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Related Articles - Conflict at New England Journal of Medicine

Boston Globe Saturday December 27, 1997- front page Web Version

Medical journal is hit by another conflict

By Larry Tye, Globe Staff, 12/27/97

The prestigious New England Journal of Medicine, which has a conflict-of-interest policy that its editor calls ''the tightest in the business,'' is again having to explain how that policy went askew.

The trouble this time was a review in last month's journal that panned a book alleging that environmental chemicals are fueling an epidemic of cancers. The reviewer was the medical director at chemical giant W.R. Grace & Co., but readers were not told that.

''We should have recognized that W.R. Grace was a conflict of interest, but unfortunately the person who handled it didn't recognize that,'' Dr. Jerome P. Kassirer, the journal's editor-in-chief, said yesterday. ''They didn't put together that W.R. Grace was a major chemical company.

'There will be a complete explanation in the journal in the next three to four weeks,'' he added.

The error might have aroused little interest if the New England Journal was not the world's most esteemed medical publication - and if similar lapses had not happened before.

In 1989 the journal ran an article downplaying the risks from environmental exposure to asbestos, but failed to note the authors' past ties to asbestos makers. The following year the journal toughened its policy to say that, rather than simply requiring authors to disclose potential conflicts, it would not accept reviews or editorials from anyone connected to firms with a financial stake in the drug or device being discussed.

But last year, the journal ran an editorial saying that the benefits of diet drugs outweigh the risks. It failed to note that the two authors had been paid consultants for firms that made or marketed one of those drugs, Redux. Journal editors, in a long editorial two months later, apologized, said they were making their conflict-of-interest policy even stricter, and urged other journals to do the same. Redux, meanwhile, had so many safety woes that its manufacturers recently pulled it off the market.

Given that history, how could another embarrassing conflict develop?

Dr. Jerry H. Berke, author of last month's book review, said journal editors ''knew my affiliation. I signed a conflict-of-interest statement which is required of all writers if anything is written for the journal, and I listed my affiliation with W.R. Grace.''

Early drafts of the review included his Grace affiliation, Berke added, but ''at the very last minute I decided to list myself as independent. ... The folks at Grace wanted to be certain I was writing my own opinion. ... I wasn't trying to be cute or duplicitous or anything.''

Another consideration in leaving out his ties to Grace, Berke said, was that he had decided to leave the company, where he was director of medicine and toxicology, and launch his own consulting business.

Kassirer said ''it's laughable that Berke would think he could write an objective review of the book given that he was an employee of W.R. Grace. ... He should never have agreed to do the book report. ... We have a statement from him that he had no conflict of interest.''

But the editor-in-chief also acknowledged that his journal failed to do its job of recognizing that conflict and canceling the review. ''Our conflict-of-interest policy is pretty tight, the tightest in the business,'' he said. ''Unfortunately in this case we didn't recognize the conflict. It was a simple oversight.''

Others, however, say the case is more complicated than that.

Berke says his review drew the ire of environmentalists less because of his alleged conflict of interest than because the review argues that chemical residues, pesticides, and other environmental contaminants are not responsible for rising cancer rates. He also says that W.R. Grace is an easy target these days, given the filming of the movie ''A Civil Action,'' which depicts the chemical company as a source of deadly contaminants in Woburn's drinking water.

Paul Brodeur, a journalist and novelist who has written extensively about environmental contaminants and has helped fan concerns about Berke's review, sees the issues very differently. Berke, he said, advanced a ''specious argument'' on the causes of cancer. Of more concern, Brodeur added, is ''a pattern at the New England Journal of deciding willfully and I think supremely arrogantly that they're not going to acknowledge a conflict of interest.

''I think there's an infection at the New England Journal that is badly in need of treatment.''

Kassirer, meanwhile, said that Berke's article ''was a rational book review'' but should not have run because of his association with W.R. Grace. And while he defended the journal's policy on conflicts of interest, he added that ''what we now are going to do is be more vigilant about affiliations.'' This story ran on page A01 of the Boston Globe on 12/27/97. © Copyright 1997 Globe Newspaper Company.


Providence Journal Bulletin Dec 24, 1997 Front page by Peter B. Lord

Negative book review raises questions of conflict

The reviewer of a book linking chemicals and cancer works for a chemical company, a fact that was not revealed when the review was published.

By PETER B. LORD Journal-Bulletin Staff Writer

How important is one negative book review?

A recent review in a prestigious medical journal has triggered a national controversy surrounding a book just published by Sandra Steingraber, a Boston-based ecologist, poet and cancer survivor.

Steingraber's book, Living Downstream: An Ecologist Looks at Cancer and the Environment , argues that there is a strong relationship between increasing cancer rates and manmade chemicals in the environment. It has received good reviews around the country.

But the New England Journal of Medicine, the country's most authoritative medical journal, panned the book several weeks ago, saying it was filled with ``oversights and simplifications.''

At first, it was one negative opinion in a sea of support from other reviewers.

But recently critics discovered that the reviewer, identified in the Journal of Medicine only as Jerry H. Berke, M.D., of Acton, Mass., is a senior scientist working for W.R. Grace, a major chemical company known in Massachusetts as the company that contaminated the Woburn water system with industrial chemicals -- an incident that became the subject of a best-selling book, A Civil Action, and soon will be featured in a movie starring John Travolta.

Word of Berke's background, initially spread on the World Wide Web, caused doctors, researchers and others to besiege the Journal of Medicine last week with angry charges of conflict of interest.

Steingraber says the credibility of both the Journal of Medicine and the medical community is at stake.

``The general reading public, including me, takes it very seriously when the Journal publishes something. I think this is symptomatic of a larger collusion betweeen industry and medicine, and if they can take hold in the Journal, what else can they do?''

Berke says the Journal knew of his relationship with Grace, but omitted it because ``some functionary'' made a mistake. ``I guess I can't win here,'' he said in an interview Monday. ``People will question my integrity and react that my view is poisoned, or in some ways tainted. But I stand by my review.''

BEYOND THE REVIEW loom more basic issues.

Why are so many Americans stricken with cancer? Are we killing ourselves with our overindulgent lifestyles -- our smoking and overeating? Or is big business and agriculture doing it to us with their heavy reliance on chemicals and pesticides?

Does a scientist lose his credibility just because he works for business? And do environmental activists get too much attention because the press automatically believes they are the ``good guys?''

Earlier this week the Journal said it wouldn't comment.

But after several inquiries from the Journal-Bulletin, Dr. Robert S. Schwartz, who edits the magazine's book reviews, announced he was accepting responsibility for what he described as an ``administrative error.''

``I assure you with all Christmas spirit that there was nothing nefarious about this,'' Schwartz said. He said the magazine had forms identifying Berke's background, but he didn't see them before sending the book to Berke for review. ``I made a mistake.''

Schwartz said he hoped that within a few weeks the Journal would publish one of the many letters criticizing its omission of Berke's employer, and also print explanations from himself and Berke.

``Let me assure you we are taking this seriously,'' Schwartz said. ``And we want to get this behind us.''

STEINGRABER WAS on a book tour in Texas last month when she first heard of the bad review. The first printing of 15,000 copies was already gone and a second printing was under way.

The book opens with the story of cancers in her adoptive family in rural Illinois, and goes on to discuss her own diagnosis of bladder cancer at age 20. She then describes the soup of pesticides and other chemicals prevalent both in rural areas and along industrialized river banks.

Steingraber argues with some passion that Americans are being forced to assume ``frightening cancer risks, without our consent or knowledge, that others decided on our behalf are acceptable.''

Four out of every 10 people living will be diagnosed with cancer, she says.

Diets high in animal fats are often blamed for high cancer rates, she says. But those fats are collectors of pesticides, dioxins and industrial contaminants that never should be allowed in the food chain in the first place.

Reviews in newspapers and magazines around the country have been good. ``Steingraber writes with the authority of a biologist and the imagination of a poet,'' said The Nation. The Chicago Tribune said the book should trigger a ``national discussion about what strategies we should implement to guarantee a healthful environment.''

The Washington Post concluded that while Steingraber fell short of proving her case, her book is ``well worth reading.''

When the New England Journal of Medicine review came out, Steingraber said she was slightly suspicious because of the hundreds of studies cited in her book, the reviewer focused on one, which was retracted shortly after the book went to press.

``That just stuck in my mind,'' Steingraber said this week. ``It felt like a bad-faith attempt to discredit my book. But I never suspected he was an employee of a chemical company that I had written about in my book.''

LAST WEEK, Steingraber was visiting some physicians and environmentalists in Vermont when she heard about ``the letter.''

Paul Brodeur, a retired writer for The New Yorker who has written several books about the hazards of asbestos and electromagnetic fields, and Bill Ravanesi, a Boston-based producer and editor, revealed Berke's identity in an essay entitled ``Can the New England Journal of Medicine be up to the same old and long discredited tricks?'' and dispersed it on the Internet.

Ravanesi said he was drawn to the issue by a friend who read the book review and was so incensed he did a computer search to find out who the author was. Ravanesi and Brodeur took it from there, sending their essay out over the Internet.

The two cited studies supporting Steingraber's thesis that environmental factors might be involved in increases of many types of cancer.

(The American Cancer Society had no one available to comment on the fracas yesterday; its national staff was out for the holiday.)

They pointed out that Berke's employer was described in the bestseller A Civil Action , as the company responsible for contaminating the drinking water supplies of Woburn, Mass.

And they contended the Journal has had trouble in the past with authors who have had conflicts of interest.

``Without a doubt, this is the most prestigious medical journal in the nation, and one of two or three [of the most prestigious] in the world,'' said Brodeur from his home in San Diego. ``And they obviously haven't learned anything about conflict of interest. But even more telling than that is the extraordinary arrogance. When queried about it, they lie to [Steingraber].''

Steingraber says Schwartz told her repeatedly last week that he didn't know who Berke worked for and he wouldn't have sent him the book if he did know.

Schwartz, in an interview with the Journal-Bulletin Monday, repeated what he had told Steingraber.

``There was no hidden agenda of any kind here,'' he said. ``This was totally against our policy. We made a mistake.''

Schwartz said Berke had signed a conflict of interest statement showing his affiliation with Grace. But Schwartz wasn't aware of it.

Berke said that he wasn't paid for the review. ``I volunteered to do it because I'm a member of the Massachusetts Medical Society and it was a prestigious appointment.''

He said he relates to Steingraber and enjoyed her writing style. But he believes serious scientists disregard much of what she says.

``We share a common background,'' Berke said. ``I grew up in Illinois as well. She describes a landscape corrupted by chemical pesticides and fertilizers and I related to that.

``But her book is not a balanced view of cancer and the environment. She talks in great length about the relationship between breast cancer and the environment, but very little about its connection to high-fat diets and obesity. It's a very emotional book, but there's no balance.''

Copyright © 1997 The Providence Journal Company


Toronto Star, Sunday Dec 21, 1997 page A2 by Michele Landsberg

"Famed journal's objectivity gets a black eye"

THE NEW England Journal of Medicine is possibly the most prestigious medical journal in North America. The fact that it has been caught out in publishing a book review whose author is in a clear conflict of interest strikes me as a serious cause for alarm.

Sadly, however, it is not a surprise. ''Those editors wouldn't recognize a conflict of interest if one jumped up and bit them on the nose," exclaimed the distinguished investigative journalist and author, Paul Brodeur, in a telephone interview. ''You can quote me on that."

Brodeur and fellow investigator Bill Ravanesi have just written a stinging critique of the book review in question. The book under attack in the journal was Sandra Steingraber's Living Downstream, An Ecologist Looks At Cancer And The Environment.

Now in its second printing, Steingraber's work has been glowingly reviewed almost everywhere. It's a powerful, moving and intensely readable discussion - likened by many to the ground-breaking book Silent Spring by Rachel Carson - of the possible links between environmental toxins and the rising incidence of cancer.

The book was scathingly denounced as ''biased" and ''obsessed with pollution" in the Nov. 20 issue of the New England Journal of Medicine. The reviewer, who signed himself ''Jerry H. Berke, M.D., MPH," called it a ''polemic" whose objective is sheer ''controversy." He condescendingly expressed ''sadness" that the author wrote from the perspective of a ''victim." (Steingraber, who has a doctorate in biology, survived bladder cancer in her early 20s.)

Berke insists Steingraber's analysis is ''not supported by serious scientific analysis," and that cancer is - implausibly enough - ''entirely explained by known factors" such as better diagnosis, longer life spans, cigarette smoking and AIDS.

The one thing Dr. Berke didn't get around to mentioning is that he is the chief of medicine and toxicology for the W. R. Grace Co., one of the largest chemical manufacturers in the U.S.

If you've read the best-selling non-fiction work A Civil Action, you'll be familiar with W. R. Grace's role in contaminating the drinking water in Woburn, Mass. The company paid $8 million U.S. to settle claims brought by seven local families whose children developed leukemia after drinking the contaminated water.

W. R. Grace also pleaded guilty on two felony counts of lying to the Environmental Protection Agency about the dumped chemicals, and paid a $10,000 U.S. fine. W. R. Grace is also a leading manufacturer of asbestos-containing building products, has been the defendant in thousands of lawsuits, and paid out millions in damages, according to writers Brodeur and Ravanesi, both of whom have documented the asbestos scandal.

Should the director of medicine and toxicology for such a company have been asked to review a book that argues there are links between environmental pollution and cancer?

''Obviously, it was an unacceptable conflict of interest," admitted the New England Journal of Medicine's book review editor, Dr. Robert Schwartz, in response to my inquiry. Schwartz claimed the journal knew nothing of Berke's affiliations.

But the journal's protestations of innocence smell something like the fish in Boston harbour to me. After all, Berke was self-identified in the journal's own pages - within the last two years - as an employee of W. R. Grace. The journal might have a more plausible case if the same sort of kerfuffle hadn't erupted on several previous occasions.

Last year, the journal published an editorial endorsing the diet drug Redux. The value of Redux stocks zoomed by 13 per cent in one day, reports Ravanesi. The drug proved dangerous and has now been removed from the market. And it was revealed that of the two doctors who wrote the enthusiastic editorial, one was a paid consultant for the maker of Redux and one was paid by the marketer.

The headline of a harshly critical editorial in the Boston Globe asked: ''Malpractice at a medical journal?"

In that case, too, the journal tried to excuse itself by saying it didn't know of the doctors' financial stake in the drug. And, just as in the case of Dr. Berke, that excuse didn't wash because the journal itself had earlier identified one of the doctors as being affiliated with the diet drug manufacturer.

''The journal knew of my affiliation with W. R. Grace when they solicited me to do the review," Jerry Berke told me in an interview.

Jolted by the book editor's denial, Berke wrote to the journal this past week that his affiliation with Grace was ''clearly listed on my conflict of interest statement, and finally, all correspondence that has been addressed to me by the New England Journal of Medicine over the past few years has been in care of my office at W. R. Grace." Berke says, ''I asked the journal not to mention it (i.e. the Grace connection) because this is my personal opinion and not the company's."

Berke says he is ''shocked" that his statement of ''a personal vision" should be construed as a conflict of interest. He says that because the review is unpaid, he stands to gain nothing financially. Furthermore, ''It's precisely my years at Grace that have made me an expert in the field," he says.

How bizarre: for Berke, advocacy on behalf of a chemical polluter is ''expertise," but environmental writing like Steingraber's is mere ''bias."

Readers, beware. There's scarcely a medical researcher or spokesperson left who doesn't turn to industry for research funds, fees and retainers. And they still think they're ''objective."

We're on our own, in an environment that's increasingly poisoned.

Our best sources of information, ironically, are those very writers like Sandra Steingraber, who labour against daunting odds including especially dismissive sneers reserved for females. Read their books for yourselves.

{Michele Landsberg's column regularly appears in The Star Saturday and Sunday.}

© Copyright 1997 Toronto Star


Boston Globe, Tuesday, January 6, 1997, Metro/Region

Journal fuels conflict-of-interest debate

By Larry Tye, Globe Staff, 01/06/98

The prestigious New England Journal of Medicine has the toughest conflict-of-interest policy of any science publication - and the toughest to enforce.

Just how difficult has become apparent during the last two weeks.

First, the Journal acknowledged it shouldn't have run a book review downplaying the risks of chemical carcinogens because the review was written by the medical chief at chemical giant W.R. Grace & Co. Since then, however, Journal editors have defended their decision to publish an editorial arguing that environmental estrogens do not cause breast cancer, even though it was written by a researcher who until recently got 20 percent of his funding from a trade group representing firms that produced those estrogens.

Readers weren't told of either author's affiliations.

The two cases are spawning a debate among medical journalists and ethicists nationwide over how to protect the public from conflicts of interest and the distorted judgments they can yield, while at the same time protecting scientists from a political correctness that can stifle the exchange of ideas. At the center of that debate is the Boston-based New England Journal, the world's most esteemed medical publication.

Arthur Caplan, who runs the Center for Bioethics at the University of Pennsylvania, says the controversy is useful if it gets the public to focus on how science is supported and how it sustains its integrity. While tough judgment calls are required, Caplan added, ''I'd rather see us err on the side of picking up on the potential conflict rather than minimizing it.

''Conflict-of-interest standards are the thin blue line of morality,'' he said.

Editors at the New England Journal agree, and say that's why in 1990 they tightened their policy on conflicts of interest. Rather than simply requiring authors to disclose potential conflicts the way other medical publications do, the Journal said it no longer would accept reviews or editorials from anyone connected to firms with a financial stake in the drug or device being discussed.

In November, however, that policy was breached when the New England Journal let Dr. Jerry H. Berke of W.R. Grace review Sandra Steingraber's book, ''Living Downstream: An Ecologist Looks at Cancer and the Environment.'' The Journal recently apologized for the breach, saying that the editor who handled the review inexplicably had not recognized Berke's conflict of interest, and promised to run a ''complete explanation'' in an upcoming issue.

Since then another, less clear-cut case has come to light. In October the Journal editorialized that environmental estrogens like PCBs and DDT are not causing breast cancer. The editorial was written by Stephen H. Safe, a toxicologist at Texas A&M University who for three years had accepted grants of up to $150,000 a year from the Chemical Manufacturers Association.

Was that a conflict?

Safe doesn't think so. He said he didn't tell the Journal about his ties to CMA because he had formed and stated his views on environmental estrogens before accepting CMA funding, had stopped taking industry money five months before his editorial ran, and ''there's hardly any life scientist in the country who hasn't had funding from the industry.''

Still, while he doesn't perceive a problem, he said, ''I can see why people would bring it up.

''I felt a little twinge'' about the potential for a conflict, he added, ''but it was not much of a twinge.''

Dr. Jerome P. Kassirer, the Journal's editor-in-chief, says that while he didn't know about Safe's CMA funding when the editorial ran, that wouldn't have stopped him from publishing it. That's because Safe's funding had stopped several months earlier, he also was getting money from neutral sources like the National Institutes of Health and the US Environmental Protection Agency, and, most important, because CMA funds made up just 20 percent of Safe's research budget.

''You could argue that 20 percent is too much, or $150,000 is too much, but we have to have some cutoff,'' said Kassirer. ''In my perspective Safe doesn't qualify as a case of conflict of interest.''

Others are less sure.

George Annas, professor of health law at Boston University School of Public Health, said that CMA would seem to pose a conflict, and yet ''almost all experts in the field at some point havetaken grant money or an honorarium from someone. It's a very, very difficult area that's fraught with land mines.''

Annas, who writes a column on legal issues for the New England Journal, applauds the publication for going further than any other in guarding against conflicts, but he adds that implementing the policy ''has turned out to be much harder than they thought it would be.''

Dr. George D. Lundberg, editor of the esteemed Journal of the American Medical Association,says the New England Journal has boxed itself in with its all-or-nothing policy banning anyone from writing an editorial who has a potential conflict of interest. JAMA, he explained, is like most other technical journals in letting people with financial stakes write reviews and editorials ''as long as we know about that, and as long as we disclose that to the reader.''

''If we were to eliminate all such people we would be depriving our readers of the knowledge of the best people in the field,'' said Lundberg. ''Our readers are not children. They're physicians, scientists, health policy experts, and medical reporters. They can figure this thing out so long as we give them the information.''

As for Safe's ties to CMA, ''I would see that as a financial disclosure necessary for the author to provide us, and useful for us to provide readers,'' the JAMA editor added, but such ties would not disqualify Safe from writing an editorial.

Even with disclosure, however, there are questions of how much is too much.

Brookline author Eve LaPlante wrote a book in 1993 called ''Seized,'' about temporal lobe epilepsy, that was panned in a May 1994 New England Journal. She is still angry that the Journal never mentioned that the reviewer, Dr. Gregory Bergey, was president of the Maryland chapterof the Epilepsy Foundation of America. The foundation, LaPlante says, ''has made a practice of not publicizing the form of epilepsy my book dealt with ... it's a conflict of interest and, at the very least, I would have liked the Journal to point this out.''

But Bergey, a professor of neurology at the University of Maryland School of Medicine, says there is a point where you can ''go overboard with political correctness.''

This story ran on page B 01 of the Boston Globe on 01/06/98.

© Copyright 1998 Globe Newspaper Company.


Washington Post, Saturday, January 10, 1998; Page A17

News To Me

I am the author of the book "Living Downstream: an Ecologist Looks at Cancer and the Environment," which was criticized harshly in a review published in the November issue of the New England Journal of Medicine. As your paper reported in a Dec. 28 Associated Press news story, the reviewer, Jerry H. Berke, is a senior official at W. R. Grace & Co., a multinational chemical manufacturer. His professional identity was not revealed in the review itself.

The headline of your paper's story, "Medical Journal Apologizes for Ethics Blunder," however, was news to me. I have received no apologies from the New England Journal of Medicine nor even a phone call of explanation.

The question of what the journal editors knew about Berke's corporate  affiliation and when they knew it is not a trivial one. If his employment was not known to the journal, why not? If it was, then why was he assigned my book to review in the first place? Berke's conflict of interest is more than philosophical. Receiving my direct attention in the book are the cluster of childhood cancers in Woburn, Mass., which formed the basis of a famous lawsuit involving W. R. Grace & Co., now the subject of a forthcoming movie.

-- Sandra Steingraber

© Copyright 1998 The Washington Post Company

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