Consumer Health Digest #17-44
Your Weekly Update of News and Reviews
November 26, 2017
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. 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.
FDA raids stores that help consumers save money on prescription drugs. In November, the FDA sent criminal investigation agents with search warrants into nine storefronts across Central Florida that help customers order drugs from pharmacies in Canada and overseas at big discounts. [Galewitz P. FDA raids Florida stores that consumers use to buy drugs from Canada. Kaiser Health News, Nov 20, 2017] The agents notified the store owners that importing drugs from foreign countries is illegal and that those helping to "administer" such medicines could face fines or jail time. The Florida stores do not dispense any drugs but merely help consumers place online orders to legitimate Canadian pharmacies that have been certified by the nonprofit company pharmacychecker.com or the Canadian International Pharmacy Association. The stores exist because many drug companies charge much higher prices in the U.S. than in other countries for the same medication. Some of the stores have been doing business for nearly 15 years. Although Americans can buy most types of products from abroad, our government has declared it illegal under most circumstances to buy medicines this way, claiming that is unsafe. It can be unsafe, because there are rogue online pharmacies whose products are counterfeit, but PharmacyChecker.com makes safe online pharmacies easy to find. [Barrett S. Pathways to lower drug prices. ACSH Web site, May 25, 2017] None of the raided stores has closed, but their owners fear that the Trump administration may have reversed a long-standing FDA "non-enforcement" policy. Prescription Justice, which advocates for legislative and regulatory reforms to help Americans who are struggling to afford prescription medication, offers a free weekly e-mail report on news related to this issue. Dr. Stephen Barrett is a board member of the group.
"Open source" journal publisher ordered to stop deceptive practices. A federal court has issued a preliminary injunction requested by the Federal Trade Commission, temporarily halting practices of academic journals that the FTC had charged with wrongdoing. The injunction against OMICS Group Inc., iMedPub LLC, Conference Series LLC, and their CEO, director, and owner, Srinubabu Gedela stems from a complaint the FTC filed last year. The defendants' Web sites promote hundreds of online academic journals and international conferences for medical professionals and other scientists. According to the FTC's complaint:
- The defendants deceptively claim that their journals provide authors with rigorous peer review and have editorial boards made up of prominent academics when in fact, many articles are published with little to no peer review and many individuals represented to be editors have not agreed to be affiliated with the journals.
- The defendants do not tell authors submitting papers for publication that, after their online journals accept an article, the defendants charge the authors significant publishing fees and often do not allow authors to withdraw their articles from submission, making their research ineligible for publication in other journals.
- To promote their scientific conferences, the defendants have used the names of prominent researchers as conference presenters, when in fact many of those researchers had not agreed to participate in the events.
The preliminary injunction requires defendants to clearly and conspicuously disclose all costs associated with submitting or publishing articles in their journals and prohibits defendants from falsely representing (a) that specific persons are editors of their journals or have agreed to participate in their conferences, (b) that their journals engage in peer review, (c) that their journals are included in any academic journal indexing service, and (d) any measurement of the extent to which their journals are cited.
FDA warns against unapproved silicone injections. The FDA is concerned about the use of unapproved silicone fillers for body contouring. [The FDA warns against injectable silicone for body contouring and enhancement. FDA Consumer Update, Nov 14, 2017] Its advisory states:
- The FDA is aware of cases in which unqualified providers—some posing as doctors or licensed healthcare practitioners—have injected illegal or unapproved body fillers like silicone or oils into patients.
- Silicone is a liquid substance. Injectable silicone is permanent and stays in your body.
- Injectable silicone is different from silicone oil used in small amounts in the eyes or the silicone used in FDA-approved breast implants, which have a shell that keeps silicone from moving throughout the body.
- When injected into areas with many blood vessels such as the buttocks, silicone can travel through those vessels to other parts of the body and block blood vessels in the lungs, heart, or brain. This can cause a stroke or even death.
- Large-scale injectable silicone for body contouring and enhancement can also result in a painful and hard, gravel-like substance that stays permanently beneath the skin.
- Side effects can occur even years after treatment. Multiple medical and surgical interventions are sometimes needed to treat symptoms years after initial injection. Even then, patients may continue to have serious side effects that require ongoing treatment.
- Some consumers who were told that they were receiving an FDA-approved dermal filler were actually injected with silicone or another unapproved product for body contouring.
- The FDA is also aware of counterfeit versions of dermal fillers that have not been FDA reviewed or approved for any purpose.
Canadian advisory group warns against neck manipulation. Manitoba's Health Professions Advisory Council has issued a report that expresses concern about "high neck manipulation," most of which is done by chiropractors. [A Report to the Minister of Health, Seniors and Active Living on the Review of "High Neck Manipulation"' under The Regulated Health Professions Act. Manitoba Health Professions Advisory Council, March 2017] The report contains little that is new but reviews Canadian laws and indicates that more should be done to warn prospective patients. It concludes:
On the whole, the material provided to the Council does not generate sufficiently definitive or conclusive evidence which would lead to a prohibition of the performance by regulated health professionals of "high neck manipulation" as part of the larger Reserved Act. The evidence does indicate, however, that the performance of "high neck manipulation" or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.
Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:
Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.
This page was posted on November 26, 2017.