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New class of antibiotics discovered

WASHINGTON: In a breakthrough, scientists have discovered a new class of antibiotics to fight deadly bacteria such as methicillin-resistant Staphylococcus aureus and other drug-resistant bacteria that threaten public health.

The new class, called oxadiazoles, was discovered by University of Notre Dame researchers led by Mayland Chang and Shahriar Mobashery in silico (by computer) screening and has shown promise in the treatment of MRSA in mouse models of infection.

Researchers who screened 1.2 million compounds found that the oxadiazole inhibits a penicillin-binding protein, PBP2a, and the biosynthesis of the cell wall that enables MRSA to resist other drugs.

The oxadiazoles are also effective when taken orally. This is an important feature as there is only one marketed antibiotic for MRSA that can be taken orally, researchers said.

MRSA has become a global public-health problem since the 1960s because of its resistance to antibiotics.

In the US alone, 278,000 people are hospitalised and 19,000 die each year from infections caused by MRSA, said researchers.

Only three drugs currently are effective treatments, and resistance to each of those drugs already exists.

The researchers have been seeking a solution to MRSA for years.

“Professor Mobashery has been working on the mechanisms of resistance in MRSA for a very long time,” Chang said.

“As we understand what the mechanisms are, we can devise strategies to develop compounds against MRSA,” said Chang.

“Mayland Chang and Shahriar Mobashery’s discovery of a class of compounds that combat drug resistant bacteria such as MRSA could save thousands of lives around the world. We are grateful for their leadership and persistence in fighting drug resistance,” said Greg Crawford, dean of the College of Science at the University of Notre Dame.

The research is published in the Journal of the American Chemical Society.

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Parliamentary panel on clinical trials seeks action against PATH

New Delhi: A Parliamentary standing committee says the government should act against a US-based non-profit for allegedly violating Indian laws while conducting clinical trials on hundreds of women and children in Gujarat and Andhra Pradesh—an allegation that is rejected by the American group.
The committee also made grave allegations of impropriety against the Indian Council of Medical Research (ICMR), the nation’s apex body for the formulation, coordination and promotion of biomedical research, and the drugs controller general of India (DCGI).
PATH carried out phase IV trials of human papilloma virus (HPV) vaccine for cervical cancer as part of a study in 2009. Phase IV safety surveillance is designed to detect any rare or long-term adverse effects over a larger patient population and longer time period than was possible during earlier phases of clinical trials.
During the trials, PATH administered Merck Ltd’s Gardasil vaccine on 108 girls aged 9-15, and GlaxoSmithKline Plc.’s Cervarix vaccine on 162 women aged 18-35. The study was suspended and an inquiry committee formed in April 2010 following the deaths of seven of those who were administered the vaccines.
However, after analysing the seven deaths—five from the Gardasil group and two from the Cervarix group—no common pattern to the deaths was found to suggest these were caused by the vaccines.
In its report presented to the Rajya Sabha on Friday, the committee urged the government to look into the roles of DCGI and ICMR for allegedly turning a blind eye to “irregularities” in the conduct of the trials.
PATH made a strong defence of its actions.
“We believe that by following the guidance provided by ICMR, as well as two state governments and three ethical review committees, we designed a project that met or exceeded the country’s existing regulatory standards for demonstration projects while providing the greatest health benefit to Indian women,” said Amy MacIver, director of media relations at PATH, in a statement issued on Friday.
But the parliamentary committee was scathing about ICMR, saying: “In their over-enthusiasm to act as a willing facilitator to the machinations of PATH, they have transgressed into the domain of other agencies which deserves the strongest condemnation and strictest action against them.”
It also questioned ICMR’s decision to promote the vaccines for inclusion in the Universal Immunization Programme even before an independent study on their utility and rationale was undertaken.
ICMR dismissed the committee’s criticism. “We have already conducted an inquiry on the deaths of the girls and no link was found between the deaths and the vaccine. The report was submitted to the ministry of health in 2010,” said Dr. Tanvir Kaur at the non-communicable diseases division of ICMR.
“The studies carried out by PATH were definitely not clinical trials,” she added.
The parliamentary panel also took on DCGI, saying it played a “questionable role”. Although DCGI initially maintained that clinical trial rules must be enforced, it stayed silent while the rules and regulations were violated, the panel said.
DCGI chief G.N. Singh responded, “Clinical trial regulations in India were not strict four years ago, but now we have a highly regulated regime.”
“We are taking the recommendations of the standing committee report in the right stride and will work on the suggestions. Such problems should not arise in the future,” said Singh, who heads the Central Drugs Standard Control Organization (CDSCO) as the DCGI.
The panel alleged that many of the consent forms for the tests had thumb impressions for signatures, or had been signed by hostel wardens. Obtaining informed consent from people participating in such drug studies is essential for clinical trials. In case of minors, forms are to be signed by parents or guardians.
The panel also raised the issue of including vulnerable and tribal populations in the trials, and the lack of preparedness to deal with adverse events.
The PATH statement said, “At the time of its review, ICMR determined the project was a post-licensure observational study and not a clinical trial.”
“The demonstration projects in India, Peru, Uganda and Vietnam generated important new evidence on the best ways to introduce HPV vaccines and are informing the work of governments across Africa, Asia, and Latin America to help prevent cervical cancer deaths,” PATH said.
The panel asked the ministry of health and family welfare to promptly report PATH’s alleged violations to the World Health Organization and UNICEF (the UN agency for children), and suggested that the National Human Rights Commission also look into the reported violations.
“It is shocking to see how an American organization used surreptitious methods to establish itself in India, performed trials on hundreds of women and children in our country with so many violations, and two of our government agencies rushed to help this organization,” said Dr. Chandra M. Gulhati, editor of Monthly Index of Medical Specialities.
India approved 475 clinical trials for “new chemical entities” not used as drugs elsewhere in the world between January 2005 and June 2012, according to documents submitted by DCGI in the Supreme Court.
The documents said 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials. They put deaths from trials at 2,644 in the past five years.
In a 3 January ruling, the apex court revoked the powers of the Indian drug regulator to approve trials for new chemical entities, placing the responsibility on the health secretary, who was asked to personally vet all approvals.
On 26 July, the Supreme Court directed the Union government to come up with a new regulatory regime for clinical trials that reflects the concerns of all stakeholders.
The National Institutes of Health (NIH), part of the US department of health and human services, cancelled about 40 ongoing clinical trials in India after the health ministry tightened regulatory norms for trials, Mint reported in July.
The health ministry amended the Drugs and Cosmetics Act with new provisions for regulation and ethical supervision of trials; compensation of trial subjects, and mandatory accreditation of all stakeholders, including institutional review boards, research institutions, sponsors and contract research organizations.

Ranbaxy’s Indian facilities under scanner: Ghulam Nabi Azad

Ranbaxy facilities in India are being reviewed after its US arm, Ranbaxy USA admitted to manufacturing certain drugs which didn’t follow the rules of ‘good manufacturing practices’ and were considered ‘adulterated’ under USFDA law, Health Minister Ghulam Nabi Azad said.

The Minister was replying to a query in Rajya Sabha on steps taken by the government to ensure that ‘adulterated’ drugs are not sold in India after Ranbaxy USA Inc admitted in the US District Court of Maryland to manufacturing and distribution of certain drugs not in conformity with GMP. The Drugs Controller General of India has been ordered to review facilities of Ranbaxy in the country to ascertain the quality of drugs manufactured for domestic market, he said.

Ranbaxy USA agreed to pay a whopping $500 million and pleaded guilty to three felony counts under the federal Food, Drug and Cosmetic Act (FDCA), and four felony counts of knowingly making material false statements to the Food and Drug Administration (FDA), it said.

Azad, in a written reply in Rajya Sabha, said, ‘The Drugs Controller General of India has already been ordered to review the GMP compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities.’  The Minister said the Supreme Court of India has not admitted the PIL against the company.

‘As per the US Law, any drug is considered adulterated, if it is not manufactured, processed, packed, etc in conformity with the Current Good Manufacturing Practice (CGMP) regulations of the USFDA. However, as per Drugs & Cosmetic Act & Rules, in India, manufacturing of drugs not in conformity with Good Manufacturing Practice (GMP) is viewed as non-compliance to GMP under the said Act & Rules,’ he said.

The Ranbaxy story till now…

The Ranbaxy episode started in September 2008 when the USFDA issued two Warning Letters to Ranbaxy Laboratories and import alert for generic drugs produced at two different plants. However, in June 2008, Daiichi Sankyo, a major Japanese company had procured a majority in Ranbaxy in a deal believed to be worth $4.6 billion dollar. A fortnight ago, Ranbaxy offered to pay a $500 million fine for selling adulterated drugs and pleaded guilty to seven criminal counts including fudging of data, intention to defraud and failing to report that its drug didn’t meet specifications. Since then a lot of dirty linen has been washed in public with the Japanese company accusing the Singh brothers – the former owners of Ranbaxy of concealing and misrepresenting critical information regarding the USFDA investigations. Malvinder Singh, the former Chairman however eschewed all guilt and claimed the Japanese company had mismanaged the company.  He said, ‘There was no misleading… Daiichi… approached us…when they came, US FDA investigations were on. They knew about it and it was public information. So there was nothing that was hidden. Whatever they wanted and asked for was shown to them. They did a due diligence. Who would risk $5 billion without a due diligence?’

Meanwhile the Drug Controller General of India (DCGI) Dr GN Singh said that all the approvals given to Indian drugs manufactured by Ranbaxy Laboratories were in order. As per the laws, there was no indication of any company violating the Indian laws, including Ranbaxy. However, Dr Singh admitted that all matters including approvals in the past would be examined again. Dr Singh added that appropriate action would be taken and a special team would be set up to examine the case. They would send officials to the US if the situation demands it.  ‘My most important concern is to assure the safety and efficacy of the drugs in India and action will be taken as per the Drugs and Cosmetics (D&C) Act, not just against Ranbaxy but other companies also if found guilty,’ Dr Singh told Pharmabiz. After these events, the  Indian Medical Association asked the Drugs Controller General of India (DCGI) to investigate the quality of drugs sold by Ranbaxy Laboratories in India.

The Ranbaxy issue evoked a strong response from the government which said that the country ‘has proven international quality standard capabilities’. India enjoys ‘a unique position of low-cost manufacturing and the highest quality medicine, the best of both the worlds’, the statement added. It invited global importers to visit factories to ‘satisfy themselves of the quality of production of drugs’. There’s a school of thought which believes that all the complaints about generic medicines originate from Big Pharma with big brands unhappy with the growing use of cheap generics, as developed nations fight to lower healthcare costs.  Also read: India vs Big Pharma

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