Pain Medication: Risks and Alternatives

Paul L. Reller L.Ac. / Last Updated: August 03, 2017


The Trouble with Narcotic Pain Medications

The Centers for Disease Control and Prevention (CDC) released a statement in January of 2012 that stated that in every year since 2003, more Americans have died from prescription painkiller overdose than from heroin and cocaine combined (the numbers in fact eclipse the actual heroin and cocaine overdose deaths). By 2016, the U.S. CDC stated that despite large efforts to enumerate the actual drugs involved in overdose deaths, with some communities not specifying the actual opiate involved on autopsy reports in up to 90 percent of cases, that approximately one fifth of all drug overdose deaths still lacked information on the specific drugs involved. This is because the medical doctors that perform the autopsies are very reluctant to admit that the great majority of these deaths are from prescription pain medications and combinations of prescription opiates with anti-psychotics, benzodiazepines, and anti-depressant drugs. Despite this lack of data, the American Society of Addiction Medicine released a 2016 report that in 2014 the number of overdose deaths recorded as attributed to prescription pain medications was almost double that attributed officially to heroin, a fact surprisingly contradicted in the 2016 CDC reports, which took an about face on the issue. In addition, it is now widely accepted that a great percentage of accidental heroin overdose deaths involve addition of the pharmaceutical opiate Fentanyl to the heroin, which comes with an alarming risk of death, and so when approved was only granted FDA permission to be used as a topical patch or lollipop. The approval for Fentanyl tablets (Buccal) specifies that only patients who have been taking a higher dose of narcotic pain reliever chronically and are "tolerant" should take this drug, and are warned that the tablets have to be held in the "buccal cavity" to dissolve, meaning the mouth, or else danger of death is great, and that children who may find and take these "buccal" tablets are in great danger of death! The fact that the word "buccal" is used is absurd, as almost no one knows that meaning of this word for the mouth. In 2016, the famed musician and songwriter Prince died of an overdose that involved Fentanyl, and had a history of Oxycodone (Percocet) use for pain, which is now proven to be much more addictive and producing a sustained dopamine release effect in the nucleus accumbens of the brain, leading to much higher potential to create an addictive syndrome than natural opiates.

Heroin, a type of morphine, was created to provide safer and more effective pain relief, but removed from medical use as it acquired a stigma of abuse in the 1960s. Today, these synthesized versions of narcotics that replaced heroin create much more drug abuse and overdose deaths, come with alarming long-term adverse effects, and do not provide the degree of pain relief of heroin, or even the initial synthetic narcotics, such as Demerol (meperidine) or Dilaudid (hydromorphone). Overdoses with prescription drugs are now the most prevalent cause of accidental death, mostly from prescription painkillers, surpassing deaths from motor vehicle accidents. The "war on drugs" appears to have shifted the profits to the pharmaceutical industry, and the results have been devastating in the United States. In 2016, Harper's Bazaar printed a previously unpublished interview with the famed John Ehrlichman, top advisor to President Richard Nixon for almost two decades, and creator of the infamous "Plumbers" that instigated the Watergate scandal, and who later was convicted to 2-8 years in federal prison. Ehrlichman was quoted as stating that he engineered the "war on drugs" using obvious lies about heroin, to be able to legally harass 'blacks and hippies' involved in political work. In this extensive interview in 1974 Ehrlichman claims that the dangers and addictive harm to the public were greatly exaggerated to turn public opinion against the political threats to Nixon and the Republican Party. The result was the complete removal of any natural narcotic pharmaceutical from use in the clinical setting, and the development of synthetic narcotics that were much more profitable, but came with an array of adverse health effects and perhaps even more addictive potential. In 2014, a study at the University of Michigan School of Medicine, in the United States, showed indeed that oxycodone produced dramatically more robust and continued increase in the neurotransmitter dopamine in the brain than morphine, which evoked an increase phase of less than a minute that quickly returned to baseline levels. Since sustained dopamine release in key centers of the brain, such as the nucleus accumbens and mesolimbic pathway, is the key to the addiction syndrome, it is obvious that these synthetic opioid pain medications were designed to be much more addictive than more natural opiates. To see a summary of this study, just click here: . It is time that we quit pretending that profit motivation is not involved in our crisis of addiction.

The cause of death from prescription drug overdose often involves the effects from concurrently prescribed drugs as well, especially the combination of pain medications with drugs that treat anxiety and depression. The combination of these drugs with alcohol or other recreational drug use also increases the risks of accidental overdose and death, as well as liver, endocrine and neurological damage. Still, there is very little effort on the part of standard medicine to shift away from prescription painkillers, and utilize healthy, safe and effective treatments in Complementary and Integrative Medicine (CIM/TCM). Programs such as the 2009 prescription drug monitoring system, set up by Governor Jerry Brown, were not even utilized. The New York Times reported that in the San Francisco Bay Area, only 86 of 30,000 doctors and pharmacists were signed up to use the system in 2011. By 2016, the PDMP was enveloped into CURES (controlled substance utilization review and evaluation system), a 1999 voluntary prescription doctor-shopping program with an acronym that downplayed the problem, and had gone to the 2.0 version with a mandated registration. This online system could quickly identify prescription drug abusers and "doctor shoppers". In 2015, only 10 states had mandated such a program, mainly due to opposition from the state Medical Associations, constituents of the American Medical Association (AMA). Prescription painkillers are the most abused serious drugs among youth in the United States, and many teenagers buy these pills from such alleged patients. By 2012, budget cuts resulting from the Great Recession have all but eliminated these programs of regulation of pain medication abuse in many states. Most of these abused opioid pain medications have a high dosage of acetaminophen as well, creating a risk of liver damage or dysfunction, especially when the buffering is broken down and the drugs are snorted or injected. The blatant manipulation of the government regulations, and practice in standard medicine, has led to an unimaginable crisis.

By 2016 the recorded incidence for death from prescription drug overdoses in the United States rose dramatically, with the drug overdose deaths recorded by the U.S. CDC for white Americans age 25 to 34 five times what they were in 1999, and the rates of drug overdose deaths for the 35-44 year old whites tripled during that time period. Analysts found that the reason for this epidemic rise in drug overdose and addiction rates for white Americans, but not for the non-white population, was that Medical Doctors had been told to restrict pain medication prescriptions to Black and Hispanic populations for fear that the drugs would be sold on the street. The mortality rates for Black and Hispanic Americans had been falling, and the rate of drug overdose deaths in these populations were held flat during this time period, according to a January 17, 2016 New York Times article entitled Drug Overdoses Propel a Rise in the Mortality Rates of Young Whites. Even as the flood of cheap heroin created by the long war and American occupation in Afghanistan reached the United States, these heroin overdoses were attributed to prior addiction to pharmaceutical narcotic pain medication, as well as the addition of pharmaceuticals such as Fentanyl to the heroin. The subject of addiction to narcotic pain medication became a hot topic for both parties in the 2016 presidential race. Many young users reported that they didn't think that there was any danger of addiction with "Oxy", since it wasn't heroin. Even with the rise of availability of heroin itself, by 2016, the U.S. CDC reported that more than 30 percent of prescription opioid deaths involved methadone, the supposedly 'safe' alternative used mainly in addiction treatment. The touted strategy of using substitute narcotics to treat heroin addiction has largely been a failure, but a great boon to the pharmaceutical industry. Addiction syndrome is a disease that needs a more holistic approach to cure.

Perhaps even more egregrious in recent years is the rise of the opioid pain medication, Fentanyl, as a substance of abuse and major contributor to overdose deaths. This drug, synthesized as an analog of the popularly prescribed Demerol (pethidine) in the 1960s, presented more danger of mortality and was used mainly in the hospital for anesthesia as Sublimaze, often combined with other drugs for surgery and tests. It was also used for end-stage cancer patients suffering from much pain. Only in the 1990s, though, did it become more popularly prescribed, introduced in non-oral forms to avoid accidental death, as a topical patch or, ironically, a lollipop, which came with warnings that this drug was very dangerous for children. Finally, it was introduced in pills with the guideline to let it dissolve in the mouth, as swallowing would be dangerous. Despite these absurd uses considering the decades of warnings of danger of mortality, Fentanyl was allowed to be sold with many different brand names, and finally as Subsys, a combination drug from the pharmaceutical company Insys Therapeutics, a name that implied gentle alternative pain relief. In 2014, in a rare case, a Connecticut clinical nursing specialist linked to kickbacks by the company was actually arrested and charged with criminal misconduct for improper promotion and prescription of this Fentanyl combo drug, prescribing more than $1 million dollars worth improperly, and billed to Medicare, and a Neurologist in Michigan was arrested for allegedly defrauding Medicare to the tune of $7 million for improperly prescribed Subsys. In 2014, the bad press resulted in the intranasal spray form of Subsys not meeting sales expectations, and a sales manager at the company, Jonathan Roper, sent an email to staff that stated: "There is no excuse for any of your docs to not take care of you at this crucial time of the quarter." The implication was that all the sales promotions showered on the prescribing Medical Doctors must be rewarded with high sales. In 2016, Mr. Roper and is associate Fernando Serrano were arrested on federal anti-kickback charges, paying large amounts of money to prescribing pain specialists to participate in 'sham' educational programs to spur millions of dollars of prescription. A June 11, 2016 New York Times article, entitled Charges of Kickback at Drug Maker, quotes the U.S. Attorney Preet Bharara: "As alleged, Roper and Serrano helped feed this devastating surge of opioid addictions by tapping into another age-old addiction, greed." Fentanyl was used in its various forms as an additive to heroin, or powdered to mix with other drugs in a cocktail, and led to many accidental overdose deaths. The pain specialist getting kickbacks for handing out the Fentanyl received as much as $3000 per speaking engagement held at fancy restaurants, and often attended only by friends of the speaker, according to the investigators, and afterward, the group often went to a strip club where all expenses were paid. One pain specialist was paid $147,245 in 2014 alone for this, and rewarded the company with $1.2 million in sales of Subsys, mostly off-label, or outside of approved FDA guidelines. There is no doubt that a systemic attitude concerning pain medication and willful ignoring of the risks and harm to public health and health spending is responsible for the alarming surge in narcotic overdose deaths and rampant drug addiction.

The debate on how best to curb overdose mortalities and accidental death from chronic use of pain medications, as well as the explosion of drug abuse associated with these prescription medications has not been productive. The focus of the debate so far has been whether to severely limit pain medication to all patients, to shift away from synthetic opioids to more NSAIDS and acetaminophen, or to prescribe more psych drugs. Treating all pain patients the same creates problems for patients with severe chronic pain, though, and denying effective pain relief is cruel. There has been little focus on increased direct soft tissue therapies, and until recently, a discouragement of the use of acupuncture combined with these physiotherapies, herbal and nutrient medicine. There has been some renewed focus on providing a minimal amount of cognitive and behavioral therapy, and mind-body focus in pain management, but often this is offered only as a gauntlet to go through before receiving long-term prescription of drugs. It is well known that opioid pain relievers, as well as other forms of analgesic drugs, do not completely relieve pain, and that adaptation in the nervous system to the drugs occurs, spurring increased dosage to get the same effect. Opioid-induced hyperalgesia and allodynia also occurs, with the long-term use actually increases the body's sensitivity to pain and even touch. Over time, the side effects from the medication may also change or increase, but the subject of risk versus benefit is rarely reintroduced in therapy.

The pharmaceutical companies, predicting the explosive alarm generated by the growth in sales of prescription narcotic pain medication, were prepared, and implemented a plan to advertise widely new forms of these medications that were reportedly difficult to abuse, using chemical coatings and preparations that made it more difficult to turn the pills into powders and liquids that could be snorted or injected. In 2007, the main company marketing these new formulations, Purdue Pharma, the manufacturer of the best selling pain medication OxyContin, was fined more the $600 million when three of its executives pleaded guilty to criminal charges for misrepresenting these new OxyContin formulations' risk for addiction. A June 7, 2015 article in the New York Times entitled Painkillers Resist Abuse, but Addicts Adjust, noted that these advertising claims resulted in almost half of prescribing doctors believing that the advertised abuse-deterrent forms of OxyContin were less addictive, and that the majority of abuse occurred in non-oral intake of the drug. These beliefs were completely untrue, and created by the publications sponsored by the pharmaceutical industry. The state of Kentucky is proceeding with a lawsuit claiming that false advertising claims of less addictive forms of OxyContin resulted in massive harm to the state, and Bloomberg News reported in late 2014 that it is believed that this one lawsuit could total over $1 billion due to strong evidence that the company used a sales campaign that deliberately misled doctors. Since 2007, 12 legal claims against the makers of OxyContin totaling over $160 million dollars included Medicare fraud, false advertising, unjust enrichment, and creating a public nuisance, and Abbot Laboratories, who had co-promoted OxyContin, but sold its share before these legal problems came to settlement, was named as a co-defendant. In Pike County, Kentucky, where the current trial is being held, a survey found that almost 40 percent of the population stated that they knew someone who had experienced legal trouble related to 'Oxy' addiction, and more than a third knew someone who had overdosed or had been seriously injured by taking the drug, with 29 percent stating that they knew someone who had died of overdose. These statistics are overwhelming.

In 2014, the United States Food and Drug Administration (FDA) finally approved an alternative to the common narcotic pain medications that are loaded with too much acetaminophen, approving a pure high-dose hydrocodone in an extended release form, called Zyhydro. This approval immediately caused controversy, as the FDA committee recommended against its approval, and many fear that this will stoke the fires of an epidemic of prescription narcotic abuse. Other experts, such as Dr. Vesna Jevtovic-Todorov of the review committee, stated in a New York Times article entitled New Painkiller Rekindles Concerns, that: "When you talk to pain specialists in our field, they will all tell you one indisputable fact - opiates are lousy drugs to treat chronic pain." The reasons cited for approval of a pure high-dose version of the current synthetic opiate pain medications is the fact that it would be cruel to deny the 100 million Americans with chronic pain their only treatment option. The continuing refusal to acknowledge that opiate narcotic pain medication is not only not the only option, but is in fact a poor option, is based purely on the need to deny the proven efficacy of more conservative therapies, especially a combination of therapeutic protocols involving physiotherapies, acupuncture, and herbal/nutrient medicine. In 2016, a meta-review of opiate pain medication and the treatment of low back pain, testing various narcotic medications, was published in JAMA Internal Medicine by experts at the University of Sydney School of Medicine, headed by Dr. Andrew J. McLachlan. This definitive review of 20 high quality randomized controlled human clinical trials found that opiate pain medication provided only mild pain relief and no functional improvement, barely performing better than NSAIDS or aspirin. It appears that we have been systematically told lies about narcotic pain meds for decades, and now we have an enormous problem with addiction and related health problems. These researchers in Australia noted that a protocol of targeted stretch and exercise works much better, and of course did not mention Complementary and Integrative Medicine and Traditional Chinese Medicine (CIM/TCM) despite now abundant proof of effectiveness of an array of protocols in this specialty.

In 2012, Dr. Andrew Vickers, a renowned health outcomes researcher at Memorial Sloan-Kettering in New York, published a definitive meta-review of randomized controlled human clinical studies of acupuncture for the treatment of chronic pain in the Annals of Internal Medicine. Dr. Vickers chose only the human clinical studies with the highest possible rating, and found that in these 29 studies, involving more than 18,000 patients with chronic pain, that acupuncture stimulation definitely outperforms the chosen sham or placebo significantly, and more importantly, outperforms standard therapy for chronic pain even more significantly than it outperforms placebo. Dr. Vickers stated that this meta-review should change the attitude in standard medicine and prompt M.D. referrals for patients with chronic pain. There is no longer any scientific doubt of efficacy.

Guideline and labeling changes in the past few years have reflected the concern that experts in pain management and drug abuse have expressed. In 2009, long-awaited guideline changes for the prescription of narcotic pain relievers was published in the medical journal The Journal of Pain, reflecting the first comprehensive, evidence-based clinical practice guidelines for prescribing potent narcotic pain medication, according the the chief author, Dr. Roger Chou M.D., director of the Oregon Evidence-Based Practice Center at the Oregon Health and Science University School of Medicine. In 2013, the U.S. FDA announced new product label warnings for long-acting opioid pain medication to combat the enormous problem of prescription narcotic abuse, addiction and overdose deaths. The updated label guidelines state that these narcotic pain medications should only be used to manage pain severe enough to require around-the-clock, long-term opioid treatment after alternative treatments in pain relief and management are found inadequate. The FDA also announced that it will soon require companies that manufacture long-lasting opioid pain medication to conduct long-term studies to assess the actual risks of abuse, addiction and overdose deaths. While this has stirred enormous debate in the medical community concerning the denial of pain medication and the growing incidence of chronic pain syndromes in the United States, what is overlooked is the enormous need to finally integrate actual direct therapies to treat and resolve these pain syndromes, not just prescribe more NSAIDS and acetaminophen, anti-seizure medications, and anti-depressant drugs. The stubborn insistence to deny patients the proven evidence-based therapies of TCM, providing a bundle of therapeutic disciplines in one treatment session, and addressing not only the local tissue causes of pain, but the modulation and regulation of the pain signals themselves in the central nervous system, and the modulation of inflammatory processes, has to stop. Not only inhibition of pain signals, but restoration of the patient has to be emphasized. Integration of TCM and the Licensed Acupuncturist and herbalist, especially those TCM physicians trained in direct soft tissue therapies, or Tui na, has to finally be promoted to solve this enormous problem.

Clearly, these issues can be handled more directly, without resorting to a simplified debate over whether or not to sufficiently medicate. Studies in recent years have clearly demonstrated that pain relief may be obtained from a number of sources, and a more careful combination of drugs and other therapies could be integrated to reduce dosage and chronic dependence. Why this more thoughtful strategy has not been implemented is the question. Recent studies have shown that cannabinoids, or chemicals in Cannabis, used topically or orally, as natural extracts or synthetic cannabinoids, or just in foods or smoked medically, actually are effective pain relievers, are synergistic with opioids, and actually reduce the neural habituation seen with opioids (see study links below in additional information). With research finally occurring after decades of restriction, there is now even cannabinoid products with low THC that may be effective, and not all use of cannabinoids has to include getting high. Topical cannabinoid creams are still unavailable in the United States, even though these obviously do not get anyone high and are proven safe. Capsaicin ointments are effective for peripheral nerve-related pain, and topical bioidentical pregnenelone is proven safe and effective, and is combined with tissue nutrients and anti-inflammatory herbal chemicals such as Emu oil and MSM (a DMSO derivative).

A large joint study by the University of Pennsylvania, Montefiore Medical Center, Albert Einstein College of Medicine, and the Johns Hopkins Bloomberg School of Public Health, published in the Journal of the American Medical Association (JAMA) online in August of 2014, showed that overdose deaths from opiate pain medications were reduced by about 50 percent between 1999 and 2010 in the fifth year of implementing laws legalizing medical marijuana, and a consistent immediate decline in these overdose deaths of about 25 percent occurred almost immediately when such laws were implemented. A thorough adoption of a variety of treatment options with more conservative protocols could save an amazing number of lives, and result in patients actually achieving much improved health and reducing dependency on pain medications, as well as marijuana use for pain, dramatically. Studies have demonstrated that use of key proteolytic enzymes for a month is more effective than some synthetic opioid medications, not providing immediate relief, but very effective in time. Increasing research is showing how persistence with various herbal medicines and acupuncture provides very significant sustained pain relief, but not after just one treatment or day of use. As patients become more educated to the possibilities in pain management, as well as the potential to correct the underlying tissue problems and actually restore healthy tissue regrowth, the ability to be more safe and successful with integration of individualized pain treatments, reduce dangerous long-term habituating drug use, and actually achieve a better quality of life, is becoming a reality. It seems that we cannot, as patients, depend on our medical doctors to educate and promote such integrative care, though. The impetus has come from patient demand.

In 2011, the U.S. FDA announced that sharp restrictions of acetaminophen content in some of the most popularly prescribed pain medications would have to occur over the next 3 years, or these drugs would be taken off the market. The FDA will also require more explicit label warnings on these prescription medications concerning the risk of acetaminophen overdose and liver damage. Drugs combining opioids and acetaminophen are prescribed more than 200 million times per year, and use of high dosage acetaminophen has become commonplace in drug prescription as more effective simple narcotic medications have been heavily restricted and discouraged.

The Public Citizen's Health Research Group, with Dr. Sidney Wolfe, director, and Dr. Peter Lurie, deputy director, have been at the forefront of a 30 year campaign to address the unspoken and unpublicized dangers of damage from overuse of the most common pain relieving drug, acetaminophen. In 1977, the FDA (Food and Drug Administration) Advisory Review Panel recommended that strong warnings be placed on all acetaminophen-containing medications: "Do not exceed recommended dosage because severe liver damage may occur" and "Do not exceed recommended dosage or take for more than 10 days, because severe liver damage may occur." By 1999, the failure to enforce even these FDA warnings of liver damage resulted in the National Hospital Discharge Survey finding that over 26,000 hospitalizations per year related to acetaminophen overdose were recorded. This was despite a reluctance to record acetaminophen poisoning by the standard medical industry. The National Hospital Ambulatory Care Survey reported nearly 57,000 emergency room visits per year related to acetaminophen injury, and the American Association of Poison Control Centers recorded 108,000 calls to Poison Control Centers in 1999 regarding acetaminophen poisoning, and 141 deaths. A review of death certificate data resulted in an estimation of 458 deaths per year related to acetaminophen use or misuse, and the reluctance to record and report indicates that this figure is probably very underestimated. These recorded figures had doubled since 1995, were widely considered underreported and underrecorded, and were expected to increase yearly unless more intense regulation and warnings were enforced.

In 2011, a study published in the British Journal of Clinical Pharmacology concluded that many of the overdose deaths caused by acetaminophen, found both in common pain relievers and combined with synthetic narcotics in prescribed pain medications, were caused by "staggered overdoses", with patients exceeding safe dosages over a period of time. These overdoses, resulting in various health problems ranging from liver damage to death, are difficult to diagnose, as the level of acetaminophen in the blood circulation is too low to trigger an overdose warning. With a succession of overdoses, gradual liver damage may occur, and in these cases, addition of alcohol increases the chance of serious liver damage or death. The addition of alcohol also makes the objective assessment still more difficult. The result, according to experts, is a severe underreporting of injury and deaths caused by acetaminophen overdose.

In 2014, results of a long-term study by the University of California Los Angeles (UCLA) and the University of Aarhus, in Denmark, published in JAMA Pediatrics, showed that the taking of acetaminophen during pregnancy is associated with a high risk that the child will acquire ADHD, or Attention Deficit and Hyperactivity Disorder. These researchers studied 64,322 children and mothers enrolled in a Danish cohort study from 1996 to 2002, and followed the children through age 7, and found that use of acetaminophen came with increased risk for the child acquiring ADHD of 13 to 37 percent, with the use of acetaminophen continuing into the second and third trimesters creating the strongest association. How could acetaminophen contribute to Attention Deficit and Hyperactivity Disorder? One of the chief researchers for the study, Dr. Beate Ritz, chair of the department of epidemiology at the UCLA Fielding School of Public Health, stated: "It's known from animal data that acetaminophen is a hormone disruptor, and abnormal hormonal exposures in pregnancy may influence fetal brain development." Dr. Ritz also cited the potential of neurotoxicity and excess oxidative stress as contributors, and recommended that more research clarify these risks, which would make acetaminophen an unsafe drug for use during pregnancy.

NSAIDS, or non-steroidal anti-inflammatory drugs, Present a Clear but Overlooked Harm in Public Health, and Need to be Taken only in Short Courses or When Needed, Not Continuously and Chronically, as Has Been Recommended by Medical Doctors for Decades

The overuse of acetaminophen seems to be a response to even greater harm from the other common pain medications. In 1998, The American Journal of Medicine, in the July, 1998 issue, stated: "Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for non-steroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications and that at least 16,500 NSAID-related deaths occur each year among arthritis patients alone. The figures of all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated." In 1999, the prestigious New England Journal of Medicine reported that the figure of deaths attributed to NSAID use in rheumatoid and osteoarthritis patients alone was considerably greater than the number of deaths attributed to AIDS, multiple myeloma or cervical cancers, asthma, or Hodgkin's disease. It was estimated that if NSAID deaths from GI bleeding were tabulated separately in national reports that it would constitute the 15th most common cause of death in the United States. By 2009, experts agreed that the number of deaths and adverse events attributed to NSAIDS each year in the United States has at least remained unchanged over the last ten years. The FDA suggests that up to 20,000 deaths per year could be attributed to NSAID use and GI bleed. Obviously the increase in the acetaminophen alternative did not have the desired effect.

After the withdrawal of the Cox2 inhibitors Vioxx and Bextra from the U.S. market in 2005, Celebrex was the only remaining Cox2 inhibitor left. An FDA black box warning was required highlighting the cardiovascular risks and gastrointestinal bleeding for Celebrex, and safety data from long-term human clinical trials was required as well. Celebrex has been heavily prescribed due to research that showed a lower incidence of gastrointestinal bleeding that standard ibuprofen and other NSAIDS, yet these decreases in risk have been questioned, and large human clinical trials showed that the benefits were no greater than ibuprofen for pain relief. Celebrex is a Cox2 inhibitor not significantly different from Vioxx and Bextra, which were removed from the market due to the risks of cardiovascular events. The CLASS clinical trial that supported the use of Celebrex was called into question when the 12-15 month time points, that were omitted in the first publication of the trial in JAMA, were revealed. Over this longer term, the FDA data revealed that the number of gastrointestinal ulcers and bleeding complications were the same as for the NSAIDs used to compare as controls. The VIGOR study of Cox2 inhibitors had also revealed that the incidence of cardiovascular adverse events was much higher than previously assumed for all NSAIDS.

A June 24, 2012 New York Times article, entitled In Documents on Pain Drug, Signs of Doubt and Deception, revealed that investigative reporters uncovered e-mails of a research director at Pfizer, the manufacturer of Celebrex, that indicated that the company had been promoting the gastrointestinal safety of Celebrex while knowing that this was untrue. This article also reveals the extent to which Pfizer had delayed the results of long-term studies clarifying the cardiovascular risks, which would not be published until the drug loses patent protection in 2014. Other e-mails cited reveal that Pfizer had selectively published data to support the prescription of a drug that performs no better than a cheaper ibuprofen, and has no real increased safety profile. Support for this drug, and for long-term use of NSAIDs in general, comes with the explanation that there is no alternative. This is patently untrue, as safe, conservative care in Complementary Medicine provides proven remedy for inflammatory and arthritic pain. In addition, a team of researchers in 2013, led by Dr. Vinay Prasad M.D. of the NIH and the Medical Oncology Branch of the National Cancer Institute, reviewed 10 years of original articles published in the prestigious New England Journal of Medicine concerning standards of current new treatments and medical practices, and found that Cox-2 inhibitors like Celebrex were among 146 medical treatments that showed no scientific evidence that they worked better than prior treatments, or in this case, simple NSAIDS like ibuprofen or naproxsen. Dr. Prasad termed these unfounded medical treatments medical reversals, and recommended eliminating them. Her field of expertise is analysis of medical research, and she finds that a great percentage of new medical treatments do not test whether they actually are better than what they replace, and are usually much more expensive, adding to the costs of healthcare, insurance and government spending for no good reason.

This cavalier attitude toward pain medication prescription and usage has evolved because of the reluctance to prescribe actual physiotherapies that both relieve pain and promote clearing of unhealthy tissue and regrowth of healthy tissue with injury and chronic pain syndromes. The reasons for the development of this attitude in medicine are multifactorial. Medical doctors were led to believe that physicians and therapists that performed these various physiotherapies, such as Licensed Acupuncturists, Chiropractors, Osteopaths, and Physical Therapists, presented a significant economic competition to their profession. Insurance companies discouraged the authorization of these physiotherapies to cure and relieve pain, presenting further disincentive to medical referral and prescription. The end result was not an economic savings for the public, as the alternatives to these physiotherapies, drug dependence and surgery, as well as disability and missed work, added up to an enormous cost, both in the price of insurance policies, and to the tax burden and cost to business in the United States. In addition, the underlying causes of slow healing and chronic pain, which may relate to a variety of health problems, were not being addressed. A holistic approach is often needed to actually address these underlying causes. Circulatory problems related to Metabolic Syndrome and poor tissue repair and maintenance related to hormonal imbalances are just two common examples related to chronic pain. Myofascial pain syndrome is perhaps the most important of these underlying causes, and is rarely addressed with any therapy today. Increased use of Complementary Medicine and the properly trained and knowledgeable Licensed Acupuncturist will dramatically decrease drug dependence and the problems associated with excessive use of pain medication.

In 2015, the U.S. FDA issued yet stronger warnings for labels of all NSAIDS besides aspirin. These new warnings reflect recent research that shows a 10-50 percent increased risk for serious heart failure and cardiovascular disease for all patients, for short term as well as long term use, and recommendations to use NSAIDS in the lowest effective dose for the shortest time period needed. The total number of people in the United States that have died due to NSAID use is estimated to be over 300,000, which is greater than the combined American deaths from World War I, the Revolutionary War, the War of 1812, the Spanish-American War, the Korean War, the Vietnam War, and the Persian Gulf war combined. With estimates of 20,000 deaths per year by the FDA, this indicates that a great number of patients are injured to a lesser degree as well from non-steroidal anti-inflammatory pain medications, usually from chronic use.

While NSAIDS have long been a concern with gastric bleeding, and acetaminophen with liver injury, mounting evidence since the investigations into harmful cardiovascular effects from COX-2 inhibitors, which led to the removal from the market of Vioxx and Bextra, has shown that almost all NSAID pain medication poses considerable cardiovascular risk with chronic use. In 2012, the American Heart Association published the results of a large multicenter study in their online journal Circulation, where over 99,000 patient histories were examined of patients over age 30 that had experienced their first myocardial infarction, and over 43,000 had been prescribed NSAIDS for chronic pain after this heart attack. The conclusions: "The use of NSAIDS is associated with persistently increased coronary risk regardless of time elapsed after the first-time MI. We advise long-term caution in using NSAIDs for patients after MI." In 2013, a meta-analysis of 280 controlled and randomized clinical trials of NSAIDS was published in the medical journal The Lancet, examining the evidence of cardiovascular risk in all NSAID medications. The results showed that the vascular risks of NSAIDS such as diclofenac and ibubrofen are comparable to COX-2 inhibitors, which were removed from the market in 2004 due to the considerable liability generated from cardiovascular deaths attributed to these drugs.

The safest of the NSAID medications, from information in these studies, appeared to be Naproxen, and the authors stated: "whereas high-dose naproxen is associated with less vascular risk than other NSAIDS." Heart failure risk was nearly doubled by all NSAIDS, and COX-2 inhibitors and diclofenac increased fatal cardiovascular events by 3 per 1000 patients (see study link below in Additional Information). While diclofenac is commonly prescribed in Europe, but not in the United States, there is little difference between this and the common array of NSAIDS prescribed or bought off the shelf in the United States. A review of this data on NSAIDS and cardiovascular risk published in the June 18, 2013 New York Times, quotes a pain expert who wrote commentary in the Lancet article, Dr. Marie R. Griffin, of Vanderbilt Unversity Medical Center: "If these drugs are making your life a lot better, that may be worth the risks, but a lot of people will tell you, 'I cant't tell if they're doing anything. I just take them every day anyway." Dr. Griffin stated that there aren't any really good choices in pharmaceutical treatment of chronic pain. Another expert associated with the study, Dr. Garrett A. Fitzgerald, of the University of Pennsylvania, stated that while Pfizer still maintains that the one COX-2 inhibitor still on the market, Celebrex, is safer than those removed, Vioxx and Bextra, this "is not borne out by the data." More and more medical doctors and patients are realizing that conservative treatments for pain and injury in Complementary Medicine are really the only choices left that are sensible.

Not only NSAIDS and acetaminophen are causing an alarming number of deaths, injuries and ill health, but narcotic pain medications are eliciting a growing alarm each year. In 2010, pharmacies received and dispensed the equivalent of 69 tons of of pure oxycodone (Oxycontine, Percodan and Percocet), and 42 tons of pure hydrocodone (Vicodin, Norco and Lortab), enough to give 40 5mg Percocets and 24 5mg Vicodins to every person in the United States. This does not include the illicit traffic in these pharmaceutical drugs, creating an enormous amount of narcotics provided by the pharmaceutical industry to the population. A growing number of these prescriptions are provided online with little oversight, with pharmacies freely dispensing prescriptions procured by individuals who have not even met the prescribing medical doctor. Most of these narcotic pain medications, both prescribed, or procured on the street, contain acetaminophen. The number of NSAIDS, COX2 inhibitors and doses of acetaminophen alone, eclipse this number of narcotics, creating a pain medication use that is astronomical.

The need to promote other medical protocols to relieve pain is a question of national emergency, yet standard medicine is still not properly promoting pain relief from increased use of such proven methods as acupuncture, traditional physiotherapies, herbal and nutrient medicines, and patient instruction in traditional self-administered protocols of pain relief and rehabilitation. In fact, the fervent zeal to restrict these proven therapies, even in the realm of Workers' Compensation law and occupational medicine, despite strong endorsement from the World Health Organization, the National Institutes of Health, and the California Industrial Medical Council, has been incredible. Failure of the federal and state governments to mandate insurance and governmental benefits for professional Complementary Medicine from Licensed Acupuncturists has resulted in an enormous underutilization of a safe and low-cost treatment proven to be effective in both pain relief and cure of most causes of chronic pain. Since there is no real alternative to these harmful and dangerous pain relieving medications in standard medicine, the failure to integrate and promote Traditional Chinese Medicine into the pain treatment protocol is now beyond controversial. This is a health care crisis. Continuing to give the impression to the public that these common pain relieving medications, both prescription and nonprescription, are harmless, is shameful. Use of pain relieving medication is, of course, essential in modern medicine, but only in safe dosage, and only in short courses of therapy. Promotion of chronic use of these drugs is unacceptable when safe alternatives exist with sound proof of medical efficacy. The public needs to become aware and speak up, for its seems that this crisis will never be addressed until there is public outrage and demand.

In 2012, the public was still told that acupuncture, herbal medicine, and physiotherapies of Traditional Chinese Medicine were still not utilized due to a lack of belief in their efficacy. This is no longer true. Scientific study now provides ample proof of efficacy. These safe and effective therapies are underutilized due to lack of access and payment. Our government has not passed laws recognizing the public right to these effective therapies, had not passed legal recognition of the profession of acupuncture and Traditional Chinese Medicine, and has not recognized these therapies in the Medicare system. There has been no mandate passed to insure the freedom of choice of patients covered under health care plans, both public and private. There is little inclusion in medical guidelines, and still an economic mandate on the part of insurance companies to restrict payment for these effective therapies. There is no question of the merits, and less and less question of the economic advantages to these low cost and effective therapies. In the realm of pain relief and treatment of musculoskeletal injury and painful disease, there is no longer a question of merit and efficacy. There is an obvious need to incorporate these therapies, as this article points out. Knowledge of the risks involved in chronic use of pharmaceutical pain medication is the first step in understanding the need for increased utilization of CIM/TCM.