Seizure Drug Trial Called a Form of Marketing
A postmarketing study of the epilepsy drug gabapentin (Neurontin) sponsored by its manufacturer was intended mainly to turn its hundreds of clinician-investigators into enthusiasts for the product, said researchers who reviewed the company's internal documents.
Called STEPS (Study of Neurontin: Titrate to Efficacy, Profile of Safety), the 1999 phase IV study "was a seeding trial used to promote gabapentin and increase prescribing among investigators," charged Joseph S. Ross, MD, of Yale University in New Haven, Conn., and colleagues.
They cited internal memos from Neurontin's manufacturer, Parke-Davis (now part of Pfizer), describing the trial itself -- not its results -- "as a key marketing tool for the promotion of gabapentin," Ross and colleagues wrote in the June 27 issue of Archives of Internal Medicine .
Not only did the trial put the product into the hands of 772 physicians recruited as site investigators, but it gave Parke-Davis multiple opportunities to provide them with marketing materials and also blocked them from prescribing alternative medications to the patients they enrolled, according to Ross and colleagues.
As consultants to plaintiffs' lawyers in litigation against Parke-Davis and its subsequent owners, the researchers reviewed some 400 documents mentioning the STEPS trial obtained from the companies.
An earlier analysis, published in Archives of Internal Medicine in 2006, had suggested that STEPS was primarily intended for marketing rather than serious research, but its authors had access to only about 250 documents and depositions from the 300,000-item litigation trove, which is now fully available.
As Ross and colleagues explained, seeding trials are ostensibly conducted to generate new clinical information but are really just a way for drug companies to develop relationships with and encourage prescribing by individual clinicians.
They are distinguished by having large numbers of site investigators without a clear scientific reason, and often by a lack of rigor -- both of which were the case in STEPS, according to Ross and colleagues.
According to the Parke-Davis documents, the company sent recruitment letters to about 5,000 clinicians for the trial and had more than 1,500 of them attend briefings where the drug, in addition to the study, was promoted.
STEPS was designed as an unblinded, uncontrolled trial that was supposed to evaluate the drug's efficacy and safety. About 2,800 patients were enrolled, or less than four for each site investigator.
Purpose Of Marketing - News
The main bulwark against such trials -- which are unethical insofar as patients are not told of the marketing purpose -- are the IRBs that must approve them. But IRBs are often lax and rife with conflicts of interest, Ross and colleagues noted -- as
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Indicators of an alternative purpose of the STEPS trial came to light as a result of litigation against Parke-Davis for illegally marketing gabapentin, which was approved by the US Food and Drug Administration (FDA) for the treatment of epilepsy,
She will be working under Scott Beaudoin, who formerly held the SVP position and has been promoted to director of cause marketing/CSR for North America. “I think MSLGroup's commitment to purpose-led marketing for huge brands lends itself to .
The call for best practices in ethical marketing campaign will be conducted by the WOMMA Membership Ethics Advisory Panel (MEAP), a panel responsible for ensuring proper ethical practices of WOMMA and its member companies. The purpose of this campaign
Transparency with a Purpose: Solid Marketing Tactics at Root of ...
Scott Tingwald
It’s no secret that that ‘transparency’ has become the cornerstone for the PR profession as social media has forever changed the rules for corporate America in dealing with crisis situations and unfavorable customer feedback. Just ask the major airlines how important it is to quickly, honestly and appropriately deal with critical comments via Twitter and Facebook. They seem to have their hands full on a daily basis, calming the social media masses after losing luggage or improperly charging passengers.
But what about full transparency being the driving force behind a corporate-generated marketing campaign? What happens when a company seeks and embraces negative feedback just as much as positive reinforcement from consumers?
That’s exactly what Miracle Whip is doing with its “Love Us” and “Hate Us” counter on its YouTube page . In an effort to revive an eroding brand, Miracle Whip launched the counter earlier this year to encourage people to pick a side in what they’ve found to be a very polarizing topic – the taste of Miracle Whip. “Rather than deny this truth, it’s something that we needed to embrace,” said Sara Braun, marketing director of Miracle Whip in a recent ragan.com feature .
Now, you may recall that a colleague here at Villing & Company, Brad Rosier, panned this strategy back in March right after the launch of the campaign. Brad makes many solid arguments that the approach, to him, doesn’t pass the smell test. I know what he’s talking about. And, indeed, to many, this campaign many come off as trying too hard to be edgy and controversial, as Brad suggests.
However, while not immune to criticism, I do think this recent campaign was solid from many marketing perspectives:
Reaching a younger demographic – Miracle Whip realized that today’s youth, which they covet, respond positively to transparency – so why relegate it to reactive PR situations? Create it yourself, step back … and spread the word. Sure, some may reject this attempt to reach them solely because it is a corporate-based marketing campaign. But I believe many others will not be as cynical and embrace their openness. Creating a buzz – Given their reported declining sales over the last decade, the brand had little to lose by stirring the pot a little.
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