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


Dr. Robert Califf 
Photo courtesy of


"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



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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Live blogging Feb. 18 City Council work session

1:03 p.m. Jillian Johnson is discussing the revised resolution about supporting the Duke unionization efforts. Mayor Bill Bell is asking that the discussion happen after a review of the agenda.

1:10: We're in the citizen comment period right now. First, how to resolve a dispute over a speed hump at 610 Carroll Street.

1:30: James Chavis speaking now. "This is a hot item, but it needs to be taken care of by the city. We're talking about racial profiling and lying. I'm the victim of that. On Jan. 17, I was followed by a police officer from East Durham to my home (on Ashe). I got out of my car. He asked if he could talk to me. He had his hand on his gun and asked me if I knew that I didn't have to talk to him.
He said I had been driving on that street two or three times. I told him he did not see me. I had just come from my sister's house, came from the bank, the gas station.
I gave him the right to talk to me. Then three more white police officers came up on my property without my consent. They looked inside my car without my permission.
I'm asking you Mayor Bell, one black man to another. ... I want a discussion about this with you and the city manager. Please look at your calendar so we can have a forum talking about this racial profiling and lying. He said he saw me, but he didn't. He was wrong. And I was right.

Bell: I'd like to know who the officers were so we know who we're talking about. Don't have to know now, but get the names and we'll set this up.

1:40 p.m. Now back to the Duke University unionization resolution. Johnson: As was requested at last work session, I revised it and am bringing it back to council. I'd like to announce that the workers have filed for union election with the NLRB.

Resolution is in support of non-tenure track faculty to bargain collectively and form a union and improve working conditions on campus. Many non-tenure track faculty have little job security and health-care benefits. These faculty want to have a collective voice. The right to unionize should be that of the workers and not be interfered with.

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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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Trash, pollution, food stamps and more: A preview of Monday's Durham County Commission meeting


It’s a new year (and a leap one at that), which means it’s time to clean and freshen—our lakes, roadsides—and reuse—our buildings. And get to work or go hungry, say our esteemed state lawmakers, who apparently are self-proclaimed experts on job searches.

Durham County Commissioners meet for the first time this year on Monday at 9 a.m. at 200 E. Main St., with a full slate of important issues.

First, food: About 2,700 Durham County residents will be affected by a new state law that determines who gets food stamps and for how long. Commissioner Wendy Jacobs has asked for a presentation from the Department of Social Services about how it will deal with ensuring the county complies with the law and as important, that low-income people can buy food.

The program is known as ABAWD—Able-Bodied Adults Without Dependents. It states that in order to qualify for food stamps for more than three months, people ages 18 to 49, who are able to work and don’t have a child under 18 on food stamps, must work, volunteer or enroll in a training program for no fewer than 20 hours a week. If those individuals don’t comply, their food stamps are cut off after three months.

Download Able Bodied Chart backup for AAF

There are exemptions: pregnant women, caregivers for an “incapacitated person,” chronically homeless, recipients of unemployment benefits, substance abusers whose illness is so severe they cannot work.

I understand that some people abuse the system, but this seems like another layer of bureaucracy that would be hard to track. It also fails to recognize that there are people, ex-offenders, for example, who would very much like to work, or even volunteer if it gave them a job skill. But employers and private agencies aren’t clamoring to put ex-offenders on their payrolls. (This is another reason to support the Ban the Box campaign.)

This impossible situation creates a feedback loop of poverty and incarceration that was a main focus of last fall's Durham City Council race. People get out of jail, some of them convicted of low-level marijuana charges, with no job prospects. With a conviction, it’s hard to find housing (and forget about public housing). It’s difficult to get federal financial aid for school. And now the state wants to further penalize these people by eliminating nutritional support.

How much in food stamp benefits are we talking about? An average of $30 a week. Yes, state lawmakers have created a new, cumbersome law for a picayune amount that will get you a bag of groceries at Food Lion.

This, in a state that for the past five years has ranked in the top 10 in percentage of food-insecure residents, according to a study by Feeding America.

I can tell you that most people do want to work. They want to earn money, contribute to their communities, be a part of something larger. If they’re not working, there is usually a good reason. This Washington Post story, chronicling suburban poverty and the lack of public transit, is an excellent glimpse into the logistical nightmare.

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Workers didn't know they were to lose governance rights, and other revelations from the Durham co-op meeting

This story was updated at 10:45 a.m. on Monday, Nov. 9, to include comments from Marilyn Scholl, who is with the consultant group CDS.

Disclosure: Until mid-August, I was a co-op member  as part of the INDY's company share. After I left the INDY, I was no longer a member. Since only members could attend last night's meeting, I asked people who were going to take notes. So these accounts are second-hand; if you attended the meeting please chime in with more info and insight.

Durham co-op workers were blindsided by the news that they would lose their shares and seats on the board if a referendum passed stripping them of those rights. In fact, some of them didn't know until last Friday that such a vote was pending. The referendum was canceled after public outcry over the lack of transparency on the measure.

These and other bombshells were dropped at Sunday's annual Durham co-op meeting.  Davis Hodge, grocery manager and three employees told the crowd of more than 100 that, “The entire staff definitely felt blindsided by this referendum.” Employees came to work at DCM with promise of ownership. “We felt like that was something that was owed us, and something that was going to be taken from us unjustly. This feels so ridiculous to me.”

Cris Rivera, finance manager, also spoke to the membership: “We just felt really disrespected. There’s something very different about a worker’s owning the means of production.”

Board chairman Frank Stasio admitted that the board hadn't talked to members or to employees about any of this. “It’s a huge error and I made it,” he said. He added that worker-ownership is a "core value" of the co-op.

How worker-shares came to be written into the articles of incorporation was also a point of contention. Stasio told the membership (and me on Friday) that the bylaws were essentially cut and pasted from those of Weaver Street Market and Chatham Marketplace. Both those co-ops include worker shares and up to two seats on the board of directors.

However, former board member Michael Bacon piped up from the back of the room, disputing that account. He said founders of Durham Co-op looked at both Weaver Street and Chatham Marketplace and made deliberate decision to include worker-owned shares. “This was a very intentional act," he said. "It wasn’t a simple photocopy.”

“Sadly, this is the first time I’m hearing about it," Stasio replied.

CDS, a coop consulting group based in Vermont, advises against worker shares and board seats because it can create a conflict of interest, Stasio said. (Marilyn Scholl of CDS commented on the original story about this issue.)

But worker shares as a separate class also allows employees to participate in profit-sharing, should the co-op turn one. That could help buoy their hourly wages, which start at $9.04. Some workers are up to $9.17. “That’s what most people are making” a worker, Anna, told the membership. She would get health benefits if she worked full-time at the co-op, but can’t afford to because she makes more money as a barista.

Which brings the discussion to finances. Co-ops, like most fledgling businesses, initially lose money. In the first six months, the store lost $87,000, below projections. Actual sales, $2.2 million, are well above projections, $1.3 million. 

But the co-op is still in the red, and paying low wages. General Manager Leila Wolfrum said average hourly wage for full-time employees, including health benefits, is $11.72, "above what I thought I'd get it at this point."

That makes it nearly impossible to reign in turnover, even though Wolfrum said, “We want people to look at this store as a career. We want them to come and stay.” 

“We caused pain," Stasio said at the meeting, "and I beg your forgiveness.”

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Comprehensive plan update gets another go-around this afternoon

Durhamites will get a chance to examine and potentially to influence one of the county’s most important planning documents this afternoon. 

The six-year-old Durham Comprehensive Plan is about halfway through its first major revision. In one way or another, the document touches upon nearly every major aspect of life in Durham County. It has 18 chapters covering land use, housing, historic preservation, commerce, conservation and the environment, transportation, recreation, education, capital projects, and public infrastructure and buildings, among other topics. 

Each chapter briefly examines relevant issues, lays out goals and details a few strategies for realizing those goals. These guiding principles often take up relatively little space. The text of the housing chapter, for instance, runs 11 pages, of which about half deal with ensuring that subsidized housing is distributed more or less evenly throughout the county. 

This part of the 18-month revision process is the time for the first of two scheduled rounds of public comments. When the next round comes, in the fall, a draft plan revision should be complete. The process is being led by Laura Woods, a senior planner in the City-County Planning Department who helped create the original plan. 

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Campaign finance complaint to state turns up heat on Durham Committee’s Allison

A member of the Durham Committee on the Affairs of Black People has asked state elections officials to investigate potential mishandling of campaign funds in the committee’s political organization. 

The move comes as some people in the 76-year-old civic group, one of Durham’s oldest and most prominent, have been calling for an ouster of its chairwoman, Lavonia Allison. 

Committee member Victoria Peterson submitted a two-paragraph letter to the State Board of Elections on Monday asking it to look into a pair of transactions that took place over a two-day stretch last fall. 

On Oct. 24, according to Peterson — but not the public document on which her claim is based — the Durham Committee’s political action committee reported receiving an $8,000 contribution from the committee of incumbent Rep. David Price (D-Chapel Hill), who was re-elected in November. The next day, records show, the PAC paid $8,822.61 as reimbursement for bulk mail postage to Allison. 

“The organization fiscal report stated that Dr. Allison paid for bulk mail, but there is no evidence of such a transaction,” Peterson wrote to Kim Strach, the state board’s deputy director for campaign reporting. 

In a brief phone conversation Tuesday afternoon, Allison declined to be interviewed but dismissed the allegations against her as falsehoods. 

“I’m not going to get into something that is totally, totally prevarications,” said Allison, who became chairwoman of the Durham Committee on the Affairs of Black People roughly 13 years ago. “People can’t even read an electronic [campaign finance] report. It’s sad.” 

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Eyes on 2012 as Durham Committee members talk leadership

A group that may be mounting a challenge to the leadership of the Durham Committee on the Affairs of Black People met Thursday evening at White Rock Baptist Church.

That much is certain. But members of the group declined to state what was discussed.

“Everybody’s upset,” said Victoria Peterson, a community activist who helped organized Thursday’s meeting, said after it ended.

But she had little more than that to say. “A lot of things were decided,” Peterson noted, without elaborating.

Other participants in the meeting stated immediately and emphatically that no one who was present would be speaking to reporters.

When asked why that was, a woman who declined to give her name answered, “Because I said so.”

The meeting had been billed, according to an e-mail missive sent to publications including BCR and summed up well in coverage by the Indy's Samiha Khanna, as a bona fide meeting of the DCABP. Its purpose? To elect new leadership following allegations by Peterson, former City Council contender Darius Little and others that the organization hadn’t made its financial records accessible as promised and had not seen effective leadership.

For the record, the committee’s longtime head didn’t seem too concerned with the talks at White Rock. When contacted by phone after the gathering, longtime head of the Durham Committee on the Affairs of Black People Lavonia Allison noted firmly that the conclave was not an official group meeting.

“We have not in fact installed our officers yet,” Allison said. “We haven’t even started for the year. We were late getting started on everything. We have not installed any officers yet.”

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Durham, Raleigh racial segregation by the dots

Yours truly was first intrigued a week ago, when Gawker, Flowing Data and other web sites pointed out an interesting Flickr photostream by Eric Fischer, who reviewed 2000 Census data for major metropolitan areas and mapped out residents by race to show, visually, what level of segregation or integration existed then in communities.

Of course, these data are likely to change come 2010, as maps nationally don't show the level of Latino population that came to many communities -- including Durham, which saw a decade-long boom in Hispanic residents. But they still show patterns of residential activity particularly in term of self-identified Caucasian (red dot) and African-American (red blue dot) residents. Asian residents appear in green, Latino in yellow/orange, and gray for other ethnicities, with each dot representing 25 residents.

The initially release of metro areas didn't include the Triangle, but the latest run of maps includes Raleigh, and Fischer was kind enough to zoom out enough in his mapping to include at least the eastern side of the Bull City. (Click on the image for a larger view.)


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City, County see Aug. votes on hotly debated billboard industry proposal

Billboards  The debate over digital billboards in Durham has been ongoing for over two years now.  

All things in life must end, however -- the billboard debate included.  

Durham's City Council and the Board of County Commissioners will be voting independently on Fairway’s proposed changes to Durham’s sign ordinances at their next meetings, Aug. 2 and Aug. 9 respectively. 

Fairway seeks to allow replacement of all billboards in Durham, with up to one-fourth of these signs being replaced with digital displays that change message every eight seconds.

Next week marks the beginning of the end of that long debate, which has seen warring web sites, opposing results from opinion polls, email campaigns and non-profit lobbying, plus the recently-debated appearance of a little-known City-Wide PAC group in the voting mix.

Will the industry's lobbying effort pay off? Or will a group of residents fighting the mix -- including some of the citizens who first lobbied themselves for a Durham anti-billboard measure in the 80s -- prevail?

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