IMCLONE IMPLICATIONS: Allen Houston looks at some of the PR lessonslearned from the ImClone saga

On May 14 last year, biotechnology start-up ImClone parlayed the buzz that had been growing around the New York-based company into a well-orchestrated media feeding frenzy that sent ImClone stock soaring, and garnered national attention.

On May 14 last year, biotechnology start-up ImClone parlayed the buzz that had been growing around the New York-based company into a well-orchestrated media feeding frenzy that sent ImClone stock soaring, and garnered national attention.

During the annual American Society of Clinical Oncology (ASCO) conference, ImClone unveiled phase II trial results of IMC-C225, a treatment it claimed could be used to fight cancer when combined with standard chemotherapies.

The most phenomenal finding was that 22.5% of colon cancer patients who used the mix achieved greater than 50% tumor regression.

The results were amazing enough to titillate the press, and make the company's findings a topic of intense discussion over the three-day conference.

And after the event, coverage was positively glowing, with IMC-C225 being touted as a possible breakthrough treatment. Bristol-Myers Squibb then paid a staggering $2 billion for a 20% stake in ImClone that guaranteed the pharmaceutical giant the marketing rights to IMC-C225 (Erbitux as it later become known). The drug seemed destined for fast-track approval, and the Waksal brothers who head the company became newly anointed emperors of the biotech sector. And then something went wrong.

On December 28, after several months of ImClone's stock climbing, the FDA refused a letter of application for Erbitux. Samuel Waksal stepped forward to tell investors that the rejection was only a matter of some missing information from the clinical trial application, but the FDA's letter to ImClone leaked out and created more controversy, hinting at deeper flaws in the company's application for Erbitux.

ImClone stock has since fallen 72%, and both Congress and the Justice Department are investigating the beleaguered biotech. Around a dozen lawsuits have been filed against it on behalf of investors. And the colorful past of the Waksal brothers has drawn further unneeded attention.

ImClone's contamination has affected the entire biotech sector. The company's downfall poses serious intellectual questions to the healthcare PR profession: When should an agency consult a client to tone down aggressive promoting?

When should an agency turn down a client? What role does expertise play in promoting a clinical trial treatment? And how do you market a drug that hasn't received FDA approval, when 80% of new treatments fall at this hurdle?

ImClone and its agency of record, GCI Group, which refused to comment for this story, might be accused of releasing information too soon and of making exaggerated claims, but there is an even stronger argument to suggest they are the scapegoats for something that is a much broader issue, with implications spreading far and wide across healthcare PR.

Given that the majority of biotechs have a low profile and a limited amount of funding, they see a need to be as aggressive as possible in raising awareness for their treatments. Biotech companies may have sophisticated views of science, but not necessarily of the role communication plays.

Many of these companies simply want PR to enhance the value of their stock, and while healthcare PR can do a lot of things to help prepare a client, if the clinical trial is not solid, there will be more cases like ImClone.

"Biotechs are generally aggressive in wanting to raise their visibility,

says David Catlett, president of Ketchum's global healthcare practice.

"But it's important for healthcare PR to take a long-term view of communications.

That should be an agency's guiding principle. As an industry, we're not in this for a quick fix, but for the long haul."

Pre-approval promotion dangers

Walking the shadowy area between promotion and hype is tricky when the product has yet to receive FDA approval. "There's nothing wrong with promoting products within the FDA guidelines or sponsoring concerts," explains Laura Schoen, president of Weber Shandwick Worldwide's global healthcare practice.

"But you need to understand the importance of the science that you have, and not mislead the public."

Susan Atkins, president of Susan E. Atkins Associates, is concerned about the way new treatments are hyped. "Making a spectacle out of human healthcare is inappropriate,

she says. "Having a party about an unapproved drug is inappropriate. Once it's approved, you can have all the parties you want. I don't think hype has any place in the information stage of an unapproved drug."

The danger of over-hype has led some PR agencies to tow a more pragmatic approach to treatments awaiting approval. "Agencies have to be conservative,

says Michael Durand, EVP of Porter Novelli's global healthcare practice. "FDA reviewers aren't going to be fooled by press releases and cover stories in Fortune and Forbes."

A biotech's need to be overzealous in marketing - and the intense pressure it feels to raise funding - can sometimes put it at loggerheads with its agency. This is especially the case during the critical FDA approval process, when in some instances, a company may want to push the envelope further than it should by making claims that can't be backed up with science.

An agency has to watch out when in-house marketing people start pushing the boundaries of a campaign or, in some instances, when the company starts making claims that the research does not support.

Susan Noonan, president of Noonan & Associates, has had to show potential clients the door because they presented the agency with scientific claims without scientific underpinnings. "Spinning data to make a product much more desirable is unacceptable,

she warns.

WSW's Schoen has had similar experiences. "There were potential clients who came to us to promote their treatments for anthrax,

she says. "And I turned them all down because they saw an opportunity to capitalize on a need. I'm not going to be part of a campaign that misleads people."

Even established companies sometimes want to promote a pipeline product in a manner that leaves them vulnerable to media attacks if the products don't perform to expectations. However, it is PR's responsibility to counsel clients even if the advice is unpopular. "Being a good healthcare PR professional doesn't always mean doing what the client wants,

says Lloyd Benson, EVP of Schwartz Communications.

Strength in knowledge

A knowledge of science can be particularly useful when it comes to taking a client through the arduous FDA approval process. Noonan Russo has eight PhDs on staff, while almost two thirds of staffers at Susan E. Atkins have science degrees. Schoen made it a priority to educate herself on healthcare. "When I decided to go into healthcare, I went back to school and took courses that I needed in the medical field,

she says. "I also read all the major medical journals.

An agency that is not up on the science is going to be very naive, and make a lot of mistakes,

she says.

Those who spin their backgrounds to attract healthcare clients are not able to deliver the kind of expertise their clients deserve. "For people who have not done this before, it's easy to step on land mines,

says Benson.

A thorough knowledge of FDA regulations is also invaluable, as is finding a third party who can validate the client's claims. The gold standard is to have results published in reputable medical journals. "Feedback from the FDA is critical,

adds Don McLearn, EVP of Fleishman-Hillard.

"Getting a peer-reviewed article gives you the kind of legitimacy that is golden with the FDA."

Labeled as "little Enron,

ImClone will have a difficult time regaining the trust of investors and the public. It's still not exactly clear what happened, though ImClone denies wrongdoing, and some doctors believe Erbitux does have the potential to be a breakthrough cancer treatment. Still, others allege ImClone was inflating results of a seriously skewed phase II test.

So, can ImClone recover from this?

"At the end of the day,

says Noonan, "ImClone has to set clear milestones, keep the public informed, and have a very steady communication plan."

Durand sees a more radical solution: "If the company wants to salvage its reputation, it's going to have to do another clinical trial and ask the Waksals to step down,

he says. "They have become a distraction as to whether the company can work or not."

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