Thursday, September 3, 2020

USA is One Selfish Country

The US of A is one selfish country! 

The administration of United States President Donald Trump (left) have said on Tuesday they will not participate in an international effort to develop and distribute a coronavirus vaccine because the initiative is tied to the World Health Organization. 

What the Americans are saying is that they are abandoning multilateralism; instead, embracing unilateralism. 

The decision to go it alone followed the White House's decision in July to pull the US out of the WHO. Trump had claimed the WHO are in need of reform and are heavily influenced by China. 

I contend that it is the US that is in dire need of reform and that the country wants to singularly dominate the world as the one and only superpower. 

Some nations – for sure, the US stands out – are already working directly to secure vaccine supplies, while many others are pooling efforts to ensure success against a disease that knows no geographical boundaries. Actually, more than 150 countries are involved in setting up the COVID-19 Vaccines Global Access Facility, or COVAX. 

That cooperative effort, linked with the WHO, would allow nations to take advantage of a portfolio of potential vaccines to ensure their citizens are quickly covered by whichever ones are deemed effective. And that is the way to go. 

The WHO correctly maintain that even governments making deals with individual vaccine makers would benefit from joining COVAX because it would provide backup vaccines in case the ones being made through bilateral deals with manufacturers are unsuccessful or less than successful. 

But White House spokesperson Judd Deere mocked WHO and China. 

"…we will not be constrained by multilateral organizations influenced by the corrupt World Health Organization and China", he had said. "This president will spare no expense to ensure that any new vaccine maintains our own Food and Drug Administration's gold standard for safety and efficacy, [and] is thoroughly tested and saves lives". 

LOL! Americans should not forget that the FDA have a history of making some pretty huge blunders that have ended in irreparable damage and even death! Here are just 3 of the many disastrous FDA mistakes that unleashed harmful drugs into the US market. 

Quaaludes (Methaqualone) were a sedative and hypnotic used as a sleeping aid between 1962 and 1985. 

They were, in a word (and in every sense of that word), volatile. Many of the helpless insomniacs and anxiety sufferers who took the drug to get a little shut-eye ended up becoming manic, seizing, convulsing, vomiting, and sometimes even dying. 

Or, they ended up addicted. Quaaludes are now considered a Schedule 1 drug (like heroin and LSD), but even before being approved by the FDA, research pointed to possible issues of dependence and abuse. By the 1970s, Quaaludes had become a wildly popular street drug. In 1982 alone, there were 2,764 reported emergency room visits as a result of Quaalude use. 

Cylert (Pemoline), first released in 1975, was intended to treat ADHD/ADD by stimulating the central nervous system. Geared towards children, it boasted its safety by proclaiming its minimal cardiovascular effects. And, indeed, there were no heart problems – only liver toxicity. 

There were 13 cases of acute liver failure reported to the FDA, eleven of which resulted in death or liver transplant. While this number may appear inconsequential, the reported figure is based on the ability to positively recognize the connection between the drug and the health problem. For any number of reasons, it can be difficult to directly make the connection. 

As a result, reported incidents of harmful side effects are often just a fraction of the actual number of incidents. As the warning label on the box (not added until 1999) stated, estimates of liver failure “may be conservative because of under reporting and because the long latency between initiation of CYLERT treatment and the occurrence of hepatic failure may limit recognition of the association. If only a portion of actual cases were recognized and reported, the risk could be substantially higher”. 

According to the nonprofit group Public Citizen (which petitioned for the removal of Cylert from the market in 2005), alongside the reported cases of liver failure, there were 193 “adverse drug reactions involving the liver in patients younger than 20 years old” between 1975 and 1996. 

Nonetheless, Cylert stayed on the market until 2010. Even then, the spokesperson for its creator, Abbott Laboratories, stated the drug was being discontinued due to falling sales, rather than safety concerns. However, in the FDA’s own reference archives, they admit that “the reporting rate for liver failure with pemoline is 10 to 25 times greater than the background rate of liver failure in the general population”. 

Vioxx (Rofecoxib), an anti-inflammatory medication intended to treat arthritis, was the subject of one of the largest recalls in history. 

After it was approved in 1999, it was prescribed to over 20 million people and was one of the most widely prescribed drugs of 2003. The following year, it was recalled. 

While original clinical trials showed no increased risk of heart attack or stroke, later studies revealed a large number of heart attacks associated with the drug. The dangers of Vioxx were made known to the FDA and the drug’s manufacturer, Merck, in 2000. 

In 2001, a cardiologist at the Cleveland Clinic, Dr Deepak L Bhatt, proposed to Merck that Vioxx be studied in patients with severe chest pain in 2001. The company declined, saying that, that kind of study would not reflect the typical Vioxx user. 

However, what’s more plausible is that Merck was simply more worried about sales. In 2003 alone, Vioxx brought in $2.5 billion. So, instead of letting troubling studies lead to a recall or even any further research, a small warning was added to the box in 2002. 

Eventually, however, trials were conducted to test the drug’s long-term effects. But that trial couldn’t even be completed because of the increased risk of heart attack and stroke among participants. 

In revealing internal memos that were eventually uncovered, one of the FDA’s own scientists, Dr David Graham, estimated that Vioxx had been associated with more than 27,000 heart attacks or deaths linked to cardiac problems. 

So, don’t even entertain the thought that America is not infallible.

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