How to Buy an FDA Approval
FDA Approval of Pure Form Hydrocodone Creates Controversy In a letter addressed to the commissioner of the FDA, a number of groups including Public Citizen were shocked at an approval of a dangerous, pure form of narcotic hydrocodone which is many times stronger than current pain medications.
Unlike the current market of pain medications, this new drug is 100% pure hydrocodone, without any additives.
This makes the bioavailability, therapeutic effect, peak concentrations, and kinetics between 500 and 1000% more effective, and more dangerous...
not to mention that the same company who makes that medication also makes a very powerful drug used for opiate ADDICTION! That's right..
they make the addicting drug and its antidote.
And the FDA approved both.
First of all, the lack of pharmaceutical education for Doctors as well as the incredible influence pharmaceutical representatives have on what professionals prescribe will make this a potentially fatal medication, literally.
"Someone unaccustomed to taking opioids could suffer a fatal overdose from just 2 capsules.
A single capsule could be fatal if swallowed by a child," reads the letter written to the FDA after approval, "[...
] the very last thing the country needs is a new, dangerous, high-dose opioid.
" Nearly 30 attorneys general from 60% of the country wrote to the chief of the FDA asking that they consider canceling the approval of the extended release version of this powerful narcotic.
According to a collective letter they wrote, "We believe your approval [...
] has the potential to exacerbate our nation's prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly 5 to 10 times more potent than traditional hydrocodone products.
" How did the FDA still approve a drug when 86% of their own advisory panel believed it was wrong? The Institute of Medicine, a powerful and influential group that is basically the standard on medical advice is a huge player when it comes to FDA approval and guidance.
Yes, they believed that nearly 40% of adults may be debilitated with chronic pain.
They're talking about the highest level of consistent chronic pain in literally nearly half of the population..
this is quite a statistic.
Dr.
Sanjay Gupta notes: "Past Journal Sentinel/MedPage Today investigations found that the boom in narcotic painkillers has been fueled in part by an aggressive push from drug companies that funded nonprofit groups which advocated for greater use of opioids.
" An incredible amount of IOM Panel members have been affiliated with these advocacy groups and were a focus of a senate committee investigation in 2012, and the FDA used their review of the new medication as reputable evidence of the need for a pure form hydrocodone.
Even when its own internal panel was against the drug, as well as a crowd of individuals from politicians, lawyers, scientists, and leaders across the country, the affiliations and conflicts of interest of important individuals who are fundamental in drug approvals were more important.
The conflicts of interest are clearly apparent in many important areas that are involved in drug approval.
The leaders and members of advisory boards are in a position where people are second priority to their own wealth, career, and ego.
Lobbyists, FDA, and Washington Many believe the FDA to be a reputable and integral part of society, yet not many understand how much they can be influenced by outside power and money.
You really don't want to believe an agency will put more priority for approval of a dangerous drug for the benefit of a number of corporate, social, and academic elites.
Although there is a role for the FDA, there is not a role for subverting our safety for profits of corporate elites and government bureaucrats.
Powerful pharmaceuticals with extensive lobbying efforts have been successful in building a profitable relationship with government officials, enough to essentially purchase an FDA approval for a medication that has widespread resistance even within the FDA's own agency through back door favors and deals in a system that rewards favoring a pharmaceutical company.
These are companies with hundreds of millions of dollars spent in the last decade just on lobbying, building these relationships, and spreading their influence to within a government agency.
This should come as no surprise as this practice is widespread across the country.
Recently, lobbying from wall street and corporate America resulted in the unrestrained ability of a corporation to denounce their American citizenship, file for headquarters in another country, and avoid paying many American taxes.
The answer is to strictly take money out of the equation, the same way money should be taken out of politics, out of campaigns, and out of Washington.
Raising awareness to this kind of injustice is a moral obligation.
From President Eisenhower,
Unlike the current market of pain medications, this new drug is 100% pure hydrocodone, without any additives.
This makes the bioavailability, therapeutic effect, peak concentrations, and kinetics between 500 and 1000% more effective, and more dangerous...
not to mention that the same company who makes that medication also makes a very powerful drug used for opiate ADDICTION! That's right..
they make the addicting drug and its antidote.
And the FDA approved both.
First of all, the lack of pharmaceutical education for Doctors as well as the incredible influence pharmaceutical representatives have on what professionals prescribe will make this a potentially fatal medication, literally.
"Someone unaccustomed to taking opioids could suffer a fatal overdose from just 2 capsules.
A single capsule could be fatal if swallowed by a child," reads the letter written to the FDA after approval, "[...
] the very last thing the country needs is a new, dangerous, high-dose opioid.
" Nearly 30 attorneys general from 60% of the country wrote to the chief of the FDA asking that they consider canceling the approval of the extended release version of this powerful narcotic.
According to a collective letter they wrote, "We believe your approval [...
] has the potential to exacerbate our nation's prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly 5 to 10 times more potent than traditional hydrocodone products.
" How did the FDA still approve a drug when 86% of their own advisory panel believed it was wrong? The Institute of Medicine, a powerful and influential group that is basically the standard on medical advice is a huge player when it comes to FDA approval and guidance.
Yes, they believed that nearly 40% of adults may be debilitated with chronic pain.
They're talking about the highest level of consistent chronic pain in literally nearly half of the population..
this is quite a statistic.
Dr.
Sanjay Gupta notes: "Past Journal Sentinel/MedPage Today investigations found that the boom in narcotic painkillers has been fueled in part by an aggressive push from drug companies that funded nonprofit groups which advocated for greater use of opioids.
" An incredible amount of IOM Panel members have been affiliated with these advocacy groups and were a focus of a senate committee investigation in 2012, and the FDA used their review of the new medication as reputable evidence of the need for a pure form hydrocodone.
Even when its own internal panel was against the drug, as well as a crowd of individuals from politicians, lawyers, scientists, and leaders across the country, the affiliations and conflicts of interest of important individuals who are fundamental in drug approvals were more important.
The conflicts of interest are clearly apparent in many important areas that are involved in drug approval.
The leaders and members of advisory boards are in a position where people are second priority to their own wealth, career, and ego.
Lobbyists, FDA, and Washington Many believe the FDA to be a reputable and integral part of society, yet not many understand how much they can be influenced by outside power and money.
You really don't want to believe an agency will put more priority for approval of a dangerous drug for the benefit of a number of corporate, social, and academic elites.
Although there is a role for the FDA, there is not a role for subverting our safety for profits of corporate elites and government bureaucrats.
Powerful pharmaceuticals with extensive lobbying efforts have been successful in building a profitable relationship with government officials, enough to essentially purchase an FDA approval for a medication that has widespread resistance even within the FDA's own agency through back door favors and deals in a system that rewards favoring a pharmaceutical company.
These are companies with hundreds of millions of dollars spent in the last decade just on lobbying, building these relationships, and spreading their influence to within a government agency.
This should come as no surprise as this practice is widespread across the country.
Recently, lobbying from wall street and corporate America resulted in the unrestrained ability of a corporation to denounce their American citizenship, file for headquarters in another country, and avoid paying many American taxes.
The answer is to strictly take money out of the equation, the same way money should be taken out of politics, out of campaigns, and out of Washington.
Raising awareness to this kind of injustice is a moral obligation.
From President Eisenhower,
"Today, the solitary inventor, tinkering in his shop, has been overshadowed by task forces of scientists in laboratories and testing fields.
In the same fashion, the free university, historically the fountainhead of free ideas and scientific discovery, has experienced a revolution in the conduct of research.
Partly because of the huge costs involved, a government contract becomes virtually a substitute for intellectual curiosity.
For every old blackboard there are now hundreds of new electronic computers.
The prospect of domination of the nation's scholars by Federal employment, project allocations, and the power of money is ever present and is gravely to be regarded.
Yet, in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy could itself become the captive of a scientifictechnological elite.
"
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