I also hope the new administration makes the changes and starts to be ethical. Can't they see that they are dealing with the most important thing - HEALTH?
Their work affects not only American citizens but citizens from all over the world.

I'd be in hog heaven if one of the "medical devices" were ECT machines. They never have been approved for "safe" use by the FDA. They are still classified in a catagory (can't remember exactly) that states it could be harmful. Since these machines had already been in use before the FDA started their approval process, they were grandfathered in. Here is part of a petition that was submitted to the FDA that holds a few pertinent details regarding this:

To: Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane (Room 1061)
Rockville, MD 20852
The Committee for Truth in Psychiatry submits this petition pursuant to 21 CFR
10.30 to request the Commissioner of Food and Drugs to maintain the electroconvulsive
theranv device (882.5849) in Class III for all indications.
Part A. SPECIFIC ACTION REQUESTED
The FDA is charged with the responsibility of categorizing medical devices
according to the degree of risk they pose and the degree of oversight they require. The
electroconvulsive therapy (ECT) device is a pre-amendments device which has never
been tested for safety or efficacy; for which manufacturers have never presented any
evidence of safety or efficacy although ordered to do so by the FDA on August 14,1995
(FR 60: 41984); and for which no Premarket Application has been called for or
submitted.
On September 4, 1979, the FDA classified the ECT device into Class III under the
Federal Food, Drug and Cosmetic Act (FR 44:5 1777), identifying eight risks to health
including brain damage and memory loss.
FDA’s original classification was correct. Since that time, more valid scientific
evidence has accumulated as to the risks of the device. Since that time, the manufacturers
have not conducted a single study nor submitted any evidence showing that the original
classification was incorrect. Under Section 515(i) (21 U.K. 360e(i)) of the Safe Medical
Devices Act of 1990 (SMDA), manufacturers of ECT devices were required to submit all
safety and effectiveness information known to them by August 14, 1997. No
manufacturer ever submitted anything in response to the order.

Great Post...Though, the acts of the FDA are not any different than those of many government agencies.

Dear Philip:

In the case of the FDA; seeing real action is believing in this particular situation! There’s lot’s of smoke coming out of those offices, but where is the action and fire? They can’t even respond to the criticism and questions from the very people they represent.

Hoping for a complete clearing house in the FDA when this new administration that is in bed with Big Pharmaceutical by all those millions of dollars they have in their pockets to get elected in the first place. I won't be holding my breath!

Yet, I guess there is always hope! And if not hope, there are still wondrous dreams of a better tomorrow.

Yours Truly,
Stan

HIT THE PAYPAL BUTTON READERS!

This is outstanding investigative journalism Philip, thank you for your time and efforts!

I ditto what Stephany just wrote!

Great work Philip!

Those that can, please HIT THAT PAY PAL BUTTON!

Yours truly,
Stan

Wow the FDA is now recognizing bi--polar disorder in children. I always knew that I was special! :)

The Conversion of Our Protector

The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States in regards to what they consume that is provided to them by manufacturers, primarily. The one person who became the catalyst for the formation of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in this book.

While the author intended with composing this book, “The Jungle”, to address and focus for the benefit of the readers the effects of capitalism, the issue regarding food safety is what ultimately captured the attention of everyone, including the president, so the FDA began during this time.

However, their purpose and function seems to have changed the past few decades, as the FDA appears to have decided to ensure the health of certain industries instead of the public health, one may posit.

One example is the large amounts of money the industry gives the FDA for various reasons created recently- amounts so large that this accounts, according to some, for about half of the FDA’s total income, although it is by definition a governmental administration. An example of stated reason for receiving such funds is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and is now required to pay the FDA for faster approval of their pending medications after pharmaceutical companies submit a new drug application to the FDA. The FDA also accepts over a million dollars from the pharmaceutical industry to give their pending new drug a priority review of 6 months instead of a year, along with a created etiology for this urgency often.

Results of this relationship, which some have called collusive and intimate, between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs as demonstrated by their removal of, or the labeling change requiring what is known as a black box warning of such drugs, which means that the drug is basically on probation. The lack of regulation and monitoring required by the FDA of such industries as the pharmaceutical one may be why there is this progressive safety concern of medications prescribed to many in the United States. In addition, perhaps, the FDA continues to validate what has been surmised through their known financial support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public. The following is an example of how corrupt the FDA now is:

The presumed intimacy between these two organizations, the pharmaceutical industry and the FDA, does in fact seem to continue to worsen. For example, and recently, the FDA considered supporting overtly this client of theirs, the pharmaceutical industry, to allow their promoters to discuss their products that may or may not have been approved by the FDA for any disease state the individual corporation may decide may be best for them, and certainly not the patients of the health care providers who may receive such discussions and encouragement. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative of the marketer of a particular medication, which remarkably mirrors the premise and objective of this industry already. So this strategy, void of any protection of public health, and this is rather delusional if not absurd, to say the least, as likely any clinician would argue this dangerous methodology.

A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically and legally, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity that deviates from the product insert that illustrates the medication’s indications. In fact, it is a federal offense for such representatives to speak off-label about the drugs they promote, and more pharmaceutical companies are and have been penalized for this activity in the form of large settlements in the past as determined to some degree by the department of justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, rarely admit guilt as part of such settlement agreements, which include agreements where the corporation is not prosecuted. Off-Label activities are only some of the federal laws that have been frequently fractured in a progressive manner as well.

This off-label FDA protocol for drug representatives that has been described and proposed by our FDA is called, “Good Reprint Practices.” This would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials that aseptic and without bias, when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug representatives, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the medications involved in such trials- often by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol suggested by the FDA, yet possibly a protocol influenced by others. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration when they did suggest this ridiculous and frightening authorization.

Furthermore, this proposal is flawed in that most pharmaceutical representatives lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug representatives have little medical or clinical training in any objective way. So this seems to further complicate the idea of this off-label concept due to the ignorance of the representatives In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for representatives of the pharmaceutical industry to embellish statements to prescribers for their own benefit in regards to their promoted medications they present to them. In fact recently, a study by Sermo concluded that 90 percent of doctors want clinical evidence based medicine from educated and trained professionals instead of pharmaceutical sales representatives, which according to this study, 80 percent of doctors do not wish to interact with these reps, yet will accept samples and literature related to of their products.

So, our previous safety administration, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices that aggravate the existing situation with the lack of efficacy of the FDA.lth, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies.

It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of any benefit to patient health.

Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.

However, there is freedom of speech, but in the amendment should certainly be restrictions in regards to public health, as speech should be accurate and objective when conducting dialogues with prescribers. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval.

Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interest, and I believe we as public citizens demand that the FDA be reconstituted and reformed to their original purpose.

“Unlimited power is apt to corrupt the minds of those who possess it.” --- William Pitt

Dan Abshear (author’s note: what has been written was based on information and belief)