The Laker/Lutz News

Food and Drug Administration

Activity increasing, as COVID-19 restrictions relax

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Gov. Ron DeSantis has signed an executive order lifting all local COVID-19 restrictions and mandates on individuals and businesses.

As a result, Hillsborough County, Pasco County and the city of Tampa have dropped their mask requirements.

The order, however, does not apply to school districts — and both Pasco County Schools and Hillsborough County Schools will keep their mask orders and other safety protocols in place until the end of the school year.

Private businesses are not subject to the governor’s order, either, meaning they can keep their COVID-19 restrictions — and at this point, many continue to require masks, limit indoor seating and follow other safety measures.

Increased traffic on area roads and more cars in retail and restaurant parking lots, however, provide clear indications that more people are getting out and about.

Air travel is up — way up.

The Transportation Security Administration reported there were 1.7 million travelers at its checkpoints on May 9, compared to 200,815 on the same day last year. However, the number of air travelers is still substantially lower than it was in 2019, when there were 2.4 million air passengers on the same day.

Many travelers — now fully vaccinated — were flying to see family for the first time since the pandemic began. Televised news reports captured emotional reunions of moms and their kids, on Mother’s Day, all over the country.

Travel experts also are advising those wishing to take summer vacations to plan early to ensure accommodations and rental cars are available.

In another sign that things are changing, more graduation ceremonies are being held live — not virtually — this year.

In addition to some area college graduation celebrations, Pasco public schools will hold in-person events again this year, scaled back as they were last year. Hillsborough public school students also will be celebrating at live events, as well.

The Diocese of Saint Petersburg also has announced that the general obligation to attend Sunday Mass will resume on May 22.

Bishop Gregory Parkes, who leads the diocese, had granted a dispensation from the obligation as a precaution against the spread of COVID-19.

Although Catholic churches have been holding services, with mask requirements and social distancing protocols in place, many parishioners opted instead to watch services remotely.

Health experts continue to caution the public to be careful because at the same time COVID-19 restrictions are being relaxed or lifted, the demand for vaccinations has been dropping.

According to the Centers for Disease Control and Prevention, as of May 9, 152 million individuals had received at least one dose of vaccine, including 83.6% of those age 65 and older. Of those in that age group, 71.3% were fully vaccinated.

If you are fully vaccinated, the CDC says you can start doing many things that you had stopped doing because of the pandemic.

When choosing safer activities, consider how COVID-19 is spreading in your community, the number of people participating in the activity, and the location.

Keep in mind that outdoor visits and activities are safer than indoor activities, and fully vaccinated people can participate in some indoor events safely, without much risk.

The CDC also notes: “While more than eight in 10 people 65 years and older have received at least one dose of vaccine, only around 1 in 3 people ages 18 to 29 have. All age groups currently eligible for the vaccine can benefit from the protection it provides themselves and others, especially as more states are easing prevention measures.”

As the pace of vaccination slows, vaccination persuasion campaigns are on the rise.

Celebrities, politicians and faith leaders are among those urging others to get vaccinated. Some efforts, as reported nationally, involve people making door-to-door visits to encourage people to get a single shot of Johnson & Johnson, or two shots of the Moderna or Pfizer vaccines.

Sites run by Hillsborough County dispense only the Pfizer vaccine, which can be given to individuals 16 years of age and older. Those ages 16 and 17 must be accompanied by a parent or legal guardian, a county news release says.

Efforts by Pfizer could lower the eligible age for its vaccine to 12, if the Food and Drug Administration approves its request for authorization — which could occur as early as this week, according to national reports.

Those seeking vaccinations should know there is no out-of-pocket cost to be vaccinated and no prescription or doctor’s note is required, a Hillsborough County news release says.

With demand continuing to decline at the large public COVID-19 vaccination sites, Hillsborough County Emergency Management is reassessing distribution strategies and developing other options for residents to get vaccinated. Companies, community organizations, and faith-based organizations interested in an on-site targeted vaccine event are encouraged to call 888-513-6321, or email .

Published May 12, 2021

Watch out for COVID-19 scams

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The Federal Trade Commission (FTC) has posted information on its website about how to avoid scams during the COVID-19 pandemic. The FTC offers this advice to consumers:

  • Don’t respond to texts, emails or calls about checks from the government. Read more at consumer.ftc.gov/blog/2020/04.
  • Be wary of ads for test kits. Most test kits being advertised have not been approved by the FDA (Food and Drug Administration), and aren’t necessarily accurate.
  • Hang up on robocalls. Scammers are using illegal robocalls to pitch everything from low-priced health insurance to work-at-home schemes.
  • Watch for emails claiming to be from the CDC (Centers for Disease Control and Prevention) or WHO (World Health Organization). Use sites such as Coronavirus.gov and USA.gov/coronavirus to get the latest information. Do not click on links from sources you don’t know.
  • Do your homework when it comes to donations. Never donate in cash, by gift card, or by wiring money.

To download a complete guide or watch videos on how to avoid scams, to read about how COVID-19 impacts finances, or to view consumer complaint data, visit FTC.gov/coronavirus.

Published June 24, 2020

Bilirakis talks health care reform

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Health care reform was the main topic during U.S. Rep. Gus Bilirakis’s visit to Zephyrhills last week.

Bilirakis, who represents Florida’s 12th congressional district, was the featured speaker during The Greater Zephyrhills Chamber of Commerce monthly meeting on Aug. 3.

He said he was “very disappointed” when the Republican party’s reform and repeal of the Affordable Care Act (ACA) stalled in the Senate.

U.S. Rep. Gus Bilirakis gives members of The Greater Zephyrhills Chamber of Commerce his take on what’s happening in Washington D.C., regarding health care reform. (Kevin Weiss)

The so-called skinny repeal bill, which the GOP titled the Health Care Freedom Act, would have eliminated the ACA’s individual mandate; delayed the employer mandate until 2025; allowed states greater flexibility in implementing market reforms, such as essential health benefits and out-of-pocket spending limits; and increased Health Savings Account limits for three years, among other changes.

However, according to the Congressional Budget Office, the skinny repeal bill would have increased the number of uninsured by 16 million over the next nine years and increased health care exchange premiums by more than 20 percent.

The measure sank on July 27, in a 49-51 Senate vote, with three Republican senators — Susan Collins of Maine, Lisa Murkowski of Alaska and John McCain of Arizona — joining the entire Democratic caucus against the bill.

The action, Bilirakis said, displayed his party’s inability to stick together.

“To be honest with you, you can’t keep voting ‘no.’ Maybe you’re a hero at home, but you’ve got to work with the leadership to get things done,” he said.

Bilirakis acknowledged he “didn’t agree with everything” in the bill, but noted it was a good starting point to replace Obamacare.

“Obamacare is failing,” Bilirakis said to a roomful of constituents. “Seventy-three percent of the counties in our state only have one provider…so we have to fix it, we have to do something different, we have to bring the (deductibles) down.

“Now, don’t get me wrong, we want to take care of the pre-existing conditions. I want to make sure that everyone has access to mental health treatment, if their family member needs it or if they need it. These are very important issues to me, they’re close to my heart,” he added.

Bilirakis said he wanted to see the skinny bill pass, mainly so it could be improved in a House-Senate conference committee.

“We don’t do that very often anymore,” he said, “where we go to conference, appoint Republicans and Democrats in a room, and make it work.”

Meanwhile, Bilirakis assigned blame to both parties for not crafting a viable bipartisan solution on health care.

“We’ve got to think of the country first, and work together. That’s what voters mostly want,” Bilirakis said.

“With health care, it shouldn’t be a political issue. It’s a personal issue, and both parties should be involved in getting this done, because both parties have good ideas,” he later added.

He also criticized President Donald Trump for his shifting stance on health care. Regarding Obamacare, the president has waffled on the following actions:

  • Repeal and replace
  • Repeal only, then replace
  • Let it “fail.”

“Listen, I am a Trump supporter, but he’s got to be consistent in what his plan is,” Bilirakis said. “These members (of the Senate) are not going to buy it, just saying we’ve got to pass a bill. It’s got to be a good bill.”

Bilirakis, though, did credit the president for reducing regulations on U.S. businesses, as well as the soaring stock market— the Dow Jones industrial average passed the 22,000 mark for the first time on Aug. 3.

“The economy’s much better. We are making a difference, but we can do better,” Bilirakis said.

Elsewhere, the congressman discussed some of his recently introduced bills, such as The Lower Costs Through Competition Act and The Open Act, both related to health care.

The Lower Costs Through Competition Act, co-sponsored by Democratic Rep. Kurt Schrader of Oregon, seeks to reduce prescription drug prices by speeding up Food and Drug Administration (FDA) approval of high-cost generic products, which lack competition.

Bilirakis pointed to last year’s EpiPen controversy, where Mylan, the makers of the life saving, anti-allergic reaction device, increased its product price by nearly 400 percent, to $700 for a twin-pack.

“The EpiPen situation — that was horrible,” he said. “There’s a couple of other drugs like that, and you have these monopolies out there that are taking advantage, and so we want to make we speed up the FDA process, the approval process and incentivize these companies to reduce the prices.”

The bill, introduced in January, has since been referred to the House Subcommittee on Health.

“It’s a no-brainer, but in (Washington) D.C., sometimes the no-brainers won’t pass, so you’ve got to keep pushing,” said Bilirakis.

Meanwhile, Bilirakis’ Orphan Products Extension Now (OPEN) Act — which also has been referred to the House Subcommittee on Health — would provide incentives for drug makers to repurpose mainstream treatments, at mainstream prices.

According to Bilirakis, there are 7,000 rare diseases affecting 30 million Americans, and yet 95 percent of those conditions have no approved treatment or cure.

The bill, as it stands, amends the Federal Food, Drug and Cosmetic Act to require the Department of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the FDA when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an orphan disease).

A common issue, Bilirakis explained, is those afflicted with rare diseases resort to off-label drugs for treatment. “We’ve got to find cures and treatments. We want to make sure it’s safe, we want to make sure we have a proper dosage,” he said.

Published August 9, 2017

Health care reforms pass House, onto Senate next

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The House of Representatives has passed legislation that could pave the way for more treatment options for people who are ill, and the bill’s bipartisan support bodes well for its passage in the Senate, said Congressman Gus Bilirakis, who has taken a leadership role on this issue.

The 21st Century Cures Act passed the House by a vote of 344-77 on July 10.

Ashleigh Pike, left, looks on as her mother, Beth Pike, describes the impacts that Ashleigh’s illness has had on the young woman’s life. (File Photo)
Ashleigh Pike, left, looks on as her mother, Beth Pike, describes the impacts that Ashleigh’s illness has had on the young woman’s life.
(File Photos)

“Now, we’re waiting on the Senate to pass a bill,” Bilirakis said, and he’s confident that will happen, perhaps by the end of the year.

Passage can’t come soon enough, Bilirakis said, noting the legislation offers hope to people who are desperate for new treatment options.

The Senate’s version of the bill will likely have fewer provisions, Bilirakis said.

To help protect provisions he believes are important, Bilirakis has sponsored stand-alone bills, as well.

One of the stand-alone bills he has introduced is called the Orphan Product Extensions Now Accelerating Cures & Treatments Act (OPEN ACT). That calls for giving drug makers and innovators incentives to “repurpose” major market drugs for life-threatening rare diseases and pediatric cancers.

The aim is to open the door to the development of hundreds of safe, effective and affordable treatments for rare disease patients, Bilirakis said.

Sen. Orrin Hatch, of Utah, has co-sponsored that bill in the Senate.

Bilirakis said he doesn’t care whether these provisions are adopted in the overall legislation or his stand-alone bill. He just wants action on these issues.

A panel of health care providers discusses ways to improve health care delivery to patients. Reducing bureaucracy, increasing funding and encouraging innovation are some of their suggestions.
A panel of health care providers discusses ways to improve health care delivery to patients. Reducing bureaucracy, increasing funding and encouraging innovation are some of their suggestions.

While legislators were drafting the 21st Century Cures Act, roundtables were held around the country to give stakeholders a chance to discuss issues being faced by patients and providers.

Bilirakis convened roundtables in Lutz, Land O’ Lakes and Carrollwood, where he listened to hours of testimony from patients, patient advocates, doctors, researchers, makers of medical devices and other stakeholders.

The settings for the sessions were comfortable meeting rooms, but the testimony delivered dealt with issues of life and death, and was often poignant and dramatic.

At a session in Lutz, patients told Bilirakis about difficulties in getting a proper diagnosis and finding effective treatments.

Ashleigh Pike was one of those patients.

Before she became ill, she was a vibrant young woman who delighted in teaching elementary school children. Now, she lives life from a wheelchair and requires full-time care.

“On the outside, I look fine,” the former teacher told Bilirakis. But, she added: “My quality of life has been greatly compromised.”

Pike suffers from a form of dysautonomia, a malfunction of the autonomic nervous system. That system controls automatic functions of the body, such as heart rate, blood pressure, digestion, kidney function, temperature control, and dilation and constriction of the pupils, according to Dysautonomia International’s website.

At another session, health care providers told Bilirakis about a variety of roadblocks that frustrate their work.

Dr. David Morgan, the chief executive of the University of South Florida’s Byrd Alzheimer’s Institute, told Bilirakis the diagnosis of Alzheimer’s patients must improve. About one in five people diagnosed with Alzheimer’s do not have the disease, Morgan said.

The disease can be accurately diagnosed with PET — positron emission tomography — scans, but those are expensive and generally not covered by insurance, Morgan said.

Proper diagnosis is important not only for treatment of patients, but also to ensure that clinical trial results are not skewed by including patients in the trials who do not have the disease.

Reforms also are needed in the way clinical trials are conducted, Morgan said, noting the current approach takes too long and costs too much.

At that same session, Dr. Richard Finkel, chief neurologist at Nemours Children’s Hospital of Orlando, told Bilirakis that the focus must be greater on patient-centered cures.

“Patients are willing to accept different levels of risk. But the FDA (Food and Drug Administration) doesn’t look at it that way,” he said. “They are very risk averse.”

Medical device makers face other obstacles, Lisa Novorska, chief financial officer for Rochester Electro Medical Inc., told Bilirakis.

Her company can know how to improve a device, but can’t pursue those improvements because of the costs to comply with FDA requirements. The FDA plays a valuable role in protecting the public, but it also creates paperwork nightmares for small businesses, she said.

Bilirakis said The 21st Century Cures Act addresses many concerns raised during the roundtable sessions, and provides an $8.5 billion increase for the National Institutes for Health.

Published July 29, 2015

Health care providers offer prescription for better services

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There’s no easy fix for the challenges facing today’s health care system. But there are some steps that can improve its overall performance, panelists said at a roundtable discussion hosted by U.S. Rep. Gus Bilirakis.

Bilirakis hosted two 21st Century Cures roundtables at The Bethany Center in Lutz last week. One focused on health care from a patient’s perspective. The other took a look at the issue from a provider’s point of view.

A panel of health care providers discusses ways to improve health care delivery to patients. Reducing bureaucracy, increasing funding and encouraging innovation are some of their suggestions. (B.C. Manion/Staff Photo)
A panel of health care providers discusses ways to improve health care delivery to patients. Reducing bureaucracy, increasing funding and encouraging innovation are some of their suggestions.
(B.C. Manion/Staff Photo)

At the Aug. 22 session, “Spurring Innovation, Advancing Treatments, and Incentivizing Investment,” Bilirakis asked panelists to talk about regulatory roadblocks and other issues that hinder patient care.

The providers had plenty of suggestions for Bilirakis and his congressional colleagues to consider as they set policy in Washington, D.C.

Dr. David Morgan, the chief executive of the University of South Florida’s Byrd Alzheimer’s Institute, told Bilirakis the diagnosis of Alzheimer’s patients must improve. About one in five people diagnosed with Alzheimer’s do not have the disease, Morgan said.

The disease can be accurately diagnosed with PET — positron emission tomography — scans, but those are expensive and generally not covered by insurance, Morgan said. Proper diagnosis is important not only for treatment of patients, but also to ensure that clinical trial results are not skewed by including patients in the trials who do not have the disease.

Morgan also sees reform needed in the way clinical trials are conducted. The current approach takes too long and costs too much, he said.

Other health care providers agreed that changes are needed regarding clinical trials. They also called for changing the Food and Drug Administration’s regulatory practices.

Dr. Clifton Gooch, of USF’s Morsani College of Medicine, said the FDA needs to focus on simplicity, transparency and consistency. Standards for clinical trials must become more flexible. The current approach looks for a particular outcome with a specific group of people, but it fails to consider how the drug benefits a sub-population.

As the nation moves toward more personalized medicine, “we need to approach nontraditional trials,” agreed Dr. Thomas Sellers, the center director and executive vice president for the H. Lee Moffitt Cancer Center & Research Institute.

“We really need to bring the right drug to the right patient at the right time,” Sellers said.

Dr. Richard Finkel, chief neurologist at Nemours Children’s Hospital of Orlando, said the focus must be greater on patient-centered cures.

“Patients are willing to accept different levels of risk. But the FDA doesn’t look at it that way,” he said. “They are very risk averse.”

A patient with a short life expectancy, for instance, may be willing to accept a much higher risk than someone who has a slow-developing disease, Finkel said.

There are various roadblocks in the research arena, panelists said.

“Funding is dismal,” Sellers said. Not only is that hurting research on specific treatments, it’s also hurting the entire research arena.

“A lot of people are getting out of the (research) game,” Sellers said, which he characterized as a “major casualty.”

Even when there is money, the grant process takes too long, panelists said. Those selecting grant winners also need to broaden their thinking, Sellers said.

“They’re not selecting for innovation. They’re not selecting for bold ideas,” Sellers said.  “Somebody has to be pushing the envelope.”

Finding money to pay for pilot trials is difficult, too.

“The trouble with pilot trials is that nobody wants to pay for them,” Gooch said.

There’s also a need to reform the regulatory process used by the FDA, panelists said. Improvements are needed not only in speeding the time it takes to get a new drug to market, but also in regulatory processes involving the development of new medical devices.

Lisa Novorska, chief financial officer for Rochester Electro Medical Inc., said her company can know how to improve a device, but can’t pursue those improvements because of the costs to comply with FDA requirements. The FDA plays a valuable role in protecting the public, but it also creates paperwork nightmares for small businesses, she added.

The agency’s inspections also can force small companies to lose valuable work time as employees are occupied answering questions on issues that seem compelling.

Geary Havran, president of NDH Medical and chairman of the Florida Medical Manufacturers Consortium, agreed. The FDA should focus on high-risk issues, not those with little or no risk, he said.

As Sellers put it: “I think the question is: What’s a reasonable amount of oversight?”

The medical device manufacturers also are calling to an end of the medical device tax, which they say has a disproportionate negative impact on smaller companies.

Payment for medical services is another huge issue.

“The payment issue is sometimes as much of a barrier as regulations,” said Glen Hortin, clinical pathology medical director of the southeast region for Quest Diagnostics.

Diagnostic tests play a substantial role in guiding physician decisions, Hortin said.

“There’s a possibility of destroying people’s access to lab tests, if the payments are cut too much,” Hortin said.

Many tests that have been developed could help doctors diagnose their patients more accurately, but are too expensive for patients to afford and are not covered by their insurance plans.

In the long-term, the nation needs to shift from operating on a “sick-care” model to placing a greater emphasis on prevention, Hortin said.

Bilirakis believes the private sector can help solve some of the problems facing patients today. Incentives are needed to spur private investments in health care, he added.

“Regulations can stand in the way of private investments in health care,” Bilirakis said. “The bottom line is the potential for reform is huge.”

Published August 27, 2014

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Patients offer their perspectives on needed health care reform

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Before she became ill, Ashleigh Pike was a vibrant young woman who delighted in teaching elementary school children.

Now she lives life from a wheelchair, with her mother providing her full-time care.

Ashleigh Pike, left, looks on as her mother, Beth Pike, describes the impacts that Ashleigh’s illness has had on the young woman’s life. (B.C. Manion/Staff Photo)
Ashleigh Pike, left, looks on as her mother, Beth Pike, describes the impacts that Ashleigh’s illness has had on the young woman’s life.
(B.C. Manion/Staff Photo)

“On the outside, I look fine,” the former teacher said. But, “my quality of life has been greatly compromised.”

The young woman suffers from a form of dysautonomia, a malfunction of the autonomic nervous system. That system controls automatic functions of the body, such as heart rate, blood pressure, digestion, kidney function, temperature control, and dilation and constriction of the pupils, according to Dysautonomia International’s website.

Pike was one of several panelists at a roundtable discussion of health care issues, as seen from the patient’s perspective.

U.S. Rep. Gus Bilirakis hosted the session on Aug. 19 at The Bethany Center in Lutz to help inform his work as a member of the House Energy and Commerce Committee’s Healthcare subcommittee. Later in the week, Bilirakis hosted a second roundtable, focusing on health care issues from the point of view of providers.

The first 21st Century Cures Roundtable, “Patients and the Patient Perspective,” put a human face on the often complicated and frustrating experiences that ill people have in trying to find treatments and cures for their conditions.

Colleen Labbadia shared the heartbreaking story of her young son, who has been diagnosed with Duchenne muscular dystrophy, a progressive condition that is always fatal. Labbadia urged a greater degree of flexibility for clinical trials in the effort to find ways to treat and cure the condition.

“Each loss of function is like a little death,” Labbadia said. “Parents like myself, we’re willing to accept significant risk.”

Dr. Samantha Lindsey advocated for Alpha-1 patients, such as herself. Alpha-1 is the most common known genetic risk factor for emphysema, and also can lead to liver disease, according to the Alpha-1 Foundation’s website.

Anyone who has been diagnosed with chronic obstructive pulmonary disease should be tested for Alpha-1, the website recommends.

Early diagnosis can make a tremendous difference, Lindsey said.

“Even though I look healthy on the outside, my lungs are like the lungs of a 104-year-old,” she said.

Gretchen Church and her husband, Michael — who both suffer from Parkinson’s disease — were at the session to advocate for better medical treatment for people who have the conditions.

“I probably don’t look like I have Parkinson’s, but believe it, I do, ” said Gretchen Church, of the Parkinson’s Action Network.

The couple said that Bilirakis and his congressional colleagues should help people with Parkinson’s by making it possible for these patients to use telehealth services — a remote form of health care delivery.

Telehealth services would make life easier for Parkinson’s patients who often have trouble getting around, Church said. It also would reduce financial burdens.

One obstacle to telehealth are current state licensing requirements that require doctors to be licensed in the state to serve patients there, Michael Church said. The problem is that many people live in states where there are no doctors specializing in movement disorders.

“For the Parkinson’s community, telehealth has the potential to be powerful,” Gretchen Church said. It could help people live independently longer, she added.

Dr. Wayne Taylor, a leukemia survivor, said there’s room for improvement in the matches for clinical trials. Taylor, a physician from Hudson, underwent a clinical trial, and once he was in remission, he was able to undergo a double umbilical cord transplant.

In a double umbilical cord transplant, the blood-forming stem cells collected from the umbilical cord blood of two babies is used for blood stem cell transplantation. One umbilical cord would not provide sufficient stem cells for the transplant.

When it comes to clinical trials, Taylor believes more people could benefit from better matching.

Patricia Stanco, a regional care manager for the ALS Association’s Florida Chapter, posed some questions for Bilirakis and his congressional colleagues to consider:

“Is there a smarter way to do research? Is there a common-sense approach to access?”

She also wonders if changes can be made in Food and Drug Administration regulations.

“There are surely ways to get more shots on goal for research,” Stanco said.

Janice Starling, a kidney transplant recipient, was there on behalf of the American Association of Kidney Patients.

“If people in Congress would do more of what we’re doing right now, we’d get more help,” Starling observed.

She noted that Medicare often doesn’t cover treatments that are effective, or will cover them only for a specific period of time when more time might be necessary.

“What is going on? Why can’t we get the help we need?” Starling asked.

Dr. David Lubin, a recently retired physician from South Tampa, also offered some observations from the audience.

“Insurance companies and big pharma are in control of medicine,” Lubin said.

With the vast array of illnesses, Lubin said, it takes “almost Solomon-like” wisdom to know where to direct efforts and resources.

From a personal perspective, Bilirakis said he’s watched family members and friends suffer from rare conditions that have no cures.

“The right thing to do is to help our people, our patients,” Bilirakis said. “I want to take the politics out of this.”

Published August 27, 2014

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