Recall the excesses in pharmaceutical sales and marketing activities of the 1990’s – paying to send doctors to major sporting events (Super Bowl, Masters, World Series, etc), handing out pre-ordered take home dinners on street corners, sales representatives were catering lunches daily, providing examining table covers with product advertising, pricey dinners and entertainment, etc.
Recently a few industry veterans met over coffee and the topic of some activities being seen in patient recruitment came up. There has been a surge in companies that provide supportive logistics for clinical trials. The logistical support includes: transportation to and from doctor appointments, temporary housing at hotels or apartments while in the clinical trial or for pre and post study visit. Lyft and Uber are being contracted to provide some of the transportation as well as “black car” limo companies.
Getting and keeping patients in a clinical trial, increases the speed at which the trial can be conducted, speeding up discovery of which drugs work and thereby reducing pain, disease and suffering. While we acknowledge how important recruiting and retaining a patient in the trial is, there’s a sense that the pendulum may be swinging too far. Typically, when that happens for too long, the government steps in and well-intentioned but burdensome regulations are added. That was done to pharmaceutical sales and marketing activities, now, pharmaceutical companies are not even allowed to give out pens and notepads. It would be better to improve our own oversight than to have something forced upon us.
Others may feel we’re over-reacting. Let us share some of the things we’ve seen and we invite you to respond with your thoughts.
- Automobile transportation: Uber Black including a uniformed driver.
- Patients being put up at Five Star hotels, after they complain about lower priced ones.
- Accommodations for extended family members are being included (for moral support).
- The current regulations allow for reimbursement of “necessary and practical” items. To accomplish this, debit/credit cards are given out and when the money runs out, more is requested and more is put back on the card. It’s been reported that a patient in one trial bought a car with their card, asked for more money and more was put on.
- Patients and families are being brought to the US from all over the globe for extended periods of time. When the study is over, do we think these families are going to want to leave?
- For their time in clinical trials, the patient and/or patient family’s financial lifestyle is being augmented and made potentially made better.
Is this excessive or necessary?
