Organ & Tissue Transplant- Policies, Technologies, etc.

Organ & Tissue Transplant- Policies, Technologies, etc.

[op-ed snap] Getting organ donation to tick again

Note4Students

From UPSC perspective, the following things are important :

Prelims level : Nothing much

Mains level : Organ Donation

Context

Organ donation day is observed with the primary objective of promoting organ donation and transplantation. This helps a number of persons suffering from organ failures, such as the kidneys and liver, as they can get a new lease of life using organs gifted by others who have lost their lives.

Undermining altruism

  • Certain negative perceptions appear to be growing and undermining the altruistic donation mindset of donor families. 
  • There is a steep drop seen in Kerala — from 76 deceased donors in 2015 to 8 in 2018.
  • This is due to a perceived scandal that private hospitals were declaring a person brain dead when they were not really so, to harvest their organs and profit from them.
  • The reasons are as below:
    • the highly privatized health-care system in India and the growing trust gap between patients and doctors in the tertiary care-seeking second and third opinion on patient treatment is commonplace today
  • Though an organ comes free, transplanting it to another person costs between ₹5 lakh and ₹25 lakh, including profit to the hospital. 
  • There will be an unavoidable suspicion that unethical practices may take place, as seen in a recently published book “Healers or Predators? Healthcare Corruption in India.”
  • A majority of accident victims who become donors are lower middle class and below. A majority of organ recipients are from the small number of persons who can afford transplant surgery and costly lifetime medication thereafter. 
  • The cost factor is the key reason why more than 3/4th of the donated hearts and lungs do not get taken.

Public hospitals cannot help

  • Very few public hospitals in the country do kidney transplants and less than five do liver and heart transplants. 
  • In a country where public spending on healthcare remains an abysmal 1.2% of GDP, priority should be on spending on areas that would benefit the greatest number of persons. 
  • A World Health Organisation Consultative Group in its 2014 report points to a study in Thailand which finds that money spent on dialysis can save 300 times more healthy life years if spent on tuberculosis control. 
  • It considers expansion of low- and medium-priority services before near-universal coverage of high priority services as an “unacceptable trade-off”.
  • It does not include dialysis or organ transplantation even in the low-priority category. 
  • If a given amount is spent on organ failure prevention, it will save many more lives than if spent on organ transplants.

Solutions

  • Regulate hospitals through acts and rules. The Transplantation of Human Organs Act, 1994 should be revisited for its effectiveness.
  • Substitution of bureaucratic procedures for hospital and transplant approval by self-declaration and mandatory sample verification involving civil society.
  • A further amendment is needed to ensure full State autonomy in this area. 
  • Avoiding the Central government’s interference in organ distribution, which is demotivating many hospitals. 
  • State organ distribution agencies need to make their operations fully transparent
  • Making online organ distribution norms and the full details on every organ donation will help build public confidence.
  • To tackle the feeling of “organs from poor to rich” moderation of the inequality in our country is needed. India figures in the top 10% of unequal countries in the world. It is among the top 10% of high proportion population spending more than 1/10th of their income on health.
  • Mandate that every third or fourth transplant done in a private hospital should be done free of cost to a public hospital patient.

Organ & Tissue Transplant- Policies, Technologies, etc.

[op-ed snap] A reckless experiment on gene-edited babies

Note4students

Mains Paper 3: Science and Technology | Science and Technology- developments and their applications and effects in everyday life. Awareness in the fields of IT, Space, Computers, robotics, nano-technology, bio-technology and issues relating to intellectual property rights.

From UPSC perspective, the following things are important:

Prelims level: Basic knowledge of the gene editing technology.

Mains level: The news-card analyses the issues and challenges associated with embryo gene-editing (‘human germline’) technology, in a brief manner.


Context

  • Recently, the Chinese scientist who created the world’s first gene-edited babies has forced researchers everywhere to take a hard look at the ethics of gene-editing.

Background

  • Chinese authorities have condemned the researcher, He Jiankui, with a government report this week saying he violated both ethics and laws.
  • Though Mr. He’s actions drew international outrage, they weren’t revolutionary in technological terms.
  • Editing DNA to correct disease mutations has been possible for a while now, which means others can also do what the Chinese scientist did.

Gene-editing: Promises and Challenges

  • The promises of such gene-editing are boundless.
  • Over a dozen clinical trials are currently on to treat diseases like HIV, multiple myeloma and other forms of cancer, using the Crispr-Cas9 editing system.
  • But none of them involve editing the so-called human germ-line.
  • Instead, they have restricted themselves to fixing genetic flaws in sick adults.

What the Chinese scientist did?

  • In contrast to the above, the Chinese scientist deactivated a gene in two human embryos, which means that the changes he made could be inherited by the next generation.
  • In doing so, he violated the widely held ethical consensus that it is too early for germline editing, for we simply don’t know enough yet about the risks of such fiddling.

Concerns over embryo gene-editing

(a) Not as precise: One pitfall of embryo gene-editing is that it is not as precise as we need it to be today.

(b) Can result in unintended mutations: Studies have shown that the technology can result in unintended mutations, which in turn can cause cancers.

(c) Danger of mosaicism: In which some cells inherit the target mutation, while others don’t.

Caution over embryo gene editing

  • However, the error-rates of Crispr are falling with each passing year. But the scientists aren’t in the clear yet.
  • Even when gene-editing becomes fool-proof, the decision to edit embryos will still be a weighty one.
  • This is because, today, scientists are far from understanding how exactly individual genes influence phenotypes, or the visible traits of people.
  • Every gene likely influences multiple traits, depending on the environment it interacts with.
  • This makes it hard to predict the ultimate outcome of an embryo-editing exercise without decades of follow-up.
  • This uncertainty became evident in Mr. He’s experiment, in which he sought to immunise a pair of twins from HIV by tinkering with a gene called CCR5.
  • The problem is that while protecting against HIV, a deactivated CCR5 gene can also make people more susceptible to West-Nile Fever.
  • Every gene influences such trade-offs, which scientists barely understand today.
  • This is why several scientific societies have advised abundant caution while fiddling with the human germline.

Way Forward

  • In a 2017 report, the U.S.’s National Academies of Sciences, Engineering, and Medicine said such an intervention would be defensible only in very rare situations, where no alternative exists.
  • The He Jiankui incident shows it is time to translate these advisories into regulations.
  • Unless this happens, the Crispr revolution could well go awry.

Back2Basics

What are Genes and Gene- editing?

Genes contain the bio-information that defines any individual. Physical attributes like height, skin or hair colour, more subtle features and even behavioural traits can be attributed to information encoded in the genetic material. An ability to alter this information gives scientists the power to control some of these features.

Genome editing

  • Genome editing/gene editing, is a group of technologies that give scientists the ability to change an organism’s DNA. These technologies allow genetic material to be added, removed, or altered at particular locations in the genome.
  • Several approaches to genome editing have been developed. A recent one is known as CRISPR-Cas9, which is short for Clustered Regularly Interspaced Short Palindromic Repeats and CRISPR-associated protein 9.
  • The CRISPR-Cas9 system is faster, cheaper, more accurate, and more efficient than other existing genome editing methods.

CRISPR-Cas9

  • It is a unique technology that enables geneticists and medical researchers to edit parts of the genome by removing, adding or altering sections of the DNA sequence.
  • CRISPRs are specialized stretches of DNA. The protein Cas9 (or “CRISPR-associated”) is an enzyme that acts like a pair of molecular scissors, capable of cutting strands of DNA. It allows researchers to easily alter DNA sequences and modify gene function.
  • It is the simplest yet powerful tool for editing genomes and also termed as the most versatile and precise method of genetic manipulation.

Organ & Tissue Transplant- Policies, Technologies, etc.

Medical registry to track implantable medical devices

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: Ayushman Bharat scheme

Mains level: The inequality between public and the private sector in healthcare and its impact on citizens especially poor


News

Faulty Designs risking patients lives

  1. A recent investigation on hip implants manufactured by well known firm required some patients to undergo revision surgeries because of allegedly faulty designs.
  2. The investigation has found the firm to be evasive in providing the information regarding the design of the implants and patient details.
  3. Such revision surgeries pose serious risks to patients.
  4. Hence registries are needed for all implantable devices to effectively study adverse effects associated with medical devices.

Proposed Registry for Implantable Medical Devices

  1. The Drug Technical Advisory Board (DTAB) will take up a proposal for setting up a national registry for all implantable high-risk devices to protect patients.
  2. The new registry being will be on the lines of the UK’s medicines and healthcare products regulatory agency (MHRA) and the Australian registry.
  3. As many as 4,700 patients in India had received ASR hip implants between June 2004 and August 2010.
  4. This will encourage healthcare professionals, patients and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues.
  5. These reports, along with data from other sources, can provide critical information that will help improve patient safety.

Expected benefits of the registry

  1. Setting up of registry will help issue warnings and alerts to the manufacturers and consumer in case of a device malfunction.
  2. The registry will also help in providing a trend analysis of performance and usage of various medical devices in India annually.
  3. Provisions will be introduced under the law to have legal backing for issuing alerts and warnings to a manufacturer.

Other Policy Measures

  1. The government is also contemplating changes under the Medical Device Rules, 2017.
  2. This will make it mandatory for companies to compensate patients in case of serious adverse events due to malfunctioning of a medical device.

Way Forward

  1. The patients have to live a restricted lifestyle with a compromised physical state, thus putting them at pain and agony throughout their life.
  2. This will also have a bearing on their dependents apart from loss of work and no amount of money can fill this void.
  3. There should be adequate compensation provided to each and every patient who had undergone revision surgery to mitigate some of the pain and sufferings.

Back2Basics

Hip Replacement Surgery

  1. Hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant, that is, a hip prosthesis.
  2. Such joint replacement orthopaedic surgery is generally conducted to relieve arthritis pain or in some hip fractures.
  3. A total hip replacement consists of replacing both the acetabulum and the femoral head.
  4. The Articular Surface Replacement (ASR) Hip uses the metal bearing acetabular cup resurfaced with metal prosthesis that fits into acetabular cup.
  5. It is secured to the patient’s femur with a short stem inserted into the top of the femur bone.

Organ & Tissue Transplant- Policies, Technologies, etc.

Prognosis is good for India’s organ transplant programme

  1. What? Meeting of the National Organ and Tissue Transplant Organisation (NOTTO), National Informatics Centre (NIC) and other stakeholders
  2. Why? To draw a road map for documenting patient progress, networking all transplant hospitals of the country
  3. Also to figure out the official policy to treat out-of-turn requests for organs
  4. Background: India’s still nascent organ transplant programme is making progress
  5. It’s not just things like life-saving traffic green corridors that are smoothening out the wrinkles
  6. Efforts to increase the knowledge base are taking off and crucial policy decisions are taking shape
  7. These are triggered by recent events in organ transplants
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