Trouble for the FDA?

Neurologicablog ^ | 9 December 2016 | Steven Novella

[MtnClimber]

There is persistent tension over the issue of drug regulations. On one side are those who think that before we sell drugs to the public with health claims, we should ensure there is a reasonable amount of objective quality scientific evidence to demonstrate that the drugs are safe and effective. I admit this is the side of the discussion on which I fall...

The other perspective is that requiring too much research and regulation slows the passage of potentially new and lifesaving drugs to the public. Potentially useful drugs should be fast tracked as much as possible. In the extreme version, held by some Libertarians, there should be no regulation (or perhaps minimal regulation for safety) and the free market should sort out what works and what doesn’t. The Food and Drug Administration (FDA) is the regulatory agency in the US responsible for ensuring the safety of drugs and that efficacy claims are backed by adequate evidence. The FDA, however, is a creature of congress, from which it derives its authority. It can only do what the law says it can do. Within that law the FDA also has a certain amount of discretion. How much evidence is enough is a judgment call. Therefore who heads the FDA can have a significant impact on how tightly or loosely regulated the pharmaceutical industry is at any given time. The FDA’s mandate is now being threatened from both ends, congressional law and possible picks by Trump to head the FDA.

Congress has just passed the 21st Century Cures act, which is a terrible law that weakens FDA regulations and shifts the power tremendously in the direction of the pharmaceutical industry. The core of the bill, however, is based upon a false premise and provide a counterproductive fix.

[MtnClimber]

I agree with that. There are terminally ill patients who cannot tak drugs that are not approved. That makes no sense.

[oblomov]

>>The treatment used a drug that had been on the market for decades at a fraction of the dosage it is used to treat other things.

Once an obscure part of the FDA code, the 505b2 pathway is now a widely used pathway to approval. It allows existing medicines to be used for new indications or in new formulations with greatly reduced requirements for clinical trials.

Using your example of Type II Diabetes, Salix Pharmaceuticals brought Cycloset (bromocriptime) to the market this way. Bromocriptine has been on the market since the 1950s for Parkinson’s Disease, but was not approved for Type II diabetes until 2009.

[stars & stripes forever]

[colloidal silver]

I was referring to nano silver.

[cpdiii]

The other perspective is that requiring too much research and regulation slows the passage of potentially new and lifesaving drugs to the public. Potentially useful drugs should be fast tracked as much as possible. In the extreme

You are 100% correct. The FDA prohibited the sale of Thalidomide in the USA though approved in Europe. This was a good call and prevented many thousands of deformities in the USA. At the same time the USA did not have access to beta blockers being used in Europe until years later.

The FDA did stop the tragedy of thalidomide deformities for thousands. However, at the same time they condemned many tens of thousands to death because doctors in the USA could not use beta blockers for hypertension.

All drug carry risks but the FDA puts to much emphasis on total safety as opposed to probably benefit.

Drugs can be dangerous, death is death and it is a terminal one way ticket with no return voucher.

I am a pharmacist.

[Rome2000]

It depends on the drug and the disease.

Any “one size fits all” solution is asinine.

[RFEngineer]

Government has made health care and medicine so expensive that people have no choice in many cases but to turn to other options. Those options should continue to be available to people who need and want them to be.

[arthurus]

Constitutionally the government has no business regulating drugs at all beyone the COnstitutionally mandated requirement to guarantee weights and measures, the wording of which originally meant that the government should fix a uniform standard of weights and guarantee that when something is claimed to weigh a pound it weighs the same as anything else that weighs a “pound.” It can be stretched to mean thatif it is claimed that there is a gram of substance in a package, that there is a uniform gram of substance in the bottle. Perhaps under the rubric of guaranteeing W&M it can be required that what is claimed to be the ingredients are in fact the ingredients. I don’t think the language can be twisted any farther than that. All the rest is government Mommy saying to hell with the rules, Everyone has to be nice andonly do what I think are nice things!

[norwaypinesavage]

The FDA requires that drugs must be shown to be "safe and effective" before they can be brought to market. It also requires that the maker must publish the makeup of the drugs. It can take more than a decade to demonstrate that a drug is "safe and effective", and costs about a billion dollars. That's a BILLION, with a B.

This $billion must be recovered by the drug maker before the patent runs out in order for the company to remain in business and to develop the next drug so they can remain profitable in the future. This is what dominates the price of drugs in the US.

[yefragetuwrabrumuy]

One of the big problems is their rigid scientific methodology.

Granted, some parts of it are essential, to insure safety and effectiveness. But other parts need new methodologies to keep from getting new drugs expensively bogged down.

Several examples:

Avon Skin So Soft was originally designed to be a mosquito barrier, but the FDA testing required to sell it as such was anticipated to cost more than the entire profits to ever be gained from the inexpensive product. So instead it was sold as a skin softener, an OTC item that required no FDA approval, because it exclusively used already approved ingredients.

DMSO (Dimethyl sulfoxide), is a very simple molecule that is very effective as a topically applied anesthetic for muscle pain. Football teams buy huge amounts and swab it on the skin over the muscle. It easily penetrates the skin and relieves the pain. But it has two very serious problems.

The first is that it creates a unique and unpleasant taste in the mouth, so it cannot be double blind tested. The other, and worse problem is that when absorbing through the skin, it can act as a carrier to other substances that are not good for you. This is overcome by carefully cleaning the area with water first, but is still a real danger.

So, for these reasons, DMSO is “sold as a solvent only”. However, it is not the only product that cannot be double blind tested, an absolute requirement for FDA approval.

Specialized case and orphan drugs. There are many rare conditions that are denied effective drugs because those drugs will *only* have an effect on the people with those conditions. But the FDA requires some control groups to be of healthy people, so when the drug does nothing for them, it is deemed ineffective.

Conversely, orphan drug approval has a litany of problems, from inadequate numbers of experimental subjects, to manufacturer only research.

[GailA]

If you are on Medicare and Tricare Life, some OTC stuff is provided. What I would like to see is holistic med covered. And a full review of all FDA approved drugs. Are you aware ALL Osteoporosis drugs are FDA FLAGGED for A-Fib, A-typical Femur Fracture and Jaw Degeneration, and the 6 month shot Forteo is also Highest Labeled with a Black Box for Bone Cancer, and the IV Reclast is NOT to be given to Asthma patients? They are NOT safe drugs.

I want Bill Gates involvement in Vaccine Gate investigated, he owns 500K shares of Monsanto and is a big pusher of unsafe vaccines.
The Gardasil Problem: How The U.S. Lost Faith In A Promising Vaccine
http://www.forbes.com/sites/matthewherper/2012/04/04/americas-gardasil-problem-how-politics-poisons-public-health/#ea5359c72739

Bill Gates’ Polio Vaccine Program Caused 47,500 Cases of Paralysis Death
http://nsnbc.me/2013/05/08/bill-gates-polio-vaccine-program-caused-47500-cases-of-paralysis-death/

Bill Gates’ Philanthropy: 30,000 Indian girls used as guinea pigs to test cancer vaccine
http://www.naturalnews.com/055513_Gates_Foundation_vaccine_experiments_human_guinea_pigs.html#ixzz4SXeD79j2

And a total review of DEA laws. I should not have to PEE in a bottle every 3 months for my seizure med that controls nerve damage pain. I didn’t say it got rid of it, it just lowers it from 9 to 4 so I can function instead of being bed ridden.

DUMBO did that. His Pain Pill for Granny was another BIG LIE. There are 1.33 MILLION chronic pain patients with INCURABLE diseases or nerve damage conditions. DUMBO has forced us into Worthless Pain Management, who are just an Internist specializing in pain who have no clue to the underlying disease, many of the new hires for a new booming med field are just GP’s. My Neurologist should not have to fear arrest or loss of license for scripting my seizure med. Yet that is what is happening.

NO CONNECTION TO PAIN MEDS
ADDICTION https://www.painnewsnetwork.org/stories/2015/6/12/there-is-no-epidemic-of-painkiller-overdoses

DEA shortage of pain meds
http://www.theverge.com/2016/10/4/13166594/dea-opioid-epidemic-manufacturer-2017-substance-

New DEA rules place more restrictions on popular painkillers
http://www.roanoke.com/news/virginia/new-dea-rules-place-more-restrictions- on-popular-painkillers/

Pain Management
https://www.painnewsnetwork.org/stories/2016/1/5/the-cdc-and-profit-driven- drug-testing

Chronic health conditions
http://www.nationalhealthcouncil.org/sites/default/files/NHC_Files/Pdf_Files/AboutChronicDisease.pdf

[Ignatz]

Annnnnd that medicine is....?

[hawg-farmer - FR..October 1998]

A “drug” that has more adverse side effects, including DEATH, than the original malady is despicable. How come we can not SUE the FDA..

[cpdiii]

I forgot to add something about fast tracking drugs. Drugs that treat AIDs are on the fast track for approval as they should be. Unfortunately they are on fast track due to political pressure. The same consideration should be given to all drugs that may cure a terrible illness of any kind.

I have absolutely no problem with the FDA slow walking a new drug in a class of drugs that can already treat an illness. They must do due diligence. To slow walk a new drug that has no comparable drugs that can treat terminal illness is immoral. People die because of this. It is also true that people may die because of a hasty approval. More people will live with fast track approval of a new and novel drug to treat terminal illness if no other drug can treat it effectively.

Drug therapy is science but not perfect. All drugs must be evaluated by risk benefit ratio. When people are dying for lack of a new drug the risk benefit ratio changes on the side of more risk.

The FDA is not the friend of the terminally ill.

I am a pharmacist and know of which I speak.

[MtnClimber]

I agree. Treatments for terminal illness needs to be fast tracked and results need to continue to be evaluated.