A Health and Human Services official, unable to attend a clinical drug trial conference, still made an appearance
The taped speech sounded almost like a confession, even a hostage plea.
“My name is Chris Galvin,” the faceless voice said, blaring out over the microphones in a conference room in the basement of the Hyatt Regency hotel in Bethesda, Md., on Wednesday afternoon. “I’m an analyst with the Office of Evaluation and Inspections for the Office of Inspector General for the Department of Health and Human Services. If you are listening to this, I apologize that I am unable to be there in person.”
Galvin, of course, was shut down, one of almost 800,000 federal employees deemed non-essential and sent home until Congress agrees on a bill to fund the government.
He had been slated to appear at a conference sponsored by the Drug Information Association, a global nonprofit organization. The conference had been scheduled for months, and was meant to wrestle with the push for greater transparency in the world of clinical drug trials.
Almost 100 people showed up, mostly from across the United States, but also from Canada, Denmark and Germany. Most spent at least $595 to attend (except for the media, who graciously were allowed in for free.) There were top officials from pharmaceutical companies, leading academics, consultants, patient advocates and two officials from the Canadian government.
What was missing: Their counterparts, the U.S. officials. Suffice it to say, it left some major holes in certain sessions.
In some ways, the conference, held on Tuesday and Wednesday in the hotel’s Haverford suite, with a small stage, inconsistent audio, a large screen backed by beige curtains, and round tables with floor-dragging white tablecloths, is a microcosm of how the country has been MacGyvering its way through the government shutdown. Most people have been finding workarounds, waiting for Congress to quit bickering, hoping that the shutdown will be lifted before something really bad happens, like poor children running out of food or, well, not getting enrolled in clinical trials for new cancer drugs.
In other ways, the conference shows how no stopgap really substitutes for the real thing, even when the real thing is the notoriously cautious and circumspect Food and Drug Administration or its parent agency, HHS.
A pharmaceutical executive and a consultant ended up reading the slides from two U.S. government officials who didn’t record their comments. PowerPoint fatigue set in. And little useful clarity emerged about where the FDA actually stood on enforcing requirements for greater and accurate disclosure of certain clinical trial results.
The determination of the conference to stay on schedule, and to hold sessions even without the government speakers, ultimately came to seem like an odd, but kind of admirable, act of defiance. Elsewhere, other meetings challenged by a distinct lack of government participants just folded. For example, the Privacy and Civil Liberties Oversight Board — better known as PCLOB —cancelled its planned hearing on Friday, after being notified “by a significant number of witnesses that they are unable to testify.”
Galvin, for sure, went beyond the call of duty. He could have just skipped the clinical drug trial conference.
But he pre-recorded his speech, even saying “next slide” whenever the moderator was supposed to click ahead in his PowerPoint presentation. (There was one moment when what sounded like a guitar string interrupted the recording, inexplicably. The audience laughed.)
Many of the conference’s participants had been most interested in his final session, “Clinical Trial Disclosure—FDA Enforcement Activities,” held on Wednesday afternoon, and featuring Galvin and for Jarilyn Dupont, the director of regulatory policy for the Food and Drug Administration. In fact, some participants mentioned that it was the main reason they travelled to Bethesda, curious what the FDA would say, especially since FDA enforcement of clinical trial disclosure rules so far seems to be just as quiet as their offices this week.
The final session’s moderator, Robert Paarlberg, a pharmaceutical consultant who specializes in global clinical trial disclosure strategy and regulations, did his best. He launched into the enforcement session, using a picture of a kayaker landing on a whale, saying that he didn’t want anyone in the audience to be stuck in that position. Two of the three chairs for speakers, reserved for Galvin and Dupont, sat empty.
First, the lone speaker, Mark Barnes, a lawyer and medical research expert with Ropes & Gray in Boston, spoke about enforcement for about a half-hour. Then Paarlberg turned on the tape of Galvin, while clicking through Galvin’s slides.
At the end, Galvin said: “Once again, I am sorry I was unable to be there and perhaps answer questions. Should you have any questions, feel free to contact me.” Galvin then gave his e-mail address.
There was a pause, before a bit of confused clapping.
“But he can’t answer the email until after this is over,” Paarlberg reminded everyone.
The Finance Ministry has finally appointed Arundhati Bhattacharya as the new chairperson of SBI. As per the norms, the candidate has to have at least two years of service left before retirement which seems to have ruled out the other three MDs of SBI
State Bank of India (SBI), the country's largest lender has appointed Arundhati Bhattacharya as its new chairperson. Earlier, she was managing director and chief financial officer of SBI.
Ms Bhattacharya replaces Pratip Chaudhuri who retired on 30th September. Chaudhuri was appointed chairman in April 2011.
Earlier, the government interviewed all the four managing directors, A Krishna Kumar, H Contractor, S Viswanathan and Arundhati Bhattacharya for the top post at SBI. Among these candidates, Ms Bhattacharya has the longest tenure left - two and half years.
According to a report from Business Standard, the Finance Ministry had sought an exemption from the current regulatory guidelines because only one of the four SBI managing directors, i.e. Arundhati Bhattacharya was eligible for the chairman’s position. As per the norms, the candidate has to have at least two years of service left before retirement which ruled out the other three MDs.
About Arundhati Bhattacharya
Born on 18 March 1956, Arundhati Bhattacharya joined SBI as a Probationary Officer in 1977. During her tenure of 36 years in SBI, she has held a number of important positions including those of deputy managing director and corporate development officer, chief general manager (Bangaluru Circle) and chief general manager (New Businesses). She also headed SBI Capital Markets Ltd, a Subsidiary of SBI.
She has also had a stint in the Bank's New York office where she was in charge of monitoring branch performance, overseeing external audit and correspondent relations. She has handled retail and corporate finance as well as treasury. She has also played a pivotal role in setting up three of the latest subsidiaries of the Bank, the general insurance subsidiary, the custodial subsidiary and the SBI Macquarie Infrastructure Fund.
Income Tax officials that were seeking tax details on their Gmail and Yahoo! email IDs would henceforth use only official email IDs for official communication
The Income-Tax (I-T) department has directed all of its officials to use official email IDs for all official communication. Moneylife had raised the issue of I-T officials sending mails to taxpayers using IDs from free email service providers like Gmail and Yahoo!.
In a circular, issued on 27 September 2013, the Directorate of I-T, has said, "Since official IDs are available with most of the Departmental Officers, it is instructed that hereinafter all official communication(s) on mail shall be only through the official email IDs detailed above. In the event that an official email is required to be sent urgently and the official email ID not available, the official IDs of the Commissioners of I-T (CsI-T) or Directors of I-T (DsI-T) may be utilised for the same.”
As Moneylife pointed out one of the I-T officers sent a reminder to a wealthy individual to pay his advance tax in time and send details to his Gmail email address.
Here is the circular issued by the I-T department...