Sunday October 21, 2018

Negligence of drug side effects data in India

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New Delhi: While 3.63 trillion medicines popped worldwide have a scientific reason for adverse side effects, India still remains the world’s third-largest medicine market.

In 2013, India reported no more than two percent of globally occurring adverse drug reactions (ADRs), jargon for side effects of medicines, logged in Vigibase, maintained by the Uppsala Monitoring Centre, a World Health Organisation collaborating centre for international drug monitoring.

India has equal side effects of medicines as in other countries.

According to a study in 2014, serious effects were seen in 6.7 percent of patients. Drug side effects have been sited as the reason for 3.4 percent of hospital admissions in India, 3.7 percent hospital readmission and 1.8 percent mortality. In the developed world, adverse reactions are believed to be the fourth-leading cause of death.

Within India, the ADR reporting rate (ADRs reported per million population) has almost doubled in the last three years to 40, but it is lower than 130

The reality is India has been ignoring the problem of adverse drug reactions or not reporting the data. That could prove costly, said experts, if it isn’t already.

Ignoring data makes drugs more unsafe.

Reporting the side effects of a drug could help determine if the medicine should stay or be pulled off shelves. A medicine labelled safe for clinical use after trials could still be found to be dangerous –as happened with Rofecoxib, a non-steroidal anti-inflammatory drug, a runaway success after its 1999 launch.

Between its launch and 2004, Rofecoxib reportedly caused between 88,000 and 140,000 cardiac events. This forced Merck, the drug’s maker, to voluntarily withdraw it from the US market and so was ban in India, although no significant cardiac event was reported.

In 2004, pharmacovigilance existed only on paper in India. Although formal monitoring began in 1986, and India signed up to the WHO Programme for International Drug Monitoring in 1997. Reporting was lax until the launch of the Pharmacovigilance Programme of India in 2010.

Carelessness and insensitivity are among reasons for India’s poor reporting of side effects.

Some key reasons behind India’s poor track record in reporting ADRs:

Nurses, who are most likely to see a patient suffering from a side effect, are expected to inform the treating doctor but seldom do.

“Doctors in India are careless in prescribing medicines because they know they will not be held accountable for their actions, and are equally careless about reporting ADRs,” said Kunal Saha, a US-based doctor who’s wife Anuradha Saha died of side effects of a drug overdose while treated for a skin allergy in 1998.

Settling Saha’s case, the Supreme Court ruled that medical negligence includes not informing patients about the possible side effects of a drug. “Physicians prescribe new drugs at the behest of medical representatives even without reading the drug pharmacology, driven by the promise of gifts, despite this being illegal,” said Saha. “Patients are prescribed excessive doses, unwarranted drugs or unwarranted combinations.”

Some doctors don’t know that drug side effects should be reported to any one of 150 ADR monitoring centres across India, nor are they adept at recognising a drug side effect.

Half of India’s population depends on drug stores not ran by pharmacists, and on doctors holding alternative medicine qualifications who aren’t permitted to prescribe allopathic medicines in many states.

Scarce data preclude regulatory action on questionable drugs

Drug side effects in India are scarcely reported, even in scientific literature.

A 65-year-old woman with cardiovascular disease developed chest pain after being put on Nimesulide, a popular pain-killer, for fracture-related pain, as this 2003 study reported. Swapping Nimesulide with an alternative, Ibuprofen, quickly alleviated the chest pain.

A 78-year-old man with heart disease was prescribed Nimesulide for a wrist injury. He developed breathlessness, blue pallor and restlessness, and quickly succumbed to further complications, another 2004 study reported.(IANS)

NewsGram view- In India a large number people suffer because of taking wrong medicines, even that has become a business that doctors don’t try to find the core of disease and prescribe medicine first. There should be data kept for drug side effects.

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Star ICC Asks Anonymous Accuser Of Sexual Assault Charges To Step Forward

The accuser said that while she was at the company, there were "clear instructions" given to make the sales team fulfil the targets.

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Star ICC
#MeToo: Star India internal panel writes to anonymous accuser to come forward

The Internal Complaints Committee of Star India on Sexual Harassment (Star ICC) has written to the anonymous accuser — who had alleged “sexual exploitation” of women employees — asking her to reach out to the committee or its external member on allegations made by her in tweets.

In a Twitter post on Friday, Star ICC, formed under the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013 said it had reached out to the accuser through two emails on the ID provided by her through her tweets. The committee’s external member is Veena Gowda, a Mumbai-based woman rights lawyer.

The accuser, who tweeted through handle @ApurvaS17 — saying she would remain anonymous — had made sexual harassment allegations against the company’s officials in an open letter.

Star ICC
Star believes that the allegations made in the tweet without the complainant coming forward and giving any further detail, is a malicious attempt.

Asked to comment on the allegations, a Star India spokesperson said in a statement that despite no response by the anonymous accuser to the messages sent, the Star ICC had “suo moto conducted a preliminary inquiry and found no basis or factual accuracy” in respect of the allegations.

“We strongly urge any genuine complainant to approach the Star ICC. At Star, we stand with women in drawing the line on any behaviour that violates human dignity or the ability for women to pursue their dreams with respect and freedom. We have a zero-tolerance policy towards sexual harassment,” read the statement in response to an email query by IANS.

It also said that the anonymous tweet shared on October 13 raised an allegation that “runs completely counter to everything we believe in and the norms and values that we deeply embrace.”

The statement further said: “Star believes that the allegations made in the tweet without the complainant coming forward and giving any further detail, is a malicious attempt to malign and defame the reputation of the company and the CEO.” It said that Star reserves its right to initiate appropriate legal proceedings in this regard.

Star ICC
The Star ICC had “suo moto conducted a preliminary inquiry and found no basis or factual accuracy.

The accuser in her tweets had said that the #MeToo movement had encouraged her to come forward and that she had quit her job at Star India in the Airtime Sales section after 26 months and nine days and was now a homemaker, “taking care of my baby and hubby in a beautiful country, far away from Mumbai.”

The accuser said that while she was at the company, there were “clear instructions” given to make the sales team fulfil the targets in case they want to continue with their employment contract, “for which even if you have to take the clients to a hotel room and sleep with them for days.”

She said there were many instances when she and three of her female colleagues (interns) had clear instructions to reach a hotel after office hours for a private party hosted for influential friends.

Also Read: India’s Junior Foreign Minister M.J. Akbar Quits Following #MeToo Harassment Allegation By Women

She says the influential friends were “mostly bureaucrats and sometimes politicians and foreign nationals” who were “all ready to violate you, force you to dance against your wishes, drink with them, make drink(s) for them, exchange your numbers and even quietly accompany them to their respective rooms if they want you to”.

Veteran writer-director Vinta Nanda, who earlier this month accused actor Alok Nath of sexually violating her 19 years ago, wrote on Twitter: “I’m neither shocked nor surprised. I salute your courage to have come out and spoken out. The rot runs deep.” (IANS)