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Trusting The FDA

In a post I put up last September, I asked “What Is Going On With The FDA??

Thanks to a couple of articles I figured it out.

There’s a reason it takes so many years for the FDA to take action against “dangerous” drugs like children’s cold meds, Rocephin, and Haldol. These drugs have all been on the market for more than 15 years and in just the past six months, the FDA came to the conclusion that they were all a threat to American lives.

Enter the GAO.

In a New York Times article, government investigators have just reported that the FDA is woefully understaffed. The article stated that at the FDA’s current staffing level, it would take more than 13 years to check every foreign drug manufacturing plant, and more than 1900 years to check every foreign food manufacturing plant. No, I didn’t have a nervous twitch on the “0” key. The article states “one thousand nine hundred” years to check all the foreign food manufacturing plants. In fact, the FDA computer systems are so bad that they can’t even create a list of which plants have been inspected and which have not.

A Wall Street Journal article reported that the FDA can’t even keep up with inspection of domestic manufacturers of medical devices (like defibrillators and contact lenses).

A former lawyer for the agency stated that “This is a fundamentally broken agency, and it needs to be repaired.”

So it isn’t like Big Pharma is paying off the FDA to approve drugs while they are on patent and then put danger labels on them when they are off patent (and no longer earn the drug cartels companies any money). It’s just that the FDA is so overworked that 15 years is about how long it takes until they can review a drug’s safety profile.

Doesn’t that make you feel better?

Hat Tip to ACEP‘s Emergency Medicine Today

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  1. What is dangerous about Rocephin other than overuse?

    See here.

  2. Holy cow and I thought the UK agency is slow.

  3. just thought I would point out that there is nothing inherently dangerous in children’ cold meds, the problem is the people administering them. Apparently parents don’t read the labels and end up overdosing the child. Now parents just end up calling the doctor and getting a dose from him.

  4. NO! Doesn’t make me feel better. BTW…our boys were usually healthy but they grew up getting OTC meds when I felt they would benefit from them.

    It is unnerving to think that things from other countries with less stringent controls can be sent over here for consumer consumption and they might not be safe. You have burst my perfect world bubble WhiteCoat! or to think that dangerous substances are getting through to the consumer.

    I know everything is about budhet today but can’t they fix the system and give them what they need to do the job right?

    Are they still using Rocephin?

  5. Rocephin is the first-line treatment for old-fart UTI requiring IV abx and pyelonephritis in our hospital. According to the big abx chart hanging on our wall it’s more effective than Cipro…

  6. When I had the big stent in when my urological treatment was really getting underway…i developed an e-coli infection and became resistant to every oral antibiotic urodoc eas giving me. i am pretty sure when he had me admitted for IV antibiotic prior to removing the stent that it was rocephin that they gave me. Do they still give it? What is the problem with it? it worked for me.

  7. When I had the big stent in when my urological treatment was really getting underway…i developed an e-coli infection and became resistant to every oral antibiotic urodoc eas giving me. i am pretty sure when he had me admitted for IV antibiotic prior to removing the stent that it was rocephin that they gave me. Do they still give it? What is the problem with it? it worked for me.

  8. Apparently there have been reports of renal calculi (stones) and/or biliary sludge (gallbladder goo) with Rocephin, plus some report that Rocephin and calcium can interact and cause some deadly lung thing.

    We use it ALL the time as one of the big sledgehammer drugs in our pneumonia protocol. We also give it in large doses to suspected meningitis cases.

    I still miss Seldane, the antihistamine that was taken off the market because it causes widening QRSs in some people (especially women). It was the only drug that took care of all of my allergies without any (visible!) side effects, AND prevented my allergic/seasonal asthma.

  9. The Conversion of our Protector

    The Food and Drug Administration (FDA) originated in its original form several decades ago, with their objective being to ensure the health and safety of the citizens of the United States regarding products that they consume, and the catalyst for its development was due to the concepts originated by a man named Upton Sinclair. However, the objective of the FDA seems to have changed, as they appear to have formed a pathological alliance with the pharmaceutical industry possibly through the money that this industry gives the FDA for various reasons, so it seems. This is such a large amount of funds issued to the FDA by the industry that it has resulted in possibly half of the FDA’s annual income for various reasons. Results of this relationship, one could posit, have been the approval of unsafe drugs on occasion and lack of sufficient regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform. In addition, the FDA lacks sufficient resources to complete thier duties completely, it has been said. In fact, in the FDA’s own mission statement, they claim that they will always protect, advance, and improve public health.
    An example of this support from the pharmaceutical industry is the Prescription Drug User Fee Act, which requires drug companies to pay around a million dollars for a priority review of a potentially approved drug of theirs. Implemented by the FDA in 1992, it has required increases in the amounts paid by drug companies since then. In fact, of the FDA’s estimated 2 billion dollar budget, about 20 percent of this money is from this act. Since 1992 and the implementation of this act, there have been no less than 12 drug recalls, which statistically is significant. To improve public health, it may be best that the FDA receive all funding from the U.S. Treasury.
    So this intimacy between the FDA and pharmaceutical industry seems to continue to progress, as illustrated with the new proposal by the FDA to allow the pharmaceutical industry’s reps to discuss their products with prescribers off-label, which means that the FDA somehow is accepting and allowing the sales reps of the drug industry to possibly create harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way, many believe.
    A prescriber, upon their own discretion, can in fact prescribe a drug off-label. Historically, however, ad for good reasons, representatives from the pharmaceutical industry have been prohibited from suggesting or discussing off-label possibilities with thier promoted products with prescribers, due to the speculative nature of the concept. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and some have been penalized for this behavior in the past in the form of monetary settlements by the Department of Justice, yet appears such penalties are not much of a deterrent for this behavior that may now be authorized and has continued to occur regardless of possible future permission by the FDA.
    This FDA protocol that is being considered, called, “Good Reprint Practices”, would require reps to use what in fact may not truly exist, which is completely truthful and authentic clinical trials related to off-label possibilities of their promoted products during any dialogues they may have with prescribers. This in itself may lack a necessary degree of validity for such discussions by reps, as it has been suspected that some clinical trials are flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials through possibly third parties, such as trial deception involving ghostwriting and invalid authors of such trials, which disintegrates the quality of such a study. These facts can be validated and have been discovered by others, so caution instead of autonomy should be utilized regarding clinical trial discussions with health care providers, some may say.
    Furthermore, this proposal is additionally flawed due to the fact that most pharmaceutical reps have little of any clinical training. So the ability for pharma reps to analyze data from trials justifying an off-label concept is unlikely. This complicates the idea of this off-label concept- this ignorance of most drug reps in regards to the complexities of these once reliable and dependable methods of proof, and that is the clinical trials. In addition, the proposed relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to manipulate statements to prescribers for their own benefit in regards to their promoted meds while disregarding the health of the consumers of these meds. So, our previous safety administration, the FDA, appears to be evolving into taking somewhat of an apathetic stance regarding the safety of public health by suggesting such practices with what appears to be deliberate intent and reckless disregard for public health, so it seems. This may be due to the FDA now viewing the pharmaceutical industry as thier sponsor or client. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be an actual benefit to public health. Furthermore, this FDA proposal 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 medications correctly, and adding this FDA proposal would just make the situation worse, it seems.
    However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the pharmaceutical sales reps, who, unlike those who may be more academically enriched, have the sole objective of increasing the market share of their promoted meds. Such people, ideally, would not have any association with the makers of such drugs spoken about to prescribers, yet this may be unlikely to occur. Regardless, awareness needs to be achieved by the public about the possible dangers of this FDA proposal, even though it’s possible that the public has heard about it through media sources. As citizens, we have the right to insist that the FDA demand and direct the pharmaceutical company to prevent potential harm that may come to patients in need instead of thier apparent desire to please thier bread and butter. More congressional oversight is needed of this Association.

    “It is difficult to get a man to understand something when his salary depends upon his not understanding it.” — Upton Sinclair

    Dan Abshear

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