Tag Archives: FDA

Wait! What?

Posted on by

Just the News posted an article yesterday about Pfizer’s coronavirus vaccine.

The article reports:

With three promising vaccines for COVID-19 in the pipeline, there’s still uncertainty about how effective they will be.

Albert Bourla, chairman and CEO of Pfizer Pharmaceutical – which has applied to the Food and Drug Administration for emergency use authorization for its vaccine – sat down with CBS’s Lester Holt on “Dateline NBC” for an interview that will air Thursday night.

Holt said: “And then what about the question, Albert, of even though I’ve had the protection, am I still able to transmit it to other people?” according to transcript provided by the network.

“I think this is something that needs to be examined,” Bourla said. “We are not certain about that right now with what we know.”

Biotech firm Moderna on Monday said it will ask the FDA to approve its experimental COVID-19 vaccine for emergency use. Moderna said new data showed the vaccine was 94.1% effective in its late-stage clinical trial, just under Pfizer’s efficacy rate of 95%. The Moderna vaccine was developed in conjunction with the Trump administration’s Operation Warp Speed.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death,” Moderna CEO Stéphane Bancel said in a statement. Bancel said last week that 20 million doses will be available by the end of the year.

So the vaccine can prevent a person from getting the coronavirus, but the manufacturers are unsure if it will prevent a person from spreading the coronavirus. I wonder if they know how long the vaccine will last. I am asking these questions because I have had the coronavirus. I have been told that I should be immune to the virus for an unspecified amount of time and that there are questions as to whether I can transmit the virus while being immune to it. I have also been told that if I decide to get the vaccine, I should wait at least 90 days from the time I recovered from the virus. Frankly, at this point, I am not convinced that the vaccine is going to get the result that is needed. It is probably a good idea for people who have not had the coronavirus to get the vaccine–at least that will slow if not stop the spread-but how long will that protection last and how thorough is the protection provided by the vaccine?

An Interesting Question

Posted on by

CNS News posted a very interesting article today. The article asks the question, “Why No Warning Label on Marijuana?” That is a fascinating question. The government puts warning labels on everything–my hairdryer reminds me not to use it in the shower, my iron reminds me that it can get hot, the coffee I buy at Dunkin’ Donuts (I did live in Massachusetts for a very long time) tells me on the cup that the contents may be hot. So why is marijuana exempt from big daddy government?

The article reports:

The best known warning label, of course, is the one that the United States Surgeon General has required on cigarette packs since 1966. Also well-known is the warning label on alcoholic beverage containers, which states that drinking alcohol during pregnancy may cause birth defects, that people should not drink and drive, and that alcohol may cause other health problems.

That marijuana is a drug there is no doubt. The FDA states that “marijuana and marijuana-derived products” are “drugs.”

According to the National Institute of Drug Abuse, marijuana is “the most commonly used illicit drug in the United States.” According to the Drug Enforcement Administration (DEA), “marijuana is a mind-altering (psychoactive) drug.”

The Surgeon General’s 1996 report entitled “Facing Addiction in America” describes marijuana as one of the “addictive drugs.”

Likewise, marijuana is not safe.

Despite all the recent changes in many state laws over the last five years and the massive public advocacy and lobbying of the emerging multi-billion-dollar marijuana industry, the FDA has not changed its position on marijuana but continues to hold that it “has not approved marijuana as a safe and effective drug for any indication.” Now, within the last nine months, two new reports on the dangers of marijuana have been issued.

So why are reports of the dangers not resulting in warning labels?

The article contains on example of the warning that would be appropriate for marijuana:

WARNING. Using cannabis can lead to the development of schizophrenia, other psychoses and other mental-health problems. Cannabis can cause hallucinations, delusions, and panic attacks. Cannabis can cause an increase in suicide ideation and suicide attempts. Smoking cannabis can worsen respiratory infections and bronchitis episodes. Using cannabis can lead to an increased risk of motor vehicle crashes. Maternal cannabis smoking is associated with the lower birth weight of babies.

The crusade against cigarettes included both warning labels and an extensive public-education campaign. Today, public education about marijuana consists in emphasizing that legalized marijuana will supply both “jobs and taxes.”

The usual answer to the type of question the article asks is ‘follow the money.’ In this case, it seems that many states are more interested in the tax money they will receive from the legalization of marijuana than the damage it will cause to the people using it. I don’t object to the legitimate use of marijuana for medical purposes, but if you look at the ads in the back of the newspaper in states where medical marijuana is legal, you quickly realize that an unethical doctor can write a prescription for marijuana to cure an ingrown toenail. There are so many areas where the government interferes to ‘protect’ Americans, it is interesting that the government chooses to remain silent about a danger that is rapidly becoming socially acceptable.

Another Industry Suffering From Overregulation

Posted on by

The Washington Examiner posted an article today on the government-caused drug shortages America is experiencing. Yes, you read that right.

The article reports that prescription drug shortages tripled from 2005 to 2010 and reached record levels in 2011 as manufacturers ceased operations or ran into production problems.

The article reports:

Last year, nearly half of hospitals reported experiencing a drug shortage on a daily basis, according to a survey of 820 hospitals by the American Hospital Association. About 82 percent of hospitals said they delayed treatment because of a shortage, and 35 percent of hospitals said patients experienced “adverse outcomes.” The survey did not categorize those outcomes, a spokeswoman said.

So what is going on? The Federal Food and Drug Administration (FDA) has increased its enforcement efforts. The article explains:

…the FDA’s “zero tolerance” regime is forcing manufacturers to abide by rules that are rigid, inflexible and unforgiving. For example, a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.

We elected this government. We are responsible. The only way to fix this is to unelect everyone who has worked toward bigger government and more regulation and elect people who want smaller government and less regulation. It’s up to us.

 

Enhanced by Zemanta

Hidden In The Small Print…

Posted on by

Big Government is reporting today on some aspects of ObamaCare that I don’t think any of us had considered. Your cell phone is about to become a medical device (yes, you read that right) and your own stem cells are drugs. Good grief!

The article reports:

And because your phone has on it the two dollar blood pressure app – the Obama FDA asserts that they can thusly regulate your entire phone.  Because according to them that one app has turned your phone into a “medical device.”

Under the FDA’s expansive parameters, almost any device on which you do almost anything regarding your health – your smartphones, your tablets, your desktop and laptop computers – will be regulated.

Did you use your smartphone/tablet/computer camera or microphone to monitor something health-related?  It just became an Obama FDA-regulated medical device.

Did you save your health care data on any smartphone/tablet/computer? That too is now regulated.

Did you send an email containing any health care information to your doctor?  The device from which you sent said missive is too now regulated.

…Obama’s FDA is concurrently asserting that the adult stem cells in your body are a “drug” – and that therefore your body is now government regulatory property.

In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!…

We have entered the Twilight Zone. If you care to leave the zone, please vote Republican in November.

Enhanced by Zemanta