March 14, 2008 9:53 am : Comments 001
Talk about ironies.
Eli Lilly announced yesterday that it has acquired the exclusive worldwide rights to develop and commercialize Transition Therapeutics’ gastrin-based diabetes therapies, which reportedly improve glycemic control in studies. One of these therapies is in early Phase II testing.
The acquisition should be good news for patients who take Eli Lilly’s Zyprexa drug, whose potential side effects apparently include obesity and diabetes. The drugmaker is currently being sued by about 10 states for not properly informing patients of these risks.
That said, Lilly getting the rights to the diabetes treatment seems akin to Philip Morris acquiring the worldwide rights to the cure for lung cancer. You know what they say about covering your bases…
Speaking of Zyprexa lawsuits, if you are interested in some impressive and insightful commentary on one of Lilly’s most recent PR gaffes — issuing one of the more dubious news releases I’ve ever seen — I highly recommend you check out this website.
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March 6, 2008 1:20 pm : Comments 001
Eli Lilly and its Zyprexa legal woes have hit the road. The Indianapolis-based company and its lawyers are in Alaska, defending against charges of improper marketing of its aforementioned blockbuster schizophrenia drug.
The State of Alaska has filed suit against Eli Lilly, contending that the drugmaker inappropriately downplayed Zyprexa’s health risks and should now be held responsible for the medical expenses of in-state Medicaid patients who contracted diabetes or other ailments after taking the drug. Many will be keenly watching this trial. Eight other states have filed similar suits and as many as 30 others are reportedly considering doing so. Opening statements were made yesterday.
This blog marks the third or fourth time I’ve written on the topic. I’m beginning to think that few outside Eli Lilly are as engrossed in the details as me and The New York Times, which has also written extensively about it. The newsworthiness of this major legal battle explains the Times‘ ongoing interest; my own stems from the broader crisis communications lessons to be learned from Eli Lilly’s handling of this matter.
While the Times did an admirable job of covering the trial’s opening arguments and setting the legal stage, I must question its reporting in that same article about Eli Lilly being investigated for “off-label” marketing of this drug – a serious no-no in the pharma world. While the reference to those charges was unquestionably relevant, the Times neglected to inform readers that the State of Alaska’s lawsuit had also alleged off-label marketing tactics, but that the presiding judge had already thrown out the claim. While I don’t know whether the dismissal was due to a lack of corroborating evidence or perhaps simply a technical glitch – the Times should have at least given the full story.
As an aside, I can’t help but note the irony of Alaska prosecutor Scott Allen reportedly characterizing Eli Lilly’s alleged conduct as being “reprehensible”. That is the same word that senior federal district Judge Jack B. Weinstein used to characterize the information-gathering tactics of Alex Berenson, the Times reporter who has been following this story for the paper.
Up until today, I had been largely mistrustful of the Times‘ Zyprexa reporting because of the alleged ethical shortcuts the newspaper had taken in obtaining the story. I refused, naively, to accept that Zyprexa, an FDA-approved pharmaceutical, could be as horrific a drug as the Times portrayed it to be. I figured that that Lilly’s communications team was simply doing a very poor job at damage control, woefully mismanaging the escalating PR crisis. The anecdotal evidence that Lilly’s outside attorneys are also actively engaged in Lilly’s media relations efforts only reaffirmed my belief.
But I admit my stance has changed now that I’ve read the initial comments made during the opening statement made by Nina Gussack of the Philadelphia-based law firm Pepper Hamilton, which represents Eli Lilly. In a nutshell, she defended the company by saying that Zyprexa’s benefits outweigh the risks and noted that Alaska’s Medicaid program continues to pay for Zyprexa.
While this cost-vs.-benefit approach is hardly a novel one, it just doesn’t sit well. I understand, of course, that there are inherent health risks with virtually any drug and that, despite the threat of possible side effects, informed patients often decide to take that gamble each and every day, starting new drug regiments to cure what ails them. I also understand that there are times when doctors have to make that decision for them, such as in emergency rooms, where the patient’s life is at risk and giving consent is not possible.
What I find morally repugnant, however, is the thought of doctors prescribing drugs that potentially cause life-threatening illnesses to patients who are unable to give their informed consent when other, less risky drug therapies are available. Is schizophrenia the more pressing health concern than diabetes or vice versa? Who gets to make that call? What about the myriad health complications that are shown to be associated with obesity in general? How do we factor them in to the prescribe-or-not-prescribe decision process?
After reading about yesterday’s Eli Lilly assertions, it is now clear to me why the company has hid behind its attorneys rather than aggressively, publicly address the allegations repeatedly raised by the Times. The “benefits outweigh the costs” rationale is a rather weak one to flog in the face of a mounting public backlash. Then again, the public comments they did make – that the Times had repeatedly taken evidence “out of context” – is hardly reassuring to investors, patients, doctors, and everyone else for that matter. As I’ve noted before, the “out of context” defense is rarely a credible one.
While I don’t think that the ends justify the means with respect to how the Times obtained some of its information for its ongoing Zyprexa coverage, I do admit that I’m grateful that much of it has come to light. Something tells me that Eli Lilly and the prescribing doctors who fell for its sales reps’ spiel are much less so.
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February 11, 2008 1:34 pm : Comments 002
It looks like we got spun again by The New York Times.
In our zeal to safeguard the integrity of our firm and its blog, we rushed an apology last week to The New York Times and reporter Alex Berenson that now appears to have been premature. The S&A post in question was based on a story that appeared on Portfolio.com earlier in the week. When the Times sent us a statement saying that the original story was “incorrect”, we took the newspaper at its word and felt compelled to retract some of our comments.
Well, it turns out the story wasn’t incorrect. In fact, one could argue that, for the most part, it scored a bulls-eye. The Times insisted that a misdirected email from one of Eli Lilly’s outside attorneys wasn’t responsible for Mr. Berenson’s page-one scoop that the pharmaceutical giant was close to reaching a settlement with federal prosecutors for $1 billion. But Mr. Berenson subsequently admitted on NPR radio, and to the editor of the Pharmalot blog, Ed Silverman, (see his comment on my apology post) that, well, it kinda was.
We could have a field day with the disclosures that have surfaced since our last blog on this topic, but we will stick to the high road and to these two thoughts:
- We owe an apology to Portfolio.com for unjustifiably discrediting its story. While some might argue that the misdirected email Mr. Berenson received didn’t have the depth of detailed information about the proposed settlement as the website hinted, by Mr. Berenson’s own admission the details it did offer provided the confirmation he needed to run with the story;
- This ongoing email saga illustrates clearly that there is truly no such thing as off-the-record. Once a reporter has their hands on a piece of sensitive information, they will finagle ways to use it, despite any handshake agreements not to. As we are forever telling clients, if you don’t want to see something attributed to you on page one of your local newspaper, it’s best you keep it to yourself.
One final thought: For all the blather about the capriciousness of bloggers and so-called citizen journalists, it is interesting to note how quickly those commenting online about this topic last week were quick to issue corrections and clarifications when it seemed their information was wrong. If nothing else, it’s encouraging to see the old-school principles of fairness and accuracy given the primacy they deserve.
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February 7, 2008 12:57 pm : Comments 002
Update: Alex Berenson admits some truth on NPR and The New York Times‘ comments had an element of spin.
When we launched this blog, there was unanimous internal agreement that we would adhere to the highest standards of fairness and accuracy. We demand nothing less from ourselves, clients, and the media with regard to the work we do every day, and the content of this blog is no exception.
With that in mind, we naturally became concerned yesterday to read a post on the Drug and Device Law blog that the Portfolio.com story upon which we based our own post Tuesday may have been inaccurate. The item in question reported that The New York Times reporter Alex Berenson was able to break the recent page-one story about a possible $1 billion Eli Lilly Zyprexa settlement because he had mistakenly received a confidential email about the talks from an attorney at Eli Lilly’s outside law firm Pepper Hamilton that was intended for a co-counsel colleague at Sidley Austin also named Berenson.
The D&DL post said that Mr. Berenson had denied that the errant email was the initial source of his scoop (Portfolio.com said he had declined to comment). Above the Law, a well-regarded and extremely popular website, also wrote about the wrong-Berenson email mistake, linking to our post and to the original piece on Portfolio.com. They, too, issued a subsequent clarification once Mr. Berenson’s denial was on the record.
And now it is our turn.
We contacted The New York Times spokespeople directly yesterday to determine if a correction or clarification was indeed warranted. We received the following statement from Catherine J. Mathis, a spokeswoman for the newspaper:
Mr. Berenson did receive a misdirected e-mail from Pepper, but that e-mail did not contain a detailed description of the status of the settlement talks. Mr. Berenson had known independently about the settlement talks for some time, and he obtained the details he published in the Times from sources other than Pepper.
The Portfolio version was incorrect.
When a newspaper the stature of The New York Times publicly discredits the reporting of another publication, we clearly take it seriously. It now appears that we inadvertently republished erroneous reporting in our blog yesterday, and for that we apologize to both the Times and Mr. Berenson.
Yet…
If Mr. Berenson knew about the settlement talks for “some time” and had received details of the settlement talks from “sources” (plural) other than Pepper, we can’t help but wonder why he then sat on the story. Doing so meant taking a huge risk of getting scooped by a rival on a story that he has pretty much owned. After all, as the Times itself reported, if the $1 billion figure was right, it would be the biggest penalty ever paid by a drugmaker for inappropriate drug marketing activities. Major newspapers typically require only two independent sources to confirm an unattributed story, which Ms. Mathis suggests he had in hand.
And therein lays a very big question. So who were these non-Pepper sources?
We can appreciate why someone on the government side might leak that settlement negotiations were underway. But we would expect that Mr. Berenson’s editors would insist that he get confirmation from someone at, or very close to, Lilly with first-hand knowledge of the talks. It’s fairly safe to assume that Lilly didn’t offer any confirmation, officially or on background, given their reported statement to the Times saying in part, “…we regularly have discussions with the government. However, we have no intention of sharing those discussions with the news media and it would be speculative and irresponsible for anyone to do so.”
Mr. Berenson’s scoop is extremely damaging to Eli Lilly. If the company does indeed settle for $1 billion, the Times will again undoubtedly give the story some pretty prime real estate and repeat all the damaging allegations regarding Zyprexa. And with the figure now public knowledge, it would seem difficult for prosecutors to accept a settlement for less than $1 billion without it appearing that they had blinked.
It will certainly be interesting to see how this fascinating story plays out.
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February 5, 2008 12:05 pm : Comments 003
Update: The New York Times claims that the Portfolio piece was “inaccurate”.
Update 2: Alex Berenson admits some truth on NPR and The New York Times‘ comments had an element of spin.
More about Alex Berenson.
The New York Times‘ pharmaceutical industry reporter Alex Berenson scored a heck of a Page One scoop last week when he revealed that Eli Lilly was looking to reach a settlement with federal prosecutors over the company’s alleged inappropriate marketing of antipsychotic drug Zyprexa. A staggering “mea culpa” settlement figure of $1 billion or more was mentioned.
This was a big story, no question about it. Eli Lilly is a publicly traded company and the $1 billion settlement would be the largest ever paid by a drug company for improper drug marketing (so said the Times).
In the piece, reporter Alex Berenson cited sources who requested anonymity “because they have not been authorized to talk about the negotiations.” He also included a statement from an Eli Lilly representative saying, in part, “…we regularly have discussions with the government. However, we have no intention of sharing those discussions with the news media and it would be speculative and irresponsible for anyone to do so.”
So how did Mr. Berenson get the scoop? It turns out that it wasn’t through any tried-and-true gumshoe reporting techniques taught at j-school. He simply had the fortune of having the same last name as one of Eli Lilly’s attorneys.
According to a story posted today on Portfolio.com, one of the drugmaker’s outside attorneys at Philadelphia-based Pepper Hamilton had mistakenly emailed detailed, highly confidential information on the settlement talks to the reporter instead of Bradford Berenson, the intended recipient (co-counsel at another law firm).
The email gaffe, unquestionably one of the greatest fears of everyone handling sensitive information, is apparently the result of very similar email addresses: Mr. Berenson, the reporter, simply goes by berenson in his email address while Mr. Berenson, the attorney, goes by bberenson.
We can’t honestly fault the Times or its reporter for breaking this story. I would have done the same thing back in the day. But Mr. Berenson mislead by omission. He should have been upfront with readers about how he learned of the settlement talks. Since there was no official confirmation from either side, doing so would have gone a long way toward letting readers judge the credibility of the story for themselves. Mr. Berenson quotes Nina Gussack, a Pepper Hamilton lawyer representing Eli Lilly, as saying she couldn’t comment on the case. Judging from Eli Lilly’s own statement, it doesn’t appear that anyone alerted the company’s spokesperson as to how Mr. Berenson got the story.
Mr. Berenson’s earlier reporting on this topic has been called into question before. According to a respected federal judge, Mr. Berenson was “deeply involved” in an “illegal” scheme that effectively amounted to “stealing” documents. (Neither the Times nor Mr. Berenson have ever publicly explained the extent of his involvement.)
Eli Lilly is reportedly sticking by Pepper Hamilton, and I applaud the company for its loyalty. That said, I can’t help but wonder why an attorney at Pepper Hamilton had Alex Berenson’s email address in her email database in the first place. As I’ve argued before, reporters and attorneys are best left in separate corners. Especially when the latter specializes in high-profile, high-stakes crisis work. By any measure, Eli Lilly’s PR handling of allegations of wrongdoing regarding its Zyprexa marketing has been a debacle. If its attorneys are driving the media relations strategy, it’s easy to understand why.
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September 25, 2007 1:54 pm : Comments 004
Other media-related posts in this series:
The New York Times vs. Eli Lilly
One of my favorite Saturday morning rituals is to pass the early hours with a steaming cup of overpriced coffee and an ambitious pile of newspapers. Call me old school, but I prefer paper to pixels, relying on printed news sources over the online variety to keep me informed of the Big Picture stuff. As a former journalist, newspaper ink still runs through my veins.
The never-quite-dormant reporter in me was jarred awake two weekends ago as I sat in my local java joint, reading The New York Times‘ business section. Buried on page two was a brief item about Dr. David Egilman, an “expert witness” hired by the plaintiffs in a legal dispute with Eli Lilly regarding its antipsychotic drug Zyprexa, who was now ‘fessing up that he had indeed given selected confidential documents, as alleged, to an Alaska attorney, who in turn gave the documents to Times reporter Alex Berenson. The story reported that Dr. Egilman had agreed to pay $100,000 to Eli Lilly to settle the case, and that he had acknowledged in a court filing that “there was another side to the Zyprexa story” that wasn’t represented in the documents that had been given to the Times.
The story piqued my curiosity. I recalled the Times had previously run a series of damning page-one articles by Mr. Berenson reporting that Eli Lilly had failed to inform doctors that Zyprexa could cause excessive weight gain and diabetes, a not-so-insignificant unwanted side effect that sparked thousands of class action lawsuits. If an expert witness involved in those cases was now publicly admitting that “there was another side of the story,” the disclosure certainly deserved considerably more prominence than a brief mention, particularly as Zyprexa accounts for nearly one-third of Eli Lilly’s profits.
There were other signs that something was radically amiss. There was neither byline nor attribution to a wire service, and the article made no mention of any attempts to contact Dr. Egilman or Eli Lilly for comment, all of which are otherwise standard for the Times. And most curious of all, the story quoted Times attorney George Freeman defending Mr. Berenson’s articles as being “newsworthy and accurate.” Hmmm… like most top-tier publications, the Times would typically offer up its editors to defend the newspaper’s editorial judgments when questioned. Was there some behind-the-curtain legal impetus driving Mr. Freeman’s involvement in this piece? I grew increasingly intrigued and started digging into the story myself.
Turns out my hunch proved correct. A respected federal judge in February accused Mr. Berenson of being “deeply involved” with Dr. Egilman (and the attorney to whom the latter had turned over the confidential documents) in an “illegal” scheme that effectively amounted to “stealing” the documents. In an impassioned decision [PDF] simmering with outrage, senior federal district Judge Jack B. Weinstein also warned that the documents obtained by Mr. Berenson “are segments of a large body of information, whose selective and out-of-context disclosure may lead to confusion in the patient community and undeserved reputational harm” to the drugmaker. Judge Weinstein went so far as to declare Mr. Berenson’s conduct “reprehensible.”
While the Times did carry a concise report on Judge Weinstein’s decision (albeit on page C7 unlike Mr. Berenson’s extensive page-one pieces), it was Mr. Freeman who officially commented, stating that the decision “vastly overstates Alex’s role in the release of the documents” (thereby suggesting that he did indeed participate in some capacity). Company spokeswoman Diane McNulty echoed the statement almost verbatim to other news outlets. The Times has yet to offer its version of the actual extent of Mr. Berenson’s involvement.
Exactly how Alex Berenson obtained and reported on the Zyprexa documents should be of critical concern to all corporations and anyone concerned with privacy rights and the integrity of the judicial system. The documents in question were among reams-worth of evidence furnished by the pharmaceutical company to expedite the settlement of some 30,000 personal injury suits relating to its drug. According to Judge Weinstein [PDF], they included “a substantial amount” of sensitive information, including individual patient medical records and proprietary trade secrets. Among other reasons, they were sealed by the court to protect litigants “from the embarrassment and oppression that would result from the unnecessary pretrial disclosure of their private information.”
First Amendment champions will no doubt continue to defend Mr. Berenson’s alleged zealousness and say the public’s right to know was well served by his reporting, even if it was based on an incomplete set of documents. Predictably, even the Times itself went down that road, albeit in a roundabout fashion. Others will speculate that the information disclosed by Mr. Berenson likely was responsible for Eli Lilly agreeing to settle the scores of Zyprexa lawsuits for more than $1 billion and that his means were justified by the end.
But it’s difficult to argue that Mr. Berenson was solely driven by the pursuit of a noble cause. After all, according to testimony by James Gottstein, the Alaska attorney who gave the Times the documents, Mr. Berenson insisted he wouldn’t publish the story [PDF] if Mr. Gottstein followed through with his original plan to disseminate them widely to other news organizations. Apparently what’s good for the Times carries a teensy more weight than what’s good for the public.
So Who is This Dr. David Egilman?
Dr. David Egilman, a Massachusetts doctor and a clinical associate professor of community health at Brown University, is a physician on a mission. Citing the influence of his father, who was interred in a German concentration camp, and the 18th century philosopher Edmund Burke, Dr. Egilman says he has “devoted” considerable time and resources studying and reporting on the effects of silence on public health. “Silence can injure and kill,” he recently posted on a website. “For public health, the sound of silence is the funeral dirge. I have not and will never play that tune.”
Dr. Egilman’s vocal orchestrations have afforded him a lucrative sideline. According to one report, he has earned millions – as much as $25 million – testifying as an expert witness at about 100 personal injury trials; another report pegs the number at about $2.5 million. His exact expertise is difficult to discern: he has been identified in one news account as “an expert on occupational lung disease,” but he has testified on subjects requiring a much wider range of medical knowledge including cardiology, obesity, and diabetes. Indeed, just a few years ago, he was involved as an expert witness in a case filed against Merck by a widow claiming her husband died of a Vioxx-related heart attack. A Merck attorney characterized Dr. Egilman as someone who “is prepared to testify to just about anything,” noting that his expert designation had been filed with the court prior to him reviewing any documents relating to the case.
Dr. Egilman is no stranger to controversy. In February 2005, he repackaged a proposed bylined article for the Journal of Occupational and Environmental Medicine as a paid advertisement after it was rejected by the editorial board, thereby bypassing the peer review process. Later that year, jurors in a landmark Colorado toxics trial were instructed to ignore Dr. Egilman’s testimony after the judge learned that he had violated a gag order and posted “scurrilous and inflammatory” information about the trial on his website. The judge ruled that Dr. Egilman was “not objective, reliable, or credible.” The doctor subsequently sued two prominent law firms for allegedly gaining improper access to his password-protected website, which was how the court had learned of his postings. After a judge ruled against him, Dr. Egilman declared: “The legal system is designed to benefit people in power. That is why courts said it was legal for blacks to be slaves or ruled it legal to deny women the vote.”
Dr. Egilman’s relationship with The New York Times dates back to at least the early nineties. After being rebuffed by 60 Minutes and other news organizations, he claims to have been responsible for a page-one story the Times ran that year about the Atomic Energy Commission being warned that it could ultimately face criticism for using human subjects to conduct radiation experiments. Dr. Egilman’s hometown newspaper wrote a story about his advocacy work, noting his media placement efforts among others (the feature presumably placed with the continued help of his publicist).
Mr. Berenson has quoted Dr. Egilman multiple times, including a 2003 story about how trial lawyers planned an onslaught of lawsuits against drug manufacturers for failing to disclose the “hidden” dangers of their medicines.
Judge Weinstein’s Perspective
Based on various testimonies, Judge Weinstein concluded that Dr. Egilman tipped off Mr. Berenson that there were some damaging documents about Zyprexa under court-ordered seal, and that the latter inappropriately acted to obtain those documents. These excerpts from his 78-page opinion [PDF] speak for themselves:
“…Alex Berenson was aware of the protective order. He discussed with plaintiff’s expert, Dr. David Egilman, means of escaping the order’s restrictions and obtaining protected documents in the expert’s possession…even though Egilman had agreed in writing to be bound by the order…”
“…Both Berenson and Egilman were cognizant of the fact that the (protective order) took account of the possibility that the protected documents could be subpoenaed by courts or executive agencies. So Berenson provided Egilman with the name of an Alaska attorney, James Gottstein, unconnected to the instant litigation, who might be willing to employ a pretense to subpoena the documents and help disseminate them in violation of the protective order…”
“…To carry out the scheme for obtaining and disseminating the protected documents, Gottstein intervened in a state case in Alaska wholly unrelated to Zyprexa. In that case, he then subpoenaed from Egilman confidential documents he knew to be under the protective order which bore no relevance to the Alaska litigation. The subpoenaed documents were sent by Egilman to Gottstein pursuant to an expedited amended subpoena about which Lilly was deliberately kept in the dark so that it would be unable to make a timely objection…Gottstein immediately sent the confidential documents on to Berenson and others…”
“…Intending that they be published extensively, Gottstein distributed the sealed documents to various organizations and individuals. No distribution to newspapers other than The New York Times was made because of Berenson’s explicit warning to his co-conspirators that if the Times was not given “an exclusive” on the story, it would not publish anything at all about the documents…”
Judge Weinstein emphasized that “this is not a case of a newspaper obtaining, with clean hands, documents provided to it by government employees, whistleblowers, or protesters. Acknowledging the Times‘ and Washington Post’s famed publication of the “Pentagon Papers”, he noted there were no allegations that those documents “were purloined” by either newspaper. “Affirmatively inducing the stealing of documents is treated differently from passively accepting stolen documents of public importance for dissemination.”
Much of Judge Weinstein’s opinion is substantiated by testimony given by Mr. Gottstein. Dr. Egilman declined to testify about his role in the “conspiracy,” invoking a Fifth Amendment privilege against self-incrimination (so much for the sound of silence being a funeral dirge!) The Times declined to allow Mr. Berenson to testify about his role citing a “long-held principle” that “it would be inappropriate for any of our journalists voluntarily to testify about news gathering at the Times.”
The New York Times Responds
When I inquired why the story was published without a byline and why it quoted the newspaper’s attorney, aforementioned Times spokeswoman Diane McNulty explained in an email that the article was “assembled by editors” (emphasis mine) because “wire services on the subject did not include a comment from the Times.” As for the decision to insert a quote from Mr. Freeman, Ms. McNulty said: “The settlement did not throw into question any editorial judgment of the Times, which is why the article quoted a lawyer for the Times rather than an editor.”
I cannot help but note the irony of the newspaper of record trying to spin a public relations executive. No byline because the paper relied on wire services? Ok, then why weren’t the wire services credited? At the risk of sounding combative, I thought “attribution” and “fully sourced” were the buzzwords in the Times‘ post-Jayson Blair newsroom. And as for the latter comment, how can the Times‘ editorial judgment not be called into question when it fails to fully cover the fallout from a series of page-one articles it published earlier based on court-sealed, ill-gotten documents leaked with the assistance of a controversial source who now admits they did not “represent the entire set of information?”
In any case, given the significance of Dr. Egilman’s declaration and the prominence given to Mr. Berenson’s damning stories, it’s noteworthy that the Times chose to rely on wire services to cover the settlement story and seemingly made no attempt to contact him or Eli Lilly for comment. The pharmaceutical company had issued a statement on the settlement, but it was not cited in the coverage. Eli Lilly’s news release references Judge Weinstein’s decision and specifically claims the Zyprexa documents were obtained “illegally.” It seems to me that a Fortune 500 company claiming to be a victim of illegal activity is deserving of mention.
Clearly, I was not the only one who had issues with the Times story. A few days after the blurb ran, a correction was issued. I leave it to you to read between the lines:
“An article in Business Day on Saturday about the settlement of a legal dispute in which a doctor was accused of leaking confidential documents to The Times from the drug maker Eli Lilly, left an incorrect impression about the admissions that the doctor, David S. Egilman, made in the settlement. Dr. Egilman acknowledged that Lilly had a different view of the safety of its schizophrenia drug Zyprexa than was portrayed in the documents. He did not admit that he accepted Lilly’s view that Zyprexa was safe.”
Here is a copy of the full declaration by Dr. Egilman [PDF]; take from it what you will.
Afterword
Let’s be clear: I have no idea why Dr. Egilman settled with Eli Lilly, nor can I determine the sincerity of his self-professed public health crusade. All I know of him and his activities are what I’ve read and researched, and the picture that doing so presents. It’s quite possible he simply settled to avoid the time and financial costs of a prolonged legal battle with the Big Company with Much Deeper Pockets. Then again, the same time/cost benefit analysis could just as easily apply as to why Eli Lilly settled with its class action plaintiffs.
For those who automatically assume the worst about drug companies, particularly with respect to drug safety disclosures, an op-ed in last week’s Wall Street Journal by Dr. Scott Gottlieb, a former deputy commissioner of the FDA, offers perspective worth considering. The reality is that drug companies don’t have carte blanche freedom to add risk information to drug labels; that’s the FDA’s call, believe it or not, and they’ve told drug companies in the past to scrub warning language that it deemed superfluous. And now Congress is considering legislation that would make it even easier for trial lawyers to belly up to the “undisclosed risk” trough.
In the case of Zyprexa, Lilly maintains that the labeling provided to physicians identified “the potentially clinically-significant weight gain that was observed in more than half of all patients treated long-term with Zyprexa, as well as the diabetes-related adverse events observed in clinical trials, including diabetes, hyperglycemia and diabetic ketoacidosis.” Perhaps the real issue is that physicians are simply relying far too much on aggressive sales reps to tell them the ups and downs of a drug, rather than actually taking the time to independently read its FDA-approved label. I’m not sure which scenario scares me more…
Eli Lilly quite understandably does not appear to be seeking any legal retribution from the Times, which is probably the best course of action for them. It’s generally accepted as a given in public relations that it is foolhardy for a major company, particularly one in an “easy target” industry that is held in low public esteem, to aggressively attack a powerful newspaper that buys ink by the barrel. Doing so would only heighten awareness of the damaging charges Lilly seeks to rebut and further exacerbate its reputational damage.
There are a great many legal and ethical themes at play in the Eli Lilly/Dr. Egilman/New York Times saga, but at the crux of it all are issues of transparency and accountability – on all fronts. While the media has done an impressive job in recent years guard-dogging the public’s interests by demanding more clarity and less concealment from our corporate leaders, it must also be willing to sound a similar clarion call when other members of the Fourth Estate totter in living up to the exacting standards they so rightfully advocate.
As the saying goes: “If you’re going to talk the talk, you’ve got to walk the walk.”
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