Current regulation of homeopathic medicine by the FDA in United States

Dr Charles Morris

Natural homeopathic remedies in the U.S. have been government-approved ever since the Food, Drug, and Cosmetic Act of 1938 recognized homeopathic preparations as drugs. In 1938, when the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted, the bill’s senatorial sponsor, Dr. Royal Copeland, himself a homeopathic practitioner, added a provision to the law recognizing the Homeopathic Pharmacopoeia of the United States (HPUS) alongside its counterparts, the U.S. Pharmacopeia and the National Formulary.

The Federal Food, Drug, and Cosmetic Act (the Act) recognizes as official the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements (Sections 201 (g)(1) and 501 (b), respectively). Those products that are offered for treatment of serious disease conditions, [such as for cancer, which the FDA is now claiming that they need to eliminate, even if they are dispensed by a licensed practitioner] must be dispensed under the care of a licensed practitioner. Under current law, if a homeopathic remedy claims to treat a serious disease such as cancer, it must be sold by prescription, so current law is already sufficient to protect people using homeopathic remedies for serious illnesses. Only products for minor health problems, like a cold or headache, which go away on their own, can be sold without a prescription.

FDA Declares All Homeopathic Drugs Illegal Threatening Remedies for Millions of Americans January 17, 2018 2:06 pm

In one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally. The FDA says that it does not intend to take action against such products at this time, but the writing is on the wall. If it wants to, the FDA could go after any homeopathic drug currently on the market. FDA’€™s process started two years ago, when the agency held a public hearing to evaluate its enforcement policies for homeopathic products. We suspected the agency was planning to tighten its grip on homeopathy, which, after all, competes with the pharmaceutical drugs that fund the FDA. We cannot let the FDA eliminate consumer access to homeopathy.

Read More…

Homeopathic remedies have been used effectively for serious diseases since the 18th century. For example, in 1918, homeopathic doctors were able to save 98.95% of their patients with homeopathic remedies, but allopathic doctors had a 28.2% mortality rate. [https://www.organicconsumers.org/news/homeopathy-successfully-treated-flu-epidemic-1918] The flu outbreak in Mexico City is another example. Important for Flu Epidemic: Homeopathy Successfully Treated Flu Epidemic of 1918 https://www.naturalnews.com/026148.html] [“Homeopathy had an amazingly high cure rate in the 1918 Spanish Flu pandemic in the USA. Just recently, during the 2009 Mexican Flu outbreak, a small group of Mexico City homeopathic doctors have revealed that homeopathy is up to the task again. This is good news considering that many over the counter and prescribed pharmaceutical flu remedies not only hazard negative side effects, but they may also not really cure current flu strains.” How did this happen if homeopathy “doesn’t work” and this was just a “placebo effect”? Doctors in Mexico City Cured 2009 Swine Flu with Homeopathy [https://www.naturalnews.com/026839_flu_homeopathy_remedies.html]

Please see the attached, “18349313-Homeopathy-in-Epidemics.pdf” for more epidemics in which homeopathy saved an outstanding number of patients compared to allopathic medicine.

Also, homeopathy has been proven to work on plants (“agrohomeopathy” [https://hpathy.com/agrohomeopathy/] http://homeopathyplus.com/homoeopathy-for-plants/ https://homeopathtyler.wordpress.com/agrohomeopathy-homeopathy-for-plantssoilfarmingcrops/  http://homeopathyplus.com/category/agrohomeopathy https://www.amazon.co.uk/Homeopathy-Plants-Maute/dp/3943309215/  http://www.nature-reveals.com/homeopathy-for-farm-and-garden-2nd-revised-edition.html   https://www.narayana-verlag.com/Homeopathy-for-Farm-and-Garden-Vaikunthanath-Das-Kaviraj/b8241 https://www.narayana-verlag.com/homeoplant/homeoplant_home_en.php and animals, which are immune to any placebo effect.]  Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC. [https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074360.htm]

A presentation (attached) from the American Institute of Homeopathy shows that patients are much happier (effectiveness) and safer (less side effects) with homeopathics than with conventional drugs. (The royalty in countries including the U.K. have a long-standing history of preferring homeopathic remedies over conventional drugs because of this). https://www.regulations.gov/document?D=FDA-2015-N-0540-0475 https://www.regulations.gov/contentStreamer?documentId=FDA-2015-N-0540-0475&attachmentNumber=1&contentType=pdf

It has been proven that homeopathy is not “just water or sugar pills”: https://hpathy.com/scientific-research/iit-researchers-prove-homeopathy-is-based-on-nanotechnology/ https://homeopathyplus.com/homeopathy-and-nanoparticles/  http://www.ircc.iitb.ac.in/IRCC-Webpage/Homeopathy-Nanoparticle-Note.pdf  http://www.homoeoscan.com/2015/04/homeopathic-medicines-contain-nanoparticles.html  http://homeopathytoday.net/research/item/127-nanoparticles-and-homeopathy The encouraging thing is that bit by bit, the mystery of homeopathic remedies is gradually being revealed, rather than just declaring them ineffective and dangerous and restricting or banning them.

Homeopathy Successfully Treated Flu Epidemic of 1918

https://www.naturalnews.com/026148.html

Doctors in Mexico City Cured 2009 Swine Flu with Homeopathy

https://www.naturalnews.com/026839_flu_homeopathy_remedies.html

https://www.scribd.com/presentation/18349313/Homeopathy-in-Epidemics  (attached)

As I have mentioned previously, I am a naturopathic doctor who has cured various illnesses, including serious diseases such as cancer, drug-resistant TB, Lyme Disease, Diabetes, and others (verified by allopathic doctors who even stated that they fully expected the person with drug-resistant TB in both lungs and brain to die because the drugs were not working), by the use of homeopathic and herbal supplements, diet and lifestyle changes, and imagery / visualization.

Right now, despite the law, FDA is attacking homeopathy to “protect” us. Starting in 2018, FDA claims the power to restrict access to natural homeopathic remedies, contrary to long-standing law, by issuing a “guidance” banning homeopathic remedies (which in the U.S. have been government-approved ever since the Food, Drug, and Cosmetic Act of 1938 recognized homeopathic preparations as drugs.) In 1938, when the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted, the bill’s senatorial sponsor, Dr. Royal Copeland, himself a homeopathic practitioner, added a provision to the law recognizing the Homeopathic Pharmacopoeia of the United States (HPUS) alongside its counterparts, the U.S. Pharmacopeia and the National Formulary.

The Federal Food, Drug, and Cosmetic Act (the Act) recognizes as official the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements (Sections 201 (g)(1) and 501 (b), respectively). Those products that are offered for treatment of serious disease conditions, [such as for cancer, which the FDA is now claiming that they need to eliminate, even if they are dispensed by a licensed practitioner] must be dispensed under the care of a licensed practitioner. Under current law, if a homeopathic remedy claims to treat a serious disease such as cancer, it must be sold by prescription, so current law is already sufficient to protect people using homeopathic remedies for serious illnesses. Only products for minor health problems, like a cold or headache, which go away on their own, can be sold without a prescription.

[Critics and the FDA are claiming that homeopathy doesn’t work and is “dangerous”. Homeopathic remedies have been used effectively for serious diseases since the 18th century. For example, in 1918, homeopathic doctors were able to save 98.95% of their patients with homeopathic remedies, but allopathic doctors had a 28.2% mortality rate. The flu outbreak in Mexico City is another example. Important for Flu Epidemic: Homeopathy Successfully Treated Flu Epidemic of 1918] [“Homeopathy had an amazingly high cure rate in the 1918 Spanish Flu pandemic in the USA. Just recently, during the 2009 Mexican Flu outbreak, a small group of Mexico City homeopathic doctors have revealed that homeopathy is up to the task again. This is good news considering that many over the counter and prescribed pharmaceutical flu remedies not only hazard negative side effects, but they may also not really cure current flu strains.” How did this happen if homeopathy “doesn’t work” and this was just a “placebo effect”? Doctors in Mexico City Cured 2009 Swine Flu with Homeopathy Also, homeopathy has been proven to work on plants (“agrohomeopathy” also: http://homeopathyplus.com/homoeopathy-for-plants/ https://homeopathtyler.wordpress.com/agrohomeopathy-homeopathy-for-plantssoilfarmingcrops/  http://homeopathyplus.com/category/agrohomeopathy https://www.amazon.co.uk/Homeopathy-Plants-Maute/dp/3943309215/  http://www.nature-reveals.com/homeopathy-for-farm-and-garden-2nd-revised-edition.html   https://www.narayana-verlag.com/Homeopathy-for-Farm-and-Garden-Vaikunthanath-Das-Kaviraj/b8241 https://www.narayana-verlag.com/homeoplant/homeoplant_home_en.php and animals, which are immune to any placebo effect.]  Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC. [https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074360.htm]

Presentation from the American Institute of Homeopathy shows that patients are much happier (effectiveness) and safer (less side effects) with homeopathics than with conventional drugs. (The royalty in countries including the U.K. have a long-standing history of preferring homeopathic remedies over conventional drugs because of this). 

https://www.regulations.gov/document?D=FDA-2015-N-0540-0475

https://www.regulations.gov/contentStreamer?documentId=FDA-2015-N-0540-0475&attachmentNumber=1&contentType=pdf

It has been proven that homeopathy is not “just water or sugar pills”: https://hpathy.com/scientific-research/iit-researchers-prove-homeopathy-is-based-on-nanotechnology/ https://homeopathyplus.com/homeopathy-and-nanoparticles/  http://www.ircc.iitb.ac.in/IRCC-Webpage/Homeopathy-Nanoparticle-Note.pdf  http://www.homoeoscan.com/2015/04/homeopathic-medicines-contain-nanoparticles.html  http://homeopathytoday.net/research/item/127-nanoparticles-and-homeopathy  But are these nanoparticles completely responsible for homeopathy’s therapeutic effects? Maybe, maybe not. Our suspicion is that researchers still need to look elsewhere for a complete answer to homeopathy’s therapeutic effect. The encouraging thing is that bit by bit, the mystery of homeopathic remedies is gradually being revealed, rather than just declaring them ineffective and dangerous and restricting or banning them.

Homeopathy is a system of medicine that dates back more than 200 years. Its use is based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. Those same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies.6 The clinical use of certain drugs according to this “like cures like” observation is called the principle of similars and forms the theoretical basis for homeopathy. Vaccines and some conventional medications, such as nitroglycerin for angina, stimulants for attention-deficit hyperactivity disorder, and digitalis for congestive heart failure, have been compared in effect to homeopathy.7  Since 1938, homeopathic medicines have been classified as drugs within the meaning of the federal Food, Drug, and Cosmetic Act (FDCA).8  Official homeopathic drugs are those that have monographs, which are official listings of drug data, in the Homeopathic Pharmacopoeia of the United States (HPUS). The HPUS is prepared by a nongovernmental organization, the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), which is composed of scientists and clinicians trained in the medical specialty of homeopathic medicine.9,10 Since most homeopathic drugs are sold on a nonprescription basis, very few are subject to reimbursement by insurance.

Homeopathy’s regulatory history in the United States
Homeopathy’s introduction into the United States is credited to an American of Danish descent who was trained in Copenhagen, Hans Burch Gram, in 1826.11 By 1871, sectarians—practitioners who were not members of the American Medical Association, including homeopaths—represented at least 13% of practitioners in the United States. By 1880, homeopaths operated 14 medical schools, compared with the 76 operated by conventional physicians.12 However, by the middle of the 20th century, the professional practice of homeopathy was all but over [due to a concerted effort by the AMA and Morris Fishbein to eliminate competition, which included attempting to close down all black- and women-run medical schools and hospitals, as well as chiropractic schools and hospitals, etc.].13 The last pure homeopathic medical college closed in 1920, although Hahnemann Medical College in Philadelphia taught homeopathic electives until midcentury.  Nevertheless, the influence of the homeopaths was not completely gone. In 1938, Senator Royal Copeland of New York, a physician trained in homeopathy and a principal author of the FDCA, included within the law’s definition of “drugs” articles monographed in the HPUS.8 Whether Congress’s acceptance of this definition was a personal concession to Copeland or an attempt by reformers to regulate homeopathic drugs more closely is not clear.14,15 The effect was to include homeopathic drugs as a formal component of food and drug law in the United States.  

The regulatory differences among allopathic drugs, homeopathic drugs, and dietary supplements are  no less complicated. Table 1 compares the regulation of the three categories of medications. For ease of discussion, it is helpful to contrast controlling law according to whether it addresses premarket approval, postmarket regulation (manufacturing, marketing, and sales), advertising regulation, or reimbursement status for the three types of products.

Allopathic drugs are governed by the federal FDCA and related regulations, published in Title 21 of the Code of Federal Regulations (21 C.F.R.). Premarketing approval is administered by the Food and Drug Administration (FDA) through the new-drug-application process for new drugs, while certain nonprescription drugs that are available for purchase directly by consumers on a nonprescription basis are subject to a separate nonprescription drug review process. Postmarketing regulation is principally specified in 21 C.F.R. and includes current good manufacturing practices (GMPs) and reporting of adverse drug events. Current GMPs specify the methods and conditions under which drugs must be produced, including validation of equipment and processes and training of staff. FDA regulates drug claims that are included in labeling.  Nonprescription drugs are limited to making claims for self-limiting conditions that do not require medical diagnosis or monitoring.8 Advertising for prescription allopathic drugs is regulated by FDA, while advertising for nonprescription allopathic drugs is regulated by the Federal Trade Commission (FTC). Reimbursement patterns for allopathic drugs vary, but the general rule is that prescription drugs are reimbursed by most private health insurance plans and may be deducted as a medical expense for federal tax purposes, whereas nonprescription drugs are generally not reimbursable but are subject to coverage under qualifying tax-advantaged flexible spending plans.19

Dietary supplements are regulated under the DSHEA, which was enacted as an amendment to the FDCA. As a practical matter, no premarket approval has applied to supplements currently on the market, since no new chemical entities have been approved since the passage of the DSHEA. All products marketed since the inception of the DSHEA are either single supplements or combinations of products that existed at the time of the DSHEA’s implementation.  Claims for the products must be reported to FDA prior to marketing, 20 and products may be freely sold unless and until the agency objects.  Until recently, there was little federal oversight of the manufacturing of dietary supplements. Supplements have become subject to recently promulgated GMP standards of their own21; however, some critics point out that GMPs for dietary supplements are less rigorous than those of their drug counterparts [which are frequently biased because they are run by either the drug companies themselves, or by ghostwriters paid by them]. [http://www.hylands.com/news/regulation.php]

Many homeopathic medicines are sold over-the counter. The FDA has now decided to reevaluate their “regulatory framework.” After sending out a safety alert concerning a homeopathic remedy for asthma in March 2015, the FDA then sent out a notice of public hearing. The hearing has been set in order to “obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products.”

Current homeopathic regulation of homeopathic medicine by the FDA

The FDA currently recognizes the homeopathic Pharmacopeia along with other drugs labeled USP. A NGO called Homeopathic Pharmacopeia Convention of the United States (HPCUS) has been regulating and monitoring the 1200 included (monographed) homeopathic remedies since 1897. In 1972, the FDA decided to “defer” review of homeopathic medicines based on their “uniqueness.” Because of this, there are no FDA safety reviews required for the sale or manufacturing of homeopathic medicines. In 1988, any “drug products” labeled as homeopathic have been able to be sold and manufactured without FDA approval, based on their Compliance Policy Guide (CPG) published that year. Compliance Policy Guide (CPG) 400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed” (see 53 FR 21728, June 9, 1988).

Notice of the FDA hearing on regulating homeopathic medicine (HFA-305):

FederalFegister.gov

Draft Guidance for FDA Staff and Industry Drug Products Labeled as Homeopathic

https://www.regulations.gov/document?D=FDA-2017-D-6580-0002

https://www.regulations.gov/contentStreamer?documentId=FDA-2017-D-6580-0002&attachmentNumber=1&contentType=pdf

A 1988 FDA decision enabled drugs labeled as homeopathic to be produced and distributed without the agency’s approval. The new policy laid out Monday would focus its enforcement powers on a range of such products including those with potentially dangerous ingredients, products marketed to treat life-threatening diseases [please see above regarding homeopathic treatment of influenza and other serious illnesses being both successful and safe] and those aimed at vulnerable populations. [People can be harmed by knives, scissors, ice picks — even pencils; instead of banning them from people who choose to use them, we should educate people of any potential dangers, and about how to use them properly, by appropriate labels and articles. People have recently become progressively less and less open-minded, to the point that if they don’t believe in, or don’t want to use, something, they also want to punish anyone who does and prohibit them from doing so. The FDA routinely weighs risk vs benefit for allopathic drugs and considers hundreds of thousands of deaths each year an acceptable price to pay for their supposed “benefits”In looking over records4 that spanned from 1976 to 2006 (the most recent year available) they found that, of 62 million death certificates, almost a quarter-million deaths were coded as having occurred in a hospital setting due to medication errors. And in 2009, there were nearly 4.6 million drug-related visits to U.S. emergency rooms nationwide,8 with more than half due to adverse reactions to prescription medications – most of which were being taken exactly as prescribed.Prescription Drugs Kill Over 100,000 People Each Year   I think I’ve heard you say upwards of 15 to 20 percent of drugs on the market are unsafe?  So up to one fifth.  How many deaths occur in the United States because of drugs that doctors are properly prescribing. Between 110 or 220 thousand people a year are dying from drugs that are properly prescribed by physicians but that have serious adverse consequences associated with them.  Certainly adverse consequences in many instances that are far greater than any person with knowledge would accept.  You would rather have your chronic ailment or your temporary and very inconvenient ailment than a drug that could kill you in one in five cases or one in ten or one in twenty cases… (Also see: https://ethics.harvard.edu/blog/new-prescription-drugs-major-health-risk-few-offsetting-advantagesDrug companies are paying the FDA, supporting a large proportion of its operating costs; homeopathic manufacturers have not.

The president of the American Association of Homeopathic Pharmacists, Mark Land, told NPR that the proposal wouldn’t affect the “vast majority” of homeopathic remedies available in the United States. The FDA noted that many products would “fall outside” the new risk-based categories. “We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm,” Gottlieb, the FDA commissioner, said. [It would be good if the FDA is only going to ensure that low potencies of certain homeopathic drugs that could be dangerous in low potencies, (e.g., mercury, lead, etc.) are restricted to homeopathic manufacturers and practitioners (they need them in order to be able to make various further dilutions of them) but we must be careful that the FDA does not use this as an excuse to further restrict homeopathic remedies that are harmless (such as sugar) even in lower potencies (i.e., 1:10 or 1:1 dilutions, vs 1: 100,000 dilutions). If the FDA restricts homeopathic medicines excessively, this will push people to make their own medicines or to purchase them from other countries, whose manufacturing standards may not be as good and as safe as if the medicines were made here.]

A 90-day public comment period on the new guidelines will take place before the plans become final.

[https://www.naturalnews.com/049290_homeopathic_medicine_homeopathy_FDA_hearing.html]

Ghost in the Machine, Part 1 — Drug Safety and Media Shaped by Big Pharma

https://www.organicconsumers.org/news/ghost-machine-part-1-drug-safety-and-media-shaped-big-pharma

https://articles.mercola.com/sites/articles/archive/2017/12/27/drug-safety-media-shaped-by-big-pharma.aspx

Story at-a-glance

  • Drug industry representatives sit on the boards of major TV and print news outlets, shaping and sometimes blocking reporting about drug safety and effectiveness
  • Academic institutions, many government agencies and NGOs are financially beholden to Big Pharma, and most academic medical centers have drug company reps on their boards
  • “Sponsored content,” also called branded or native content, is now the prevailing online advertising model making drug advertisements and Pharma messages look like real news

By Dr. Mercola

If you have noticed that prescription drugs are becoming more dangerous — and more expensive — you are right. As the drug industry’s influence over the U.S. Food and Drug Administration (FDA) increases, dangerous drugs are approved and marketed despite their clear risks to patients.

Recent examples include the aggressively promoted blood thinners Xarelto and Pradaxa which cause uncontrollable bleeding, the testosterone drug Androgel, for “Low T” linked to noncalcified plaque buildup in coronary arteries, and fluoroquinolone antibiotics. When warnings are added to these dangerous drugs or they are withdrawn, like 28 popular drugs have been, many wonder why media failed to report the safety risks while they were occurring.1

Of course, the reason is obvious. Mainstream media is essentially owned by the drug industry, so positive messages about new drugs are unfiltered Pharma messages.2 The New York Times has had on its board Schering-Plough and Eli Lilly affiliates and The Washington Post, Johnson & Johnson affiliates.3

Even so-called “public” media like PBS and NPR have accepted money from GlaxoSmithKline and UnitedHealthcare.4 No wonder the dangers of the bone drugs bisphosphonates, hormone replacement therapy, statins, SSRI antidepressants (especially Paxil), heartburn drugs (PPIs), antibiotics such as Levaquin and arthritis drugs like Humira seldom reach the public.

Sadly, when makers of dangerous drugs admit their products caused harm, the settlements usually include gag orders so that new, unwitting victims are no safer. Conflicts of interest are hardly limited to media companies. Government agencies, from the FDA to the Centers for Disease Control and Prevention (CDC) also have disturbing financial conflicts of interest that make a mockery out of objectivity.

Yes, the FDA Can Get Worse

When Robert Califf was confirmed in 2016 as FDA Commissioner despite 23 financial links to Pharma and cheerleading for Vioxx and Xarelto, many felt the industry taint at the FDA could not get worse.5 But the likely new FDA Commissioner, venture capitalist Dr. Scott Gottlieb, is so enmeshed with Pharma profits, conflicts of interest at the FDA could definitely get worse. The New York Times reports:6

From 2013 to 2015, for example, Dr. Gottlieb received more than $150,000 to advise Vertex Pharmaceuticals, a company whose two approved drugs are seen as breakthrough treatments for cystic fibrosis but carry list prices of more than $250,000 a year.

He’s the acting chief executive of Cell Biotherapy, an early-stage cancer biotech firm that he helped found. He has served for years as a consultant to pharmaceutical giants like GlaxoSmithKline and Bristol-Myers Squibb and is paid by other companies for his expertise …

In 2007, Dr. Gottlieb returned to the private sector, becoming a partner at New Enterprise Associates, where he advised the firm’s health care team, and began consulting for a range of companies. Dr. Gottlieb also held seats on a number of corporate boards, including Tolero Pharmaceuticals, a Utah company working on cancer treatments, and MedAvante, which assists pharmaceutical companies with clinical trials.”

When Gottlieb was first considered for an FDA post as deputy commissioner for medical and scientific affairs in 2005, the then-editor of The New England Journal of Medicine, Jerome Kassirer, said, “Gottlieb has an orientation which belies the goal of the FDA.”7 “The appointment comes out of nowhere,” said former FDA Commissioner Donald Kennedy. “Anything but a reassuring signal,” said Time magazine. And Gottlieb’s financial links to Pharma have only deepened since 2005.

Other Government Conflicts

The military serves as a reliable revenue source for the drug industry thanks to conflicts of interest at the highest levels. In just nine years, the U.S. Department of Veterans Affairs (VA) spent $717 million on risperidone, the generic form of Risperdal, to treat post-traumatic stress syndrome (PTSD) in troops — even though it worked no better than placebo.8

In a video (which has since been taken down), Matthew Friedman, former executive director of the VA’s National Center for PTSD, admitted receiving money from drug giant AstraZeneca9 on whose drugs the VA spent $125.4 million in 2009 alone.10 Elspeth Ritchie appeared in a webcast funded by AstraZeneca and Eli Lilly while serving in the U.S. Army Surgeon General’s Office, praising the drugs made by the companies.11

Mark Hamner directed PTSD clinical care at Ralph H. Johnson VA Medical Center in Charleston, South Carolina, while publishing AstraZeneca-funded research about PTSD clinical care.12 Questions also persist about industry relationships at the CDC. According to the BMJ:13

“Despite the agency’s disclaimer, the CDC does receive millions of dollars in industry gifts and funding, both directly and indirectly, and several recent CDC actions and recommendations have raised questions about the science it cites, the clinical guidelines it promotes and the money it is taking …

The CDC’s director, Tom Frieden, did not respond to a question about the disclaimer. He told The BMJ by email, ‘Public-private partnerships allow CDC to do more, faster.’”

Frieden’s report “looks like classic stealth marketing, in which industry puts their message in the mouth of a trusted third party, such as an academic or a professional organization,” wrote the BMJ’s Jeanne Lenzer. Not-for-profit organizations that work closely with government are also Pharma funded. The National Council on Aging’s (NCOA) 2016 corporate sponsors is a who’s who of Pharma companies.14

Academics Paid to Ghostwrite for Pharma 

Recently, Pro Publica15 and Consumer Reports16 reported how Big Pharma is surreptitiously enlisting professors at the nation’s top universities to write blogs and articles, and even host conferences to defend its new sky-high drug prices which are climbing to $1,000 per day and $40,000 to $94,000 for a course of treatment. Pro Publica wrote:

“To persuade payers and the public, the industry has deployed a potent new ally, a company whose marquee figures are leading economists and health care experts at the nation’s top universities. The company, Precision Health Economics, consults for three leading makers of new hepatitis C treatments: Gilead, Bristol-Myers Squibb and AbbVie.

When AbbVie funded a special issue of the American Journal of Managed Care on hepatitis C research, current or former associates of Precision Health Economics wrote half of the issue. A Stanford professor who had previously consulted for the firm served as guest editor-in-chief.”

Even before the extreme-priced drugs of the past few years, “research” has often been ghostwritten by the drug industry with a media professional or professor’s name attached for credibility. The popularity of the withdrawn Vioxx,17 the birth defect-linked Paxil,18 Neurontin19 and cancer and heart disease-linked hormone replacement therapy20 drugs were all courtesy of ghostwritten papers.

Shocking Partnerships Between Academia and Pharma

Thanks to the Bayh-Dole Act of 1980, which enabled lucrative academic/Pharma partnerships and “technology transfer” (even though most drug development is funded by taxpayers and profits should belong to the public) medical centers are unapologetic arms of the drug industry.

A 2014 research letter in the Journal of the American Medical Association (JAMA) revealed that almost all large U.S. drug companies have leaders in academic medical centers on their boards including deans, chief executive officers, department chairs, trustees at academic medical centers, school of pharmacy officials and university presidents.21

Susan Desmond-Hellmann was invited to apply to be Chancellor of the University of California, San Francisco (UCSF), which includes a medical school, while serving as president of product development at Genentech.22 No conflicts there. She remained at UCSF until 2014 and went on the Gates Foundation.23 Northwestern University made so much money selling the anti-seizure drug Lyrica to Pfizer it built an entire new research building on the money it made.24

In 2010, it was reported that Thomas Insel, director of the National Institute of Mental Health (NIMH), assured the University of Miami’s medical school dean that NIH grant money would flow if he hired Charles Nemeroff despite Nemeroff’s $9 million NIH grant having been terminated because of wrongdoing.25 (Since then, Insel has joined a semi-secret Google life sciences venture headed by former chairman and CEO of Genentech, Art Levinson).26

While I applaud the scrutiny in recent years on doctors receiving free lunches and other perks from Pharma reps, the exchanges are minor when you consider entire wings of medical centers are funded by Pharma. (In one Chicago-area NorthShore University HealthSystem hospital,l there are six Searle wings.)27

Drug Safety Is Now in Pharma’s Hands

Clinical trials were once hosted by hospitals or medical centers but now are run by for-profit groups hired by Pharma. The organizations, called contract research organizations (CROs), are experts at the “game” of bringing a drug to Wall Street as soon as possible. They also free Pharma from the cost of maintaining its own clinical trial staff. CROs provide drug companies with a drug trial design, recruitment, enrollment and consent of subjects and preparation of the final FDA submission package for approval.

They will even do the marketing and branding of the new drug. One reason so many dangerous drugs are now brought to market despite clear safety signals is the ability of CROs to speed drug approvals.

Institutional review boards (IRBs), groups of medical professionals, laypeople and ethicists to monitor human safety in trials are also no longer conducted in academic or hospital settings, but have become for-profit. What is wrong with a for-profit IRB? It is the same ethical problem of a stock rating agency being paid by the companies it is supposed to rate objectively. This is how a Public Library of Science (PLOS) article puts it:28

“Anyone who can bring together five people, including a community representative, a physician, a lawyer and an ‘ethicist,’ can set up shop and start competing for business … The problem is that commercial IRBs are paid in full by the very companies conducting the research. What is more, those companies are free to shop around for any IRB whose reviews they find congenial.

Research participants who are worried that they may face death or injury in a study sponsored by a pharmaceutical company are unlikely to feel more secure knowing that their safety has been entrusted to a panel of paid experts whose financial livelihood depends on a company paycheck.”

IRBs have become such shams, one recently agreed to participate in a phony study concocted by a federal undercover investigation in a sting operation. The fake study purposely included multiple characteristics of “significant risk” from existing FDA guidance but one IRB was still willing to be involved.29

‘Sponsored Content,’ Once Known as Advertorials, Has Invaded Health News Sites

Do you sometimes find yourself reading a health article that promotes a product or therapy so enthusiastically you realize it is not real journalism? That it is completely one-sided? Before the internet, there was a strict firewall in newspapers and magazines between news and ads and ads were even marked “advertisement” to leave no doubt. Not anymore.

Thanks to the internet, sponsored content, also called native or branded content, written by marketers passes as real journalism. (The internet has also brought us “programmed” ads based on your personal searches and buying habits which have been spied upon.) While native content, often videos, is the hallmark of young companies like Vice and BuzzFeed, established outlets like The Atlantic, Slate, The Huffington Post, The Washington Post, Business Insider and The New York Times have also climbed aboard.30

In fact, in one quarter in 2015, The New York Times earned $9 million from such ads, though it was soon forced to drop the word “Stories” from its label “Stories From Our Advertisers.” Readers charged the title was misleading and the content was just advertising.31 The Times had just hit its 100th such native ad at the time.32

Sponsored Content Is Not Harmless

The sponsored content is a media response to banner ads that are widely ignored, ad blocking technology and readers’ almost universal dislike of pop-ups and screen takeovers. It also fills webpages without the need to pay writers — instead, sponsors pay the media on whose site or in whose publication the content appears. Some of the content, like a slide show called “Dogs Caught Tipping Over the Garbage When Their Owners Are Gone,” is innocuous and even amusing.

Other sponsored content like “Could Statins Cut Alzheimer’s Risk?” or “How Testosterone Benefits Your Body” is unabashed Pharma marketing masquerading as content.33

Media leaders defend such content as valuable to readers. “It’s not advertising. It’s about big issues that relate to thought leadership,” said president and CEO of the very Pharma-friendly Forbes Media, Michael Perlis. But other media figures are appalled. “I am aghast at this,” Andrew Sullivan, former editor of the New Republic, said about advertiser-supplied, sponsored content. “Your average reader” doesn’t “realize they are being fed corporate propaganda.”34

Please propose and sponsor legislation to protect our access to homeopathic medicines, including those for serious illnesses such as cancer, and to protect access to low dilutions (1:1 mother tinctures, 1:10 dilutions, etc.) so that homeopathic doctors and manufacturers can still use them to make various further dilutions that are needed (they need to start with these low dilutions to make the medicines properly).

Dr. Charles Morris
morrischuck@earthlink.net

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