Ethical issues nanotechnology in medicine
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ethical issues in nanotechnology
Ethical considerations and issues in research and development stipulate that before nanomedical and nanotechnology products can be used in the diagnosis, prevention, or treatment of disease, also in medicine they must undergo extensive testing in both laboratory and human settings.
The toxicological, pharmacological, and safety implications of various nanomaterials are only now being investigated.
Various initiatives have been undertaken by the United States Environmental Protection Agency, the National Institute of Environmental Health Sciences, the National Science Foundation, and the National Institute for Occupational Safety and Health to investigate the risks of nanomaterials.
In addition, a lab has been set up at the National Cancer Institute to test in vitro how well ENM works for cancer detection and treatment.
According to most experts, safety and risk issues must be adequately handled before society may enjoy nanotechnology's benefits.
Nanoparticles share no characteristics other than size, making it difficult to determine whether they are safe to handle (1 to 100 nm).
Since nanoparticles do not form a uniform group, it is necessary to evaluate each material separately.
Materials that are poisonous at 50 nm may likewise be harmful at 1 nm, since changes in size and shape may have substantial and unanticipated implications for their physical and chemical characteristics.
Nanomaterials' size and shape may change inside a living thing because they are sensitive to their surroundings.
There is the possibility that a particle with a 100 nm size might either change into a particle with a 1 nm size or decay into a 1 nm particle.
Certain nanoparticles' actions within a living thing may vary greatly from those in cell culture.
Several studies on animals and tissues have shown that many different human and natural nanoscale compounds, including diesel exhaust particles, smoke, and viruses, activate toxicity-neutralizing pathways, such as oxidative stress, inflammation, and innate and adaptive immune responses.
It's possible for nanomaterials to spread to other parts of the body after initial contact with a specific area.
They are able to cross both the cell membrane and the blood-brain barrier, like certain other substances.
The capillaries are a potential entry point for inhaled nanomaterials; from there, they can travel to the organs mentioned above.
Nanoparticles have the potential to accumulate in various organs, where they can cause damage.
Nanoscale materials can be dangerous in different ways depending on how they're exposed; a particle that's safe to ingest might be harmful if inhaled.
Because humans have evolved defenses against natural nanoparticles, these man-made versions pose a greater risk to our health.
Although studies on animals and in vitro analyses can shed light on a wide range of nanomaterials, they cannot eliminate all of the unknowns that come with a human's first exposure to a nanomedical product.
To comply with ethical standards and legal mandates, any risks to human subjects must be adequately justified in light of the benefits to individuals and society.
Risk assessment, risk management, and risk communication are three of the biggest challenges facing nanomedicine clinical research.
The results of a phase I trial using the monoclonal antibody TGN1412 in the United Kingdom have provided scientists with some sobering insights.
Six participants in this study became extremely ill after receiving an antibody dose that caused no adverse effects in animals.
One important takeaway is the need for extreme care when working with substances like antigens and antibodies that can trigger an immune response.
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Drugs or chemicals that are perfectly safe for one species of animal at a certain dose may cause serious problems in another.
Clinical researchers should keep these considerations in mind as they begin testing nanomedicine products on human subjects, as the lessons learned here are applicable to clinical trials involving a wide variety of materials.
Even if a drug makes it past phase I's barriers, serious risks may still exist in phases II and III of clinical testing.
It is important to have a data and safety monitoring board (DSMB) present during clinical trials to keep an eye out for any unwanted effects or problems with the investigational product.
This data will be analyzed on a regular basis by the DSMB in order to identify potentially harmful patterns and mitigate their effects on people.
Extensive review of relevant literature, sound research design, appropriate inclusion and exclusion criteria, clinical monitoring, knowledgeable staff, timely reporting of adverse events, confidentiality protection, standard operating procedures, and post-study follow-up with subjects are additional methods for lowering research risks in clinical trials of nanomedicine.
The need for doctors to report adverse reactions and unanticipated side effects to the relevant safety agency (such as the FDA) and for companies to conduct Phase IV trials highlights the importance of both.
create a study (after marketing).
Although the FDA does not require companies to conduct post-marketing studies, such a study should be required for certain nanomedicine products.
Some nanopharmaceutical products may also require long-term (5–10 year) studies to track their safety.
The drug safety system has some weak points, and long-term monitoring and assessment is one of them.
Adverse effects from new treatments are sometimes not noticed until they have been on the market for many years.
This is because clinical studies rarely involve enough people to uncover unusual side effects, and because some health issues require years of exposure.
Research on the long-term effects of exposure to nanopharmaceutical products should be funded by government organizations since private companies are not required by law to conduct such studies on their medical goods.
Another difficult issue is the risk of nanotechnology spreading to researchers and the general public.
The subject (or his representative) must be informed of the study's purpose, methods, benefits, risks, alternatives, confidentiality protection, and other relevant information before he or she can make an informed decision about whether or not to participate.
Individuals need to know what's going on.
According to research, participants frequently downplay the potential risks and overstate the benefits of taking part in studies.
Furthermore, volunteers often misunderstand the primary purpose of a clinical trial, which is to generate new information that may benefit other patients rather than to provide optimal medical treatment for those who are taking part in the study.
When applying for approval to conduct nanomedicine research, scientists must accurately detail the potential benefits and risks of the endeavor.
Researchers have a responsibility to inform participants of the potential risks involved in a clinical trial of nanomedicine that involves exposing them to novel compounds that have not been thoroughly studied.
Achieving and maintaining public acceptance of nanomedicine requires open dialogue about potential risks with local residents.
The public may struggle to understand some of the more nuanced aspects of nanotechnology, such as the size dependence of physical or chemical characteristics of nanomaterials.
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Scientists have a responsibility to inform the public of the potential benefits and dangers of nanomedicine, as well as the potential applications of nanotechnology in the medical field.
Uninformed people are more likely to view novel technologies as potentially dangerous or disruptive.
The European public's negative reaction to GM food shows how important it is to have an open dialogue about innovative technologies.
Manufacturers and industry representatives attempted to force their agenda on Europeans rather than engage the public in an open conversation about GM foods, which contributed to Europe's negative reaction to GM foods.
Many Europeans were enraged by the apparent lack of respect for their ideas and safety.
Manufacturers, researchers, and government agencies involved in nanomedicine should develop an integrated program, possibly in collaboration with museums, to educate the public about nanomedicine and engage in an honest and open discussion about ethical, social, and legal issues to prevent repeating previous mistakes.
The issues it createsMedical applications and ethicsAs soon as a nanomedicine product leaves the research and development phase and enters the market, a whole new set of challenges arise.
As the manufacturer enjoys a temporary monopoly thanks to its patents, the initial cost of a brand-new medical product can be very high.
After a new product's patent expires and competing products flood the market, prices typically drop.
As generic alternatives become available and manufacturing efficiencies improve, prices continue to drop.
Although it may take some time for the cost of nanomedicine products to decrease, this is to be expected given the field's complexity and uniqueness.
By encouraging investment in biomedical R&D, the IP system ultimately improves human health and reduces health inequities.
Intellectual property, however, may have a short-term negative impact on health equity because low-income people may be unable to afford cutting-edge medical innovations.
The initial release of nanopharmaceutical products is expected to be extremely expensive, and there is some concern that they could temporarily exacerbate existing national and global health inequities.
This is especially concerning in countries like the United States that do not provide citizens with universal access to medical care.
To ensure that producers do not have undue market power due to intellectual property laws and regulations, and to ensure that people with lower incomes have access to nanomedicine, governments should create health care financing mechanisms to help with the cost.
There are a number of ways to lower the price of nanomedicine, including acquiring it, participating in international efforts to help developing nations gain access to it, negotiating equitable trade agreements, and pressuring pharmaceutical firms to implement tiered pricing structures or other rules that reduce costs.
Using nanotechnology for cosmetic purposes rather than medical treatment raises additional moral questions about social justice.
Nanomedicine is just one example of how advances in medicine are being put to use to improve people's lives.
Almost every new medical technology that can be used to diagnose, prevent, or treat disease can also be used to improve people's lives by making them stronger or more attractive.
For instance, doctors may recommend anabolic steroids to aid in injury recovery, but athletes may also use them to increase their performance.
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An important impact is expected for nanomedicine to have on the treatment versus enhancement debate in the medical field.
Some neurology applications of nanotechnology that work to prevent or replace memory loss could also be used to help people remember better.
Therapeutic applications of nanotechnology to improve learning difficulties have the potential to boost intelligence in otherwise healthy people.
There are many people who, for various reasons, find medical progress to be morally objectionable.
To begin with, advertising can fuel unhealthy levels of competition.
Those who have advanced physically or intellectually have an unfair advantage over those who are less advanced.
It's possible that enhancements could give people a leg up in fields like sports, academia, and the job market.
Second, if the wealthy are the only ones who can afford the hikes and pass them on to their children and grandchildren, the increase may exacerbate existing economic and social disparities.
Those who are already wealthy will only increase their fortunes.
Third, there may be a rise in social inequality as those who succeed feel superior to those who fail.
Although society would benefit greatly from anticipating and adjusting to the use of nanomedicine in healthcare, doing so may prove challenging.
Both enhancement and therapy depend on the vague concept of "natural," so it can be difficult to tell them apart.
While therapies aim to restore people to normal functioning, enhancements aim to make people "better than" normal.
It's not easy to determine what constitutes "normal" or "beyond normal," which is why human growth hormone (hGH) may be useful in treating children who are too short for their age.
For growth hormone to be effective, what minimum age and predicted height do you recommend? Imagine you were 10 inches shorter than the average American adult.
What do you think about eight inches? If someone wants to lose ten inches but gain eight, is it safe to give them hGH? Difficult boundary problems may arise as a result of the contrast between cure and augmentation.
Furthermore, norms differ between societies.
A man who is 5 feet tall as an adult in the United States is considered extremely short by members of the dwarf culture.
In societies where literacy is essential for participation, dyslexia is classified as a disorder, but in cultures where knowledge is passed down orally, it is not.
Second, it may be difficult to implement any rules or regulations regarding the beneficial use of nanomedicine.
Successful law enforcement requires a system for reliably identifying violations of the law.
It can be difficult to tell if an athlete has used performance-enhancing drugs because they may only use them for a short time, they may choose drugs that are difficult to detect, or they may take medications that mask the effects of the drugs.
Furthermore, it could be challenging to enforce a law if the vast majority of people were breaking it.
Most motorists, for instance, travel at speeds that are significantly higher than the posted limit on highways and freeways.
Highway patrol officers can only catch so many speeders in a given period of time.
Each of these problems raises questions about how well society can make rules about how nanomedicine can be used for therapeutic purposes.
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