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A Doctor's Note on Innovation
Posted by on July 9, 2020

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July 9, 2020

Dear Friends,

Today, the Energy and Commerce Subcommittee on Consumer Protection and Commerce held a hearing on “Consumers Beware: Increased Risks During the COVID-19 Pandemic.” My questions centered around how technology is being used to help address COVID-19 issues. To this end, I recently introduced H.R. 6928, the Advancing 3D Printing Act.

We have seen numerous innovative uses of 3D printing. The University of Miami is completing a project to 3D print 1,000 nasopharyngeal swabs per day. The University of Minnesota is developing a 3D printing technique using motion capture to print electronic sensors directly on organs that are expanding and contracting, which could help patients with lung issues. Faculty and staff at the University of North Texas are also using 3D printers to create face shields.

American innovation has led us out of crises before and it will do so again.

National Updates
The Centers for Medicare and Medicaid Services released an updated Provider Burden Relief FAQ document, which describes some available provider flexibilities and the resumption of certain program integrity activities that have been suspended because of the public health emergency.

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has established a clinical trials network that will help enroll volunteers in large-scale clinical trials testing for a variety of COVID-19 investigational vaccines and monoclonal antibodies.

The Federal Communications Commission’s Wireline Competition Bureau approved an additional 25 funding applications for the COVID-19 Telehealth Program, completing the distribution of allocated funds. Overall in Texas, over $7 million was distributed to 24 locations.

The Department of Defense awarded $34.6 million to Emergent Biosolutions to fund their collaboration with Mount Sinai Health system and ImmunoTek Bio Centers to develop and conduct a clinical trail testing a COVID-19 hyperimmuno globulin candidate.

The Health Resources and Services Administration awarded over $21 million to expand COVID-19 testing capacity and otherwise support health centers.

The Centers for Disease Control and Prevention published information to help in the effort to learn more about how far COVID-19 spread throughout the United States, including information on serology surveillance, the seroprevalence in blood donors and large-scale geographic seroprevalence surveys.

Texas Updates
COVID-19 is still spreading throughout our communities in Texas, and we all need to do our part to stop the spread. Even young people with no underlying health conditions have become severely ill or died from COVID-19. As you go about enjoying your summer, remember to stay home if you feel ill, social distance, wear a mask, and wash your hands.

If you or someone you know is feeling ill and seeking a COVID-19 test, check this map of testing sites to find one near you.

Stay healthy Texas!

Until next time, this is your doctor's note.

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Congressman Michael C. Burgess, M.D.

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USA Today: Can hydroxychloroquine help COVID patients early on? We need more science and less politics.
Posted by on July 9, 2020
by Dr. Marc Siegel 

My father, who is 96 years old, felt suddenly fatigued back in March with some shortness of breath and fever. He laid down on his couch and said he didn’t think he was going to get up again. He has heart disease and a pacemaker, and his cardiologist weighed the options and agreed to start him on hydroxychloroquine. He was much better within a day.

I made the same decision in several patients with COVID-19 or suspected COVID-19 in my practice over the first few months of the pandemic, after prescreening them for risk of heart rhythm abnormalities. I understood that the benefits I saw were anecdotal and not strictly scientific. 

Even so, I was glad when the Food and Drug Administration issued an Emergency Use Authorization (EUA) for hospitals on March 28. A study in the journal Nature that month demonstrated hydroxychloroquine’s anti-viral activity against the SARS-CoV-2 virus responsible for COVID-19. There was also longtime evidence that the drug decreased inflammation that could lead to the “cytokine storm” that damages the lungs in severely ill COVID-19 patients.

Politics prevented thorough trial 

There was every reason to be excited. The drug is incredibly cheap, a generic version is less than 50 cents per pill, and it has been around for more than 65 years. It has been well tolerated by millions as a treatment for various forms of arthritis and as a preventative against malaria.

But then the bad news began to pour in. With President Donald Trump championing the drug this spring, it became a third rail political issue, and studies (including one from New York, published in the Journal of the American Medical Association in May) showed that the drug wasn’t effective against COVID-19 — at least very late in the game when the patient was dying and side effects of the drug were also more likely at that point. 

The political fallout interfered with the science. On June 15, less than a month after President Trump admitted to taking hydroxychloroquine as a prophylactic, the FDA revoked its EUA.

An Oxford study published in The Lancet showed the drug to be ineffective when given to very sick patients, and even to hasten death. But the study was soon withdrawn because it relied on a questionable company called Surgisphere, which had few employees and limited, unverified data. 

Instead of learning a lesson from the failed Lancet study that more carefully conducted research was essential, both the National Institutes of Health and the World Health Organization have now halted their clinical trials on hydroxychloroquine. 

The hope of hydroxychloroquine

Luckily, one bold and innovative group has not stopped. The Henry Ford Health System in Detroit has just released a large retrospective study in which the drug was given very early in the hospitalization. I spoke with its chief academic officer, neurosurgeon Steven Kalkanis.

“We stand behind our recent Henry Ford study where we looked at 2,500 patients and we found that the use of hydroxychloroquine alone cut the death rate in half (from 26% to 13%),” he told me.

According to Dr. Kalkanis, the study screened heavily for those with preexisting conditions, including cardiac disease. He said the key to success is using the drug early in the course of the illness, before significant inflammation occurs. 

Rep. Michael Burgess of Texas, a doctor and the senior Republican on the House Subcommittee on Health, told me he is receiving calls from all over the country asking why the drug isn’t in front-line use.

Unfortunately, the answer is more politics than medicine. I am glad the Henry Ford group is also studying the drug as a preventive in 3,000 health care workers, and I hope the FDA and the NIH reverse their course and continue to participate in these efforts.

I can’t tell you for certain that my father and several of my patients survived COVID-19 because of hydroxychloroquine, but I want science to prove me wrong, not politics. We desperately need treatments for COVID-19, not dogma and divisiveness.

Dr. Marc Siegel, a member of USA TODAY's Board of Contributors and a Fox News medical correspondent, is a clinical professor of medicine and medical director of Doctor Radio at NYU Langone Health. Follow him on Twitter: @DrMarcSiegel


Originally published here.
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Burgess: The Supreme Court’s Decision Protected the First Amendment
Posted by on July 8, 2020

Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX), a member of the House Rules Committee and Republican Leader of the House Energy and Commerce Subcommittee on Health, released the following statement after today’s U.S. Supreme Court ruling that The Little Sisters of the Poor, a Catholic charity, cannot be forced by the government to act in violation of their religious beliefs.

“Today’s Supreme Court decision protected our First Amendment rights,” Burgess said. “The Constitution protects religious freedoms, and the government has no business requiring an organization to go against its religious beliefs just as the Little Sisters of the Poor experienced.

“Congress should not be putting forward policies that disregard constitutional rights. For that reason, I joined fellow members of Congress in signing an amicus brief urging the Supreme Court to restore the rights of the Little Sisters of the Poor.

“I appreciate the Supreme Court for continuing to protect our religious freedoms with their decision today.”

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A Doctor's note on Coronavirus
Posted by on July 7, 2020
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July 7, 2020

Dear Friends,

This morning, I joined Mark Davis to discuss the latest with COVID-19 and what this fall might look like.

National Updates
The U.S. Food and Drug Administration issued an emergency use authorization for the third combination diagnostic test that will help differentiate between flu and COVID-19 viruses in individuals, in order to help health care providers prepare for the upcoming flu season amidst the pandemic.

The Department of Health and Human Services(HHS) and Department of Defense (DOD)announced a $1.6 billion agreement with Novavax, Inc.to fund manufacturing of the company’s COVID-19 investigational vaccine, thereby purchasing 100 million doses to be distributed as part of a clinical trail or a vaccine campaign.

Texas Updates
Last week, Governor Abbott issued an executive order requiring Texans in counties with more than 20 cases of COVID-19 to wear face coverings in public places. He also issued a proclamation giving mayors and county judges the authority to impose restrictions on some outdoor gatherings of over 10 people.

Texas hospitals are encouraged to continue planning to facilitate surge capacity as Texas experiences increasing COVID-19 case counts.

  • The Texas Hospital Association has a waiver tracker proactively monitoring the necessary waivers and flexibilities required to extend capacity.

Dallas County saw a 16 percent increase in hospitalizations yesterday.

The Texas Hospital Association published a one-pager with strategies to help health care workers manage stress and cope with COVID-19 as hospitalizations continue to rise and hospitals are expanding capacity.


Until next time, this is your doctor's note.

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Congressman Michael C. Burgess, M.D.

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Rep. Mike Burgess to Newsmax TV: Loud Noise Environments Increase COVID Risk
Posted by on July 7, 2020
by Brian Trusdell

Loud noise environments may increase a person’s risk for contracting the novel coronavirus, nine-term congressman and doctor Rep. Mike Burgess told Newsmax TV on Tuesday, because it causes people to move closer than the 6-foot "social distancing" suggestion to be heard.

Burgess is a 69-year-old Republican who has three decades as a doctor in North Texas and represents Texas’ 26th Congressional District in the northern section of the Dallas-Fort Worth area. He was reacting to claims, such as the one from the World Health Organization earlier in the day, that "emerging evidence" shows the virus is spread through the air as well as "respiratory droplets."

"Interestingly enough, high-noise environments seem to be one of those things that works out to be a risk factor," Burgess said on "Spicer & Co." "It maybe why bars have been identified as being problematic. You certainly look at the people in the meat processing industry, and that’s a high-noise environment. They’ve got to get right up on top of each other to be heard.

"That is an environment in which the transmission of the virus does seem to be increased."

Burgess’ comments come as debate has heightened in his state following Texas Gov. Greg Abbott’s executive order last week requiring face coverings be worn in public, after an increase in cases appeared in the state, and an increasing number of sheriffs saying they can’t or won’t enforce the directive.

A report by West Texas Dr. Richard Bartlett, who claims that the inhaled steroid budesonide, or as its known by its brand name Pulmicort, is a "silver bullet" for COVID-19, the flu-like respirator disease caused by the novel coronavirus, also has attracted Burgess’ attention.

"I do have asthma myself, and I do use an inhaled steroid – not the nebulizer that he recommends, but an inhaler, and I wondered about that early on," Burgess said. "Both sides of the question: No. 1, am I increasing my risk for getting an infectious disease that is inhaled into the lungs by using an inhaled steroid, which could reduce the body’s ability to fight infection; or, am I improving because I’ve reduced the body’s response to inflammation.

"I guess it’s an open question. I know the doctor. I have heard him speak, and he seems quite passionate about this, but we’re going to need to see some studies before there is a recommendation for widespread use of Pulmicort."

Published here

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WBAP Morning News: What Can We Expect From The Next Stimulus Package?
Posted by on July 7, 2020

Congressman Dr. Michael Burgess joined the WBAP Morning News with information that is being considered for the next stimulus package. 

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The Mark Davis Show: Congressman Michael Burgess – COVID 19 numbers to rise in Texas
Posted by on July 7, 2020
 

Congressman Michael Burgess discusses the rising COVID-19 numbers in Texas. 

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KLIF News: A Major Supreme Court Ruling On The Electoral College, And A Converstaion With Texas Congressman Michael Burgess
Posted by on July 7, 2020
 

A Major Supreme Court Ruling On The Electoral College, And A Conversation With Texas Congressman Michael Burgess
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Healio: Patient safety advocates oppose updated contact lens Rx release rules
Posted by on July 6, 2020

An industry group is concerned over the Federal Trade Commission’s changes to the Contact Lens Rule that permit computer-generated phone calls to verify prescriptions and require more stringent documentation for prescription release.

The Health Care Alliance for Patient Safety said in a press release that it will continue to work with Congressman Bobby Rush (D-Ill.) and Congressman Michael C. Burgess, MD (R-Texas) to pass the Contact Lens Prescription Verification Modernization Act, or HR 3975, to protect patients.

Rush said in the release that HR 3975 would correct the “outrageous loophole” of robocalls “by prohibiting automated verification calls, a practice that has no place in verifying sensitive medical information.”

A safer, more responsible and efficient verification would be email, the alliance said in the release, a cost-effective method that could provide clear, written communication to ensure patients receive their correct prescription.

Alliance chairperson Deanna Alexander, OD, said in the release that continued use of the “antiquated prescription verification” method “means incorrect prescriptions will continue to be sent to patients, which could lead to adverse vision health outcomes.”

The final rule from the FTC, announced June 23, also requires eye doctors to collect, maintain and store for 3 years signed paperwork that acknowledges the patient received their prescription.

Alexander said this requirement is an administrative burden that does not improve patient care and health outcomes.

She said the alliance “will continue to advocate for more effective means of communications with patients that don’t shift physician offices’ focus away from patient care.”

Burgess, a cosponsor of HR 3975, said in the release, “I will continue working to ensure that patients and their doctors [remain] at the center of prescribing and safe use of regulated medical devices.”

Originally published here.

 

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A Doctor's note for July 4th
Posted by on July 2, 2020
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July 2, 2020

Dear Friends,

This Independence Day weekend, as you relax and reflect, please take the proper precautions to protect your family and yourself from COVID-19. Social distancing, wearing a mask, and staying home if you are sick are little things that can make a big difference in slowing the spread.

If you need access to a COVID-19 test, there are several locations across Texas.

National Updates
The Trump Administration reestablished the Ready Reserve Corps as part of the U.S. Public Health Service to help improve our public health preparedness and response. This action is thanks to the inclusion of my bill, the United States Public Health Service Modernization Act, in the CARES Act.

Pfizer and BioNTech announced positive preliminary data emerging from one of the four mRNA vaccine candidates currently under their review.

The Department of Health and Human Services will extend its partnership with national pharmacy and grocery retail chains CVS, Rite-Aid, Walgreens, Quest and eTrueNorth to continue providing access to COVID-19 testing.

The Centers for Medicare & Medicaid Services published FAQ documents for state Medicaid and Children’s Health Insurance Program agencies on topics such as eligibility and enrollment, testing, and premiums and cost sharing.

The Federal Communications Commission’s Wireline Competition Bureau approved an additional 70 funding applications for the COVID-19 Telehealth Program, including one more in Texas.

The Centers for Disease Control and Prevention released interim guidance on COVID-19 testing for K-12 schools and institutions of higher education.

Congress passed a bill to continue the $670 billion Paycheck Protection Program through Aug. 8.


Until next time, this is your doctor's note.

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Congressman Michael C. Burgess, M.D.

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