It was just a matter of time before Celgene Corp. would cross paths with the Thalidomide Victims Association of Canada (TVAC) in its quest to obtain FDA clearance to market and sell Thalomid, a version of the controversial drug Thalidomide.
TVAC is the most vocal force against the drug's resurgence to treat a variety of illnesses, but the common ground - safe drug distribution and a comprehensive education - was too compelling for either organization to ignore.
As the Celgene-TVAC relationship continues to unfold, it already is being regarded as a far-reaching case study in how pharmaceutical companies and adversarial advocacy groups can work independently toward a common goal. Although the two will never completely see eye to eye, they've established a base level of respect that is allowing each organization to keep the safety issue at the forefront.
Now, the pivotal question is trust especially given Thalidomide's horrific history. The drug, which was prescribed to pregnant women for morning sickness in the late 50s and early 60s, caused thousands of birth defects. At least 200 Canadian babies were harmed, and at least 125 of them are alive today.
Celgene, which recently received FDA clearance to market Thalomid for leprosy but ultimately wants to get the green light for other applications, including AIDS-related and cancer-related conditions, has TVAC worried.
"Basically [Thalomid] was licensed for AIDS and cancer treatments, not necessarily leprosy. Celgene and the FDA should have been more honest [about their intentions]," says Randy Warren, TVAC's president.
Despite the trust issue, both sides agree that the distribution model in place, called System for Thalidomide Education and Prescribing Safety (STEPS), is a step in the right direction to ensure the drug's appropriate use. STEPS, which will be in place when the drug is marketed (potentially as early as this summer), incorporates several safeguards for pregnancy prevention.
When Celgene met with TVAC for six hours last year in Canada, neither company knew what to expect. "We were both anxious, TVAC thought that drug companies had not been fair and candid about their intentions [for Thalidomide] and we were worried that they might pull a PR stunt to embarrass Celgene," says Bruce Williams, Celgene's VP of sales and marketing.
The meeting proved to a sobering ice-breaker with most of the time spent educating Celgene on TVAC's plight with the government and drug companies exhibiting a lack of respect for Thalidomide survivors and locking them out of research efforts.
Ultimately TVAC evolved to the position that if the drug is proven to effectively treat certain medical conditions; TVAC wouldn't stand in the way of its progress. But this cooperation was far from a full nod of support.
Common Ground
Celgene and TVAC agreed to disagree on the following issues:
- Putting a skull and cross bones on the labeling;
- Recommending that the FDA ban off-label prescribing (which would restrict physicians from prescribing Thalomid for any condition except leprosy right now);
- Developing an aggressive physician certification; and
- Establishing a healthcare fund for potential Thalidomide babies.
In spite of their areas of disagreement, Celgene's marketing initiatives, including STEPS, represent a major collaborative milestone.
For instance, the packaging - at TVAC's insistence - will feature the strong language "Don't get pregnant" that will be accompanied by the universal symbol (an encircled picture of a pregnant woman with a line drawn through it). And the patient education video highlights major Thalidomide side effects using Giselle Cole, a TVAC member and Thalidomide survivor, as a visual reminder of why pregnant women should not take the drug.
Thalomide: The Breakthrough
The PR strategy, engineered by New York-based Makovsky & Company, focuses on repositioning Thalomid as a breakthrough drug of the 90s and avoiding the "ethical" trenches by highlighting favorable clinical data and positioning key health experts for the media, says Diane Weiser, who heads the agency's effort.
Coordinating PR efforts with TVAC also has put the agency in a unique position. "This account has been an emotionally important experience. We have walk a fine line to achieve our client's goals and objectives while being sensitive to all of the [advocacy] groups that will be impacted [by Thalomid's FDA approval]," says Weiser. (Celgene, Bruce Williams, 732/805-4091; Makovsky, Diane Weiser, 212/508-9670; TVAC, Randy Warren, 519/681-0357)
Patient Education Program Stresses Safety
Celgene's System for Thalidomide Education and Prescribing Safety (STEPS), which targets patients, physicians and pharmacists, is the result of a concerted effort between the drug company, FDA and the Thalidomide Victims Association of Canada (TVAC). The Warren, N.J.-based pharmaceutical manufacturer is using the program to monitor the drug's safety. The initiatives require:
- Physicians and pharmacists to register to receive educational materials explaining risks and pregnancy prevention methods;
- Female patient candidates to take pregnancy tests before starting a treatment program and agree to use birth control;
- Men taking Thalomid to use condoms;
- Patients to sign an informed consent form after a physician consultation.
Source: Celgene