Month: February 2018

In An Effort To Curb Drug Costs, States Advance Bills To Prod Feds On Importation

(Kaiser Health News) Norm Thurston is a “free-market guy” — a conservative health economist in Republican-run Utah who rarely sees the government’s involvement in anything as beneficial.

But in a twist, the state lawmaker is now pushing for Utah to flex its muscle to spur federal action on ever-climbing prescription drug prices.

“This is something that a red state like Utah could do. I don’t think this is a partisan issue,” Thurston said. “Those outrageous cost increases are not the result of the free market.”

The approach: Let the state contract with wholesalers in Canada, importing cheaper prescriptions from up north and distributing them to the state’s health care system.

Recommended: Start Eating Like That and Start Eating Like This – Your Guide to Homeostasis Through Diet

Other states — Vermont, West Virginia and Oklahoma, among them — are following similar paths, pushing legislation that would seek permission from the Trump administration to launch their own plans to import drugs from Canada.

For years, American consumers have tried to buy cheaper drugs from their northern neighbor, sometimes packing into buses for day trips to Canadian pharmacies, or patronizing American stores that help them order drugs from abroad. But the practice is illegal.

The states want to change that, and set up a formal process that nets broader savings. The idea is for the state health department to set up a wholesale program that buys drugs from Canada and resells them to local pharmacies and hospitals. Individual states would be responsible for ensuring that the medications are safe and that importing them does save money.

“This statute is putting pressure on the federal government to take a harder look at these questions,” said Rachel Sachs, an associate law professor at Washington University of St. Louis, who researches drug price regulations. “The state legislatures can say, ‘Look, we’re doing everything we can, but we do need the federal government to help us out on this.’”

The federal government has been slow to act on this issue, and skeptics say a 30-page Trump administration memo on drug pricing released late last week would likely have only limited impact.

Recommended: Sugar Leads to Depression – World’s First Trial Proves Gut and Brain are Linked (Protocol Included)

But states, whose budgets for Medicaid and state employee health programs are squeezed by these costs, are moving forward.

In Vermont alone, drug spending has gone up by 35 percent from 2010 to 2015, the most recent year for which data are available.

Backers of the state plans say the strategy is a no-brainer that could save hundreds of millions of dollars. They discount concerns about drug safety, arguing that drugs from Canada are made by reputable companies, often in the same facilities and by the same firms that sell them in the U.S. — but at much higher prices.

“We would be bringing in drugs intended for the Canadian market, and therefore at Canadian pricing,” Thurston said. “One would assume if we could come up with a program that meets the recommendations of federal law, what justification would the [Health and Human Services] secretary have for saying no?”

The state measures follow model legislation developed by the National Academy for State Health Policy that uses a framework put in place by the 2003 federal law that created the Medicare Part D program. That law says the U.S. Department of Health and Human Services can approve drug importation plans if it is convinced the plans will save money and will not create any public health concerns.

Once passed, these laws task state health departments with overseeing the development of these programs. After the health department settles on the specifics, state officials must negotiate implementation with HHS. That could take years.

It is also likely to be an uphill battle.

Recommended: Holistic Guide to Healing the Endocrine System and Balancing Our Hormones

In 15 years, HHS has never acted upon the 2003 law by approving any drug importation program.

Last spring, when members of Congress pushed a national bill, a bipartisan group of former Food and Drug Administration commissioners came out in opposition, arguing it would be impossible to verify drug safety absolutely. That bill ultimately failed to garner a majority vote.

It’s unclear where the current administration stands on this issue.

Alex Azar, the newly confirmed HHS secretary, has been coy on the subject — though in a confirmation hearing last fall, he said importing drugs from Canada could create safety concerns. Despite multiple requests, HHS did not provide comment for this story by the publication deadline.

The pharmaceutical industry echoed the cautions about safety.

“The proposals we are seeing in states across the country threaten the safety of patients and families and will not deliver the savings they promise,” said Priscilla VanderVeer, a spokeswoman for the trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

In the states, though, backers say their bills address that concern.

And other analysts argued that, regardless, safety of Canadian drugs isn’t a real issue.

“A lot of the drugs used in the United States and in Canada are made in the same plants, in countries like India or Europe,” said Michael Law, a pharmaceutical policy expert and associate professor at the University of British Columbia’s Center for Health Services and Policy Research. “The U.S. FDA and other regulatory agencies rely on other agencies’ inspections — the idea that Canadian drugs are these dangerous drugs is a red herring.”

A bigger question, he said, is the amount of savings these bills would generate.

Thurston pointed to Utah state analyses that suggest the state could save $70 million in the private sector, and another $20 million to $30 million in state-funded insurance programs. If approved, he said, the state would target 15 to 20 drugs to import — insulin, for instance, because it is bought in large quantities, or expensive drugs that treat hepatitis C or HIV.

Others expressed skepticism.

For one thing, the true price of prescription drugs isn’t always clear. There’s the list price — and generally, those are much higher in the United States. But insurance plans often negotiate rebates, or discounts, from the drug company — meaning they can end up paying far less than what’s advertised. Those discounts aren’t public, making it much harder to compare prices between the two countries.

The drug industry would also likely employ strategies to counter importation.

Pharmaceutical companies, Law noted, stand to lose if American states are importing cheaper drugs. That could motivate them to tamp down how many prescriptions they sell in Canada, or find other ways to discourage Canadian wholesalers from participating.

“My guess is any Canadian distributor to engage in that would find their [medication] supply dwindle quickly, because the drug companies would stop supplying,” he said. “The supplier systems in the United States would probably find it hard to get a [Canadian drug] supply in the long term.”

That’s certainly a real concern, said Claire Ayer, a Vermont state senator and Democrat who chairs her legislature’s Health and Welfare Committee.

“We can’t tell drug companies or wholesalers what to do in Canada,” she added.

VanderVeer said PhRMA could not speculate on how individual drug companies may react to importation.

Still, these state efforts could spur the federal government to take action, Sachs suggested — even if it’s unclear how large an impact importation would have.

“Importation will not solve all the problems — and I don’t think states see it as such,” she said. “But it could be a useful way to put pressure on a federal government and White House that has thus far largely been inactive on this topic.”

Dog Almost Dies From Human Hair Dye — What Does That Tell You?

(Dr. Mercola) Just because a product is sold over-the-counter in stores, it does not mean it’s safe. There are nearly 13,000 chemicals found in personal care products sold in the U.S., and only 10 percent have been tested for safety. To compound the problem, the U.S. Food and Drug Administration (FDA) has the ability to regulate personal care products only after a product has demonstrated harm.1

Additionally, the FDA has handed over the responsibility of ensuring public safety to manufacturers whose financial health is dependent upon selling their products, and those manufacturers are not legally responsible to report adverse effects to the FDA.2 What this means is that while you may be health conscious, body lotions, deodorants, soaps or shampoos you use may have harmful chemicals even if the product is labeled nontoxic and safe.

The average American woman uses 12 personal care products daily, containing an average of 168 chemicals.3 Men are exposed to nearly half that amount, but teens, who average 17 personal care products a day, are exposed to an even greater number.

This everyday exposure to toxic chemicals has been associated with a number of health conditions, including early ovarian dysfunction and menopause that may lead to early development of heart disease and osteoporosis. While personal care products may be hazardous for you, using these products on your pet may have lethal consequences.

Violet Demonstrates Dangers of Hair Dye

A 5-pound Maltese mixed dog named Violet recently brought to light the extreme danger owners put their dogs in when attempting to dye their fur using hair dye meant for people.4 The dog was brought to the Pinellas County Animal Services to be treated for her injuries, which included badly burned skin. Once at the facility, the staff washed as much of the chemicals off the dog as possible. Since dogs instinctively lick their coat, there was concern Violet may have suffered internal burns as well.

The next day she was put under anesthesia to have her coat shaved off. It was only at this point the staff recognized the extent of the damage to the dog’s skin, which started to slough off after being shaved.5 The hospital staff bandaged her, gave her antibiotics and intravenous fluids but was unsure if she would make it through the first night. After three months of arduous treatment, including honey, pain medication, continued antibiotics and bandage changes, Violet appears to have made a good recovery.

Violet is now in the care of a new owner who has experience grooming pets. Dyeing animal fur is not only stressful to the animal, but also increases the risk of chemical burns and allergic reactions, in much the same way these chemicals may affect you or your child.

Children and Adults at Risk Using Hair Dye

Many adults who use hair dye seek to cover gray hair or add highlights to their locks. In Europe, hair dye manufacturers warn their products are not designed to be used on children younger than 16.6 However, when a 12-year-old went undercover to test if salons would refuse hair treatment based on warnings, just one of 17 salons told her she was too young to have the color applied. Shirley Davis, industry expert and the Hair Council’s7 representative for Wales, U.K., viewed the results of the secret filming, saying:8

“I am absolutely appalled, they should’ve all said I’m sorry you’re not 16, we can’t do it and sent her away. Everyone within the industry is trying to professionalize it and we have salons that are actually contemplating coloring a young person’s hair. If they did something with this young girl and she had an anaphylactic shock she could die — that’s how serious it is. You have to patch test over-16 and under 16 it’s a no-no.”

People have been using hair dye to change their look for centuries. The synthetic dye process has been used for decades and continues to remain in practice. When you apply a synthetic-based hair dye, you first combine two chemicals that are not colored, in order to produce a chemical reaction that colors your hair.9

Early in development, hydrogen peroxide was used as a bleaching agent to extinguish your natural color and force a reaction between paraphenylenediamine (PPD) molecules, the basis of many permanent hair dyes on the market today. Other methods have been proposed, but many manufacturers continue to produce hair color with either PPD or a related compound, p-aminophenol.10

One of the issues with how dyes work is in the oxidative stress they place on your hair follicles and skin. The color molecules created in a chemical reaction become electron scavengers as they produce brown coloring. The need for electrons can’t be completely filled by the chemicals so the reaction pulls electrons from your skin. This is the basis for allergic reactions and potential DNA damage.11

David Lewis, Ph.D., emeritus professor at the University of Leeds in the U.K., acted as a consultant for cosmetic companies for years until his discomfort in using the same oxidative formula in hair dye triggered the launch of a company aimed at developing safer consumer products.

Lewis worries the beauty industry has too much power over the safety of consumer products and commented on the process that continues to be used in hair dye, saying,12 “Now, I know a lot about dyes and dye stuffs in the textile industry. We would never dream of using this on textiles. Primitive, archaic, all these things come to mind. Why do they persist on putting it on human heads?”

Progressive Sensitization Increases Your Risk of Injury and Illness

After researchers found women who used permanent hair dye once a month were at a much higher risk of developing bladder cancer,13the European Union (EU) took notice and recommended a reassessment of the safety regulations of distributed hair dye. During the past decade, the Science Committee on Consumer Products (SCCP), a commission mandated by the European Commission to evaluate the safety of consumer products, has evaluated a number of hair dye ingredients.14

Their results show sensitivity to the product ingredients is becoming more prevalent. The EU categorized 27 ingredients as those that are more likely to produce sensitive reactions in users. Initially these chemicals may not produce a reaction, but over time you have a higher risk of suffering skin reactions, even anaphylactic shock leading to death.15

The SCCP evaluation also led to the ban of 22 chemicals used in hair dye in the EU, with more expected in the coming years. Operating differently from the FDA, which bans chemicals only after reports of illness, damage or disease, the European Commission bans chemicals when there is any doubt of safety. In 2006, Gunter Verheugen was the European Union Commission vice-president.

He made a statement in a press release regarding the banning of those 22 chemicals, saying,16 “Substances for which there is no proof that they are safe will disappear from the market. Our high safety standards do not only protect EU consumers, they also give legal certainty to European cosmetics industry.”

Hair Dye May Raise Risk of Breast Cancer and More

Bladder cancer and hypersensitive reactions to the chemicals in hair dye are only two of the reactions women may suffer when using synthetic hair dye. A study at Rutgers University evaluated the use of hair dye in nearly 4,300 African-American and Caucasian women, both with and without a diagnosis of breast cancer.17 The researchers were particularly interested in hair straighteners, dye and conditioners containing placenta or cholesterol.

They discovered African-American women who used dark brown or black hair dyes had a 51 percent increased risk of developing breast cancer and a 72 percent increased risk of developing estrogen receptor positive breast cancer.18 Among Caucasian women, chemical relaxers and straighteners were associated with a 74 percent increased risk of breast cancer. This study demonstrated a link between darker colored hair dye and breast cancer.

However, the National Cancer Institute already states there are over 5,000 known chemicals in hair dyes, some of which are in fact known carcinogens.19 An estimated one-third of women over the age of 18 are using hair dye, exposing themselves and their families to the chemicals in these dyes. Epidemiologist Tamarra James-Todd, Ph.D., a professor at the Harvard T.H. Chan School of Public Health, who was not involved in the study, told Reuters:20

“I would be concerned about darker hair dye and hair straighteners. We should really think about using things in moderation and really try to think about being more natural. Just because something is on the market does not necessarily mean it’s safe for us.”

This study included the largest population of African-American women examining breast cancer risk and dark hair dye. The research team wrote of about previous studies that had shown an association between long-term use of dark hair dye and a fourfold increased risk of fatal Non-Hodgkin lymphoma and fatal multiple myeloma, as well as bladder cancer.21,22

Get the Lead Out

Women and pets are not the only groups who experience problems with hair dye. Many men may be inadvertently exposing themselves to dangerous lead levels when they use hair dye with lead acetate, used in products designed to gradually reduce the appearance of gray hair.23 Several consumer groups, including the Environmental Working Group (EWG), Earthjustice, Chicago School of Law, Breast Cancer Fund and the Environmental Defense Fund have filed a petition with the FDA requesting a ban on lead acetate.24

Prolonged exposure to lead may lead to brain damage, neurotoxicity and nerve damage. While the FDA approved the use of lead acetate in 1980,25 the chemical has been banned in the EU and Canada for almost a decade.

Results of studies assessing the safety of lead acetate done by American and Canadian researchers are vastly different. While the U.S. study found “no significant increase in blood levels of lead” in the trial subjects, and that “the lead was not shown to be absorbed into the body through such use,” Health Canada stated:

“The results showed that relatively small incremental exposures, such as those which would occur with regular use of hair dyes containing lead acetate, could result in the accumulation of potentially harmful body burdens of lead.”

Personal Care Products Hazardous to Your Health

Although many studies have demonstrated risks associated with using personal care products, from deodorant to body lotions, the Personal Care Products Council, an industry trade group, continues to counter these studies with statements such as:26

“Those who use cosmetics and personal care products can feel confident that they are protected by a combination of strong federal safety regulations enacted by the U.S. Food and Drug Administration and the science-based safety assessments from the companies that manufacture these products.”

Unfortunately, there are no strong federal safety regulations and many independent science-based safety assessments do not concur with industry-funded studies. To discover more about the personal care products you use in your home, search the EWG Skin Deep Database.27 You can also find more information in my previous article, “Dangerous Cosmetics Causing Major Harm to Skin.”

Health Threats to Salon Workers Even Greater

A study published in the International Journal of Epidemiology, researchers found hairdressers had a higher than average risk of cancer than the general population for lung, larynx and bladder cancers and multiple myeloma.28

The International Agency for Research on Cancer (IARC) of the World Health Organization (WHO), concurs that hairdressers and barbers work in conditions that are potentially carcinogenic.29 Individuals working in nail salons may suffer some of the same health conditions, including dizziness, cancer, headaches and asthma.30

Reports of adverse health conditions in salon workers have included reproductive problems, skin conditions and dermatitis.31 Salon workers absorb many of the toxic chemicals through their skin, or inhale fumes from hair dyes, hair sprays and other products into their lungs.

In their report, “Beauty and It’s Beast,”32 Women’s Voices of the Earth detailed some of the issues and challenges faced by salon workers, including exposure to acetone, toluene, ammonia and methyl methacrylate in hair dyes and bleaches, permanent wave solutions and acrylic nail products.

The report documented an increased risk of delivering low-birth weight babies, suffering miscarriages or delivering children with cleft palates and other birth defects. Cosmetologists also experience a higher risk of depression compared to other jobs and have a greater risk of Alzheimer’s disease, pre-senile dementia and motor neuron disease, compared to people working in other job positions.33

Natural Hair Health and Coloring

You don’t have to use synthetic conditioners, shampoos, sprays or dyes as one of the best products may already be in your kitchen cabinet. Coconut oil is not only beneficial to your health and beauty when taken internally, it can also be used topically on your skin and hair. Discover how to use it to detangle your hair, as a deep conditioner and even as a base for natural hair dye in my previous article, “How to Use Coconut Oil For Hair Health.”

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Interested In Muscle? Eat Whole Eggs Rather Than Egg Whites

(Natural Blaze by Natasha Longo) Egg yolks contain over 80 percent of the overall vitamins and minerals that can be found within the egg as a whole. The yolk also contains enzymes which help the body absorb the protein in the white. People who consume protein from whole eggs or from egg whites after engaging in exercise differ dramatically in how their muscles build protein, a process called protein synthesis, during the post-workout period, researchers report in a new study.

For years, this misunderstood food — low in calories, containing every single vitamin (A, B, D, E, K) except C, and nearly perfect in protein — was once shunned for threats to cholesterol intake.

Specifically, the post-workout muscle-building response in those eating whole eggs is 40 percent greater than in those consuming an equivalent amount of protein from egg whites, the team found.

The discovery, reported in the American Journal of Clinical Nutrition, suggests that the widespread practice of throwing away egg yolks to maximize one’s dietary protein intake from eggs is counterproductive, said Nicholas Burd, a University of Illinois professor of kinesiology and community health who led the research. The USDA National Institute of Food and Agriculture Hatch project supported this research.

The yolks also contain protein, along with key nutrients and other food components that are not present in egg whites, Burd said. And something in the yolks is boosting the body’s ability to utilize that protein in the muscles.

Egg yolks actually contain all the healthy, fatty acids that are contained within the egg. It is a nucleus of wholesome goodness that supplied our ancestors with their sustenance since before they were upright. When you strip away the egg yolk and eat only the white, you’re completely missing out on the benefits of those fatty acids like the Omega-3 fats.

Another reason to avoid separating the egg from the yolk relates to biotin. Avidin is a component in egg whites that bonds with biotin, preventing the nutrient’s absorption.

“This study suggests that eating protein within its most natural food matrix tends to be more beneficial to our muscles as opposed to getting one’s protein from isolated protein sources,” he said.

In the study, 10 young men engaged in a single bout of resistance exercise and then ate either whole eggs or egg whites containing 18 grams of protein. Researchers administered infusions of stable-isotope-labeled leucine and phenylalanine (two important amino acids) to participants. This allowed the scientists to maintain and precisely measure amino acid levels in participants’ blood and muscles.

The U. of I. Poultry Research Farm developed eggs for the study that also were isotopically labeled with leucine. This allowed for precise tracking of where the food-derived amino acids ended up after participants ingested them.

The team took repeated blood and muscle biopsy samples to assess how the egg-derived amino acids were appearing in the blood and in protein synthesis in muscles before and after the resistance exercise and eating.

“By using those labeled eggs, we saw that if you ate the whole egg or the egg whites, the same amount of dietary amino acids became available in your blood,” Burd said. “In each case, about 60 to 70 percent of the amino acids were available in the blood to build new muscle protein. That would suggest that getting one’s protein from whole eggs or just from the whites makes no difference, as the amount of dietary amino acids in the blood after eating generally gives us an indication of how potent a food source is for the muscle-building response.”

But when the researchers directly measured protein synthesis in the muscle, they found a very different response.

“We saw that the ingestion of whole eggs immediately after resistance exercise resulted in greater muscle-protein synthesis than the ingestion of egg whites,” Burd said.

Previous studies suggest this difference has nothing to do with the difference in energy content of whole eggs and egg whites — whole eggs containing 18 grams of protein also contain about 17 grams of fat, whereas egg whites have no fat. Studies from Burd’s lab and others show that simply adding fat to an isolated protein source in the diet after exercise does not boost protein synthesis.

“There’s a lot of stress on protein nutrition in modern society, and research is showing that we need more protein in the diet than we once thought to maintain health,” Burd said. “As world population grows, we need cost-effective and sustainable strategies for improving the use of protein in the diet. This work is showing that consuming egg protein in its natural matrix has a much greater benefit than getting isolated protein from the same source.”

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Drug Companies Responsible for Massive Environmental Pollution

(Dr. Mercola) Environmental pollution is a tremendous concern, and the sources of toxic pollution are many. One source that has managed to skirt below the radar is the drug industry.1,2,3,4 In 2016, the nonprofit foundation Changing Markets issued a report on “Impacts of Pharmaceutical Pollution on Communities and Environment in India,”5 on behalf of Nordea Asset Management, a major investment firm in Sweden.

According to this report, the severe water pollution problem in India can be, to a significant extent, traced back to the generic drug industry. Between 2010 and 2015, the number of contaminated waterways in India more than doubled, and by 2015, more than half of the nation’s rivers were polluted. India’s low cost of manufacturing has lured a number of drug companies to set up shop, congregating in the city of Hyderabad and along the Andhra Pradesh coastline.

Recommended Reading: How to Detoxify From Antibiotics and Other Chemical Antimicrobials

According to a recent economic survey by the Finance Ministry of India, Hyderabad’s drug industry accounts for nearly half of the country’s drug exports.6 “Outsourcing of production to the emerging markets, where labor is cheap, workforces skilled and environmental standards lax, has now become second nature for the pharmaceutical majors, many of which are based in the United States and Europe,” the report noted.

The report also stressed that there’s a disturbing lack of transparency within the drug industry about the origin of active ingredients and the finished drugs, and that while regulators “who could easily demand greater transparency from the drug industry, have so far shied away from taking action.”

New Report Calls Renewed Attention to India’s Pollution Crisis

In a follow-up report,7 the Changing Markets Foundation now calls renewed attention to the pollution crisis in Hyderabad, with a focus on heavy metal and other toxic waste pollution created by the “bulk drug” industry operating in India.

Based on visits to the area, interviews with experts and locals, and analysis of published research and media articles, the report concludes that drug companies in Hyderabad continue to “discharge untreated or inappropriately treated wastewater into the environment and that local and national authorities are failing to get the situation under control.”

In fact, in the two years since the publication of the first report, the situation in Hyderabad has deteriorated further. What’s worse, plans to expand drug production in the city, combined with a lack of regulations to control toxic waste emissions, makes for “a grim future” for local residents in the area, the report warns.

In addition to the release of untreated effluent, local media investigations have revealed the practice of illegal toxic waste dumping, where drug companies are discarding hazardous waste under the cover of night, using unmarked vehicles.8,9 Mass die-offs of fish have also made headlines, and the dead fish were found to contain toxic solvents used during the drug manufacturing process.

Source: Changing Markets Foundation, 

Hyderabad’s Pharmaceutical Pollution CrisisWater sampling near drug factories in the area, collected in September 2017, reveal significant amounts of heavy metals — including lead, mercury, copper, cadmium, vanadium, hexavalent chromium, nickel, zinc and arsenic — as well as toxic industrial solvents, are being released into the city’s waterways.

“In some cases, these were found to be present at extremely high concentrations, orders of magnitude higher than maximum regulatory limits or safe exposure levels, which points to substantial human and ecological risk potential,” the report states, adding “The mere presence of some of these substances is cause for alarm given their extreme toxicity.”

Antibiotic Production Poses Grave Risks

The report also highlights previous studies showing factories manufacturing antibiotics pose a grave risk by fueling antibiotic resistance in the environment. Antibiotic pollution is a problem not only in India, but also in China, Pakistan, Korea, Denmark, Norway and Croatia, and promotes the development of drug-resistant pathogens.

In November 2016, German researchers collected water samples from “the direct environment of bulk drug manufacturing facilities, the vicinity of two sewage treatment plants, the Musi River and habitats in Hyderabad and nearby villages.”10

Twenty-eight sampling sites were surveyed, and the water samples were analyzed for 25 anti-infective pharmaceuticals as well as multidrug-resistant pathogens and certain resistance genes. Disturbingly, all of the samples were contaminated with antimicrobials, including high concentrations of moxifloxacin, voriconazole and fluconazole. Area sewers also contained elevated concentrations of eight other antibiotics.

Some of the water samples contained antimicrobials at levels up to 5,500 times higher than the environmental regulation limit. What’s more, more than 95 percent of the samples also contained multidrug-resistant bacteria and fungi. The researchers called the contamination “unprecedented” and blamed it on “insufficient wastewater management by bulk drug manufacturing facilities, which seems to be associated with the selection and dissemination of carbapenemase-producing pathogens.”

Toxic Antibiotics Pollute India’s Waterways and Farmland

What happens is that during the drug manufacturing process, significant quantities of antibiotics are flushed out into wastewater, which then find its way into rivers, drinking water and farmland. The Patancheru water treatment plant, located near Hyderabad, receives 400,000 gallons of wastewater from 90 drug companies each day. All of this manufacturing effluent is combined with domestic wastewater, less than 25 percent of which actually undergoes treatment.

Swedish researchers, who have studied and published environmental reports about Hyderabad since 2007, have reported that some drug levels found in wastewater are higher than what is found in patients’ blood.11 The worst water contaminant detected was the antibiotic ciprofloxacin, which was found at a concentration high enough to give 44,000 people a full course of treatment.

Cipro is a fluoroquinolone antibiotic, a class of synthetic antibacterial drugs that directly inhibit bacterial DNA synthesis, and has been linked to permanent nerve damage in some patients. Due to their tremendous health risks, fluoroquinolones should be reserved for treating serious bacterial infections that will not respond to any other treatment. The idea that Cipro is being disseminated at those levels into the environment and people’s drinking water is disconcerting, to say the least.

Antibiotic Pollution Promotes Spread of Drug-Resistant Genes

Researchers have also confirmed that this wastewater is toxic to a number of organisms, and promotes drug-resistant genes. DNA samples taken downstream from drug manufacturing facilities reveal nearly 2 percent of the samples contain drug-resistant genes. Aside from direct ingestion, contaminated wastewater also finds its way onto crop fields via irrigation and sludge (biosolids) used as fertilizer.

In this way, drug-resistant genes are spread, shared and multiplied throughout the environment. A 2013 paper12 published in Environmental Health Perspectives addresses management options for reducing antibiotics and drug-resistant genes into the environment — such as safe disposal practices, wastewater and biosolid treatment, limiting agricultural and aquacultural use of antibiotics — and using alternatives to antibiotics whenever possible. But, so far, regulators and the industry itself have done virtually nothing.

Indian Drug Manufacturers May Lose European Supply Contracts

According to Changing Markets, Indian drug manufacturers who fail to clean up their act may soon lose their competitive advantage though. According to the report:13

“European NGOs have recently called for major procurement bodies, including the U.K.’s National Health Service, German health insurance companies, and French hospitals, to blacklist the worst-offending polluters and embed environmental criteria in all the contracts with pharmaceutical suppliers. Several of these organizations are now reviewing the situation. In Sweden, the country’s regions have come together and introduced environmental criteria and audits in their contracts.”

Sasja Beslik, who heads Nordea’s Group Sustainable Finance, also warned that “The pharmaceutical industry has to take action to tackle pollution at Indian factories supplying medicines to the global market,” adding that Nordea is willing to “continue the engagement with the pharma industry in order to find constructive and concrete solutions for these significant challenges that are impacting millions of people and the environment.”14 Changing Markets’ campaign manager Natasha Hurley also stressed that:15

“Multinational pharmaceutical companies which outsource API [active product ingredient] production to India to cut costs and maximize profits have a responsibility to take rapid action to put a stop to pollution in their supply chains.

Given the lack of transparency within the industry and the slow progress the global pharma giants have made on this to date, it is of paramount importance that regulators introduce environmental criteria that guard against such bad practices, both at national and international level.”

Pollution From Drug Manufacturing — A Supply Chain Problem That Must Be Tackled

According to the report, pollution from drug manufacturing has been “clearly exposed as a supply chain problem,” and the answer lies in holding drug companies responsible for their supply chains. While some have started taking steps in the right direction, “the industry and regulators are not moving fast enough to address the threat,” Changing Markets warns, saying that multinational drug companies that outsource production of active ingredients to India must step up and “take rapid action to end pollution within their supply chain.”

Regulatory agencies and medical agencies must also add environmental criteria to the good manufacturing practices standards, to prevent uncontrolled pollution within drug manufacturing. It’s a truly sad irony that millions of people in India are being poisoned by the very industry producing “lifesaving” medication for the rest of the world.

On a personal level, there’s not much you can do about this state of affairs. Governments and the drug industry need to address these problems head on, and hopefully Nordea’s push to hold drug companies accountable will have a marked effect.

Cleaning Up Your Own Household

That said, it’s important to remember that pollution is a global problem, and that pollutants don’t stay in any one area. Toxins and drug-resistant pathogens in India’s waterways spread far and wide. As noted in a 2008 report16 by the U.S. Centers for Disease Control and Prevention, multidrug-resistant E.coli bacteria have even been found in the Arctic; brought there by migrating birds!

So, no matter where you live, it would be wise to consider the purity of both your food and water. Also be mindful of not adding to the problem yourself. Never dispose of unused drugs by flushing them down the drain or toilet. It’s also inadvisable to throw them out in your garbage, as then they just end up in a landfill. For guidance on proper drug disposal, see this previous article.

Unfortunately, toxic biosolids may be used even in organic farming, and may be found in USDA 100 percent organic compost, mulch and potting soil for use in your own backyard. These products do not need to disclose the presence of biosolids, but some companies will list “milogranite” on the label, which means it contains toxic biosolids.

Your best alternative is to contact your local nursery and ask them if they use biosolids in their compost. Another alternative is to make your own, using a composting bin or wood chips for example. When it comes to buying organic food, the only way to find out if biosolids were used is to talk to the farmer.

Lastly, consider installing a high-quality water filtration system in your home, as drugs are a commonly occurring contaminant just about everywhere. The reason for this is because water treatment facilities are not equipped to filter these substances out. For more information and guidance on water filtration, see “How to Properly Filter Your Water.”

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Are Homeopathic Products Now Illegal?

(By Dr. Mercola) About 5 million U.S. adults and 1 million U.S. children use homeopathy every year, and the remedies are known to be “generally safe and unlikely to cause severe adverse reactions,” according to the U.S. National Institutes of Health’s National Center for Complementary and Integrative Health.1 Yet, if the U.S. Food and Drug Administration (FDA) continues on its latest crusade, this natural health modality may soon be much harder to come by.

In a draft guidance document released in December 2017, the FDA takes aim at homeopathic remedies, or as they put it, “drug products labeled as homeopathic.”2, 3 In a reversal of a long-standing decision to treat homeopathic remedies differently from other drugs, the FDA has now labeled virtually all of these products as “new drugs” that are “subject to FDA enforcement action at any time.”

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FDA Declares Homeopathic Drugs Illegal, Plans to Ramp up Enforcement Actions

While deaths from drugs like opioids are now a public health crisis, homeopathy has maintained a much lower, and presumably safer, profile. Yet, the FDA is using its limited resources to target the latter, citing a need to “protect consumers who choose to use homeopathic products.” Why now? The FDA also cited a “large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions,” to the extent that homeopathic products are now a close to $3 billion industry.4

Perhaps that’s $3 billion too much for Big Pharma, FDA’s cozy partner in crime. “[I]n one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally,” the Alliance for Natural Health USA (ANH USA) wrote5 — and it’s not an exaggeration. In essence, the FDA’s guidance reads:6

  1. Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug
  2. FDA has not determined that any homeopathic drugs are GRAS/E
  3. A new drug cannot be marketed unless it goes through the FDA’s approval process
  4. No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process

The FDA then states that it’s proposing a “new, risk-based enforcement approach” and first plans to target the “unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients.” This includes:7

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Products with reported safety concerns Products that contain or claim to contain ingredients associated with potentially significant safety concerns
Products for routes of administration other than oral and topical Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
Products for vulnerable populations Products that do not meet standards of quality, strength or purity as required under the law

FDA Does About-Face, ‘Penalizes an Entire Industry’

The draft guidance is a complete turnaround from the FDA’s prior stance on homeopathic remedies, which stated, under the 1988 Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, they did not need to get FDA approval prior to coming on the market. Instead, the ingredients in homeopathic remedies were to be verified by the Homeopathic Pharmacopoeia of the United States (HPUS). As noted by law firm Venable:8

“Essentially, the HPUS creates a monograph for homeopathic drugs to follow, not dissimilar to the OTC drug monographs that FDA has developed for allopathic drugs. Accordingly, by virtue of an ingredient’s inclusion in the HPUS, the ingredient has already been closely examined and determined to be safe and effective by the HPCUS [Homeopathic Pharmacopoeia Convention of the United States].

Compliance with the HPUS functions as a premarket review of safety and effectiveness in the homeopathic context. By classifying homeopathic drugs as unapproved new drugs, the FDA is requiring a second showing of safety and effectiveness, a step that is unnecessary, not to mention impractical, given that the Agency intends to hold homeopathic products to an allopathic standard that is inappropriate, given the nature of homeopathic products.”

Further, it was by the FDA’s own deliberate decision that homeopathic drugs were excluded from former drug approval processes and intended to be a separate category. Venable continued:9

“The FDA deliberately excluded homeopathic drugs from both the Drug Efficacy Study Implementation (DESI) review (the process by which all drugs approved between 1938 and 1962 were retrospectively evaluated by the FDA for effectiveness) and the OTC Drug Review in 1972 (the process used to develop OTC drug monographs for allopathic drugs), deciding instead in the latter case to regulate homeopathic products separately because of their uniqueness.

By withdrawing the CPG and classifying all homeopathic drugs as unapproved drugs subject to FDA drug approval, the FDA is now requiring higher regulatory thresholds for OTC homeopathic drugs than are applicable to allopathic OTC drugs, many of which are permitted to be sold pursuant to the FDA monograph system. This move in effect penalizes an entire industry for the Agency’s 1972 decision.”

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FTC Targeted Homeopathy in 2016

The FDA isn’t the first government agency to target this centuries’ old natural medicine system. In a notice filed in November 2016, the FTC stated that in order for homeopathic remedies to claim they are effective, their makers must provide proof. If no proof is provided, the remedies must state there is “no scientific evidence that the product works.”

In order to not mislead consumers, the FTC further stated that homeopathic remedies lacking sufficient proof must communicate to consumers that “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”10 Dana Ullman, MPH, CCH, one of the leading advocates for homeopathy in the U.S., said at the time:11

“Considering the longtime safety history of homeopathic medicines, it is surprising and even shocking that the FTC would consider proposing new regulations now.

One cannot help but wonder who or what is pulling their strings … policies … commonly result from powerful economic forces at play … it is clear that this governmental agency is ignoring important scientific evidence, and one must wonder if they are protecting Big Pharma from competition more than protecting the consumer.”

Does Homeopathy Work?

Based on the theory that “like cures like,” or the Law of Similars, homeopathy was founded by German physician Dr. Samuel Hahnemann. The idea is that health conditions can be healed by treating a person with minute doses of a substance that would produce similar symptoms to their health condition if given in larger doses.

Homeopathy’s other guiding principle is that of the minimum dose, which is based on the premise that the more a substance is diluted, the more potent homeopathic remedy it becomes, known as the “law of infinitesimals.” Homeopathic remedies may be made from plants, minerals or other substances and are commonly administered in pellet form, dissolved under the tongue. A number of intriguing studies suggest homeopathy is effective and safe for a variety of ailments, including flu. According to Ullman:

“The use of a homeopathic medicine called Oscillococcinum is an example of a remedy that can be effective for many people with the flu, though clinical experience suggests that it is most effective when used within 48 hours of getting flu symptoms. Although most homeopathic medicines are made from the plant or mineral kingdom, Oscillococcinum is unusual in that it is made from the heart and liver of a duck.”

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In one study, nearly twice as many patients who were given Oscillococcinum recovered from the flu within 48 hours as those given a placebo.12 Further, Ullman noted:

“A different group of researchers conducted a randomized, double-blind study involving 372 patients (188 treated with Oscillococcinum and 187 with placebo) of both sexes, ranging in age from 12 to 60, who presented rectal temperature ≥ 100.4 F, muscle pains, headache, or at least one of the following symptoms: shivering, chest pain, spine pain, coughing, irritation of nasal mucosa or feeling of malaise.13

Patients received three tubes of Oscillococcinum or placebo each day (morning, noon and night) for three days. The results of this trial show a highly statistically significant difference between the two groups, for what concerns disappearance of symptoms after 48 hours (19.2 percent in the Oscillococcinum group versus 17.1 percent in the placebo group) and improvement in symptoms (43.7 percent versus 38.6 percent for placebo).”

Additional research shows homeopathy’s promising role in the following conditions:

In patients with allergies, those using homeopathy reported improvements in nasal airflow compared with a placebo group.

With homeopathic treatment, the researchers described a “clear, significant and clinically relevant improvement in nasal inspiratory peak flow, similar to that found with topical steroids.”14

 Homeopathy significantly reduced the severity and duration of chemotherapy-induced stomatitis (swelling and sores in the mouth) in children.15
Homeopathic medicine was effective in treating acute childhood diarrhea, decreasing both the duration of the diarrhea and the number of stools per day.16,17 Homeopathy has positive effects in children with attention deficit hyperactivity disorder (ADHD), particularly in the areas of behavioral and cognitive functions.18
Homeopathy lessened tender point pain and improved quality of life in people with fibromyalgia.19 Homeopathic was effective in treating the early stages of vitiligo in a report of 14 cases20

FDA Continues to Crack Down on Natural Substances, Protect Big Pharma

The FDA’s new push to regulate homeopathic products is eerily reminiscent of their recent crackdown on the plant kratom. Leaves from the kratom tree have been used for pain relief for hundreds of years, but scientists now know they contain compounds that target the brain similarly to opioids, helping to relieve pain. It appears the plant may be safer than opioids for pain relief and could even act as a tool to help those suffering from opioid withdrawal.

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In November 2017, however, rather than targeting the prescription opioids that are the root of the opioid epidemic, the FDA issued a public health advisory regarding risks associated with kratom use, suggesting that its usage could “expand the opioid epidemic.” What this comes down to, for some, is the right to choose what form of “medicine” to put in your body. As Dr. Lee Hieb, an orthopedic surgeon and past president of the Association of American Physicians and Surgeons, wrote in WND:21

“I’m not here to tout any particular over-the-counter remedy, but who gave the FDA total ability to limit what we can take into our bodies, while virtually forcing us to be given what they prescribe? It’s none of their business whether a ‘homeopathic remedy’ is worthless.

That’s an issue of commerce and truth in advertising. I, for one, want the freedom to research and decide for myself what supplements to take, even if my supplements ultimately do me no good. (Many do a great deal of good as Big Pharma knows only too well.)”

People have the right to choose their treatment, and doctors (many of whom admit to prescribing placebos to their patients) also retain the right to offer treatments they deem useful, whether it be homeopathy or another remedy.

As for the FDA’s new draft guidance on homeopathic drugs, it’s attempting to discredit such remedies’ proven healing powers before their mechanisms of action have even been fully understood. If you want to express your opinion on the matter, the FDA is accepting comments from the public until March 30, 2018.