Dr. Rocco Rotello | Cedarville University
As with most disciplines, including scientific and medical fields, clinical teams, marketing and business minds seek out a spokesperson — or Key Opinion Leader (KOL) — who will help launch a new product and with whom patients can identify. This was evident in the late 90s, which observed a new therapeutic class that entered the post-menopausal osteoporosis scene, bisphosphonates, mainly Fosamax, Actonel and Boniva. For example, Actonel from Procter & Gamble (P&G), the second drug to market bisphosphonate, had a once-a-day and then once-a-week therapy. A few years later, Actonel faced stiff competition from the launch of the once-a-month Boniva. P&G could not complete with the message of Sally Field, a well-known actress who became the face of for aging women and a key spokesperson for Boniva. Patients told their doctors they wanted what Sally was taking to protect their bones. With this as a backdrop, one can begin to see how a strong voice for an idea, product or trend can be important within the scientific and medical fields.
To track and monitor how opinions are swayed in the health care industry and combat and prevent Medicare and Medicaid fraud, the Attorney General and the Secretary of Health and Human Services teamed up to form the Health Care Fraud Prevention and Enforcement Action Team (HEAT). The Department of Justice is committed to protecting the integrity of physician prescribing decisions and ensuring that financial arrangements in the health care marketplace comply with the law. This partnership between these two entities became real during the latter part of 2015. The purchasers of P&G Pharmaceuticals and its two main brands, Actonel and Asacol, in 2009, Warner Chilcott PLC (now Actavis-Allergan), pleaded guilty in October 2015 to a felony charge of health care fraud. The Department of Justice announced that Warner Chilcott, between 2009 and 2013, at the direction of its management team, knowingly and willfully paid remuneration to high-prescribing physicians in order to induce those physicians to prescribe Warner Chilcott drugs. In addition, the government alleged that Warner Chilcott sales force used questionable practices in persuading doctors to write scripts through weak science explanations for superior mechanism of action.
Some important questions remain difficult to answer in the gray area of the KOL kingdom:
- How do KOLs become KOLs?
- Who decides who influences who in the industry?
- In what levels of an organization do KOLs need to fit into?
- Who decides to strategically bring them into a program and secure their opinion and when?
- How do you persuade them to join the team, and do they believe in the story and the data and the potential market?
- Is this product a me-too drug or is it truly break through?
- Will it add to the KOLs career accomplishments and make them more well-known and available to other teams or organizations?
- What is the compensation for the KOL?
Ultimately, companies need to decide if having a well-known KOL is worth the investment, as was the case with Sally Field and Humira’s choice of Phil Mickelson. At the end of the day, KOLs and how they might be integrated in a promising new therapy or become a speaker at medical education events or dinners, might just come down to who you know or serendipity.
Most often, the tried-and-true method of networking, building trust and securing a KOL that has demonstrated success for other programs works. In upstart biopharmaceutical companies, the KOLs or consultants are usually inventors, previous employees at a similar companies and board members and management team members who have made connections in previous settings. Therapeutic areas and various societies usually have a handful of experts who are really headliners and are important to sell the conference. For example, when precision medicine hit the radar, Leroy Hood was sought after to give opening talks.
KOLs also arise out of seminal publications. In the early 90s, when apoptosis (cell death) was a hot topic, the original inventor of cell death genes in the nematode, Robert Horvitz at MIT, was routinely invited to companies and keystone symposia to speak on the latest developments. Dr. Horvitz went on to share in the Nobel prize in this field. Investigators with a lab or practice, with a well-known procedure or technique that is successful, usually spawn multiple KOLs. For example, the new human gene editing technique, CRISPR, is generating KOLs that speak to the technique itself and the ramifications if performed in humans, which opens up a whole new area of KOLs: ethical standards, what voice is correct? It won’t be long before popular TV hosts jump on the bandwagon and have a voice!
In conclusion, one has to be cautious of trends and positioning spokespersons on your side. In the early stages of the biosimilar scene, companies like Amgen were trying to persuade everyone that you would never be able to duplicate an original biologic/antibody, and they pushed hard to inform all areas of drug discovery and development and put out numerous stories by KOLs to guard their sacred territory. However, many leaders have shown that biosimilars are real and provide a breath of fresh air in hot area of biologics and humanized antibody therapies.