A Better FDA? Why Not? [From the December 2011 GxP Perspectives Blog]
Is FDA necessary? Most people I know would say yes. We need a strong, independent, effective FDA. Does FDA need improvements? Again, most people I know can point to numerous issues that FDA could handle better. Today, in the Business Section of the New York Times, there is an article on why we need government and the benefits of better government. Yes, the article by Robert H. Frank is about the Tompkins County New York Department of Moter Vehicles, but he outlines some basic principles for better government. Like better use of technology to make government more efficient. FDA is making similar efforts regarding technology. That’s great and I encourage the development. Here are three other areas that I think that FDA can improve:
1. Consistent training for field investigators….
- Sen. Chuck Schumer Pressures the FDA on SPF Safety (bellasugar.com)
- The FDA Is Cracking Down on Cosmetics Claims (bellasugar.com)
- HCG Diet Slapped by FDA, FTC (fooducate.com)
- Santa Claus Would be the FDA’s Public Enemy #1 if He Were Real, Says Former FDA Regulatory Counsel (prweb.com)
- Hangover Cure is Approved by the FDA Just in Time for Holiday Parties (thenewx1023.radio.com)
- Should the FDA Recall Yaz and Yasmin? (prweb.com)
- Obama FDA ‘forced’ to review BPA safety (junkscience.com)
Excerpt from Dr. Rubin’s blog
In 1979, the publication of Healthy People: The Surgeon General’s Report on Health Promotion and Disease Prevention represented the first report emphasizing the importance of decreasing early mortality through health promotion and disease prevention programs. This led to the Centers for Disease Control and Prevention’s development of specific, national 10-year health objectives, contained within a collaborative initiative known as Healthy People. The 2010 objectives fell within 28 public health focus areas including cancer, diabetes, immunizations and infectious diseases, injury and violence prevention, nutrition and overweight, and many others (the full list can be found here).
So as a country, how well did we meet the Healthy People 2010 objectives? I guess that depends on your definition of success. A final review of the 2010 results showed that of the 733 objectives for which data were available:
23% met the 2010 targets
48% made progress toward the 2010 targets
5% showed no change from baseline
24% moved away from the 2010 targets
Structured Evidence Queries (SEQs) for the Healthy People 2020 Leading Health Indicators
Healthy People 2020 (HP2020) is a ten-year health promotion program for improving the health of all Americans. Led by the U.S. Department of Health and Human Services, HP2020 is organized into 42 subject areas with 600 public health objectives. These objectives, developed and selected through consultation with a broad range of organizations, groups, and individuals, provide a framework for monitoring and measuring improvements in health status of the American population over the ten-year period from 2010 to 2020.
The Leading Health Indicators (LHI) are a set of objectives carefully selected to represent high-priority health issues and actions that can be taken to address them.
The Healthy People 2020 Structured Evidence Queries (SEQs) are pre-formulated PubMed search strategies intended to support both public health practitioners and researchers in their efforts to achieve specific HP2020 public health objectives. The HP2020 SEQs provide citations to the most up-to-date peer-reviewed literature from the PubMed database of the National Library of Medicine.
For persons interested in using the SEQs or other NLM resources to create products for the LHI App Challenge, e.g., for mobile devices, please contact the PHPartners Team. More general information about PubMed linking and E-utilities is available from Entrez Programming Utilities Help
The Structured Evidence Queries link each Leading Health Indicator objective to PubMed citations related to that objective. For two LHI objectives, in Clinical Preventive Services (vaccination rate for toddlers) and Injury and Violence (fatal injuries), a set of SEQs is provided to further assist users. Your feedback will help us refine the SEQs over time.
To use an HP2020 SEQ to search PubMed, please expand the Leading Health Indicator topic area (“+”) and click the button by the LHI objective.
[Go to http://phpartners.org/hp2020_lhi.html to use the structured evidence queries below]
1. Access to Health Services
2. Clinical Preventive Services
3. Environmental Quality
4. Injury and Violence
5. Maternal, Infant and Child Health
6. Mental Health
7. Nutrition, Physical Activity and Obesity
8. Oral Health
9. Reproductive and Sexual Health
10. Social Determinants
11. Substance Abuse
- Healthy People? Not Quite Yet. (drrubinblog.com)
- Improving health will take a village (jflahiff.wordpress.com)
- Collaboration Of Public And Private Health Partners Is Essential For Health Improvement (medicalnewstoday.com)
- Syphilis Rises 36% In USA In Four Years (jflahiff.wordpress.com)
- Thank you Public Health! (healthygenerations.wordpress.com)
- Public Health Investments Pay Off (jflahiff.wordpress.com)
- Public health experts condemn plans (mirror.co.uk)
Excerpt from the article
…For decades, hundreds if not thousands of studies have examined the relationship between our activity levels and our health. Only recently have researchers turned their attention to the consequences of sitting at a desk all day and lying on the couch all evening.
“We’re talking extensively and producing public health messages about what we don’t do. And we don’t talk at all about what we do do: We don’t move very much, but we do sit idle,” says Dr. Mark Tremblay, director of healthy active living and obesity research at the Children’s Hospital of Eastern Ontario Research Institute.
The average person now spends 9.3 hours a day sitting. People who sit for six or more hours per day are 40 per cent more likely to die within 15 years compared to someone who sits less than three hours a day, even if they exercise. Obese people sit 2½ hours more each day than people of normal weight, according to data compiled by Medical Billing and Coding, a U.S.-based organization….
- Is Your Desk Job Killing You? (bigthink.com)
- Bad Office Chairs: Crippling Workers in the European Union – Until Now. (prweb.com)
Whether you call it Health 2.0, Medicine 2.0, or e-Health 2.0, the Internet is changing medicine in ways that challenge the status quo. This article explores how a group of amateurs who call themselves “health hackers” and “citizen scientists” are trying to use the Internet to connect with other patients, run experiments, and conduct clinical trials on their own diseases.
Dr. Gunther Eysenbach states “Medicine 2.0 applications, services and tools are Web-based services for health care consumers, caregivers, patients, health professionals, and biomedical researchers, that use Web 2.0 technologies as well as semantic web and virtual reality tools, to enable and facilitate specifically social networking, participation, apomediation, collaboration, and openness within and between these user groups.” One review examined 46 different definitions of Health 2.0, and Eysenbach’s definition does not emphasize a key component of the concept: amateurs can use these new Internet tools to do work that in the past was only done by professionals….
Charles Blanke, MD, Director of Gastrointestinal Oncology at the Oregon Cancer Institute summarizes the advantages and disadvantages of their patient-initiated approach:
This is powerful and compelling work! I remain incredibly impressed by the data-coordinating abilities of the Life Raft personnel. I see the major purpose of this sort of data as hypothesis generating. Unfortunately, it cannot be free of bias and thus cannot stand by itself, but it certainly can point investigators and the Company in the right direction and let us know what we need to be looking at more closely. Thus, its importance cannot be overstated….
,,,The tension between the traditional approach to medical research and patient-initiated research can only be resolved by cooperation and two-way communication between the two groups. The Mayo Clinic and PXE examples clearly show that both groups can benefit by meaningful and respectful partnership. The AIDS and ALS examples demonstrate that patients with few options and new Internet tools will continue to push the traditional research community to be open to new ideas, new approaches, and new possibilities. Gilles Frydman, founder of the Association of Cancer Online Resources, has stated, “Better-informed people are more willing to participate in the advancement of science. Those patients taking Gleevec do not consider themselves guinea pigs. They are recipients of experimental medicine.”…
- DocGreet Steadily Grows as the Leader in Health 2.0 and Medical Social Media (prweb.com)
- Connect with Project HealthDesign at Health 2.0 (projecthealthdesign.typepad.com)
- Reflections on the Medicine 2.0 conference at Stanford #med2 (medicineandtechnology.com)
- Health IT and Patient Safety: Building Safer Systems for Better Care (jflahiff.wordpress.com)
- During the Fifth Annual Health 2.0 Conference, Dr. James Mault of HealthyCircles will Showcase Innovative Technology that will Help Transform Health Care (prweb.com)