Through the Looking Glass at FDA

What is the vision at the Food and Drug Administration?

I take a look at the contradictory world of the FDA  – especially as it relates to the ophthalmology industry -in a piece for MillennialEye.

Progress:”Through the political maelstrom and bureaucratic twists and turns, there is progress, according to Carl Tubbs, MD, an ophthalmologist with InSight Vision Group in Denver, a member of the American Glaucoma Society and president of the American National Standards Institute.

“We have seen a willingness from the FDA to move standard development forward in a more direct path,” he says. “The process has included the presence of more consistently involved FDA members in the standards process so that our team is more familiar with ongoing issues and we do not need to readdress them, and what I perceive is better inter-departmental communication within the FDA itself.”


The FDA is moving along with the approval process, but it is still understaffed and occasionally stumbles in bureautic obstacles.

“The (FDA)  is a vision of two worlds: the focus of major regulatory reform that aims to hasten the approval process for high-quality drugs and devices, but also a federal agency significantly understaffed and bogged down in bureaucratic uncertainty,” the article states

It adds: “The FDA has taken steps in recent years to improve its review and evaluation of drugs and devices, recently becoming more efficient, for instance, than the European Medicines Agency (EMA), its counterpart agency in Europe. FDA officials also say they are now working closer than ever with private industry to develop product innovations and move products quicker to market”.  — Joe Cantlupe

For Skin Cancer Patients, A Needed Online Meeting Place

Skin cancer isn’t talked about much until something seems to go wrong, like someone asking: what is that mole that I didn’t see before? And we’ve moved from a sun worshipping society to a more skeptical and smart sun worshipping society, like thinking it is silly and dangerous putting aluminum foil on a board near your face to reflect the sun (yeah, people once did that), or running outside and hitting those tennis balls on the spur of the moment without thinking twice about sunscreen.

Some Baby Boomers, for instance, may not have thought about sun damage in their youth before reams of scientific information showed how bad it could be.

Years ago, “most people worshipping in the sun, who were tanning all the time (as kids) until adulthood never thought about the long term diagnosis,” says Marcia Kavulich, director of Health Union Community Development. “The diagnosis usually came as a shock.” Health Union is an organization that has developed online communities for patients with various illnesses, with skin cancer a new focus.

As many people head to the beaches these summer, there are some important considerations and data shock: “skin cancer is the most commonly diagnosed cancer in the U.S., and most cases are preventable,” says the Centers for Disease Control and Prevention.

Nearly 5 million people are treated for “all skin cancers combined, with an annual cost estimated at $8.1 billion,” the CDC says. About 9,000 people die annually from melanoma.

The CDC adds: “The number of Americans who have had skin cancer at some point in the last three decades is estimated to be higher than the number for all other cancers combined, and skin cancer incidents have continued to increase in recent years.”

Yet, we as a society don’t really give it much notice…until…

And patients who have skin cancer, too often feel they don’t have the resources to help them navigate their needs, about the scientific ins-and-outs of sun and care, as well as something else: their worries, says Anna McClafferty, SVP Health Union Insights.

That’s where Health Union’s newest online community,, has been extraordinarily effective in steering the conversation for skin cancer patients, its officials say.

“Many people tend to not give much thought to skin cancer, until they or someone they know are diagnosed with it,” said Judy Cloud, a patient advocate for Cloud has received treatment for skin cancer. “Unfortunately, there typically hasn’t been as much information readily available about skin cancer as other types of cancers, nor are support groups prevalent,” she said in a statement.

In a recent survey of 900 patients, Health Union found that many patients who have or had skin cancer are extremely worried about their cancer reoccurring, and they become “hyper vigilant,” ever looking for changes in their skin. Whatever they find increases their stress levels, says McClafferty.

Although skin cancer may return, many patients have a great chance for recovery and are receiving much support from family and friends, Yet the stress seems ever present: one out of three skin cancer patients – 33 percent — report their condition negatively affects their mood and emotions, according to Health Union

While it’s important that people take care of their skin, it’s equally important they do not become overstressed, which can lead to other ailments, says McClafferty. “Compared to other cancers, skin cancer is very treatable,” she adds. That’s one of the great things about the new online community, to help with patients who can reach out for support among advocates, other patients and experts in the field. Patients can ask questions about different types of skin cancer, treatments and prognosis. “They can have a greater understanding of their condition, chances for reoccurrence, and about wearing protective sunscreen,” McClafferty says.

“The results of this survey give us a better idea of the journey for people living with skin cancer, says Tm Armand, president and co-founder of Health Union in a statement. “People come to because they are the uncertainty of their future and are looking for support and reassurance. We are excited to be able to provide this much needed resource.”

Skin cancer can be detected early if people see “signs such as reddish patches of skin, or changes in moles that include looking for variations that involve asymmetry, border, color, diameter, and edges—called the ABCDEs,” according to Health Union. Basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) are the most common types of skin cancer. More than half of BCC and SCC survey respondents had reddish patches of skin, and more than two-thirds of melanoma patients had a mole meeting the ABCDEs of skin cancer, the organization says.

According to Health Union’s survey respondents, 57 percent had BCC, 46 percent had melanoma, 44 percent had SCC and 10 percent had another type of skin cancer.

Cloud, the patient advocate, said she was thrilled about

“It’s a place people go for information and support and also be able to share their experience. No one should fight this alone and with no one has to,” Cloud says.

In 2014, there was a Surgeon General’s Call to Action to prevent skin cancer, calling on “partners in prevention from various sectors across the nation to address skin cancer as a major public health problem.”

A team approach – what is all about – is the kind of thing the nation’s top doctor wants. — Joe Cantlupe