Posted on 01/29/2021 2:08:13 PM PST by Kaslin
Source: Official White House Photo by Shealah Craighead
COVID-19 has upended our lives and highlighted government incompetence, but it is also necessary to showcase government’s successes during the pandemic. Perhaps the greatest example of government success concerning the pandemic is the Trump administration’s Operation Warp Speed.
In short, due to the Trump administration’s no-nonsense approach regarding the development of the vaccine, in which the federal government partnered with several private companies and drastically reduced red tape and regulatory hurdles, the United States has three viable vaccines.
Remarkably, Operation Warp Speed has resulted in multiple vaccines in less than a year. Before Operation Warp Speed, it took years to develop and approve vaccines.
Arguably, one of the key reasons the development of these vaccines occurred in such a short period is due to groundbreaking mRNA technology. This new approach to vaccine delivery is revolutionary and could lead to all sorts of other health care breakthroughs. In the future, the use of mRNA technology to cure other life-threatening diseases, like cancer, is what we can and should hope for.
Given the overwhelming success of Operation Warp Speed, one cannot help but wonder if the same approach should be applied across the board in terms of drug development. On average, it takes 12 years and $2.9 billion to bring a drug from lab to market. But like we saw with the successful development of the COVID-19 vaccine, this is not the way it has to be.
Millions of Americans are suffering with chronic diseases other than the coronavirus. The same urgency should be applied to developing drugs and treatments for their ailments.
Supporters of Food and Drug Administration (FDA) reform simply desire to put the best interests of patients first and foremost. There are several ways this can be done. For example, removing regulatory barriers to innovation is a first step. Free to Choose Medicine (FTCM) is a policy proposal that does just that.
Free to Choose Medicine (FTCM) would apply free market principles to the draconian drug approval process by allowing patients to have access to therapies before they have received the gold stamp of approval from the FDA.
In short, FTCM would create a pathway for patients who have exhausted all other treatment possibilities and want access to unapproved, yet potentially life-saving, therapies.
Currently, Right to Try (RTT) legislation contains a similar goal, but RTT is internally flawed because it doesn’t provide a market incentive for a bio-pharmaceutical company to bypass efficacy testing.
FDA has the final say on all drug production in America. Unfortunately, onerous FDA regulations stifle drug development because of the high costs and extended timeline they impose on drug manufacturers. When patients have no good options, it should be up to them to choose whatever medicine they prefer, not the FDA.
FTCM would bring drugs to market sooner and would lower costs by removing the labyrinth of unnecessary efficacy testing.
If a drug has passed initial safety testing, it should be made readily available to patients fighting for their lives. If a drug is being tested on patients via clinical trials, then any patient suffering should have the freedom to choose it as a treatment option as well.
The goal of FDA should be to allow good drugs to succeed sooner, and bad drugs to fail faster. We saw this happen with the COVID-19 vaccine. We know it can be done.
America should be front and center, leading the world in the development of the state-of-the art drugs and treatments. But unfortunately, FDA’s arbitrary regulations blunt the development of timely, affordable drug development. It is time for FDA to act as a bridge to innovation, not a barrier, and build off the success of Operation Warp Speed, which is a testament that drugs can be developed in record time, as long as the FDA gets out of the way.
It still takes years. We are just cutting corners, and not jumping to approval, when, in reality, it's still phase 1.
What we learned from Operation Warp Speed is that Shaft is not the only bad mother...(shut your mouth!) around. President Trump made that program happen.
And several others jumped ahead of where they would have otherwise been. We also learned that smart negotiation can yield fantastic results. For example, negotiating to buy doses ahead of time from the most promising vaccine candidate manufacturers allowed those manufacturers to begin producing doses before clinical trials were complete so that if they passed muster, we wouldn’t have to wait several months for factory retooling and production to begin. That alone shaved several months - at least - off the timelines for these vaccines.
I wouldn’t get near the vaccine. Imho, this vaccine is one of Trump’s bad calls. He didn’t have a lot of them, but this is a pick-6.
Agree with xzins!
For a most interesting interview on this subject, (until they pull it down!) Lee Merrit, M.D.
https://www.youtube.com/watch?v=3mPIomjWwd4
The administrative state put the kibosh on investigating treatments like Ivermectin and HCQ basically for this reason. Of course there is no profit in generic drugs so they wanted the tens of billions of dollars in research into vaccines. But ultimately, perhaps at the expense of many lives, they wanted the money hoping this mRNA tech could become more versatile down the road. There was no reason they couldn't have done both, except that they needed the virus to remain lethal to justify the expense. Fauci and the FDA/CDC/(NIH) basically did the same thing when it came to HIV/AIDS research, only it took them more than a decade to approve a treatment regimen. Of course people like Magic Johnson were able to get on the treatments while more than 10,000 regular people, gay or straight, wasted away and died waiting.
This is a Democrat talking point used to smear President Trump's efforts. Why repeat Pelosi and Cuomo's nonsense?
"in reality, it's still phase 1."
No, Phase 1 clinical trials were in March and April 2020. Phase 2 clinical trials ran through July. Phase 3 clinical trials ran through November 2020.
This is going through the normal process. The FDA has 4 distinct approaches for accelerated approvals, and anything going onto any of the accelerated tracks must be reviewed and approved just to start that process. These are established programs that have existed for decades. More information on them is here. These have been used before for other things and they'll be used again for other things. There's nothing unusual about the testing and approval process for these vaccines.
Pfizer Admits Vaccine Does Not Prevent COVID
Lol. The Democrats are pushing the vaccine 100%.
No, Phase 1 clinical trials were in March and April 2020. Phase 2 clinical trials ran through July. Phase 3 clinical trials ran through November 2020.
Just because you call something by a name, doesn't make it true.
Phase 1 trials don't take two months. Phase 2 trials can last a couple years. Phase 3 trials last 1 year to 4 years.
Now that Biden is in office, sure. When these were the Trump vaccines they were "rushed" and "extremely dangerous" (-Pelosi) and Governor Cuomo "wouldn’t recommend to New Yorkers based on the federal government’s opinion". Louis Farrakhan called the vaccines "toxic waste". Kamala Harris, Joe Biden, most of the rest of the Democratic leadership have questioned or outright claimed that President Trump was rushing the vaccines for political purposes. So again, these are Democrat talking points used to smear President Trump. They're not based in fact.
"Phase 1 trials don't take two months. Phase 2 trials can last a couple years. Phase 3 trials last 1 year to 4 years."
You've again completely ignored the FDA's 4 distinct processes for making new drugs available quickly when there is an urgent need. Here is the link again in case you missed it.
There is nothing unusual about this. These processes have existed for decades.
Just because the FDA says it, doesn’t make it true. Look what happened in 1976. Look how many FDA-approved drugs have to be recalled.
Remember when President Trump declared an emergency because of COVID? And Obama/Biden era rules made it so that under an emergency only the CDC could do testing, and any other labs could be charged criminally if they did not run all proposed testing through the CDC approval processes?
1) The Deep State is in control. ALWAYS.
2) The way COVID cases are defined CHANGES the day the Demonrat Pretendent is inaugurated, when Trump gave up and stepped down.
3) Fauci tells lies every single day. ALWAYS.
4) The vaccines are not necessary, except for the very old and infirm, and even then, the side effects are terrible. You may even die from it.
Remember also when the government went to retrieve stockpiles of emergency medical supplies, PPE and Ventilators, and found that they had been used and not bothered to be replaced under the Obama Administration? And many states hadn’t bothered to procure what they were supposed to either?
If you have to go back 45 years to find a significant example of a problem, that seems like a good track record. And sure, some drugs have been recalled; not because of a flaw in any of the accelerated tracks, but because sometimes new evidence only comes to light after 50 million people have had the thing because the particular issue is that rare or difficult to spot.
That's why we have VAERS as a supplement to all the clinical trials and all the routine monitoring that's done to identify any issues with new drugs or vaccines: to find anything else that falls through the cracks.
The criticisms you're levying here are not against the COVID-19 vaccines, nor the process used to approve their use. You're critiquing the entire FDA approval process as being somehow too lenient, when in fact it's one of the most stringent in the world and often keeps new life-saving drugs out of the hands of people who desperately need them for years. That's the entire basis for why the expanded access ("compassionate use") program was created: because the FDA drags their feet on everything. And even in that slow meandering process, some things get missed.
If you want to demand perfection, you'll never see a new drug or vaccine ever approved for use ever again. No one will even bother trying.
Most respectfully, you’re wrong.
One commenter had written this:
“Before Operation Warp Speed, it took years to develop and approve vaccines.”
You replied with this inanity:
“It still takes years. We are just cutting corners, and not jumping to approval, when, in reality, it’s still phase 1.”
Who cares some the FDA hacks define “development”, “approval”, Phase I, Phase II and Phase XXVII
Here’s the reality.
The vaccines have been shown to work,and they are being given to a million people a day.
TRUMP tried to get Americans Hydroxychloroquine but the Medical Industrial Complex fought him...
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