Prescription Painkillers Lack Evidence of Safety and Effectiveness for Long-Term Use

By Dr. Mercola

Painkillers have been identified as one of the primary causes of lethal overdoses, not to mention widespread drug addiction. Prescriptions for opioid painkillers have risen by a staggering 300 percent over the past 10 years.¹

According to 2010 data,² there were enough narcotic painkillers being prescribed in the US to medicate every single adult, around the clock, for a month. As of 2012, 259 million prescriptions for opioids and other narcotic painkillers were written.³

This equates to 82.5 prescriptions for every 100 Americans, and those narcotics are responsible for 46 deaths per day. The excessive use of over-the-counter (OTC) painkillers like acetaminophen is equally troublesome, accounting for about 100,000 emergency room visits each year due to overdosing.^4,5

Taking just 25 percent more than the daily recommended dose of acetaminophen—the equivalent of just two extra strength pills per day—can cause liver damage after just a couple of weeks of daily use,⁶ and acetaminophen poisoning accounts for nearly half of all acute liver failure cases in the US.

These drugs do have a place in medicine. However, it's quite clear that they're being overprescribed, and can easily lead you into addiction and other, more illicit drug use. I strongly suspect that the overreliance on them as a first line of defense for pain is a major part of our current drug abuse problem.

Death Toll from Opioids Still Rising

On January 12, the US Centers for Disease Control and Prevention (CDC) released its 2013 Drug Overdose Mortality Data,⁷ which shows no improvement in mortality rates associated with prescription opioids, which ranks number one in terms of drug overdose deaths.

Overall, poisoning deaths from all prescription drugs increased by six percent between 2012 and 2013. Deaths from opioids increased by one percent. Heroin deaths surged by 39 percent, and deaths from cocaine increased by 12 percent.

According to CDC Director Dr. Tom Frieden:

"Deaths from drug overdose are tragic, and we need to scale up both prevention and treatment of addiction. Most people who use heroin in the US today used prescription opioids first. Reducing inappropriate prescribing will prevent overdose from prescription opioids and heroin."

Dr. Andrew Kolodny, chief medical officer at a drug treatment center called Phoenix House has also spoken out on this issue, noting that:⁸

"Heroin use is increasing because we have an epidemic of opioid addiction (caused by overexposure of our population to painkillers) and not enough has been done to expand access to treatment in communities hit hardest."

Ditto for Dr. Sanjay Gupta, chief medical correspondent at CNN, who explains the rise in heroin addiction by linking it to dependence on prescription opioids.⁹ Indeed, what many fail to realize is that opioid prescription painkillers are very similar to heroin.

This is part of why so many painkiller addicts end up using heroin when their tolerance level surpasses their allotted prescription dosage, or when they can no longer refill their prescription. Gupta writes:¹⁰

"Doctors have been less willing to prescribe medications, especially in states like Florida, formerly known for its pill mills, where tighter restrictions on prescribers led to a 23 percent drop in overdose deaths between 2010 and 2012.

The drugs themselves have been tweaked as well. In August 2010, an abuse deterrent version of Oxycontin was released to great fanfare. It was reformulated so it could not as easily be crushed or solubilized so abusers would have a difficult time injecting or snorting it.

Within two years, the choice of Oxycontin as a drug of abuse went from 35.6 percent to 12.8 percent.¹¹ That was the good news. The bad news is that the same study showed heroin use nearly doubled...

Oxycontin used to be called the hillbilly heroin. Society and technology helped fix that problem. But addicts started turning back to real heroin instead."

Opioids and heroin bind to the same receptors in your brain and produce identical results, including an increased threshold for pain and euphoria. On the downside, they produce drowsiness, and at higher doses can slow your breathing, which can turn into a lethal event. They're also equally potent in their ability to cause addiction.

Interestingly, research published last year suggests that medical cannabis may be a safer alternative for people with chronic pain. Dr. Gupta discusses these findings in the featured video. Marijuana led to a 25 percent drop in deaths from painkiller overdoses, which is a fairly significant reduction.

Evidence on Opioids' Safety and Effectiveness Found Lacking

Despite dramatic increases in prescriptions, two recent papers assert that no solid evidence can be found in the medical literature supporting the long-term safety and effectiveness of narcotic painkillers.

Many suffering from chronic pain end up using painkillers for years on end, yet there are no studies longer than one year on record. Most trials do not go past six weeks. There's also a lack of standardized trials evaluating the side effects of opioid use, which is the "golden standard" of medical science-based evidence.

As reported by Reading Eagle:¹²

"The two papers,^13,14 published in the Annals of Internal Medicine, highlight a key issue in one of the major medical controversies of the last decade: how America got thrust into an opioid epidemic...

Investigations by the Milwaukee Journal Sentinel and MedPage Today have documented the lack of evidence supporting use of narcotic painkillers for chronic, non-cancer pain.

The stories also revealed that behind that surge in opioid prescribing was a network of pain organizations, doctors, and researchers that pushed for expanded use of the drugs while taking in millions of dollars from the companies that made them."

I addressed this issue in July last year, when the US Food and Drug Administration (FDA) approved yet another narcotic painkiller, Zohydro ER (Zogenix). The drug, which is the first drug containing pure hydrocodone (synthetic heroin), was approved at the same time that the FDA was also recommending tighter controls on narcotic painkillers, in light of alarming addiction rates and deaths linked to accidental overdoses. All other hydrocodone-containing painkillers on the market are mixed with other non-addictive ingredients. Zohydro ER was approved for patients who need around-the-clock pain relief, and contains an opioid dose that is five to 10 times greater than anything else on the market.

Are Conflicts of Interest Driving Addiction Rates?

When FDA Commissioner Margaret Hamburg was criticized for the agency's approval of Zohydro, she countered saying that "100 million Americans" suffer from severe chronic pain warranting use of the drug. This 100 million statistic has been tossed around in the media ever since.¹⁵ But this figure amounts to about 40 percent of the US adult population and, if true, would be an epidemic of staggering proportions.

Alas, there are problems with this 100 million figure, which originated with a report created by the Institute of Medicine (IOM), titled: "Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education, and Research."¹⁶This report warns against restricting the use of opioid drugs for the fact that so many people "need" them. Not surprisingly, nine of the 19 panel experts that produced this statistic were found to have undisclosed financial ties to companies that manufacture narcotic painkillers.

Pain experts went on the record stating that the 100 million number was completely misleading, as the IOM defined "chronic pain" as pain lasting three to six months, regardless of the cause or severity. The 100 million figure includes not only those with chronic but manageable pain, but also those recovering from surgery or undergoing cancer treatment. According to the National Institutes of Health Pathways to Prevention Workshop paper¹⁷ that was just published, an estimated 25 million Americans have "moderate to severe chronic pain that limits activities and diminishes quality of life"—a much smaller number than the 100 million used to justify the approval of yet another, extremely potent narcotic pain reliever.

Tylenol Also Found Ineffective for Back Pain

Back pain is perhaps the most common form of chronic pain. An estimated 80 percent of Americans will suffer from back pain at some point in life, and an estimated 25-30 percent end up struggling with persistent or chronic back pain, leading many in search for relief in a pill. However, according to research^18,19 published last year, taking acetaminophen for back pain is no more effective than taking a placebo!

There was virtually no difference in the number of days needed to recover between the two groups—in fact, the median time to recover was one day faster among those who received a placebo! According to lead author Dr. Christopher Williams, "The results suggest we need to reconsider the universal recommendation to provide paracetamol [acetaminophen] as a first-line treatment for low-back pain..."

Women Beware: Opioids May Cause Birth Defects

Another issue that is rising to the forefront is concerns about birth defects. As reported by Kaiser Health News,²⁰ nearly one-third of American women of childbearing age are prescribed opioid painkillers such as Vicodin and Oxycontin, despite the fact that these drugs carry risks of birth defects and other pregnancy-related problems. Even more shocking, one recent study^21,22 found that more than 14 percent of pregnant women were prescribed opioid drugs during their pregnancy.

Back pain—a problem most pregnant women have to deal with—was the most commonly cited reason for the prescription. Narcotics were also prescribed for complaints of abdominal pains, migraine, joint pains, and fibromyalgia. Clearly, if you are planning a pregnancy or are pregnant, you should go to great lengths to avoid narcotic drugs. Many of the non-drug alternatives listed below can be helpful for addressing pregnancy-related aches and pains.

Consumer Reports Guide to Safe Opioid Use

Last summer, US Attorney General Eric Holder announced his office is taking steps to address the mounting problem of opioid addiction. This effort includes but is not limited to tracking drug overdose trends, educating health care professionals and the public about prescription drug abuse, and promoting programs shown to prevent such abuse.

The federal government will also r equire manufacturers of extended-release and long-acting opioids to provide prescribers with educational programs explaining the risks and benefits of opioid therapy, and how to select appropriate candidates for such therapy. While I urge you to seriously reconsider the need for a narcotic pain reliever, there are times when they may be warranted short-term. In such cases, please make sure you adhere to the following common sense advice issued by Consumer Reports²³ to limit your risk for adverse effects, accidents, and addiction as much as possible:

Read the label and never exceed the maximum dose. Take the smallest dose necessary for as short a time as possible	Do not drive when taking opioids
Do not mix with alcohol, and do not take in combination with drugs without consulting with your doctor first. Taking a narcotic pain reliever with sleeping pills is one of the most deadly combinations	Make sure to keep the drugs in a locked medicine cabinet to prevent misuse by family or other visitors. Properly discard unused pills by taking them back to the pharmacy
If you have sleep apnea, opioids can exacerbate the condition with potentially lethal consequences. Also, if you have a cold, asthma, or bronchitis, you may need to lower your dose until you've recovered, as opioids tend to interfere with breathing	Make sure you're under regular monitoring by your doctor

Non-Drug Alternatives for Pain Relief

With all the health risks associated with acetaminophen and opioid painkillers, you'd be wise to exhaust other options before resorting to these drugs. Below I list some of the most effective non-drug alternatives for the treatment of pain that I know of. If you're in pain, I recommend trying these first, before even thinking about prescription painkillers of any kind.

Medical cannabis	Medical cannabis has a long history as a natural analgesic.24 At present, 20 US states have legalized cannabis for medical purposes. Its medicinal qualities are due to high amounts (about 10-20 percent) of cannabidiol (CBD), medicinal terpenes, and flavonoids. As discussed in this previous article, varieties of cannabis exist that are very low in tetrahydrocannabinol (THC)—the psychoactive component of marijuana that makes you feel "stoned"—and high in medicinal CBD. The Journal of Pain,25 a publication by the American Pain Society, has a long list of studies on the pain-relieving effects of cannabis and would certainly seem worth the effort for anyone with chronic pain to utilize. Just be sure to seek out a knowledgeable cannabis physician, as many have no idea of the proper dosing. If you are seriously considering medical cannabis for pain, it is imperative that you view my interview with Dr. Alan Frankel, who is one of the leading medical cannabis physicians in the US. He can do consultations on the phone if one needs specific questions answered.
Eliminate or radically reduce processed foods	Avoiding processed grains and refined sugars (particularly fructose) will lower your insulin and leptin levels and decrease insulin and leptin resistance, which is one of the most important reasons why inflammatory prostaglandins are produced. That is why stopping sugar and sweets is so important to controlling your pain and other types of chronic illnesses.
Take a high-quality, animal-based omega-3 fat	My personal favorite is krill oil. Omega-3 fats are precursors to mediators of inflammation called prostaglandins. (In fact, that is how anti-inflammatory painkillers work, they manipulate prostaglandins.)
Optimize your vitamin D level	Optimizing your vitamin D level by getting regular, appropriate sun exposure and taking a vitamin D3 supplement can help reduce pain via a variety of different mechanisms.
Emotional Freedom Techniques (EFT)	EFT is a drug-free approach for pain management of all kinds. It borrows from the principles of acupuncture, in that it helps you balance out your subtle energy system. It helps resolve underlying, often subconscious, negative emotions that may be exacerbating your physical pain. By stimulating (tapping) well-established acupuncture points with your fingertips, you rebalance your energy system, which tends to dissipate pain.
K-Laser Class 4 Laser Therapy	K-Laser therapy can be an excellent choice for many painful conditions, including acute injuries. By addressing the underlying cause of the pain, you will no longer need to rely on painkillers. K-Laser is a class 4 infrared laser therapy treatment that helps reduce pain, reduce inflammation, and enhance tissue healing—both in hard and soft tissues, including muscles, ligaments, or even bones. The infrared wavelengths used in the K-Laser allow for targeting specific areas of your body, and can penetrate deeply into the body to reach areas such as your spine and hip. For more information about this groundbreaking technology, and how it can help heal chronic pain, please listen to my previous interview with Dr. Harrington.
Avoid sitting down	One of the most common causes of pain is low back pain. Even I struggled with it for many years. The only thing that eliminated it, yes entirely 100% gone, was radically reducing the number of hours of sitting from 15 hours a day to less than one.
Chiropractic	Many studies have confirmed that chiropractic management is much safer and less expensive than allopathic medical treatments, especially when used for back pain. Qualified chiropractic, osteopathic, and naturopathic physicians are reliable, as they have received extensive training in the management of musculoskeletal disorders during their course of graduate healthcare training, which lasts between four to six years. These health experts have comprehensive training in musculoskeletal management.
Acupuncture	Research has discovered a "clear and robust" effect of acupuncture in the treatment of: back, neck, and shoulder pain, osteoarthritis, and headaches.
Physical therapy and massage therapy	Both have been shown to be effective for painful conditions such as torn cartilage and arthritis.
Astaxanthin	Astaxanthin is one of the most effective fat-soluble antioxidants known. It has very potent anti-inflammatory properties and in many cases works far more effectively than anti-inflammatory drugs. Higher doses are typically required and you may need 8 mg or more per day to achieve this benefit.
Ginger	This herb has potent anti-inflammatory activity and offers pain relief and stomach-settling properties. Fresh ginger works well steeped in boiling water as a tea or grated into vegetable juice.
Curcumin	In a study of osteoarthritis patients, those who added 200 mg of curcumin a day to their treatment plan had reduced pain and increased mobility. A past study also found that a turmeric extract composed of curcuminoids blocked inflammatory pathways, effectively preventing the overproduction of a protein that triggers swelling and pain.26
Boswellia	Also known as boswellin or "Indian frankincense," this herb contains specific active anti-inflammatory ingredients. This is one of my personal favorites as I have seen it work well with many rheumatoid arthritis patients.
Bromelain	This enzyme, found in pineapples, is a natural anti-inflammatory. It can be taken in supplement form but eating fresh pineapple, including some of the bromelain-rich stem, may also be helpful.
Cetyl Myristoleate (CMO)	This oil, found in fish and dairy butter, acts as a "joint lubricant" and an anti-inflammatory. I have used this for myself to relieve ganglion cysts and a mild annoying carpal tunnel syndrome that pops up when I type too much on non-ergonomic keyboards. I used a topical preparation for this.
Evening Primrose, Black Currant and Borage Oils	These contain the essential fatty acid gamma linolenic acid (GLA), which is useful for treating arthritic pain.
Cayenne Cream	Also called capsaicin cream, this spice comes from dried hot peppers. It alleviates pain by depleting the body's supply of substance P, a chemical component of nerve cells that transmits pain signals to your brain.
Mind-body techniques	Methods such as yoga, Foundation Training, massage, meditation, hot and cold packs, and other mind-body techniques can also result in astonishing pain relief without any drugs.
Grounding	Grounding, or walking barefoot on the earth, may also provide a certain measure of pain relief by combating inflammation