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 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.