Dr. Woodcock and the FDA’s Attempt to Curb Drug Abuse

It’s practically a thankless job. Worse than that, the good people at the United States Food and Drug Administration are frequently under pressure from all sides of many a heated debate. Patent holders want to sell more drugs and prefer that the FDA make all plants illegal. Well-intentioned promoters of natural health like Dr. Mercola and others regularly accuse the FDA of only looking out for the interest of Big Pharma. Some bureaucrats are innocently stuck in the crossfire.

The government does seem to push the patented synthetic drugs–each with its own unenviable list of horrible side effects–when there are certainly better, less harmful solutions out there. But certainly not all of its officers are corrupt. Let us not lose sight of the fact that  the FDA is charged with no easy task. And let us never be slow to recognize the great work of the few outstanding officials that are legitimately fighting for the health and wellness of all.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, well deserves a round of applause for her efforts to reduce the number of fatal drug overdoses in the United States and beyond.

Roughly 22,000 Americans die each year due to drug overdoses. And federal data confirms that prescription drugs cause a full 75% of these deaths, roughly 16,500. Also, the number of deaths from opioids has increased by 400% since 1999. Dr. Woodcock has recommended a measure that will surely reduce the number of opiate overdoses: tighter controls on the most commonly-prescribed opioid, hydrocodone. Specifically, Dr. Woodcock recommends raising hydrocodone up one class level, from “Schedule 3” to “Schedule 2”.

Controlled Drugs are divided into five schedules, based on their medical use and their potential for abuse and addiction. These schedules are enforced by the D.E.A.

  1. Schedule I includes the drugs with a high potential for abuse that cannot be legally prescribed. Included are Heroin, LSD, Ecstasy and (absurdly) Cannabis.
  2. Schedule II lists the drugs with the most potential for abuse, but can be legally prescribed. Included in Schedule II are: Cocaine, Morphine, Oxycodone, Methadone, and Ritalin.
  3. Schedule III controlled drugs are considered less dangerous than the above lists, and are among the most available to abusers. Roughly 70% of opioid prescriptions contain hydrocodone, which is currently classified under Schedule III.
  4. Schedule IV includes Xanax and Valium.
  5. Schedule V drugs include tiny doses of narcotics, for relief of diarrhea, cough, etc.

The drugs that contain a combination of hydrocodone and a painkiller like acetaminophen or aspirin are most frequently prescribed to treat pain from injuries, arthritis, and dental extractions. Most patients take such medications for just fourteen days, while the law currently allows that a six-month supply be given to such patients, and the excess (up to 92.3%) is often sold on the black market to abusers.

In 2011, the government estimates that 131 million prescriptions for hydrocodone-containing medications were written for 47 million patients. That’s around five billion pills.  If patients only use 7.7% of the maximum allowable dose, the 92.3% surplus would leave up to 4,615,000,000 (4.6 billion) extra pills ‘on the street’. And that is one staggering figure that surely contributes to the thousands of accidental deaths by drug overdose.

Dr. Woodcock‘s recommendation to reclassify the drugs containing hydrocodone as Schedule II would reduce the maximum prescription to three months. If the patient still requires the drug, his or her doctor must then write a new prescription. Although this recommendation seems abundantly reasonable (and the D.E.A. appears to be on-board since last decade), it does not go into effect without the rubber stamp of  the Department of Health and Human Services. Even if the bureaucracy finally comes to its senses, expect the approval to take several months.

And expect the drug pushers to do everything in their power to halt the measure. The  American Medical Association, the National Community Pharmacists Association and other drug lobbyists are citing “significant hardships and delayed relief for vulnerable patients”.

Dr. Woodcock said that F.D.A. is aware that the rescheduling will affect some patients. But the impact on public health caused by the abuse of the drugs had reached a tipping point. “These are very difficult trade-offs that our society has to make,” she said. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”

The epidemic that she is referring to, is the needless death of thousands of Americans per year. Let’s do the math together, based on the official government estimates:

22,000 deaths by drug overdoses per year.

75% of these are by prescription drugs = 16,500, of which Opiates account for the largest portion.

Roughly 70% of the opiates contain the target hydrocodone = 11,550

Since we are not eliminating this drug, but rather, simply going to check in with patients two extra times per year, it is probably unrealistic that we could eliminate all 11,550 needless deaths per year. But I would venture a guess that Dr. Woodcock’s recommendation may save upwards of 5,000 lives per year.

Dr. Woodcock correctly pointed out that “If you are needing chronic therapy of this magnitude,” she said, “you should be seeing your prescriber… after three months, rather than six.”

With Chemotherapy, Less is More

Oncologists continue using chemotherapy drugs because of the scientific studies that support their use while alternative health “experts” are screaming the benefits of natural substances that are helpful and less dangerous. After carefully considering the pros and cons of each, it is clear that while small doses of chemo may provide some benefit to some patients, higher cumulative doses should be avoided.

Doctors are scientists that are focused on one thing: using the best tools available whose effectiveness are scientifically proven to improve or lengthen the life of the patient. Naturopaths and other alternative practitioners also attempt to improve and lengthen the patient’s life, but very often relies on common sense, folk traditions, and informally-gathered “anecdotes” that may or may not qualify as legitimate evidence, depending on who you ask.

If you ask me, I say that medicines continue to be handled by doctors, herbs continue to be handled by herbalists, and evidence continue to be handled by lawyers and judges.

Scientists prefer to base their opinion on larger, more formal studies, with strict procedures for comparing the effect of one substance against a fake. In most cases the look-alike is a sugar pill or a saline injection that tricks the patient into believing that she is receiving an active ingredient. To achieve the so-called “gold standard” of scientific studies, the randomized, double-blind, placebo-controlled study, even the doctor must be fooled into thinking that she is administering the drug.

No herbalist can afford to conduct such a study. Herbs are in the public domain, available to patients for free or for next to nothing. The herbalist has heard that a particular natural substance will have a beneficial effect based the vitamins or minerals that it contains, or based on the success stories from past users. But these “anecdotes” are considered unscientific.

Where is the truth in all of this?

A wise man that I know taught me to go to great lengths to find the truth, the whole truth and nothing but the truth, no matter how obvious the truth may seem on the surface, and no matter how confusing things get when you dig up heaps of seemingly-disconnected facts. Only the most thoughtful and most patient among us are willing to take the time to carefully examine each scientific study and each “unscientific” anecdote to decide which of these belongs in the final weighing of the evidence.

In a perfect world, there would be wonderful studies comparing the effects of synthetic drugs against the natural alternative. There would be no need for deceiving hard-working, intelligent doctors, no more fooling the innocent and cooperative patients. Less money wasted messing around with sugar and salt.

I admit that it is mildly interesting to see how many patients are healed just by taking a moot pill, since this phenomenon proves that a person’s positive thoughts do in fact have a positive influence on her healing. But this has been proven and re-proved. On to other matters that are yet unclear in the minds of many.

We all want to know exactly how well does the notorious chemotherapy work when compared directly against the mighty dandelion, or raw natural cannabis?

There are heated debates, but rarely does a debate end with both sides having the same view of the truth.

Physicians and alternative practicioners must find some common ground. We must work together, without finger-pointing or name-calling. We must remember that we all want the same thing: to heal the patient, with the best means possible. We must be civil and fair. Each one of us must strive for the extremely-high standard of fairness that a wise judge strives for.

As Lown said in his 1996 book, the Lost art of healing, “Caring without science is well-intentioned kindness, but not medicine.”

The New England Journal of Medicine is a highly-prestigious weekly medical journal that is strictly devoted to science. In its pages you will find the observations and opinions of the most highly-trained professionals in the field of medicine.You will not find a great many studies on natural substances, not because the contributors or the editors are against nature, but simply because this type of study in fact doesn’t exist. But there is no shortage of information on chemotherapy agents, like doxorubicin.

On September 24, 1998, the NEJM published a report by K. Pawan and others, stating that with higher doses of doxorubicin, up to 36 percent of patients suffered cardiomyopathy or congestive heart failure. (“Higher” means a cumulative dose of more than 601 mg/sq m of body surface area.) At a medium dose, the risk was still up to 18 %. The researchers proposed a “dose cap” of 500 mg/sq m of body surface area, which seems to cap the risk of heart attack at “just” 4 %.
Clearly, even those that argue in favour of chemotherapy agree that its use should be minimized to avoid its most dangerous side effects.

In numerous studies, cannabis has been found to have antineoplastic, analgesic, antiemetic and appetite-modulatory properties. And raw cannabis has never been proven to harm a patient. Smoked cannabis does produce unwanted side effects such as undesired psychotropic changes and a slight risk of hypoxemia. But raw cannabis juice poses no such risks and contains the essential nutrients THC-acid and CBD-acid.

According to Dr. William Courtney, the tolerable dose of THCa is 60 times higher than with THC (600mg vs 10mg). The low human tolerance for THC explains why a slight change in dose will take some from a pleasant “high” to an unpleasant “acute toxic effect”. [Gerra G et al. Recent Pat CNS Drug Discov . 2010;5(1):46–52]

Dr. Courtney used a tincture of raw cannabis to treat a “massive…inoperable brain tumor” in an 8-year-old. At 2 months: a dramatic reduction. At 8 months: the tumour had nearly disappeared. Thus the child avoided side effects of chemotherapy/radiation.

Two pre-clinical trials have shown that CBD thwarts breast cancer growth. […the effects of CBD on the reduction of breast cancer cell proliferation, invasion, and metastasis”. Breast Cancer Res Treat. 129 (1): 37–47. 2010.] -and- [McAllister SD et al (2007). “Cannabidiol as a novel inhibitor of Id-1 gene expression in aggressive breast cancer cells”. Molecular Cancer Therapeutics 6 (11): 2921–7.]

A study at the University of Windsor showed that dandelion tea caused cancer cell apoptosis (cell suicide) in cancer cells.

Cannabis has been well-known and documented for more than 5,000 years. Dandelion has been known for at least a century, and neither plant is known to be dangerous to humans. Yet each of these natural remedies is a long way from gaining the acceptance of the overall community of physicians and healers. Or are they? Hundreds of thousands have been spent thus far showing dandelion’s promise. But several hundred thousand more are needed to complete a “gold standard” study.

to be continued.

Patrick Ducharme

My dad, AKA The Chief, is the toughest guy I know.  Take one look at his blog and you will see what I mean. If you can read it without laughing and crying, then you are better than me.

Warning: visit Patrick Ducharme’s Blog ONLY if you have thick skin and if you can handle the (often) ugly truth.

Pictured, below, my dad is dressed up as the “dictator” of the Ducharme Revolutionary Independence Party (DRIP) for a charitable event.

Patrick Ducharme DRIP
Patrick Ducharme DRIP

Limon

Lotus Garden Ocean View
Limon Panorama
Limon Panorama

Limon is paradise on Earth. It is ideally situated less than an hour from the central hub of the Americas, and just three minutes from the highway that connects every country in North and Central America. Limon enjoys spectacular views of the Pacific Ocean and of the majestic mountains that surround Panama’s First National Park. At 500meters (1,600 feet) above sea level, Limon receives a fresh breeze year-round, making it the most comfortable place in the entire region. Limon provides perfect living conditions for humans, and nearly every kind of plant and animal. In fact, several hundred varieties of birds either live here or visit frequently, including some of the rarest Eagles and Toucans, which are a testament to the purity of the surroundings.  Yet Limon is smack in the middle of the country with easy access to the city, the beaches, resorts, shopping and more. Limon is just 15 minutes from the closest beach, and there is a veritable smorgus board of beaches to choose from, literally more than fifteen choices within a one-hour drive. True beach lovers will appreciate having such easy access to such a wide variety of beaches (with any colour sand, and any size of wave) without having to live 24/7 in the scorching heat and salty-humidity that beach-dwellers frequently complain of… the salt in the air destroys their appliances, plus the sand gets all over the home, not to mention the sand-flies… it is decidedly better to visit the beach as often as desired then return home to a comfortable, fresh climate with glorious views.

Limon is Panama’s best-kept secret. Other mountain towns with a similar climate but much further from the City and Beaches have been developed long ago. Amazingly, the closest mountain to Panama City is the last one to be developed. Yes, we have saved the best for last. This mountain may not be the coldest but it is definitely the coolest. It will soon be known by the destinations that are being developed right now: castles, hotels, spas and luxury homes to name just a few of the projects under way.

 

Robo-Mosquitoes Are a Serious Threat to Human Life

The mosquito is certainly among Earth’s most hated creatures, and for a variety of reasons. The least important of these reasons–its annoying buzz–is enough to summon the first degree murderer in nearly every human. Who among us has the mental fortitude to lie tranquilly in bed without plotting the violent death of a mosquito that lurks in the protected airspace? Aside from the sleep-disturbing sound caused by mosquitoes of both genders, the female mosquito provokes more serious concerns ranging from an itchy allergic reaction to her otherwise-benign probe, to the sometimes-fatal consequence of passing viruses between people. A look at world history will reveal that the mosquito may be more deserving of the title “public enemy #1” than even the most horrendously deranged humans. Since mosquitoes can easily spread diseases like malaria, yellow fever, west nile, and dengue fever, humans have a good reason to take preventative defensive measures. In the past, even the mightiest empires have underestimated and misunderstood the world’s tiniest air force, and with devastating consequences. Today, we must be more intelligent and more strategic than ever. We must learn from our past, and make calculated decisions. And we must always remember that some things are incalculable!

Queen Elizabeth, take note!

Oxitec Ltd. of England has developed a genetically modified mosquito dubbed OX513A that also flies under the aliases “suicide mosquito”, “dead-end bug” and even “Frankenskeeter”.

But G.M. is no joke!

The all-male robo-mosquitoes contain a “lethality gene” that is supposed to ensure the premature demise of the subsequent generation of mosquitoes. If all goes smoothly, the local mosquito population will drop. But that is one enormous “IF”. The half-baked plan contains at minimum, the following gigantic flaws:

  • if the mosquitoes are exposed to the antibiotic tetracycline, the mutant mosquitoes will survive as flying zombies with untold capabilities and subject to an infinite number of future mutations.
  • tetracycline is commonly used by humans and other animals, so it is a practical certainty that some percentage of mosquitoes will be exposed.
  • the plan requires “overwhelming” the native mosquitoes with transgenic ones at a ratio of 10 to 1.
  • the plan targets only the Aedes Aegypti mosquito, and does nothing to prevent other types of mosquitoes from adapting to fill its disease-spreading niche, and both natural and engineered adaptations are likely to result in new  species that are stronger than the present target.
  • according to Camilo Rodriguez-Beltran, a Chilean biosecurity expert that was trained in France, the gene-altered mosquitoes could cross international boundaries, violating international treaties on biosafety. “All consequences that could occur are unforeseen,” Rodriguez said. “It’s been developed very rapidly.”

And very stupidly, I may add. The mosquito is already dangerous enough as it is. Screwing with its genes could prove to be detrimental to human life. Olmedo Carrasquilla, a Panamanian environmental lawyer, said that Panama should educate the public on mosquito control. He asks “Why invest millions in methods and technology when there are no guarantees and when there are rudimentary methods that work?” 120,000 people in South Florida apparently agree. Angry residents temporarily blocked a plan to test Oxitec’s robo-mosquito in the Florida Keys last year. Here’s hoping the plan will be dropped rather than delayed. Oxitec mosquitoes have been tested in the Cayman Islands, Brazil and Malaysia and may soon be  tested in India, Florida and Panama, unless governments can WAKE UP to the imminent dangers in time. Besides the best-known strategy for mosquito prevention of dumping stangnant water to reduce mosquito breeding, there are other strategies. My favorite strategy comes from the Kuna indigenous tribe, which currently resides in the beautiful Caribbean archipelago called San Blas, or Kuna Yala in the Kuna language. The Kunas have survived for thousands of years in jungles, mountains and islands. Their survival depends on a healthy co-existence with nature. The Kunas have developed an advanced and complete system of natural medicine that is known as Tuleina. Tuleina is not well-recorded (yet!) but it contains the knowledge of thousands of beneficial plants, at least one for every known and unknown medical condition. To protect themselves from the pesky mosquito, the Kuna take one cup of herbal tea, which successfully wards off mosquitoes for a month or longer. I have taken this tea only a few times in the past eleven years, and I’ve not had a single mosquito bite in over a decade! And I’ve never had to resort to using (toxic) bug spray, not do I fumigate, nor do I sleep in a net. The mosquitoes simply do not come near me.  Even when sitting outside, surrounded by others that complain about the nasty insects, the tiny predators keep a healthy distance from me. So much so that in the last decade, I’ve scarcely even heard their once-familiar buzz. The lesson to be learned here is that, when confronting a natural problem, it is far better to search for the natural solution, rather than seeking the most complicated, most expensive, and most patentable “solution”, that will eventually reveal itself as the most idiotic, most ridiculous and most dangerous course ever taken.