Author Archives: Ed Silverman

Recent reporting relied on incomplete releases

We all know that press releases are, by definition, designed to highlight positive news. And that’s being generous. But a pair of rather skimpy releases issued by biopharma companies over the past few days takes the notion of spin to a new and troubling level.

In the first case, Medarex last weekend issued a release saying a Mayo Clinic study of two men found that its experimental prostate cancer drug had their tumors shrink dramatically. Oddly, as the Associated Press noted, there was no info on how many people participated in the trial, whether other patients improved or worsened, how long they had survived or whether the study is an early, midstage or late-stage trial. Moreover, the two men still had to undergo surgery to remove the remaining tumors. Just the same, Medarex stock popped more than 20 percent on the news.

A couple of days later, Chroma Therapeutics issued a release touting an alliance with GlaxoSmithKline to use its technology to discover and develop four compounds to treat inflammatory disease. The deal has the “potential” to generate more than $1 billion if all four programs are successful, but no other figures concerning milestone and option payments were mentioned. As The In Vivo Blog pointed out, that $1 billion is highly contingent on all sorts of hurdles being cleared. But how often does anything go according to plan? Nonetheless, the eye-popping $1 b figure was duly noted by various mainstream and trade media.

We asked Reuters‘ Ben Hirschler for his take on the Chroma story and he wrote us that reporting such announcements is a “perennial issue, because the smaller partner routinely wants to play up the maximum figure, while details of the terms are often not disclosed. We always stress the number is a potential payout that depends on success in development and payments could be years away. You could, as you say, argue such figures are spin … since it is unlikely the company will actually hit the jackpot and get the top payout. But … reporting the ”up to” figure (alongside the much smaller upfront element) can be useful for investors, because it gives an indication of how significant any successful drugs from a collaboration could be, if everything goes right.”

In these two cases, however, vital info was missing from the press releases, which made it virtually impossible to make useful comparisons. Meanwhile, the companies still succeeded in getting across their bottom-line messages and impressions. We’re not suggesting that such press releases should be ignored. But companies need to be held accountable for such omissions or journalists may find these gambits will become an accepted practice.

First Amendment defense fails InterMune exec

If any company thinks a press release is protected speech under the First Amendment of the U.S. Constitution and, therefore, can’t be used by the government when bringing criminal charges, well, they can forget about it.

That’s what W. Scott Harkonen, a former chief executive at InterMune, is learning this month, thanks to a federal court ruling that decided a press release can be used by the U.S. Department of Justice to press a criminal indictment; in this case, the charges are wire fraud and misbranding of a medication under the Food, Drug and Cosmetic Act.
The backdrop: InterMune marketed a drug called Actimmune to treat chronic granulomatous disease and severe, malignant osteoporosis. In 2000, the company began studying the drug for combating idiopathic pulmonary fibrosis (IPF), a fatal lung disease, but the study didn’t show effectiveness. In a 2002 meeting with FDA staffers, InterMune was told a subgroup analysis suggesting a survival trend for some patients was insufficient for approval.

Nonetheless, InterMune began promoting the drug to treat IPF and, in 2002, issued a press release announcing the results of its clinical trial and the headline boasted the drug demonstrated a survival benefit and reduced mortality in people with mild to moderate effects of the disease. Harkonen wrote the headline and byline, and controlled the content of the entire press release, according to the ruling. InterMune also hired a marketing firm to determine whether the press release would affect prescribing behavior of pulmonologists; a survey indicated it would.

But it looks like Harkonen’s words will come back to haunt him. U.S. District Court Judge Marilyn Hall Patel refused to dismiss the indictment, writing: “It is undisputed that the government has the right to regulate false and misleading statements made to doctors and patients about drug products in interstate commerce.  Accepting the indictment’s allegations as true for the purposes of this motion, it is clear to the court that the speech at issue is not outside the bounds of the FDCA’s regulatory reach as being wholly protected by the First Amendment as a matter of law.”

Hat tip to FDA Law.

Pharma industry still finding its way in social media

Big pharma continues to dabble, tentatively, with social media. The latest example is GlaxoSmithKline, which this week launched its very own corporate blog, called More Than Medicine. The effort, which is edited by a corporate communications person identified only as Michael M, will purportedly devote more space to health issues but largely avoid discussion of Glaxo products, citing “unique regulatory parameters governing our communications” as a drug maker.

The inaugural blog post, which follows several weeks of internal testing that produced a few posts now on full view, contains some mixed feelings. On one hand, Michael M writes that “it is still unclear how, and in some cases, if pharma can appropriately utilize blogs, wikis, and applications like YouTube and Facebook to provide information about our products.”

“Yet,” he adds, “there is no question that patients, physicians, media, investors, payers, policymakers and others are increasingly turning online to social media resources for information about healthcare issues and products. So we feel obliged to these stakeholders, as well as our shareholders, to productively and appropriately engage in this new space.”

In other words, some trepidation remains, although perhaps not quite as much fear as existed several months ago (look here). Johnson & Johnson launched a corporate blog two years ago, although a blog run by its Centocor unit was recently lost to a corporate reorganization, and Glaxo runs a blog devoted to the Alli diet pill – sort of. There haven’t been any posts since September. However, Novartis, Boehringer-Ingelheim and AstraZeneca all use Twitter to deliver news about their activities; and Sanofi-Aventis and AstraZeneca launched branded YouTube channels.

Nonetheless, in a recent story, Marissa Miley and Rich Thomaselli of Ad Age wrote that big pharma is lumbering toward the digital age. Glaxo, for its part, may disagree. But if the drug maker truly wants to create dialogue around issues at the core of its corporate mission, Michael M should be identified properly. Glaxo is more likely to connect with the public if the public feels a real person is at the helm, not an semi-anonymous mouthpiece.

European ruling equates journalism, advertising

Can information about medicines that is communicated by third parties – such as journalists – constitute advertising? How about when the journalist has no connection to the manufacturer or marketer of the product? If this sounds like  non-starter, think again.

In a recent ruling, the European Court of Justice (ECOJ) determined that a Danish journalist – who published information on his Web site about a product that was promoted for treating gout, kidney disorders and diarrhea, among other things – violated a European Union directive. The offense? In 2003, Frede Damgaard posted info about Hyben Total – four years after Danish regulatory authorities refused marketing authorization for the product.

He was subsequently prosecuted and appealed. Now, though, the ECOJ decided that the EU directive defining the concept of advertising meds “does not rule out the possibility that a message originating from an independent third party may constitute advertising, nor does (it) require a message to be disseminated in the context of commercial or industrial activity in order for it to be held to be advertising.” The court went on to say that such “advertising … is liable to harm public health,” even when it is carried out by “an independent third party outside any commercial or industrial activity.”

Attorney General Damaso Ruiz Jarabo-Colomer

Advocate General Damaso Ruiz Jarabo-Colomer

Never mind that the court’s own Advocate General, Damaso Ruiz-Jarabo Colomer, wrote an opinion backing Damgaard, who was found to have posted the info on his own initiative and didn’t have any ties to the manufacturing or marketing of the product.  The AG believes final say rests with individual EU states: “It is for the national authorities and courts … to ensure the correct balance between, on the one hand, the objectives of protecting health and promoting the rational use of medicinal products and, on the other, the right of the party concerned to freedom of expression, taking into account the special protection afforded to the party concerned, if it is established that he is a journalist.”

In the end, the ECOJ agreed with that much by writing that it’s up to Danish national courts to “determine whether that dissemination (on Damgaard’s Web site) constitutes a form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.”

Damgaard’s attorney Susie S. Ekstrand, according to the CosmeticsDesign-Europe.com Web site, said “It is a restriction of freedom of speech and journalists need to be careful now, especially those writing online across many member states.”

Panel: Is media to blame for pharma’s poor image?

Several months ago, Ray Kerins, a top Pfizer public relations exec, bemoaned the perception of the pharmaceutical industry in a speech that was widely viewed on the Internet. Here’s what he said:

“When we’re dealing with the media, I see a problem. If we’re not willing to engage, we only have ourselves to blame. I blame myself and those of us in the industry for the bad reputation the pharmaceutical industry has. We develop life-saving medicines that you take, that will prolong your life, that will help cure certain diseases. How in the hell do we have such a bad reputation? It makes no sense.”

He then disclosed that, prior to his arrival at Pfizer, the PR team routinely ignored initial media calls.

Of course, such policies only contributed to a larger problem – the growing debate over pricing, promotional practices and safety concerns that have been at the center of several controversies over the past few years. From ghostwritten journal articles and hidden clinical trial data to surreptitious funding of advocacy groups and senior citizens unable to afford their meds, the pharmaceutical industry has found itself on the defensive. The tales have played out in court, at congressional hearings and in the media.

But does the media really have it right? Are drug makers, basically, well-behaved entities, not counting some regrettable lapses? Or does the pharmaceutical industry hide behind its right to make profits as an excuse for failing to adopt more palatable business practices?

To explore the issue, the 6th World Conference of Science Journalists next month will hold a panel discussion at its conference in the UK on whether the industry’s image reflects the reality of self-inflicted wounds or the trumped-up product of journalists who are seeking a villain. Does that sound familiar? It should to our regular readers — a similar panel is planned in November in Monaco at the annual meeting of the International Forum on Mood and Anxiety Disorders.

And the panel has some interesting members: Vera Hassner Sharav, a consumer activist and industry critics who runs the Alliance for Human Research Protection; John Ilman, a former journalist at various UK papers who now runs a pr crisis management firm that serves, in part, drugmakers; Michael Rawlins, the chairman of the UK’s National Institute of Health & Clinical Excellence, which is famous for rejecting government coverage of certain meds due to cost; and Paul Stoffels, who oversees global research and development for Johnson & Johnson.

Expect some fireworks.

Panel to explore media’s ‘wanton witch hunt’

Is there a wanton witch hunt against academic experts by the media? That’s what a panel will explore this coming November in Monaco at the annual meeting of the International Forum on Mood and Anxiety Disorders, a European-based organization that convenes to discuss the latest psychiatric trends.

The brochure, which you can peruse here (if prompted for a password, just use AHCJ), and Web site offer precious little information about the scheduled discussion. However, the specter of a media witch hunt is being raised, not so coincidentally, after months of sustained headlines in the U.S. about a probe by the Senate Finance Committee into conflicts of interest involving academics who accept NIH grants and fees from the pharmaceutical industry.

At issue is the extent to which payments are properly disclosed and monitored. The ongoing investigation has focused on several high-profile psychiatrists, including Harvard University’s Joseph Biederman, Brown University’s Martin Keller, Emory University’s Charles Nemeroff and Stanford University’s Alan Schatzberg. In fact, Schatzberg is listed one of the forum’s scientific advisers.

Since the probe began, Nemeroff stepped down as chair of his psychiatry department and the NIH suspended a grant; Keller is vacating his post as Brown psychiatry chair and Schatzberg resigned as lead investigator of an NIH grant and Stanford is searching for a new psychiatry chair, although his pending departure is unrelated to the probe, according to Stanford. Meanwhile, the NIH changed research heads and the American Psychiatric Association, which Grassley also targeted, is phasing out industry-supported symposia and meals.

Why does this group think a witch hunt may be under way? Will they address the issue of conflicts of interest? Why is there no one from the media or Grassley’s staff invited to speak? The group’s public relations person begged off in response to a note and the organization itself has yet to respond.

CSPI shuts down Integrity in Science Watch

The ongoing economic crunch has claimed yet another casualty – the Integrity in Science Watch program that was run by the Center for Science in the Public Interest. The nonprofit organization, which is based in Washington, D.C., last week closed the effort due to a lack of funding, according to a CSPI spokesman.

ISW was a valuable source of weekly information that spotlighted the various conflicts of interest in science and medicine that are found in government agencies, academia, hospitals and industry. The digest, which was overseen by AHCJ member Merrill Goozner, a former journalist for the Chicago Tribune, aimed to highlight examples that the media may have missed and regularly follow up pertinent examples that faded from public view.

The ISW project was launched nearly three years ago as a way of publicizing conflicts, highlighting attention to the issue, and “casting an investigative eye on stories that had not yet hit the public eye,” says Goozner, who is contemplating transferring the effort to his weekly blog about health topics called GoozNews. “I think the Integrity in Science project at CSPI helped raise the profile of the conflict of interest in science in general, and in medicine in particular.”

What was he proud of pursuing? Analyzing the prevalence of  failures to disclose conflicts in medical literature (2004); helping The New York Times unmask conflicts on the 2005 FDA advisory panel that evaluated Vioxx after the drug was withdrawn; lobbying for a ban on conflicts of interest on FDA advisory committees through the House (which failed in the Senate but obtaied greater disclosure of waivers and a two-week advance notice provision as a compromise – 2006); put that into law (2007).

Nature survey: Scientists gain influence with blogs

As newspapers shrink, fold or migrate entirely to the Internet, what will happen to science journalism? Like other topics, coverage is becoming fractured and the likelihood that the public will find meaningful and important stories as readily as before is uncertain, at best, according to an interesting

A survey by the publication of 493 science journalists shows that jobs are being lost and the workloads of those who remain are on the rise – 18.5 percent reported their workloads have increased dramatically. At the same time, researcher-run blogs and Web sites are growing in both number and readership. Moreover, traditional journalists are increasingly looking to these sites to find story ideas, although there’s also an increasing reliance on press releases and public relations machines.

“Whether directly or indirectly, scientists and the institutions at which they work are having more influence than ever over what the public reads about their work,” according to the Nature story. That’s because press releases and blogs, typically, can’t reach the same widespread audiences as mainstream media. However, some bloggers are gaining a wider audience. One example is Derek Lowe, a Vertex Pharmaceuticals scientist who writes the “In the Pipeline” blog and columns for The Atlantic.

piece in the latest issue of Nature.

” … unlike books and lectures, science blogs operate with a quick turnaround that more closely resembles that of the traditional media.”

Whether such sites can compensate, at least in part, for the upheaval appears unlikely, according to one traditional journalist. Peter Dykstra, who was executive producer of CNN’s science, technology, environment and weather unit before it was closed down last year, and is now at the Woodrow Wilson International Center for Scholars, worries that the flow of information is forever changed. Science and environment news, he tells Nature, will be “ghettoized and available only to those who choose to seek it out.”

In a related editorial, Nature urges scientists to change old attitudes and “recognize the contributions of bloggers and others, and they should encourage any and all experiments that could help science better penetrate the news cycle.”

Related

Survey finds barriers to shared decision making

Do doctors really want their patients involved in decision making? And even if many do, what are the barriers that prevent such involvement from taking place? Well, a new survey sheds some light on the issue and finds that many doctors would welcome more interaction with their patients when it comes time to make decisions, according to the Foundation for Informed Medical Decision Making.

The survey of 402 primary care physicians found that 93 percent say that the concept of shared decision making sounds like a positive process, and 52 percent described it as a “very” positive process, particularly for tackling lifestyle problems and chronic conditions. In fact, about 80 percent say patients would be “much” more likely to improve in these areas with the technique. But there was slightly less confidence about using the method for reviewing surgery, cancer screening and taking new medications.

There are some important barriers, though, to implementing shared decision making. Time was cited as the largest challenge, followed by the perception that patients do not understand all they need to know and preferring patients rely on physician advice for medical decisions. For example, 82 percent say it is “very” important for patients to be informed about taking new prescription medications, but only 16 percent say most of their patients are well informed in this area.

And 78 percent say recent changes in reimbursement rates have, not surprisingly, decreased the time they can spend with each patient. And 51 percent say they are very concerned, in general, about not having enough time to spend with patients.

Just the same, the foundation believes that, by using shared decision making, physicians and their patients can “determine which choice matches what is most important to patients – delivering high quality care that is both evidence-based and patient-centered.” Here is the white paper with still more interesting insights.

FDA leader warns staff about leaking information

One day, President Barack Obama is calling for open government and transparency. The next, the acting FDA commissioner, Frank Torti, is warning agency employees not to disclose information. In his memo, issued late last week, Torti didn’t mince words about the consequences – leaking confidential info may result in disciplinary sanctions, criminal charges or could cause the FDA to be sued for damages.

Frank Torti

Frank Torti

Although Torti paid lip service to open government and transparency, he went on to write that the FDA “must comply with its obligations to keep certain information in its possession confidential.” He then cited five types of info to be kept confidential: trade secrets; confidential commercial info; personal privacy data; law enforcement records and privileged intra-agency and inter-agency documents, such as emails, memos and letters between between FDA employees. Of course, these can be fodder for a good story.

An FDA spokeswoman told The In Vivo blog, which broke the story, that the unusual memo speaks for itself. Nonetheless, as In Vivo pointed out, the memo appeared after two episodes involving the discussion or release of what FDA officials may view as privileged info. In the first, FDA scientists wrote the Obama adminstration that the review process for medical devices was corrupted by agency managers. The other involved a prominent doctor who was booted from an FDA advisory panel just before it was to review an Eli Lilly drug. The wrinkle – the doctor was publicly critical of the drug and Lilly called the FDA to complain.

Coincidentally, this occurred just after the Association of Health Care Journalists urged the White House to end existing policies that require public affairs officers to approve journalists’ interviews with federal staff, including the FDA. The policies hamper newsgathering and make it difficult for reporters to fulfill their obligation to hold government agencies accountable, according to the AHCJ letter.