Distrust, Belief, and the Placebo Effect in Modern Medicine

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

Where we are today in modern medicine with patient trust

The patient today is confronted with a modern medical system that is both extraordinarily expensive and bureaucratic, and creates scores of drugs that are required by law to list pages of potential adverse health effects, euphemistically called 'side effects' and risks, often being withdrawn from the market after years of use due to harm that we find the pharmaceutical company knew about in the first place. A commission formed by the U.S. Senate Committee on Finance, and headed by a conservative Republican senator from Iowa, Charles Grassley, has uncovered the most egregious abuses of research fraud, enormous payments to top research specialists by pharmaceutical companies, ghost writing of many research reports and even textbooks for medical schools set up by pharmaceutical companies, and an elaborate system of enormous monetary incentives and promotions to guide drug prescription. Recent fines of up to $3 billion (GlaxoSmithKlina in 2012, Pfizer and Eli Lilly in 2010, and Johnson and Johnson in 2013) for illegal marketing of drugs (to medical doctors and prescribing clinical nursing specialists) for medical conditions not approved as safe by the FDA, and for alleged kickbacks to promote these unapproved prescriptions in nursing homes, with the United States Attorney General stating that these pharmaceutical giants needlessly put the health of our most vulnerable members of society at risk, highlight the ongoing problems with public trust and the medical system. The independent nonprofit journal ProPublica reported the more than $13 billion in such pharmaceutical settlements in the U.S. between 2009 and 2014, and the industry responded with more than a doubling of the money spent on lobbying and advertising to reverse the economic impact, but not a ceasing of such activity. The Washington Post reported that in 2013, the declared amounts spent on advertising and marketing by the big pharmaceuticals was twice what they spent on research and development, which has proven to be artificially inflated as well to gain longer patent protection. Requirements by the federal and state governments that all financial ties to drug companies be publicly addressed and NIH researchers sever all ties to special financial interests, after an anonymous survey found that over 40 percent admitted to taking financial incentive to alter medical research, underscores the enormity of this problem of public trust in the medical institutions that we depend on. Unfortunately, this public information is presented in such a way that few people ever see it, and even fewer can understand the presentation. As with many important public health issues, the enormity and complexity of the situation leads to the public largely lacking the patience to understand the problem and do something about it. 

Dr. Marcia Angell, who served as the first editor-in-chief at the prestigious New England Journal of Medicine, and later as a Senior Lecturer for the Department of Global Health and Social Medicine at Harvard Medical School, Boston, Massachusetts, U.S.A., is one of the few renowned figures in standard medicine in the United States to voice intense criticism of the health system and systematic corruption. Her 2004 book, entitled The Truth About the Drug Companies: How They Deceive Us and What to Do About It described the systematic fraud of modern drugs and drug promotion, falsification of research, and enormous sums of money given to medical doctors, researchers and professors to support this system. Dr. Angell has stated that the system of tying the length of time of a drug patent to the cost or research and development has led to an average of an eight-fold exaggeration of the this cost, passed on to consumers and the government. She has also voiced intense criticism of the focus on selling the volume of healthcare to patients that don't need it, while denying healthcare to those most in need, and of marginalizing Complementary Medicine as "Alternative" even after it is proven to be safe and effective. Dr. Angell stated in a PBS interview that we have evolved the worst health care system imaginable, spending over twice as much as any other developed nation per capita, with failing outcomes.

Many experts assumed that with these 2010 changes in reporting financial incentives in research, that the act of misconduct, or falsification, in published scientific studies, would dramatically decrease. Instead, a large study by Albert Einstein College of Medicine in New York, published in 2012 in the Proceedings of the National Academy of Sciences, found that of 2,047 retracted articles in biomedical and life sciences in recent years, about 3/4 of the retracted papers were withdrawn due to misconduct. Dr. Arturo Casadevail, an author of the study, was quoted in the New York Times as stating that the problem of lying and falsifying scientific data was a lot worse than was thought. In 2011, the journal Nature reported that this number of retracted scientific studies and papers had risen tenfold in the last decade. Many experts, such as Dr. Ferric C. Fang of the University of Washington, are stating that the problem reflects perverse incentives that drive scientists to knowingly publish false data, or to make sloppy mistakes due to reduced time and budgets allotted for these studies. The biggest problem cited, though, is the fact that many of these falsified scientific studies are still cited without update of fraud or mistake. While the percentage of overall papers retracted due to fraud was relatively small, the effects include a falsified citing of data that is useful to promote products and convince patients. Added to these retractions are hundreds of thousands of papers that have published corrections, also useful in the business of citing the wrong data to sell medicine. The systematic culture of only rewarding medical and scientific research that is published first, not the best, most accurate, or most pertinent studies, is blamed as the chief cause of all of this falsification in published studies. Manipulation of the system of published medical science has created enormous problems and eroded public faith in the system. 

By 2014, esteemed research scientists, such as Dr. John Ioannidis, a professor in public health research at Stanford University, were gaining traction in pointing out the systemic failures to insure that medical research was valid to a high standard. Citing the facts that bias is not acknowledged in scientific studies, falsely exaggerating benefits of specific treatments while falsely denying the proven benefits of others, that contradicted findings in follow-up studies are rarely published or even performed for select medical treatments, and that we still largely base our treatment guidelines on evidence that is not actually confirmed by sound RCTs (randomized controlled human clinical trials), Dr. Ioannidis shows with his scientific research that most of our medical research evidence is not accurate, and the main reason for this is the profit motive, with U.S. medical research spending rising to over $240 billion by 2015, and putting the emphasis on the need to publish, not on the goal of finding new proven medical treatments that are actually better than what we are already using. Dr. Ioannidis found that of 25,190 medical studies published by the 6 most esteemed journals between 1979 and 1983, that 101 of these claimed that the treatments studied would lead to dramatic cures, yet only 27 of these 101 were validated by follow-up studies and RCTs, and of these 27, only 5 were finally licensed for clinical use in 2003, and only 1 of these 101 dramatic cures was still used for the original purpose it was designed for. The research bias, "conscious, unconscious and subconscious" was the biggest concern, and the belief by the public and the medical community that all of this medical research was largely producing scientifically proven treatments that offered a much improved medical care, was also a chief concern for Dr. Ioannidis. The question is how to create a more rational system, and not just belief based on false advertising, which in contrary to the goals of modern science. We appear to have replaced the bias of ideological and religious beliefs with a new type of irrational belief system in science.

In 2015, as reported in a New York Times article of October 20, 2015, entitled Shake-Up In Study of Hearts, a Yale study found that more than half of medical research studies funded by the U.S. National Institutes of Health (NIH) were not published in the 30 months after completion. A group at Duke University Medical School found in a study of more than 13,000 human clinical trials of drugs that most of these had not been published by 5 years after completion, despite an FDA rule that demands publication of all of these RCTs by one year after completion, and Dr. Michael Lauer, renowned Professor of Medicine, Epidemiology and Biostatistics at the Cleveland Clinic Lerner College of Medicine, appointed as the deputy director of research at the National Institute of Heart Lung and Blood and the NIH in 2015, reported that 40 percent of human clinical trials funded by the Heart and Lung institute were never published, or only published after incredibly long delays. These findings show that a selection process is used to control what scientific information in medical science is used to provide "evidence" and manufacture guidelines. While we may think that the enormous billions of dollars of public money spent on medical research is providing us with the most reliable information, it is certain that instead this information is selectively used to promote certain medical treatments and drugs, and not reveal potential findings of lack of effectiveness, and harmful adverse health effects, when the medical journals and institutions are monetarily manipulated to not publish adverse findings. In response to these findings, calls to reform clinical trial design were made, calling for trials to study more relevant endpoints, related to the disease course and outcome, not just the factors such as lowering of cholesterol or A1C, and decreasing the length of time to complete clinical trials because so many patients are excluded when their health profiles are found to potentially shed a negative light on outcome measures. By narrowing the participant selection carefully, the outcomes can be manipulated, as was the case in the infamous Vioxx clinical trials, where participants with potential cardiovascular problems were removed from the trials, and later we found that the Cox-2 inhibitors caused tens of thousands of cardiac deaths. Many studies involve initial human clinical trials with small numbers of participants, and when findings adverse to the industry are shown, these are turned down for publication, negating the ability to fund a larger trial. The Times article cites an example from Dr. Rhonda Cooper-DeHoff of the University of Florida, who found that many common high blood pressure medication protocols worsened the blood sugar metabolism in people at risk for diabetes. All the standard medical journals refused to publish the results of this study, and the only option would be to pay a huge sum to publish in an open-access journal. Dr. Lauer of the NIH lamented that many thousands of volunteers for these clinical trials enter with the belief that their time and effort will result in published information to help other patients, and science, only to find that clinical trial data is selectively published.

Even with increased government scrutiny and enormous fines, the problems of unethical and illegal behavior from our health care industry is not going away. The pharmaceutical industry, often now referred to as "Big Pharm", is a prime example. In 2012, the U.S. government collected its largest fine yet for improper marketing of drugs for medical conditions not approved by the FDA. GlaxoSmithKline agreed out of court to settle charges of both criminal and civil crimes for $3 billion in fines for promoting its best selling antidepressives, such as Paxil and Wellbutrin, for unapproved uses, and failing to report safety data when its best selling diabetes drug, Avandia, was approved. It was discovered by foreign regulators that Avandia came with considerable cardiovascular risks, and sales have since plummetted. Marketing of a number of drugs for medical conditions not approved, and illegal sales techniques, were found with such often prescribed drugs as Advair, Flovent, Imitrex, Lamictal, and Valtrex. A settlement for fraudulent marketing and explanation of risks of the popular antidepressant Prozac for $1.42 billion was part of $2.9 billion of settlements paid over 8 years by Ely Lilly, who settled for $500 million to cover patients who sued for acquiring diabetes and obesity from taking the drug Zyprexa to treat bipolar depression, before the company added these warnings to the label. Many lawsuits still remain to be settled for Zyprexa, which has been popularly prescribed for many off-label conditions, including eating disorders, and injured patients contend that there is evidence that Ely Lilly knew of these risks for obesity and diabetes well before adding them to the label warnings, heavily promoted Zyprexa before revealing these risks, and benefitted greatly from this strategy. These settlements often come with an agreement that sales representatives are no longer compensated by the volume of sales, which has led to many of the improper marketing strategies of drugs, rewarding physicians and hospitals with financial incentives to increase sales, instead of allowing prescription to be determined by what is best for the patient, and most economical for the healthcare expenditure. Such agreements are quickly countered by an array of other marketing strategies that hold equal potential to influence choices in drug prescription.

These enormous settlements for fraudulence in marketing drugs may be just the tip of the iceberg, though, as long as the eventual profits exceed the fines and settlements. Also in 2012, Abbot Laboratories agreed to a $1.6 billion settlement of fines, and Johnson and Johnson may settle a case for $2 billion. These enormous fines have not changed the way business is done, though, as the companies were shown to already have set aside such enormous sums of money in anticipation of fines, and apparently, this was figured into the cost of the drugs, which of course is passed on to the consumer and taxpayers. Indeed, in 2016, Johnson and Johnson was investigated for fraud in the reporting of the clinical trial data concerning their blockbluster drug Xarelto (rivaroxaban), when investigators found from a whistleblower that the company was aware that a device used to measure blood clotting factors, the INRatio (Alere), was inaccurate and gave false readings for the comparison drug in the clinical trial Warfarin, leading to more episodes of bleeding and stroke for the Warfarin controls, which made Xarelto falsely appear to be much better than Warfarin. The inaccurate readings led the doctors to prescribe too much Warfarin to the patients, now the subject of large lawsuits. Of course, the Duke Clinical Research Institute, and the lead researcher, Dr. Robert M. Califf, who is the leading nominee in 2016 to head the U.S. FDA, assure us that these 'irregularities' did not actually affect the validity of the Xarelto clinical trials. Once again, the complex design of the malfeasance creates a scenario that is easy to overlook, as long as top experts involved say it all worked out for the best. INRatio was investigated by the FDA and taken off the market in 2014, and Duke Clinical Research was allowed to do followup studies that confirmed that Xarelto was perfectly safe and effective. Many experts have stated that it is uncertain whether the trials and followup are real science or just politics, with the nomination of Dr. Califf a potential embarrassment that could spur the government to just let this go rather than risk a blowup and embarrassment. Once again Johnson and Johnson gets away with this even though they just admitted to research fraud and paid a $2 billion settlement. It seems that drug companies, like banks, are just "too big to fail".

Patients and taxpayers remain largely unaware of how the enormous expenditures for pharmaceutical marketing, settlements of fines and injury from fraudulent marketing and warnings of risk, and payments to influence scientific study and medical publication, are passed on to the general population in the forms of higher insurance premiums, out-of-pocket payments, and state and federal debt due to outlandish health expenditures. This scenario has become too complicated to comprehend for most people, but an increasing awareness among health experts and public health advocates has resulted in so many reports of misconduct that this is now overwhelming the ability of the public to grasp the situation. The Obama administration has responded by creating the federal Physician Payment Sunshine Act, a name that was surely added due to lobbying to downplay the dark side revealed in the business of medicine. The actual name to this act, which comes into play in 2014, is the National Physician Payment Transparency Program (Open Payments), which requires pharmaceutical and medical device companies to publicly report all payments made to physicians and teaching hospitals greater than $50, and is in response to a number of states already requiring such payment be made public, after numerous findings of enormous improper payments of sometimes over a million dollars a year to an influential doctor or researcher for minimal consulting expertise. Already the pharmaceuticals have showed planning for just such disclosure, increasing the financial outlay enormously for gifts to medical doctors and university medical researchers under 50 dollars. An enormous amount of money is now paid yearly to treat doctors to lunch or dinner at expensive restaurants, pay them to attend lectures promoting drugs and devices, and add to the treats and gifts provided at continuing medical education courses. While most physicians state that surely such perks cannot influence them in their decision making, many public health experts who have studied the problems assert that the purpose of such promotion is to create such repetition of message that a set of beliefs are generated among prescribing physicians. To search Open Payments, simply tap this link: http://www.cms.gov/openpayments/index.html . Of course, the website is set up so badly, on purpose, that finding the information on the over $3.5 billion paid out to physicians in 2013 for promotion of products, and industry research, by the medical industry is pretty difficult. Good Luck.

A new twist in prosecution of the health industry malfeasance occurred in 2015, with a Connecticut nurse who worked in a pain clinic and was the top prescriber in the nation for a narcotic pain medication called Subsys, from a pharmaceutical company in Arizona called Insys Therapeutics, pleaded guilty to charges of accepting $83,000 in kickbacks to prescribe the drug. Health Alfonso was paid this large sum of money for "speaking engagements", but most of the time only Insys representatives were in the audience, unlike speaking engagements for Medical Doctors, where it is easy to get other Medical Doctors to come to the talk. While federal prosecutors have documented many cases of these types of promotional kickbacks for prescribing drugs, this is the first case that a recipient of the money has been charged and prosecuted, and may signal a new strategy to discourage this enormous amount of illegal pay to play. This clinical nursing specialist was responsible for almost $1 million in Medicare billing for this pain medication, and while the drug is approved only to treat cancer pain, many of the patients receiving the drug from this clinic did not have cancer. Last year, 5 of the 20 physicians that received the most money from Insys had also faced legal or disciplinary action, and Insys had hired adult children of at least 2 of these physicians to serve as their parent's sales representatives, receiving a sizable salary. With just one company acting so brazenly to pay such amounts of money to create sales, we can assume that the practice is now common, with no fear of actual prosecution, only monetary fines that can be then calculated into the sales return.

Elliot Spitzer, former attorney general for the state of New York, has long investigated such healthcare illegality, and stated: "What we're learning is that money doesn't deter corporate malfeasance. The only thing that will work in my view is C.E.O.s and officials being forced to resign and individual culpability being enforced (with prison sentences)." (NY Times July 3, 2012). Mr. Spitzer sued GlaxoKlineSmith for similar criminal acts in improper marketing as New York Attorney General in 2004. In the first half of 2012, over $10 billion has been agreed to in settlements for fines for these criminal acts, and over $30 billion in the last 3 years. To stop this attorney general, large corporate donations from conservatives and the medical industry were given to help him with the election as New York governor, and once in office, an unprecedented FBI investigation turned up the fact that he was using a small out-of-state escort service, creating a scandal that ended his career in public office. With out of court settlements, the public is not made aware that such enormous criminal and civil fines are levied, and little public pressure to change the culture of pharmaceutical and medical prescription and treatment results, despite the enormous costs passed to patients to pay for these fines, and the enormous amount of harm from improper treatment and adverse effects. Even the New York Times only reports these stories in the business section, not the general news section of the paper, keeping it out of the public eye. But slowly, the public is becoming aware.

In 2013, a study of the amazing rise in robotic surgeries and the enormous failure to report serious injuries and even mortalities resulting from these surgeries was conducted by Dr. Martin A. Makary and others at the esteemed Johns Hopkins Medical School, finding that despite requirements of reporting of adverse surgical events to the U.S. FDA database, these were often unreported. Between 2007 and 2011, robotic surgery grew more than 400 percent, and Dr. Makary noted that an anonymous 2010 survey conducted by the FDA revealed that 56.8 percent of surgeons surveyed said that they had experienced irrecoverable operative malfunctions while using the da Vinci system of robotic surgeries. He stated in a September 10, 2013 article in the New York Times, that: "This whole issue is symbolic of a larger problem in American health care, which is the lack of proper evaluation of what we do. We adopt expensive new technologies, but we don't even know what we're getting for our money - if it's of good value or harmful." Dr. Diana Zuckerman Ph.D., president of the National Research Center for Women and Families, and an expert on medical devices and safety, stated in this article that it is well known that reports of injury from medical devices to the FDA only represented the tip of the iceberg of surgical complications and adverse drug reactions. This gives a false impression to both medical doctors and patients of risk versus benefit, and discourages safer practices that may be tried first. Dr. Zuckerman has also worked as Special Assistant to the Office of Science and Technology Policy in the U.S. Government, in the U.S. Department of Health and Human Services, and has taught and researched at Vasser, Yale and Harvard. A 2014 article in The Wall Street Journal showed that despite almost no real oversight of medical devices by the U.S. FDA, that the number of recalls of these devices nearly doubled between 2003 and 2012, with 1,190 recalls of medical devices in the United States occurring in 2012. Awareness of these systemic problems in standard medicine have long been discouraged as undermining patient confidence, but such awareness coupled with positive changes is what is needed to restore confidence and trust. It seems that only a considerable outcry from the public and patients will change this system.

The failure of modern medical industry research to provide reliable and complete data for patients, physicians, and governments to choose the best therapy

In 2011, the esteemed medical researcher, Dr. Peter C. Gotzsche, of the Nordic Cochrane Centre, at the University of Copenhagen, Denmark, published a paper in BMC Medicine, entitled Why we need easy access to all data from all clinical trials and how to accomplish it. In this paper, Dr. Gotzsche stresses the imminent need and importance for international registration of all human medical trials of pharmaceutical and other medical treatment, and outlines steps to achieve this goal, which would stop the hiding of important public health information, and provide a reliable method to judge the actual efficacy of pharmaceutical treatments.

Dr. Gotzsche pointed out that similar calls for action have come from the World Health Organization (WHO), Organization for Economic Cooperation and Development (OECD), the US National Institutes of Health (NIH), the US Congress, the European Commission, the Cochrane Collaboration, th UK Medical Research Council, and funders of medical research, such as the Bill and Melinda Gates Foundation and the Hewlett Foundation. Such open data sharing from private companies is a moral imperative, and would lead to enormous improvement in utilization of healthcare resources based on research that we can trust, according to Dr. Grotzsche. The paper he presented can be accessed by clicking on this link: http://www.trialsjournal.com/content/12/1/249. Dr. Grotzsche cited present laws that have been instrumental in reducing public harm, such as the US Freedom of Information Act, which has been used by the FDA to uncover false reporting of adverse effects and risks of new pharmaceuticals, and prevent public harm. He also cited the efforts of the New York Attorney General in uncovering repeated and persistent fraud by pharmaceuticals, and investigations by the European Medicines Agency, which have uncovered ghost writing and falsehood in various cases of drugs approved based completely on industry studies, such as Tamiflu.

While we assume that our drug regulatory agencies are effective in protecting the public welfare, Dr. Grotzsche notes that these drug regulatory agencies have been the exception to the call for open data sharing of human clinical trial data. He notes that of all drugs approved in the US and Europe between 1997 and 2000, 5.3 percent were later withdrawn from the market because of serious public harm, and that this figure appears to be rising steadily. When the drug is voluntarily withdrawn from the market due to adverse health risks versus benefits, drug regulatory agencies do not publish the reason for this withdrawal of the drug from the market. The reason cited for withholding this information is that individuals could selectively use the information to further malpractice legal claims, and that the government regulatory agencies should have ultimate control of such data. As time goes on, though, the world public is growing increasingly wary of risks of new pharmaceuticals, and increasingly losing trust in the institutions set up to protect the public from such harm.

Not only the lack of complete public access to medical research and clinical trial information, as well as the lack of public access to information concerning the reasons why drugs are voluntarily withdrawn from the market when the government finds fraudulence in these clinical trials and research, but also the integrity of this research itself is facing increasing scrutiny. In 2013, an article in Scientific American, entitled FDA Lets Drugs Approved on Fraudulent Research Stay on the Market, outlines how a whistleblower at the large Houston, Texas laboratories of Cetero Research, which conducts clinical drug research for pharmaceuticals worldwide, led the FDA to discover years of fraudulent research on many commonly prescribed drugs.

While routine investigations for years failed to find anything out of the ordinary, this notice by an employee led the inspector, Patrick Stone, to subpoena the company's research, and when it was produced, 8 flatbed carts full of files, the facility's president, Chinna Pamidi, admitted to the inspector that much of the lab's work was fraudulent. The FDA studied the files and concluded that the laboratory studies were so flawed that all of the studies conducted there between 2005 and 2009, involving about 100 drugs, most of them generic versions of other drugs, might be worthless. The drugs were kept on the market based upon the fact that the companies had used a variety of these labs to confirm safety and efficacy, and the FDA would have to conduct years of investigation to declare all of the research that market approval was based on null and void. Instead, the FDA required the repeat of the drug trials analyzed at Cetero Research, but nearly 4 years later, the companies submitted new research on just 53 of the nearly 100 drugs, and the FDA had only finished the review of 21 of these resubmissions. The journal ProPublica outlined how 6 of these drugs were important chemotherapies and pain medications, still widely prescribed despite the fraudulent research that FDA approval was based upon. The industry, with massive profits, has found how to make the subject of reliability of clinical drug research so complicated that by the time a complete case is made to nullify the clinical findings, the drug probably would be already replaced by a new drug, and the profits protected, while the patients taking these drugs would have little recourse to gain information to sue for malpractice and fraudulent treatment effects.

In 2012, the renowned research experts Lee M. Ellis (University of Texas M.D. Anderson Cancer Center) C. Glenn Begley (former global head of Oncology Research at Amgen) published a review of current clinical research quality in the journal Nature, entitled Drug Development: Raise standards for preclinical cancer research. They noted that cancer drug research has the highest failure rate in clinical trials of any therapeutic specialty, and that of 53 studies deemed "landmark", only 6 were able to be reproduced to confirm the scientific claims. The authors suggest that the poor reliability of preclinical research was to blame, often with scientific authors eager to produce success and thus choosing preclinical research that would verify their wishes, rather than carefully relying on the whole of scientific study. They stated that the academic system and peer-review process encourages such misconduct, with much pressure to obtain funding, jobs, tenure and promotion, which is now dependent on successful publication of such research. The lack of serious criticism in this field of medical research has also encouraged such misconduct, and the abstraction of research findings as a separate subject from the actual benefit or harm to the public grows wider each year, encouraging such justification for improper behavior. To read this article, click here: http://www.nature.com/nature/journal/v483/n7391/full/483531a.html#affil-auth. While patients are now reliant upon a belief in the advice of their treating doctors, tied to industry guidelines based on such research, as well as the numerous advertisements we now see, the basis for such trust continues to be undermined. The enormous profit motive assuredly must be separated from the search for better, and more affordable, medical treatments.

The extent of manipulation of scientific evidence extends far, even into public universities. In 2014, the University of Minnesota and the head of psychiatry, Dr. D Charles Schulz, came under intense scrutiny from an independent review board set up by the University after years of criticism that the clinical trial practices in psychiatry were being mishandled in unethical ways. An April 19, 2015 article in the New York Times, entitled A Drug Trial's Frayed Promise, outlines how this commission found that psychiatric drugs were inappropriately given to vulnerable subjects in institutions and treatment facilities, some licensed by the Minnesota Corrections Department, and that "a culture of fear" and sloppy clinical drug trial design and facilitation pervaded the department. In the case in question, AstraZeneca paid Dr. Schulz to conduct a randomized controlled human clinical trial of the atypical antipsychotic drug Seroquel XR for the treatment of Borderline Personality Disorder, a disorder affecting about 1-2 percent of the population for which there is no approved pharmaceutical treatment, but for which psychological counseling works well. Prior studies did not use a placebo-controlled clinical trial to verify positive effects, and this trial showed significant benefits, which were immediately published in the American Journal of Psychiatry, prompting increased prescription of Seroquel XR. The review panel found, though, that at least 2 of the study participants were in corrections treatment as sex offenders and had been paid $300 each to participate. Staff members at Alpha Human Services, though, caught these 2 inmates using the Seroquel to dope the breakfast oatmeal of patients and staff, and employees complained of feeling drugged and sedated. This example is just one of many egregious acts uncovered in this internal investigation, with just this one conservative Midwest university cited for a long history of unethical and fraudulent conduct in the field of medical research. In the past, a felony conviction for research fraud by a psychiatrist, an FDA disqualification of another psychiatrist for enrolling illiterate Hmong refugees in a drug trial without their consent, and a suicide by a young man in a drug trial of an antipsychotic medication whose mother had objected to his participation as dangerous, are just the tip of the iceberg. Such behavior, and the consistent overlooking of this behavior, and under-reporting of it, indicates that there is little regard for the honest scientific evidence regarding pharmaceutical drugs, and a serious problem of big money altering such research outcomes that the public depends on.

Carl Elliott, Professor in the Center for Bioethics and the Departments of Pediatrics and Philosophy, was just one of many that had been calling on the University of Minnesota to overhaul the oversight of pharmaceutical trials, and an array of complaints had been registered over a number of years. For instance, it was revealed that Dr. Schulz had served on the advisory boards of AstraZeneca and received a large sum of money between 2002 and 2007. The internal review board (IRB) found that trial patient screening and monitoring was "sloppy", although they failed to make strong remarks and changes, but after a second critical report by an auditor assigned by the Minnesota legislature, the University announced that it would halt all drug trials and that Dr. Schulz would step down as the head of psychiatry at the Medical School, although this was announced as a normal voluntary resignation to make way for a new head of the department. In 2013, this particular drug trial was closed, 4 years after enrolling almost 100 volunteers at facilities overseen by 3 university medical schools for 8 weeks of study, and costing an enormous sum of money, totaling over $700,000. While the controversies and failures of this RCT are well known, and thus no FDA approval and marketing of Seroquel XR will result, the trial was touted in prominent medical journals and will affect the prescription of the drug enormously. This scenario described in this New York Times article is perhaps a common occurrence in "evidence-based medicine" today. In fact, in response to the watered-down response by the University of Minnesota, Professor Elliot responded in a May 26, 2015 New York Times editorial that the University of Minnesota Department of Psychiatry conduct concerning unethical violations of medical research conduct, and research fraud has been documented for 25 years, extends into the school administration, and is systemic in the research system in the U.S. Professor Elliot cites the history of research Institutional Review Boards (IRBs) set up to protect medical research in the 1970s that rely on an internal honor system that has been greatly violated in a complex manner by the enormous amount of corporate money that public universities now depend on, and called on the U.S. to finally create independent review boards to oversee public medical research.

Pharmaceutical research and fraud is not the only concern in recent years. As technology grows, the complexity of medical devices has faced the same problems that advancing technologies in synthetic pharmacological medicines faced after World War II, with alarming reports of harm from new products. It was only in 1976 that the U.S. FDA began a regulatory system for approval of new medical devices, and even today very few of these devices are held to the standard or randomized controlled human clinical trials (RCTs) that pharmaceuticals are held to. On the other hand, the medical device called the acupuncture needle, which has a history of no harm whatsoever of consequence, has been strictly held to this standard to receive payment from the insurance industry and government health plans, with widespread denial of payment for effective treatment due to a lack of "evidence-based" proof of efficacy in these RCTs over a supposed "placebo acupuncture". Most medical devices are still approved and considered "evidence-based" based purely on a single clinical study by the manufacturer. FDA oversight is also very weak when reports of injury and malfunction are reported, and an increasing array of these devices have been found withdrawn or recalled only after they were on the market, promoted heavily, and widely used for years. In response to the growing alarm and publicity concerning harm from medical devices, the industry spent more on political lobbying and achieved a duplicitous federal congressional bill passed by a Republican Congress in 2015 that was entitled the 21st Century Cures Act, that would mandate that manufacturers of new medical devices could continue to gain FDA approval based only on anecdotal evidence, not randomized controlled human clinical trials to prove safety and efficacy. This bill also insured that new technology could be approved on a fast-track system even without proof that it was more effective than existing technology, insuring that more expensive medical technology would be paid for, even if it posed increased risk of harm and was not proven to be more effective than existing treatment. Some experts expressed concern that such legislation is passed purely on the belief that there is enough public ire at "Obamacare", or the Healthcare Affordability Act. The burden for evidence of safety and effectiveness would supposedly occur well after the device was being used on very many unsuspecting patients, who, of course, would assume that any procedure their medical doctor suggested was proven to be safe and effective, not just a means to make more profit from their disease burden. A New York Times editorial of July 17, 2015, by Dr. Rita F. Redberg M.D. and cardiologist at the University of California San Francisco, and Dr. Sanket S. Dhruva M.D. a cardiologist at Yale University, noted that a report in 2014 showed that the U.S. FDA has never issued a warning letter or penalty for a postmarket study delay.

The response of the health industry to erosion of public trust

The scope of this problem of healthcare industry malfeasance is so overwhelming that the public and patients often no longer know what to trust. On the one hand we have a big problem with erosion of patient trust in their prescribed healthcare and rising costs that are discouraging care. On the other hand, we have a history of healthcare that operates on the notion that the patient adopts an attitude of unconditional and complete trust in their physicians and takes what is prescribed or undergoes treatment that is recommended, often not even knowing the name of the drug or what it actually does. The underlying issues of trust and care have prompted many patients to turn to the internet to research their medical issues and treatments in order to take a more proactive approach and feel more assured in the medical decisions, but are here faced with a daunting amount of information and presentation driven by commercial interest, advertising and promotion, and slanted presentations. There seems to be no way to get back to a system where one feels reassured that there are compassionate professional doctors whose main concern is the patient's health and well being.

This growing problem has stimulated the health care industry to adopt more "patient-centered approaches" and adopt such protocols as "mind-body medicine". Patient-centered approaches have been created in response to widespread patient distrust in a system where there is no longer a single familiar general practice doctor to explain and guide care. Instead, patients are led through an elaborate labrynth of specialists who increasingly spend less time with patients and make medical decisions focused on just one aspect of the health problems without much knowledge of the whole medical history and scope. The patient-centered approach promotes integrating the assessment of a health problem with understanding of the whole person, building a long-term relationship between the doctor and patient and finding common ground in goals of therapy, incorporating prevention and promoting healthy practices in the patient's life, realistically confronting the impact of costs and time in the patient's life, and allocating resources in practice that are practical for the patient. In essence, moving allopathic medicine in the direction of Complementary Medicine and the holistic approach.

The other major response to a growing patient discomfort and distrust of the modern medical industry was adoption of the "mind-body medicine". This twenty-first century approach in modern allopathic medicine seeks to respond to the enormous research evidence that ties psychological and social factors to physical function and health outcomes. The goal of experts in this field was to have the physician confront psychosocial stress, such as emotional problems, anxiety and depression disorders, behavioral and cognitive disorders, and even the subject of individual profiles of work stress, family interactions, and emotional responses that often have a great effect on both the advent and course of disease, and the response to symptoms and perpetuation of the disease or symptoms related to injury. Here too, modern medicine seems highly influenced by the history and practice of Complementary Medicine and the holistic approach. In the classic early comprehensive test of Traditional Chinese Medicine, the Huang Di de Nei Jing (patriarch Huang Di's Canon on physical medicine and the holistic approach), TCM physicians in 300 BC stated that a central cause of disease in internal medicine is emotional and social constraint, and devoted much attention to the importance of understanding these aspects in the individual patient when assessing their medical condition. Whether or not this newfound emphasis on "mind-body" medicine and a "patient-centered" approach is a new attempt to displace Complementary Medicine by trickery or an actual evolution of the integration of Traditional Chinese Medicine and holistic medical science is still in question.

A third approach to reform the present system of medical research and guidelines is to finally adopt a a more Personalized Medicine, or Precision Medicine, using a Big Data approach to treatment guidelines rather than a dependence on manipulated one-sze-fits-all placebo-controlled clinical trials. Research in recent years has explored the actual outcome measures on current pharmaceutical therapy, and come up with some alarming statistics that have been stubbornly ignored. In 2015, Dr. Nicholas J. Schork, a Professor of Psychiatry and Biostatistics at the University of California, San Diego, and Director Bioinformation and Biostatistics at the esteemed Scripps Translational Science Institute, reported in the journal Nature that "the top ten highest-grossing drugs in the United States help between 1 in 25 and 1 in 4 of the people who take them." Study of the widely prescribed statin drugs to lower cholesterol shows that as few as 1 in 50 patients that take them may benefit. You may see this article by clicking here: http://www.nature.com/news/per...  . Obviously, almost 100 percent of patients believe that when they are prescribed a medication that it works. It is also obvious that a vast majority of patients believe when they are told by their Medical Doctors, or medical institutions, that herbal medicine and acupuncture will not benefit them, and could be contraindicated, that they believe them, despite the now abundant proof in both traditional measures of clinical efficacy, and modern randomized controlled human clinical trials, as well as in vivo and in vitro laboratory studies, that these treatments, when applied correctly, do work. It is the hope of many physicians and patients that a better system than this is soon adopted. In the present system, if patients selected in an industry set of clinical trials are not significantly harmed, and it is shown that a majority of them receive a measurable narrow outcome that is a few percentage points better than a placebo pill, in the short term, the drug being studied is approved, if a majority of experts on a select panel agree that there is sufficient evidence of safety and effectiveness over a placebo. In Translational Medicine, health care will be guided not just by FDA approval and industry trials, but by actual evidence that particular treatment will most likely help particular patients. While the cost of accumulating this 'Big Data' is daunting, the amount it may save in overall healthcare costs is enormous, not to mention the benefits to patients, and avoidance of adverse 'side' effects. It is also the hope that we may see an inclusion of CIM/TCM in this new healthcare model.

The big question confronting modern medicine is how to present this complex system of confusing elements and issues to the patient and also help them feel more at ease. On the one hand, the patient confronted with serious health problems just wants someone to take care of them, and wants to trust this person. On the other hand, there is much distrust now built into the system, and the health care providers seem increasingly detached from the individual and part of bigger and bigger institutional frameworks, prompting many patients to feel uncomfortable with completely putting their treatment in the hands of strangers in this institutional framework. The age of the family doctor is over, unless you have the money to afford the quickly growing "concierge practice", where for a yearly fee, your medical doctor will act as the family physician of the past, taking the time to create an actual knowledgeable relationship between physician and patient, and guiding all diagnostics and decision-making with a patient-centered approach. Even though our medical field is adopting these new tactics related to holistic medicine, though, the industry is driving more and more physicians out of private practice and into a corporate controlled world of health managed organizational care. Here, the actual practice of the patient-centered approach may be merely mimicked.

The results of these changes are that some prominent HMOs, such as Kaiser, and some prominent MPGs (medical provider groups), such as Brown & Toland, as well as many large healthcare corporations, such as Sutter Health, are now spending enormous amounts of money advertising their new "patient-centered" and "mind-body" approaches and emphasis on a holistic preventative and healthy friendly approach in medicine. Many patients are not feeling reassured by massive advertising that these approaches are being taken seriously. Massive advertising itself generates mistrust. Many of these new approaches also seem to be creating salesmanship and treatment approaches that offer an array of somewhat superficial treatment for serious chronic health problems, such as light massage, stress management classes, relaxation techniques, imagery, biofeedback, and hypnosis. The adoption of treatment techniques and preventative medicine developed over centuries in China, such as practices of Tai Chi, yoga, Qi Gong, individualized lifestyle and dietary counseling, and incorporation of a variety of treatments, such as deep tissue massage and soft tissue mobilization, nutrient and herbal medicine, and acupuncture are usually not included in this new "mind-body approach" and "patient-centered" medicine, and even effective standard treatment, such as cognitive and behavioral therapy and counseling, are not easily obtained. Economics and marketing still seems to play a too prominent role in the offering of these "mind-body therapies". The sense of distrust on the part of the patient will not be alleviated by such tactics.

For those of us that follow medical trade and industry journals, we have noticed that the evolution of Complementary and Integrative Medicine (CIM) into standard care hit an immediate snag when hospitals and clinics experimented with opening so-called Complementary and Alternative Medicine (CAM) clinics as part of their complexes. These clinics were kept separate from the standard care facilities, and over a few years, reports of economic disincentives were reported in trade journals.

The CAM clinics succeeded in being well liked and appreciated by the patient population, with high ratings of success, yet statistics showed that they hurt the bottom line of the hospital and clinic in most cases, reducing the number of total patient visits and profits. Many of these CAM clinics were subsequently closed or reduced in scope. Although more than a third of major hospitals in the United States now offer some form of acupuncture, the practice of acupuncture and Complementary Medicine is almost always very controlled and restricted in these institutions, and this replaces support for acupuncture and Complementary Medicine in general, with few referrals allowed outside of the system to respected physicians in private practice that specialize in acupuncture, herbal and nutrient medicine, and the traditional physiotherapies. Similar stories were generated by programs that sought to assign a system of medical overseeing to each patient, coordinating care, and giving a more holistic perspective to the use of various specialists, often by utilizing a less expensive clinical nursing specialist to organize the patient care and testing, and establish a more proactive relationship with the patient. Trials of these programs were also reported to be well liked and efficient, yet the number of patient visits to the doctors and clinics were significantly decreased, and the economics of this strategy curtailed expansion of such holistic care management programs.

True nonprofit programs, not fake nonprofits, were also devised in some states, such as Oregon and Michigan, Iowa and Nebraska, and these alternatives to standard insurance, such as Coops, provided a more patient-centered approach and coordination of care, which reduced costs and was very popular with patients and highly rated. Unfortunately, these too have been discouraged in the healthcare reform debate due to economic concerns, or manipulated into quick bankruptcy by the industry.

When a provision was included in the healthcare reform in Oregon, allowing employees to opt for these healthcare coops instead of being restricted to the plans in a company agreement, this too was fiercely attacked and eliminated in the 2011 budget debate. The complex manipulation of the market quickly caused collapse of some of the biggest nonprofit Cooperative Healthcare Companies, such as CoOpportunity Health in Iowa and Nebraska, a very popular insurance organization that was quickly bankrupted by industry manipulation, with too many high-cost patients forced to adopt this plan on the state exchanges. The result, of course, is that the healthcare exchange in Iowa will be left with just one corporate insurer if the healthcare Coops are left to fail financially, a big win for corporate insurance. All of these public health initiatives and changes in the healthcare industry, such as patient-centered healthcare cooperatives, are spurred by public interest and demand, as well as a growing concern that wasteful spending in healthcare is creating a strong public health and financial burden, both on the individual and business purchasers of health insurance, and on the taxpayer, as the federal and state budget deficits grow out of control due to rising health care costs. Adoption of low-cost holistic medicines, holistic individualized management of total health care, healthcare insurance Coops where a family practice physician may spend time with each patient to actually institute real patient-centered and mind-body medicine, and an improved system of low-cost community healthcare clinics accessible to all, are ways to both decrease total health care costs and provide renewed public trust in the U.S. healthcare system. Re-establishing public trust and belief in our healthcare system is primarily a public health concern, rather than a pure economic interest, and is important for many reasons, but most importantly to improve the quality and effects of healthcare. Trust and belief are an important part of this equation. True empathy for the sick and injured needs to be re-established, and it needs to be more important than enormous profits.

Certainly, the spiral of exploding healthcare costs, institutionalizing of healthcare beyond expectations, and the massive amount of healthcare fraud and lobbying for enormous profits in public health have caught many Americans off-guard in the debate over healthcare reform. While most Americans now see a need for serious healthcare reform, the widespread distrust in governmental management of healthcare is also a serious concern. Such books as the 2010 bestseller Deadly Spin, an insurance company insider speaks out on how corporate PR is killing health care and deceiving Americans, by Wendell Potter, one of the most powerful spinmeisters for the healthcare industry, show how the governmental debate on healthcare is easily controlled by enormous PR spending by Big Medicine. Mr. Potter explains how he helped come up with the terms "death panels" and "government-run health insurance" to spin public opinion against health care reform, but now regrets his corrupt and unethical business behavior because it has caused, and will cause, so much unnecessary suffering in the U.S. Mr. Potter, a former public relations executive at Cigna, explains how the killing of the public option insurance exchange allowed the healthcare industry to continue to focus on shareholder profit over healthcare benefits and ethical delivery of healthcare to the public, and to continue to manipulate doctors into putting profits before patients. He states that he was surprised that so many Americans could be so easily turned against an insurance option that would save them so much money. The reason for this is a widespread public distrust of medical delivery in this country, either governmental or private. The question of how this massive loss of trust in medicine occurred, and how to restore it, may be a defining social question of the twenty-first century.

Mind-body medicine and the role of the Placebo in the regulation of new medical drugs - the complexity of this placebo effect and its ethical and unseen use in medicine

One intriguing aspect of the mind-body emphasis in medicine is the growing body of research that has investigated the placebo effect. For many years, the general attitude in medicine was that the psychosocial and mental aspects of physical disease were in many ways unreal. If standard tests reported negative findings, the "it's all in your head" attitude was a prevalent response, and the classic notion of the hypochondriac was a frequent implication.

The term hypochondriac itself is revealing in medical history. The term actually means below the ribs, with hypo- meaning below or under, and chondrial referring to the rib cage. Many patients, especially women, with complaints of symptoms of fullness and discomfort under the rib cage in the abdomen were dismissed when no significant test findings revealed classic physical diseases such as peptic ulcers or heart problems. Subclinical liver dysfunction and gallbladder congestion were the actual cause of these complaints in most cases, and sometimes they were episodic and dependant on cyclical stress on liver metabolism related to menstrual cycles and hormonal fluctuations. The term "hypochondriac" was dismissive. In modern years, the patient still receives such common dismissiveness, with more difficult to diagnose chronic problems attributed to "stress" or aging. Many chronic pain complaints are now treated with anti-anxiety and anti-depression drugs, and anti-psychotic drugs are being used extensively for a wide variety of off-label symptoms. In effect, some degree of "placebo effect" is being tried by prescribing so many psych drugs for so many different physical complaints. A renewed rise in interest in somatic disorders, or somatoform disorders, now again acknowledged and real and prevalent, has occurred, but once again, these disorders with real physical symptoms, such as somatic pain syndrome, somatization disorder, body dysmorphic disorder, and hypochondriasis, are again dismissed as an inexplicable mental disorder, despite the sound scientific evidence of the pathophysiology of these diseases. As more and more patients find that their symptoms are not explained by the diagnostic testing in standard medicine, though, and no actual diagnosis is confirmed, leaving them with an idiopathic disease, the dismissal of mind-body disease, or somatic disease, somatization, or somatoform disease is becoming at best annoying. Simply dismissing patients when tests are negative, or prescribing treatment that is not evidence-based, in essence guessing at the diagnosis and just trying something, is extremely common, yet we continue to deny somatic disease as well as the placebo effect. This neurosis has gotten out of hand.

Perhaps nothing describes the present quandary over public trust and the placebo effect like a New York Times article in the Sunday Review of July 10, 2011. Here, Peter D. Kramer, a Brown University professor of psychiatry, bemoans the spate of articles by experts in the field that doubt the actual efficacy of antidepressant drugs. This article, entitled In Defense of Antidepressants, makes the case that antidepressant drugs did not statistically outperform placebo pills by a significant effect for mild to moderate depression, or show appreciable long term benefits versus an array of health risks, when the full array of research was reviewed by Dr. Irving Kirsch, a renowned professor of psychology and research specialist, because the pharmaceutical companies were so nervous about having to conduct two clinical trials by the government that they rushed these studies without analyzing the study participants properly. The rationale in this article was that the poor pharmaceutical companies were rushed into completing human clinical drug trials and so allowed patients without actual depression into these trials, thus creating excess positive benefits for the placebos. Now, logically, even if this could possibly be true, and the poor pharmaceuticals were not paying attention to choosing patients in their clinical drug trials that would make them look good, one has to ask why this logic does not apply to the group taking the antidepressant drugs as well. If these studies were rushed and patients got into the clinical trials without actually experiencing a depressive mood disorder, this would logically make the outcomes better for the patients in the study taking the actual drug as well. Reading this article, which supports antidepressant drugs, may serve to undermine public trust even more than the books and articles cited that cast doubt. Dr. Kramer's 1993 book, entitled Listening to Prozac, heavily promoted this SSRI medication, noting that it made patients feel "better than well" and perhaps healthy patients should take Prozac as well to induce more socially desirable personality traits. Why Dr. Kramer is now responding to a 2002 article in Newsweek magazine by Dr. Kirsch, titled "The Empereror's New Drugs", in which Dr. Kirsch, a University of Connecticut and University of Lum, United Kingdom, professor, researcher, and psychologist, and expert on the placebo effect, states that in reviewing all clinical study data, not just that data proven to be selectively presented when seeking approval, that antidepressant drugs "may have no meaningful pharmacological effect at all", is not clear. As always the story on drugs, research and public trust is so complicated as to conveniently confuse the public.

Much is made of the placebo effect, but does the public actually understand what this is and why drugs are compared to placebo? The placebo effect is the benchmark for modern scientific evidence of effectiveness of new drugs. After World War II, many new synthetic pharmaceuticals emerged from the vast amount of medical research and often misguided experiments performed by various nations during the war. In fact, the main reason for the wide number of civilian internment centers in World War II, by not only the Germans and Japanese, but many countries, was not a strict racial, religious or ethnic "cleansing", but the urge to research many of the medical findings that emerged from extensive creation of chemical warfare agents in World War I, such as mustard gas etc., and the synthetic drugs created to treat numerous health problems that threatened to undermine military effectiveness. Before World War II most drug medicines were still based on herbal chemistry. After World War II, the science of synthetic drug medicine thus grew in an explosive manner. The U.S. created regulatory agencies to insure that a degree of safety was assured for these new drugs on the market when some of them created public alarm with unforeseen deaths, birth defects, and severe medical harm and risk. Public mistrust in the institutions that created new synthetic medicines prompted government intervention and minimal guidelines.

It was in World War II that an anesthesiologist by the name of Dr. Henry Beecher discovered that a nurse working in the surgical theater with him was giving shots of normal saline solution to wounded soldiers when supplies of morphine ran low, and that these injections had a remarkable placebo effect to relieve pain. After the war, Dr. Beecher continued his study at Harvard and studied the placebo effect, eventually publishing important papers outlining these effects, and proposing that the FDA improve its evaluation of new pharmaceuticals by including a randomized and double-blinded trial that compared the drug effects and side effects to that of the placebo.

Dr. Beecher published the famous article entitled The Powerful Placebo in the Journal of the American Medical Association (JAMA), and stated that any drug therapy may attribute about 35 percent of its effects to this placebo effect. Eventually, this research was deemed sound, and the FDA adopted the RCT, or randomized controlled trial, to assess more fully whether a new drug actually had a measurable effect beyond the placebo effect of about 35 percent of its effectiveness. The question was not whether the drug outperformed the placebo, but by how much, because it was assumed that about 35 percent of the positive effects of any pharmaceutical medication was due to the placebo effect. If true placebos performed just as well as the actual drug, this would be a much less expensive alternative, and would put in question the measurable efficacy of a new drug. Since the placebo effect also created significant adverse effects as well, new drugs were evaluated for safety and risk also by comparing the drug to the adverse placebo effects of true placebos. With all of this built into the system, how a general belief was perpetuated that a placebo effect was not an actual effect is a big question.

In 2013, another randomized placebo controlled human clinical was conducted by the famed Harvard researcher and professor, Ted Kaptchuk, who is also a longtime Licensed Acupuncturist, and published in the medical journal Science Translational Medicine. This study showed that for patients with chronic frequent migraines, when they took a common migraine medication, Rizatriptan, in an envelope with a message that this pill was really Rizatriptan, they had more than twice the effective relief of their migraine symptoms as when they took the same pill in an envelope with a note that the pill was just a placebo. Conversely, when these patients took an actual placebo pill that was accompanied by a note that the pill was really Rizatriptan, that, surprisingly, they reported nearly the effectiveness in relieving their migraine symptoms as when they took the real drug. Such novel research is showing that our understanding of the placebo effect, and the use of this effect in FDA drug evaluation in human clinical trials, may be grossly inadequate. The study design could dramatically affect the outcome of the human clinical drug trials. It also shows the true power of mind-body medicine, and explodes the myth that by its very nature acupuncture is only exerting a placebo effect, and is thus worthless.

The history of all of this government emphasis on drug testing versus the placebo effect is interesting as well. The Federal Food and Drug Administration (FDA) arose from the 1944 Public Health Service Act, which had its root in the Federal Food Drug and Cosmetic Act of 1938, the first significant regulatory agency of new drugs. Failures of the Public Health Service Act, which depended upon a large body of expert physicians and public health experts to advise on the safety of new drugs, somewhat voluntarily according to guidelines, resulted in the Drug Efficacy Study Implementation, which grew out of the Kefauver-Harris Drug Control Act of 1962, which required proof of effectiveness and safety of all new drugs before approval. This amendment of the Federal Food, Drug and Cosmetic Safety Act was spurred by the introduction of the drug Thalidomide, a morning sickness medication in pregnancy, that resulted in thousands of children being born with serious birth defects. Besides the evidence of physiological effect in scientific study, drugs had to prove that they were both safe and effective. The balance of risk versus benefit needed to be considered by the FDA to judge the appropriate level of safety, and the degee of actual effectiveness determined the allowance of increased risk. The chosen way to judge this was to compare the developed drug to a placebo in a series of clinical trials on human volunteers, simultaneously comparing efficacy to the placebo, and recording the side effects noted in both the patients using the drug and the placebo. The placebo effect, though, made this assessment more difficult, as patients taking the placebo showed both positive effects and increased incidence of potential side effects, which was hard to accept. This, in a sense, has made medical research a complicated issue to objectively evaluate, and an a priori assumption that the placebo has no actual effect became an integral part of the official analysis of research, despite this history that actually acknowledges the reality of the placebo effect.

Since this time, the notion that modern science was only validated by such evidence has become an accepted part of our scientific perspective as a whole, mistakenly substituted for Scientific Method. Empirical evidence, or observational evidence, of effectiveness and safety was deemend "unscientific", although empirical evidence (observed physical reality) is an integral part of Scientific Method, which is then confirmed by whatever means of measurement is possible, and subjected to principles of scientific reasoning. Proof of efficacy, or effectiveness, in these drug trials, was purely judged by comparison to a placebo, though, and sufficient proof of effectiveness greater than the "placebo effect" became the benchmark for judging how much risk and side effect we allowed in new drugs. The Placebo Effect became all important, not true scientific method. Despite this, a disbelief in the placebo effect has continued, though. An industry and science was created to design these human clinical trials in such a way to prove a large degree of effectiveness, so that increasingly risky drugs could be introduced onto the market under the FDA guidelines. Passage of the 1962 Drug Efficacy Amendment (Kefauver Harris Amendment) to the Federal Food, Drug and Cosmetic Act became the benchmark for regulation of new medical drug safety by assessing the actual positive effectiveness of the drug in human trials compared to placebo, and analyzing this degree of actual effectiveness, or efficacy, in relation to health risks presented by the drug. When negotiating this drug safety legislation, the pharmaceutical industry got certain concessions to insure business success, the most important of these concessions was the linking of the amount of money spent on research, development and clinical trials to be tied to the length of time that the company could hold an exclusive patent to the created drug before this became public domain. The length of time before the drug became "generic" determined the profits to be gained, and this was proportional to the amount of money spent on research, development and clinical trials. This spurred an industry that enormously overspent on research and development, as well as the clinical trials themselves. In time, this has added an enormous cost to medications for public health problems, and to the costs to government in the form of prescription drug benefits paid out under government programs. The "placebo effect" has become a very important issue to the enormous profits of the big pharmaceutical industry, and healthcare in general, but we still insist that the placebo effect is not real, the same way that we still insist that somatic diseases are not real.

This unreal belief concerning placebo effect was utilized to deny the effectiveness of Complementary Medicine, and especially acupuncture stimulation, which merely stimulates normal homeostatic effects in the body. By insisting that acupuncture benefits were merely a placebo effect, which was proven to be untrue, public belief in acupuncture, and support, were undermined. Now, it is proven long ago that pharmaceutical medicines may attribute about 35 percent of their benefit to the placebo effect, yet we do not denigrate pharmaceutical benefits as merely placebo effects. Most of the public was hoodwinked into believing that benefits of acupuncture stimulation were just placebo effects, though, and that this was a fake set of benefits, a scam. As acupuncture has been abundantly supported by scientific evidence in the last few decades, this general belief has worked against its effectiveness, as even patients who now accept the proven benefits of acupuncture stimulation still have a subconscious belief that it may be a placebo effect, and that this is fake. The clinical effectiveness of acupuncture may be undermined by this false belief system, yet many in standard medicine continue to imply that acupuncture has benefitted from this issue of the placebo effect, fooling patients into belief of actual benefits. Why this irony is not apparent is the question we should be asking.

Somehow, placebo-controlled drug trials became confused with Scientific Method, a guideline in European science since the 17th century, where physical reality is first empirically observed by scientists, then whatever means of measurement are applicable are applied to verify the observed findings, and subjected to scientific reasoning to come to the best possible conclusion. The placebo-controlled drug trials do not meet these criteria, but play a part in the overall scientific evaluation. Traditional Chinese Medicine, on the other hand, is based on centuries of empirical evidence and scientific reasoning, repeatedly subject to the most modern means of measurement, both clinical outcome measures, as well as biochemical reactions, and now even measurable effects on brain function with advanced imaging. Such scientific measurement of the effects of acupuncture have been performed since the mid-1800s. There is no more thorough application of Scientific Method possible than what has been applied to acupuncture, herbal and nutrient medicine, as well as energetic medicine now. The persistent declaration that acupuncture and Traditional Chinese Medicine is not a science, not supported by science, and in fact unscientific, is patently absurd. When even science teachers continue to confuse placebo-controlled drug trials with Scientific Method, there is something amazingly wrong with our scientific community. Science is not based on blind faith and doctrine, as are our religious ideas and metaphysical reality, which cannot be measured, but our modern scientific society has confused these worlds. Science is not a religion.

Implications of the placebo effect in judging efficacy of a variety of non-pharmaceutical treatments, including acupuncture stimulation

In recent years, large analysis of the placebo effect has found that it is still poorly understood, and that it has in fact changed over the last 40 years since the initiation of placebo clinical trials for drugs to judge benefit versus risk in the population. Studies have shown that the placebo effect in these clinical trials has in fact increased in efficacy itself.

In effect, since 1962, the year of introduction of the Drug Efficacy Amendment to the Federal Food, Drug and Cosmetic Act, the ability of the placebo pill to actually improve the symptoms and health of the patient in clinical trials has steadily increased as the public has become more used to the notion of the placebo as a sound scientific principle employed in modern scientific method. In many cases, the new drugs being tested, no matter how potent they are, perform only slightly better than the placebo, and both the drug and the placebo appear in the clinical trials to have a very positive effect. Of course, one thing that is overlooked in general in these trials, is that we are also comparing the adverse effects seen in the patients receiving the drugs to these same effects noted in the placebo group. The curious fact is that the adverse effects noted in the placebo group have also increased over time. This works to the advantage of the drug industry, though, because the drug, despite the evidence of many adverse effects, does not seem to produce adverse effects much worse than the placebo. The entire evaluation of safety and efficacy is being altered by the apparent strength of the placebo effect in the general population. Some extreme examples of the placebo effect studies include a Japanese study of chemotherapy drugs for cancer. In this now famous study, a large group of patients volunteered to receive a new chemotherapy drug, and the patients were told to expect that their hair would fall out due to adverse effects of the drug. Not only all of the patients taking the drug had significant hair loss, but almost all of the patients in the placebo group also lost their hair. The dramatic efficacy of the placebo effect was, and is, baffling. Some mental process must be causing objective physiological changes that were as potent as any tangible drug we could create. Such ideas in science as Morphic Resonance, touted by the Harvard-educated professor of biochemistry at the University of Cambridge, Dr. Rupert Sheldrake, could explain how this has come about.

These findings of an increased placebo effect are not widely discussed, though. The public, and research scientists and physicians, all have tried to avoid the subject of the placebo effect as much as possible. The level of uncertainty and distrust in modern science that could be generated from this topic is enormous. On the other hand, many competing medical treatments over the years, such as nearly all traditional medicines, had been routinely dismissed as quackery that had nothing to do with modern science, and were accused of being effective in the history of humankind because of the placebo effect, and not because of merits of the medicine itself. Acupuncture was a prime example of such criticism. Since the insertion of hair-fine needles under the skin does little by itself, and works purely by stimulating trigger points to effect normal physiological reactions, many of them in the mind, or brain, standard medicine dismissed the science of acupuncture as a mere "placebo effect". This was an ironic criticism, since the placebo effect was shown to be very effective in the very clinical trials that proved efficacy of modern drugs. The standard medical industry went even farther with their criticisms, and demanded that the same double-blinded placebo-controlled clinical trials be used to prove efficacy of acupuncture before it was allowed to be paid for by standard insurance and government health programs. Despite an enormous amount of evidence of physiological effects and benefits from acupuncture, much of it dating to the nineteenth century in Europe, especially France, acupuncture was not going to be paid for, or incorporated into the standard medical system, until it passed these placebo-controlled trials. Now, this, of course, was problematic. Designing a placebo for sticking a patient with a needle, or any manual treatment technique for that matter, was a difficult problem. Blinding both the patient and the treating physician in the trial to whether they were using the "placebo" acupuncture or the real stuff was also an obvious problem. This type of difficulty, though, actually spurred an intense amount of research and study in the field of acupuncture. The challenge to researchers was enormous, and acupuncture became the most scientifically studied manual treatment in human history. The only problem was that in designing double-blinded human clinical trials with supposed "placebo", or sham, acupuncture, that the actual acupuncture stimulation was dumbed down to such methods as an insertion via a blinded box on the skin. This type of acupuncture has much less potential effect than an expert actually using real stimulation techniques to achieve the correct trigger point effects. Since the introduction of these simplified human clinical trials of acupuncture, many human trials have now proven that actual needle stimulation techniques are much more effective than simply inserting the needle without stimulation.

Now, other manual therapies, such as surgery, electrical stimulation, physiotherapy, massage, etc. were not studied and proven with double-blinded placebo-controlled human clinical trials. The AHRQ (Agency for Healthcare Research and Quality), a part of the NIH (National Institutes of Health) and a part of the U.S. Department of Health and Human Services (which also includes the FDA), issued a statement in about 2005, showing that less than 15 percent of manual therapies were proven effective by a double-blinded placebo-controlled human clinical trial. Acupuncture, in fact, was almost the only manual treatment that was proven effective with this standard, according to the AHRQ! Surgery and other manual medicines did not have to prove efficacy with double-blinded placebo-controlled human clinical trials to approve use and payment. This demand on acupuncture was merely a means to delay its public acceptance. Certainly, these types of trials, designed to protect the public from adverse harm from new pharmaceutical synthetic drugs, were not demanded to protect the public from harm in acupuncture. The scientific community already understood that acupuncture was proven to be the safest medical treatment in human history, with almost no adverse effect or injury at all. The long history of this involved putdown of acupuncture and Traditional Chinese Medicine did also spur an intense interest in world research into the subject of the placebo and the placebo effect, though, which has been very elucidating.

A placebo is a simulated medical intervention, or sham treatment. The placebo effect was noted a long time ago, as the placebo, or sham treatment, also produces perceived or actual medical improvement. Placebos have historically long been used in medicine to treat patients, usually when standard treatment did not work. Even in ancient history, the documentation of placebo treatment was acknowledged as able to achieve great success with some patients when nothing else worked. The ethics of prescribing placebos, though, has been a considerable disincentive, as this entails lying to, or deceiving, the patient. Nevertheless, this type of therapy has been widely considered by governmental health authorities throughout history, and usually discouraged because of the deception involved, decrease in public trust engendered by the practice, and supposedly unpredictable and unreliable outcomes of treatment. The book The Powerful Placebo in 1955, by Henry K. Beecher, generated quite the renewal of scientific interest in the subject, as well as extreme debate. When trying to access the 1955 Journal of the American Medical Association (JAMA) article on this important research publication today, the public now finds that the original article reviewing Beecher's research has been removed. This debate over the placebo effect became so intensified, with widespread acknowledgement of the placebo effect as an effective protocol, as evidenced by thousands of human clinical trials, that an effort was made to analyze this subject again, and again try to discount the placebo effect. In the meantime, a number of medical doctors were impressed with the placebo effect and had their patients sign agreements to the potential use of placebo in their therapy, thereby skirting the issue deceiving patients. The American Medical Association responded by condemning this practice. Some medical specialties, such as psychotherapy, touted the powerful benefits of the "placebo effect" in their work, though, and cited meta-analysis that showed that much of the positive effect of psychotherapy was in part due to the placebo effect. This branch of medicine, now an integral part of "mind-body medicine" had been criticized and denied insurance and government funding in the same way that acupuncture had been. Meta-analysis of research (cited below) in 2005 found that in some areas of treatment, such as depression disorders, research shows that the placebo pill actually outperforms standard pharmaceutical medication, whereas in psychotherapy, standard treatment consistently outperformed placebo psychotherapy.

Due to the amount of research investigating the placebo effect, especially in relation to acupuncture, this issue again surfaced in the 1990s. Denial of payment for the legitimate and proven effects of acupuncture was still in effect, and much of the reasoning behind this denial of an effective medical practice was that we did not really know whether these positive benefits could be attributed mainly to a placebo effect. Critics of this reasoning stated that even if acupuncture worked to some extent because of a placebo effect, that it still worked, and the patient was agreeing in full knowledge to receive the treatment. The criticism of acupuncture had generated a renewed debate about the embarrassing placebo effect in medicine.

In 2001, a meta-analysis of the placebo effect was again conducted by the University of Copenhagen Department of Medical Philosophy and Clinical Theory (Asborn Hrobjartsson MD), which concluded with a systematic review of the Cochrane database that there was no evidence to support the notion that placebos had powerful clinical effects. A careful reading of the study produces some disturbing questions, though. The study authors also stated that although placebos did consistently show benefits on studies, that no significant effects on objective or binary outcomes was evident when compared to randomly chosen patient populations that received no treatment whatsoever, although they acknowledged that true benefits with placebos were seen in the treatment of pain in these studies, and when studies recorded continuous subjective outcomes. Now, the limiting of data to studies that actually recorded the outcomes of the placebo success, and that included a randomly chosen group that received no treatment, to establish this as a baseline, limited this study to only about 120 studies out of many thousands, or even hundreds of thousands. The choice of statistically judging the placebo effect with a binary outcome, which means that the outcome was judged only by two values, success or failure, severely limited the scope of analysis. When continuous subjective outcomes were measured, the effects of placebos were evident. Many researchers may claim that the outcome of this study was determined by the study design (or, in fact, rigged). And, in fact, this same ploy was used in the past to discount the placebo effect. Nothing new, here is some money, this is what I want to determine, design a study, publish the findings, and quote this study as the definitive proof. Unfortunately for the pharmaceutical industry, this study was widely criticized, and a subsequent study in 2010 had to be performed to try to get rid of the widespread continuing belief that scientific research shows that the placebo effect is indeed real. A big problem for health authorities and standard medicine had again occurred, and just won't go away.

The ongoing debate over the placebo effect affects not only the public perception of pharmaceutical drug efficacy, but is integral to the subject of mandating health care coverage of acupuncture and Complementary Medicine. On the one hand, acupuncture could not be paid for until it was definitively proven to not work via a placebo effect, and on the other hand, the placebo effect was being denied even its existence. This presents a complex and confusing conundrum for the health care industry. The denial of real positive physical benefits from acupuncture stimulation hinges on the notion that these effects are completely explained by the placebo effect, yet acknowledging the power of the placebo effect calls into question our whole system of judging drug safety by comparing effects of drugs against a placebo. Mental puzzles like these are not comfortable issues, and we are easily convinced to avoid thinking about them too much. But what are we to trust?

One problem for standard medicine is that if the public believes that the placebo effect is real, that trust in the randomized double-blinded placebo-controlled trials, and thus trust in the pharmaceutical industry, may be further undermined. This would equal a big loss of profit, and since most of modern medicine has evolved into writing pharmaceutical prescriptions, the loss of income may be substantial. The real question that many medical ethicists and philosophers ask, though, is not whether we should be administering placebos as standard therapy, which may never be acceptable to the public or the physicians, but how do we use the placebo effect and the knowledge of the study of the placebo effect to come up with treatments that actually benefit the public. A number of proposals and theories have resulted. In response to the 2001 attempt to once again discount the placebo effect, Daniel Moeoman and Wayne Jonas MD, proposed in the Annals of Internal Medicine that the term "placebo effect" in modern use often had little to do with an actual placebo, and the debate confused the public, and perhaps we should rename the effect "meaning response", reflecting the broad observed and measured effects given to belief, as well as therapies that had little or no intrinsic objective effect on their own, such as acupuncture, but still elicited a measurable objective, as well as a subjective, effect. In modern terms, these experts stated, the term "placebo" has been applied for effect to a wide number of beneficial biological, social and human interactions, such as counseling in so-called "faith healing" as well as a wide number of medical treatments, many of which have been used successfully for millenia and now discounted as a so-called "placebo". Such therapies that are now proven successful, such as color therapy, magnetic therapy, sound therapy, art therapy, and even prayer, as well as Qi Gong, Reiki, Therapeutic touch, etc. are now becoming again popular and accepted, even by some prominent medical organizations, yet we continue to discount the effects as placebos, when these interventions are not like a placebo pill in pharmaceutical studies. Even with placebo pills, studies have shown measurably different responses when one pill is red and the other blue. The mind-body effects here are complicated, and the general learned beliefs, cognitive and behavioral patterns in society and the human genome and epigenome are indeed complex.

A study of the placebo effect in 2010, headed by Ted Kaptchuk, Associate Professor of Medicine at Harvard Medical School, received much attention in the press because the participants, 80 patients with more severe symptoms related to Irritable Bowel Syndrome, improved remarkably when taking a pill that they were told was a placebo. The patients who were randomly assigned to a group that were given pills marked placebo showed significant improvement over those that received no pill or treatment whatsoever. These patients were told that the placebo pills contained an inert substance, such as sugar, that was proven in clinical studies to produce significant improvements in IBS symptoms through mind-body healing processes, and that following a strict schedule and dosage was critical to the effect. 59 percent of the patients taking the pills marked placebo showed significant improvement, compared to 35 percent of those that were not given any pills. All participants continued on their standard therapeutic regimens, and all participants received the same warm and empathetic attention from physicians administering the trial. The outcome was measured by questionaires that asessed symptoms of discomfort, pain, bloating, constipation and diarrhea. The results were remarkable given that the patients were told that they were taking a placebo pill that contained no actual medicine. If this were a trial of a pharmaceutical drug, this drug would be hailed as a remarkably successful and potent new drug, and billions of dollars in profit would be made. This clinical trial demonstrated the complex scope of the "placebo effect" in clinical practice. Another larger trial was being designed at the time of this 2010 trial to confirm these findings of the effectiveness of the placebo even when the patient is informed of treatment utilizing a placebo. This 2013 study was noted above in this article, and revealed how Dr. Kaptchuk showed that patients with chronic frequent severe migraine headache syndromes at Beth Israel Deaconess Hospital, associated with Harvard Medical School, in Boston, Massachusetts, U.S.A., noted a dramatically reduced effectiveness of a common migraine medication, Rizatriptan, when it came in a pill with a note that the pill was a placebo, and almost as much relief of symptoms when they took a sugar pill from an envelope that had a note from the doctor that this pill was really Rizatriptan. This randomized placebo-controlled human clinical trial had an array of variants in the form of the medication or placebo taken with randomized notes from the prescribing doctor describing the pill as either a true medication or a dummy pill. The application of such a novel study to severe intransigent migraines rather than the symptoms in Irritable Bowel Syndrome, which are sometimes less clear, continues to strengthen this proof of the actual placebo effect in medicine.

Some of the questions that arise from this study are 1) do most people think that they are actually being tricked in such a study, and actually taking an effective medicinal pill? 2) how much can we really trust standard blinded, placebo-controlled trials of pharmaceutical medicines if the placebo works so well, and some of the effects of the real pill are a placebo effect? 3) What exactly makes a person get better? 4) does the general public now fully believe in mind-body healing effects? and 5) how do we utilize this effect in clinical practice? The questions that Dr. Kaptchuk was trying to answer is how does a placebo effect work? Ted Kaptchuk is a renowned physician that practices acupuncture and Traditional Chinese Medicine (TCM) successfully, heading pain clinics at various Boston hospitals in his career since earning a Doctor of Oriental Medicine in 1975 by completing study at the Macau Institute of Chinese Medicine in southern China. Dr. Kaptchuk served as director of a pain and stress clinic at Lemuel Shattuck Hospital in Boston, and now directs the Asian Medicine and Healing Program at Harvard, where he holds the title of Associate Professor. The difficulties of convincing medical doctors that acupuncture did more than just exert a placebo effect, despite very successful outcomes of almost all clinical studies with patients, has been a motivator for Dr. Kaptchuk to thoroughly study the placebo effect. Early in his career, he wrote a widely read book on acupuncture and TCM called The Web that has no Weaver, which sought to explain Asian traditional medical science in terms that were familiar to modern scientists. Later, as scientific study of the effects of acupuncture stimulation and herbal medicine were conducted in Europe and the United States, under the stipulation that acupuncture must adhere to standards of clinical trials set up to judge the safety and efficacy of new drugs, which no other manual medicine in modern use had to adhere to, Dr. Kaptchuk found himself swimming uphill, or against the tide of a strong bias in Western medical journals and research. If he said, well, in a sense, the acupuncture stimulation, which is fairly inert on its own, does exert a type of "placebo effect", and this is its strength, and makes it an effective and safe therapy when performed correctly, standard medical experts would say, "Aha", I told you it was just a placebo effect, and not real or dependable. If Dr. Kaptchuk would say, but it's not really a placebo effect like that from a sugar pill, since it actually stimulates a set of real physiological reactions, like ultrasound or cold radiation therapy, then the medical experts would say then that most of the effects attributed to it were only "placebo effects" that depended upon the relationship of the patient and physician, or the beliefs of the patient. This circular putdown seemed like it would go on forever, and was often published in newspapers and magazines, as well as being constantly told to doctors and then passed to patients. Obviously, if is widely believed that acupuncture stimulation does not work, then this makes the 'placebo effect' work against effective outcomes, not for it. The majority of patients that try acupuncture today come in with a belief that it could work, but is not proven, and probably does not work well, creating a negative 'placebo effect', yet it is safe to say that a majority of patients realize medical benefits from the treatment, or this type of therapy, mostly paid out of pocket, would not be growing in use and popularity worldwide. 

Is their use of a placebo effect in modern pharmaceutical medicine? A 2008 study that Dr. Kaptchuk participated in found that 50 percent of U.S. physicians admitted to secretly giving placebos to unsuspecting patients. This study was published in the British Medical Journal. The ethical implications, though, to this practice, have long generated much criticism, both in the medical community and the patient public, and the threat of lawsuits from this practice is obviously high. On the other hand, recent studies show that in some parts of the United States, an examination of all pharmaceuticals on the market showed that almost 20 percent of them were fake, or contained medication but not manufactured by the company that the drug label indicated, due to criminal misconduct in pharmaceutical distribution. Studies have also shown a widespread market in expired drugs that were relabeled and sold by relatively large businesses. One wonders whether a significant amount of benefits are derived as a placebo effect from these illicit drugs, as doctors and patients are not coming forth to claim that these purchased pharmaceuticals are fake or illicit, or less effective than the real pharmaceuticals that they have used in the past. Illicit, fake or expired pharmaceuticals, which now is a big business, has not produced a significant complaint of poor treatment effects. Perhaps an expanded attitude toward placebo effects and use of placebos will soon become part of our sociocultural norm. This may finally dispel the criticisms of acupuncture as a mere placebo.

By 2012, we finally have seen some serious randomized controlled trials of manual procedures and devices, such as surgery and pacemakers. The U.S. government database ClinicalTrials.gov, though, reports that only 4.8 percent of new protocols for medical devices utilize a sham device in human clinical trials. One such study, with a sham cardiac pacemaker utilized, revealed that the actual cardiac pacemaker had no benefit greater than a placebo device. A 2002 surgical study of arthroscopic surgery to repair osteoarthritic knees utilized a sham surgical procedure that left the patient with incision scars, and the long-term outcomes with real and sham surgery showed no statistically significant difference. As more of these RCTs of surgical procedures and medical devices are finally performed, serious questions are being raised, as with acupuncture, concerning the extent of the placebo effect, and the proven efficacy of the procedure or device over placebo.

The questions of trust, distrust, belief, and the many aspects and implications of the placebo effect will continue to be a defining problem in modern medicine for some time. The introduction of a more patient-centered approach, mind-body medicine, and integration with holistic medical sciences is a positive step forward for humanity, though. Hopefully, as a society and culture we can use this tricky subject and debate to make our healthcare system more effective, economical, and safer.

Comparison of the effects and benefits proven by randomized, placebo-controlled human clinical trials of acupuncture and herbal medicine compared to these effects and benefits seen in the same randomized, placebo-controlled human clinical trials of pharmaceutical drugs and standard therapies

For many years, the public has been convinced that acupuncture and herbal medicine is not a scientifically valid medical science, purely because there is not sufficient modern scientific proof from randomized, double-blinded, placebo-controlled human clinical trials (RCTs). Now, scientific method has used many means to judge scientific validity besides these trials, which were only demanded as a means of scientific judgment in the 1950s when the U.S. government created an agency to oversee and regulate new synthetic pharmaceutical drugs and cosmetic drugs. These types of trials were created as the easiest method to prove safety of new pills, not as a means of proving effect. In fact, it was well known to scientists at this time that the placebo effect was very powerful, and comparison to placebo was not a completely valid means of judging the degree of effect of the new drug. Nevertheless, this type of trial was simple, and effective, to gauge the relative safety, and the results of the both beneficial effects and negative effects of the drugs, compared to the placebo effect, could help regulators gauge the risk versus benefit ratio, and add to the judgment of whether new drugs with significant health risks and side effects were still worth approving for the market. In the past, though, the human culture has used many different scientific methods to explore scientific fact. Even modern scientific method depends on a series of scientific steps, from observation (empirical) to theory, and then confirmation of theory by objective analysis. Some aspects of our reality can be duplicated in a laboratory, and today, we are even building enormously expensive laboratories, such as the large Haldron particle accelerator, to replicate even cosmic effects, such as the creation of actual particle building blocks of physical reality.

On the other hand, some aspects of our reality are not able to be duplicated in a laboratory. Here, scientists observe, measure, hypothesize, theorize, and try to objectively confirm theories with these measurements and calculations. In medicine, much or our treatment science is still based on demographic studies, which operate by comparing a section of the population associated with a particular health aspect, and comparing statistics within this population to match one type of fact to another. For example, we take the population that smokes cigarettes, look at their health problems, calculate patterns of disease, and declare that cigarettes cause these diseases. So, the use of a placebo-controlled trial is not the only scientific means of confirming something. With acupuncture, use of a placebo in study is, of course, very problematic, and so much study of the acupuncture effects in the past 180 years measured physiological changes and effects that appeared to result from the acupuncture stimulation. We now know in recent years, with the use of advanced technology, such as the functional MRI, and genetic testing, advanced molecular anaylysis, etc. that the acupuncture consistently produces strong physiological effects, and that these effects correspond to the traditional empirical observations and theories generated over thousands of years. Nevertheless, many scientists insisted that acupuncture was not a proven science until it passed the placebo-controlled trials.

In the last twenty years, acupuncture has become the single most studied medical treatment in history across the world. Much of this was due to the complexity of the physiological effects, and scientific curiosity, but a great amount of this study was generated both by the challenge to deny or confirm medical necessity and payment, and the challenge to actually verify acupuncture effects against a placebo, when the placebo needed to trick both the patient, and the physician administering the test, that this placebo could actually be a real needle stick into the flesh. Of course, in reality, this cannot be truly accomplished. We must settle for a compromise. The compromise was often the use of an acupuncture needle inserted into the skin, but at points other than those being studied, by a Licensed Acupuncturist that was hired and told that this acupuncture needle insertion was real, and should be performed to achieve a therapeutic effect. When the so-called sham, or placebo, acupuncture produced effects similar to the so-called real acupuncture, the scientists controlling the trial acted surprised that this so-called placebo actually worked, producing real benefits. The study summary concluded that the real acupuncture did not outperform this so-called placebo acupuncture by a significantly statistical percent, said statistically significant percent determined by the study designers, of course. The summary stated that there was no proof here that the acupuncture worked better than placebo.

To the astonishment of many, though, even with such a study design, the acupuncture, performed in the most minimal manner, without the usual needle manipulation that makes it effective, and utilizing a standardized point selection, instead of the more effective standard individualized point selection in actual clinical acupuncture practice, did significantly produce amazing therapeutic benefits and outperformed the so-called placebo, which was actually often just another actual needle stimulation. In the most accepted study design, a device, such as a box that held a guide tube for a needle, was used, thereby allowing the study to use sham needles that showed only the needle handle and lacked an actual needle point. The problem with this study design was that the patients probably could tell that they were not being stuck, and the physician administering treatment could only tap a needle handle, not actually use a trained technique to elicit the physiological responses important in acupuncture. In some cases, you could say that no real acupuncture stimulation, as seen in normal clincial use, was actually performed, and in these strange treatment trials, the effects could theoretically all be attributed to a placebo effect, since even the real acupuncture was not actually real acupuncture, but just a mechanical tapping of a needle into the skin.

Considering these obvious problems with this study design to judge acupuncture efficacy, how did these randomized, placebo-controlled human clinical trials actually compare to the same type of pharmaceutical trials. Let's look at an analysis of this question, performed by the standard of medical scientific analysis that most professionals cite, the Cochrane Library. A 2005 report of all CAM-related systematic reviews of randomized clinical trials (RCTs) of Complementary Medicine, meeting the most rigorous standards, compared to conventional treatment: These studies in the Cochrane Report found that for CAM, 38.4% of all studies concluded positive effect or possibly positive (12.4%) effect, 4.8% concluded no effect, 0.69% concluded harmful effect, and 56.6% concluded insufficient evidence. An assessment of conventional treatments (i.e. mostly pharmaceuticals) found that 41.3% concluded positive or possibly positive effect, 20% concluded no effect, 8.1% concluded net harmful effects, and 21.3% concluded insufficient evidence. However, the CAM review used the 2004 Cochrane database while the conventional review used the 1998 Cochrane database. These findings show that Complementary Medicine (most often in the form of acupuncture and herbal medicine) showed a medical treatment efficacy in RCTs comparable to scientific evidence of standard therapies, yet a considerably safer overall effect. This is not the impression that we usually get, though, from standard experts in the field, or from published stories in newspapers, magazines, hospital websites, insurance websites, or even government websites. This actual comparison is, in fact, astonishing. The fact that these acupuncture trials, with all the above stated problems to overcome, in fact performed as well as pharmaceutical trials, with much less evidence of harmful effects, is incredible.

Despite all of these facts, though, the vast majority of the public in the U.S. are still expected to believe that acupuncture and professional herbal and nutrient medicine, or Complementary Medicine, is still not proven scientifically. Slowly, this belief is changing, but the public in general now believes that more people actually "believe" acupuncture and herbal medicine than is actually the case. A 2002 study by the Centers of Disease Control found that while over 76 percent of Americans reported using Complementary and Alternative Medicine (CAM), that less than 2 percent had used acupuncture in the prior year. In this study, prayer was cited as the type of CAM used by about 45%, and self-medication with commercial non-prescribed herbs and nutrients was cited as about 20% of CAM therapy. Even meditation and yoga was cited as the form of CAM utilized more frequently than even chiropractic medicine. Sadly, despite a vast amount of scientific evidence, the belief and trust of the public is still easily manipulated by a commercial industry, and real scientific evidence is easily discounted. Now, human culture has long ago separated the physical and metaphysical, or science and religion. In science, we learn and observe the facts to generated a logical judgment. In religion, the subjects elude measurement, and in this realm we must believe. Nevertheless, the most frequently heard statement concerning acupuncture is whether or not you "believe" in acupuncture, despite the fact that acupuncture is not a religion, but a science. The second most frequently heard statement concerning acupuncture is whether you have a needle "phobia", but this is another realm of societal belief that we perhaps shouldn't even get into here.

Information Resources / Additional Information

  1. A 2014 report in the independent non-profit journal ProPublic details the more than $13 billion in settlements paid by large pharmaceutical companies for illegal marketing of their drugs for treatments not approved as safe by the U.S. FDA. Such enormous fines have not stopped the practice, as the profits generated eclipse even these fines, and no admittance of guilt or actual legal punishment is demanded. Big pharmaceuticals, like big banks, are 'too big to fail': http://projects.propublica.org/graphics/bigpharma
  2. A 2010 report in the independent non-profit journal ProPublica details the whistleblower lawsuits that showed the widespread practice of paying and tracking medical doctors to 'push' pharmaceuticals for non-approved off-label prescriptions at free luncheons and 'educational' seminars purporting to be independent presentations: https://www.propublica.org/article/lawsuits-say-pharma-illegally-paid-doctors-to-push-their-drugs
  3. A current report on government lobbying by the independent journal OpenSecrets, provides evidence that the biggest lobbying group in the federal government is the pharmaceutical industry, spending billions of dollars just to lobby lawmakers to adjust legislation in their favor. Such lobbying is considered just the tip of the iceberg, as it represents the official administration of such spending and influence: https://www.opensecrets.org/lobby/top.php?indexType=i
  4. A 2015 article in The Washington Post, entitled Big pharmaceutical companies are spending far more on marketing than research, shows that public records indicate that the large pharmaceuticals now (2013) spend twice the amount on advertising and marketing than they do on research and development, whose costs have been shown to be highly inflated as well to justify longer patent protection and higher prices: https://www.washingtonpost.com/news/wonk/wp/2015/02/11/big-pharmaceutical-companies-are-spending-far-more-on-marketing-than-research/
  5. A 2014 article outlines the findings presented to the Harvard School of Public Health by one of the most esteemed researchers, Dr. John Ioannidis, a professor at Stanford University, in Palo Alto, California, U.S.A, that shows just how inaccurate our "evidence-based" system in medicine is, with an enormous amount of money spent in the industry creating systemic bias in medical research, much of which is unconscious, and only a tiny fraction of new medical technologies studied actually proving to be useful and better than prior technology in the long term: http://www.macleans.ca/society/life/when-science-isnt-science-based-in-class-with-dr-john-ioannidis/
  6. A 2015 article in the journal Nature outlines a new approach in standard medicine and medical research that expands the narrow "evidence-based" guidelines that are used to approve or deny medical care, and is used in the medical industry in a manipulative manner. One of the terms used to describe a more holistic and individualized system of study and medical guidelines is called Personalized Medicine, and in 2015 a national Precision Medicine Initiative was announced to expand this use of an individualized and holistic approach. Other terms used to describe this more integrative approach is Big Data, and the goal would be to determine not whether a medical treatment was supported in a one-size-fits-all system, but how to apply treatments to types, or subsets, of patients. As this article shows, most of the leading pharmaceutical medicines do not actually work for a majority of the patients, or types of patients, that they are prescribed in actual care, but with a one-size-fits-all clinical trial approach to evidence-based therapies, this does not matter at present in the decisions to authorized or deny payment for the treatment: http://www.nature.com/news/per...http://www.nature.com/news/personalized-medicine-time-for-one-person-trials-1.17411
  7. A 2002 article addressing the problems in labeling treatments as placebo effect and treating such a wide array of therapies as a placebo, without nuancing this meaning, and making it seem as if all of these therapies were the same as a sugar pill, is discussed in this article in the Annals of Internal Medicine: http://www.annals.org/content/136/6/471.full
  8. An article in the Harvard Magazine, from the esteemed Harvard University, in Boston, Massachusetts, U.S.A. explains the research of the Harvard Professor Ted Kaptchuk, a renowned TCM Physician, or Licensed Acupuncturist, that has worked in an integrative medical system for most of his life. Professor Kaptchuk completed a series of randomized controlled human clinical studies to better define the widely used 'placebo effect' in medical studies. His findings, unique in scientific research, show that the use of this placebo effect is not exempt from bias and manipulation, and does not present the simple objective scientific proof that most of us assume. His 2013 landmark study showed that a wide array of adverse side effects were seen for both pills and acupuncture treatments, objectively measured, and that these adverse side effects depended on the understanding of the potential adverse side effects prior to administering treatment. In this particular study in his series, Professor Kaptchuk used only sugar pills and sham acupuncture devices, and no actual drugs or real needle stimulation, to objectively demonstrate his point. His research has of course been characterized and maligned by standard medical experts extensively, and unfairly: http://harvardmagazine.com/201...http://harvardmagazine.com/2013/01/the-placebo-phenomenon
  9. Placebo responses have been attributed to standard therapy as well. This 1968 article in Rheumatology examines the anti-inflammatory effects of ultra-sound therapy as a placebo effect: http://rheumatology.oxfordjournals.org/content/25/1/77.long
  10. A 2005 analysis of the placebo effect at the University of Wisconsin found that re-analysis of the studies used to deny the placebo effect in 2001 in fact showed that the placebo effect was robust and actually approaches the treatment effect in a number of medical disorders. For example, with the treatment of depression, pill placebo therapy is shown to be nearly as effective as active medications, wheras pyschotherapies are shown to be more effective than psychological placebos in human clinical trials: http://www.ncbi.nlm.nih.gov/pubmed/15827993
  11. A 2003 review of the placebo effects in clinical trials of antidepressant medication found that in the trials that demonstrated a high placebo response (>30% improvement of symptoms with a placebo pill), the placebo actually outperformed the medication in about 80% of cases, whereas in studies demonstrating a low placebo response (less than a 30% improvement over baseline symptoms with use of a placebo pill) the medications consistently outperformed the placebo pills, although not dramatically. The variance in the placebo response is thought to be a factor of study design, and highlights the complexity of the placebo effect: http://www.ncbi.nlm.nih.gov/pubmed/12695731
  12. A 2006 study of placebo effects utilizing a sham acupuncture device versus an inert pill, conducted by Ted Kaptchuk DOM, Associate Professor at Harvard Medical School, showed that the placebo effect is indeed nuanced and complex: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1370970/?tool=pmcentrez
  13. A number of studies, including one large study printed in the British Medical Journal, in 2008, showed that a survey of U.S. physicians found 50% admitting to using a placebo pill in treatment at some time in their career: http:/www.findingdulcinea.com/news/health/September-October-08/Doctors-Placebo-Prescriptions-Have-Some-Crying-Foul.html
  14. A 2010 study by Dr. Kaptchuk at Harvard found that the placebo effect worked even when the patients were told that they were taking an inert placebo: http://www.whereismydoctor.com/news/placebos-work-even-if-patients-are-in-on-the-secret_948
  15. A 2010 article in the New York Times Health section by Dr. Amir Afkhami, an assistant professor at George Washington University, and an author of the U.S. State Department's Iraq Mental Health Initiative, found that interviewing and observing an Islamic faith healer showed that there was much similarity in his approach to standard supportive therapy in Western medicine, and the effects, which could be labeled a sham, or placebo effect, were indeed helpful to the patient observed and counseled: http://www.nytimes.com/2010/12/28/health/28cases.html
  16. A 2013 article in the Scientific American, reporting on information published in ProPublica, outlines the 5 years of fraudulent clinical drug trial research found at a large facility in Houston, Texas, Cetero Research, only noticed when a company employee finally became a whistleblower. The company had passed routine FDA inspection for years while admitting to blatantly falsifying research on nearly 100 drugs. Cetero Research, with numerous facilities over the country, who touted its affiliation with the United States Food and Drug Administration, declared bankruptcy after these findings. In 2012, the company stated that it completed its planned sale to lenders, overhauled the company management, changed its identity to PRACS Institute, and started a new company called Phase One Solutions, claiming that the years of blatant falsification of clinical drug research data occurred at only one of its facilities: http://www.scientificamerican.com/article.cfm?id=fda-let-drugs-approved-on-fraudulent-research-stay-on-market
  17. A number of public interest organizations are now providing information concerning the mistakes made by the U.S. FDA in approving harmful drugs. This ProCon.org site shows 35 of the prescription drugs recalled from the market after the actual facts of harm or lack of effectiveness were revealed, much of which was hidden by the manufacturer. This is just a portion of the recalled drugs: http://prescriptiondrugs.procon.org/view.resource.php?resourceID=005528
  18. A 2014 article in ProPublica, a public interest news journal founded by the Wall Street Journal managing editor, Paul Steiger, outlines the array of enormous fines agreed to by big pharmaceutical companies in the last few years to avoid prosecution for criminal activity, continuing an accelerating path of arrogance in the healthcare industry, with "too big to fail" and enormous sums of money with political lobbying creating a system where even billions of dollars in losses, and more in lobbying, can easily be passed onto consumers and the government healthcare spending by taxpayers: http://projects.propublica.org/graphics/bigpharma
  19. A 2014 article in the Wall Street Journal shows that recalls of defective or unsafe medical devices in the United States nearly doubled in the decade from 2003 to 2012, with the total number of recalls in 2012 rising to 1,190 such medical devices. The U.S. FDA still does not require that safety and efficacy are determined by multiple randomized controlled human clinical trials of these devices, and the U.S. Congress passed further legislation to insure that new medical devices are able to go to market without proof of effectiveness or safety outside of anecdotal evidence, or opinion:http://www.wsj.com/articles/SB10001424052702304756104579452062734883356