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- An expert committee report on faulty hip prosthetics sold by a subsidiary of the U.S. firm Johnson & Johnson has revealed incriminating details about its negligence in dealing with Indian patients. It indicated that the company has suppressed key facts on the harmful effects of the company’s “faulty” hip replacement systems, withdrawn globally after complications required many patients to undergo revision surgery.
- The medical device has debilitated a number of patients, and leaving them with excruciating pain, disability and, in some alleged cases, even death.
How is hip replacement done?
The hip joint consists of a ball and a socket, which are covered with cartilage and surrounded by a lubricating membrane to protect against wear. In total hip replacement, all components are replaced with prosthetic components. While a metal stem is placed into the hollow centre of the thighbone (femur), the prosthetic ball, socket and cartilage can be made of strong plastic, metal or ceramics. The commonest hip implants are metal on polythene, and ceramic on polythene.
What is the issue with the current system?
- The hip replacement that was being used are metal on metal, with cobalt, chromium and molybdenum as major constituents. Called ASR (Articular Surface Replacement) XL Acetabular System and ASR Hip Resurfacing System, these were being manufactured and sold for several years by Deputy International Limited (DePuy), UK, a subsidiary of Johnson & Johnson. Metal was being used as it reported a lower rate of wear and a wide range of motion.
- When the prosthetic ball and socket rub against each other, it causes wear. If the implant is metal on metal, this can sometimes releases metallic debris into the bloodstream. This can lead to complications, sometimes requiring revision surgery.
To what extent has it happened in India?
- The company got the licence to import the device in 2006 to India
- By the time it was recalled worldwide, an estimated 4,700 ASR implants had been done in the country.
- Amid concerns worldwide, the Health Ministry set up an expert committee in 2017 to examine issues arising out of faulty ASR implants in India. The committee reviewed action taken by the company to replace faulty ASR implants, and reviewed compensation provided to those who had suffered.
Findings of the Committee:
- More than 3,600 of the 4,700 patients could not be traced. The committee sent letters to 101, of whom 22 responded.
- The committee concluded that not only did patients undergo revision after first surgery, but in some cases, more than one revision surgeries have been performed.
- Some of the patients had reported that they had to undergo excoriating pain during all these and more particularly after the implant.
- Many patients reported general fatigue or local issues such pseudo tumour, pain walking, metallosis (increase in Cobalt and Chromium levels, Asthenozoospermia (reduced sperm motility), cyst in kidney, claudication pain.
- Some of them informed that they are still having difficulty in carrying out their routine activities and are confined to bed.
- The cost of revision surgery was reimbursed either by the company or the insurance firms.
Recommendations of the Committee:
- The company should be made liable to pay at least Rs 20 lakh to each patient with such complications, and the reimbursement programme be extended until August 2025.
- A central expert committee and a regional expert committee should be constituted by the Ministry for evaluation of patients’ claims in respect of disability and suffering caused due to use of faulty ASR.
- The regional committee will determine whether there is permanent disability, and whether such disability has affected or will affect the patient’s earning capacity, and then submit its report to the central expert committee.
- The central expert committee will determine the quantum of compensation. The patient should be given compensation on the basis of suffering on “account of monetary loss due to wages and other loss” and percentage of disability.
- It has recommended that the maximum amount be at par with the maximum granted for clinical trial-related death and permanent disability as per rules and guidelines of the Drug Controller General of India.
- Provisions for compensation should be included in Medical Device Rules if any serious adverse event or death is caused due to the sole use of a medical device.
- Health assessment of patients should be reported once a year till 2025 and compliance report periodically.
- An independent registry should be established for tracking usage of high-risk medical devices.
How have other countries addressed issues relating to ASR?
- Australia, which had approved the product in 2004, was the first to take regulatory action against it.
- In 2007 the System was associated with a higher-than-average replacement rate.
- In 2009, ASR was removed from the Australian market, By 2016, ASR had the highest revision rate for any hip implant used in Australia.
- In the US, in 2014 found that the ASR had the highest all-cause revision among resurfacing brands.
- It recommended continued clinical surveillance and laboratory monitoring of patients.
- The patient should be given compensation on the basis of suffering on “account of monetary loss due to wages and other loss” and percentage of disability. It is to be noted that reimbursement is not the same as compensating a patient for the pain, suffering, disability and loss of work.
- The learning is the importance of a materio-vigilance programme to track adverse events of medical devices. India established one in 2015.
- But if a programme along the lines of Australia’s National Joint Replacement Registry had existed in 2006, perhaps Indian patients would have received help sooner.
- Even today, eight years after the recall, the Indian government seems to be still deliberating on the issue. With an unknown number of implant recipients still unaware that they could have received a faulty device, time for deliberation is past. The authorities must show that when private corporations fail to protect patient interests, they will be held accountable.
- Floods often wash away rich, weathered soil and the gradual loss of soil productivity can have a lasting impact on the local economy. The rehabilitation programmes often fail to consider this loss.
- In the case of Kerala and Kodagu, the undulation and force of the water would have led to severe soil and land erosion.
Impact of floods on soil:
- Flooding impacts the nutrient levels in the soil. Flooding and long periods of waterlogging result in the depletion of nutrients.
- Floods also result in denitrification of the soil.
- When the upland soils are under water for days or weeks it causes oxygen depletion, or reducing conditions, which may in turn affect the chemistry of the soil-water system and, consequently, soil aggregation.
- Loss of soil aggregation impacts agriculture by decreasing soil quality and crop production.
- Surface crusting is an issue after flooded soils dry out.
- Soil degradation due to flooding is a serious concern.
- A 2014 review of soil degradation in India by multiple institutions shows that an estimated 14 million hectares suffer soil degradation due to flooding annually.
- The impact of floods on soil was also studied in detail following the 2009 floods in North Karnataka. Researchers from the National Bureau of Soil Survey and Land Use Planning (NBSS&LUP) and other institutes estimate that 13 flood-hit districts lost 287 million tonnes of top soil and soil nutrients across 10.75 million hectares of farmland.
- Under market prices, the replacement of nutrients such as nitrates, phosphates and iron would have cost Rs.1,625 crore, while another Rs.853 crore would have been spent on replenishing organic material lost. To recover and replace would take a “considerable” amount of time, and a steadfast programme of recovery, they noted.
- Nine years later, there is no comprehensive scheme for recovery, and the effect of the floods is still visible on the ground.
- A soil profile of a few affected districts, done under the State’s integrated watershed scheme, shows large swathes of these areas having “shallow or very shallow” soil depth, organic carbon deficiency, and low productivity of land.
Are all floods bad for the Soil?
- Not all floods are bad for the soil, as seen in the frequently occurring floods along the banks of the Ganga, Kosi, Brahmaputra and other rivers taking birth in the Himalayas.
- There, the gushing river emanating from the mountains carries with it loosened alluvial soil, and not only washes over farmlands, but also replenishes flood plains with fertile soil.
- However, in south and central India, floods wash away rich, weathered soil, which are deposited in reservoirs or as sand bars along the river bed or in the sea.
While roads and houses will be rebuilt, and crop losses compensated partially through insurance, the gradual loss of soil productivity must also be taken care of. Any rehabilitation programme must consider the lost soil.
It is a dialogue mechanism that would include defence and foreign ministers of the two countries. It is similar to India-Japan 2+2 dialogue format between foreign and defence secretaries and ministers of the two countries. It replaces earlier India – Japan 2+2 dialogue format between foreign and defence secretaries and ministers of the two countries. It restores earlier India-US Strategic and Commercial Dialogue.
- Afghanistan has been one of the longest fought battles for USA to establish peace and bring stability in the region. But with the assent of Trump as President of USA things have also changed as peace process is not easy to come by.
- The Taliban has created an atmosphere of violence with increase in violence set of coordinated assaults around Afghanistan even rejecting an offer of a three-month ceasefire by President Ashraf Ghani.
- U.S. Special Forces and the Afghan National Defence and Security Forces were not able to neutralize the strong hold of Taliban beyond 150 km from the center of Kabul.
- But with repeated interventions by US air force Taliban did suffer casualties, so did the Afghan Army.
Impact of Taliban Assault:
The impact of the Taliban assault in Ghazni and other cities including the deadly bombing of a Kabul school, was three-fold:
- It cast serious doubt on any U.S. plans to draw down troops as Mr. Trump may have envisioned.
- The June Id ceasefire did not result in an outcome. This was despite six months of concerted American punitive actions on Islamabad, the Pakistan establishment is not shutting down support for Taliban fighters.
- Ghani even accused Pakistan of treating the terrorists in hospitals close to the Afghan-Pakistan border, while his Ministry of Defence said Pakistani fighters, including from the Lashkar-e-Toiba were among the insurgents. Pakistan denied the charges.
- The violence this year has also put 2018 on course to be the deadliest year for Afghan civilians, with an average of nine people killed every day, according to UN data.
- Kabul’s security structure has seen a series of sackings and resignations in the aftermath.
- National Security Adviser has been replaced by Afghanistan’s Ambassador to the U.S. The Defence Minister, Interior Minister, head of the National Directorate of Security and deputy chief of the National Security Council all tendered their resignations, over differences with Mr. Ghani’s working; he hasn’t accepted them.
- The developments, along with the faltering peace process, will make the task of holding parliamentary elections due in October, as well as presidential elections in April 2019, much more challenging.
- The approach of USA in reference to Russia, China and Iran, has been even more perplexing.
- With the constant Pressure from USA a possible talks with Taliban on the table initiated by Russia was also disturbed as Mr Ghani backed off.
- However, the U.S. has itself entered into direct engagement with the same delegation led by “political chief” Sher Mohammad Abbas Stanikzai, a UN-sanctioned former Minister in the Taliban government, when Ms. Wells went to Qatar, making U.S. disavowal of the Moscow process seem more discourteous than principled.
The Iran angle:
The Trump administration’s collision course with Iran is another hurdle to realising its South Asia policy.
- Iran is a neighbour to both Afghanistan and Pakistan, and any action against Tehran will have consequences on the region.
- The new American push to sanction and isolate Iran will undoubtedly shift the focus from the task of resolving the situation in Afghanistan.
- This mirrors earlier U.S. offensive actions — in Iraq in 2003, Libya in 2011, Syria in 2014 — each of which took its eye off the ball in Afghanistan.
- Iran is also an alternative route for landlocked Afghanistan’s trade routes to the sea, which ties in with India’s desire to circumvent Pakistan by developing the Chabahar port.
- In fact, if the US was in good terms with Iran, it may have benefited from access to the alternative supply lines to U.S. soldiers in Afghanistan.
- Insisting on India cutting off ties with Iran, will only jeopardise this route, and affect Iran’s desire to assist with the access.
Role of India:
- To begin with, it is necessary that the Indian government spells out clearly its policy towards talks with the Taliban.
- India would also have to become party, hypothetically, to any future agreement that brings the Taliban into a power-sharing arrangement in Kabul.
- The government must carefully study the implications of that departure from past policy.
- India must focus on assisting Afghanistan in every manner possible to ensure that the country’s elections are as peaceful and participative as possible.
- On the military front as well, India must move quickly to provide helicopters as well as engineering/tech support for Afghan hardware.
- India’s development assistance has been the source of its considerable influence and goodwill among Afghan citizens, and this is not the time to make cuts.
- The outlay for 2017-18 was far lower than its commitment in 2015-2016. Officials say this is because major projects, such as the Salma Dam and Parliament building in Kabul, that began in 2008-09, have now been completed.
- While the current crop of Small Development Projects launched in 2016, encompassing drinking water plans for several cities including Kabul, supply of buses, construction of low-cost housing, and assistance in health and education are important, India’s regional status demands more.
- The Indian government must realise that its consistent undermining of the South Asian Association for Regional Cooperation (SAARC) because of problems with Pakistan is also weakening Afghanistan’s engagement with the subcontinent, which India had worked hard to foster.
- The conversations at the 2+2 meet must take into account not just India’s role in Mr. Trump’s South Asia policy but its own role in its neighbourhood.
- Genetically modified mustard- Dhara Mustard Hybrid (DMH -11)
- DMH -11 is transgenic mustard had been developed by a team of scientists Centre for Genetic Manipulation of Crop Plants at Delhi University led by former Vice-Chancellor Deepak Pental under Government sponsored project.
- It is genetically modified variety of Herbicide Tolerant (HT) mustard. It was created by using “barnase/barstar” technology for genetic modification by adding genes from soil bacterium that makes mustard self-pollinating plant. DMH -11 contains three genes viz.
- Bar gene, Barnase and Barstar sourced from soil bacterium. The bar gene had made plant resistant to herbicide named Basta.
About Genetic Engineering Appraisal Committee (GEAC)
- GEAC is apex body under Ministry of Environment, Forests and Climate Change for regulating manufacturing, use, import, export and storage of hazardous micro-organisms or genetically engineered organisms (GMOs) and cells in the country.
- It is also responsible for giving technical approval of proposals relating to release of GMOs and products including experimental field trials. However, Environment Minister gives final approval for GMOs.
- The environment ministry is set to convene this month a special meeting of the Genetic Engineering Appraisal Committee (GEAC) to decide on field-trial approvals for the controversial transgenic mustard developed by the University of Delhi’s Centre for Genetic Manipulation of Crop Plants (CGMCP), according to a person familiar with the developments.
- The CGMCP had earlier applied to grow transgenic mustard (DMH-11) in plots in Delhi and Punjab to test the plant’s effects on honeybees after the GEAC, which had initially cleared the GM crop for commercial cultivation, backtracked and demanded more tests and additional data on honeybees and other pollinators and on soil microbial diversity.
- The GEAC, the apex regulator of transgenic products, had in July put a decision on proposed field trials on hold after some members objected to the use of “unapproved pesticides/herbicides” in the project proposal, according to a record of the meeting made public this week.
- The CGMCP team had proposed to use endosulfan — a banned pesticide — as part of their experiment.
- The trial protocols had also been submitted just three days before the GEAC meeting and some members had voiced objections over the lack of time to examine the field safety protocol.
- The field safety protocol specifies what measures can be undertaken in case of a pest attack. Mustard is usually sown in October and typically takes three months to mature.
- In March, the GEAC had sought more tests for GM mustard in the wake of a chorus of objections to the transgenic crop and following Union Environment Minister Harsh Vardhan’s intervention in the matter.
- Environmentalists, farmer groups and some scientists argue that transgenic mustard poses several environmental and health risks.
- Among these is a contention that it contains a foreign gene from another species, that tests so far have failed to show any appreciable gains in yield over traditional varieties and that it could, if commercially approved, make farmers growing the GM crop dependent on glyphosate — a weedicide that has been linked to cancer.
- Google will soon be helping the Election Commission (EC) keep tabs on online political advertising.
- It will develop a mechanism that will not only ensure pre-certification of political advertisements but also enable it to share with the authority, details about the expenditure incurred on its platforms.
- A committee has been set up to explore possible modifications in Section 126 (election silence) and other provisions of the Representation of the People Act, 1951 in view of the expansion and diversity of media platforms.
Keeping an eye on Election Expenditures
- Google will keep track of political advertisements and ensure that they are pre-certified by the EC’s Media Certification and Monitoring Committees.
- This would entail Google asking prospective clients, whenever an order is placed, whether they have been pre-certified.
- Google has also assured that it would set up a mechanism for sharing information on the cost of the political advertisements.
- The ECI is the nodal body for pre-certification of advertisements of a political nature, released by either an individual or an organisation.
- This would be of use to Returning Officers when it comes to calculating the election expenditure of individual candidates.
- The ECI asks the candidates to declare their official social media accounts.
- As soon as someone is declared a candidate for any election, all the money spent by the person for campaigning gets added as election expenditure.
- The EC’s committee has agreed with Facebook to develop tools for removing any content related to election matters during the 48-hour period when the ‘prohibition protocol’ is in place.
- It is working on ways to check fake news and share details of expenditure on poll-related advertisements.
- During the Karnataka Assembly polls, Facebook tied up with the Indian fact-checking agency, Boom Live, which confirmed over 50 cases of fake news.
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