August 1
IN THIS ISSUE / AUGUST 1, 2018
- Physicians suing patients over negative reviews
- FDA to laser device manufacturers: Stop marketing for vaginal rejuvenation
- FDA releases biosimilars plan to increase access, encourage competition
- Blood test may be able to detect melanoma
- Health care cyberattacks on the rise, sensitive data exposed
- FDA grants orphan drug status to dermatomyositis drug
Physicians suing patients over negative reviews
Physicians typically have had little or no recourse to pursue misleading or false claims. However, some physicians are now filing lawsuits against patients who have posted false comments or reviews online, reports USA Today.
While the First Amendment protects patients’ rights to post their opinions, defamatory statements that harm the reputation of the physician may provide a legal course of action. Consumers need to know there can be consequences if they post factually incorrect information, said Ryan Lorenz, an attorney who has represented both consumers and businesses on cases involving online comments. Consumers can, however, offer opinions that do not address facts, he said.
Experts say doctors take on extra risk when they sue a patient. Eric Goldman, a professor at Santa Clara University’s law school, has tracked about two dozen cases of physicians suing patients over online reviews, and he found that physicians rarely win the cases and sometimes must pay the patients’ legal fees.
Learn more about how to respond to online defamation in Dermatology World.
Related Links:
- Avoiding the pitfalls of social media – Dermatology World (July 2017)
- Five-star practice, one-star reputation? – Dermatology World (October 2012)
- Practice management webinar: Likes, Reviews, and You: Social Media Marketing for Your Practice
- Academy product: Simulated Patient Encounter – Dealing with Difficult Patients
FDA to laser device manufacturers: Stop marketing for vaginal rejuvenation
The U.S. Food and Drug Administration (FDA) has issued warning letters to manufacturers of laser devices telling them to stop marketing laser devices for unapproved ‘vaginal rejuvenation’ procedures. Devices that use laser beams or radiofrequencies are approved for some gynecologic uses such as “destruction of precancerous cervical or vaginal tissue.” However, the FDA has not cleared the devices for issues related to menopause, urinary incontinence, or sexual function. FDA Commissioner Scott Gottlieb, MD, stated that, “In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.”
“We strongly encourage any of our members using these ‘energy-based’ devices to take notice of this warning,” says Suzanne Olbricht, MD, FAAD, President of the American Academy of Dermatology. “Our first duty to our patients is to provide safe, effective care and to discuss the benefits and risks of all available treatment options for vaginal symptoms with your patients.”
Find out what the top cosmetic procedures performed by dermatologists were in 2017 in Dermatology World.
Related Links:
- Body contouring carves out its niche – Dermatology World (June 2016)
- A new spin: Examining the theory behind the use of platelet rich plasma for dermatologic procedures - Dermatology World (May 2018)
FDA releases biosimilars plan to increase access, encourage competition
In recent remarks given at the Brookings Institute, FDA Commissioner Scott Gottlieb, MD, revealed the agency’s Biosimilars Action Plan, an 11-step proposal that encourages competition in the pharmaceutical industry by streamlining the biosimilar approval process. Dr. Gottlieb was critical of drugmakers who create expensive biologics and then use tactics to keep biosimilar medicines off the market. Having a safe, effective market for biologic and biosimilar products is critical for patients and the health care system, he said.
One of the plan’s proposals includes allowing biosimilar manufacturers to show that their products are nearly identical to the versions of biologics sold in Europe. “We’re looking at whether or not we can have data sharing agreements in place with the European regulatory authorities, and we can use that knowledge to allow biosimilar sponsors to use a European product as the reference product,” Dr. Gottlieb said. “That could help them purchase the product more cheaply.”
Biologics make up 40% of total spending on prescription drugs, Dr. Gottlieb said. While the FDA has approved 11 biosimilars so far in 2018, only three are available in the U.S. An FDA analysis of biosimilar competition showed that if all FDA-approved biosimilars were available in the U.S., Americans could have saved more than $4.5 billion in 2017.
Will biosimilars really reduce the cost of biologic therapies? Learn more in Dermatology World.
Related Links:
- Battling for biologics – Dermatology World (September 2015)
- Experts profile the future of biologic treatments – Dermatology World (September 2015)
- The promise and pitfall of biosimilars – Dermatology World (June 2013)
- AADA resource: Prior authorization assistance
Blood test may be able to detect melanoma
Australian researchers have developed an experimental blood test that they say is the first blood test capable of detecting melanoma in its early stages with a high degree of accuracy. Scientists at Edith Cowan University tested blood samples for 10 combinations of protein autoantibodies typically created by the immune system in response to melanoma. Results published in the journal Oncotarget show that the test was able to identify people with melanoma with 79% accuracy and people without melanoma with 84% accuracy. If further trials are successful, the test could be available internationally in up to five years, said Professor Mel Ziman, leader of the university’s Melanoma Research Group.
About 5% of melanoma cases have unconventional features. Learn more about what features are most helpful in diagnosing challenging melanoma cases in Dermatology World.
Related Links:
- Treating metastatic melanoma – Dermatology World (April 2018)
- AAD/A resource: Melanoma clinical guidelines
- For your patients: I’ve been diagnosed with melanoma! Now what?
- AAD product: Digital patient education subscription
Health care cyberattacks on the rise, sensitive data exposed
In recent months, physicians across the U.S. are seeing an increase in cybersecurity breaches, exposing sensitive data from hundreds of thousands of people, reports Bloomberg. The breaches include malware attacks, computer thefts, and unauthorized network access, among other breaches, according to a Department of Health and Human Services (HHS) database that tracks attacks in the health care sector.
In addition to detailed personal information like Social Security numbers, hackers could access a patient’s medical and treatment history, and/or could paralyze entire hospitals or other health systems. For physicians in academia, intellectual property and business data may also be vulnerable. Since May 2018, there have been more than 80 reports of data breaches in the U.S.
Is your practice protected from cyberattacks? Find out how to keep your practice safe in Dermatology World.
Related Links:
- How safe is your information – Dermatology World (December 2017)
- Get Smart: Digital devices in dermatology – Dermatology World (July 2017)
- Cybersecurity: Are you at risk of being hacked? – Dermatology World (April 2015)
- AAD product: A Guide to HIPAA and HITECH for Dermatology Manual
FDA grants orphan drug status to dermatomyositis drug
The FDA has granted orphan drug designation to lenabasum for the treatment of dermatomyositis, a rare inflammatory disorder marked by muscle weakness and a distinctive skin rash. Previously, standard of care treatments included antimalarial drugs and immunosuppressive agents. Lenabasum, on the other hand, is intended to “turn off” chronic inflammation and fibrotic processes by binding to the cannabinoid receptor type 2 (CB2) expressed on activated immune cells and fibroblasts.
An orphan drug is a drug that has been developed specifically to treat a rare medical condition or ‘orphan disease.’ In the U.S., it is easier to gain marketing approval for an orphan drug to encourage drug manufacturers to develop drugs that might otherwise lack financial motivation.
As researchers learn more about this disease, the inflammatory pathways are becoming clearer. Read more about the development of biologic treatments for the skin-predominant cases of dermatomyositis in Dermatology World.
Related Links:
