Filed under: pharmaceutical marketing, Uncategorized | Tags: Big Pharma, bmj, brands, cochrane, pharma, pharmaceutical, tamiflu, transparency, trust
The internet was blazing hot yesterday and today about the latest, in now an ever-growing list of transparency issues with Big Pharma and blockbuster drugs. The latest victim – Roche’s Tamiflu. According to a recent analysis published by the British Medical Journal, it was concluded that Tamiflu had “modest effectiveness” against the symptoms of the flu in otherwise healthy adults — cutting symptoms by about a day.
The report, an update of a 2005 analysis by Cochrane Collaboration, excluded eight studies funded by Roche that haven’t been published and whose full data wasn’t given to the researchers. The exclusion reversed the group’s earlier finding that Tamiflu protects against complications.
The report raises questions about how drugs are reviewed, approved and distributed, Fiona Godlee, the British journal’s editor in chief, wrote in an editorial. The studies originally used to establish the benefits of Tamiflu were written by Roche employees and paid consultants, under-reported serious side effects and failed to clearly identify all the authors, she wrote. In at least one case, a study was attributed to a researcher who disavowed any involvement to the journal, Godlee wrote.
Follow the story here:
Filed under: advertising | Tags: advertising, AdViews, marketing, pharma, pharmaceutical, television, youtube
Simple and effective. More classics can be found at AdViews.
Filed under: interactive, mobile, pharmaceutical marketing | Tags: advertising, android, Big Pharma, iPhone, layar, marketing, mobile, pharmaceutical, physicians, video
Coming to a mobile phone (Android and iPhone) near you, in the not so distant future, is the world’s first Augmented Reality Browser – Layar. Layar is a free application for your mobile phone, which shows what is around you by displaying real time digital information on top of reality through the camera of your mobile phone.
Layar is derived from location based services and works on mobile phones that include a camera, GPS and a compass. By looking through the phone’s camera lens, a user can see houses for sale, popular bars and shops, jobs, etc. I can see a world of opportunity for the healthcare industry, especially for providers and physicians. What do you see?
Filed under: pharmaceutical marketing | Tags: advertising, agency, Big Pharma, FDA, marketing, pharmaceutical
In pharmaceutical advertising, we find ourselves in a state of constant regulation as everyone tries to ensure each piece created meets FDA requirements. This struggle between advertising the benefits of a drug and satisfying the necessity to indicate the risks (in increasingly larger quantity and size) is one we face daily. With the recent release of the draft form of Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion , a set of non-binding recommendations for print and broadcast promotion, the FDA is attempting to help us along. The stated goal of the draft guidance is to clarify the factors the FDA considers in evaluating ads and promotional labeling for prescription drugs and restricted medical devices.
Overall, the FDA is clarifying the presentation of risk information so that it is equivalent to the presentation of benefit information, which is nothing new. But they are doing this by including more detail and examples. Their examples and occasionally vague language indicate how tricky this situation can be, not only for advertisers but also for the people doing the regulating.
One of the most exciting aspects of the draft guidance is the fact that the FDA will be accepting comments and suggestions for a 90-day period. Though no one can say for sure if the FDA will implement the suggested changes they receive, now is the time to review these draft recommendations and share your thoughts. If you think the examples they provide are not sufficient, you should request more, better examples. If you think their recommendations aren’t practical, you should tell them that and explain why. Maybe they’ll agree. We now have the opportunity to perhaps gain some control over a situation that affects pharmaceutical companies and advertisers daily. We shouldn’t let that opportunity pass without at least trying to make a difference.
Comments and suggestions can be submitted until August 24, 2009. Be sure to include the docket number, FDA-2008-D-0253, from the notice of availability that came out on May 27, 2009.
Send comments to
Division of Dockets and Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Filed under: Uncategorized | Tags: AMWA, clinical study, communications, content, data, drugs, EMWA, FDA, ghost writing, guidelines, healthcare, ICMJE, medical journals, pharma, pharmaceutical, physicians, WAME
The debate over who should write medical journal articles has been raging for years. Although heated and passionate at times, these debates are often imprecise about what constitutes ghostwriting or what possible benefit there is in employing a professional medical writer. Let’s clear up some half-truths and misconceptions.
He’s not a ghost if you can see him.
There are definitely ghostwriters among us. At its most extreme, ghostwriting is the use of an invisible writer hired by the marketing department of a pharmaceutical company to produce a selectively favorable report of their product, with authorship attributed to a high-profile investigator whose sole participation is cashing their honorarium check. This extreme example is shunned by most who are responsible for producing medical communications. More often than not, journal articles are written by medical writers who adhere to rigorous ethical guidelines (EMWA, ICMJE, WAME, AMWA). Central to appropriate medical writing is close collaboration of the professional writer with faculty authors who direct and control content.
Who are you going to call?
Another crucial aspect of professional medical writing is transparency. Successful medical publications are a team effort. Just as physicians investigate, statisticians calculate, and peer reviewers authenticate, the job of the medical writer is to communicate. Skilled medical writers perform the time-intensive tasks involved in clarifying and translating data into a submission-ready manuscript. Full disclosure of the contributions of all members of the team is essential to restore trust in medical literature.
Is it time to give up the ghost?
Investigators cite limited time as the most common reason why they do not convert clinical trial data into publishable manuscripts. A 2005 study of publication rates of oncology clinical trial data found that up to one third of clinical research in oncology remains unpublished. A recent survey for the Food and Drug Administration found that encouraging the participation of medical writers would help reduce the non-publication rate associated with industry-sponsored clinical trials.
And now a word from our sponsor…
Much of our medical literature is funded directly or indirectly by the pharmaceutical industry. We need them and they need us. At our best, the collaboration results in significant advances in healthcare. A final step toward eliminating hidden biases and restoring trust in medical literature is full disclosure of industry support and open access to clinical study data.
Filed under: Uncategorized | Tags: Big Pharma, gifts, marketing, medical conferences, meeting planning, pharmaceutical, PhRMA and AdvaMed codes, physicians, reps, swag, tchochkes, trade shows
Tchotchke—originally from a Slavic word for toys. The term has a connotation of worthlessness or disposability, as well as tackiness. The word may also refer to swag, in the sense of the logo pens, key fobs , and other promotional freebies dispensed at trade shows, conventions, and similar large events.
It appears that the time has come for banning the promotional giveaways typically offered at booths. What do you think?
Are the docs ready to give up that maze and souvenirs for their family?
While a number of the attendees at medical conventions are there for the education, there are a fair number who still enjoy the tchotchkes. What about populating the exhibit hall with simulation centers, workshops, and demonstrations? Sounds like a good idea to me; I have noticed that the lines are the longest in the booths with the simulators, rivaled only by the lines to the coffee bar and the ice cream station. So what are your thoughts? Do you think the simulation centers, workshops, and demonstrations will be the pit stops along the paths of the exhibition halls of the future?
We, as healthcare meeting organizers, need to help those who are faced with the new PhRMA and AdvaMed codes.
Exhibitors are attempting to focus on highlighting educational experiences at their booths to draw attendees. The American Epilepsy Society is exploring the possibility of helping exhibitors arrange for snacks from their booths. They are looking to help exhibitors access a popcorn machine, coffee bar, ice cream station, chair massage, or even a shoeshine stand. Do you feel that these incentives “walk the line” between meeting and violating new codes?
It’s apparent that medical associations and pharmaceutical corporations are well aware of the changes to the PhRMA and AdvaMed codes, but that’s not necessarily the case for meeting attendees.
Some of the associations have been asked how they are going to inform attendees about the changes so they understand why they’re not getting the same kinds of giveaways at exhibit booths. Randy Bauler, CEM, corporate relations and exhibits director of the American Association of Critical Care Nurses, Aliso Viejo, California is quoted saying, that AACN is putting a statement in its exhibits directory as well as notices in the conference daily. “We’ll call attention to the new codes [and explain] what that means to them, the attendees, when they visit booths,” he says. “We believe we have an obligation as an association to help educate our attendees about these changes.”
What are your thoughts on this? Do you have any ideas on how our industry can make this change, conforming to regulations while pleasing both meeting attendees and our clients? I would love to hear your comments.
Debbie Hagan| Senior Event Planner