Woffling On

Friday, August 11, 2006

US Organic Milk Deception Under Fire

One of the nation’s most aggressive organic watchdogs filed a formal legal complaint (linked at bottom) on August 10, 2006 against the country’s leading organic brand, Horizon, alleging a well-financed campaign to greenwash milk produced at factory farms that fail to meet USDA regulatory standards. The complaint and call for a thorough investigation was filed with the USDA’s Office of Compliance.

The crux of the controversy, which has smoldered within the organic industry for over six years, stems from a small handful of industrial-scale dairies, managing 2000-10,000 cows, that are allegedly producing milk in feedlot conditions without adequately grazing their cattle as required by law.

“These large factory farms, mostly operated in desert-like conditions in the arid West, have allegedly been doing more talking about pasturing their cows than the hard work required to truly produce organic milk,” said Mark Kastel, Senior Farm Policy Analyst for The Cornucopia Institute, which filed a complaint. “What is even more repugnant to ethical farmers and consumers alike is that large corporations like Dean Foods, the world’s largest dairy concern with almost $11 billion in annual sales, are apparently trying to use their power to deceive loyal organic supporters,” Kastel added.

The current legal complaint alleges that Dean’s Idaho farm, now managing approximately 8000 head of cattle, has carefully created the “illusion” of pasturing, by putting their cows out on green fields “temporarily” for VIP visitors, but do not routinely offer pasture that has any feed value.

“I had the opportunity to visit, at the invitation of Dean Foods officers, their Idaho drylot dairy earlier this year,” said Kastel. “The majority of their cattle were in what they called their ‘winter housing,’ which amounted to a confinement feedlot. They did constantly rotate cattle, during my visit, out to what they referred to as ‘pasture’ but in actuality, it was just for show.”

The Wisconsin-based Cornucopia contends that the unusual pasture crop that they were offering their cows–mature oats, which had gone to seed and was about 2 1/2 feet tall–was not palatable or digestible by cattle and did not legally constitute pasture as defined by the federal regulations governing organic livestock production. “All the animals were doing was trampling down this tall crop and not consuming any nutrition. Instead, what they were really eating was highly refined feed from troughs in their feedlot, forcing them into a very high production and stressful existence,” Kastel lamented. Photographs of the Idaho farm can be viewed at Cornucopia’s web site.

The complaint also cited, as evidence, the fact that they were putting cattle out on to what they call pasture in conditions of extreme heat, well into the 90s, without affording livestock any access to water. “If this is what Horizon is doing, their management doesn’t cut it under any valid definition of managed grazing,” says Joel McNair, publisher of Graze, a magazine that reports on dairy grazing. “Humane farming standards and common sense dictate that cattle have access to shade and water if they are going to be spending more than a few minutes in very hot and sunny conditions. At best cattle will graze very little under such conditions. At worst they will die.”

In prior interviews with employees at Dean’s Idaho facility, their technique was referred to as a, “dog and pony show” to impress visitors. Through these interviews, Cornucopia staff learned that Whole Foods CEO, John Mackey, and upper management from the nation’s leading natural foods grocer, were exposed, on May 15, to the same kind of “illusionary” farming practices that Kastel experienced during his visit in late June. In addition, a number of journalists were given the same make believe pasture show earlier in June.

The Cornucopia Institute’s legal complaint also included allegations that proper pasturing was not occurring on the corporation’s other large farm on the eastern shore of Maryland. “We have received expert testimony from a number of current and former employees, and outside contractors, who have told us that pasture had been eliminated this year as a primary feed source,” stated Will Fantle, the Research Director for the Institute. “In addition to first-hand testimony, we received photographic evidence of all cattle in confinement when pasture conditions and weather were ideally suited for grazing.”

Along with requiring access to pasture, the federal organic regulations very specifically outline when cattle can be temporarily kept in confinement due to concerns about the animals’ health or environmental factors.

“Our customers expressed skepticism that they were not getting what they thought they were when they bought a Horizon product,” said Goldie Coughlan, a former member of the USDA’s National Organic Standards Board and Nutrition Education Manager at the country’s largest natural foods cooperative, PCC Natural Markets in Seattle. “They said they felt misled by the Company’s corporate spin because organic milk by definition should be from cows grazed on pastures.” She stated the co-op agreed with their 40,000 members and recently dropped all Horizon products in their eight stores.

With the pasture controversy growing too hot to handle, Horizon announced last December a number of modifications to their factory farms that would make them more acceptable in the eyes of the organic consumers. Officers of Dean Foods and Horizon officials have since been hopscotching the country by corporate jet in an attempt to stem the exodus of consumers and retailers from the brand. In addition to actions by retailers, the largest organic consumers group in the country, the Organic Consumers Association, called for a boycott of Horizon products earlier this year.

If that’s not enough bad news for the country’s largest marketer of organic dairy products, Dean was forced to face off with concerned investors at their annual shareholder meeting, and spent at least a third of the meeting time attempting to refute the concerns articulated by the consumer and farm advocacy groups.

“It is important for Dean Foods to recognize that the concerns of investors focusing on corporate responsibility are aligned with their customers in the organic marketplace,” stated Margaret Weber, Coordinator of Corporate Responsibility for the Adrian Dominican Sisters.

“We have a saying out in the country, ‘You can’t make a silk purse out of a sow’s ear’,” said Kastel. “We had been in discussions with Dean Foods for months trying to help them understand that no matter how much they spend on attempting to greenwash their factory farms, that scale of production will never be ethically acceptable to organic consumers.” While the company does buy organic milk from three hundred small farmers, some estimates place the firm’s reliance on factory farm milk at nearly 50% of its total supply

The Cornucopia Institute stated that they still hold out hope that Dean Foods will shift their strategic direction, selling their holdings in corporate-owned factory-dairies, and shifting production, like the majority of their competitors, exclusively to family-scale dairy farms. We stand ready to assist them if they decide to make that change to their business model,” Kastel said in closing.

The Health Gazette reported on poor performance practices in this industry before. See this post.

A copy of the legal complaint filed with the USDA can be viewed at www.cornucopia.org/HorizonComplaint8-06.pdf.

Tuesday, August 08, 2006

Scientists Call for Improved Fat Contents Food Labeling

Not all fats are bad. Let's be clear about this; we actually need to consume fats or oils to be healthy. Indeed, the essential vitamins D and K are fat soluble and while vitamin D can be manufactured within your skin given sufficient direct sunshine exposure and vitamin K can be manfactured within your bowel given the right number and types of intestinal microflora, we do generally rely on dietary sources and they should be consumed with fats and oils to facilitate their absorption.

However, not all fats are created equal, to say the least. When fats and oils break down in the digestive process and are absorbed into the bloodstream they circulate as what we call lipids. You have no doubt been exposed to the avalanche of health information explaining that there are "good fats" (low density lipoproteins - LDL) and "bad fats" (high desnsity lipoproteins - HDL) followed by the later avalanche explaining that actually both are needed but the correct or "optimum" ratio of LDL to HDL should be achieved.

You can be excused for finding this all rather confusing and for wondering: what next? That's a good question given all the information, misinformation, disagreements, debates and extraorinary marketing claims. Don't expect too much headway while pharmaceutical companies are making many billions from the confusion and "wooley" science that support them in pedalling their poisons called statins.

However, there is quite sound-looking evidence to suggest that we do need to ensure ample Omega-3 fatty acids and that we should maintain a good ratio between Omega-3 and Omega-6. We also know beyond any serious doubt that trans fats are pretty lethal and best avoided completely.

Given that some things about fats and oils are indeed well known and thoroughly documented, some scientists from Britain's prestigious Oxford University have proposed the use of food labels that should list all fats to help cut heart disease. This may be a good idea, but only if the right knowledge can also be provided.

It is imperative that people understand that not all fats and ois are bad. Recent research has demonstrated that essential fatty acids are essential for brain health and play a role in preventing diabetes.

Writing in this week's British Medical Journal (BMJ Vol. 333 p214), the Oxford experts argue that labeling products with their individual fats contents is vital in the fight to combat the UK's number one killer, cardiovascular disease. Being excessively heart focussed could send the wrong signals, just like dermatologists' obsession with avoiding sunshine has backfired badly, reducing people's levels of vitamin D and thereby increasing risk of cancer, and of death from cancer.

Actions to reduce consumption of trans fats will contribute to health improvements. Let's just hope that we get this message right. Of course, one other thing to consider is whether food labels work. Would more details about fat contents work or would actual warning labels be required? This could grow into an interesting debate in time.

Friday, August 04, 2006

Latest Sexually Transmitted Diseases Treatment Guidelines

The Centers for Disease Control and Prevention (CDC) MMWR Recommendations and Reports August 4, 2006 /55(RR11);1-94 provides comprehensive sexually transmitted diseases treatment guidelines for 2006. While the intended audience is the treatment community, there is plenty of straightforward (even quite basic) information of value for prevention (which in my view is always better than treatment).

Such information shoud be given as wide circulation as possible. Whatever information can contribute to prevention should be put to maximum use. I also consider it valuable and important for consumers to have access to the best-practice guidelines that should be followed by any health professional who may be providing services and recommending treatments.

The report is substantial. It is well laid out and can be skimmed to find relevant material. It can be easily accessed in full here: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5511a1.htm.

Thursday, August 03, 2006

FDA Moves to Ensure Easier Access to Plan B

The US Food and Drug Administration (FDA) announced today it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option. The Agency and the Sponsor will discuss the Sponsor's proposed restricted distribution and risk management plan as part of the framework for potential approvability as a non-prescription product for women ages 18 and older.

FDA and the Sponsor have agreed to meet immediately to discuss the approvability of the Sponsor's amended application and the framework by which this medicine can be made available over-the-counter. The Agency hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks.

Plan B is often referred to as emergency contraception or the "morning after pill." It contains an ingredient used in prescription birth control pills-only in the case of Plan B - each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B is currently available to all women as a prescription drug.

In the letter to Duramed, the Agency communicated its plan to proceed working with the Sponsor in order to move Plan B from prescription only to over-the-counter status for woman ages 18 and older. The steps FDA has taken with respect to this application and the letter it issued to the Sponsor of Plan B today underscores FDA's commitment to public health and safety.

This decision is the result of a thoughtful and comprehensive scientific and public policy process undertaken by the Agency to resolve the novel and significant issues presented by the Sponsor's amended application. Foremost in the Agency's concerns is to establish a framework that strikes a balance between providing access to medicines considered safe and effective and ensuring the right policies are in place to promote their safe use. The Acting Commissioner, Dr. Andrew von Eschenbach, believes resolving this public health issue is an important step in moving the Agency's broad and critical agenda forward.

Essentially, it appears the FDA is seeking to fast track changing the accessibility to the so-called "moring after pill" from prescription only to over the counter. This will undoubtedly make the drug easier to obtain and is likely to substantially increase its use.

Wednesday, August 02, 2006

Report Recommends Beter Approach to Achieving Healthy Air

Finally, some consideration has been given to setting and achieving (dare one hope, even implementing?) air quality standards. Ffesh air, free from pollutants, is a fundamental requirement for good health and wellbeing.

A new report from the National Academies' National Research Council illustrates a broader, more comprehensive approach the U.S. Environmental Protection Agency should use to evaluate changes to New Source Review, a part of the Clean Air Act that governs large, stationary sources of air pollution such as factories and power plants. Although the report's analysis focuses on the likely effects of EPA's 2002 and 2003 revisions to the rules – changes that have since, in large part, been struck down by federal courts – it can serve as a case study for how future revisions could be assessed, said the committee that wrote the report.

Under New Source Review, before a new facility can be built or an existing one modified, an applicant must obtain a permit by showing that the new plant or equipment will not disrupt progress toward attaining air quality standards in an area, or significantly worsen air pollution in a locale that already meets them. The applicant also must show that advanced emission-control devices will be added to the plant. In 2002 and 2003 EPA made changes to New Source Review that, among other things, expanded the range of modifications a facility can make without getting a permit.

The agency and other supporters predicted that the revisions would not result in significant changes in emissions and would give industry more flexibility to modernize plants and improve energy efficiency. Opponents maintained that the revisions would slow progress in cleaning the nation's air and thus damage human health. Because of the controversy, Congress asked the Research Council to estimate the revisions' effects.

It is impossible to quantify with certainty the changes' impact on emission levels, human health, or energy efficiency, because existing models have limitations and data so far are scarce, the Research Council's report says. A portion of the 2002 revisions was struck down by a court last year, and the remainder has gone into effect in only a few states. The 2003 revision, known as the Equipment Replacement Provision (ERP), has not been implemented because it was stayed by a court in 2004 and struck down earlier this year.

Modeling can provide some insights into the changes' likely effects, the report says. Its analysis estimates future national emissions of sulfur dioxide and nitrogen oxides from coal-fired power plants under ERP and compares them with emissions levels that could be expected if pre-revision rules continued. The committee used the same model as EPA, but also added different assumptions to account for other possible scenarios of how aggressively New Source Review might be enforced, other relevant regulations, and varying economic and technological conditions.

For example, EPA's analysis had assumed that if pre-revision rules continued, plants would avoid making modifications that would trigger New Source Review requirements – resulting in older, higher-emitting equipment operating longer without repair. The new analysis, on the other hand, compares emissions under ERP with another scenario, one in which pre-revision rules are enforced more aggressively and lead to more replacements of deteriorating equipment.

For sulfur dioxide, ERP would be expected to result in a moderate decrease in emissions for the first six years or so, followed by a six-year period of little change. But after 12 years ERP would likely result in higher emissions, perhaps substantially so, compared with what would result if pre-revision rules continued – assuming aggressive implementation of the pre-revision rules would have required all power plants to add emission controls by that point. ERP also would be expected to cause an increase in emissions of nitrogen oxides – again, possibly substantial – under certain circumstances after the first few years.

But the difference in emissions between pre-revision and revised rules would be lessened, the committee said, if EPA implements its 2005 Clean Air Interstate Rule (CAIR), a "cap-and-trade" program aimed at lowering emissions from power plants in Eastern and Midwestern states; such programs set limits on overall emissions in an area but allow individual plants to buy and sell pollution "allowances." With CAIR in place, differences in total sulfur dioxide emissions between pre-revision rules and ERP would be minor, the model suggests. CAIR would also probably moderate an expected increase in nitrogen oxide emissions caused by ERP and delay it for a dozen years, for the scenario in which all facilities would otherwise have added emission controls under the pre-revision rules.

Because current models shed little light on the expected effects of EPA's rule changes on particular plants and geographic locations and local populations with varying characteristics, no conclusions can be drawn about how the revisions would affect human health, the report says.

At a national level, the model analysis suggests that a cap-and-trade program with caps below those specified by CAIR would be a more cost-effective approach to lowering emissions than aggressive regulation under New Source Review; however, the committee's analysis was limited because it could not assess specific, local emission changes and their impact on public health.

Models must be improved to better account for how New Source Review and revisions to the rules affect individual plants' decisions about whether to install new equipment, the report says. And to assess health effects, future models will need to incorporate detailed meteorological information on the appropriate scale, such as regional or local.

Better data collection also is needed to aid future analyses of the revisions' effects after they are implemented, the committee added. EPA and state agencies should create and maintain a central database of permits issued under New Source Review, as well as minor permits issued by states, so that emissions from plants in states governed by the revised rules can be compared with those from plants operating under pre-revision rules. Data should also be collected on plants' investments in pollution-control equipment and programs, to allow investigators to study whether the rule changes lead plants to invest more or less in these improvements.

The report was sponsored by the U.S. Environmental Protection Agency. The National Research Council is the principal operating arm of the National Academy of Sciences and the National Academy of Engineering. It is a private, nonprofit institution that provides science advice under a congressional charter.

Tuesday, August 01, 2006

US Medication Errors Injure 1.5M People Annually and Cost Billions

Sometimes it feels like I'm a lone voice crying in the wilderness, trying to persuade people to take responsibility for their health and to not fall for the seductive lies of the pharmaceutical-medical system. I regularly warn people of the many dangers within the so-called health care system (which I assert is quite misnamed). Of course, I realize I'm not really alone; several voices join mine in a chorus of warnings.

However, sometimes it is very affirming to have the heavy hitters provide supporting evidence in a very powerful way. Even though those same heavy hitters may remain totally deluded about the real natures of the pharmaceutical industry and medical system, they do at least recognize some of the serious threats that they pose. Consider the following for example, which comes from a highly prestigious and entirely credible source.

Medication errors are among the most common medical errors, harming at least 1.5 million people every year, says a new report from the Institute of Medicine of the National Academies. The extra medical costs of treating drug-related injuries occurring in hospitals alone conservatively amount to $3.5 billion a year, and this estimate does not take into account lost wages and productivity or additional health care costs, the report says.

The committee that wrote the report recommended a series of actions for patients, health care organizations, government agencies, and pharmaceutical companies. The recommendations include steps to increase communication and improve interactions between health care professionals and patients, as well as steps patients should take to protect themselves. The report also recommends the creation of new, consumer-friendly information resources through which patients can obtain objective, easy-to-understand drug information. In addition, it calls for all prescriptions to be written electronically by 2010 and suggests ways to improve the naming, labeling, and packaging of drugs to reduce confusion and prevent errors.

"The frequency of medication errors and preventable adverse drug events is cause for serious concern," said committee co-chair Linda R. Cronenwett, dean and professor, School of Nursing, University of North Carolina, Chapel Hill. "We need a comprehensive approach to reducing these errors that involves not just health care organizations and federal agencies, but the industry and consumers as well," she said. Co-chair J. Lyle Bootman, dean and professor, College of Pharmacy, University of Arizona, Tucson, added, "Our recommendations boil down to ensuring that consumers are fully informed about how to take medications safely and achieve the desired results, and that health care providers have the tools and data necessary to prescribe, dispense, and administer drugs as safely as possible and to monitor for problems. The ultimate goal is to achieve the best care and outcomes for patients each time they take a medication."

Estimates of Rates and Costs

Medication errors encompass all mistakes involving prescription drugs, over-the-counter products, vitamins, minerals, or herbal supplements. Errors are common at every stage, from prescription and administration of a drug to monitoring of the patient's response, the committee found. It estimated that on average, there is at least one medication error per hospital patient per day, although error rates vary widely across facilities. Not all errors lead to injury or death, but the number of preventable injuries that do occur -- the committee estimated at least 1.5 million each year -- is sobering, the report says.

Studies indicate that 400,000 preventable drug-related injuries occur each year in hospitals. Another 800,000 occur in long-term care settings, and roughly 530,000 occur just among Medicare recipients in outpatient clinics. The committee noted that these are likely underestimates.

There is insufficient data to determine accurately all the costs associated with medication errors. The conservative estimate of 400,000 preventable drug-related injuries in hospitals will result in at least $3.5 billion in extra medical costs this year, the committee calculated. A study of outpatient clinics found that medication-related injuries there resulted in roughly $887 million in extra medical costs in 2000 -- and the study looked only at injuries experienced by Medicare recipients, a subset of clinic visitors. None of these figures take into account lost wages and productivity or other costs.

Improving the Patient-Provider Partnership

Establishing and maintaining strong partnerships between health care providers and patients is crucial to reducing medication errors, the report says. The committee called on consumers to be active partners in their medication care and on physicians, nurses, and pharmacists to know and act on patients' medical care rights.

The report recommends specific steps that physicians, nurses, pharmacists, and other health professionals should take to ensure that their patients are fully informed about their drug regimens and to minimize opportunities for mistakes to occur. Health care organizations also should make it a standard procedure to inform patients about clinically significant medication errors made in their care, whether the mistakes lead to harm or not. Currently, health care providers typically do not inform the patient or the patient's guardians about errors unless injury or death results.

The report also provides consumers with a list of specific questions to ask health care providers, such as how to take their medications properly and what to do if side effects occur. Also included are actions consumers should take, such as requesting that their providers give them a printed record of the drugs they have been prescribed. Patients should maintain an up-to-date list of all medications they use -- including over-the-counter products and dietary supplements -- and share it with all their health care providers. This list should also note the reasons they are taking each product and any drug and food allergies they have.

New and Improved Drug Information Resources

Although consumers can find helpful drug information online or in the printed materials provided by pharmacies, this information often is too difficult for many people to understand, too scattered, or otherwise not consumer-friendly. The quality of the drug information leaflets that accompany prescriptions varies widely, and these printouts are typically written at a college reading level. The U.S. Food and Drug Administration (FDA) should work with other appropriate groups to standardize the text and design of medication leaflets to ensure that they are comprehensible and useful to all consumers.

The committee called on the National Library of Medicine (NLM) to be the chief agency responsible for online health resources for consumers; it should create a Web site to serve as a centralized source of comprehensive, objective, and easy-to-understand information about drugs for consumers. In addition, NLM should work with other groups to evaluate online health information and designate Web sites that provide reliable information. The committee also recommended that NLM, FDA, and the Centers for Medicare and Medicaid Services evaluate ways to build and fund a national network of telephone helplines to assist people who may not be able to access or understand printed medication information because of illiteracy, language barriers, or other obstacles. This telephone network should also enable consumers to report medication-related mistakes or problems.

Electronic Prescribing and Other IT Solutions

New computerized systems for prescribing drugs and other applications of information technology show promise for reducing the number of drug-related mistakes, the report says. Studies indicate that paper-based prescribing is associated with high error rates. Electronic prescribing is safer because it eliminates problems with handwriting legibility and, when combined with decision-support tools, automatically alerts prescribers to possible interactions, allergies, and other potential problems, the committee found. While it acknowledged that significant regulatory issues and problems with automated alerts still need to be worked out, the committee said that by 2008 all health care providers should have plans in place to write prescriptions electronically. By 2010 all providers should be using e-prescribing systems and all pharmacies should be able to receive prescriptions electronically. The Agency for Healthcare Research and Quality (AHRQ) should take the lead in fostering improvements in IT systems used in ordering, administering, and monitoring drugs.

All health care provider groups should be actively monitoring their progress in improving medication safety, the committee recommended. Monitoring efforts might include computer systems that detect medication-related problems and periodic audits of prescriptions filled in community pharmacies.

Drug Naming, Labeling, and Packaging

Confusion caused by similar drug names accounts for up to 25 percent of all errors reported to the Medication Error Reporting Program operated cooperatively by U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). In addition, labeling and packaging issues were cited as the cause of 33 percent of errors, including 30 percent of fatalities, reported to the program. Drug naming terms should be standardized as much as possible, and all companies should be required to use the standardized terms, the report urges. FDA, AHRQ, and the pharmaceutical industry should collaborate with USP, ISMP, and other appropriate organizations to develop a plan to address the problems associated with drug naming, labeling, and packaging by the end of 2007.

The report also recommends studies to evaluate the impact of free drug samples on overall medication safety. In general, there has been growing unease among health care providers and others about the way free samples are distributed and the resulting lack of documentation of medication use, as well as the bypassing of drug-interaction checks and counseling that are integral parts of the standard prescription process.

The study was sponsored by the U.S. Department of Health and Human Services and Centers for Medicare and Medicaid Services. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.

In Conclusion

Of course, the safest route to take by far is to avoid the need for pharmaceuticals in the first place. No administration errors occur for people who do not consume medications. The vast majority of prescribed drugs are simply not necessary anyway.

Start your journey towards health, or ensure you maintain it, by establishing a healthy lifestyle. An approach based on internal cleansing is provided in my soon to be released boook available at SafeColonCleansing.com. It covers proper colon cleansing -- far more than typical colon cleansing approaches.