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What (if anything) does “natural” mean?

"When I use a word," said Humpty Dumpty said in a rather scornful tone, "it means just what I choose it to mean -- neither more, nor less." Lewis Carroll, "Through the Looking Glass"

“When I use a word,” said Humpty Dumpty in a rather scornful tone, “it means just what I choose it to mean — neither more, nor less.”
Lewis Carroll, “Through the Looking Glass”

What does the term “natural” mean on a label? Does it mean anything? Should it mean anything? Good questions. And complicated ones, judging from the list of questions the FDA needs your help in answering.

The FDA has resisted defining “natural” in food product labeling, including whether foods that are genetically engineered, or contain genetically engineered ingredients, can use the term. Back in 1991, the agency set out to issue regulations but abandoned the effort and has since held to an informal policy that “natural” means

nothing artificial or synthetic (including color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.

The only official legal requirement for using the description “natural” on a food label is that it not be misleading or false, which is forbidden by the Food, Drug & Cosmetics Act of 1938. In that appetite-suppressing way of statutory language, “food” is defined by the Act as

articles used for food or drink for man or other animals, chewing gum, and articles for used for components of any such article.

For regulatory purposes, dietary supplements are also considered foods in most cases. (more…)

Posted in: Genetically modified organisms (GMOs), Legal, Nutrition, Politics and Regulation

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Regulating CAM Aussie Style

640px-Flag_of_Australia.svg
CAM proponents view National Health Interview Surveys recording the supposed popularity of CAM, an amorphous conflation of anything from conventional medical advice to mythical methods, as an invitation to unleash even more unproven remedies on the public. My interpretation is quite different. I see the same figures as proof that we are doing too little to protect the public from pseudoscience.

In fact, state and federal governments are acting as handmaidens to the CAM industry by legalizing practices and products that have insufficient proof of safety and efficacy and, in some cases, are so scientifically implausible that they can never meet that standard. The federal government keeps “integrative” medicine centers at major academic institutions and private foundations afloat with taxpayer money by funding research that has failed to improve public health or the treatment of disease, despite seemingly endless trials, because “more research is needed”.

As we shall see, Australia has a more effective regulatory system for dealing with CAM. And the advocacy group Friends of Science in Medicine (FSM), an organization with goals similar to our own Society for Science-Based Medicine, is keeping the government on its toes, investigating violations of the law on its own and reporting them. We in the US could learn something from their two recent successful campaigns attacking misleading health claims. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Guidelines, Legal, Naturopathy, Politics and Regulation

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Patient Beware: Off-label drug promotion by pharmaceutical companies

In truth, physicians are rarely this happy to see a drug rep.

In truth, physicians are rarely this happy to see a drug rep.

Pharmaceutical companies and their sales reps can distribute information, such as medical journal articles, about unapproved (“off-label“) uses of their drugs as long as they adhere to FDA guidelines. However, the FDA takes the position that this information must be distributed separately from information that is “promotional in nature,” i.e., for marketing purposes, a position that is now open to question.

Off-label promotion of a drug for a use that has not been approved by the FDA is, in the FDA’s view, a violation of the federal Food, Drug & Cosmetic Act (FDC Act). It is subject to criminal prosecution, because promoting a drug for new, unapproved uses is evidence of an intent that the drug be used before it has gone through the extensive process of clinical trials and a review of the evidence of safety and efficacy by a panel of experts, as required by law before a drug can be marketed. Thus, off-label promotion is seen as an end-run around the approval process that perverts the purpose of the FDC Act, which is to protect the public from ineffective and unsafe drugs.

Studies show that personal sales visits to physicians by pharmaceutical reps (called “detailing”) drives prescriptions in favor of the drugs being promoted. This is true even though physicians’ view of detailing ranges from neutral to highly negative, a “necessary evil,” and physicians are aware of potential conflicts of interest these visits precipitate.

While there are restrictions on off-label promotion, off-label prescribing by a physician is not illegal. Physician practice is regulated by the states and not within the jurisdiction of the FDA. In fact, off-label prescribing is considered both ethical and within the standard of care in appropriate circumstances. (I am currently taking a drug for an off-label use, and was informed of this, plus the risks and benefits, by my physician prior to his prescribing it.) It is also common, according to an article by law professors Ryan Abbot and Ian Ayers in the Duke Law Journal, which is well worth reading:

for the 3 leading drugs in each of the 15 leading drug classes, off-label use accounts for approximately 21% of prescriptions. Moreover, off-label uses may be the norm in some areas of practice, such as oncology, pain management, and palliative care, and in some patient populations, such as children, the elderly, and the severely ill. For example, about 80 percent of all drug prescriptions for children are off-label, and between 80 and 90 percent of all drug prescriptions for rare diseases are off-label. [Footnotes omitted.]

(more…)

Posted in: Clinical Trials, Ethics, Legal, Pharmaceuticals, Politics and Regulation

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Laws Limiting Vaccine Exemptions Work

VaccineIt’s nice when a question can be resolved with objective numbers of unequivocal outcomes. Subjective outcomes give scientists a headache.

In this case we are talking about the effect of vaccine exemption laws on vaccine compliance rates. The question here is not the ethical one, the rights of parents to determine the fate of their children vs the right of the state to protect the health of children and the public health. I think the latter trumps the former, but some disagree.

Regardless of what you feel about the ethical question, we need to know if the laws we pass to achieve our goals actually work, or if they don’t work, or even have unintended consequences. Having an admirable goal is not enough; when you make actual decisions (practice decisions, policy decisions, healthcare decisions for you and for family) you want to know that those decisions are having the desired effect.

(more…)

Posted in: Legal, Public Health, Vaccines

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Docs v. Glocks: government regulation of physician speech

Glock 19 pistolA few years ago, an Ocala, Florida, pediatrician, as part of a routine visit, asked a patient’s mother whether she kept firearms in the home. She refused to answer, feeling the question constituted an invasion of her right to privacy. The pediatrician then terminated the relationship and told the mother she had 30 days to find a new doctor for her child. In another incident, a mother reported she was separated from her children while medical staff asked them whether their mother owned firearms. And, according to a Florida legislator, he was told to remove firearms from the home during an appointment with his daughter’s pediatrician.

Complaints to Florida legislators about these and similar incidents prompted the introduction of a bill that would have, among other things, criminalized any

verbal or written inquiry by a . . . physician, nurse, or other medical staff person regarding the ownership of a firearm by a patient or the family of a patient or the presence of a firearm in a private home . . .

As finally passed by the legislature and signed by Governor Rick Scott, the 2011 Firearm Owners Privacy Act subjects physicians to disciplinary action for making “verbal or written inquiry” into a patient’s firearm ownership when the physician does not “in good faith believe” such inquiries are “relevant to the patient’s medical care or safety of others.” The Act included amendments to the Florida Patient’s Bill of Rights and Responsibilities, adding similar provisions. (The Act also applies to health care facilities, but here we will discuss only its effect on physicians and their patients.) Physicians may not enter any information regarding firearm ownership into the patient’s medical record if they know this information is not “relevant to the patient’s medical care or safety, or the safety of others.” They may not “discriminate” against a patient “based solely on the patient’s Second Amendment right to own firearms or ammunition.” Finally, physicians must refrain from “unnecessarily harassing” a patient regarding firearm ownership during an examination. (more…)

Posted in: Ethics, Legal, Politics and Regulation, Public Health

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Legislative Alchemy 2015: Another losing season for CAM practitioners

legislative-alchemy-image
One of the main, but perhaps underappreciated, reasons quackery thrives in the United States is that the states legalize it by licensing practitioners of pseudoscience as health care providers. These practitioners are placed under the regulatory jurisdiction of, well, themselves. I call the whole deplorable process Legislative Alchemy, and you can see all posts on the topic here. It gives practitioners an underserved imprimatur of state authority and leaves public protection from harmful practices to the oversight of those who are themselves engaging in the very same conduct. Each year, dozens of bills are brought before the state legislatures to establish initial licensure or, once that goal is achieved, scope of practice expansion.

Most attempts fail, but CAM practitioners are a dogged bunch, and they will come back each year until they get what they want. It took chiropractors about 60 years to become licensed in all 50 states. Acupuncturists are almost there. Naturopaths lag far behind, but are slowly gaining ground each year, even if it is only via practice expansion in states where they are already licensed. 2015 was a losing season for all, but not without advancement toward larger goals.

(more…)

Posted in: Acupuncture, Chiropractic, Diagnostic tests & procedures, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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Home birth tragedies lead to changes in Oregon

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Oregon Health Plan (OHP), the state’s Medicaid insurer, will no longer cover planned home and birth center births for women whose pregnancies aren’t classified as low risk, based on newly-established criteria. The Health Evidence Review Commission (HERC), a group of experts designated by the state, came up with criteria that will exclude women with a substantial list of conditions, such as high blood pressure, diabetes, previous cesarean section, multiple gestation (more than one fetus), and various complications in previous pregnancies. Feelings ran high on both sides of the issue, which was described as the most contentious ever to come before the HERC.

The HERC’s decision was based on an exhaustive 100-page evidence review; a review, according to them, hampered by the low quality of the evidence on the safety of planned out-of-hospital births. Actually, there is a paucity of evidence altogether. Studies and statistics from other countries, like the Netherlands, were of limited utility because those countries have more stringent midwifery education and training requirements and non-hospital births are better integrated into the health care system.

Most planned out-of-hospital births in Oregon are attended by what are known as direct-entry midwives (DEM), as opposed to nurse midwives, and a few naturopathic doctors. (We’ll look at the many variations of midwifery in a minute.) Since OHP pays for 23% of Oregon births, the economic impact on direct-entry midwives could be substantial. This effect will be amplified when other insurers, who are expected to follow OHP’s new criteria, change their own coverage rules. (more…)

Posted in: Guidelines, Legal, Naturopathy, Obstetrics & gynecology, Politics and Regulation, Public Health

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Brian Clement claims Hippocrates treatments “reverse” multiple sclerosis

Brian Clement

Brian Clement

American charlatan Brian Clement made another trip to Canada recently and was caught on audiotape claiming multiple sclerosis could be “reversed” at the Hippocrates Health Institute (HHI), where he serves as Director. This is yet another in a series of his misrepresentations about the effectiveness of the quack treatments offered at HHI. Indeed, Clement calls to mind the old joke about inveterate liars:

Q: Know how can you tell this guy is lying?

A: His lips are moving.

Once again, the Canadian Broadcasting Corporation (CBC), which has done an outstanding job exposing Clement and his mendacity, caught him in this particular fabrication. (The American media, by contrast, has largely ignored the story, even to the point of printing credulous puff pieces about Clement.) According to the CBC, it:

obtained a recording of a lecture Clement gave in September in Montreal where he said, “Last week, we had somebody at the institute that reversed multiple sclerosis.”

He went on to claim that many other people who visited his Florida spa, the Hippocrates Health Institute, saw similar results.

“A nurse that came to us two years ago was crippled, had braces on. By the time she left Hippocrates, she reversed the multiple sclerosis.

“And mainstream medicine, they think it’s remarkable. I’ve seen lots and lots of people over the years did that.”

(more…)

Posted in: Cancer, Health Fraud, Legal, Politics and Regulation, Science and the Media

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US Department of Justice Goes After Supplements

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The Food and Drug Administration (FDA) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The Federal Trade Commission (FTC) is also reviewing the claims made by the homeopathy industry, and even gave a nudge to the FDA to fix its regulation.

Now the US Department of Justice (DOJ) is getting in on the fun:

USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.

This action by the DOJ raises the stakes to a new level – criminal charges. While the FDA and FTC do the best they can, they often lack teeth when it comes to supplements. The FDA might issue a polite request and then escalate to a stern warning when companies step out of line. The FTC can issue fines which amount to little more than a slap on the wrist – the cost of doing business. Both agencies are playing whack-a-mole and losing.

(more…)

Posted in: Herbs & Supplements, Legal

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