Confidence in the FDA has hit bottom.
The latest survey on trust in the FDA comes from Harris Interactive, who regularly surveys the public’s faith in the regulator.
see the FDA’s #1 job as "ensuring the safety and efficacy of new
prescription drugs," cited by 61% of the public; however, 58% of people
have a negative view of the FDA’s role in this job, compared to only
35% who think positively about the FDA’s performance in this key role.
This latest drop in confidence in the FDA is driven by the Heparin scare, blogged about here.
Other factors eroding confidence in the FDA include toy safety, food safety,
the recent toothpaste scare, and perceived lags in approving necessary
Jane’s Hot Points: Lack
of trust in our institutions is driving people toward nodes of positive
trust: first and foremost, to "people like me." I continue to refer to
the Edelman Trust Barometer on this issue, a source the I trust.
have lived with risk in daily life since Adam and Eve were tempted in
the Garden of Eden. There is a rising wave of risks, at least as we
perceive them, in our daily lives. The sub-prime mortgage crisis leads
us to mistrust financial services companies. The rising price of gas
drives us to mistrust oil companies. Health insurance denials for care
and increasing health costs compel us to mistrust insurance companies
and those who supply products to the industry.
management requires us to seek information that helps us manage those
risks on a daily basis. Increasingly, people are looking for
trustworthy sources in new places, offline and online. But in the case
of the FDA, which is charged with protecting the public’s health, where
else can we turn? Whether it’s to assess E. coli or new medsAmeri or that
new toy, we need a vigilant, productive, and effective FDA in our
corner. And, for now, 2 in 3 Americans is frustrated with the agency
that’s supposed to protect them.
Have They Switched Sides?
The Food and Drug Administration originated in its primitive form at the time several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed, as they appear to have formed a pathological alliance with the pharmaceutical industry through the money the industry gives the FDA for various reasons, yet so large amounts of funds are issued to the FDA by the industry that it has resulted in possibly half of the FDA’s annual income. Results of this relationship, one could posit, have been the approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform, and have failed to do so as much as they should for our benefit.
And the intimacy between the two organizations seems to continue to progress, as illustrated with the new proposal by the FDA to allow the pharmaceutical industry reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. 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 with the Department of Justice.
This FDA protocol that is being considered, called, “Good Reprint Practices”, would require reps to use what does not truly exist, which is truthful and authentic clinical trials when they do speak off-label to prescribers. This in itself lacks etiology for such discussions by reps, as most clinical trials are flawed due to the trials being possibly manufactured by the pharmaceutical companies of the meds involved in such trials. Additional trial deception involves ghostwriting and invalid authors of such trials. These facts can be validated and have been discovered by others.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability to analyze data regarding this issue accurately is unlikely, for the most part, I surmise. This complicates the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the 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. So, our previous safety association, the FDA, appears to be evolving into our harmful association by suggesting such practices with deliberate intent and reckless disregard for public health, so it seems. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. 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.
However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds. 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 are overall 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.
“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
—- Carl Jung
The Heparin Horror may be only the tip of the iceberg. Most Americans assume that the FDA is actively working to ensure that the medicines we take contain exactly what the manufacturers say and nothing else. In reality, the FDA relies on the honor system.
Just as the FAA counted on the airlines to voluntarily inspect airplanes, so too the FDA relies primarily on drug companies to voluntarily comply with regulations and police their own products.
We now know that the FDA doesn’t have the resources or the manpower to inspect drug manufacturers overseas. Even when it does visit a foreign company, the visit must be arranged far in advance. This allows a best face presentation. Problems that might exist could easily get tucked away out of site long before inspectors arrive. Yet, an estimated 80 percent of our medications (raw ingredients and finished products) now come from abroad.
Most health professionals and patients are unaware that the FDA does virtually no monitoring of finished drugs off the shelf to determine the quality of marketed products. That means that hospital pharmacies and neighborhood drug stores must rely on the integrity of their wholesalers, distributors and an enormous worldwide network of manufacturers. Are all these companies honest? We do not know…and neither does the FDA!
Next time you get a generic prescription filled for an antibiotic or a blood pressure pill, you may not know who made it or where it came from. Your shoes, socks, shirts and foods have country of origin labeling. Not your medicine!
The FDA needs both the resources and the will to do a better job monitoring the safety and quality of our medicines. Until then, you are on your own. If you suspect that your medication is not performing as expected, trust your instincts and notify your health professionals. Report the problem to the FDA at MedWatch, but don’t expect the agency to spring into action.
Joe & Terry Graedon just posted their amazing social-media -meets-FDA story at e-patients.net. Here’s an excerpt:
Since the Bush regime took over I have seen less and less of the FDA fulfilling it’s mission of public safety first and more and more of fulfilling a mission of ensuring manufacturers make maximum profits. Who do you think the FDA was working for in the latest Westland/Hallmark meat recall scandal when not only didn’t FDA Inspectors protect us from downed cattle, but they watched plant workers use torture to attempt to force sick and diseased cows to stand and pass FDA inspection. I don’t trust the FDA anymore and actually view them as endangering public safety because they lull people into false security when manufacturers proudly say, “FDA certified”. Once again government not working for its citizens but working for corporate political contributers.
1. Don’t fund the FDA.
3. Private Certification Labs
The FDA is presiding over a transformation in medicine as scientists come to understand diseases in a more detailed way that could improve doctors’ ability to treat patients. Much of what has been done previously has been based on the antiquated model of empiricism (the so-called evidence-based medicine).
They want to see that doctors will be able to intervene with medical treatments more effectively to a specific patient’s illness. Doctors treat illnesses based on how well “average” people have responded to a given treatment. Now they can develop a tailored (personalized) response built around understandings of the patient, the treatment and the disease.
Advances in cancer medicine have taught researchers that cancer is a diverse disease, and what works to treat one person’s disease may not work for another. In order to have the kind of personalized medicine for the future, it will be necessary to be more flexible in how we evaluate potential new treatments, and flexibility is crucial to clinical trials.
Researchers want to be able to design trials to look at multiple potential treatment combinations and use biomarkers to determine who is responding to what medication. Using methodologies like the Bayesian approach, a trial design exploits the results as the trial in ongoing and adapts based on these interim results. That’s anathema to the “standard” approach.
I don’t know how much of the FDA’s discrepancies are due to readjustment pangs from old-fashion empirical measurements or how much comes from outside influences, but there seems to be a lot to be desired these days.
I also get frustrated at times with the FDA, but I think they are taking an unfair hit here. Their job is virtually impossible to perform these days. Think about this, all in the name of capitalism – Baxter outsources its heparin supplies to some other outfit (I forget the name – American Products or something?) – which outsources ITS heparin production to China, which uses at least 12 different plants which clearly no Chinese official is inspecting, and those plants rely on individual Chinese farmers for their source of raw heparin.
Now why does Baxter do this? To save money, of course. So why should we taxpayers pay for the FDA to open an office in China to inspect plants where the workers don’t speak their language, probably have no clue about quality control issues, and the managers are of doubtful integrity? (In my opinion there’s a very high chance this adulterant was added deliberately). So is the FDA going to chase drugs to Thailand, Vietnam, Korea, etc. just to help these companies save money?
The companies should have to either pay for the FDA to come to China to inspect the plants, or do clinical trials to prove the outsourced drug is equivalent to existing sources. Don’t blame the FDA for this one, people!