Robert Califf, former head of Duke Clinical Research Institute, is new FDA Commissioner, but ties to pharma still an issue

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Dr. Robert Califf 
Photo courtesy of fda.gov

 

"Dr. Califf, it's no secret that during your time at Duke University, you received significant financial support from the pharmaceutical industry, both for you personally and for your research. And I know it's common practice for principal investigators on clinical trials, but it naturally raises questions about your relationship with the drug industry."
— Senator Elizabeth Warren at Robert Califf’s confirmation hearing for FDA commissioner
on Nov. 17, 2015

 

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The Duke Clinical Research Institute is not shy about announcing itself. Its administrative offices sit on the eighth floor of a 15-story downtown office tower that is encased in reflective glass and in granite imported from Finland. Capped with a large sign that bears its name, the building is a defining feature of the city’s skyline. 

The DCRI itself is also the defining accomplishment of Dr. Robert Califf, the Duke University cardiologist whom the Senate confirmed yesterday as the commissioner of the Food and Drug Administration.

Download Robert Califf CV 01_2013

Twenty years ago, Califf founded the institute as a place for Duke doctors and scientists to run clinical trials for hire. Under Califf’s watch, DCRI has grown to become the largest such academic research organization in the world. More than half of its research funding now comes from the drug and device companies.

These industry ties were the focus of much debate at last fall’s Senate hearings. Critics from presidential candidate Bernie Sanders to the consumer advocacy group Public Citizen challenged Califf over his long involvement with company-sponsored trials, questioning whether, if confirmed, he can do an honest job of overseeing the pharmaceutical industry.

Although, Califf has been under scrutiny for these financial ties, many experts, including fellow academic researchers and bioethicists, say these relationships are typical. Academic research institutes turn to pharmaceutical companies for money because of a lack of government and other public funding,

“Califf has more conflicts of interest than most, and on its face that’s unsuitable for the FDA,” said Dr. Howard Brody, a medical ethicist at the University of Texas Medical Branch at Galveston. But “industry money is necessary,” he added. “It appears to be the norm.”

Califf's conflict of interest forms:

Download Califf-COI_2014    Download Califf-COI_2013 
Download Califf-COI_2012    Download Califf-COI_2011    Download Califf-COI_2010

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Affordable housing, body cameras, Duke union and more: Live blogging the City Council work session

1 p.m. Council member Jillian Johnson is bring up the resolution in support of non-tenure track faculty to bargain collectively.  She is citing facts about Duke, including average student tuition of $61,000 a year, and the students' dependence on non-tenure track faculty for their coursework. Cost of living in Durham is increasing, but these faculty have no job security or raises. City of Durham is stronger when citizens have secure jobs for the long-term. The decision to unionize is solely that of the workers and not to be interfered with. 

Mayor Bell is readjusting the agenda because he has to leave at 3:20. After the Duke unionization public comments, this will be the order. Don Moffitt is also adding a resolution regarding the Human Relations Commission.

19. Poverty reduction task force

18. Rental assistance, affordable housing

20. Underground utilities permits

4. Body cameras for Durham Police Department

 

Jim Haverkamp: He is a non-tenure track faculty member. We want a seat at the table. We work semester to semester, year to year. We don't have opportunity to meet with administration and discuss this. If you'd be willing to add a voice to ours, that would be appreciated.

A man whose name I did not get: I stand in strong support of non-tenure track faculty, they provide excellent education for students despite having no job security. Their security is our security. Their stability is our stability. It's an important benefit not only for the students but the Durham community.

Mayor Bell: I've long supported the rights of labor unions. Unions tend to come in where companies refuse to provide benefits to workers. Even though we are a right to work state. However, when I look at this resolution, it's been the position of the council, if there are any figures or items that may be questionable, we want them verified. There are numbers in here, while I don't contest them, I'd like to see the source of the numbers. There are some statements that aren't pertinent, such as Duke's exemption from $8.5 million in property taxes because they are nonprofits. The gist of what I see is that the resolution that mayor and City Council support Duke non-tenure track to unionize. I support that, just not the entire resolution. 

We have a letter from Phail Wynn (vice president of Durham and regional affairs): Duke will support their legal right to unionize, but it will provide information and communicate with employees. [This is in reference to union supporters' statement that Duke has provided misleading information about the effects of a union.]

Bell: I think it would be more appropriate to have a letter from Council to Duke president supporting the right to unionize, not a resolution.

Moffitt has a question for Jim Haverkamp: I heard you say "contingent faculty," is that the bargaining unit?

Haverkamp: Non-tenure track, adjunct, lecturers. Many of us work year to year or semester to semester.

Moffitt: The resolution supports the effort to organize, but another line says "endorses the right to organize." There's a difference. I strongly endorse the right to organize, but I believe that the decision belongs solely to the workers. I would like to add a friendly amendment saying "effort."

Bell: I don't expect us to vote on this today.

Cora Cole-McFadden: Concerned about the unionization pamphlet being handed out because there is a lack of sensitivity to all races, lack of diversity in the photos. I haven't had time to read it. I'm troubled by the lack of representation.

Johnson: There is supplemental information about diversity and gender pay gap.

Steve Schewel: I'm a non-tenure faculty at Duke. I'm a visiting assistant professor. I have signed the union card. I asked Patrick Baker, city attorney, if I should recuse myself.

Baker: There's a conflict of interest if this would improve your position or financial relationship. This resolution doesn't do this. You may ultimately benefit, but none of your decisions right now would directly influence this. 

Schewel: I think there are many non-tenure track faculty at Duke who don't have the situation I do, so I'm very supportive.

Eddie Davis: Supports the unionization effort and collective bargaining. I would like to see this resolution polished.

Charlie Reece: For my own part, I would vote to approve the resolution as it is today, but I appreciate concerns of council, and look forward to voting on a revised revolution that reflects those.

Bell speaking with Johnson: Work with administration and city attorney's office to word the resolution. It should come back to a work session.

Cole-McFadden: I do want to say that I support unions.

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I Walk the Line: Ninth Street, a beer, a book and a train

Man asleep 2                                  Near the train tracks along Ninth Street   Photo by Lisa Sorg

 

Candace Mixon, her dog, Jelly, and Matthew Lynch were spending a perfect fall afternoon sipping beers at a picnic table outside Sam’s Quik Shop. (To clarify, Jelly was not drinking.) They looked young and metropolitan, like people who might know  which end of the regional day pass to stick in the card slot.

It turned out they were ardent public transit fans, and using our own code, we traded observations on buses and trains in the way that regulars and commuters do.

“The 400 and the 405 used to take forever, an hour just to get to Chapel Hill.”
“It’s better now that they don’t go to New Hope Commons.”
“I take the bus to Cary.”
“Is that the 100 to the 300?”
“I sometimes take the Amtrak to Raleigh. And I used to commute to Greensboro on it.”

And so on. It’s not that they or I oppose cars—we each own one—but driving has become a drag.

Read more about plans for an elevated train and the Ninth Street station.


N&O, H-S veteran Jim Wise announces retirement


It's literally the end of a Bull City era in print journalism: Jim Wise has covered his last City Council meeting.

JimwiseAnyone who's picked up a newspaper in Durham since, oh, the Reagan administration has had a pretty good chance of having read or been influenced by his work.

A dedicated student of Durham and regional history, Wise has always had the unique opportunity to take something out of the current headlines and tie it back to some other time in history -- even back to the 19th century hardscrabble founding of the Bull City, when needed.

And his voice will be missed.

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Transit plans getting one more public review before board votes this month

It will be years, if ever, before a Triangle Transit train pulls into any station in Durham, Orange or Wake counties. But a plan for investing more than $2 billion in regional rail and bus transit is about to pull out of the station. 

The Durham County mass transportation investment plan could be adopted as soon as this month by leaders of three key groups: the Durham-Chapel Hill-Carrboro Metropolitan Planning Organization, which oversees transportation strategies; Triangle Transit, which operates DATA bus service in Durham as well as regional bus service, and which would likely operate any new rail system; and the Board of County Commissioners

The first two organizations will both consider the plan on June 22; county commissioners will hold public hearings on the plan itself and on a referendum for a half-cent sales tax on June 13. Commission action on either or both issues may come on June 27. 

Durham’s share of the plan would amount to about $1.4 billion. A quarter of the project revenue is expected to come from the government of North Carolina, half would likely come from the federal government, and the remainder would be paid by a combination of sources including the half-cent sales tax, vehicle registration increases of $10 and a rental car tax. 

The new levy would not apply to housing, food, medical, utility or gasoline purchases, thus somewhat blunting the regressive nature of the sales tax. 

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Residence Inn ready to accommodate Trinity Park residents? Once-contentious negotiations seem near an end

A proposed hotel that once bitterly divided one of Durham’s tonier neighborhoods now seems closer to securing support from residents. 

On Wednesday evening, the Trinity Park Neighborhood Association board and a number of interested residents learned about a deal that a group of members has worked out with developers of the Residence Inn proposed for 1108 W. Main St. between North Buchanan Boulevard and Watts Street. 

While the presentation didn’t put every concern about the project to rest, it did result in a consensus that negotiators have struck an arrangement neighbors can accept. 

“This is such a huge credit to you who have negotiated this,” Laura Gutman, who lives about a block north of the hotel site on Watts, said after the deal was presented. “I mean, this is just night and day in what looks like an outcome. It’s just amazing when you think of ... the agony that the neighborhood went through fruitlessly.” 

She said that the deal “looks like an outcome” because it remains subject to a yet-to-be-scheduled vote by the neighborhood association board -- not to mention ultimate support from elected officials.

The negotiating process involved some give and take by both sides, with the developer agreeing to some big alterations to its initial plans. But as important as the process has been for this one project, it may have even more significance for future projects. 

This result, if it is finalized, will send a signal to other potential developers, said Dan Jewell. He’s a partner in the Coulter Jewell Thomas landscape architecture and planning firm, which dropped out of the Residence Inn project before the negotiations with the neighborhood began. 

“There can be a win-win situation” when developers go to work in Trinity Park, Jewell told others at the board meeting. “Because I’ve been involved in those groups where it’s always just ‘no, no, no,’ and it’s going to be a fight to the end... This is a going to be a great precedent.” 

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Duke bid on tobacco warehouse could extend the university’s downtown footprint

Durham County is putting the old Carmichael warehouse up for sale, Ray Gronberg reported in Tuesday’s Herald-Sun, following Duke’s submission of a $6.8 million bid for the building. What does that mean for downtown Durham? 

Good things, according to Bill Kalkhof, the impresario of downtown Durham and the president of Downtown Durham Inc. 

“The county has a very solid offer that I think is a very fair offer for the property,” Kalkhof said. “And it’s being made by a great institution, and the offer can only get better from here.” 

The statutory process by which the property is being sold gives other interested parties 10 days from the date a formal notice of sale is published to submit upset bids. Such a bid must exceed the preceding offer by 5 percent. Each upset triggers a new advertisement and a new 10-day window for further bidding.

The county is not obligated to complete a sale. 

A transfer of the Carmichael, a tobacco drying and storage warehouse built by Liggett and Myers in 1926, has been brewing for years. The space is currently occupied by part of the county’s Department of Social Services. By 2013, those offices should be set to move into the finished Human Services Complex on East Main Street, which is already partially occupied. 

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Blackstone announces major grant initiative to support new businesses

Some of the most prominent figures in the Triangle and the state joined forces Monday morning for the announcement of a new type of entrepreneurial incubator

The launch of the Blackstone Entrepreneurs Network, held in Bay 7 of American Tobacco Campus, drew around 300 attendees. The network, described as the first regional integrated initiative, is being funded by a grant from the Blackstone Charitable Foundation. 

Steve Schwarzman, the co-founder, CEO and chairman of investment and advisory firm the Blackstone Group, predicted that the foundation’s investment would provide an enormous boost to the state’s economy. 

“In creating an ecosystem to support aspiring entrepreneurs, the Blackstone Entrepreneurs Network [is] expected to double the number of startups coming out of this region, attract venture capital at all stages, create approximately 17,000 jobs, attract over $800 million in venture capital, generate revenues of close to $5 billion and [have] countless secondary impacts on the local economy,” he said. 

“The potential is tremendous. The time is right, and the talent sitting in this room, [exemplified] by the heads of these universities and the Research Triangle, is really a remarkable group.” 

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Renovated Chesterfield could continue downtown’s upturn

Just a few years ago, anyone who wanted to travel Main Street between downtown and Brightleaf Square had to pass through an urban dead zone. The tobacco factories and warehouses between the Downtown Loop and North Duke Street, seemingly devoid of  life, loomed threateningly on either side of the street. 

It’s not like that today, of course. The mixed-use West Village project now appears to be thriving, and a city streetscaping project has furnished motorists with smooth pavement and pedestrians with attractive sidewalks on either side. Day and night, Pop’s restaurant and the West End Wine Bar both draw customers to an area that was once a depressing monument to this city’s defunct tobacco economy. 

But one very prominent spot was not so welcoming, according to a member of the Durham County Board of Commissioners: the corner of Duke and Main, where the still-empty Chesterfield Building looms. 

“I know at night that block there can seem, you know, dark and very vacant,” said Ellen Reckhow, the board’s vice chairwoman. “I’ve walked it after dark in that area, and it’ll be good to breathe some life into what I consider to be a critical block.” 

The resuscitation comes courtesy of developer Josh Parker, who is about to take control of the former cigarette factory. The project has been delayed a few months, as The Herald-Sun’s Laura Oleniacz reported this morning, but it is still on track to get under way by summer, Parker insists. 

“We’ve now set June 30 as our closing date, with construction to follow immediately thereafter,” Parker told Bull City Rising. “We were hoping to get started late April and just started running out of time.” 

Continue reading "Renovated Chesterfield could continue downtown’s upturn" »


Win two tickets to the Nasher Museum of Art's fifth-anniversary gala event after-party

Great-hall Duke's Nasher Museum of Art is celebrating five years as part of the arts community in Durham and the Triangle. And they've been a part of the cultural elevation in the region, from the El Greco to Velázquez exhibition to hosting showings of works and writings by artists like Picasso and Warhol, to a far broader range of exhibits from emerging artists, modernists and more.

That celebration comes to focus on Nov. 13 with the Nasher's 2010 Benefit Gala, an annual event that raises funds for the museum in West Durham; proceeds support the Nasher's free K-12 and adult education and exhibition programs.

And thanks to the generosity of the Nasher, BCR readers have a chance to win a pair of tickets to the Gala's after-party. (Value of the tickets: $150 per.)

This year's benefit gala will honor Larry Wheeler, the director of Raleigh's North Carolina Museum of Art -- whose cultivation of friendship with the widow of securities firm Cantor Fitzgerald's founder led to the NCMA putting together one of the largest Rodin castings collections in the country, as the N&O noted earlier this year. Governor Perdue will also be in attendance.

A Gala-specific art installation by artist Jennifer Rubell (who'll be in attendance), interactive iShadow lighting from New York, and the after-party -- featuring DJ and music writer Dave Tompkins -- will be highlights of the night.

The pre-reception starts at 6:30pm on Saturday, Nov. 13, with the gala underway at 7:30 and the after-party kicking off at 9:30pm. Tickets to the full gala run $250-$500+ per person.

To enter to win BCR's pair of tickets in the contest, email info@bullcityrising.com to express your interest; a winner will be selected at random on Nov. 8. To find out more about the gala or to buy tickets, visit http://www.nasher.duke.edu/gala.