Tuesday, October 27, 2009

Risks vs. Benefits

Risks vs. Benefits
The public consciousness of risk vs. benefit was raised considerably with the media’s discussion of the benefits of taking a Cox II inhibitor (Celebrex and Vioxx) vs. the potential risks (Cox II inhibitors are linked to the risk of gastrointestinal bleeding as well to an increased risk of heart attack).

That consciousness raising continued in the days between October 13 and October 18, when the following were mentioned in the media:

60 percent of those with Alzheimer’s disease are prescribed antipsychotic medication. In the United Kingdom alone, the annual cost of these drugs is 80 million pounds. But in 2006, a 42-center U.S. trial found no significant differences between the placebo and the antipsychotic medications after 12 weeks.

French scientists analyzed 19,000 patients with inflammatory bowel disease. The patients who took immune-inhibiting drugs (thiopurines such as Imuran) were more than five times as likely to develop lymphoma than those who had never received the drugs.

Gardasil vaccine is suspected as the cause of ALS/Lou Gehrig’s disease in two young women. According to the 8/18/09 issue of the Toronto Globe and Mail, 23 million doses of the HPV vaccine have been administered to young women in the United States, resulting in 32 deaths, 12,424 reported adverse reactions and 772 reported severe reactions (blood clots, pancreatic failure, motor neuron disease and anaphylaxis).

An analysis by the National Trauma Databank has highlighted that the rate of warfarin/blood thinner use has increased significantly: from 7.3 percent in 2002 to nearly 13 percent in 2006. Warfarin use was associated with a 30 percent increase in risk of death among trauma patients and a 20 percent increased risk in those aged 65 and older. And according to the Canadian Medical Journal, the rate of heparin-induced lesions is four times what was officially reported.

An analysis of 1998-2005 Medicare data has shown that patients with new lower-back pain were more likely to have surgery if they were treated in an area that had a higher-than-average concentration of MRI machines — even though, according to previous research, increased back surgery has not produced improved outcomes for patients. The Wall Street Journal had earlier reported that Pittsburgh has more MRI scanners than all of Canada.

Research published in the October 2009 Chest reviewed the current guidelines for using an inhaled steroid along with a long-acting beta agonist for COPD. Researchers found the benefit of the two-drug approach was limited and accompanied by substantial risks of pneumonia and other infections.

The FDA has announced plans to work with the National Eye Institute and the Department of Defense to review LASIK eye surgery. Of the approximately 6 million Americans who have undergone the surgery, which permanently reshapes the cornea, 5 percent are dissatisfied with the results. The long-term safety of the surgery is unknown. There have been reports of permanent damages to the eyes following surgery, including double vision, dry eye and halos around objects at night. Letters citing inadequate reporting of adverse events were sent to 17 LASIK eye surgery centers.

It is staggering to think these seven examples are drawn from only one week of media coverage. When we consider the number of prescription drugs used daily in American medicine, as well as the number of surgical and scanning procedures, it becomes clear we have little appreciation for the risks of prescription drugs and medical procedures. To address America’s healthcare costs in a meaningful fashion, the risks as well as the benefits of a therapy must be considered.

47 Members of Congress Support Consumers’ Right to Choose Their Health Practitioners

47 Members of Congress Support Consumers’ Right to Choose Their Health Practitioners
The legislators have sent House Speaker Nancy Pelosi, D-Calif., a letter proposing a ban on discrimination against integrative MDs, DOs, chiropractors and other well-trained and credentialed healthcare providers who have not previously been discriminated against under federal law. If discrimination is not forbidden, conventional licensed practitioners will try to use federal law, as they have used state law, to restrict competition from alternative and integrative sources.

The letter, dated September 14, 2009, urged that any healthcare reform legislation passed include "a provider non-discrimination provision at the federal level, and make it applicable to all plans." Although the letter does not mention any particular healthcare disciplines, it was supported by the American Chiropractic Association. The association notes that "while ACA remains focused on many chiropractic-specific legislative initiatives, there are certainly some areas where the profession shares concerns with a larger body of health care providers.” Rep. Bruce Braley, D-Iowa, and Rep. Martin Heinrich, D-N.M., led the drafting of the letter, which focuses on the importance of patients’ being able to choose the type of healthcare provider who will treat them. It also stresses the need to prevent insurance plans from discriminating against entire classes of healthcare providers. A third focus is on maintaining any hard-won rights providers have gained at the state level.

Do mandatory vaccinations achieve higher rates of immunization?

Tami Wahl, ANH-USA’s legislative director, attended the 4th International Public Conference on Vaccination, held in Reston, Va., October 2-4, 2009. The conference was hosted by the National Vaccine Information Center, a nonprofit educational organization founded in 1982. The oldest and largest consumer organization advocating for the institution of vaccine safety and the protection of informed consent in the mass-vaccination system, NVIC is an independent clearinghouse for information. Consequently, it does not promote the use of vaccines; nor does it advise against their use. Rather, it supports the availability of all preventive healthcare options, including vaccination, and the right of consumers to make educated, voluntary healthcare choices. NVIC’s work aims to ensure that public-health policies are based in science and not influenced by industry.

At the conference, hundreds of parents, grandparents, health practitioners, medical doctors, former pharmaceutical sales representatives, concerned citizens, community activists and members of the media heard a variety of noted speakers. The topics covered included the history of vaccination, the status of the H1N1 and HPV/Gardasil vaccines, legal matters (including manufacturer liability), constitutional law (including protections against mandatory vaccination), informed consent, pet vaccination, homeopathy and immunization. There were also sessions that allowed for interaction with the speakers.

An especially compelling presentation compared how Japan and the United States handle vaccinations. For example, Japan completes vaccinations for infants over an extended period of time (as opposed to the tight “schedule” implemented in the United States) and does not vaccinate infants under 3 months of age. Since 1994, Japan has utilized a “voluntary vaccination” plan and found it to be highly effective. In short, mandatory vaccinations don’t always mean higher rates of true immunization. The Japanese government has pulled certain vaccines from the schedule when these were deemed unnecessary or not completely safe. As a result, the Japanese have a high degree of trust in their vaccine schedule.

The conference also addressed the problem of studies that fail to compare a tested vaccine with a true placebo control-group. Often, the placebo contains mercury or some other toxic substance. Sometimes another vaccine is used in the control group in lieu of a true placebo.

Several speakers gave pointers for individuals who want to get involved at the local level: 1) Become informed about the side effects of vaccines; 2) be familiar with your state’s laws (e.g., is a religious exemption available?); 3) educate others, such as legislators and family members (www.nvic.org).

On a related note, a New York state Supreme Court judge has granted a temporary restraining order against the requirement that all healthcare workers get the H1N1 vaccine. The restraining order, granted October 19, 2009, will be in effect until New York’s Supreme Court reviews the case in a hearing scheduled for October 30. The original order indicated that workers not vaccinated against seasonal flu and the H1N1 virus would be subject to disciplinary action after November 30. A 1990 court ruling rejected healthcare workers’ opposition to mandatory rubella vaccination.

Does the Safeway Amendment address workplace wellness in a financially responsible manner?

As the debate for healthcare reform continues inside the beltway, on the airwaves, and around many a dinner table and water cooler, how can we — a nation known for ingenuity and entrepreneurship — deliver quality care for a reasonable price? Former House Speaker Newt Gingrich, in his book Saving Lives, Saving Money, is but one voice suggesting that America could do much better. Princeton economist Professor Ute Reinhardt has also condemned our current system for wasting money, doing little to create wellness and all-too-frequently serving vested interests rather than patients’ health.

Business journals and newspapers, including The Wall Street Journal, have charted the impact of America’s rising healthcare costs on the nation’s industrial competitiveness. In his 1986 book America’s Health Care Revolution: Who Lives? Who Dies? former Secretary of Health, Education and Welfare Joseph Califano Jr., revealed that Chrysler was spending more on healthcare (Califano called it “sick care”) than on steel for its automobiles. Whole Foods CEO John Mackey and Safeway CEO Steve Burd have published editorials in The Wall Street Journal about their commitment to a financially responsible approach to employees’ health. Given the $1.7 trillion deficit, many of us wonder if the concept of financially responsible healthcare reform resonates with our elected officials.

The fall 2009 issue of The American Acupuncturist included an article, “Evaluation in Acupuncture: Past and Future,” by a team of authors led by New York acupuncturist Michael Jabbour, LAc, MS. Jabbour had examined the literature for all studies of acupuncture that focus on costs. A key thrust of his article was to give a monetary value to "quality of life years" gained by the use of acupuncture. The authors, who noted the importance of including "indirect costs and intangible costs" in economic studies, concluded that "acupuncture has the capacity to offer cost-effective treatment, even when compared to conventional medicine”.

Economist and researcher Patricia Herman, ND, MS, Ph.D., published “Herman's Systematic Review Yields Top 9 Therapies/21 Conditions with High Quality Evidence of Cost Savings from CAM” in the August 27, 2009, issue of The Integrator. Herman noted that the most intriguing finding by the studies she has so far been able to evaluate is that "over 50% show cost savings." She underscores that "this is beyond cost-effectiveness to cost-savings," adding that "this is not likely just an artifact of publication bias because there is no disincentive for publishing something as cost-effective vs. cost saving." Herman notes that this is particularly interesting given "the typical conventional point of view that CAM increases cost."

Both the Safeway amendment from the Senate Finance Committee and HR 3200 (America’s Affordable Health Choices Act) address workplace wellness, including incentives for participation in voluntary wellness programs. Existing HIPAA legislation permits insurance premium discounts of up to 20 percent when an individual meets wellness program criteria. For example, the current Safeway wellness program requires employees to meet healthy weight, blood pressure, and cholesterol benchmarks and requires that they not smoke. If the individual fails to meet these criteria, premiums may be raised by 20 percent. The Safeway amendment increases the discount limits to between 30 percent and 50 percent. A group of 65 industry organizations have recently written a letter to Congress stating, “We believe that allowing employers to vary premiums by up to 50 percent of the total cost of employee coverage could lead to discriminatory practices and make health coverage unaffordable for those who need it the most.” However, the current model, which leads to a mentality of “Bill my insurance,” has done little to encourage individuals covered by employer-paid plans to control their own healthcare costs. It is true that the insurance discount must be carefully managed to avoid employer violation of employee privacy. Employers should not have access to an employee’s blood pressure numbers. But rewarding healthy lifestyle choices can be done without invading privacy. And of course in the long run people shouldn’t have to look to their employer as the only source of tax favored health insurance.

According to economist Dr. Ute Reinhardt, the wage controls during World War II, which inspired the current system of employer-paid health insurance, with its tax benefits solely for businesses, is unsustainable. Individual responsibility and freedom of choice have driven America’s use of integrative medicine. More importantly, integrative medicine is effective and costs less than disease care. This approach also protects the privacy of medical records.

Thursday, October 15, 2009

New studies find that most men aren’t told about the benefits and risks of PSA screening.

Two new studies published in the Sept. 25, 2009, online edition of BMJ —one by Benny Holmstrom, a urologist with Gavle Hospital in Gavle, Sweden; the other by Jennifer Stark, a research fellow at Harvard School of Public Health in Boston — highlight once again the lack of patient education regarding the risks associated with prostate cancer screening using the PSA blood test. According to Dr. Michael Pignone of the University of North Carolina at Chapel Hill, the chance of dying from prostate cancer for American men is 1 in 1,000. The chance of dying from heart disease, cancer or other causes is 113 in 1,000.

The British National Health Service first sounded the alarm two decades ago, declaring that routine PSA screening was costly, did not help men live longer or live better, and also subjected men to the risks of over-diagnosis and treatment for false-positive test results. Stanford University followed suit in 1987, calling PSA screening clinically useless. This year Harvard weighed in as well. In his 2004 book Should I Be Tested for Cancer, Maybe Not and Here’s Why, Gilbert Welch, M.D., professor of medicine at Dartmouth University, alerted readers to the lack of science validating routine PSA screening. Mass screening wastes money while endangering men’s quality of life. Targeted screening for men at high genetic risk, or for those with lifestyle risks, was suggested as a much more sound choice both medically and economically.

The two new studies point out that when a positive PSA test leads to a prostate biopsy, 75 percent of the time there is no cancer present. While men screened for prostate cancer are 2 to 4 times more likely to be diagnosed, the death rate from prostate cancer is the same for those screened as for those not screened. For men treated aggressively, the risks of consequent impotence and incontinence threaten quality of life.

Healthcare Reform as it presently exists won’t change the fact that the medical profession takes decades to abandon its harmful and wasteful practices. It’s long been medicine’s inside joke that it takes a generation of physicians to be trained, practice and die before meaningful change occurs. The American Cancer Society says it expects to alter its PSA recommendations next year. But why wait? When is the U.S. system of healthcare going to wake up?

EPA unveils plan to analyze and regulate six high-profile chemicals.

A number of recent studies point to the increased incidence of neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease, in the United States. And the October issue of the journal Pediatrics publishes a new government study suggesting that autism, a neurodevelopmental disorder, is more prevalent than previously thought, affecting 1 in every 91 U.S. children.

A search of the literature points to exposure to manganese while self-pumping gasoline, to chronic mercury exposure, to pesticide exposure and to a myriad of unknown factors that may affect genetic expression. A research team from the California-based Parkinson’s Institute recently found that the most common pesticides used in gardening tripled the incidence of Parkinson’s disease. The NIH Website www.medlineplus.gov lists 29 published studies linking Parkinson’s disease with pesticide exposure.

The causes of neurodevelopmental disorders — including autism, ADHD and Asperger’s syndrome — remain elusive. But clearly, to quote Walter Willett, M.D, M.P.H., of Harvard’s Department of Nutrition, the fact that we’ve changed the fat in our diet has a role to play. Changes in diet and activity, the increased use of vaccines, toxins in the environment (including mercury, lead and phthalates) and genetic susceptibility to the multitude of environmental changes could affect our children, whether as individuals or collectively. The combination of factors could impact each child differently.

In an announcement September 29, 2009, the EPA noted that U.S. consumers are “understandably anxious and confused” about chemicals in the environment and in their bodies. Quoted as saying the 1976 toxics law was “inordinately cumbersome and time-consuming”, EPA Administrator Lisa Jackson indicated that in the coming months the Obama administration will promote a new law placing responsibility on the chemical industry to prove that its compounds are safe.

In the interim, Jackson said, the EPA would begin to analyze and regulate six chemicals that have raised high-profile health concerns. These include bisphenol/BPA, found in hard, clear polycarbonate bottles and in dentistry materials; phthalates, found in vinyl and cosmetics; brominated flame retardants; perfluorinated compounds used in nonstick coatings; paraffins found in lubricants; and benzidine dyes and pigments. It is feared that these six chemicals mimic hormones. They have already been linked to reproductive problems, the obstruction of fetal development, cancer and other health disorders.

Using its authority under existing law, EPA may restrict the use of these six chemicals or require that product labels warn consumers of the risks associated with their use.

October 13, 2009

Citing steroids in supplements, Congress considers tweaking dietary regulations.

According to the New York Times, federal agents have recently raided several companies suspected of making bodybuilding products that illegally contain steroids and selling them as over-the-counter dietary supplements. On September 29, 2009, Sen. Arlen Specter, D-Pa., chair of the Senate sub-committee on Judiciary, Crime and Drugs, convened a hearing on the topic. The forum was entitled “Body Building Products and Hidden Steroids: Enforcement Barriers”.

The FDA has warned consumers not to use bodybuilding products that contain steroids or steroid-like substances advertised as enhancing testosterone levels. Among the witnesses at the hearing was former college baseball player Jareem Gunter, who suffered acute liver failure after taking a bodybuilding product adulterated with steroids. Steroid-adulterated products are linked to liver failure, kidney damage and other serious health consequences. According to Travis Tygart, chief executive of the US Anti-Doping Agency: “These companies are exploiting the lack of premarket regulation to sell magic powders and pills in a bottle while using the reputation of the health food and vitamin industry to cloak themselves with the appearance of safety and respectability.”

Michael Levy, director of the FDA’s division of new drugs and labeling compliance, stated that the “FDA has to undertake painstaking investigation and analysis to prove they are illegal.” But Richard Kingham, an attorney specializing in food and drug law, stressed that the agency already has enforcement tools sufficient to address these misbranded products.

Sen. Orrin Hatch, R-Utah, the ranking member at the hearing, disagreed with Sen. Specter’s contention that the premarket review of dietary supplements should be reexamined. Instead, Hatch said he continues to push for increased resources at the FDA and DEA in order to enforce more actively existing laws designed to prevent the marketing of illegal steroids masquerading as dietary supplements.

There’s a misconception, continually repeated in the mainstream press, that dietary supplements are unregulated. In fact, since 1994 the FDA has had the authority and responsibility to address misbranded dietary supplements. The dietary supplement industry, in implementing GMP/Good Manufacturing Practice certification and USP certification to police its own, has demonstrated an enviable safety record, according to government statistics. As Michael McGuffin, president of the American Herbal Products Association, stated: “Companies that are willing to ignore current laws would also ignore any new law. Enforcement is a better answer.”

It's Time to Put "Health" Back into Healthcare! Tell Your Senator to Support True Healthcare Reform

How can we, as a country, reduce exploding healthcare costs? By changing the way we do medicine. Too often we rely on treating symptoms and addressing health problems after they have reached the crisis state. Under the old way of thinking, this usually means hospital stays, vastly expensive surgery, expensive drugs with undesirable side effects, and other procedures common to conventional chronic care.

Preventive medicine should be, by definition, the prevention of disease before it takes hold. Diagnostic tests may be useful for early detection, but they often involve little understood risks such as radiation. Moreover, the screen may be used to redefine normal conditions as pre-diseases requiring expensive and often dangerous lifelong drug treatment. And whether the screen is used to diagnose a pre-disease condition or a disease, the opportunity for true prevention has already passed.

Although both the Senate HELP and Finance Committee healthcare bills incorporate prevention, they do not define what it means in key provisions. Without a clear definition of which preventive measures will be covered by insurance, for example, we could end up with nothing more than a long list of approved screening measures and drugs to be used on all ages, including the very young.

We are concerned that the current healthcare discussion doesn’t go far enough and would actually further constrain your access to a truly integrative and preventive medical model.

Equally alarming are the following provisions in the Senate healthcare bills:

A one-size-fits-all health insurance mandate would impede your right to choose and receive the healthcare that works best for you. It’s not exactly clear which services would be provided by a mandate, but it is apparent that we would have only one option! Those who currently pay out of pocket for healthcare services and opt to work outside of the insurance system or choose to purchase minimal coverage for catastrophic events will have the burden of additional insurance expenses without receiving additional benefits. We may ultimately be unable to afford our healthcare options of choice. Even if we can afford them, the natural healthcare option may be simply regulated away in a one-size-fits-all medical world.

Flexible Spending and Health Savings Accounts will be capped at $2,500. They may also be subject to taxes applied to high-end plans. These types of accounts are frequently used to pay for integrative medicine options, including preventive services. The net impact could be less access to healthy options! Since the house bill is more restrictive of deductibles and thus more destructive of HSA’s, a combined bill could yet eliminate HSA’s entirely.

The Comparative Effectiveness Research (CER) program is structured to reinforce and strengthen the current medical paradigm, which is stacked against integrative medicine. A newly created commission will be charged with identifying and recommending the most effective and appropriate healthcare services and procedures. That commission is required (required!) to include representatives of the pharmaceutical industry, but no one is included from the integrative health community. It’s crucial that less invasive, less expensive and more natural integrative medical treatments be examined and compared in head-to-head studies.

Electronic Medical Records (EMR) are an invasion of privacy and, in the worst case, may be used to target practitioners who are using alternative therapies. The government and potentially many others will have access to all of your EMRs. Do you trust them to keep your records secure? It is also likely that state medical boards, attorneys general and the FDA will access and use these data to target practitioners who offer integrative approaches. Any EMR system should have an option for individuals to opt out!

The Senate Finance Committee voted to pass America’s Healthy Future Act out of committee on Tuesday October 13 and the Senate will now merge the HELP and Finance bills together. Without further amendments, the resulting bill will commit us to one-size-fits-all options, stifling creative innovation, and giving special interests free rein to reinforce the status quo — pushing integrative medicine and true prevention further outside of the medical system.

We need your help! Let’s put “health” back in the healthcare bill! Please write your senators to let them know that you want to see true healthcare reform. If you are a practitioner, please identify your area of practice and highlight the need to ensure equal footing for natural and integrative medicine.
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