As a patient advocate, I daily review all of the information that I receive regarding cancer research and education so that I can share it with patients. The purpose is to provide information and updates to patients so that they can discuss their findings with their medical professionals when they find something that they believe may be a potential treatment for themselves on an individual basis.
Patients need to become involved when legislation is hurting/hindering their opportunities for treatment.Barbara Jacoby
This has become even more important in the last few years as patients find that they have less time to discuss their treatment with their doctors and doctors find that with all of the new regulations that they face, they have less time to keep up on all of the current research that is occurring. Therefore, I was extremely troubled when I came across the following summary regarding pending legislation in the CA Senate, known as SB790– Senator Maguire, quoted below:
1. Prohibits companies from conducting research in California
· Bans necessary contracting with providers, including hospitals, for research.
· Limits peer-reviewed publications backing vital clinical research.
· Blocks reimbursements in support of a clinical trial or research activities.
· Halts collaboration and consortium in the furtherance of research activities.
· Discourages participation in research studies that help healthcare providers with educational and patient-care information.
· Eliminates equipment, materials, supplies or other expenses associated with a clinical trial.
· Interrupts participation on Data Monitoring Committees – The U.S. Food and Drug Administration (FDA) requires compensation to providers for serving on these committees.
California’s life sciences sector currently includes over 3,000 firms employing nearly 300,000 Californians and generating $147 billion in revenue ($15.6 billion in taxes).
2. Would prohibit education to providers – hindering patient care
· The FDA approves any materials provided by manufacturers about their medicine. Educating providers is a way to communicate essential information about innovative treatments, including:
· Information on a new medicine.
· New treatments approved for the medication.
· New clinical trials.
· Changes to package inserts.
These education sessions can take hours and companies would be prohibited from providing meals.
3. Duplicates existing laws that prevent undue influence
· The federal Anti-Kickback Statute already prohibits any actual or offered value transfer in exchange for healthcare business, which is precisely the behavior targeted by SB 790, with stiff penalties for any violations.
· Federal guidance has been issued to drug manufacturers on what is necessary to comply with anti-kickback laws. In fact, California already has laws requiring manufacturer compliance with that federal guidance.
· Federal Physician Payments Sunshine Act – The activities targeted by SB 790 are already reported for physicians and teaching hospitals under the Act, which had an estimated compliance cost of $269 million in the first year and $180 million for each year thereafter. SB 790 would require, at great cost, state-specific monitoring of these activities for not just physicians, but hundreds of thousands of additional California healthcare professionals for these activities, negatively impacting research and innovation.
· California law – SB 1765 ((2004) California Business & Professions Code 119400, 119402) requires pharmaceutical companies to set an annual aggregate limit on certain promotional expenditures provided to a medical or health care professional as defined under the statute.
For all cancer patients, or for any person dealing with a medical issue, research, including the clinical trials that ultimately bring new treatments to the market, are of primary importance. The efforts to further restrict such trials that are already under strict governance is one more way to restrict the results of research that is intended to benefit the patient. Further, by adding additional restrictions to medical providers by not allowing them to receive compensation for time, travel, etc. to attend conferences where they can provide their expertise and/or receive new/updated education about treatments that may be of great importance to their patients is unacceptable.
In this day and age, asking anyone, whether as a medical professional or a patient expert to not receive compensation for their time, travel, etc. for the work that they do where they are providing input or receiving information to share with patients on any level is unacceptable. And although this legislation is a CA bill, you may want to check what is going on in your own State’s legislature since patient advocacy is now more important than ever. Patients need to become involved when legislation is hurting/hindering their opportunities for treatment.