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


The World’s Greatest Deliberative Body? Or Maybe A Few Heroes…

So there was room for heroism in the Senate early this morning, after all. And it came down to someone who is used to being a hero, John McCain.

Two days after the 80-year-old Senator from Arizona went to the Capitol after being hospitalized for brain cancer, the former Republican presidential candidate was very presidential, and a Profile in Courage: He voted with his heart, for his state. For his country.

McCain, the one-time prisoner of war, defied being a prisoner of politics.  He joined heroines, Lisa Murkowski and Susan Collins, other Republican Senators,  in voting against a so-called GOP “skinny repeal” — a watered down version of other big Republican plans to overturn Obamacare.  After all the drama, the ups and downs, build-ups, and Trumpian tweets, the seven-year GOP effort to get rid of Obamacare collapsed in the weight of the will of Americans wanting decent healthcare, plain and simple. McCain, Murkowski and Collins carried their torch, along with the Democrats.

Even though the legislation was dubbed a lightweight, it still could have been lethal to Obamacare, eliminating the individual and employer mandates, for instance, and raising the possibility 16 million more Americans without health insurance.

Earlier yesterday, McCain stood with colleagues who seemed to go ahead with voting for the bill even though – – a bit of craziness here – they thought it was not right and hoped a better piece of legislation would come out of a House-Senate conference.

Pretty dicey.  McCain, who this week lambasted nonsensical politics and loudmouth know-nothings, did what he had to do. He fought for what he believed in.

Now Democrats and Republicans should work together to make Obamacare better than ever, for all of us. — Joe Cantlupe



A Different Kind of Courage

In a dramatic moment, Sen. John McCain today came back from surgery and the war hero lectured his colleagues about playing politics. Then he, er, kind of played politics.

With his vote today, (and Vice President Pence breaking a 50-50 tie) the Republicans were able to set the stage for debate on whatever legislation they may want in their largely unfocused but determined effort to erase Obamacare, despite the potential of having millions of people losing their health insurance as a result.

McCain, indeed, is a heroic man, and he has not indicated whether he would support the GOP bills in a future vote. But the real GOP heroes on this day were Sens. Susan Collins of Maine and Lisa Murkowski of Alaska, who voted their conscience and against their colleagues for even continuing the process.

While President Trump grumped about their votes, Illinois Sen. Dick Durbin, the Senate’s No. 2 Democrat called their collective actions acts of political courage, according to the Associated Press. Collins and Murkowski have expressed concerns about deep Medicaid cuts in the GOP bill and have called for bipartisan legislation, according to AP.

Of all the reactions today, the American Federation of Teachers, which represents 1.6 million employees, had one of the most significant – and telling – comments about the healthcare bill: what McCain receives, and deserves, in healthcare, and questions surrounding millions of other Americans. “Sen. John McCain is an American war hero who will get, and should get, the best healthcare our country can provide, ” the AFT said. “The debate about healthcare should be about ensuring all Americans have that same standard of care. That doesn’t start by repealing Obamacare.”

“As a result, we are deeply disappointed by the motion to proceed on a bill that would take away healthcare from at least 22 million people, hurt the vulnerable an others with pre-existing conditions.” – Joe Cantlupe




So What Are The Senate’s Aspirations for the People?

Will the Senate be a chamber of heroism today…or not?

Let’s turn back the clock a bit, first. There was a piece of legislation, observed the President several years ago, that would “set in motion reforms that generations of Americans have fought for and marched for and hungered to see.”

“Today, we are affirming that essential truth every generation is called to rediscover for itself that we are not a nation that scales back its aspirations,” President Barack Obama said in March, 2010, as he and supporters celebrated the passage of the Affordable Care Act.

Are we a nation that turns back its aspirations, or is this what this GOP led Senate (and House for that matter) wants to do?

Today, Sen. Mitch McConnell may try to cobble together enough procedural votes as a first tally whether it would have enough members to actually then vote on healthcare reform bills. President Trump desperately wants that, but so many lawmakers are pretty lukewarm, at best. There is even confusion among Republicans about exactly what they may be voting on. Republicans want to repeal. Or repeal and replace Obamacare with the Better Care Reconciliation Act (BCRA). Or repeal and just let it stay that way until they find something better. Or… you see what I mean.

There is a dramatic build-up to be sure, as Republican Sen. John McCain of Arizona is expected to return from his recent brain tumor diagnosis for a vote, saying last night he wants to continue work on important matters, including healthcare. The Republicans are counting the numbers to determine whether they move forward, or if they can. Getting 50 votes may be tough. Previously, three women Senators have courageously been vocal critics of the legislation. In the meantime, the Congressional Budget Office has said millions of people could lose healthcare if BCRA is approved, or if Congress lets Obamacare go without replacing it. A ticklish situation.

And here, as the Republicans gather, the idea of not really knowing what they are voting on not only seems bizarre but is certainly contrary to their oath. As the MaddowBlog noted, “This isn’t how legislating in the United States is supposed to work on any issue, but it’s especially indefensible when dealing with life or death policymaking.”

A friend of mine, as he was throwing out the trash yesterday, said: “Why can’t Republicans and Democrats come together, do whatever is needed to fix Obamacare. Does Trump even know what he’s talking about?”

When you think of the eloquence of Obama, contrast that with Trump, railing in front of families who have had trouble getting coverage because of Obamacare. Trump criticized GOP Senators who oppose the bill, adding with flourish: “Obamacare is death. That’s the one that’s death.”

“Americans desperately need relief,” the White House said in a statement earlier yesterday. “Congress needs to step up and do their job, by repealing and replacing Obamacare. The legislation working its way through Congress right now provides the choice and control people want, the affordability they need, and the quality they deserve in healthcare?”

Not much elaboration to the word “want.” Simply, Americans don’t like the bills that Congress is moving forward to replace Obamacare. A Monmouth University poll said that only 27 percent of Americans approve the Senate health care reform bill introduced last week while 56 percent disapprove. In an understatement, the university pollster said: “There are signs that Republicans may be losing confidence in how this issue is being handled by their party’s leadership…the Congress as a whole as well as its partisan leadership receive generally negative reviews.”

Among those opponents to the Senate bills to repeal or repeal and replace Obamacare, is the American Medical Association. In a July 21 letter to McConnell and Minority Leader Chuck Schumer of New York, James L. Madara, MD, CEO an Executive Vice President of the AMA, said the Senate legislation lacking in these areas:

  • Efforts to ensure that those currently covered do not become uninsured
  • Preservation of key insurance market reforms and efforts to stabilize and strengthen the individual insurance market, “ensuring that low and moderate income families are able to secure affordable and meaningful coverage”
  • Provision (for) adequate funding for Medicaid and other safety net programs.

“Unfortunately neither the proposed ‘Better Care Reconciliation Act” (BCRA) nor the “Obamacare Repeal Reconciliation Act” (ORRA) adequately addresses these key concerns,” wrote Madara. “Each bill results in millions more Americans without health insurance, weakened markets, less access to affordable coverage and care, and the undermining of funding for state Medicaid payments.”

I think about my friend mulling the Congressional action. Why can’t the Republicans and Democrats work out an agreement?

“Republicans in the Senate could work together with Democrats to find at last a short-term bipartisan solution. Democrats have indicated a willingness to work with them, wrote Tim Jost, an emeritus professor at the Washington and Lee University School of Law who blogs for Health Affairs. “There is wide public support for bipartisan reform. And there are short term fixes that could be adopted on a bipartisan basis.”

“It is time to set aside partisanship, to fix immediate problems in insurance markets, and to begin a national debate on what we want our health care system to look like going forward.”

Does the Senate have the courage to do that? – Joe Cantlupe

IT Needed In Fight Against Antibiotic Resistance

Antibiotics are certainly powerful in fighting infections. But now hospital organizations are finding that they need to battle the impact of antibiotics, too, stemming from patient and prescribing overuse. For hospital leaders, innovative IT systems are becoming critically important to accomplish that task.

Overprescribing antimicrobials have led to antibiotic resistance. At least 700,000 people die each year from antibiotic resistant infections, and that number may reach 10 million each year by 2050.

That’s stunning.

Something called antimicrobial stewardship – a way in which hospitals keep an eye on such prescribing – is what some health systems are trying to do to cut down on antimicrobial infections. That means ordering, dispensing, administering and monitoring antimicrobial stewardship practices. It also means working with patients, educating them about the appropriate use of medications.

IT technology is a key element in helping physicians access timely clinical information about antibiotics at the point of care. In that way, they can figure out the antimicrobial puzzle. While many hospitals are improving their IT system to carry out the task, not enough are using antimicrobial stewardship programs so they can reach their potential in helping patients.

“Many stewardship programs in hospitals today only provide feedback on antibiotic prescriptions, one or more days after the patient has already been started on an antibiotic,” says Brandon Palermo, MD, MPH, executive director and chief medical officer, for ILÚM Health Solutions in HIStalk. “But it’s important to use technology to engage and guide clinicians in real time from the beginning with an antibiotic ordered and to continue tracking pathway adherence as additional microbiology data becomes available and it’s important to be able to support this within their existing workflows.”

ILÚM Health Solutions says it provides an array of tools and services that help hospitals and health systems improve outcomes for conditions like sepsis and pneumonia while implementing key components of their antimicrobial stewardship initiatives. The company offers a technology-powered program that helps hospitals improve their infection disease outcome and supports antimicrobial stewardship programs. It is part of Merck’s Healthcare Services and Solutions group and operates independently from Merck’s pharmaceutical products business.

The ILÚM system works by leveraging data within existing hospital IT systems to promote “optimal decision-making and appropriate use of antimicrobials” through its clinical decision support (CDS) system and Command Center, an electronic dashboard, according to the company.  These solutions “enable case monitoring and prioritization – on an individual and aggregate level based on disease state – and promote early recognition of infectious diseases, appropriate interventions, and adherence to evidence-based clinical pathways,” the company says.

Technology needs to effectively connect everyone on the stewardship team – doctors, nurses, quality managers, pharmacists and healthcare executives, Palermo says. In addition, he says hospitals and clinicians need help accessing important data that are often buried within complex systems.

Hospitals are now required to establish antimicrobial stewardship programs as an organizational priority, under a Joint Commission requirement that became effective Jan. 1, 2017, Palermo says. Palermo wrote in Becker’s Hospital Review that antibiotic stewardship programs can save hospitals a bundle, too. He referred to a University of Maryland study that showed one institution saved $17 million in seven years by implementing such a program.

“Technology needs to give us antibiotic foresight, not just hindsight,” he says in HIStalk. “A root cause of antibiotic resistance is the systemic overuse and inappropriate use of antibiotics. While many factors account for this, a key issue is the lack of timely clinical information at the point of care.”

The Battle Against Sepsis

One hospital that has worked feverishly on this issue is East Jefferson General Hospital, 424-bed general medical and surgical hospital in Metairie, La., which reported a pilot study last December at the Institute of Health Improvement’s Quality Forum Institute of Health Improvement’s Quality Forum. East Jefferson General Hospital partnered with ILÚM as part of a hospital-wide initiative targeting sepsis quality improvement, which included “multi-disciplinary departmental collaboration and sponsorship from administration and medical leadership,” said Raymond DeCorte, chief medical officer for EJGH.

“This innovative solution has helped us to identify patients with sepsis faster, care for them better and reduce the use of critical hospital resources,” he says.  Antibiotic resistant bacteria are often the root cause of infections that trigger sepsis, according to the Mayo Clinic.

Sepsis is a potentially life-threatening complication of an infection, resulting in 750,000 deaths in the U.S. every year and is a major cost driver of health systems. Studies show that hospitals spend an average of $34,000 for each patient with sepsis.

The clinical decision support system helped physicians improve sepsis recognition and adherence to evidence-based care, leading to significantly improved outcomes and reduced resource utilization.

Among patients with all sepsis types, a reduction in hospital length of stay – 7.11 to 6.81 days -was observed. Among patients with severe sepsis, significantly fewer patients developed hospital-onset shock in the study group compared to the control group, 19 percent vs. 35 percent. All cause mortality rates decreased from 23.2 percent to 7.9 percent.

Palermo says automated outcomes reporting is configured to hospital-specific initiatives that track quality program performance.

“We know that following evidence-based pathways for sepsis can save lives, but it’s not that simple,” he told HIStalk. “These pathways call for interventions where time is critical, and early recognition of sepsis is a challenge that continues to vex health systems. I can tell you from my own experience as a practicing physician that this can be a huge hurdle.

“Our collaborations with partner hospitals launch with two parallel tracks – benchmarking and integration,” Palermo added in the interview with HIStalk. “We assist with benchmarking to establish baselines and identify target areas for quality improvement. Our plan is to build out disease modules for various types of infections using a value and data driven approach. We plan to expand to hospitals and health systems across the country and continue to bring key industry players together.”

IT helps us to determine appropriate use of antimicrobials and to execute against stewardship priorities by analyzing and reporting data that reinforce the impact of the program, wrote Debra A. Goff, PharmD, FCCP, a clinical associate professor and infectious diseases specialist at the Ohio State University Wexner Medical Center.

“It can also help prioritize patients in real time by providing actionable intelligence,” Goff adds. “You can also drill down to look at individual prescribing habits, individual drugs and who may be driving those prescriptions within the hospital.” — Joe Cantlupe



Latest CBO Score Today on GOP Measure to Replace Obamacare: 15 Million More Without Insurance Next Year

A GOP Senate replacement bill for Obamacare, if enacted, would result in 15 million more people without health insurance next year, and 22 million by 2026, according to a Congressional Budget Office report released today.

The latest score followed an analysis released yesterday of a proposed repeal of the Affordable Care Act without a replacement. That  would have resulted in 32 million more people without health insurance in 2026.

In its report today, the CBO says of the replacement proposal: “In 2018, 15 million more people would be uninsured under this legislation than under current law. The increase in the number of uninsured people relative to the number under current law would reach 19 million in 2020 and 22 million in 2026.”

By the CBO’s estimation, about 82 percent of all Americans under age 65 would be insured in 2026, compared with 90 percent under current law.

The numbers generally don’t seem to be in President Trump’s favor as he continually presses  Congress to overturn his predecessor’s signature legislation.

The data has a bit of good news: Federal deficits, under the measure, would be reduced by $420 billion over the next decade, the CBO says.

— Joe Cantlupe