Monday, 27 September 2021

Exploring Ethics in Clinical Research

                           Image Source: Pixabay (https://pixabay.com/photos/laboratory-analysis-chemistry-2815641/)

If there are any positives to be discovered in the wake of the devastating COVID-19 pandemic, they may be found in the way that the outbreak has illuminated the clinical research process. The urgent search for life-saving therapeutics and vaccines has shed new light on the process of developing, testing, and disseminating medical treatments.

By Indiana Lee

Additionally, it has brought public attention to the all-important issue of ethics in clinical research. The reality is that the ethical implications of clinical research run deep, presenting a host of moral questions which provide few clear or easy answers. Clinical research has been and always will be necessary and urgent work, as with the case of COVID-19. Yet it is attended by a myriad of ethical dilemmas which may never be entirely resolved.

The Risk/Benefit Analysis

Clinical research, by definition, is seldom fully free of risk, and this means that it is incumbent upon researchers and stakeholders alike to accurately assess whether prospective benefits do, in fact, outweigh potential risks. This, however, can be a formidable challenge, particularly in the early stages of the process, when the unknowns may significantly outnumber the certainties.

 

In the presence of so much ambiguity, undertaking pharmacological or other forms of clinical research necessarily puts some persons at risk in the hope of achieving a significant benefit for the many. And this is, inherently, a fraught process, one deeply embedded in systems of power, equity, and social justice.

 

For all its lofty ambitions and ostensibly principled motivations, the history of clinical research is replete with examples of breathtaking abuse and exploitation, from the infamous “twin experiments” of Dr. Menghele to the notorious Tuskegee trials. Further, throughout the history of clinical research, it has been the powerless and the marginalized who have typically borne the greatest risk and, all too often, who have paid the price to serve the needs and interests of the powerful.

Research Ethics and Power Inequities

The rampant ethical abuses of past decades have been largely eradicated, or at least curtailed, by intensive international regulations designed to prevent the recurrence of past horrors. However, that by no means suggests that power inequities have been wholly erased, as can be seen perhaps most starkly in the rise of the so-called “professional patient.”

 

Professional patients are ones who habitually enroll in clinical trials, often including multiple simultaneous trials, despite regulations forbidding this. In addition to undermining the validity of the trials in which professional patients are enrolled, the professional patient must also be understood to reflect deeper, more systemic ethical challenges in clinical research.

 

For example, professional patients may use clinical trials as a primary source of income or even of medical care. And this means that clinical researchers may be exploiting vulnerable persons, those who may have been denied access to stable employment and quality healthcare by an inequitable social structure. And, thus, the powerful continue to benefit through the suffering of the weak.

The Issue of Informed Consent

Ethical clinical research, whatever form it may take and for whatever purposes it may be intended, must be grounded in the fundamental principles of beneficence, justice, and respect for individuals. The concept of informed consent derives from and is motivated by these three pillars of ethical clinical research and practice.

 

Informed consent, above all, is predicated upon the presumption that no individual should be made the subject of clinical research against their will. Further, the concept holds that consent cannot be given unless and until the individual, or the person(s) designated to act in the person’s best interest, is fully aware of the purposes, processes, and potential and known risks of the research, as well as their own right to refuse or to withdraw consent at any time.

 

In theory, of course, informed consent would seem to provide the ultimate safeguard against unethical research practices. In reality, however, informed consent is rarely if ever what the name suggests. For informed consent to function as intended, then it would have to be assumed that all study populations in all clinical research studies are not only in possession of their full mental, physical, and emotional faculties, but that they also possess full and unblemished understanding of the study and its risks.

 

While this is an admirable goal to aspire to, it is hardly ever achieved, if at all, “on the ground,” particularly in the study of some of humanity’s most devastating illnesses, such as Alzheimer’s, pediatric cancers, or mental illness. In cases such as these, researchers are often tasked to draw from a population of vulnerable subjects, including children, seniors with cognitive impairments, and persons with mental illness. All are groups that are unlikely to be able to provide informed consent.

 

To be sure, a constellation of internal and external safeguards exists to protect these populations. This includes not only the requirement that designated guardians provide informed consent by proxy but also that regulatory agencies and institutional review boards (IRB) oversee all phases of clinical research, from concept to execution to reporting. The goal in doing so is not only to ensure that all subjects and stakeholders are treated ethically, but also that the study is necessary and relevant, serving a purpose for which the potential benefits outweigh prospective risks.

 

An important example of this is the recent research into the use of antidepressant medications to treat patients with anxiety. Without observational studies of the reported benefits of these medications helping anxious patients, clinical trials might never have been pursued and, without research evidence to support treating some patients who have generalized anxiety disorder (GAD) with antidepressants, then these patients would have been denied access to the most effective treatment.

The Takeaway

Clinical research is a necessary and life-saving endeavor. But it is also one fraught with ethical challenges, including power inequities, social in/justice, and individual rights. Nevertheless, through mechanisms such as informed consent and institutional review, it is to be hoped that ethics in clinical research will continue to be prioritized and pursued.

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Sunday, 26 September 2021

The Importance of GMP Labels


                                 Image: TGA at https://www.tga.gov.au/figure-2-components-medicine-label

Proper labeling, especially in the pharmaceutical world, is crucial. It is important that both consumers, as well as medical professionals, understand exactly which ingredients are included in drugs, as well as the proper form of administration. While this may seem obvious due to advances in technology and clear labeling guidelines, accurate and appropriate labeling wasn’t always available. When it comes to purchasing and consuming pharmaceutical drugs now, products must include a clear GMP label that includes all necessary information.

What is GMP?

GMP stands for Good Manufacturing Practice. GMP is a system that ensures the consistent production and control of consumer goods according to set quality standards. These standards are created and enforced to minimize the risks involved in the production and administration of any and all pharmaceuticals.

The U.S. Food and Drug Administration requires manufacturers, processors, and packagers of drugs, medical devices, and other products to take proactive steps to ensure that their products are safe, pure, and effective for consumer use. This protects consumers from purchasing a product that is not effective, or worse, potentially dangerous. The GMP is an enforced measurement, and companies that fail to comply could see a recall of their products and a seizure of their manufacturing, as well as suffer fines and jail time. Ultimately, the GMP was created to provide peace of mind for manufacturers, prescribers, and consumers alike, brought forth by extensive testing, consistent manufacturing, and clear labeling of a variety of packaged materials.

History of GMP

Establishing the GMP took considerable time and effort from both lawmakers and businesses alike. The GMP was developed largely due to incidents and tragedies that highlighted the need for consistent and systematic regulation. There are a few key regulations and acts that have set the legal standards we now adhere to today. These include:

The Pure Food and Drug Act of 1906

At the beginning of the 20th century, there were no federal regulations. This meant that there was no secure protection for the public against potentially dangerous products. The technology at the time was also much more primitive, meaning we lacked the means to carry out and enforce detailed testing of not only products but also the effects they had on the body and mind.

 

At this point in history, ice was still the main source of refrigeration, milk was unpasteurized, chemical preservatives were uncontrolled, and medicines included harmful drugs. Medicines often contained drugs such as opium, morphine, heroin, and cocaine. There were no restrictions relative to the use of these dangerous and potentially deadly drugs, and often labels didn’t even acknowledge or admit to their presence within a drug.

At this time, there was no way to know what you were consuming, and this was true for both patients and medical professionals. The Pure Food and Drug Act occurred in response to the book “The Jungle,” written by Upton Sinclair, that revealed the horrors of the meatpacking industry.

As the public became aware of the real risks associated with having no regulations, the Pure Food and Drug Act of 1906 established stricter guidelines when it came to the production and distribution of food and drugs.

Drugs were no longer unregulated and had to be sold with labels indicating their exact contents. Food or drug labels could no longer legally include false information or be misleading in any way. This meant that the presence and the exact amount of ingredients needed to be clear, especially when certain dangerous ingredients were used, such as cocaine, heroin, or alcohol. This was the first big step towards the GMP.

The Federal Food, Drug, and Cosmetic Act of 1938

This act continued to expand on the guidelines established by the earlier Pure Food and Drug Act and required that drug manufacturers prove that the content of their products was safe before manufacturing.

Drug Amendment of 1962

This amendment tightened control over prescription drugs, new drugs, and investigational drugs. The effectiveness of manufactured drugs had to be demonstrated and proved before they could be approved for distribution and use. Drug firms also had to submit any potential or real adverse reaction reports to the FDA. When advertising drugs in medical journals, it became a requirement that complete information was provided to the doctors relevant to both the effectiveness and risk(s). This amendment essentially formalized the GMP.

The Fair Packaging and Labeling Act of 1966

This act solidified the role of GMP, especially when it came to labeling. This required that all consumer products be honestly and informatively labeled. This was a huge step in ensuring that both medical professionals and consumers could trust their pharmaceutical products.

Pharmaceutical Labels

As a result of these moments in history and the development of the GMP, pharmaceutical labels are held to the highest standards to protect patients. Labels are required to be concise and legible so it is clear to consumers what the product is and what exactly it is composed of. The GMP also allows medical professionals to confidently prescribe medication to their patients, simultaneously assuring patients that their prescription is safe and effective. It is crucial that all necessary information is provided and that the labels are coherent, as this protects both the physician and their patients.

To meet safety standards, labels are required ​​to explain the type of drug, the brand name, as well as the generic name, dosage details, and clear instructions. The label should also list potential side effects, drug interactions, adverse reactions, and warnings — all tailored to prevent any illness, injury, or death.

Trusting Labels

GMP labels are important for both the consumer and the medical professional. By enforcing this standard, the risks involved in prescribing and consuming medication are low. This is largely due to both parties having a full understanding of what is included in the drug, and the proper way to use it. GMP labels show both parties that strict guidelines and restrictions have been followed. Labeling is crucial in ensuring peace of mind, as well as adhering to safety standards.

Royal Label takes its commitment to GMP labels seriously. With years of experience working with GMP standards, Royal Label understands the importance of properly labeled pharmaceutical products and can produce quality custom labels that meet all FDA and other regulatory agencies’ requirements. 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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