Wednesday October 16, 2019

Government Experts Back Experimental Treatment for Children with Peanut Allergies

The outside panel of advisers to the Food and Drug Administration voted overwhelmingly in favor of the treatment from Aimmune Therapeutics

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Government, Experts, Experimental
FILE - Health experts endorsed an experimental treatment, Sept. 13, 2019, for children with peanut allergies. An estimated 1.6 million children and teenagers deal with peanut allergies. VOA

Government experts Friday backed an experimental treatment for children with peanut allergies that could become the first federally approved option for preventing life-threatening reactions.

The treatment is daily capsules of peanut powder that gradually help children build up a tolerance.

The outside panel of advisers to the Food and Drug Administration voted overwhelmingly in favor of the treatment from Aimmune Therapeutics. The nonbinding vote amounts to an endorsement for approval.

The FDA is expected to make its final decision by January.

Government, Experts, Experimental
Government experts Friday backed an experimental treatment for children with peanut allergies that could become the first federally approved option. Pixabay

Important option

The panelists said the medication was an important option for parents and children dealing with peanut allergies. However, several also said they had concerns because the pill has to be taken continuously to maintain its effect.

An estimated 1.6 million children and teenagers in the U.S. would be eligible for the medication, to be sold as Palforzia, which is intended for ages 4 to 17.

Peanut allergy is the most common food allergy in the country and the standard treatment involves strictly monitoring what children eat. That approach doesn’t always work and accidental exposure is common, sending 1 in 4 children with peanut allergies to the emergency room every year.

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‘Peace of mind … invaluable’

Parents at Friday’s meeting urged approval of the drug, describing the anxiety of watching their children’s diet and daily routine, even avoiding public places and transportation because of possible peanut residues.

“These are constant and real fears with extreme consequences,” said Cathy Heald of Dallas, whose 12-year-old son Charlie took part in a study of the treatment.

Heald said her son’s improved tolerance allowed him to travel overseas by himself for the first time.

Government, Experts, Experimental

The treatment is daily capsules of peanut powder that gradually help children build up a tolerance. Pixabay

“The peace of mind this treatment brings is invaluable,” said Hill, whose trip to the meeting was paid by Aimmune.

Risks of treatment

After one year, about 66% of study participants who took the pills could tolerate the equivalent of three to four peanuts, compared to just 4% of patients who received a dummy treatment. At the beginning of the study, most participants could not tolerate even a minuscule amount of peanuts.

But the benefits of the treatment came with risks. More than 9% of patients taking the pills reported severe allergic reactions, more than twice the number in the placebo group. And 11% of patients dropped out of the company’s study because of side effects.

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“The effectiveness of the treatment has, in fact, not been demonstrated,” said Dr. John Kelso, of Scripps Clinic in San Diego, who voted against the treatment.

The California-based company has previously said it expects the first six months of treatment to cost $5,000 to $10,000 and $300 to $400 a month after that. The company declined to elaborate on price earlier this week.

Aimmune is pursuing other treatments for common food allergies, including eggs. The company does not yet have any products on the market. (VOA)

Next Story

Modi Regime in Favour of ‘Minimum Government’

The transformative outcome of 2014 general election, giving BJP under Modi's projected leadership a majority of its own for the first time

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Modi, Regime, Government
The political-bureaucratic nexus is what had made the regimes preceding Prime Minister Modi's, a hallmark of permissive corruption. Pixabay

A democratic regime runs on two important premises – first, that the predominant majority of citizens were law abiding people and the enforcement agencies could use this to their advantage and, secondly, that the political executive governing the nation should look strong but without letting the bureaucracy including the police behave like ‘rulers’, not public servants. The remarkable rise of Prime Minister Narendra Modi in 2014 was very much due to his image as a leader who would deal with the corrupt with an iron hand and get his administrative machinery to focus totally on public delivery and development. Modi’s policies in the spheres of international relations and safeguarding of India’s strategic interests are extremely successful – and this includes the handling of that perpetual trouble spot in J&K, the Kashmir valley. But the approach to ‘tightening the screws’ on violators of law has apparently shifted from a meaningful effort to improve the working of enforcement agencies including the police, to merely providing harsher laws.

The problem of governance in India over the decades was not so much the absence of deterrence of law as was the known lack of integrity in the bureaucracy and police agencies that led to highly suboptimal delivery in the areas of both development and law and order management. The political-bureaucratic nexus is what had made the regimes preceding Prime Minister Modi’s, a hallmark of permissive corruption and lack of accountability – running top down – to the great distress of the average loyal citizen of India. The transformative outcome of 2014 general election, giving BJP under Modi’s projected leadership a majority of its own for the first time, is traceable to the wish of the law abiding voters to put a people-centric set-up in power that would tone up the performance of public servants too.

It is possible that the bureaucracy – taking the cue from the new regime’s explicit desire to provide a ‘strong’ government – sensed an opportunity of becoming the ‘policy maker’ themselves on behalf of the political leadership, scaling down its own prime accountability for policy execution and started working for stronger laws and rules rather than for ensuring implementation of those already available on the shelf. Introduction of a harsh jail term for non- compliance with Corporate Social Responsibility (CSR) provisions and more recently revision of Motor Vehicles Act to multiply the scales of punishment for traffic defaults seemed to reflect this approach of civil servants and the police. The CSR clause had to be hastily ‘decriminalised’ and the implementation of new traffic laws had to be left to the discretion of state governments. Financial scams needed to be busted with all the force of law and gross violations of traffic rules required to be identified and punished but without causing anxiety to the well meaning lot who might have transgressed a little without intention.

Look at the crime and traffic scene in Delhi. The problem on the road was created basically by cab drivers and rash young people on the wheels who indulged in ‘lane surfing’, overtaking from the wrong side and mindlessly blocking the left turn at a crossing. Large groups of traffic policemen can be seen at important junctions but there is little effort made over the years to educate people on ‘lane driving’ and haul up those who just drove ‘between two lanes’ all the time. No traffic men were deployed on the stretch between traffic signals to detect the violators of lane discipline and inform the next check point for further action against an identified vehicle.

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The problem of governance in India over the decades was not so much the absence of deterrence of law as was the known lack of integrity in the bureaucracy and police agencies that led to highly suboptimal delivery in the areas of both development and law and order management. Pixabay

Also, there is a tendency to leave everything to the lowest echelons – the reported directive recently issued by Commissioner of Police, Delhi to the Deputy Commissioners of Police (DCPs) to monitor the worsening crime situation on the streets of Delhi reflected in the rise of snatching cases and violent assaults in public, somewhere points to this. The ‘punitive drive’ of the police in the follow-up on the new traffic laws scared the law abiding more than what it did to the habitual violators. Exercise of a sense of ‘discretion’ between a speed of say 52 km and 60 km – against the displayed limit of 50 km – on the part of law enforcers would have helped to retain the public goodwill but this will happen only when senior officers are in the picture and ‘misuse’ of discretion would not be an issue.

In the initial phase of a sudden switch over to harsher rules affecting the population in general, there is a certain importance of ‘education’ and ‘warnings for first violations’ going together with punitive fines. Memories of harsh behaviour towards the public linger on – the middle class being particularly sensitive to any administration trying to ‘rule’ the people. Any defence of the overzealous drive to collect traffic fines on the plea that it added to the revenue of the government is absurd and somewhat demeaning from the people’s point of view. The traffic police is seemingly banking more on detecting speed limit violations through a hastily assembled CCTV system and not yet devoting to the painstaking job of catching drunken drivers which should be a top priority for the law enforcers.

The basic philosophy of law enforcement in a democratic set-up is that the violation of criminal law, big or small, would not be spared but any extenuating circumstances would be taken due notice of – even the Indian Penal Code defines a set of General Exceptions. Policing today is as much a task of guiding and educating the public as it is of prompt action against a law breaker. As it is, police has to do much better in the area of preventing crime and bringing hardened criminals to justice. If the law abiding shun the police, it can affect our capacity to detect and identify an enemy agent running a ‘sleeper cell’ in the midst of population.

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The Modi regime is in favour of ‘minimum government’ which is an idea incumbent on a smaller bureaucratic and police machinery working at its efficient best and seniors assuming greater responsibility for delivery. Political credit in a democratic rule accrues a great deal from the image of the administration – it has to be people friendly while creating deterrence for the anti-social elements and criminals out there. (IANS)