WHO- contradictions- Gag order on Reproductive Health and Guidance for hormonal contraceptive


Invitees who attended back-to-back World Health Organization (WHO) consultations at the start of February were required to sign confidentiality agreements prohibiting them from talking about the meetings. They had to promise not to divulge anything that was said during the three days — not to colleagues, not to their networks, and especially not to journalists, who might misreport the facts. The world health body explained that journalists often exaggerate, and the UN doesn’t want to induce panic. The media will be informed when WHO holds an additional meeting of UN insiders on February 15, behind closed doors, and prepares a carefully worded public statement for release the next day.

The highly classified topic of discussion wasn’t a nuclear threat or a new virus that can kill within days. It was birth control.

WHO’s gag order is just the latest in a years-long effort by the United Nations’ AIDS apparatus to limit how much women know about possible links between HIV and injectable hormonal contraceptives. The UN appears to have forgotten that its job is not to control women’s sexual and reproductive decisions, but to inform them.

Here’s what the UN knows: In July 2011, researchers led by Renee Heffron at the University of Washington in Seattle presented findings from studies involving 3,790 sero-discordant couples (one HIV-negative and one HIV-positive partner) in east and southern Africa.1 The data compared women who had and women who had not used hormonal contraceptives during the research periods: twice as many HIV-negative hormonal contraceptive users acquired the virus. The rates of transmission from HIV-positive women to their male partners was also two times higher for users of hormonal contraceptives. (The findings focused on injectables because very few study participants took hormonal contraceptives in pill form, making the higher rates of HIV infection and transmission in that group “statistically insignificant.”)

In laypersons’ terms, hormonal contraceptives are products that adjust a woman’s hormone levels to prevent ovulation and pregnancy. In the east and southern African countries where the research was carried out, injectable hormonal contraceptives (“depot medroxyprogesterone acetate,” or DMPA) are the top choice of women who use contraceptives, and the Depo-Provera brand owned by pharmaceutical giant Pfizer, Inc. is the most widely used. Despite common side effects, popular features of the method are that one injection lasts three months, and a woman’s sex partner need not know that she is using a contraceptive.

The findings by Heffron and colleagues weren’t definitive; it would take years of additional research to determine beyond a doubt whether or not hormonal contraceptives actually double women’s risks of acquiring or transmitting HIV during unprotected sex. But the research team was concerned enough last July to say: “Our findings argue for policies to counsel women about the potential for increased HIV-1 risk with hormonal contraceptive use, especially injectable DMPA use, and the importance of dual protection with condoms to decrease HIV-1 risk.”

Read Original Artical here

and GUESS WHAT ?, WHO has just declared that “hormonal contraceptives are safe to use for women with or at risk of HIV” based on the meetings discussed below.

WHO upholds guidance on hormonal contraceptive use and HIV

Geneva, 16 February 2012. WHO has concluded, on the advice of its Guidelines Review Committee, that women living with HIV or at high risk of HIV can safely continue to use hormonal contraceptives to prevent pregnancy. The recommendation follows a thorough review of evidence about links between hormonal contraceptive use and HIV acquisition.

Current WHO recommendations in the Medical eligibility criteria for contraceptive use (2009 edition) therefore remain: there are no restrictions on the use of any hormonal contraceptive method for women living with HIV or at high risk of HIV. Couples seeking to prevent both unintended pregnancy and HIV should be strongly advised to use dual protection – condoms and another effective contraceptive method, such as hormonal contraceptives.

Read more here

Drug trials : Madhya Pradesh chief secretary fails to report to NHRC


 Feb1, 2012, Asish Gaur TOI

INDORE : The National Human Rights Commission (NHRC)’s order to the Madhya Pradesh chief secretary to report to it the details of the controversial human drug trials in Indore, has run into a procedural wall.

Taking suo motu cognisance of a TOI report on drug trials conducted on 233 patients of the government-run mental hospital attached to the Mahatma Gandhi Medical College in Indore, the NHRC had asked the chief secretary to furnish the details by last Tuesday. But the latter has not obliged, maintaining that the laws allow the concerned doctors to keep all details of the trials confidential.

Forty two of these patients were given Dapoxetine, a drug to cure premature ejaculation. However, an earlier report of the Drug Controller General of India (DCGI) had said they were not mentally ill, but were seeking psychiatric help for premature ejaculation.

Among other points. the NHRC had also specifically asked the MP chief secretary to report if the doctors had followed Indian Council of Medical Research (ICMR) guidelines, while conducting the trials on the basis of approval obtained from independent ethics committees attached to private hospitals _ bypassing the medical college’s own institutional ethics committee.

The chief secretary, Avni Vaishya, told TOI that he was not in a position to submit the report.”The doctors have kept the trial documents under wraps. The details are confidential according to the laws for the conduct of clinical trials. Only central regulatory bodies such as the DCGI or MCI can investigate the matter,” he said.

The NHRC, however, has decided to press the issue. NHRC spokesperson Jaimini Kumar Srivastava said the commission will write to the chief secretary again. “We have not received any communication from the chief secretary as of now. The time allowed to submit report has lapsed. We are going to write again asking to submit the report at the earliest.”

2-FEB-2012

NEW DELHI : Union health minister Ghulam Nabi Azad on Wednesday asked an explanation from the Madhya Pradesh government on the malpractices surrounding the recent clinical trials conducted in Indore.

“Irregularities were found in the clinical trials conducted there and the state government needs to explain what action has been taken against the doctors involved,” he said.

The drug controller general of India (DCGI) had recently issued a stern show cause notice to five doctors of Indore’s Mahatma Gandhi Medical College for not following good clinical trials (GCT) norms, while conducting clinical trials on 241 patients visiting the College’s psychiatry ward.

Notices had also been sent to three companies – Cadilla, Mcure and Intas – to explain the deficiencies at the earliest.

The DCGI has threatened blacklisting of the doctors from all other trials they are involved in if they fail to reply at the earliest. Two hundred and forty one patients in Indore were subjected to clinical trials to check the efficacy of various drugs, including 42 for Dapoxetine, a drug used to cure premature ejaculation.

An independent team of investigators sent by the DCGI submitted its report to the health ministry recently.

The report has cleared the investigators of carrying out the trial on “mentally ill” patients. The investigating team however took serious cognizance to the fact that investigators did not posses with them the original informed consent forms.

The forms were taken away by the sponsors of the trial, “which is a serious offence”.

A ministry official said, “Most of the patients were suffering from erectile dysfunctions and were being treated by psychiatrists from that medical college. That is why they were visiting the psychiatric ward and not because they were suffering from any mental illness.”

“However, show cause notices have been served on the doctors for the serious administrative lapses and deviation from GCT guidelines while carrying out the trial,” the official added.

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