Tuesday, November 15, 2011

Million Hearts Program and The New York Blood Center

Cardiovascular disease is the leading cause of death in the United States.  Two million Americans have a heart attack or stroke every year and more than 800,000 of them die.   The economic affect of these events is estimated to exceed $450 billion annually.  A recent initiative to reduce these events, Million Hearts, is a joint venture involving governmental agencies together with private sector partners.

This effort will focus on the management of the ABCDS of heart disease - Aspirin for high risk patients -  Blood pressure control - Cholesterol management - Diabetes -  Smoking cessation.  Management of these factors has more potential to prevent deaths and reduce morbidity than any other prevention program.  Less than half of the individuals with hypertension who are being treated have it adequately controlled.  The definition of hypertension has been refined and new limits for what is now considered prehypertension have been established. A review of recent studies suggests that young and middle-aged people with slightly elevated blood pressure, or prehypertension, are at much greater risk of stroke than those whose blood pressure is in the normal range.  People under age 65 with prehypertension had a 68% increased risk of stroke compared with those with normal readings, independent of other known risk factors.  Only a third of those with high cholesterol levels are receiving proper treatment.  Fewer than half the individuals with pre and early diabetes are aware of it.    

The increasing prevalence of obesity and diabetes demand that we attend to these identifiable and correctable issues in order to control the incidence of heart disease and stroke. The American College of Cardiology, American Heart Association and American Medical Association have established specific goals for treatment that may require patients to take one or more antihypertensive medications to achieve the desired blood pressure readings.  Control of low-density lipoprotein cholesterol (LDL-C) to levels below 100mg/dl has been identified as a central issue in the management of high blood pressure.  To achieve this a prescription for a statin drug is indicated.  Stopping smoking is another goal of treatment of the patient with hypertension. 

The Affordable Care Act (ACA) provides a foundation for the Million Hearts' project by increasing coverage and facilitating improved care.  It waives patient cost sharing or insurance copays for preventive services, including blood-pressure and cholesterol screening and smoking-cessation counseling and treatment, for enrollees in new private insurance plans.  While cost is a significant factor in establishing most preventive medical programs, the biggest hurdle for all efforts to identify those at risk of untoward events is the identification of those individuals for whom treatment is both possible and appropriate.  For many conditions, population wide screening to identify those with important risk factors is not cost effective.  

The New York Blood Center, NYBC, a community based, nonprofit, independent organization, is the central blood collection facility that provides blood components to 200 area hospitals serving more than 20 million people.  With approximately 2000 blood donors a day being processed at the blood center's facilities, it has designed and implemented an extensive donor screening program for abnormal levels of cholesterol, blood sugar and blood pressure.  The NYBC's Cardiovascular Disease Risk Assessment and Prevention Program is a demonstration project providing free screening, risk assessment, education, and referral of at-risk persons for further evaluation and treatment.  The program is intended to advance cardiovascular disease prevention, motivate lifestyle changes, and ultimately improve the health of the people who provide blood donations each year to the NYBC.  This screening program is integrated into their blood collection routines.  The efficiencies of this program make it an appealing template for the identification of those at risk who would benefit from medical intervention to reduce their risk of heart disease and stroke. 

Effective preventive medicine strategies rest on the identification and mobilization of efficient methods to capture the appropriate at risk populations.  Only by employing the practices, procedures and processes of independent ancillary health organizations such as the New York Blood Center will it be possible to achieve the ambitious goals of the Million Hearts program.     

Wednesday, November 2, 2011

Medical Practice and Government Regulation

In July, the Food and Drug Administration issued a warning about serious complications associated with the use of surgical mesh in gynecological surgical procedures. Based on 1,500 reported complications between 2008 and 2010, the letter advised surgeons to consider the risks of using mesh and recommended that patients be fully informed of potential complications.  The mesh was approved for use 10 years ago and has been placed in thousands of women.  Complications include perforation of the intestine, hemorrhage and death.  Still more disconcerting, the FDA warning points out it is not clear that surgery with surgical mesh is any more effective than alternative procedures without mesh; and use of it may expose patients to greater risks, including impairment of quality of life and the possibility for multiple surgeries to remove it.  Furthermore, they warn it may not be possible to remove the mesh entirely and complications may never be completely resolved.

The FDA summarizes the adverse events reported through its Manufacturer and User Device Experience data base as well as from peer reviewed literature.  This warning ends with the recognition that rigorous comparative effectiveness research is now essential to prove product safety and efficacy    http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.

It was as a result of a spate of public health disasters associated with a few new drugs and medical devices in the 1970s that public attention was focused on the potential for these kinds of problems.  At that time, laws were passed to protect the public.  In the 1990s Congress enacted additional regulations to the original statutes.

This is hard to believe but the standard for approval of medical devices is safety and effectiveness, which is interpreted to mean a new device is equivalent to a previously approved device. The implicit assumption is if a new device is equivalent to a previously approved similar device, it will be as safe and effective as that one.  Recently, on several occasions, the FDA and the courts disagreed with that assumption which is at the very least confusing.  However, we have a system in which a new device can enter the market because it is substantially equivalent to another device that may have been approved only because (again) its manufacturer showed it was substantially equivalent to yet another previously approved device.  This could and may already have resulted in a cascade of approvals going back to devices that might never have been assessed for safety or effectiveness.  To top it off, a new device without any single product to which it is similar can be cleared by having various characteristics that are equivalent to individual traits of two, three or more different previously cleared devices and those devices do not even have to have been marketed!  In this case, there may be no real-world experience to provide a basis for assessing safety or effectiveness.

Recently, a committee of the FDA decided this house of cards should be replaced with an integrated, pre-marketing and post-marketing regulatory process where a data base is created to permit ongoing evaluation of the safety and effectiveness of a device.  The experience with the use of surgical mesh in gyn surgery demonstrates that the only hope for capturing the information needed to maximize the likelihood of uncovering significant risk of serious complications quickly is rigorous post-marketing surveillance.  The realization that such a program is sorely needed for all devices and drugs led the FDA to establish the new Risk Evaluation and Mitigation Strategies, REMS.

Recognizing that 90% of adverse drug reactions go unreported and that such events reported by physicians is the primary way drug safety is monitored in the U.S. by the FDA, the Physicians Desk Reference network which is an organization that is a link between physicians and drug manufacturers has established a mechanism to report such events that is a simple, free online service for reporting adverse drug events https://www.rxevent.org.

As a reaction to the thousands of lives damaged or ended and billions of dollars spent as a result of widely used, unproven methods and with the acknowledgment that so much of medicine is based on subjective and highly idiosyncratic interpretations of treatment responses, the journal Evidence-Based Medicine http://ebm.bmj.com was founded in 1995 as part of the British Medical Journal group.  Evidence-Based Medicine systematically searches a wide range of  medical journals applying strict criteria for the validity of research.  Experts critically review the most clinically relevant articles and summarize them including commentary on their clinical applicability.

Effective regulation is in its infancy.