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Consumer Health Digest #18-38
September 23, 2018

Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H
http://www.calstatela.edu/faculty/william-m-london
., with help from Stephen Barrett, M.D
http://www.quackwatch.org/10Bio/bio.html
. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making. Its primary focus is on health, but occasionally it includes non-health scams and practical tips.

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Myers cocktail marketer agrees to stop deceptive health claims

A & O Enterprises Inc., doing business as iV Bars Incorporated and iV Bars, and owner/manager Aaron K. Roberts a/k/a Aaron Keith have signed a consent agreement
https://www.ftc.gov/system/files/documents/cases/1723016_iv_bars_decision_order_9-20-18.pdf
under which they must refrain from making misleading claims for Myers Cocktails and other intravenous products.

The company operates clinics in Texas and Colorado. The products, sometimes referred to as "intravenous micro-nutrient therapy," "intravenous vitamin therapy," and "hydration therapy" are simple mixes of water, vitamins, minerals, and herbs administered directly into the bloodstream for between $100 and $250 per "treatment."

The products have been marketed as treatments for serious diseases such as cancer, multiple sclerosis, diabetes, fibromyalgia, neurodegenerative disorders, and congestive heart failure. In many instances, the company claimed that its products were more effective and better tolerated than standard medical therapies.

The FTC complaint
https://www.ftc.gov/system/files/documents/cases/1723016_iv_bars_complaint_9-20-18.pdf
publicly released together with the consent order, contains screen captures of the allegedly misleading claims.
Source: FTC brings first-ever action targeting "iV Cocktail" therapy marketer
https://www.ftc.gov/news-events/press-releases/2018/09/ftc-brings-first-ever-action-targeting-iv-cocktail-therapy

FTC news release. Sept 20, 2018. The proposed agreement prohibits the company and its owner from:

* making any express or implied health, safety, or efficacy claims unless they are not misleading and are supported by scientific evidence

* misrepresenting, in advertising, marketing, promotion, or sale of any covered product, that it has had medical professionals test or approve the product, or that it has a research facility

* misrepresenting the existence or conclusions of any scientific evidence, or that a product, including iV Cocktails, is scientifically or clinically proven to produce any benefit

* making false or unsubstantiated claims that its iV Cocktails are effective in treating any of the diseases included in the complaint; produce fast, lasting results; or cure, mitigate, or treat any diseases

In addition to agreeing to the terms of the proposed order, iV Bars emailed a notice to consumers 
https://www.ftc.gov/system/files/attachments/press-releases/ftc-brings-first-ever-action-targeting-iv-cocktail-therapy-marketer/iv_bars_consumer_notice_sent_8-16-18.pdf
who bought products before the FTC-challenged claims were eliminated from the company’s advertising. The notice, signed by Roberts, states:

* Contrary to the company's marketing materials, studies have not shown that the Myers Cocktail is an effective treatment for any disease, including nine specific diseases, ranging from cancer to multiple sclerosis and diabetes.

* Consumers should consult a doctor or other healthcare provider before using any alternative disease treatments.

* Consumers should talk with their doctor or healthcare provider before stopping any prescribed treatments.

* It is important for consumers to talk with their healthcare provider to ensure all aspects of their medical treatment work well together.

It is not clear whether the FTC case will have any effect on medical doctors, osteopaths, and naturopaths who make similar claims but obtain their Myers cocktail supply from compounding pharmacies or other sources.

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AbbVie sued for illegal kickbacks in promoting HUMIRA

The California Department of Insurance has filed an fraud complaint
http://www.insurance.ca.gov/0400-news/0100-press-releases/2018/upload/nr111-2018AbbiVieComplaint091818.pdf
in Alameda County Superior Court charging that biopharmaceutical company AbbVie Inc. gave illegal kickbacks to health care providers to prescribe HUMIRA
https://www.humira.com/

In properly selected cases, HUMIRA can be extremely effective against Crohn's disease and other autoimmune diseases, but it should not be prescribed unnecessarily because of potentially serious side effects. The complaint charged that AbbVie paid healthcare providers to prescribe it far more than they would have without the kickbacks by engaging in a far-reaching scheme that involved:

* classic kickbacks that included cash, meals, drinks, gifts, trips, and patient referrals

* more sophisticated kickbacks—free and valuable professional goods and services to physicians to induce and reward HUMIRA prescriptions, such as free insurance processing, prior authorizations, gifts of medical practice management hardware and software, and even marketing assistance

* sending its registered nurses—whom AbbVie calls "ambassadors"—into homes of patients, presenting them as extensions of the HUMIRA-prescribing doctors' offices

* instructing ambassadors to send patient complaints directly to AbbVie and not the patients' treating physicians

* training ambassadors to tout the drug but avoid directly answering patient questions about serious risks

The allegations of wrongdoing were brought to the department's attention by a nurse who was employed as an AbbVie Nurse Ambassador in Florida.

The case, filed under the Insurance Frauds Prevention Act
https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=INS&division=1.&title=&part=2.&chapter=12.&article=1.
, alleges that private insurers have paid out $1.2 billion in HUMIRA-related pharmacy claims, making this the largest health insurance fraud case in the department's history.

[Jones sues biopharma giant AbbVie alleging illegal kickbacks in promoting HUMIRA
http://www.insurance.ca.gov/0400-news/0100-press-releases/2018/release111-18.cfm
California Department of Insurance press release. Sept 18, 2018]

The New York Times has reported that HUMIRA is the top-selling drug in the world, rising from about $1,900 per year per patient to more than $38,000 per year in in 2018.
[Hakim D. Humira's best-selling drug formula: Start at a high price. Go higher
https://www.nytimes.com/2018/01/06/business/humira-drug-prices.html
The New York Times, Jan 6, 2018]

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Stephen Barrett, M.D.
Consumer Advocate
287 Fearrington Post
Pittsboro, NC 27312

Telephone: (919) 533-6009

http://www.quackwatch.org (health fraud and quackery)
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