AUG
14
0

Plaintiffs may find Vitaminwater settlement hard to swallow

Another food fight in the courtroom has been halted, at least temporarily, by a judge's preliminary approval of a settlement agreement in several class actions.  This time the product is Vitaminwater, from the Coca-Cola company.

Via the magic of marketing, Vitaminwater looks like a healthy alternative to sugary sodas such as that other famous Coca-Cola product, Coke.  After all, two essential ingredients of health, "vitamins" and "water" are its very name. Vitaminwater comes in a rainbow of colors and 18 flavors that perpetrate this healthy image, with names like "Defense – Raspberry-Apple (Vitamin C + Zinc),"  "Rescue – Green Tea (Vitamin C + EGCG)" and "Endurance – Peach-Mango (Vitamin E + Ribose)."  The labels tout it as a “nutrient enhanced water beverage" and include the catchy phrase “vitamins + water = all you need." The black and white, non-frills labels, devoid of images, suggest a prescription label.  

But there is more in Vitaminwater than vitamins and water. Specifically, a good bit of sugar.  According to the label, each 20 oz. bottle of Vitaminwater contains 2.5 8 oz. servings. There are 13 grams of sugar and 50 calories in one serving, so a whole bottle contains 33 grams of sugar and 125 calories. (This is for the "B-relaxed jackfruit-guava" flavor.) By way of comparison, a 12 oz. regular Coke contains 39 grams of sugar and 125 calories.  A 20 oz. container of Coke would be 64 grams of sugar and 240 calories. But they're not labeling that Coke "Vitaminwater" either.  And what about the fruit juice in those fruity-sounding flavors?  Slim to none.  

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4835 Hits
AUG
09
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Enforcement of FDA gluten-free food labeling begins

On August 5th, the FDA began enforcement of a rule promulgated last year defining the term "gluten free." The threshold for the use of the claim will be 20 parts per million, which means that, unless a packaged food meets that standard, it can't be labeled "gluten free" or similar terms, such as "no gluten" and "without gluten."  The FDA also said that restaurant menus "should" comply with the rule, although there is some question whether "should" is the legal equivalent of "must."

According to Michael R. Taylor, the FDA’s Deputy Commissioner for Foods and Veterinary Medicine,

Celiac disease is a serious health issue and there is no cure. The only choice for the more than 3 million Americans living with the disease is adherence to a diet free of gluten — proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals, and possibly leading to a host of other health problems.

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4484 Hits
JUL
29
0

2014: a losing legislative season for naturopaths

By my count, naturopaths attempted to gain licensure in 10 states in 2014. (In states with two-year legislative sessions, the 2014 bill was in some cases a holdover from 2013). They attempted to increase their scope of practice in 4 states. On the other hand, in Hawaii there was a rare legislative attempt to put more backbone in naturopathic regulation. In Utah, a single bill both increased scope of practice and stiffened regulatory requirements.  There was a bill in Colorado which would have allowed "traditional naturopaths" a safe harbor from prosecution without registration. (It failed.) We won't count that in our tally because it wouldn't have affected the practice of "naturopathic doctors."

Many state legislatures have adjourned for the year, or at least will not vote on any more bills, although they may continue to meet.  The results are in for all naturopathic bills except in three states: New Jersey, Pennsylvania and Michigan. The Pennsylvania House passed a licensing bill with a disturbingly broad scope of practice, but it has been stuck in a Senate Committee since October, 2013.  The Michigan bill has been sitting in a House Committee since last year as well, and hasn't even made it to the Senate.   It may be a long time before we know the results in New Jersey, whose session doesn't end until January, 2016. 

 

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3877 Hits
JUL
26
0

California Legislature tries to reform Acupuncture Board (again)

The California Acupuncture Board, which regulates the state's approximately 11,000 acupuncturists, has a long and messy history.  Ben Kavoussi recounted that history in two informative posts (here and here) over on Science-Based Medicine.  Some highlights:

1988: The long-time chairman of the Board (then called the Acupuncture Committee) was caught selling answers to the licensing exam for $10,000 - $20,000 a pop, netting him a take of half a million dollars or more.  He was sentenced to five years in prison, but only a few of his customers were caught.  This means that some acupuncturists are almost certainly still practicing who are dishonest enough to buy their way into licensing and who may not have been able to pass the exam on their own.  

2002: A special commission appointed to look into long-standing problems with the Board determined that the Board had

too frequently acted as a venue for promoting rather than regulating the profession [resulting in] missed opportunities to protect the public by providing accurate and complete information about the therapies that licensees can provide.

The commission also found the Board had not "adequately incorporated emerging scientific evidence into board policies, regulations and public communications."

 

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4795 Hits
JUL
11
0

Zarbee's busted by FDA for dietary supplement claims

The Dietary Supplement Heath and Education Act of 1994 essentially removed dietary supplements from pre-market regulation by the FDA.  According to federal law, a dietary supplement is 

  • a vitamin or mineral; 
  • an herb or other botanical; 
  • an amino acid; 
  • a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or 
  • a concentrate, a metabolite, a constituent, or an extract.

Based on the largely unproven claim that taking these substances can improve health, Americans down them to the tune of $30 billion a year (2011).

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5375 Hits
JUL
11
0

"Safer" raw milk is not safe raw milk

Afficionados of raw milk, including sellers, have banded together to form the Raw Milk Institute ("RAWMI"), which aims to make raw milk safer. RAWMI is frustrated that regulation of raw milk sales varies a great deal from state to state.  It wants to institute a voluntary safety compliance program to reduce the risk of getting ill from consuming raw milk.  That is both good and bad news.  Good if it reduces the incidence of illness.  Bad in that it may give consumers a false illusion of safety.

Raw milk is unpasterized milk, which means it can be chock full of all sorts of infectious organisms, such as  Salmonella, Escherichia coli O157 and Campylobacter.  As you may have noticed, the milk production facility of the cow is located quite close to the endpoint of the cow's digestive system.  This is not an ideal food production setup unless you are a calf. 

Consumers and sellers of raw milk claim that it is more healthful because pasteurization, which involves heating the milk, destroys some of its benefits, like good bacteria.  The risks, on the other hand, are great.  Per the CDC:

the incidence of reported outbreaks [1993-2006] involving nonpasteurized dairy products was ≈150× greater, per unit of dairy product consumed, than the incidence involving pasteurized products. If, as is probably more likely, <1% of dairy products are consumed nonpasteurized, then the relative risk per unit of nonpasteurized dairy product consumed would be even higher.

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6932 Hits
JUL
06
0

Research shows research doesn't matter

Do the facts matter? 

When Beliefs and Facts Collide, an opinion piece by Brendan Nyhan published over the weekend in the NY Times, thinks not, not when it interferes with identity issues, like religion and politics.  Dismayed scientists have concluded from this that more education is in order. If people just knew the facts! But according to a new study from Yale, cited by Mr. Nyhan, facts don't matter. The study concludes

that the divide over belief in evolution between more and less religious people is wider among people who otherwise show familiarity with math and science, which suggests that the problem isn’t a lack of information. When he instead tested whether respondents knew the theory of evolution, omitting mention of belief, there was virtually no difference between more and less religious people with high scientific familiarity. In other words, religious people knew the science; they just weren’t willing to say that they believed in it. 

According to Mr. Nyhan, this helps explain why he and his colleagues have found that 

factual and scientific evidence is often ineffective at reducing misperceptions . . . .

Tell us about it!  If he thinks it's difficult with issues like health care reform (another stubborn issue he mentions), he should try CAM beliefs. 

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4137 Hits
JUN
29
0

Compare and Contrast: MDs v. NDs practicing without residencies

The Missouri Legislature recently passed a bill which would allow newly minted MDs and DOs to practice medicine without having completed a residency, but only in medically underserved areas.  The idea is to use medical school graduates who didn't match with a residency program to help fill the primary care physician shortage.  

The Governor has until July 15 to sign or veto the bill and there is no word yet on what he will do. For the political record, the Missouri State Medical Association lobbied for the bill, the Missouri Academy of Family Physicians isn't taking a position, and the American Academy of Physician Assistants, along the Missouri Academy of PAs have been vocal in their opposition.  

Which brings me to the subject of "naturopathic doctors."  Why?  Because NDs claim that they are capable of practicing as primary care physicians with the same degree of skill as MD and DO PCPs.  ND licensing bills routinely start out by defining them as PCPs, including the authority to prescribe drugs.  Fortunately, that scope of practice rarely ends up in their practice acts in the few states that license them.  That doesn't keep them from coming back to the legislature each year to ask for more.  

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4107 Hits
JUN
22
0

Connecticut naturopaths gain "modern" scope of practice

Connecticut's naturopaths (or "naturopathic physicians" as they like to call themselves) felt their state's "antiquated" naturopathic practice act was cramping their style, so they set out to change it.  The practice act defines naturopathy (or "natureopathy," as it is spelled in the Connecticut statutes) as 

the science, art and practice of healing by natural methods . . .

Naturopaths are limited in their practice to counseling and naturopathic standards like colonic hydrotherapy, physiotherapy and "treatment by natural substances."  There is no specific authority to diagnose or to perform or order diagnostic testing.  Unfortunately, all of that is about to change.

The Connecticut Legislature recently passed Senate Bill 437, giving naturopaths, according to the American Association for Naturopathic Physicians, a more "modern" scope of practice. An odd choice of words considering that naturopathy is based on vitalism, a pre-scientific belief that some incorporeal "life force," unknown to science, governs bodily functions. Nothing modern about that.

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7790 Hits
JUN
15
0

It's only natural. Or maybe it's not.

A plethora of class action lawsuits have been filed in the last few years alleging that customers were deceived by a product's claim that it is made from "natural" ingredients" or the product is "all natural." (You can find a list and description of these suits on the Top Class Actions website by typing in the search term "natural.")  It's hard to know who to have less sympathy for in these suits: the consumers who are scientifically illiterate enough to believe that a product is superior solely because its ingredients are "natural" or the companies who are trying to exploit the consumer craze for all things "natural" by marketing their products as such.  I could go either way.

The allegations in these suits center around the claims that the products advertised as natural actually contain GMOs and/or man-made ingredients.  Food products are the most common subjects of these suits, but not exclusively. Makers of sunscreen, toothpaste, shampoo, deodorant, cosmetics and disposable diapers have also been hit.  

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4171 Hits
JUN
07
0

Canadian dietary supplement regulation in race to bottom with U.S.

I am so relieved to learn that the United States is not the only country that allows "Big Supp" (the dietary supplement industry) and its allies to run the show!  Perhaps my following pro-CAM legislation here all year round has left me paranoid that we are the only ones who engage this sort of dangerous folly. 

Scott Gavura, a Canadian pharmacist and blogger over on Science-Based Medicine, reports that the Canadian Parliament is on the verge of passing a new law that would tighten up drug regulation by imposing additional adverse event reporting requirements, substantially increasing fines, allowing for post-marketing monitoring, requiring updating drug labels in the face of new information, and giving the Canadian government the authority to remove drugs from the market.  The proposals for change have been dubbed "Vanessa's Law," after a daughter  of a Canadian member of Parliament who died of an adverse drug reactions.  And here I note another similarity between Canadian and American legislators: it sometimes takes a legislator's own tragedy to get the attention of politicians. 

Frankly, this is one time I was actually rather proud that American regulation was ahead of the Canadians.  Otherwise, their single-payer health care system runs rings around ours.

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3965 Hits
JUN
02
0

Homeopathic remedies: the naked emperor changes outfits

Homeopathic remedies enjoy a distinct legal status in the United States apparently conferred only on "alternative" medicine.  It is fraudulent to sell homeopathic remedies as an effective treatment for any disease or condition because these products contain only water or water dripped on a table made of a medically inert substance, such as sugar.  Yet, at the same time, it is legal to sell homeopathic remedies because a federal statute employs the fiction that they are drugs subject to FDA jurisdiction, even thought the FDA won't have anything to do with them. This has resulted in something of a "shooting fish in a barrel" type class action lawsuit that is becoming a legal subspecialty.  The plaintiffs' attorneys simply stand over the barrel with a shotgun waiting for the homeopathic remedy to swim by and "boom" -- instant lawsuit. Numerous class actions against homeopathic remedy maufacturers, based on fraud and violation of various consumer protection laws, are pending or have been settled in the U.S.

This has soured at least one homeopathic remedy manufacturer on the U.S. market.  Heel Group, a German manufacturer of homeopathic remedies, announced it is ceasing all U.S. and Canadian operations.  As a company press release explains:

In the USA and Canada, manufacturers of OTC homeopathic medicinal products have been confronted with accusations through class action lawsuits. Heel Inc., the Heel Group’s U.S.-based subsidiary, was also faced with two such attempts recently. Both cases have been settled without conceding the allegations. The financial burden on Heel Inc., however, was substantial.

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4390 Hits
MAY
25
0

Naturopaths now covered by Medicaid in Washington

Naturopathic doctors, that is, naturopaths who go to four-year naturopathic "medical"schools, want to become licensed in all 50 states with the same scope of practice as a primary care physician.  Their education and training falls far short of that of an M.D. or D.O. family practice physician.  But because their education system is accredited by a private agency created by, and operated by, naturopaths, no independent body has ever evaluated their education and training. Thus, for now, they can get away from claiming they are capable of practicing as PCPs, but only a minority of the 18 states where they are licensed or registered have bought into their claims.  

Another goal is insurance coverage for their services.  Naturopaths pinned their hopes on Section 2607 of the Affordable Care Act, which prohibits "discrimination" by insurers against any provider licensed by a state.  However, the Department of Health and Human Services has not required any insurer to include naturopaths as providers, although final regulations have not been issued.  They've been trying to get covered as Medicare providers too but have failed in that endeavor.

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4499 Hits
MAY
18
0

Will insurers be forced to pay for pseudomedicine? Tell HHS "no!"

Section 2607 of the Affordable Care Act (ACA) prohibits "discrimination" against state-licensed health care providers:

(a) PROVIDERS.—A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.

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4192 Hits
MAY
11
0

Naturopaths suffer several legislative setbacks

Naturopaths want to be licensed as primary care physicians with full prescription privileges in all 50 states.  Fortunately, it has been quite a while since they achieved that goal in any particular state. NDs are licensed or registered in 18 states now, but recent legislative successes fall far short of full PCP scope of practice. And there has been pushback against their prescribing privileges in one state.

Colorado passed a registration (not full licensing) law for naturopaths last year, but with significant restrictions on their practice.  They cannot see patients under two at all.  If the patient is between two and eight years old, the law requires NDs to provide a schedule of recommended vaccinations, tell the parents that the Department of Health and Human Services recommends that the schedule be followed, disclose that the ND is not a physician, and recommend that the child have a relationship with a licensed pediatric health care provider.  It also requires NDs to have 3 hours of continuing education each year in pediatrics. 

In accordance with the American Association of Naturopathic Physicians' plan to come back and ask for more every year until they get what they want, the NDs were indeed back before the Colorado Legislature seeking to eliminate these restrictions. They failed and the restrictions remain in place. 

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3556 Hits
MAY
04
0

Homeopathic remedies: perfectly legal, the perfect fraud, or both?

Homeopathy took another well-deserved hit recently when the Australian National Health and Research Council concluded it doesn't work. The report said a lot more but that is the jist of it.  Maybe someone in authority in the U.S. will listen this time.  Hasn't worked before, but we can hope. 

If you are not familiar with homeopathic remedies, they come in two forms: water, and water evaporated on a tablet.  As Harriet Hall explained a few days ago in The Skeptical Inquirer

Scientific knowledge about chemistry, physics, and biology tells us it should not work; careful testing has shown that it does not work

To me, the most intriguing feature of homeopathy is not that people use it but rather that it can be sold at all.  By all rights, a company shouldn't be able to sell a small bottle of overpriced water or sugar tablets as a remedy for what ails you.  And no health care pracitioner should be allowed to prescribe it.

But they do.  How?  In the U.S., homeopathic remedies are considered a special class of drugs under federal law.  Back in 1938, a homeopathic physician named Royal Copeland succeeding in dumping the entire Homeopathic Pharmacopeia of the United States [HPUS] into federal law when Congress passed the Food, Drugs and Cosmetics Act, an otherwise admirable law that tried to bring effective oversight to the drug industry.  At the same time, though, homeopathic remedies were exempted from virtually all regulations governing drugs, including premarket testing for safety and efficacy, safe manufacturing practices, and reporting requirements. In fact, pretty much all meaningful regulation.  These exemptions have survived the many amendments to the orginal FDCA.

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4999 Hits
APR
27
0

An unwarranted expansion of expanded access to investigational drugs

In the US, drugs (and medical devices) must go through a rigorous FDA-monitored procedure of safety and effectiveness testing via clinical trials before they can be marketed.   Some patients with serious or life-threatening diseases can access drugs not yet approved, referred to as "investigational drugs."  This is known as  "expanded access" or, colloquially, as "compassionate access."  Access is carefully controlled and there are a number of safety features in place to ensure proper use.  For example,  each expanded access request must be approved by an Institutional Review Board, a special committee designed to insure the protection of a patient's rights and safety, including a requirement that the patient is aware of all risks. A physician must determine that there is no comparable alternative treatment available and that the probable risk from the investigational drug is not greater than the probable risk presented by the disease.  The FDA must decide whether there is sufficient evidence of safety and effectiveness based on a particular patient's medical history, which provided by the patient's physician.  

Society's interest in access to a supply of safe and effective drugs is protected as well.  Access will not be granted if it will interfere with clinical trials of the drug.  And, if access is granted, there is follow up so that the drug's effect on the patient can inform the it's use in other patients.

But expanded access is limited access.  Some patients will be turned away.  This has led to attempts in the state legislatures and Congress to expand access even further, even at the risk of the process becoming so porous that expanded access threatens to become a crowd-pleaser (or, perhaps more accurately, vote getter) rather than a sober analysis of whether a particular investigational drug might benefit a particular patient and ensuring that it does not do so at the expense of the rest of us. 

 

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4828 Hits
APR
20
0

There is no "right" to refuse vaccination for your child

The National Vaccine Information Center is a faux vaccine information organization. In reality, NVIC is anti-vaccination.  We bloggers at Science-Based Medicine have followed David Gorski's lead in calling it the National Vaccine (Mis)information Center, a name that more truly reflects its purpose.  

NVIC has been deprived of its favorite vaccination boogey man, the fake autism-vaccination connection.  That lie has been so thoroughly discredited that even NVIC doens't make it the centerpiece of its misinformation campaign anymore.  Rather, it has moved on to "informed consent."  Or, as Dr. Gorski has aptly named the NVIC's version of informed consent, "misinformed consent." 

The NVIC is all about parents making informed choices before vaccinating their children. But by the time parents wade through NVIC's website, they will be so misinformed that they may well reject some or all vaccines. NVIC emphasizes the risks that childhood vaccinations present , even though the risk-benefit analysis of vaccination comes out overwhelmingly in favor of vaccinating.  They underplay the seriousness of vaccine-preventable infectious diseases and focus on the limited effectiveness of some vaccines.  NVIC especially loves the Vaccine Adverse Event Reporting System.  VAERS is a government program that collects information about adverse reactions to vaccinations in order to improve vaccine safety, an admirable objective.  It urges anyone to report any clinically significant medical event following vaccination even if you are not sure that it was caused by vaccination.  Of course, this inflates the numbers by including events that have absolutely nothing to do with vaccination other than that they occurred after the vaccination took place.  

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4350 Hits
APR
13
0

Rhode Island becomes the latest state in push for naturopathic licensing

Naturopaths are aiming to become licensed as primary care physicians in all 50 states with the same scope of practice as MD/DO family practice doctors, including prescription privileges.  However, they will settle for less and keep bugging the legislature year after year until they get what they want.  We see that playing out right now in Colorado where, after having become legally allowed to practice last year, they are back in front of the state legislature for more.  The latest front in the war is Rhode Island, where a licensing bill was introduced on April 9th.  

Rhode Island Senate Bill 2874 is disarming in its simplicity.  Apparently, the naturopaths have learned the art of subtlety in drafting -- getting what you want by not calling too much attention to what it is you are asking for.  But to those who know how to decode the language of naturopathy and are familiar with their ambitions, reading between the lines is illuminating.  

In order to be primary care physicians, they need unlimited authority to diagnose and treat.  This bill starts off innocuously by defining naturopathic medicine as "a system of health care that utilizes education, natural medicines and natural therapies."  But for what purpose does it "utilize?"  To "prevent, diagnose and treat."  In other words, hidden right there, is the authority to diagnose and treat any patient with any disease or condition. In other words, they can do anything an MD or DO can do. 

 

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4712 Hits
APR
06
0

Naturopaths win a couple; chiropractors and acupuncturists strike out (so far)

No man's life, liberty or property are safe while the Legislature is in session.

Or health, we might add. State legislatures are in large measure responsible for the pervasive infiltration of pseudo-medicine into the American healthcare system.  The states hold the power to license chiropractors, acupuncturists, Traditional Oriental Medicine practitioners, naturopaths and homeopaths.  And, unfortunately, they do license them.  It is thus that subluxations, adrenal fatigue, chronic yeast overgrowth, and blocked qi become legally permissible diagnoses instead of fraud. Ditto for pseudo-remedies such as green tea suppositories, homeopathy,glandulars, colonic irrigation, cupping, subluxation adjustments, auricular acupuncture detox and the ever-increasing number of other illegitimate treatments for both real and imaginary conditions being dreamed up by CAM practitioners. 

To give credit where credit is due, Congress is responsible, via passage of the misleadingly named Dietary Supplement Health and Education Act, for the plague of vitamins, minerals and dietary supplements scarfed down by Americans to mostly no benefit, but great cost.   And it is Congress that allows the sale of homeopathic products as remedies for various diseases, mild (colds) to major (influenza).  Not to mention Congress's creation of the taxpayer-funded ($2 billion and counting) National Center for Complementary and Alternative Medicine.  

(And, also to give credit where credit is due, that quotation is from New York County Surrogate (i.e., probate judge) Gideon J. Tucker, who penned it in a probate case in 1866, although it is sometimes incorrectly attributed to Mark Twain.)  

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