Delhi HC Expresses Displeasure Over Being ‘Kept in Dark’ About Rare Disease Clinical Trial

The Delhi High Court on Wednesday expressed its displeasure over being “kept in dark” about an ongoing trial here for Duchenne Muscular Dystrophy (DMD) when it has been dealing with issues pertaining to indigenous treatment of the rare disease on petitions by several affected children.

The court said that the petitioners before it could have participated in the trial had it been informed about it earlier and asked AIIMS to give a report with respect to the possibility of the children participating in the trial after their evaluation.

The petitioners are children suffering from several rare diseases, including Duchenne Muscular Dystrophy (DMD) and Mucopolysaccharidosis II or MPS II (Hunter Syndrome). They have sought a direction to the Centre to provide them uninterrupted and free of cost treatment as the therapy for these diseases is very expensive.

DMD, one of the various forms of muscular dystrophy, is a rare genetic disease that affects boys almost exclusively and causes progressive weakness. MPS II is a rare disease that is passed on in families and it mainly affects boys and their bodies cannot break down a kind of sugar that builds bones, skin, tendons and other tissues.

The court was informed by the doctor concerned from AIIMS that a clinical trial is being conducted here by ‘Sarepta’ with a few patients, including one of the petitioners, and the company has now sought permission from the authorities for inducting more patients.

“Why was this court kept in the dark about this trial? Neither government is telling nor is AIIMS. Government, DGCI, Health Ministry, petitioners…everyone kept the court in the dark,” remarked Justice Prathiba M Singh, adding that nobody is “coming clean” in the present case.

“These petitioners could have participated? Why wasn’t the court informed about the approval to Sarepta trial? We are exploring indigenous trials,” she added.

Last year, the court had observed that DMD being a rare disease which is prevalent in a large number of patients in India, indigenous development of therapy for DMD was extremely crucial in order to avoid investment on expensive medication which is also not easily available in India.

Central government counsel said that the trial in question is a “global clinical trial” and the intention was never to not inform the court.

The court said there should be coordination amongst the authorities in the present matter while clarifying that it was getting into a “blame-game” but adopting a solution driven approach.

“I will ask all of the petitioners to appear before you. You will file a report,” the court told the doctor from AIIMS.

The doctors from AIIMS said that not everyone can be enrolled in the trial and there are criteria that one has to meet to qualify for participation.

The matter would be heard next on March 6.

In December 2021, the court had directed AIIMS to forthwith start the treatment of eligible children suffering from rare diseases and asked the Centre to provide funds, saying it is painful to see kids in this situation and they cannot be made to suffer.

It had said the direction to AIIMS and other Centres for Excellence (COE) to commence the medical treatment of these children will include procurement of medicines whose expense will be borne by the central government and funds will be given to COE.

Earlier that year, the court had passed a slew of directions in connection with the treatment of persons with rare diseases, including a direction to notify the National Health Policy for Rare Diseases by March 31, 2021 and setting up a National Consortium for Research, Development and Therapeutics, a rare diseases committee at AIIMS and a fund for such ailments.

Last month, the court had directed the Centre to release Rs 5 crore to AIIMS for treatment of children suffering from rare diseases.

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