Trump’s F.D.A. Pick Could Undo Decades of Drug Safeguards


#1

President Trump’s vow to overhaul the Food and Drug Administration could bring major changes in policy, including steps to accelerate the process of approving new prescription drugs, setting up a clash with critics who say his push for deregulation might put consumers at risk.

Mr. Trump has been vetting candidates to run the agency, which regulates the safety of everything from drugs and medical devices to food and cosmetics. Among them is Jim O’Neill, a former official at the Health and Human Services Department who is an associate of the Silicon Valley billionaire and Trump supporter Peter Thiel. Mr. O’Neill has argued that companies should not have to prove that their drugs work in clinical trials before selling them to consumers

nytimes.com/2017/02/05/health/with-fda-vacancy-trump-sees-chance-to-speed-drugs-to-the-market.html?hp&action=click&pgtype=Homepage&clickSource=story-heading&module=first-column-region&region=top-news&WT.nav=top-news


#2

Remember when there was a government requirement for an automobile bumper crash standard. Whatever happened to that?

there is a cost for all those safeguards.

It’s still nice to know that we have a constitution that enshrines a balance of powers. I wish that balance was a little more visible and active, as a rule. One federal judge can block a presidential order? We shall see.

Roe v Wade could have been overturned by an act of Congress or a constitutional amendment, but we have seen a notable failure of Congress to make such a move, to give the states the opportunity to pass on it.


#3

If you think safety standards are costly, consider the alternative: more crippling injuries and deaths.

Another way to look at it is that the money we invest in safety pays us back many times over in terms of increased health and productivity. It is not wasted money, but a wise and profitable investment.

This goes for food and drug safety, auto safety, clean air and water, and much more.


#4

Unfortunately not necessarily. Listed below is a video by a former drug researcher which discusses the costs of the over regulation and slow process. In part, many medications already widely used in the world are not available to Americans due to the beauracratic process.

youtu.be/CDb2RDAh5Dw

I’m not saying no regulation is needed, just that over regulation can cause harm as well.


#5

Like Thalidomide?


#6

What about the people that suffer and die because the drugs that could save them aren’t being approved in a timely manner? Those are costs too. It’s not all about money.


#7

:thumbsup: Exactly! And that is only one example.


#8

Rushing a drug to market can do more harm than good. How do you know it is efficacious and safe without adequate testing?

You put too much faith in the pharmaceutical companies to test adequately and make their production and marketing decisions with efficacy and safety as their primary (overriding) concerns.


#9

They were rolled back by the Reagan administration for not being cost-effective.

there is a cost for all those safeguards.

Yes, and sometimes the cost is worth it and sometimes it s not, which is why regulations must be evaluated on their particular merits and not as a class.

It’s still nice to know that we have a constitution that enshrines a balance of powers.

The constitution does not rule out all regulations just because they are regulations. But rational people will rule out those regulations that do not make sense and keep those regulations that do make sense.


#10

I think you are exaggerating the problem. An expedited process might do some harm but it’s also going to make treatments more affordable and faster, which does save lives.

Regarding Thalidomide, at the time of the drug’s development, scientists did not believe any drug taken by a pregnant woman could pass across the placental barrier and harm the developing fetus. It was primarily a problem in Europe, as I recall.

We can reduce regulation and not revert back to 1950’s standards.


#11

I suspect the amount of risk a person is willing to take depends on their prognosis. If you have a terminal illness, you probably don’t have 5-10 years to wait for the FDA to perform “adequate” testing. When you have a year to live, your definition of adequate testing is probably quite different from an FDA lawyer. If you’re in chronic, severe pain, you may be willing to trade a few years of your life for effective pain management.


#12

I’ve always found it interesting that the FDA requires such a long and involved process to bring new drugs to the market but they do not regulate vitamins, minerals and other herbal supplements in the same manner.

fda.gov/AboutFDA/Transparency/Basics/ucm194344.htm

As someone who works in Pharmacy and has seen first hand the rise in costs of life saving medications that should be at this point be cheaper than they were when I started have increased in price dramatically. The Epi Pen price gouging made the news but why is it that a vial of Lantus Insulin has increased by 168% from 2010 to 2015 with out so much as a peep? Drug makers say its to fund innovation, except they already get a patent on the drug and are the exclusive manufacturers for a period as a means to recoup their Research and Development (i.e. innovation) Which keeping a generic equivalent from the market, therefore bringing costs down for both patient and insurer.

The FDA is more of a bureaucratic entity involved in approving drugs safety and efficacy for sale, in reality the FDA has little ability to regulate the Pharmaceutical Industry. The drug manufacturers aren’t prohibited from deciding to stop making a drug if the profitability is not enough for them nor are they accountable for shortages. The only thing the FDA requires from them is notifications of interruptions that could lead to a meaningful supply disruption, & discontinuations. However the FDA does not penalize the Pharmaceutical Industry for NOT reporting at all.

For several years now there has been an ongoing shortage of chemotherapeutic agents, quite literally forcing physicians to choose who gets treatment and who doesn’t.

nytimes.com/2016/01/29/us/drug-shortages-forcing-hard-decisions-on-rationing-treatments.html

Its far past time to revamp the FDA, and to put in place safe guards to keep the big pharmaceutical industry in check. Unfortunately this issue is under reported in the media and the average American may not ever realize the full extent until they have a life threatening condition and the drugs they need aren’t available due to shortage or just plain pulled from the market for profitability reasons. We are allowing profits to come before people, an most of us just turn a blind eye.

A change in who heads the FDA won’t affect the drugs currently on the market or the safety of them, only new drugs that are in the trial phases of approval. In terms of drug safety we are already behind other countries.


#13

If I recall, the automobile bumper crash standard didn’t have anything to do with safety, it had to do with reducing the amount of damage a car would suffer in a low speed crash. I think the original standards was a bumper had to survive a 5 mph crash, and the standard was dropped to 2.5mph. At that point it becomes a cost equation. Does the cost of mandating the 5 mph standard exceed the cost of the damage prevented by the higher standard?


#14

My point exactly.

Thalidomide had been approved for prescription for, if I remember right, morning sickness in Europe, but had not been approved in the United States, thanks to the FDA’s longer and more rigorous approval process.


#15

Right. It has little in common with the present discussion of drug safety.


#16

This is a very good point. There should be more than just one standard for drug safety. The worse a person’s prognosis the more liberal should be the safety standard for drugs he might take. Of course it must be balanced with clear informed consent so that the patient understands the risks.


#17

I believe there are provisions in the regulations for the use of “experimental” drugs and treatments in extreme situations.


#18

The vitamins and minerals that are made from fruits and vegetables shouldn’t be regulated
by the FDA. Most reputable manufactures of natural vitamins, minerals and supplements
have very high standards and we already know the benefits of bananas, blueberries,etc
vs the chemicals used in medications. By the way, I am talking about v and m from
natural sources NOT chemicals.


#19

Right. Drugs made from chemicals are designed to have a very strong effect. Therefore they are inherently more dangerous and more care is needed in approving them. Supplements made from plants are essentially food. They might help you. But they are much less likely to hurt you.


#20

It’s the Food and Drug Administration, regardless of their status as “Natural” versus “Chemical” it makes no difference when it comes to safety and efficacy. There are multiple drugs and chemotherapeutic agents on the market that would fall into your “Natural” category yet they are still regulated by the FDA and subject to the same process as “Chemical” A quick Google search of Docetaxel, Paclitaxel, Etoposide and Topotecan will confirm that the source material for those particular chemotherapy agents are in fact plants thus they would fall into your “Natural Sources Category” Certainly wouldn’t make them safe to sell over the counter.

Let’s take vitamin A for example it is important for normal vision, the immune system, and reproduction. Vitamin A also helps the heart, lungs, kidneys, and other organs work properly. Vitamin A comes from two sources. One group, called retinoids, comes from animal sources and includes retinol. The other group, called carotenoids, comes from plants and includes beta-carotene. The body converts beta-carotene to vitamin A. Regardless whether the source is natural or synthetic vitamin A too large of a dose is toxic because it is a fat soluble vitamin and is stored in fat cells then metabolized and excreted at a much slower rate than a water soluble vitamin. Once again in both forms vitamin A is “Natural” yet in too large of a dose it will cause birth defects, liver failure and even death.

Even the most reputable manufacturers use synthetically sourced vitamins and minerals because they are so much less costly than sourcing from whole foods. Not to say there aren’t products like that on the market I am sure that there are.

I would absolutely agree with trying to get your daily recommended from a well balanced diet.
However to automatically assume that because the original source material is from nature the products are safe is in some cases quite dangerous. There is not even a legal definition for the term “Natural” when it comes to the FDA

fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm456090.htm

Back to the OP I will repeat my assertion that a change in who heads the FDA won’t affect the drugs currently on the market or the safety of them, only new drugs that are in the trial phases of approval. In terms of drug safety we are already behind other countries. I personally don’t think that a change in FDA leadership will change much of anything. There are already systems in place to fast track medications and put them to market before they are fully tested, specifically the Orphan Drug Act. There would be no new drugs on the market if it weren’t for clinical trials where people volunteer to be human test subject in order to determine safety and efficacy, patients are required to give consent and understand that they may not receive the actual medication tested due to the use of placebos and necessity of double blind trials to avoid confirmation bias on the part of researchers.

fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm


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