CDC Works To Untangle Mystery of Zika and Guillain-Barré Connection

Of all the stories about Zika, one of the great mysteries involves its link to the Guillain-Barré Syndrome. Can it involve lightning strikes? Or even past surgeries?

Maybe nothing so outlandish, or could it? Such is the uncertainty surrounding Guillain-Barré (GBS) and Zika.

In the U.S. there has been one case of GBS reported for someone who traveled in an area with Zika, the Centers for Disease Control and Prevention says. Snce 2013, at least 12 countries in Central and South America have reported increases in GBS following the “first introduction” of Zika into those countries.

The Zika virus is transmitted primarily by the Aedes mosquito, and can be spread by sexual contact. The virus infection during pregnancy can cause serious birth defects and is linked with other adverse pregnancy outcomes. On Friday, the Food and Drug Administration Food and Drug Administration recommended “universal testing” of donated blood as another effort to shield the nation from Zika exposure.

So what’s the connection, no manner how tiny, between Zika and GBS?

The CDC is looking closely.

“The CDC is continuing to investigate the link between GBS and Zika to learn more,” says Dr. Jim Sejvar, a neuroepidemiologist at CDC, who has been leading its Zika-related GBS work. “We began conducting enhanced GBS surveillance in Puerto Rico in advance of the island’s Zika outbreak. We are gaining more information about the development and progression of GBS as the Zika outbreak progresses.”

GBS occurs in only a small number of people with recent Zika virus infection, he says. All countries which recently reported increasing numbers of GBS cases have the mosquito species capable of spreading Zika, Sejvar says, noting they have climates conducive to mosquito survival year-round. Generally, cases of GBS occur for no known reason, and true “clusters” of cases of GBS are very unusual.

GBS is an uncommon sickness of the nervous system in which a person’s own immune system damages the nerve cells, causing muscle weakness, and sometimes paralysis. Rates of GBS in the United States and around the world are fairly stable, Sejvar says. That amounts to an estimated 3,000 to 6,000 cases, or 1-2 cases for every 100,000 people, develop GBS each year in the U.S. Most cases of GBS occur for no known reason, and true “clusters” of cases of GBS are very unusual.

Early treatment of GBS with intravenous immune globulin (IVIG) or plasma exchange/plasmapheresis halts the progression of GBS. When treated quickly, patients are less likely to have severe disease or death.

CDC Explores the Connections

There’s a lot of uncertainty involving Zika and GBS.

In 2013, health officials in French Polynesia reported a “concerning increase” in GBS cases that coincided with a large outbreak of Zika, which was the largest outbreak of the virus to that point, Sejvar says. Most people with GBS report an infection before they have GBS symptoms.

Generally, researchers do not fully understand what causes GBS, other than “it’s the body’s response to stimuli,” he says.

“As the (Zika) outbreak continues, we are learning more and we hope to be able to better understand the relationship between the two conditions,” Sejvar says. “We are gaining more information about the development and progression of GBS as the Zika outbreak progresses.”

“Like with other illnesses that may lead to GBS, it’s not known how infection with Zika may trigger GBS,” he adds.

There are some interesting, and sometimes intriguing clues, but they have all to be explored.

For one thing, older people may be at a greater risk of developing GBS, and “that also appears to be the case with Zika,” Sejvar says. “We are working to learn more about what other factors may play a role.”

Oddly, a “number of other non-infectious stimuli such as surgery or a lightning strike have been associated with GBS,” he adds. On rare occasions, vaccinations have been associated with the onset of GBS.

With the transmission of Zika in two small areas of the Miami, Fla. Area, the CDC is working with officials from the state’s Department of Health to identify Zika and any GBS cases, ostensibly to develop or find any links. In addition, the CDC began conducting “enhanced GBS surveillance” in Puerto Rico in advance of the island’s Zika outbreak, according to Sejvar.

He has a warning for doctors:

“Clinicians in the United States should be aware of the potential for GBS cases in travelers returning from areas with Zika, and of the potential for Zika spreading to other areas of the United States,” Sejvar says.


Fentanyl: The “Counterfeit” Deadly Drug 50 Times More Potent Than Heroin

It’s one thing how dangerous too many legitimate prescription pills for people may be.

It’s another how deadly counterfeit prescription pills may be, such as those containing fentanyl, an opioid painkiller that is 50 times more potent than even heroin. It has so much, unfortunately, that is packed in so little:

The Drug Enforcement Administration says that a powerful dosage of fentanyl can be counted as a microgram. Let’s put it this way: just a few granules of table salt.

Fentanyl represents the latest drug-related crisis. The DEA says that many fentanyl pills are being sold “underground” as oxycodone or other opioids, often unknown to the buyers. Fentanyl also is mixed into or sold as heroin, again, without the purchasers having a clue.

Illicit traffickers are cashing in by counting on the “high demand for authentic prescription drugs as an incentive to produce the counterfeit drugs, and thus increase their revenue,” the DEA says.

In the words of the DEA, “hundreds of thousands of counterfeit prescription pills have been introduced into the market.”

“The DEA is facing an unprecedented threat in battling fentanyl and fentanyl-related compounds, many of which are more deadly or lethal than heroin,” the agency says in statements to HealthDataBuzz and in recent reports, including the DEA’s intelligence brief released last month, “Counterfeit Prescription Pills Containing Fentanyls: A Global Threat.”

Between late 2013 and late 2014 alone, there were more than 700 deaths related to fentanyl in this country. But that may not be the whole story, says the DEA, noting that some of those deaths – which may be linked to fentanyl – may be attributed solely to heroin. As the DEA puts it: “Those figures may be under-estimated.”

Since 2014, law enforcement agencies have been seizing the counterfeit pills, which in many ways resemble “the authentic medications they were designed to mimic,” the DEA says. Fentanyl is hard to detect, and can only be done through a laboratory analysis, the agency adds.

Prince’s Death

Was the singer Prince, who died April 21 following an accidental overdose of fentanyl, a victim of what was up the road essentially a counterfeit scheme?

Pills seized inside the singer’s Paisley Park compound were labeled as hydrocodone but actually contained fentanyl, which was responsible for Prince’s death, the Minneapolis Star Tribune reported, according to its source. Investigators are “theorizing” that Prince did not know the pills contained fentanyl, according to the news account.

Even more counterfeit drugs

There have been several incidents earlier this year in which the DEA made arrests related to counterfeit prescription pills.

Earlier this year, DEA officials said they arrested an alleged counterfeit prescription pill producer in New Jersey and the agency also issued a search warrant in Los Angeles targeting similar operations involving fentanyl and other synthetic opiates.

In the New Jersey case, the pill producer was charged with allegedly producing 6,000 pills, the DEA said. And, indeed, the pills were made to “resemble” 30-milligram Oxycodone pills, but lab results showed they contained either fentanyl citrate or acetyl fentanyl.

The DEA noted deaths in other cases this year in Florida and California from counterfeit Xanax and counterfeit Norco pills containing fentanyl.

Although Norco is an opioid like fentanyl, Xanax  is a benzodiazepine. “This demonstrates,” the DEA said, “that though traffickers are interested in expanding the fentanyl market to the other counterfeit opioid medications, they are also willing to utilize fentanyl in other non-opiate drugs with exploitable user populations.”

For law enforcement and emergency responders, fentanyl also could have significant adverse consequences. Just touching fentanyl or accidentally inhaling the substance can result in sudden absorption through skin, the DEA said.

As a result, officials could face “disorientation, coughing, sedation respiratory distress or cardiac arrest,” the agency said in an alert. Such an impact could be “very rapid and profound,” the agency says, “usually occurring within minutes of exposure.”

That can be said, too, about the widespread illicit trafficking and use of fentanyl: rapid and profound.

A Vision of Hope For Diabetic Retinopathy Patients

“Our mission is to eliminate preventable blindness,” says Dr. Sunil Gupta, founder and CMO of IRIS (Intelligent Retinal Screening Systems) of Pensacola, Fla.

Imagine making a decision to go to an eye doctor’s office that can mean the difference between having a satisfying life, or one fraught with loss of vision. That’s the potentially dramatic situation of patients with diabetic retinopathy, the leading cause of blindness in working-age adults.

For many of these patients, they wait too long to get their eyes checked by a specialist, and by then their vision has been severely disrupted or gone entirely. They may need significant surgery and expensive medications to maintain their eyesight. Even with intervention, therapies don’t always work.

Diabetic retinopathy is the most common cause of vision loss among people with diabetes. It involves changes to retinal blood vessels that can cause them to bleed or leak fluid, severely distorting vision.

Dr. Sunil Gupta, a physician and an engineer, says that 60% of diabetic retinopathy patients often avoid going to an eye doctor. This negligence can cause devastating consequences for the patients and their families, and impact on healthcare expenses.

Because diabetic retinopathy shows no symptoms is until the disease is in advanced stages, experts say that people with diabetes need a diabetic eye exam at least once a year. That hasn’t been happening as much as it should be, says Gupta, founder and chief medical officer of IRIS.

“When patients do show up for an eye exam, they have been losing vision, and now it’s a problem, and there is damage to the tissue,” he says. “At this stage, it’s an uphill battle. The patient can’t drive. The patient can’t watch TV. The patient can’t focus. And glasses can’t fix the problem. The key is to get to these people for an examination before that happens. If a doctor had gotten to (examine) the patient sometimes years earlier, this would have been all preventable.”

In practice, it is each primary care physician’s (PCP) responsibility for getting patients to this eye exam. However, the PCPs rely on ophthalmologists for these services. Physicians were left to trust that their patients would follow through in seeing an eye doctor, but less than 40% actually would. The idea of a telemedicine solution is to “remove the silos,” Gupta says. By having a team approach, Gupta says primary care and eye specialists can make it easier for patients to be compliant with their necessary care plans.

Gupta is working to drastically improve eye care. “We decided, ‘why not automate the process for the primary care doc’’ he recalls, “and bring the exam to the patient?” He and his IRIS team have developed an FDA-cleared Class II telemedicine platform that securely sends images from primary care to ophthalmology through a cloud-based Grading Platform. The retina specialists are then able to diagnose the image with pathology, and a final, graded report is returned to the PCP to include in the patient’s electronic medical record.

A Success

So far, IRIS is a success, Gupta says. Through partnerships with independent physicians, insurers and others, at least 110,000 otherwise unexamined patients have gotten this necessary exam. Ophthalmologists and retina specialists have diagnosed over 40,000 instances of diabetic retinopathy. Gupta says.

About 15,000 patients have been referred for moderate to proliferative diabetic retinopathy. “We think those patients would have gone blind if we had not picked up the disease,” he says. “It [the diagnosis] is a ‘shot across the bow’ for these patients and prompts them to manage their disease better.”

Keeping with the theme of making it easy and automated for primary care practices, Gupta’s team has developed bidirectional integrations with multiple EHRs (electronic health records) – including Epic. When the ophthalmologist signs the patient report, the data is integrated directly back into the EHR. Gupta notes that overall, IRIS’s integration with EHR systems has led to significantly more patient usage and more physician engagement.

In 2013, the Harris Health System in Houston, Texas, partnered with IRIS to improve their evaluation of diabetic patients. “It’s important all patients are evaluated, especially inner-city populations of African-Americans, Latino and Southeast Asia population, all of whom have a high-rate of diabetes,” Gupta says. Harris Health, considered a “safety net” for all residents of Harris County, is the largest county health system in Texas, and the 3rd largest in the country.

“We were able to drive home improved outcomes,” Gupta says. “Right now, Harris Healt actually does better than most private groups in the country.” He adds that Harris’s diabetic exam rate is consistently near or near 80% compliance.

Growing Diabetic Population

Nationally, the diabetic population in the United States is growing. Over the last 4 years, Harris’s diabetic population has gone from 47,000 to 58,000. To maintain and improve exam access, Harris added the bidirectional integration to their already successful IRIS platform in late 2015. To measure the effectiveness of this integration, Harris Health conducted a study of its providers and patient care technicians in the programs. The analysis evaluated efficiency, engagement and patient access.

Among the findings:

  • 86% of primary care physicians (PCPs) said that the IRIS-EHR integration increased access for patients receiving diabetic retinal exams.
  • 83% of PCP respondents considered the IRIS reports to be helpful for managing diabetic patients.
  • After implementing the system, patient exam volume increased 49.4% compared to the same period in the prior year.

Gupta is happy with those numbers, but is always looking for improvement.

Grady Health System in Atlanta, Ga. got a glimpse of the success at Harris Health. Looking for similar results, Grady entered their own relationship with IRIS, Gupta explains. Grady has an estimated 45,000 diabetic patients who are not compliant with their eye exam every year. At least 12,000 of these patients will have pathology that otherwise until now has gone undiagnosed.

“We want to give access to everybody out there who needs a diabetic evaluation. I’d be the happiest guy in the world if we can get all these people and help them see,” Gupta says. As he sees healthcare, the importance is “taking care of the patient in front of me, not just patients at large.”

Ultimately “our mission,” Gupta concludes, “is to eliminate preventable blindness.”


For Clinton and Trump, It’s a Low-Key Skirmish Over Affordable Care Act

It’s not 2012, and Obamacare appears to no longer cause much visceral passion on both sides, or many words, from the presidential candidates. There are so many other issues, aside from healthcare, never mind questions over Donald Trump’s outrageous statements, or Hillary Clinton’s email. While healthcare was not front-and-center in their nomination acceptance speeches and statements on the economy, Clinton and Trump are very much opposed, especially when it comes to Obamacare,  also known as the Affordable Care Act.

Let’s look at Trump’s GOP-nomination acceptance speech first, because, well, it’s easier to dispatch: essentially, he didn’t have much to say about health care for the general population.

17 words.

“We will repeal and replace disastrous Obamacare. You will be able to choose your own doctor again,” he said in his acceptance speech.

Of course, he probably figured he didn’t have to do any explaining, which is not unusual for Trump. In healthcare, that’s his trump card: Trump has repeatedly called for the repeal of Obamacare.

Trump  emphasized on his Website:“On day one of the Trump Administration, we will ask Congress to immediately deliver a full repeal of Obamacare,”citing runway costs, and websites that don’t work, among other issues.

In his economic address, Trump again pounded on Obamacare, but with few words, or explanations. “One of my first acts as President will be to repeal and replace disastrous Obamacare, saving another 2 million American jobs,” Trump said. Trump’s claim about the potential savings has been disputed, as  Modern Healthcare reported.

Clinton Talks More About Health Plans, Still Light on Details

Although Clinton didn’t reveal any detailed new proposals about how should we handle healthcare, she did mention in  her  acceptance speech how she worked on healthcare issues throughout her career, and her continued support for Obamacare.  Clinton mentioned briefly her failed attempt at healthcare reform during her husband’s administration, and talked about “20 million more Americans with health insurance,” under Obamacare.

Yesterday, in Detroit, Clinton said in her economic speech she would “defend and improve the Affordable Care Act, and for me, that includes giving Americans, in every state, a choice of a public option health insurance plan that will help everybody afford coverage, it will strengthen competition  and drive down costs.” As she did in her acceptance speech, Clinton also inferred in her economic address that she would work to reduce the cost of prescription drugs.

Referring to proposed tax cuts espoused by Trump —  the “Trump Loophole” she called it, citing his business interests – Clinton said her opponent’s plans would lead to massive budgetary cuts in priorities such as healthcare.

In her acceptance speech, Clinton talked about her vow to protect a woman’s right to make her own health care decisions, and she criticized Trump when he “mocks and mimics a reporter with disabilities.” She also mentioned the need for more mental health care in this country.

Clinton offered up names of people she helped working through healthcare policy.

She met Ryan Moore when he was 7, and wearing  a full body brace and weighing about 40 pounds. “Children like Ryan kept me going when our plan for universal health care failed and kept me working with leaders of both parties to help create the Children’s Health Insurance Program” and “twenty million more Americans with health insurance,” Clinton said.

She talked about Lauren Manning, who was gravely injured in the Sept. 11, 2001 attacks, and how she worked on behalf of the 9/11 families “and our first responders who got sick from their time at Ground Zero.”

Citing her history, TClinton talked about how she “sweat the details of policy,” from her work for children for the Children’s Defense Fund,  in New Bedford, Mass in 1973

Clinton’s statement about her work in Massachusetts didn’t sit well with some people in New Bedford. The town’s leaders were upset at Clinton’s “depiction of the Whaling City as a place where handicapped children were abandoned at home because the schools lacked accommodations for youngsters with special needs,” according to The Boston Herald

Trump and Clinton Clash Over Veterans

In his acceptance speech, Trump targeted his assistance for veterans. “We will take care of our great veterans like they have never been taken care of before,” Trump said. “My opponent dismissed the VA scandal as being not widespread- one more sign of how out of touch she really is.”

In his healthcare plan, Trump said he would make changes in veterans assistance that – in his oft-repeated refrain: “will make America great again. ” Trump said 300,000 veterans have died, waiting for care. Trump vowed that, if elected, he would decrease wait times, improve healthcare outcomes and “facilitate a seamless transition from service into civil life.”

While Trump criticized Clinton over veterans, she, in fact, did not mention veterans in her acceptance speech. She has said on her Web site that she would ensure veterans have opportunities and tools they need to succeed upon returning home, and build a “21st century Department of Veterans Affairs to deliver world-class care.”

Clinton said she was outraged by the recent scandals at the Veterans Administration and will demand “accountability and performance from VA leadership.” So Trump’s assertion about Clinton dismissing the VA scandal: inaccurate.

Whatever vow about healthcare for veterans Trump made got swallowed up, and rightfully so,  in the aftermath of his incredible tweeting and lashing out of the family of Capt. Humayun Khan, who died in Iraq in 2004. It followed after the slain soldier’s father, Khizr Khan, criticized Trump for his proposed ban on Muslims entering the  U.S. and called on the GOP to reject the candidate.

What’s Ahead?

As we get closer to the election, it will be interesting how detailed Clinton and Trump get in their speeches and policy statements on healthcare, or if they continue on this path of generalities.