Highlight HEALTH

We are witnessing a transformation of healthcare in the information age. The Internet has become a powerful healthcare resource for both physicians and patients. e-Patients represent a new type of informed health consumer, a term encompassing both primary patients who use the Internet to educate themselves about a given medical condition for their own illness and the friends and family members who go online on their behalf [1].

In 2003, a WebMD study found that the Internet was the primary source of health information for consumers, spending more time researching health information online than any other media source [2]. According to another study, Internet health seekers reported two effects of online health resources - better health information and services, and different (but not always better) relationships with their doctors [3]. A 2005 survey found a significant number of respondents that turn to the Internet for health issues. When extrapolated to millions of American adults who utilized the Internet for decision making, 7 million online users said the Internet played a crucial or important role as they coped with a major illness, and another 17 million online users indicated that the Internet played a crucial or important role as they helped another person with a major illness or medical condition [4]. However, only 15% of Internet health seekers consistently check the source and date of health information they find online and an additional 10% check these two essential information quality indicators “most of the time” [5].

These numbers underscore the need for a system to evaluate reliability and credibility of healthcare information found on the Web. Indeed, a recent study by The Pew Internet & American Life Project, an organization that explores the impact of the Internet on (among other things) healthcare, found that 73% of health seekers have at some point rejected information from a website during a health search due to lack of credibility [6]:

“Still, 73% of health seekers have at some point rejected information from a website during a health search for one reason or another. Here are the major reasons they cite for turning away from a site:

• 47% of health seekers have decided not to use information they found because the website is “too commercial and seemed more concerned with selling products than providing accurate information.”
• 42% of health seekers have turned away from a health website because they couldn’t determine the source of the information.
• 37% of health seekers have turned away from a health website because they couldn’t determine when the information was last updated.
• Other reasons for turning away: no visible “seal of approval”, sloppy or unprofessional design, or the presence of bad information (as judged by the health seeker or the health seeker’s own doctor).”

The most widely recognized standard-setting organization on the Internet, the Heath On the Net (HON) Foundation is attempting to guide the growing community of healthcare providers and consumers on the World Wide Web to sound, reliable medical information and expertise through quality assessment and systematic and stringent peer review. The HON Foundation Code of Conduct (HONcode) addresses the issue of reliability and credibility of healthcare information found on the Internet, and sites that follow the HON Foundation’s code of conduct can display a HONcode seal. The HONcode seal links to a registration status report on the HON Foundation site and allows a visitor to verify the site’s registration. Over 4,700 HONcode accredited websites honor the standards for disclosure and responsibility in online medical publishing, making it the largest voluntary accreditation network on the Web [7]. Thus, e-Patients using the Internet to educate themselves about a given medical condition can have confidence that websites bearing the seal comply with the HONcode standard for trustworthy health information.

I’ve written a number of articles here on Highlight HEALTH that advocate taking an active part in managing your health. But how much is too much? In his article Self-Management: How Far Should you Go?, Dr. Charlie Smith writes:

“In general, it seems proper for patients to take responsibility for educating themselves about their condition, carefully consider questions they would like the physician to answer, and commit themselves to an overall fitness plan. The physician should commit to monitoring their condition, obtaining appropriate laboratory and screening tests at the right time, performing periodic examination, filling and refilling medication prescriptions, and providing recommendations and suggestions about modifications to treatment approaches.

But, this is not a clearcut forumula and, I think, the only way to strike a proper balance in defiing the right roles for an empowered patient-doctor relationship is to maintain an open attititude, discuss the issues regularly, and be prepared to adjust roles over time.”

With that in mind, here are some suggestions for managing your own healthcare in partnership with your doctor:

• Keep a copy of all your health records.
• Request an immunization schedule and maintain a record of your child’s immunizations.
• Use the Internet to educate yourself about your medical conditions.
• Ask both your doctor and pharmacist questions when you are prescribed medication.
• Research your medications and familiarize yourself with possible drug interactions.
• Prior to visiting your doctor, make a list of all prescription and non-prescription medications you are currently taking. Non-prescription medications include dietary supplements (vitamins, herbs) as well as over-the-counter products such as cold medicine and pain relievers.
• Ask if you can email your doctor with questions between visits.
• Maintain a journal of doctor visits with details on your symptoms, what was discussed and what was done (e.g. medications prescribed, x-rays ordered).
• Provide your doctor with regular feedback regarding office visits and staff.
• Maintain a healthy lifestyle. Don’t forget to wash your hands!

I encourage e-Patients and physicians to comment with their own suggestions.

References

1. Ferguson and Frydman. The first generation of e-patients. BMJ. 2004 May 15;328(7449):1148-9.
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2. Research Reveals That Internet Has Become Primary Means by Which Consumers Access Health Information. WebMD press release. 2003 Feb 10.
3. Fox S and Fallows D. Health searches and email have become more commonplace, but there is room for improvement in searches and overall Internet access. Washington (DC): Pew Internet & American Life Project Report. 2003 Jul 16.
4. Horrigan J and Rainie L. Reports: Family, Friends and Community. Washington (DC): Pew Internet & American Life Project Report. 2006 Apr 19.
5. Fox S. Online Health Search 2006: Most internet users start at a search engine when looking for health information online. Very few check the source and date of the information they find. Washington (DC): Pew Internet and American Life Project. 2006 Oct 29.
6. Fox S and Rainie L. How Internet users decide what information to trust when they or their loved ones are sick. Washington (DC): Pew Internet and American Life Project. 2002 May 22.
7. Boyer and Geissbuhler. A decade devoted to improving online health information quality. Stud Health Technol Inform. 2005;116:891-6.
   View abstract

I’ve been so busy the last few weeks I missed this altogether. Many thanks to Jenny, a Highlight HEALTH email subscriber, for bringing this to my attention.

A new U.S. Food and Drug Administration (FDA) docket was published on the FDA website last month. The draft guidance, when finalized, will represent the FDA’s current thinking on complementary and alternative medicine (CAM). Docket No. 2006D-0480: Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration [1] discusses when a CAM product is subject to the Federal Food, Drug, and Cosmetic Act (the Act) or the Public Health Service (PHS) Act.

Here’s the important part in the draft:

The draft guidance makes the following two fundamental points:
First, depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the Act or the PHS Act.
Second, neither the Act nor the PHS Act exempts CAM products from regulation.

Now, I do believe there exists a number of problems with the “natural health” industry. Foremost in my mind are issues regarding supplement extraction and processing, quality, absorption and bioavailability - there are no mechanisms in place to address any of these issues and protect consumers. [Indeed, these are some of the many reasons I recommend scientific review and assessment of third-party research and independent clinical studies.] However, the FDA draft guidance wording is so vague with respect to the extent of regulatory reach, any product used in CAM therapy or practice may be regulated. From the draft:

… depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the Act or the PHS Act. For example, the PHS Act defines “biological product”, and the Act defines (among other things):

• Cosmetic;
• Device;
• Dietary supplement;
• Drug, as well as “new drug” and “new animal drug”;
• Food; and
• Food additive.

According to the Act, “dietary supplements” include vitamins, minerals, herbs or other botanicals, amino acids, dietary substances for use to supplement the diet by increasing the total dietary intake, and a concentrate, metabolite, constituent, extract, or combination of any ingredient previously listed.

It gets better:

Second, neither the Act nor the PHS Act exempts CAM products from regulation. This means, for example, if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for foods in the Act and FDA regulations, including the hazard analysis and critical control point (HACCP) system requirements for juices in 21 CFR part 120. If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act.

Did you get that? The Act would allow the FDA to regulate raw vegetable juice if it were used as part of a disease treatment regimen.

Thankfully, the FDA has decided NOT to regulate mind-body medicine, such as relaxation, meditation or group support. No, really …

NCCAM describes mind-body medicine as focusing on “the interactions among the brain, mind, body, and behavior, and the powerful ways in which emotional, mental, social, spiritual, and behavioral factors can directly affect health” [13]. It states that mind-body medicine “typically focuses on intervention strategies that are thought to promote health, such as relaxation, hypnosis, visual imagery, meditation, yoga, biofeedback, tai chi, qi gong, cognitive-behavioral therapies, group support, autogenic training, and spirituality” [14].
In general, CAM practices in this domain would not be subject to our jurisdiction under the Act or the PHS Act.

Needless to say, the natural health community has been up in arms about this. The flexibility of regulation the draft guidance allows the FDA is unprecedented and dangerous. Surprisingly however, the Organic Consumers Association (OCA) published this statement:

… after painstaking review of the FDA guidance document we have determined that the document does not call for any NEW regulatory or enforcement action, but merely clarifies existing ways that the FDA classifies (or “thinks”) about different types of products used in alternative and complementary medicine. After some discussion with our colleagues in the natural health freedom movement, we have decided that this document is not of any real significance.
This is not to say that we are happy with the FDA. We are NOT. Due to political appointees from the pharmaceutical and agribusiness industries, they’ve been asleep at the wheel with GMO, synthetic food additive, and pharmaceutical safety testing. It is high time they subject these products to the same type of rigourous scrutiny they seem to have for natural health products. And should the FDA decide to further target natural, non-synthetic health products, we will hit back with all our might.

The OCA statement really confuses me, because the entire issue stems from how the FDA wants to “think” about CAM products. The language used in the draft guidance is so broad that it would allow the FDA to regulate any dietary supplement that has any beneficial effect as though it were a drug. The draft continues:

… unless it is generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

Regina over at Weight of the Evidence summed it up nicely:

The document, if approved, specifically medicalizes complementary and alternative therapies, along with the products, supplements, devices and even foods often part of those therapies. By using “treatment” rather than “therapy”; “medical” rather than “modality”; the document terminology sets traditional and alternative approaches to well-being and health inside allopathic or conventional medicine in the United States and will regulate products currently protected by congressional legislation, in DSHEA (Dietary Supplement Health and Education Act of 1994).

The FDA is accepting public comments on the docket until April 30th. Be sure to include the docket Number 2006D-0480 and submit your comments here.

Recommended reading: Jon Barron.

For those of you interested, you can read the draft document in its entirety here.

References

1. Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. U.S. Department of Health and Human Services, Food and Drug Administration. 2006 Dec.
2. Health freedom action alert: FDA attempting to regulate supplements, herbs and juices as “drugs”. NewsTarget.com. 2007 Apr 11.

Highlight HEALTH serves as an information medium to provide knowledge and understanding of dietary supplements, nutrition and health news. We evaluate scientific information, disseminate research results and educate readers who are seeking better health to promote an enhanced quality of life.

The information presented at Highlight HEALTH is intended for the general public, patients, healthcare providers and caregivers, and is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her existing physician.

Improvement of dietary habits can be crucial for the prevention of disease and promotion of health. Similarly, vitamin, mineral and herbal supplementation can play an important role as diet alone is often inadequate to provide all essential nutrients. Along with diet, the elimination of household toxins can improve home health and have a significant impact on a person’s overall health.

Articles on Highlight HEALTH reflect the following:

1. Documentation and References: Health science, including research in nutrition, biochemistry, metabolism and medicine, are essential resources for determining the effects of nutritional supplementation. Published clinical trials are required for determining supplement efficacy and safety. Undocumented claims and hearsay are not acceptable for website publication. All articles presented on Highlight HEALTH include bibliographic citations and research article abstracts from published scientific literature.

2. Home Health: Your home should be the safest place in the world. According to the American Association of Poison Control Centers, 89% of poison exposures occur in the home and cosmetics/personal care products and cleaning products are two of the most common forms of poisoning for children under the age of six [1]. Most household cleaners contain toxic chemicals such as chlorine, ammonia and petroleum [2]. The Consumer Product Safety Commission has identified more than 150 chemicals in the home that have been linked to allergies, birth defects, cancer and psychological abnormalities [3].

3. Myths and Education: What you don’t know can hurt you. In the world today, it’s difficult to sort out the corporate propaganda from what’s best for you and your health. Unfortunately, much of the health advice and possibly care we receive is motivated by marketing objectives and individual profit. Educate yourself so that you can protect you and the ones you love.

References

1. Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System, American Association of Poison Control Centers, 2000. Quick Facts on Poison Exposure in the U.S.
2. Answers.com - chemical poisoning.
3. Dadd, DL. Home Safe Home. Tarcher, 1997.