Excellent FDA Q&A for Patients Regarding Avastin Breast Cancer Withdrawal

Note: This post appeared originally on 18 November 2011 at my Chemical & Engineering News CENtral Science blog, Terra Sigillata. I found the FDA document so useful that I wanted to reproduce the post here for our Take As Directed readers and for my students in the BIOG 5400 – Physiology and Pharmacology class at North Carolina Central University – yes, students, this is required reading!

As reported around the wires today, US FDA Commissioner Dr. Margaret A. Hamburg formally revoked the accelerated approval of the antiangiogenic drug Avastin (bevacizumab) for breast cancer treatment. Avastin is a humanized mouse antibody that binds and inactivates the vascular endothelial growth factor VEGF-A, a mediator of blood vessel growth. Andrew Pollack at The New York Times does a nice job condensing this episode for us.

The highlights are that Avastin was approved based on the surrogate endpoint of progression-free survival in metastatic breast cancer, meaning that it appeared to increase the time from treatment to return of the growth of cancer metastases. However, the true endpoint is long-term patient survival. There, subsequent studies showed that Avastin had no benefit.

Moreover, Avastin also use appears to increase the risk of hemorrhage and bowel perforation. These are potentially life-threatening side effects and are considered too great of a risk when no statistical benefit of survival or quality of life are apparent.


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Category: Cancer, Clinical Trials, Drug Safety, Pharmaceuticals, Toxicology | 1 Comment

Scientist copy-checking: Point-counterpoint at the Guardian

Should science journalists solicit scientist sources to fact-check article content prior to publication? Or do scientists have no more right to do so than, say, politicians previewing the latest criticism of their policies.

"Just try fact-checking with me, pal." The legendary Helen Thomas. Credit: helenthomas.org

I have to admit that I had not quite anticipated the magnitude of interest in these questions when I first wrote about the topic in late September. I had been watching an episode of Vincent Racaniello’s excellent netcast, This Week in Virology (TWiV), from the the International Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The first 35 minutes saw Vincent and Rich Condit turn the tables to interview Chicago Tribune science and medical reporter, Trine Tsouderos. Trine is perhaps best-known of late for her coverage of the faulty link between XMRV and chronic fatigue syndrome as well as the suspension of Dr. Mark Geier, a physician using a chemical castration drug to treat people with autism.

Trine mentioned in the interview that she often runs passages of complex science from her articles past the scientists she had interviewed for the piece. She doesn’t do so for approval or in any way to affect the tone of her writing but rather to be sure that she has interpreted the scientific findings accurate (my words, not hers).


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Category: Journalism, Science Journalism, Shameless Self-Promotion | 5 Comments

University milestone dashed by distant copy editing

My university just received approval to launch its first PhD program in almost 50 years. Neil Offen of the Durham (NC) Herald-Sun wrote a really nice article on this milestone, one of enough importance locally to garner the top of page one. However, the copy editor indicated in the header that the new PhD program was at the much larger system university 25 miles to the southeast, in a county not even listed above in the coverage area.

NC State and NC Central are not the same university.

How could this happen when there are only two universities and one community college in the city of Durham, NC?

Back in August, the owner of our local newspaper decided to move copy editing over 600 miles away to the Owensboro (Kentucky) Messenger-Inquirer. When this came down, friend of the blog and former Herald-Sun reporter Ginny Skal gave a personal perspective on this increasingly common trend in the newspaper industry to cut costs.

I don’t blame the Herald-Sun staff at all. I assume that they sent out a perfectly accurate header with “NC Central University” and it was “corrected” by a Kentucky-based editor who had only ever heard of NC State.

A minor issue, you might say. But at my university I’m certain that many would like to proudly display the frontpage news of our major accomplishment, one that university researchers and administrators have been working toward for over ten years.

Well, at least Photoshop allows one to easily remove the errant header.

I guess that’s worth eliminating some local jobs.

Addendum (10 October, 7:30 am):  Former newspaper man R.L. Bynum alerted me to two posts he wrote recently at his Running Tar Heel blog a few months ago on moving copy-desk and design responsibilities off-site.

From July, a review of the unfortunate metastasis of this phenomenon:
Off-site copy desks: A bad idea that keeps spreading

From September, some examples that are afflicting the Raleigh News & Observer: It really should be called the Charlotte N&O

Thanks for the tips, R.L.

Category: Academia, Journalism, North Carolina | 6 Comments

What’s the difference between HeLa and HeLa S3 cells? Part I: Launching the lab

With this entry, I’m reposting a three-part series that I first wrote back in March 2009 at the former ScienceBlogs home of my original blog, Terra Sigillata. The impetus for this repost was the lovely pleasure I had this past week of speaking at the College of Health and Human Services of the University of North Carolina at Charlotte. My visit with faculty, students, and folks from the local community reminded me that I hadn’t moved this story over to Take As Directed. For those of you who visited with me at UNC-Charlotte, this is the expansion of the story I began on the Colorado connection with HeLa cells – for others, my wish is that you still find it interesting.

Dr. Florence Rena Sabin


When I first started my independent academic laboratory in 1992, it was in a brand new facility across the parking lot from a then 40-year-old building named in honor of the woman to the right. I took on a big teaching load from day one and while I had some cash left from the $50,000 start-up package, I didn’t hire a technician immediately. So it fell upon me to do all the ordering of the basic supplies to get the operation rolling. No problem, right? I ordered much of my own stuff as a postdoc so it should be no problem to get everything I need to start the lab from scratch.

One of the most common buffers used in molecular and cell biology labs is “Tris,” short for a base called tris(hydroxymethyl)aminomethane. By adding different amounts of hydrochloric acid to it, you can create buffers from pH 6.8 to pH 9 so it’s pretty versatile.

So, I opened the old Sigma catalog (this was when companies were only just starting to get their catalogs online). There were five varieties of Tris and nine varieties of Trizma®, Sigma’s brand of Tris base (there are now six and 15, respectively).

So which do I order? The ACS reagent grade >99.8%, the JIS special grade >99% or do I go for the BioUltra Trizma?

But the Bioultra Trizma comes in two forms, one for molecular biology and another for luminescence. I definitely needed a molecular biology grade tested RNase-free that I could also use for cell culture.

Hmmm, how ’bout the “Biotechnology Performance Certified, meets EP, USP testing specifications, cell culture tested, ≥99.9% (titration).”

And so, for each chemical I needed to start the lab I had to go through and evaluate why I needed one form over another, and what the difference was between all of the terminology.

When it came time to bring in the cultured cell lines for my work, I decided that I was going to start all of my cultures from an original, traceable stock obtained directly from a cell repository instead of the more common practice of soliciting colleagues around campus for hand-me-downs of their established lines. You never know where someone’s cells have been, how long they might have been passaged, whether they have been cross contaminated, or if they have latent mycoplasma infections.

The 2010 best-selling book by Rebecca Skloot.


So I knew I needed HeLa cells – those ones we’re hearing all about these days from Rebecca Skloot’s New York Times-bestselling book, The Immortal Life of Henrietta Lacks, about the 31-year-old rural black woman whose cervical carcinoma gave rise to the first immortalized human cell line.

The two most common vendors for original cell culture stock are the American Type Culture Collection (ATCC) and the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ), or German Collection of Microorganisms and Cell Cultures. There are others, including major national research institutes, and dozens of other vendors have modified cells for a variety of specialized uses.

ATCC is a private, non-profit organization that traces its roots back to 1925 when scientists realized a need for a central laboratory that distributed certified strains of microorganisms. If you isolate your own cell line that you wish to make available to the scientific community, you can deposit it with ATCC and they will handle requests for it from other investigators, using sales fees to support their operation.

Not only does ATCC serve as a central repository but it also contributes to the continuity of the biomedical research enterprise. I had a physician-scientist colleague a few years back who was closing his research lab and moving to private oncology practice. But he had developed a series of drug-resistant clonal populations of two, common human leukemia lines. These are very useful cells for investigating why cancer cells develop tolerance to drug therapy but since there would be no one left to distribute them, he deposited them with ATCC (example).

OK, so back to 1992: I open the ATCC catalog (again, before it was online) and, hmm, you’ve got HeLa cells (catalog designation CCL-2). Great. Let’s order ‘em up.

But then there are also HeLa 229 (CCL-2.1), and HeLa S3 (CCL-2.2).

Hrumph. I just want some freakin’ HeLa cells – what’s up with these other ones? They all kind of look the same, all from the same woman, all grown in the same medium.

So what the difference?

In her Los Angeles Times interview last month, Skloot remarked that the Lacks book began with a manuscript she was planning to meet the requirements of her MFA at the University of Pittsburgh:

“I was in class, and I got out a piece of paper and I wrote at the top ‘Forgotten Women in Science,’ ” she remembers. She planned to do 12 essays. “Number 1, I wrote Henrietta Lacks, and then I was like, hmmm.”

So over a series of posts this weekend, I wish to tell you about a woman in science indirectly related to HeLa cells. She may not necessarily qualify as a “forgotten woman of science” but her story is perhaps not well-appreciated today because her contributions occurred so long ago.

Florence Rena Sabin, MD (1871 – 1953), a daughter of a Colorado coal mining family, became a female pioneer in medicine and public health. With the simple notation of “S3″ she is forever linked to the first clonal population of these cervical cancer cells from the poor Virginia tobacco farmer.

Image credit: Sabin color portrait from Women in the Rockefeller Archive Center

Category: Cancer, HeLa, History, REPOST | 1 Comment

How do scientists view fact-checking by science writers?

Many thanks to Columbia University virologist and science communicator Vincent Racaniello for providing great blog fodder last week in his This Week in Virology interview with Chicago Tribune science writer Trine Tsouderos. For those who didn’t follow the discussion last week, Trine spoke of her approach to fact-checking her work published at the Tribune by running content past the scientist sources cited therein. (Thanks also to Dr. Racaniello for selecting the post as his weekly pick.)

I have to admit to a certain degree of humble pride that our discussion about journalist fact-checking of science writing drew such widespread attention. The comment thread reads like a Who’s Who of science writing – to avoid the risk of leaving anyone out, just take a scroll through the comment thread and click on a few of the commenters’ URLs.

Thank you to all of you practicing writers for your contributions. I plan to distill and arrange the discussion in some other format that’s more readable than the nested format of blog comment threads. Many thanks also to James Hrynyshyn and Maryn McKenna for suggesting that we pitch a session on this topic for the upcoming ScienceOnline2012 unconference here in North Carolina in January.

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Category: Academia, Science Journalism | 33 Comments

Trine Tsouderos on This Week in Virology: When do you fact-check article content with sources?

I have long been a fan of Columbia University virologist, Dr. Vincent Racaniello. Vincent is an outstanding scientist who has also worked extensively make virology accessible to students with his own textbook and the award-winning Virology blog. For me, one of the best offshoot features of the blog has been his weekly podcast with Dick Despommier, This Week in Virology (TWiV).

This past week, TWiV Episode 149, spent the first 35 minutes or so interviewing Chicago Tribune science and medical writer, Trine Tsouderos, while at the International Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in the Windy City. Because the netcast was held at the meeting, Vincent and the gang put together a very nice video of their panel discussion:

I’ve admired the writing of Trine Tsouderos for the last few years (you’ll learn that she is Norwegian-Greek and that her name is pronounced TREE-na soo-DARE-ose), particularly on the anti-vaccination movement and the questionable association of XMRV with chronic fatigue syndrome. I also learned some exciting homeboy things about her from the interview such as her undergraduate education at UNC-Chapel Hill in international studies, her taking organic chemistry for fun while she struggled with wanting to be a writer vs. go to medical school, and her first job covering minority and rural infectious disease issues in Wilson, North Carolina.

But what got a Twitter discussion going last night and this morning was Trine’s discussing her practice of sometimes running quotes, paragraphs, and even full articles past scientists she’s interviewed for fact-checking purposes. Particularly in cases where she is interviewing someone about complex original research literature, she expressed her motivation as the desire to get it right “because you can’t retract 300,000 newspapers.” (Trine, please correct me if I misrepresented what you said.)

The relevant section begins around 12:55 of the interview and runs through about 16:30 (but please do listen to the whole episode when you get a chance.).

She acknowledged that this is often a no-no in science reporting but I’ve now heard on Twitter from revered science journalists like John Rennie, Scott Hensley, and Maryn McKenna that some special cases may warrant such fact-checking and is often a sign of thoroughness. But Scott Hensley issued the cautionary tweet that, “Checking facts is 1 thing. Deputizing source as editor is another.”

Well, the response to this little Twitter banter leads me to think it may be valuable to bring the discussion out to more than 140-character bursts. For example, I know that Maggie Koerth-Baker, Science Editor at BoingBoing, has proposed a ScienceOnline2012 session on the problem of journalists growing too close to their sources as stimulated by her reading of the book, Wrong.

So, my dear professional science and health journalist friends: how do you negotiate this slope of prospectively sharing article content with scientist sources?

Please feel free to use more than 140 characters in your comments below.

Category: Journalists, Awesome, Science Journalism, Stuff I Don't Know About | 128 Comments

HeLa High!

Just got some terrific news from Renee Coale, a Washington (state)-based friend and personal assistant to author Rebecca Skloot.

Get this: A new health and biosciences high school to be opened in 2013 in Vancouver, Washington will be named after Henrietta Lacks!

“It is such an honor to name our new school after a person who so impacted the world of medicine and science,” said school board member Victoria Bradford, who also served on the naming committee. “It is also a privilege to be the first organization to publicly memorialize Henrietta Lacks by naming this school building after her.”

The Henrietta Lacks Health and Bioscience High School will be known informally as HeLa High. The name was a unanimous choice out of three options considered by the Evergreen Public Schools’ Board of Directors.

Vancouver is just across the state border from Portland, Oregon.

This is so full of awesome.

Now to consider the name of the school’s mascot. . .

Category: Awesomesauce, Civil Rights, Race in Science and Society | 2 Comments

Personal reflections on a September 11 hero

Here is why I will always remember.

Originally posted on 11 September 2006 at Terra Sigillata on ScienceBlogs.

wtcgriff.jpg

Let me tell you about John Michael Griffin, Jr.

Griff, as he was known in high school, was a friend of mine.

Late in the first half of our lives, he stood up for me physically and philosophically, for being a science geek. John’s endorsement was the first time I was ever deemed cool for wanting to be a scientist.

Griff died an engineer and hero in the collapse of one of the World Trade Center towers [ten] years ago today.

We lost touch almost twenty years before, but his kindness and friendship formed not only one of the cornerstones of the scientific life I have today, but in the person and father I have become as well.

—–

At a northern New Jersey Catholic high school in a predominantly Irish town, being a gangly Polish boy from two towns over was not the formula to cultivate one’s popularity or self-preservation.

Throwing the curve in biology and chemistry classes didn’t help either, nor did being a David Bowie fan in a place where Bruce Springsteen was as revered as St. Patrick. That’s probably where the nickname, “Zowie,” came from – the name of the glam rocker’s first child.

Worse, I had skipped a grade in elementary school, and being a year behind physically was not compatible with self-preservation during high school gym class.

But, it was a very simple gesture, sometime in junior year, when one of the packs of scoundrels had me cornered, slamming me against the wall and throwing my books down the hallway. I believe that the offense was that our biology teacher had taken to buying me a Pepsi everytime I scored 100 on one of his exams, and I had been enjoying yet another one.

John, already well on his way to his adult height of 6′ 7″ or 6′ 8″, stepped in and said, “Hey, lay off of Zowie. He’s goin’ places.” And with that, the beatings stopped.

I didn’t play sports, at least not any of the ones offered by our school. At that time, soccer hadn’t taken off in the States but I was a huge player and had met John at Giants Stadium in the NJ Meadowlands where I had season tickets (Section 113, row 7, seat 26) for the relocated New York Cosmos. At just $4 a ticket for kids 16 and under, I could afford season tickets to see some of the greatest international soccer stars of the late 20th century: Germany’s Franz Beckenbauer, Italy’s Giorgio Chinaglia, Yugoslavia’s Vladislav Bogiçeviç, and, of course, Brazil’s great Pelé.

All accounts of John as an adult include his devotion to the Giants, NY Rangers, and NY Yankees, but few recall those soccer days. John’s family were long-time Giants season ticket holders and probably got their Cosmos season tickets three rows behind me as some sort of promotional giveaway. I recall that John was surprised that a science dork such as I would be cool enough to know about soccer and come to games myself, my father dropping me off outside the gates so he could go home and watch his beloved football games.

But, we Jersey boys loved soccer at a school where American football and basketball reigned supreme. Many Saturday and Sunday afternoons were spent at the massive stadium during soccer’s American heyday of the late 1970s, with crowds of 50,000 to 75,000 that have yet to be matched today.

—–

Among John’s gifts was the ability to make anything fun and to make anyone laugh. I recall sitting with him in a ski lodge in Amsterdam, NY, as I was recovering from frostbite during an ill-prepared class trip ski weekend. He pulled me into an imaginary board game with a napkin dispenser, where he pretended each napkin contained a message as to how to proceed during each turn. We looked at each other in horror when the waitress came unannounced and cleared our table of the napkins.

As a teenager, John was a physical caricature, handsome but a goof, self-effacing but self-confident, and had a clever and caustic wit, both of which he carried into adult professional life and fatherhood. His 15 Sept 2001 missing notice in the Bergen (NJ) Record noted that schoolkids called him, “Barney,” to reflect how they flocked to his presence.

No one was safe from John’s good-hearted and bombastic comedy routines. My father was nicknamed, “Groucho,” by John due to the resemblance of his thick mustache to that of the 1930′s comedian – John would burst spontaneously into seemingly classic Marx Brothers riffs, but with the content imitating my father carrying on about some printing press mishap.

From Class of 1981, St. Mary's High School, Rutherford, NJ: Clockwise from John with cap in the foreground: Kevin Tormey, Joe McGuire, Matt DiTomasso, Walter Marlowe (valedictorian), Benn O'Hara. Taken at my boyhood home in Wallington on the afternoon between Communion breakfast and evening graduation ceremonies.

My last remembrances of John are half a life away, from the impromptu high school graduation party he called at my house to his pride at finishing his engineering degree and managing facilities for a million-square foot building in Manhattan.

Perhaps he protected me as a kid because he knew that way deep down, he was destined to become an engineering geek himself. And a hero, a much bigger hero, in protecting the lives of others in a very real way.

—–

On the glorious fall morning of 11 Sept 2001, I was fixing coffee for my wife who had been sleeping in when the newsreader on my pager announced that a jet had struck the south tower of the World Trade Center.

I had missed my recent 20-year high school reunion and had not known that John had only months before been appointed director of operations at the WTC by Larry Silverstein’s, Silverstein Properties.

I did not learn until two weeks later that John had facilitated the escape of dozens of workers, handing out wet towels so people could breathe on their way down the stairs. In the 102 Minutes book by New York Times writers Jim Lynch and Kevin Flynn, John is immortalized in the corroborated account of the elevator rescue of 72-year-old Port Authority construction inspector, Tony Savas.

When he returned to 78, Greg Trapp saw a group of three Port Authority employees at work on the doors to the elevator where Tony Savas, a seventy-two-year-old structural inspector, was trapped. Trapp peered into the small gap and saw him, a man with thinning white hair, seemingly serene. One of the workers grabbed a metal easel, wedging the legs into the opening, trying to spread the doors from the bottom, where they seemed to have the greatest leverage. But their efforts had the opposite effect at the top of the doors, which seemed to pinch tighter.

At that moment, John Griffin, who had recently started as the trade center’s director of operations, came over to the elevator bank. At six feet, eight inches tall, Griffin had no problem reaching the top of the door to apply pressure as the others pushed from the bottom. The doors popped apart. Out came Savas, who seemed surprised to find Griffin, his new boss, involved in the rescue. Savas seemed exhilarated, possessed of a sudden burst of energy, rubbing his hands together, or so it seemed to Trapp.

“Okay,” Savas said. “What do you need me to do?”

One of the Port Authority workers shook his head. “We just got you out-you need to leave the building.”

No, Savas insisted. He wanted to help. “I’ve got a second wind.”

John and Mr. Savas stayed behind.

John’s wife, June, sweetheart of the class behind us, was quoted in John’s NYT, Portraits of Grief:

“He was at the back of about 30 people they were evacuating,” his wife, June Griffin, related from the accounts of survivors. “He had been in fires before — he should have gotten out.”

Mrs. Griffin speculated that her husband, instead of running for the exits, headed for the fire control center, where his training as a fire safety officer would have directed him. “He was an engineer,” Mrs. Griffin said. “He must have thought, ‘Buildings don’t just fall down.’”

John also left two daughters, both now teenagers, his parents, a younger brother and older sister, and literally hundreds of friends.

Not just any friends, either – anyone who knew John still says that when he talked with you, it was as though you were the most important person in the world.

—–

Leaving New Jersey in the mid-1980s and running on the tenure-track treadmill 1,600 miles away caused me to stop living life and lose track of a great many friends. I am deeply saddened not to have known John as an adult, a devoted husband and, by all accounts, a remarkable father.

Since John’s death, we’ve all found a little more time in our schedules to make time for one another. As the father of a little girl conceived in the months after the terrorist attacks, I try to respect June’s privacy and just send little gifts for the girls every so often. I cannot imagine how they and nearly 3,000 other families deal privately with the most public of tragedies.

I finally worked up the guts to go to Ground Zero [five years and] two months ago for the first time. Despite all the bickering about what the memorial should look like, there is a small memorial area set up in the interim. John’s name sits at the top of one column of names on the placards commemorating those lost.

He’ll always be at the top of my list.

John's wife, June, put up this as her Facebook profile photo for the 2010 anniversary.

Many thanks go also to Dr. David Ng at the University of British Columbia in Vancouver for asking permission to reprint his expertly edited version of this post at The Science Creative Quarterly.

And a personal note from June as it appears on Facebook today:

I want to thank everyone for their thoughts and prayers this weekend. It has been quite rough , so it is much appreciated. What would really help is if you posted a happy or funny memory of John (Griff) It is better for us to celebrate his life then to be dwell on his horrific death. There is NO way we can every forget that, so we want to choose to remember the happy times! I think that would would make us smile. Thank you!

So, if you ever knew Griff, leave a happy memory here. I can tell you that there are a billion of ‘em.

Category: Free-Range Writing, New Jersey, Personal | 1 Comment

The inescapable reminder

I may be just as guilty as the mainstream media but here goes…

I’ll have my annual September 11th repost up on Sunday. But I learned the other day just how painful this week is for families of victims of the 9/11 terrorist attacks. The abrupt loss of a loved one is the most personal of tragedies.

Yet for 9/11 families, they have to relive their losses annually – or even more often when politicians and policymakers point to the date of their loss for whatever initiative they’re promoting at the time.

The most personal of tragedies – suffered under the most public of circumstances – again and again. How many of us repeatedly are forced to witness images of events knowing that our loved one is being crushed or incinerated at that very moment? My fingers are shaking even as I write these words.

These past two weeks have been particularly difficult to people I know from my home county in New Jersey. I want you to know that I am thinking of you.

But, then again, I hope you are not reading. I should have been one less voice reminding you of what needs no reminding.

Category: New Jersey, Personal | Tagged , , , , | 1 Comment

Stetson Kennedy, 94 – Florida folklorist, Klan-buster, and all-around thorn in the side of the rich and the racist

Stetson Kennedy (right) at his Beluthahatchee home in Fruit Cove, Florida, with the author following the launch of the Stetson Kennedy Foundation, 30 January 2006. Credit: Jill Bowen

On Saturday morning, a force as strong as this weekend’s hurricane left us for good. Stetson Kennedy, the folklorist and writer best known by my generation from Freakonomics and the Billy Bragg/Wilco adaptation of Woody Guthrie lyrics, died Saturday morning at Baptist Medical Center South in Jacksonville, Florida. He would have been 95 on October 5th.

Charlie Patton’s article in The St. Augustine Record and Jeff Klinkenberg’s reflections in the St. Petersburg Times are the best places to learn more.

A Jacksonville native who took a writing course from Marjorie Kinnan Rawlings at the University of Florida in the mid-1930s, Stetson left college during the Depression to capture Florida folklore for the Works Progress Administration – he *was* StoryCorps before there was a StoryCorps. Traveling with author, Zora Neale Hurston, they recorded stories and Negro spirituals from the oppressive turpentine camps in the north to the Bahamian and Cuban communities in the far south at Key West.

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Category: GoodPeople, I Can't Believe My Life Happens to Me, Race in Science and Society, REPOST | 3 Comments