Saturday, May 31, 2014

Lasers May Repair Teeth...No More Fillings and Cavities and Root Canal!!

For the millions of Americans who suffer cavities each year, the ominous threat of a root canal may soon be a worry of the past.
Now, researchers from Harvard University claim they have discovered a novel way of regrowing parts of people’s teeth using an unlikely tool: Lasers.
In a new study published in the journal Science Translational Medicine, lead researcher Praveen Arany and colleagues detailed how they used focused laser light therapy on rats to stimulate the growth of lost dentin, the calcified tissue that comprises teeth.  They noted that if the therapy proves effective in humans, it could potentially eliminate the need for crowns, fillings and other complex dental operations in the future.

The procedure’s success all revolves around a native protein called transforming growth factor beta, or TGF-beta.  During preliminary tests of dentin tissues, the researchers discovered that this growth factor changed very drastically when introduced to a focused beam of light.  Further analysis revealed that when hit with light, TGF-beta actually stimulated the stem cells already present in dentin.
“Once [TGF-beta] is activated by the laser, it can bind to stem cells resident in the tissue, and then it induces those stem cells to differentiate so they can proliferate and reform dentin,” David Mooney, the Pinkas Family Professor of Bioengineering at Harvard University, told
Numerous studies have focused on ways to manipulate stem cells in order to spur tissue regeneration, but most of these techniques have revolved around reintroducing altered stem cells into the patient or directing stem cell populations externally through added growth factors.  With this form of laser therapy, the only external factor that is being introduced is light, which activates TGF-beta that’s already in the body.
According to Mooney, it’s not the laser’s heat that stimulates TGF-beta but the energy of its photons.  When light is focused on dentin, the photons get absorbed into the tissue and activate molecules called reactive oxygen species (ROS), which naturally occur in the body.  These ROS then stimulate TGF-beta, which spurs the chain reaction ultimately leading to dentin reformation.
However, Mooney noted that the power of the laser must be at a specific level of intensity and cannot produce any heat in order to be effective.
“It’s kind of like Goldilocks, too little won’t do enough and too much will become destructive,” Mooney said. “It has to be just right.”
To test their light therapy’s effectiveness, the researchers created a group of rats with tooth defects, by using a drill to remove pieces of their dentin.  They then shined a laser on their exposed tooth structures and soft tissues underneath it.  Sure enough, after 12 weeks, the team observed that new dentin had formed in the rats’ teeth.
Given their trial’s success, Arany and his team hope to test this type of dentin regeneration in human clinical trials, which could potentially alter modern dentistry.  Currently, if a patient has a chipped or decayed tooth, dentists will use synthetic materials to fix the problem or perform a root canal if the tooth has become too infected. Yet, Arany noted that laser therapy could erase the need for these uncomfortable dental procedures, simply by regrowing the part of the tooth that is missing.
He also noted that focused laser therapy could be used to grow more protective dentin in teeth that have grown sensitive due to gum recession.
“As we grow older our gums recede, exposing our teeth root,” Arany, assistant clinical investigator for the National Institutes of Health, told “The root is covered by cementum, which is not as protective as enamel, so you get dentin sensitivity….What we hope is in tooth sensitivity, [laser therapy] is able to generate an intrinsic protective barrier on the inside of the tooth.”
Expanding beyond the world of dentistry, the researchers note that TGF-beta is found in other bodily tissues, such as skin and bone, and that laser therapy could potentially help regrow tissues in those systems, as well.  Also, since TGF-beta is known to control tissue inflammation, the growth factor could perhaps be stimulated to control certain inflammatory diseases.
But for now, the team is focused on TGF-beta in relation to teeth, and they are hopeful that their laser therapy could be used in a clinical setting relatively soon.
“This laser is already a big part of the clinic, since so many of the clinicians use it for other purposes,” Arany said.  “So the barrier to clinical trial translation is relatively low.”
Paddy Deighan J.D. Ph.D

Psoriasis Now Recognized as a Serious Health Concern

At the 67th World Health Assembly, the World Health Organization (WHO) member states adopted a resolution on psoriasis, recognizing it as “a chronic, non-communicable, painful, disfiguring, and disabling disease for which there is no cure.” The resolution also acknowledges the psychosocial burden of the disease and that many people with psoriasis suffer due to lack of awareness and access to sufficient treatment.

Lars Ettarp, president of the International Federation of Psoriasis Associations (IFPA) comments:
“IFPA, together with its member associations and leading medical societies, has long called for the WHO and its member states to recognize the serious nature of psoriasis. Finally, the voices of the more than 125 million people who live with psoriasis have been heard, and on this historic day for the global psoriasis community we wish to express our great appreciation for all the stakeholders involved in bringing about this important resolution, especially all the WHO member states that have shown their support for our cause.”
Panama is one of the WHO member states that has actively supported the resolution and the campaign for recognition of psoriasis. HE Ambassador Alberto Navarro Brin of the Permanent Mission of Panama to the United Nations in Geneva, states:
“Together with Argentina, Ecuador and Qatar, Panama recognized the need for greater awareness of this disease which has such a major impact on the health-related quality of life for its sufferers, and initiated discussions with other WHO member states to gain their support. We are very pleased that this resolution has now been adopted and will continue to work with civil society to help build a better world for people with psoriasis.”
One of the stakeholders that have engaged with IFPA in advocacy for global recognition of psoriasis is the International League of Dermatological Societies, ILDS. Professor Wolfram Sterry, the President of ILDS, comments:
“As a dermatologist I have seen first-hand how deeply psoriasis affects people in their daily lives, as have the many members of our worldwide organization. Together with the psoriasis patient associations, we have been able to educate policy makers on the impact this disease has and what can be done to ease its burden. This resolution gives us a platform from which we can engage even further with policy makers to help improve access to the treatment and care that people with psoriasis need and deserve.”
Kathleen Gallant, Secretary of IFPA and Chair IFPA Task Force on NCDs, agrees that the resolution is an important platform from which to effect change:
"The adoption of the psoriasis resolution by the 67th World Health Assembly sends a powerful, global message that psoriasis is a serious immune-mediated, painful and disabling NCD that needs greater public awareness of its inflammatory nature, many physical and psychosocial impacts and shared risk factors with other, more deadly NCDs. This is a great opportunity for education and greater understanding, making a tremendous collective first step towards alleviating the devastating effects of this chronic inflammatory disease."

Paddy Deighan J.D. Ph.D

Sunday, May 25, 2014

A Contrarian View of Free Radical Theory

Past research has suggested that free radicals - occasionally harmful molecules produced by the body as it processes oxygen - contribute to the aging process. But new research from McGill University in Canada finds that free radicals may actually increase lifespan rather than shorten it.
Free radicals, also known as oxidants, are unstable and highly reactive atoms that have at least one unpaired electron. They can be formed naturally in the body or can be introduced into the body from external sources, such as smoking or pollution.

When free radicals interact with cells, proteins and DNA in the body, they can cause damage by modifying their chemical structure. Past research claims that constant cell exposure to harmful free radicals over time causes aging. But this latest study, published in the journal Cell, suggests otherwise.
The research team, including senior author Siegfried Hekimi of the Department of Biology at McGill, used a model organism - the roundworm Caenorhabditis elegans nematode - to reach their findings.

Findings 'turn theory of free radical aging on its head'

The researchers discovered that free radicals can stimulate apoptosis, also referred to as "programmed cell death" - the process by which damaged cells "commit suicide." They may do this to avoid becoming cancerous, for example, or to destroy viruses that have taken over the cell.
The team found that when free radicals stimulate apoptosis in a certain way, the cells' defenses are reinforced, meaning their lifespan is increased.
Explaining the team's findings further, Hekimi says:
People believe that free radicals are damaging and cause aging, but the so-called 'free radical theory of aging' is incorrect.
We have turned this theory on its head by proving that free radical production increases during aging because free radicals actually combat - not cause - aging. In fact, in our model organism we can elevate free radical generation and thus induce a substantially longer life."
Hekimi adds that demonstrating the molecular mechanism by which free radicals increases the lifespan of cells provides solid evidence that they have positive effects as signaling molecules.
Furthermore, he notes that the findings mean that apoptosis signaling may be used to trigger processes that decelerate aging.
"Since the mechanism of apoptosis has been extensively studied in people, because of its medical importance in immunity and in cancer, a lot of pharmacological tools already exist to manipulate apoptotic signaling," adds Hekimi. "But that doesn't mean it will be easy."
He says that such a process could be important in neurodegenerative diseases. He explains that apoptotic brain signaling may be focused on increasing the resistance of damaged cells rather than destroying them, since it is more difficult to replace dead neurons than other cell types as a result of the complexity in their connections.
Paddy Deighan, J.D. Ph.D

Saturday, May 24, 2014

Dermal Fillers and Potential Vision Loss?

Dermal injection of cosmetic fillers into the forehead can lead to irreversible blindness, according to a study published in the May issue of JAMA Ophthalmology.

Michelle V. Carle, M.D., from the Retina-Vitreous Associates Medical Group in Los Angeles, and colleagues describe irreversible vision loss from central retinal occlusion occurring after cosmetic facial enhancement.

The authors note that although cosmetic facial fillers are not approved for use in the forehead, they are frequently used off-label for enhancement in this region. No prior reports of blindness cause by filler injected into the forehead have been published. Three cases of central retinal artery occlusion due to fillers were reported shortly after cosmetic procedures, with the assumption that the filler enters the central retinal artery via the external-internal carotid anastomoses and becomes embedded in the retinal tissues. One patient had a small amount of recovery after aggressive therapy.

"Physicians performing cosmetic enhancement procedures involving facial fillers need to be aware of this potential complication and should include significant vision loss as a possible rare complication," the authors write.

As an attorney, I can tell you that this is potentially a huge issue.  There needs to be more dissemination of information about this and more studies as well. At the very least, aesthetic physicians need to amend the consent forms with patients. They need to include "loss of vision" provisions in the consent forms if the procedure is a dermal filler in the forehead region. Although the loss of vision is rare, it is still a serious complication and it must be addressed. 

Paddy Deighan J.D. Ph.D

Sun Screen You Can Drink?

It is possible that the first sun screen protection that can be drank like water has arrived!! Harmonised H20 UV provides users with up to 30 percent protection, helping sunbathers to soak up the rays for longer without fear of getting burned.  UK MailOnline reports this exciting development.
According to U.S. company Osmosis Skincare, the product's liquid molecules cancel out 97 percent of UVA and UVB rays after vibrating on the skin upon being ingested.

The price is $29 for a 100 ml bottle.  There are two varieties available - "tanning" and "non-tanning," the former allows users to achieve a tan while being protected from harmful sun rays.On its website, the medical skincare brand advises, "Take 2ml every 4 hours while in the sun (preferably with 2+ oz. of water)."  
"Wait 1 hour before exposure to the sun. Monitor sun exposure carefully. Take second dose if still in sun 3 hours after first dose."
"For extended intense exercise outdoors or if taking sun-sensitizing medications, use alternate protection after 30-40 minutes."
Dr. Ben Johnson, who founded the company, said in his blog, "If 2 mls are ingested an hour before sun exposure, the frequencies that have been imprinted on water will vibrate on your skin in such a way as to cancel approximately 97 percent of the UVA and UVB rays before they even hit your skin." 
"This results in coverage for approximately three hours," he said. "This is similar to the amount of UV reflection created by SPF 30 titanium/zinc sunblocks but distinctly better than UVB chemical sunscreens which prevent certain damage that leads to the visible/painful/inflammation reaction we identify as sun damage."
Although none of the dermatologist bodies have endorsed Harmonised H20 yet, testimonials for the product are listed on the company's website.
"I tested the UV Protection Harmonized Water (my skin burns in 15 minutes w/o sunscreen so i was nervous) SUCCESS!! I was outside for 2 hours with NO sunscreen during peak hours and wasn't even pink!" one, submitted via Facebook, said.
"My year and a half year old drinks it as well and hasn't burned once this summer and is outside everyday! Thank You, Thank You for this product!"

Paddy Deighan J.D. Ph.D

Tuesday, May 20, 2014

Allergan and SkinMedica Sued over Potential Claims

Consumers recently filed a  lawsuit against Allergan Inc. and its pharmaceutical company subsidiary, SkinMedica. The suit may become a class action. The plaintiffs' claim that the companies have misbranded and unlawfully marketed Tissue Nutrient Solution (TNS). TNS is a skin care product line that contains human growth factors (HGF) obtained from human foreskin tissue. The plaintiffs claim that such tissue could increase the risk of cancer and pose other health risks.
“A healthcare company’s primary obligation must be to deliver products that are properly tested for safety, and meet all the appropriate regulatory requirements”
The lawsuit was filed by a consumer rights law firm  in the U.S. District Court for the Central District of California. It claims that for at least the past four years, SkinMedica has failed to disclose significant safety concerns associated with TNS products while marketing the products without appropriate government approval, proper labeling, or adequate safety studies.
“A healthcare company’s primary obligation must be to deliver products that are properly tested for safety, and meet all the appropriate regulatory requirements,” said Steve Berman, attorney for the plaintiffs. “In this case, we intend to show that SkinMedica and Allergan skirted laws that required them to disclose the significant safety concerns at issue and the lack of regulatory approval.”
“We believe that in SkinMedica’s zeal to market its skin care products, it created a serious health risk for those who used TNS products,” Berman added.

According to the firm’s investigation, SkinMedica’s TNS products, which have been sold nationally through doctors’ offices and retailers, contain a proprietary mix of “human growth factors” derived from human foreskin tissue. Human growth factors are intended to mobilize, stimulate, or otherwise alter the production of cells, including the ability to initiate cell division, which could stimulate growth of cancerous tumor cells, according to the complaint.
The suit alleges that in marketing their TNS products, Allergan and its subsidiary SkinMedica did not adequately disclose the health risks associated with these growth factors.
SkinMedica’s TNS products – which the company calls “cosmeceuticals” – did not have government approval and could not be sold lawfully in the U.S. without such approval, something else the company did not disclose to consumers, according to the complaint. The suit alleges that because neither the U.S. Food and Drug Administration nor the California Department of Public Health found TNS products to be safe for their intended use, and because TNS products omit required disclosures relating to safety concerns, the products have been misbranded under both federal laws and parallel state laws.
The lawsuit is a proposed class action based upon California’s consumer protection laws, and seeks to represent a class of all persons in the U.S. who purchased SkinMedica’s TNS products during the last four years.
Paddy Deighan J.D. Ph.D

Saturday, May 17, 2014

Aesthetic Laser Treatments on the Rise!!

The use of aesthetics laser and energy-based devices among dermatologists increased 34% in 2013. This information is courtesy of a  a new survey from the American Society of Dermatologic Surgery (ASDS).
When the ASDS surveyed its members, it found that 2.25 million laser, light and energy-based treatments were performed in 2013, compared to 1.68 million in 2012. This is an astounding increase!!!
“Not only have treatments become much more effective, but they also have become safer, so patients typically are experiencing less downtime,” said ASDS President-elect George Hruza, MD.
Treatments for facial redness, including rosacea-related erythema, topped the list at 454,000 procedures in 2013. Several other procedures saw increases of more than 50%, according to the survey:
  • Birthmark removal (up nearly 90%)
  • Laser facial resurfacing to erase fine lines and wrinkles, smooth and tighten eyelid skin, improve crow’s feet around the eyes and improve skin tone and texture (up 85%)
  • Surgical and traumatic-injury scar treatment and removal (up 79%)
  • Tissue tightening (up 75%)
  • Tattoo removal (up 52%)

Dr. Hruza attributes these increases to advancements in the field that make treatments safer and more effective; a growing awareness of these technologies; and a recovering economy. “Patients may have been waiting to see a dermatologist about that facial redness or removing unwanted hair,” he said. “Now many are more informed, plus they have more economic freedom to act on their desire to improve their appearance.”
Paddy Deighan J.D. Ph.D

Friday, May 16, 2014

Medical Compounding Laws Have Changed!!!

Have you noticed that many compounding pharmacies have changed their business model? Perhaps they even stopped producing a product for you. Many physician practices and medical spas have suddenly discovered that they can no longer obtain compounded products for their facilities. Many are scrambling to find a new supplier.  Many compounding pharmacies have closed and others have had to discover new ways to manufacture a product.  

There are a lot of problems associated with the changes in compounding laws. To make matters worse, the changes were sudden. Many believe that the law was enacted as a result of a meningitis epidemic in November of 2013. 

The Compounding Quality Act 

President Obama signed the Drug Quality and Security Act at the end of 2013. The Compounding Quality Act which first removes certain provisions from section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) that were found to be an unconstitutional restraint of commercial free speech by the U.S. Supreme Court in Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002).

Subsequent lower court decisions were split over whether 503A was unconstitutional in its entirety or only in part. The Compounding Quality Act clarifies this issue by eliminating the controversial advertising prohibition.

Section 503A otherwise remains unchanged, and continues to set out the requirements for 
traditional compounding created in the FDCA – the pharmacist must compound the drug for 
individual patients based on a prescription (or a prescription history of an individual or order 
history of a physician). One of the FDA guidance documents addresses traditional compounding 
and is clear that traditional compounding will generally remain under state pharmacy board 
oversight as long as the compounding facility meets the requirements of 503A. A pharmacy that 
compounds in compliance with the 503A requirements is exempt from federal good 
manufacturing practice (cGMP) requirements, adequate directions for use, and new drug 
approval requirements. 

Secondly, the Compounding Quality Act adds a new section 503B to the FDC 
Act, 21 U.S.C. § 353b, to create a new regulatory classification of compounding facilities called 
“outsourcing facilities,” which are to be overseen by FDA instead of state pharmacy boards. 
Unlike traditional compounding pharmacies, outsourcing facilities can compound medications 
without a patient-specific prescription and sell such products to hospitals and other health care 
providers. While an outsourcing facility is exempt from FDA approval requirements and 
adequate directions for use, it is subject to cGMP requirements and will be inspected by the FDA 
according to a risk-based schedule.

Paddy Deighan J.D. Ph.D

Friday, May 9, 2014

Lasers Aid in the Delivery of Medication

There is yet another use for laser. Laser has revolutionized medicine and the additional apllications of light based devices seems limitless. Laser-assisted drug delivery can enhance the permeation of topically applied agents, according to a review published in the April issue of Lasers in Surgery and Medicine. This has the potential to be an astounding turn f events. 

Lindsay R. Sklar, M.D., from the Henry Ford Hospital in Detroit, and colleagues conducted a literature review to assess the existing applications of laser-assisted drug delivery.

The researchers found that lasers are a safe and effective means of enhancing the delivery of topically applied agents through the skin. The most commonly used lasers for drug delivery are the carbon dioxide and erbium:yttrium-aluminum-garnet lasers. Laser pretreatment of the skin can increase the permeability and depth of penetration of topically applied drug molecules for both local cutaneous and systemic applications, according to multiple studies.

"Laser-assisted drug delivery is an evolving technology with potentially broad clinical applications," the authors write.One author disclosed financial ties to the laser industry.

Paddy Deighan J.D. Ph.D