Monday, July 25, 2011

Three Perspectives: Can you tell which one is the one I actually support? (this was for school if that's not obvious- oh, and APA formatting sucks))

Essay Against Natural Products Being Made Illegal

Nine years ago, congress unanimously passed DSHEA, a legal act allowing natural medicinal products to be sold over the counter, without requiring or allowing the food and drug administration to regulate safety and quality before it is sold. This law reflected the desires of consumers in America. In the PBS Frontline video, The Alternative Fix (2003), it was explained that One hundred million people who take or support the availability of dietary supplements wrote letters to Congress to support this act. This is a huge show of support, and exceeded the number of letters that came in during the Vietnam War. Much of the motivation to support DSHEA came from people’s desire to keep supplements affordable, as well as a fear that many supplements that people need would be outlawed. (Section “How Safe are Your Vitamins?”). Recently, the issue has arisen that the FDA should have control, and that natural products and therapies should be tested before becoming available to the public, because of concerns about possible drug interactions and lack of consumer knowledge. This worries David Eisenberg MD of Harvard Medical School (2003). He thinks that many consumers don’t realize that the herbal remedies at drugstores, displayed near over-the-counter drugs, are not scientifically tested or proven to be safe and effective, and that their interactions with other medications could be dangerous and possibly life threatening (Section “Where is the Evidence?”). While safety is important, this line of thinking takes decision-making power about people’s own bodies and medical care, away from them. Also, testing natural remedies is not always possible because of the prohibitive expense of the tests and the problem of a lack of interest in alternative products on the part of those who hold the money and power to decide what is tested. Patients respond to natural therapies in a wide variety of ways, and these responses are sometimes subjective and difficult to measure scientifically. Dr. Andrew Weil says (2003), “We don't have the resources to test everything that's out there in the world of alternative medicine using randomized controlled trials. And practitioners are always going to be guessing and operating in the midst of great uncertainty.” (Weil. Section “Where is the Evidence?”) If an individual feels supported by a therapy and is experiencing increased wellness, but a positive result cannot be scientifically be detected, there is little sense in denying the person’s subjective experience and/or taking away the therapy for lack of knowledge about it. This is well stated in a quote from Frontline’s The Alternative Fix, in chapter 5 (2003): “good progress with illness cannot always be documented. Sometimes you have to trust the patient who is sure that they are doing better.” (Section “The Alternative Doctor) A similar idea was expressed with conviction by a cancer patient who is convinced that an untested therapy has worked for her (2003). “I’m getting results and I’m feeling well. It would be ridiculous for me to not trust what is happening. Nothing that anybody could say would make me feel differently.” (Section “The Mainstreaming of CAM”)

To require that all natural medicines be proven safe, could be called extreme, considering that patients choose natural medicine in part because of it’s gentle nature and the lack of side effects (2011). “One of the expressed reasons for the popularity of homeopathy among patients at the RLHH is that it does not have the side effects associated with many conventional drugs.” (2011, Safety and Cost Effectiveness) Additionally, consumers are probably capable of making good decisions about products if they take the time to read labels carefully.

According to the FDA (2011), manufacturers must make sure that product
label information is truthful and not misleading. Under the FDA Final Rule 21 CFR 111, all domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPS) for quality control. (2011, Dietary Supplements)

Also, the FDA (2011) is already monitoring new ingredients more carefully than some people think, which
could be enough to suffice for safety. The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. (See Section 413b of the act (21 U.S.C. 350b).) Generally, the notification must include information that is the basis on which manufacturers/distributors have concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. (2011, Dietary Supplements)

Finally, it seems possible that the argument about regulation and the threat to force scientific testing on all products and therapies, is a way for mainstream medicine and drug companies to remain in control of all things medical or health related. If they are feeling at all threatened by the increasing popularity of complimentary and alternative medicine, then they would have sufficient motivation to propose an extreme change in regulation. “The 500-patient survey at the Royal London Homeopathic Hospital showed that many patients were able to reduce or stop conventional medication following homeopathic treatment. (2011, Clinical Outcomes Studies) “Another research group in Germany compared homeopathic and conventional GPs’ outcomes in chronic diagnoses commonly treated in general practice (adults – headache, low back pain, depression, insomnia, sinusitis; children – atopic asthma, dermatitis, rhinitis). They collected data at 6 and 12 months regarding symptom severity, quality of life, and costs of consultations, medication, physiotherapy, hospitalisation, sick pay and medical devices. 493 patients were treated by 101 homeopathic GPs and 59 conventional GPs. The findings suggested that patients who received homeopathic treatment had better outcomes for similar cost.” (2011, Clinical Outcomes Studies)

Studies and surveys such as this show the increased popularity of replacing traditional medical care with holistic care, which could make doctors and drug companies mighty uncomfortable. It is unfortunate though, that their desire to remain in control and profitable could influence them to make decisions about changing regulation that will decrease freedom of medical choice and ultimately reduce the availability of viable care options and ultimate healing for citizens. Ideally, the current policy set up by DSHEA, which calls for minimal regulation until reports of harm show a need for intervention by the FDA, will remain intact. This policy seems to best facilitate a path toward motivating people to take responsibility for their own health and achieve maximum wellness.
References:
PBS Frontline (2003). The Alternative Fix. Chapter 4. “How safe are your vitamins?” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/view/4_hi.html

PBS Frontline (2003). The Alternative Fix. Chapter 3. “Where is the Evidence?” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/view/3_hi.html?wm


PBS Frontline (2003). The Alternative Fix. “Where is the Evidence?” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/snake/evidence.html


PBS Frontline (2003). The Alternative Fix. “The Outlaw Doctor” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/view/5_hi.html

PBS Frontline (2003). The Alternative Fix. “The Mainstreaming of CAM” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/view/6_hi.html?wm

Sharples F, van Haselen R. Patients’ perspectives on using a complementary medicine approach to their health. A survey at the Royal London Homoeopathic Hospital NHS Trust. London, 1998, as cited in Faculty of Homeopathy (2011). Safety and Cost Effectiveness. Retrieved from http://www.facultyofhomeopathy.org/research/safety_cost_effectiveness.html

US Department of Human Services. FDA US Food and Drug Administration (2011). Food. Dietary Supplements. Retrieved from http://www.fda.gov/Food/DietarySupplements/default.htm

US Department of Human Services. FDA US Food and Drug Administration (2011). Food. Dietary Supplements. Retrieved from
http://www.fda.gov/Food/DeitarySupplements/uc109764.htm

Sharples F, van Haselen R, Fisher P. NHS patients’ perspective on complementary medicine. Complementary Therapies in Medicine, 2003; 11: 243–248., as cited in Faculty of Homeopathy (2011). Research. Safety and cost Benefit. Retrieved from http://www.britishhomeopathic.org/research/safety_cost_benefit.html

Witt C, Keil T, Selim D, et al. Outcome and costs of homeopathic and conventional treatment strategies: a comparative cohort study in patients with chronic disorders. Complementary Therapies in Medicine 2005; 13: 79–86), as cited in Faculty of Homeopathy (2011). Research. Safety and Cost Benefit. Retrieved from http://www.britishhomeopathic.org/research/safety_cost_benefit.html



Compromise Essay

There is great controversy between the greater American public, who continue choose complimentary and alternative medicine, and those who seek to outlaw products and services that have not been or cannot easily be scientifically tested. The former group wants a wide range of options and good faith to exercise appropriate caution, and latter group wants to put the control in the hands of the food and drug administration, regarding what is and is not safe to sell. With both interests in mind, there are surely solutions that allow freedom of medical choice while prioritizing safety and minimizing risk.

One thing to bring to light in this controversy is that it is possible that products do not need to be tested as much as consumers need to be educated about products and choices. This could be achieved though a focus on good labeling practices. Bottles of herbs should have clear statements about whether or not they have been tested, and that they can not be guaranteed to be safe with prescription drugs or for certain health conditions. This is not necessarily the responsibility of the FDA, but rather the Federal Trade Commission (FTC) (2011). “The FTC is the Federal agency charged with protecting the public against unfair and deceptive business practices. A key area of its work is the regulation of advertising (except for prescription and medical devices)”. (2011, “Are You Considering Complimentary and Alternative Medicine?”)

As far as scientific testing is concerned, it must be noted that the apparent safety of drugs and therapies that have been scientifically tested and approved is questionable, mostly because the studies themselves are questionable. These studies tend to be biased and misleading, as is suggested by the following questions asked in Richard Smith’s article about medical journals (2011): “Why are pharmaceutical companies getting the results they want? Why are the peer-review systems of journals not noticing what seem to be biased results?” (2011, “Audio File About the NCCAM Health Care Provider Portal”) His proposed answer is that “the companies seem to get the results they want not by fiddling the results, which would be far too crude and possibly detectable by peer review, but rather by asking the “right” questions—and there are many ways to do this.” (2011, “Audio File About the NCCAM Health Care Provider Portal”) In looking at the results of studies created by or funded by the companies that own what is being tested, the findings were concerning. “Overall, studies funded by a company were four times more likely to have results favourable to the company than studies funded from other sources. In the case of the five studies that looked at economic evaluations, the results were favourable to the sponsoring company in every case.” (2005, “Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies”). So, to prove safety, we need to make sure that both the testing and the journal reporting is accurate.

Richard Smith of the Medical Society of London stated his opinion in the article, “Medical Journals Are an
Extension of the Marketing Arm of Pharmaceutical Companies” (2005), Firstly, we need more public funding of trials, particularly of large head-to-head trials of all the treatments available for treating a condition. Secondly, journals should perhaps stop publishing trials. Instead, the protocols and results should be made available on regulated Web sites. Only such a radical step, I think, will stop journals from being beholden to companies. Instead of publishing trials, journals could concentrate on critically describing them. (2005)

Once the accuracy of the scientific process and subsequent reporting is improved, a workable compromise could be established about what alternative products and therapies truly need to be tested, and which are passable as benign and not worth the investment of science. This evaluation would be fundamental to solving one funding problem for testing natural medicinal products.

Dr. Andrew Weil presented this solution in his interview with Frontline’s The Alternative Fix (2003).
One concept that I'd like to get across is that I think it would be very useful if people, instead of just calling for evidence based medicine, if we conceived of a sliding scale of evidence that would work this way: that the greater the potential a treatment has to cause harm, the stricter the standards of evidence it should be held to [in terms of] efficacy. … That kind of sliding scale of evidence would simplify things because we don't have the resources to test everything that's out there in the world of alternative medicine using randomized controlled trials. And practitioners are always going to be guessing and operating in the midst of great uncertainty. (Weil, Section “Where is the Evidence?”)

Dr. Weil’s point is important, because it seeks to have the two sides meet at a halfway point, testing when necessary, but trusting nature and people’s free choice when appropriate. In this way we can remember that in all things we must seek balance. If we live in a world completely run by science and devoid of intuitive influence, we may lose our sense of spirit, and of humanity. Matt Fink of Beth Israel Medical Center says (2003), “There will always be a certain art to the practice of medicine. Part of it is art, and part of it is beyond science.” (2003, “The Mainstreaming of CAM”)

References:

National Center for Complementary and Alternative Medicine (2011). Health Info. “Are You Considering Complimentary and Alternative Medicine?” Retrieved from http://nccam.nih.gov/health/decisions/consideringcam.htm#effectiveness

Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality. BMJ 326: 1167–1170. F., as cited in National Center for Complementary and Alternative Medicine (2011). News and Events. Audio File About the NCCAM Health Care Provider Portal. Retrieved from http://nccam.nih.gov/news/multimedia/audio/HCPportal.htm

Sackett DL, Oxman AD (2003) HARLOT plc: An amalgamation of the world's two oldest professions. BMJ 327: 1442–1445., as cited in National Center for Complementary and Alternative Medicine (2011). News and Events. Audio File About the NCCAM Health Care Provider Portal. Retrieved from http://nccam.nih.gov/news/multimedia/audio/HCPportal.htm

PLOS Medicine (2005). Article. Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. Retrieved from http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020138

PBS Frontline (2003). The Alternative Fix. Chapter 3. “Where is the Evidence?” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/snake/evidence.html

PBS Frontline (2003). The Alternative Fix. Chapter 6. “The Mainstreaming of CAM” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/view/6_hi.html?wm



Essay For Making Alternative Products and Therapies Illegal

For the safety of the American public, consumers must be able to trust that the products sold at retail stores and medical establishments have been scientifically tested, and that their side effects and interactions are fully tested and widely known. This is also true of any services, therapies and procedures offered by health care professionals. Currently, untested herbal and natural products are widely available for purchase and use. This is of concern to David Eisenberg MD of Harvard Medical School (2003). He worries that many consumers probably don’t realize that the herbal remedies at drugstores, displayed near over-the-counter drugs, are not scientifically tested or proven to be safe and effective, and that their interactions with other medications could be dangerous and possibly life threatening (2003, “Where is the Evidence?”). Frontline’s The Alternative Fix (2003) stated that there have been more than 700 adverse reports linked to increase blood pressure, heart palpitations and in some cases death, received by the FDA regarding dietary supplements in recent years.” (2003, “How safe are your vitamins?”) This history raises a red flag to the FDA, and they are working on legislation that would allow them to pull all supplements from the shelves and illegalize all therapies and treatments that have not been scientifically tested and proven to be safe and effective. Opponents of the requirement of scientific testing argue for historical proof and validity, which supposedly replaces the need for further testing.

Dr. Bratman makes the following statement about the subject (2004):
Most alternative medicine methods are grounded in tradition, common sense, anecdote, and testimonial. On the surface, these seem like perfectly good sources of information. However, double-blind studies have shown us otherwise. We now know that a host of “confounding factors” can easily create a kind of optical illusion, causing the appearance of efficacy where none in fact exists. The double-blind study is thus much more than a requirement for absolute proof of efficacy (as is commonly supposed) — it is a necessity for knowing almost anything about whether a treatment really works….

…Think of the practice of “bleeding,” slitting a vein to drain blood. Some of the most intelligent people in our history were sure that bleeding was a necessity, and the medical literature of past centuries is full of testimonials to the marvelous effect of this “medical necessity.

Today, though, it’s clear that bleeding is not helpful, and no doubt was responsible for killing a great many people. (2004, “Double Blind Studies: A Major Scientific Advance of the 20th Century”)

Clearly, modern scientists have gained understanding over years of research, and the practice of medicine is not as simple as it once was. Frontline’s The Alternative Fix pointed out (2003): “The content of these herbal drugs is far more concentrated than how they were used historically, and many people are on other medications these days. (2003. “How Safe are Your Vitamins?”)

This awareness is echoed and reinforced by the words of Steven Strauss MD, Director of National Center
of Complimentary Health and Medicine, National Institute of Health (2003). We know today that dietary supplements are chemically active. They must be, of course, if they're going to be beneficial to one's health. [But] those activities can interfere with the body's handling of life saving drugs. When people ate herbs 100,000 years ago, they didn't have to worry about whether it was going to interfere with their AIDS drug, but today we have that concern and some do interfere with AIDS drugs (2003. Steven Strauss).

With the knowledge and warnings that come with many years of advancement and cultural change, as well as recent history of dangerous drug interactions, many believe that it would be irresponsible to continue to allow unproven products and therapies to be condoned and easily accessed by the general public.

References:

PBS Frontline (2003). The Alternative Fix. Chapter 3. “Where is the Evidence?” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/view/3_hi.html?wm

PBS Frontline (2003). The Alternative Fix. Chapter 4. “How safe are your vitamins?” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/view/4_hi.html

Mendosa.com. (2004). Steven Bratman M.D. “Double-Blind Studies: A Major Scientific Advance of the 20th Century”. Retrieved from http://www.mendosa.com/bratman.htm

PBS Frontline (2003). The Alternative Fix. Steven Strauss. “How safe are your vitamins?” Retrieved from http://www.pbs.org/wgbh/pages/frontline/shows/altmed/consumers/vitamins.html


3 comments:

Tatiana said...

Holistic Health was a great class! ;o)

Ani said...

Ah, Tatiana- you recognized the assignment, I see. I have enjoyed it up to this student citation stuff that is so picky. It seems to be a relatively easy class to get an A in though.

Tatiana said...

Yeah, I did way more than needed to get an A (as I'm sure you are too, knowing you.) It was just really refreshing to take a class where the instructor is so engaged and proactive with using digital media in more ways. Plus it was super interesting. The citation stuff is a headache, but it will be there for the rest of our academic careers! I have found Zotero w/ the plugin for Word generates accurate citations (except for capitalization of titles, that I always had to do by hand) and when I updated my MS Office suite by about 10 years last term I found that the new version has great tools for handling citations, too. Its one of those areas where bothering to learn the complicated technology has paid off, since I do a lot of that kind of academic writing and will continue to do so for probably years. Hit me up if you want some more specific guidance about being set up with good tools for that.