FDA

Will more or less time save or cost lives? Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research

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Will more or less time save or cost lives?

 Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research

According to Dr. Steven Goldstein, founder of the Houston Healthcare Initiative, it usually takes years for any vaccine to be developed, tested on humans and finally introduced to the public. What of the Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research? The much-anticipated vaccine for the Coronavirus/Covid-19 pandemic is progressing at unprecedented speed. But why is this the case and should the public be concerned? On his regular podcast Dr. Goldstein provides explanations. The listen to the Houston Healthcare Initiative podcast visit: Soundcloud, Libsyn, iHeartRadio, Apple Podcasts, Spotify, Stitcher, and Radio.com,

Timing

Will more or less time save or cost lives?
Will more or less time save or cost lives? Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research.

Dr. Goldstein described to his audience some of the reasons these vaccine trials were progressing so quickly. “Given the urgent need for a vaccine to help end this global pandemic, some vaccine developers are compressing the clinical process by running trial phases simultaneously,” Dr. Goldstein said. “Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said that independent Data and Safety Monitoring Boards can end trials early if their interim results are overwhelmingly positive or negative, so that is another time saver.”

Caution Takes Time

The Food and Drug Administration (FDA) promised to fast track the approval process for a Covid-19 vaccine. But they have also said that there are far more rigorous standards in place than is typical for the Emergency Use Authorization (EUA) process for this vaccine. So while the NIAID made a way for the work on the vaccine to proceed more quickly than normal, the FDA says that its work will be ‘a careful evaluation with no rushing.’

The FDA Speaks

In an article published in the October 27, 2020 issue of USA Today, Dr. Peter Marks states that “this process will not be rushed. There will be no shortcuts in developing the relevant phase 3 efficacy results.” Dr. Marks also said that the public’s trust is important for the Covid-19 vaccine so it gets taken by the public. “Trust means everything. Trust in vaccines facilitated the incredible positive impact that vaccination had on public health in reducing illness and death over the past century.”

Not Predicting The Future But

Dr. Goldstein admitted that he was not very good at predicting the future, but he believed that the Coronavirus/Covid-19 vaccine could be available as early as January 2021. “There are currently dozens of vaccines under development and in the advanced stages of approval,” Dr. Goldstein said. “That the government has streamlined some of the requirements without compromising safety to help advance development is remarkable. But nothing in the world of medicine is without risk and the ultimate introduction of the Coronavirus vaccine is no exception. The laws and regulations, at least for now, seem to strike a balance that protects the public and aids in the fast delivery of a vaccine.”

About The Houston Healthcare Initiative

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America.

 

Federal Government Goofs Delayed Coronavirus Tests By 6-8 Weeks

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The United States badly bungled coronavirus testing.
The United States badly bungled initial coronavirus testing. Federal Government Goofs Delayed Coronavirus Tests By 6-8 Weeks.

Federal Government Goofs Delayed Coronavirus Tests By 6-8 Weeks. On his regular podcast Dr. Steven Goldstein described how failures within the federal government delayed proper testing for the Coronavirus/Covid-19 virus by several weeks.  The outcome? Tracking and tracing the infection early in the process was impossible. The Houston Healthcare Initiative Podcast is available on SoundCloud, iHeartRadio,LibSyn, Spotify,  iTunes, Radio.com, Stitcher, ListenNotes, Podcast Addict, or the Houston Healthcare Initiative web site.

Early Kit Troubles

Early in the testing process the Food and Drug Administration (FDA) sent Coronavirus/Covid-19 test kits to approximately 100 health labs across the country. Initially the FDA had done all the testing in in-house, but more cases meant that tests had to be available in more locations. There was just one, very important mistake and that was there was no way to validate the tests and its ingredients all acted the same way when used, regardless of the location.

Thirty-six of the approximately 50 tests returned results to the FDA that were ‘inconclusive’. Manufacture of new ingredients for the tests took 3 weeks. The failure to get working test kits into public-health labs came at a really bad time. Early in any outbreak, contact tracing, isolation, and individual quarantines are used to contain the spread of disease. These steps don’t work when suspected cases cannot be tested. The gap made by the bad test kits made it impossible for public-health officials to get a read on how far and fast the disease was spreading. The result, Covid-19 spread undetected for several weeks. “The government was not prepared when it came to identifying and quarantining contacts of the first patients and preventing sick patients from entering the country,” Dr. Goldstein told his listeners. “Government bureaucracy delayed the development of laboratory tests for 6-8 weeks.”

Worse still, when an Emergency Use Application (EUA) test was sent via email and followed up with phone calls from the University of Washington Virology Lab to the FDA for approval, the applicants learned that U.S. law required a hard copy of the applications be sent with a CD or thumb drive via the U.S. Postal Service to be considered. Instead of using more advanced communications like e-mail the lab was forced to use ‘snail mail’. (The F.D.A. has since dropped the requirement to send a CD-rom or USB drive with a copy of the application).

Bureaucrats Want More Power Not Less

According to Dr. Goldstein, issues like this have more to do with the bureaucratic class maintaining its influence than protecting the public or any devotion to science. “People ensconced in government bureaucracy want to preserve their authority and it seems that they are willing to take drastic measures to preserve that power,” Dr. Goldstein said. “These people are very invested in expensive, high tech treatments. Low tech measures like contact tracing and quarantining and testing anyone entering the country could have controlled the epidemic early on.” One possible lesson from this is to remember that government takeover of any health crisis will persist long past any benefit is exhausted. Finding ways around these career government employees should be part of any proposed reform for the healthcare industry.

About the Houston Healthcare Initiative

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America. Federal Government Goofs Delayed Coronavirus Tests By 6-8 Weeks.

 

Possible Remedy for the Coronavirus/Covid-19 Global Pandemic Invites Immediate Controversy

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Blood Plasma
Possible Remedy for the Coronavirus/Covid-19 Global Pandemic Invites Immediate Controversy
Treatment with blood plasma from recovered patients is an accepted practice that goes back to the early 20th century.

Possible Remedy for the Coronavirus/Covid-19 Global Pandemic Invites Immediate Controversy.

On August 23, 2020 the Food and Drug Administration (FDA) announced a decision to grant blood plasma treatment for Coronavirus/Covid-19 patients with a fast-track authorization for its emergency use as a treatment for hospitalized COVID-19 patients.

The next day, claims about the effectiveness of this treatment were retracted. Subsequent news coverage about this potential treatment did little to clarify blood plasmas’ usefulness or lack thereof. The idea that there could be a political motivation behind the fast track authorization for this potential treatment, other than looking for a useful therapeutic, is troubling.

Who Can Americans Believe?

On his regular ‘Houston Healthcare Initiative’ podcast, respected neurologist Dr. Steven Goldstein defines how this decision triggered an outcry from scientists and doctors, who said the decision was not supported by adequate clinical evidence and criticized the FDA for what was perceived as bowing to ‘political pressure’.

Dr. Goldstein also reviews those who believed this approach was worthwhile. Generally, treatment with blood plasma from recovered patients is an accepted practice that goes back to the early 20th century. Many believe the possibility that blood plasma from recovered Coronavirus/Covid-19 patients could help people fight off the virus was worthy of further investigation.

Who is correct? Who should the American public rely on for the best information about treatment for this global health emergency?

The Houston Healthcare Initiative podcast can be heard on: SoundCloud, Apple Podcasts, Stitcher, Listen Notes, iHeartRadio, and the Houston Healthcare Initiative web site.

About Houston Healthcare Initiative And Dr. Steven Goldstein

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America. Blood plasma treatment for Covid-19 patients invites controversy.

The Reforms Big Pharmaceutical Companies Need

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Reforms for the pharmaceutical industry.
Dr. Steven Goldstein has ideas that will make the pharmaceutical industry more responsive to the American public.

The Reforms Big Pharmaceutical Companies Need. On his regular podcast, Dr. Steven Goldstein advocated dramatic reforms for the pharmaceutical industry and with good reason. To hear the podcast go to: SoundCloud, iHeartRadio, Stitcher, Backtracks, LibSyn, or the website at www.houstonhealthcareinitiative.org. Dr. Goldstein insists that for the health and welfare of the American public, the congress must pass reforms that limit the influence of the pharmaceutical industry and its lobby.

What Has To Change – Ban Pharmaceutical Lobbying

“Corporate lobbying by pharmaceutical companies should be illegal,” Dr. Goldstein told his audience. “It isn’t right.” The companies who make more expensive treatments for ailments that could be treated with generic medicines spend millions of dollars lobbying the congress. According to a study by Brigham Young University, the health sector lobby’s spending increased more than 10% in the first quarter of 2020 while the non-health lobby sector increased 1%. Meanwhile, the number of new lobbyists registered in the health sector increased a staggering 140% while non-health sector registrations increased 63%.

Patent Reform

Drug companies should not be permitted to obtain patents because of small modifications to already existing patented medication. “That is not what the spirit of patent protection was meant for,” Dr. Goldstein said. He also advocates that existing antitrust laws be enforced to stop price fixing. “An example is the predatory practice of larger drug companies paying off small generic manufacturers in order to eliminate competition,” Dr. Goldstein said.

Prescription Reform; Physicians Prescribe Not Pharmacists or Bureaucrats

Physicians should be free to prescribe drugs “off-label” without fear of lawsuit or sanctions from state or federal regulatory boards. “Full stop, no questions from non-physicians, pharmacists or government regulators,” Dr. Goldstein stated.

FDA Reform

The Food and Drug Administration (FDA) is charged with making sure drugs are “safe and effective”. “If you think about it, there is no such thing as a drug that is 100% safe or 100% effective,” Dr. Goldstein said. “Even aspirin can cause gastritis and intestinal bleeding that in rare instances can cause death. Drugs used to treat epilepsy are only about 50% effective.  How then does the FDA decide what drugs to approve? After randomized controlled trials are performed, a panel of “experts” decides which drugs to approve.”

About Houston Healthcare Initiative and Dr. Steven Goldstein

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America. The Reforms Big Pharmaceutical Companies Need.