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“The 21st Century Cures Act” Is On Its Way – Here’s Why You Haven’t Heard About It

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The 21st Century Cures Act is going through the U.S. Congress right now, and it will likely pass into law unless some opposition materializes (it passed through the House of Representatives Energy and Commerce Committee with a vote of 51 to 0).  The Act is a give-away to the pharmaceutical industry, removing many of the safety mechanisms in place that are supposed to keep the public protected from unsafe drugs and medical devices.

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The 21st Century Cures Act allows drugs to be rushed to the market, removes phase 3 testing as a requirement for drug approval, bases drug approval on biomarkers rather than actual health outcomes, and encourages the production of new antibiotics at a time when microbiome destruction is increasingly being linked to chronic diseases.

Rushing Drugs to Market

With the passage of the 21st Century Cures Act, drugs will be rushed to market with little testing required. A New York Times piece, “Don’t Weaken the F.D.A.’s Drug Approval Process” notes that the 21st Century Cures Act “could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death.” The Act weakens an already weak regulatory process that is currently doing a poor job of protecting the public from adverse reactions to drugs and medical devices. (In the currently weak system, preventable medical errors in hospitals are the third leading cause of death in the United States, and, “between 210,000 and 440,000 patients each year who go to the hospital for care suffer some type of preventable harm that contributes to their death.” source)

The End of Evidence Based Medicine

Modern medicine is supposed to be “evidence based medicine” backed up by replicable, placebo controlled scientific experiments that show that a drug or medical device effectively treats the disease or symptom that it is purported to treat. This standard of evidence will no longer exist if the 21st Century Cures Act passes into law. The Act will allow drug approval to be based on biomarkers and surrogate measures rather than health outcomes. This has been disastrous in the past and it will be even more disastrous in the future. For example, we’re now seeing that statins do well at reducing cholesterol, but despite improving that biomarker, they don’t improve health outcomes for large portions of the population (notably, the female portion of the population).

A New England Journal of Medicine (NEJM) article, “The 21st Century Cures Act — Will It Take Us Back in Time?” notes that:

But though a drug’s effect on a biomarker can make approval quicker and less costly, especially if the comparator is placebo, it may not always predict the drug’s capacity to improve patient outcomes. Bevacizumab (Avastin) delayed tumor progression in advanced breast cancer but was shown not to benefit patients. Similarly, rosiglitazone (Avandia) lowered glycated hemoglobin levels in patients with diabetes even as it increased their risk of myocardial infarction. In 2013, patients began to receive a new drug for tuberculosis approved on the basis of a randomized trial relying on a surrogate measure of bacterial counts in the sputum — even though patients given the drug in that trial had a death rate four times that in the comparison group, mostly from tuberculosis.

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Representative Diana DeGette (D-CO), one of the co-sponsors of the 21st Century Cures Act, bragged on Twitter that, “In 120yrs we have gone from #snakeoil to mapping the #humangenome. W/your help #Cures2015 is ready to take us further.”  But if pharmaceuticals are no longer required to have evidence that they improve health outcomes, how are they any better than snake oils? One only needs to look as far as the recent history of psychiatry to see that the line between snake oils and “evidence based medicine” is already woefully thin.  Removing regulatory and procedural requirements from the drug approval process, via the 21st Century Cures Act, will just encourage the production of more dangerous pharmaceuticals that are no better or safer than snake oil.

Diminishing requirements for evidence of efficacy is bad for the medical system too. Basing medicine on scientific inquiry and actual evidence of efficacy is a bedrock of medicine, and without it the medical system will lose credibility.

The Loss of Informed Consent

The 21st Century Cures Act will diminish another bedrock of modern medicine – informed consent. The NEJM article notes that:

“Informed consent by patients in drug trials has traditionally been sacrosanct, with exceptions made only when consent is impossible to obtain or contrary to a patient’s best interests. But another clause in the proposed law adds a new kind of exception: studies in which ‘the proposed clinical testing poses no more than minimal risk’ — a major departure from current human subject protections. It is not clear who gets to determine whether a given trial of a new drug poses ‘minimal risk.’”

Informed consent is crucial not only for the credibility of modern medicine, it is crucial for liberty.

Dangerous New Antibiotics

One of the least controversial, but in reality most dangerous, parts of the 21st Century Cures Act is its encouragement of new antibiotics. Before I go into why this part of the Act is dangerous, let me acknowledge that bacterial resistance to antibiotics is a huge problem, and antibiotic resistant infections are causing many deaths. Without being able to keep pathogenic bacteria in check, many medical procedures will be impossible, and many lives will be lost.  But we got into the predicament of bacteria being resistant to antibiotics by over-using antibiotics in both agriculture and medicine, and to encourage increased use of antibiotics will only perpetuate the problem. The solution to antibiotic resistance is prudent use of available antibiotics and finding sustainable ways to reduce harm caused by pathogenic bacteria (perhaps by using healthy bacteria to keep the unhealthy bacteria in check), not doubling down on the “kill all bacteria” tactic that led us to the problem of antibiotic resistant bacterial infections in the first place. Bacteria will continue to adapt in us and around us, and increasing the intensity of the war between us and bacteria is beyond foolish.  We will lose any war that we wage against bacteria because we need bacteria – they are not separate from us – and they play a larger role in human health than we can currently imagine.

A healthy and balanced microbiome (“the ecological community of commensal, symbiotic and pathogenic microorganisms that literally share our body space”) is crucial for all areas of health, and a disturbed microbiome has been linked to all of the diseases of modernity, including mental health disorders, neurodegenerative diseases like Parkinson’s and Alzheimer’s, autoimmune diseases, inflammatory bowel disease and Crohn’s disease, mysterious diseases like fibromyalgia, autism, etc. And while there is acknowledgement of the role that a healthy microbiome plays in these diseases, researchers and journalists alike have been loath to acknowledge the role antibiotics have played in contributing to these diseases of modernity. No one wants to be anti-antibiotic. Everyone knows that antibiotics have saved millions of lives, but that doesn’t mean they are without consequences. And the good that penicillin has done doesn’t mean that all antibiotics are equally safe or effective. I can make a pretty thorough argument that fluoroquinolone antibiotics, like Cipro/ciprofloxacin and Levaquin/levofloxacin, drugs that work by “inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination,” are at least partially responsible for many of the diseases of modernity (more information can be found HERE, HERE and HERE). Fluoroquinolone antibiotics do not have the same safety profile as amoxicillin, and to assume that they do because both are categorized as antibiotics, is foolish on multiple levels.

The 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. Doctors Avorn and Kesselhem note in the NEJM that:

The proposed legislation would make immediate changes with respect to new antibiotics and antifungals by enabling their approval without conventional clinical trials, if needed to treat a “serious or life-threatening infection” in patients with an “unmet medical need.” In place of proof that the antimicrobial actually decreases morbidity or mortality, the FDA would be empowered to accept nontraditional efficacy measures drawn from small studies as well as “preclinical, pharmacologic, or pathophysiologic evidence; nonclinical susceptibility and pharmacokinetic data, data from phase 2 clinical trials; and such other confirmatory evidence as the secretary [of health and human services] determines appropriate to approve the drug.” Antimicrobials approved in this manner would carry disclaimers on their labeling, but there is no evidence that such a precaution would restrict prescribing to only the most appropriate patients. If passed in its current form, the bill would also provide hospitals with a financial bonus for administering costly new but unproven antibiotics, which could encourage their more widespread use. The bill gives the secretary of health and human services the authority to expand this nontraditional approval pathway to other drug categories as well, if “the public health would benefit from expansion.”

Fluoroquinolone antibiotics like Cipro and Levaquin, some of the most popular antibiotics on the market, cause a chronic illness known as fluoroquinolone toxicity syndrome or, colloquially, “floxing,” that includes damage to connective tissue (tendons, ligaments, cartilage, fascia, etc.) throughout the body, damage to the nervous systems (central, peripheral, and autonomic), and more. Rather than putting mechanisms in place that help victims of iatrogenic antibiotic poisoning, or to prevent their pain and suffering in the first place, the 21st Century Cures Act opens the door for more damaging antibiotics to flood the market.

The Ever-Increasing Power of the Pharmaceutical Industry

The current medical system lacks the mechanisms required to protect consumers from the dangers of pharmaceuticals. The FDA is failing to protect people from dangerous drugs, the justice system is failing to compensate people for harm done by dangerous drugs, doctors, pharmacists and even research scientists are so indoctrinated in the “there’s a pill for that” culture that they fail to question it, and the drug-consuming public ends up poisoned and sick because no one is keeping the pharmaceutical companies in check. All powerful entities need checks and balances, the pharmaceutical industry is no exception.  The 21st Century Cures Act gives the too-powerful pharmaceutical industry even more power, power that will undoubtedly be abused.

Pros and Cons

There are a couple good elements to the 21st Century Cures Act. It increases the NIH budget, which some can argue is an improvement. It also focuses on finding pharmaceutical solutions to rare diseases, which many people with rare diseases will find to be cause for hope.

I fear though, that people with rare diseases will be turned into guinea pigs because the pharmaceutical companies seeking cures for their rare diseases will have no limits put on what they can do to the people suffering from them.  I also find it objectionable that there is no mention in the Act of investigating the causes of “rare” diseases or “rare” adverse drug reactions.

The potential harm that can be brought on by the 21st Century Cures Act far outweighs its potential benefits, and I encourage all Americans reading this to contact your Congressional Representatives to voice your concerns about this bill.

Human Health is Too Important to Leave to Congress 

The human body is amazingly, beautifully, mind-bogglingly complex and intricate. New discoveries about our biology are being made every day. For example, it was recently discovered that the brain has a lymphatic system, a discovery that may have huge implications for human health. Additionally, the burgeoning fields of epigenetics and microbiome research have far more questions than answers within them, and exciting discoveries are being made within those fields every day. Though there are undoubtedly brilliant scientists working in the biological sciences, even they are far from knowing “enough” about unforeseen consequences of messing with a biological system (through use of a drug) that connects to all other biological systems.  Any doctor or scientist who is worth his/her title realizes how little anyone knows about the complex workings of the human body, is aware that medicine is constantly changing as new discoveries are made, and has humility about the consequences of what he/she doesn’t yet know.

If scientists can’t possibly know “enough” about human biology to produce pharmaceuticals that are exact and without side-effects (aka collateral damage), the shills and corporate-whores in Congress certainly don’t know “enough” about human health to legislate major changes that affect how medicine is implemented. They have that power though, and the 21st Century Cures Act is a consequential piece of legislation that is going to have major effects on the entire medical system if it is signed into law. Most of those effects are negative.

The 21st Century Cures Act diminishes the rocks on which modern medicine are based – informed consent, individual body autonomy, the Hippocratic Oath, and basing medicine on scientific evidence. The people of America, and the world, need to fight to keep those bedrocks in place. If all medical decisions, and all medical legislation, were made with informed consent, individual body autonomy, the Hippocratic Oath, and scientific evidence in mind, the world would be a much better place. Don’t assume for a second that current medical and legislative decisions are being made with those basic principles in mind. They are constantly being eroded.  Diligently protect them to the best of your ability – and call your Representatives.

Resources:

  1. New York Times, “Don’t Weaken the F.D.A.’s Drug Approval Process
  2. The New England Journal of Medicine, “The 21st Century Cures Act — Will It Take Us Back in Time?
  3. Medscape Medical News, “Bill Aims to Expand Drug Indications Minus Randomized Trials
  4. Modern Healthcare, “Beware a 21st Century Quackery Act
  5. Public Citizen, “Cures for the 21st Century: Five Simple Ideas Congress Has Ignored

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

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Boy or Girl – Baby Gender Selection Issues

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Some parents have the possibility to opt for gender selection; however, being able to decide whether to have a baby boy or girl is a controversial issue.

Many couples expecting a baby do not think it’s a big issue whether they have a boy or a girl; however there are several medical, social, and personal reasons that could influence parents to recur to some form of gender selection.

Like many other controversial practices, the legality of gender selection, also known as sex selection, varies from country to country.

The Legality of Baby Gender Selection

The United States has perhaps some of the most relaxed laws regarding baby gender selection in the world. Most European countries and Australia, on the other hand, have bans on sex selection and only allow it for medical reasons. For example, if a parent is a carrier of a mutation or gene with more chances of manifesting itself in a certain gender, baby gender selection is valid. However, if parents simply wish to balance the ratio of boys and girls in their family, they are not allowed to recur to sex selection.

This has generated a form of medical tourism in which couples from countries where gender selection is illegal, like the UK, travel to the US in order to be able to choose whether to have a baby boy or girl.

On the other hand, sex selection is illegal in the two most populated countries on Earth, China and India. In these countries, baby gender selection has been performed clandestinely for many years and for reasons other than family balancing or avoiding genetic diseases. In these societies, having a baby boy is preferred mainly for cultural and economic reasons. Parents believe that boys have better chances of earning income and eventually support them when they reach an old age.

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Methods of Baby Gender Selection

There are two major types of gender selection methods: the first one is called sperm sorting, and involves separating X-chromosome sperm from Y-chromosome sperm by flow cytometry, a purification technique in which chromosomes are suspended in a stream of sperm and identified by an electronic detector before being separated. Intra-uterine insemination or in-vitro fertilization can then be performed with the enriched sperm. The success rates for this method vary from 80% to 93%.

The other method, called pre-implantation genetic diagnosis, consists in generating several embryos through in-vitro fertilization, which are then genetically tested to determine a baby’s gender. The chosen embryos can then be implanted. This method has a success rate of almost 100%; however, it can be quite expensive, costing up to $15,000.

Issues Regarding Baby Gender Selection

While there are few objections against baby gender selection when it is performed for medical reasons, it has become a highly controversial issue when it is used for balancing the number of boys or girls in families. Some people raise the obvious ethical question of whether people who opt for gender selection are “playing God” by manipulating whether to have a baby boy or girl. Others believe that new parents will raise a baby more appropriately if he or she belongs to their preferred gender.

Gender Imbalance Caused by Baby Gender Selection

Gender selection has caused demographic concern in China and India since it has contributed to generate a gender imbalance in the populations of those countries. In some regions of China, for example, the sex ratio for newborns is 118:100, boys to girls. This phenomenon has in turn been associated with social problems such as an increase in violence and prostitution.

It seems like a logical solution for governments around the globe to legalize baby gender selection but to analyze the personal reasons why each couple intends to select a baby boy or girl. Gender selection for medical reasons should even be encouraged, since it could prevent serious genetic diseases such as cystic fibrosis, Huntington’s disease, and Haemophilia A. Balancing the gender ratio of a family should be accepted if by doing this, a healthy family environment is created. On the other hand, China and India have shown that baby gender selection as a result of a bias towards a particular gender can not only create a gender imbalance in the population, but contribute to social problems as well.

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

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Organic Certification: What the USDA Organic Label Means

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In Brief

  • The Facts:

    Organic and natural labels mean different things, and various types of labels tells you what percentage of ingredients are actually organic. We'll explore what to look for.

  • Reflect On:

    Do you sometimes buy products thinking they are organic or fully natural based on their wording? Have you later found out that those products aren't natural or organic at all? Read labels more closely at grocery stores to be aware.

Don’t get conned by fraudulent claims of “natural” or “organic.” Learn what to look for, and why it’s important, to ensure you’re getting the quality you are paying for.

The industrial age of the 20th century brought about changing agricultural practices that have generated increasing alarm about the effects of these practices on the environment and health. The use of chemical fertilizers and pesticides, antibiotics, hormones, irradiated and genetically altered food and fiber products has created a groundswell of rightful concern. It has led to the growing demand for non-toxic, organic products that many are willing to pay a higher price for to ensure the healthful purity of food and clothing provided for their families.

With such profit opportunities, it’s little wonder that the lucrative organic product market has suffered abuse with so-called “organic” labels being fraudulently placed on products that have not earned the right. As a result of pressure from farming and consumer groups, legislation for the standardization of organic certification was introduced in the 1980s. It has been updated to include more vigorous enforcement and control methods since, with the current standards established in 2002 by the USDA.

The Standards of USDA Organic Certification

Specific standards must be met in order to legally claim a product as USDA certified organic. Organic producers must utilize methods that conserve water, maximize soil health, and reduce air pollution. The specific standards to earn USDA organic certification include:

Free of synthetic chemicals such as insecticides, herbicides, fertilizers, hormones, antibiotics, and additives

Free from irradiation and genetically modified organisms

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Agricultural products grown on land that has been free of prohibited substances for a period of three years

Animals used for meat, eggs, milk or other animal products must be exclusively fed foods that are organically grown, may not be given antibiotics or hormones, and must have access to outdoors.

Clean and sanitized harvesting and processing equipment throughout the process from harvest to finished, packaged product

Detailed chain-of-handling records from the field through final sales

Physical separation of certified organic products from non-organic products throughout the process of production

Regular on-site inspections from USDA-approved inspectors to ensure compliance

Understanding the Certified Organic Label

Once the rigorous process of certification has been completed, organic producers may place the USDA certified organic seal on their products. Currently, there are four levels of certified organic products, with a specific definition of the percentage of organic ingredients the final products contains. They are as follows:

• 100% organic: all production methods and ingredients are USDA certified organic.

• Organic: at least 95% of the production methods and ingredients are USDA certified organic with remaining ingredients included on the National List of allowed ingredients.

• Made With Organic Ingredients: at least 70% of the ingredients are USDA certified organic with remaining ingredients included on the National List of allowed ingredients.

• No organic wording or seal: less than 70% of the ingredients are USDA certified organic and no claims may be made on the front or back of the product.

Manufacturers or producers who knowingly label a product “organic” when it does not meet the USDA standards are subject to fines up to $11,000 per violation.

Why Organic Certification is Important

When you see the official USDA organic certification seal on food, clothing, and bedding products, you can be assured that these products have met the meticulous standards required and are free of chemicals, toxins, antibiotics, and hormones. When you see the USDA certified organic label, you will understand the value of the higher priced organic products as compared to non-organically produced products.

With the current stringent organic certification requirements enforced by regular inspections from USDA accredited agents, the USDA certified organic label has great meaning and importance to the consumer. Look for the label to know that you are getting the quality you are paying for.

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

Watch the interview here.
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WHO Finds Global Lack Of Inactivity Rising Especially In Wealthier Countries — What You Can Do

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In Brief

  • The Facts:

    Inactivity is on the rise and it's the cause of a wide range of health concerns. Our population is only becoming more inactive, not less, and it's time to change that.

  • Reflect On:

    There are many factors of our modern world that make us less active. Our jobs, driving rather than walking/biking, too much screen time. What can you do differently to bring more activity into your life? What story stops you from starting?

The World Health Organization (WHO) estimates that more than a quarter of the entire population on this planet are not getting enough physical exercise, this number has barely improved since 2001. There are many factors that contribute to this, but just how much damage are we doing by failing to be active?

The lack of physical exercise raises the risk of many health problems, such as heart disease, type-2 diabetes and various types of cancers.

Interestingly, according to their study published in The Lancet Global Health, higher income countries, such as the UK, were among the least active population. Women were also found to be more sedentary throughout the world, excluding two regions in Asia.

The study looked at self-reported data on activity levels from 358 population based surveys covering 168 countries and included 1.9 million people.

The populations of higher income countries, which include the UK and USA showed an increase in the proportion of inactive people and had actually risen from 32% in 2001 to 37% in 2016, in the lower income countries it remained at 16%.

Those who were classified as inactive did less than 150 minutes of moderate exercise and around 75 minutes of intense activity per week.

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It was found that women were less active than men overall, except for in South and Central Asia, the Middle East, North Africa and higher-income Western countries. The authors believe that this was caused by a few different factors including extra childcare duties and cultural perspectives that may have made it more difficult for them to exercise.

Why More Inactivity In Wealthier Countries?

According to the researchers, in the wealthier countries, many of the jobs have transitioned to more office or desk jobs, meaning a more sedentary type of lifestyle. On top of that much of the population of these countries drive automobiles or take public transit to and from work which in many cases accounts for a lot of their time.

In the lower income countries, many of the jobs require the people to be more active, are physically demanding and people often have to walk to and from their jobs.

The WHO has had a goal to reduce the global levels of inactivity by 10% by 2025, the authors of the study feel that at the rate we are currently going, this target will be missed.

Lead author of the study, Dr. Regina Guthold said, “Unlike other major global health risks, levels of insufficient physical activity are not falling worldwide, on average, and over a quarter of all adults are not reaching the recommended levels of physical activity for good health.”

Regions with increasing levels of insufficient physical activity are a major concern for public health and the prevention and control of non-communicable diseases.”

Co-author, Dr. Fiona Bull added, “Addressing these inequalities in physical activity levels between men and women will be critical to achieving global activity targets and will require interventions to promote and improve women’s access to opportunities that are safe, affordable and culturally acceptable.”

According to the WHO,

Exercise guidelines for 19- to 64-year-olds

How much?

  • at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity every week
  • strength exercises on two or more days a week that work all the major muscles
  • break up long periods of sitting with light activity

What is moderate aerobic activity?

  • Walking fast, water aerobics, riding a bike on level ground or with a few hills, doubles tennis, pushing a lawn mower, hiking, skateboarding, rollerblading, volleyball, basketball

What counts as vigorous activity?

  • Jogging or running, swimming fast, riding a bike fast or on hills, singles tennis, football, rugby, skipping rope, hockey, aerobics, gymnastics, martial arts

What activities strengthen muscles?

  • lifting weights, working with resistance bands, doing exercises that use your own body weight, such as push-ups and sit-ups, heavy gardening, such as digging and shovelling, yoga

What activities are both aerobic and muscle-strengthening?

  • circuit training, aerobics, running, football, rugby, netball, hockey

Final Thoughts

I was surprised to see that the WHO didn’t touch on inactivity due to too much screen time — watching television, Netflix, Facebook scrolling, messaging, texting, browsing etc. Certainly, the increase in screen time plays a roll with the amount of inactivity, especially in the higher income countries. If you are someone who spends too much time staring at a screen, then it is important to consider the above information. Can you limit your screen time and replace it with something active? Or would you consider jumping rope, or rebounding while watching the television? Our health is our greatest wealth and having awareness about an issue is the first way to create change and take responsibility for our lives.

Could you walk or bike to work instead of drive? What about trying a new sport? Could you commit to adding a few hours each week of physical activity? These small decisions could have a profound impact on your health, longevity and overall well-being.

Much Love

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

Watch the interview here.
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