assessments that sales of the new drug would not be as profitable as hoped (Psaty and Rennie 2003).
The Influence of Marketing
Applbaum studied in depth one of the case examples I will refer to later, the newer classes of antidepressants. For such a questionnaire to have the desired effect, other aspects of the channel must be favorable.
Case Study: Antidepressants
Everyone knew that antidepressants were not addictive, so part of the marketing campaign worked well. Perhaps the single most successful aspect of SSRI marketing was selling the general public, as well as the medical community, on the serotonin theory of depression.
Case Study: Diabetes
So it's reasonable to ask what the scientific evidence shows about the relationship between tight blood sugar control and the prevention of these serious complications. In general, studies using medications to more tightly control blood sugar did not significantly reduce the rate of complications.
The Public Health and Inverse Benefit
In short, the drug was declared a success in the absence of any data that patients benefited. Drug marketing almost inevitably tries to spread drug use through this population, which in turn almost always poses a threat to public health.
Is There a Legitimate Concept of Drug- Centered Care?
Their practices may be objectionable in many ways, but they are not to blame for failing to deal with their professional conflicts of interest. Industry employees simply do not have a conflict of interest in the same way that members of the professions do.
Drugs Are No Different from Other Commodities
If these menus threaten the health of Garden State residents beyond acceptable caveat emptor limits, the state must set limits. In fact, New Jersey took action against the dangers of liquid eggs in 1992 (Osgood 1992).4 The US drug regulatory system is similarly paternalistic (Flanigan 2012).
The Rejection of Drug-Centered Care Is Based on Inadequate Conceptions of What It Means to Be Healthy
For the health of the individual as a person, the important facts are not facts about biology, but facts about goals, which differ from person to person. Assuming that the goal is not removed by the filters mentioned above (consistency with other goals, authenticity, etc.), taking that goal is a drug-centered decision, and taking that drug contributes to one's health as a person.
Drug-Centered Care and Enhancement
The characteristics of self-actualized people, including accuracy of perception, ethics, and resistance to cultural influences, among others (Maslow, provide the filters required in the previous theory. So both in the context of persons health and in the context of - text from Maslow's broad sense of psychological sanity, we can envision situations where a decision can be drug-oriented without being morally or medically suspect on that basis.
Drug-Centered Care and Quality of Life
If there is more than one measure for which augmentation is permitted, the decision to pursue augmentation on one measure over another may well be based on the availability of a drug—a drug-centric decision. Each of the four lines of reasoning pursued here has provided a way of describing drug-centered care that we could accept as unassailable, or at least not overtly corrupt.
Prescription Paternalism: The Morality of Restricting Access to Pharmaceuticals
After spending some time defining paternalism and outlining some of its implications for access to pharmaceuticals, we will consider two arguments to question the current restrictive policy: what we will call the liberal critique and the empirical critique mention. As part of that discussion, we will consider an amendment in which the physician must also certify that the patient has a condition that is generally considered to be susceptible to the drug that the individual wishes to purchase.
The Paternalism Problem
It's not clear that the current requirement to get a prescription from a doctor to access legendary drugs is in the best interest of the patient. It was a valuable choice in which the patient's doctor could not be assumed to be an expert.
Alternatives to Prescribing
It would not be a written statement that the doctor believes the drug is best for the patient. simply be a testimony that the patient is sufficiently informed. A form simply confirms that the patient is sufficiently educated to purchase a particular drug.
Conscientious Refusals in Pharmacy Practice
The arguments advanced share their origins with those in the medical conscientious objection debate, and the same basic principles apply to any profession. Where the discussion diverges slightly is how these principles play out in practice, given the particularities of pharmacy and the obligations pharmacists have that compete with their right to conscientious objection.
Conscience and Integrity Conscience
First, if integrity is related to doing the right thing, its protection would be instrumentally valuable to the profession. They believe that integrity is valuable in itself, so to force a person to act against their integrity would be to do them a great injustice.
Practical Resolutions Conventional Compromise
It is based on the principle that the duty to provide health services to the patient is stronger than the right to conscientious objection. In such cases, prior notification of a conscientious objection is less likely to benefit the patient.
Conscientious Objections in an Educational Context
The main difference between the qualified pharmacist and the pharmacist in training is the purpose of the procedure. Similarly, students could examine a member of the same sex instead of a member of the opposite sex, where sexual characteristics are not relevant to the educational exercise.
Imperfections and Opportunities for a Better Approach
The conventional compromise is widely accepted by the pharmacy community, so it is likely to be considered a workable, if imperfect, solution. It is relatively easy to establish certain limits (for example, the objection must not be based on prejudice and must not be based on claims that are factually incorrect), but other potential limitations pose greater challenges, for example in defining and testing reasonableness and authenticity.
Conclusions
For example, this chapter has focused on integrity (because this is an important underlying concept for conscientious objection), but it is possible that conscientiousness clauses are better supported by other notions, such as freedom, tolerance, and political harmony. Ethical, religious and factual beliefs about the provision of emergency hormonal contraception by UK community pharmacists.
Usage
Self-Transformation, Identity, and Authenticity
Francis’ Request
Although Francis, like his friends, sometimes marvels at how well he's managed to function in his professional life, he wants to better focus on the tasks ahead. He also wishes he could focus better when a task requires constant attention, and to have some control over when his mind wanders into the universe of his imagination.
Medical Enhancement
We can distinguish between the question of whether his making the request is problematic because of the magnification factor and the question of whether it would be morally problematic for the same reason if his psychiatrist approached it. Rather than reread the arguments in support of this view, I refer the reader to other works that provide what I believe to be a compelling case that the mere fact that a particular medical intervention would involve enhancement does not make it morally problematic, even if the related issue (e.g. wise use of scarce resources, fair distribution of access to the intervention, safety) are important for any thorough moral assessment of the improvement in question.5.
A Threat to Identity?
But to make premise 2 plausible by understanding it in terms of numerical identity is to make the argument fallacious, because by shifting the meaning of "identity" from the narrative to the numerical sense, the argument commits the fallacy of ambiguity. However, it is possible that commentators who are concerned about using enhancements to change one's identity are focused entirely on narrative identity.
What About Authenticity and Self-Transformation?
Meanwhile, I deny that there is any good reason to think that Francis's self-transformation involves self-disrespect and therefore inauthenticity. In this way, it may be useful to think of intentional self-transformation as the autonomous writing of one's own self-narrative.
Heuristic for Human Enhancement
In other cases, we may benefit from increased functionality or a new capacity and yet not benefit from the improvement because the intervention also causes unacceptable side effects.2 The evolution heuristic is a tool to help us think whether some proposed improvement is likely to produce a net benefit. Evolution "designed" the system to operate in one type of environment, but now we want to deploy it in a completely different type of environment.
Changed Tradeoffs
The new feature that the upgrade gives us may have been maladaptive in the EEA even though it would be adaptive now. We can see why these improvements would have been maladaptive in the EEA and why they may nevertheless have become entirely useful now that the underlying trade-offs have changed as a result of the availability of new resources.
Value Discordance
