safety concerns

Everyone wants a magic bullet when it comes to serious illness. That’s why doctors and patients are willing to take chances if they think a new medication or medical device could ease pain, or prolong life. Even so, most people assume that the Food and Drug Administration is a tough task master. FDA drug approvals are supposed to be stringent and guarantee both safety and effectiveness. Prepare yourself for a big Ooops!

Beware Fast-Track FDA Drug Approvals:

There is a fascinating loophole in FDA drug approvals. It is called “accelerated approval.” Normally, the FDA requires large clinical trials that can last many months or even years. These randomized, double-blind, placebo-controlled studies are the gold standard for FDA drug approvals. Outcomes are often based on things both doctors and patients care about. Namely, heart attacks, strokes, hospitalizations, longevity or quality of life.

Accelerated approval permits the FDA to grant a green light based on what doctors call “surrogate endpoints.” This might be a lab value such as blood sugar or cholesterol. In other words, a drug might lower bad LDL cholesterol and be granted accelerated approval even if it doesn’t prevent heart attacks and strokes or delay death.

Fast-track designation allows for accelerated approvals. It is supposed to speed drugs and devices to market. The evidence supporting their use may not be as good as people imagine.

Two articles in JAMA describe the limitations of this approval process. Follow-up studies that were supposed to provide more solid support were frequently delayed or abandoned. Those that were completed on time often did not meet the highest standards of research.

What They Found:

The researchers reported that (JAMA, Aug. 15, 2017):

“The FDA granted accelerated approval to 22 drugs for 24
indications. Clinical trials conducted before (n=30) and after
(n=18) approval had similar design characteristics, such as lack of
blinding, randomization, and comparator groups. Of the required
postapproval confirmatory studies, half were completed a
minimum of 3 years after approval, and of these, most showed
some benefit but relied on surrogate measures rather than clinical
outcomes.”

High-risk medical devices were frequently approved on the basis of trials that were not blinded, randomized or controlled (JAMA, Aug. 15, 2017). The authors conclude that such studies need significant improvement.

What to Do?

When your doctor recommends a new medication or suggests a new device such as a pacemaker or joint replacement, find out when it was approved by the FDA. Ask your health professional about the quality of the research supporting the product. The prescriber or the surgeon has a duty to do homework about the quality of the data. Ask about effectiveness data. How many people out of 100 treated get meaningful benefit?

Sometimes it pays to wait awhile so all the side effects can be assessed. It may take a few years for the FDA to learn about unusual complications that did not show up during the fast-track review process.

[JAMA, Aug. 15, 2017]
http://jamanetwork.com/journals/jama/article-abstract/2648631
http://jamanetwork.com/journals/jama/article-abstract/2648630

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  1. Deloris
    Reply

    To me, fast-tracking a drug or device’s approval by FDA is just a way to use ordinary people as guinea pigs. The pharmaceutical companies use optimistic pre-marketing tactics on both doctors and patients to get their hopes up, while absolutely nothing is known about a product’s safety, effectiveness, or interactions with other products, especially in the long term.

  2. Mary
    Reply

    Although I completely agree with your concerns about moving drugs too quickly through the approval process, there is one type of fast-tracking which is extremely important – that is, when a drug is shown to have outstanding potential in treating diseases which might otherwise be fatal. My husband benefited greatly from this process when the FDA fast-tracked an oral medication for his specific type of cancer. After several years of trying various drugs, this one immediately put him back into remission, with absolutely no side effects, for two wonderful years. However, it was only released early for this very specific type of cancer, which is quite different from fast-tracking a drug to treat a general problem like cholesterol. Thanks, as always, for the wonderful service you provide!

  3. Ed
    Reply

    When I see anything that says “approved by the FDA” I stay away. This is another swamp that needs draining. Maybe good in the past but not so hot today. That’s my opinion.

  4. Phil
    calif
    Reply

    With the revolving door between big PHARMA and the FDA, it makes one very suspicious of just about any approval, let alone a “fast track” approval. Too many times it looks like the FDA is protecting one existing product over a new possible drug, or “generic” trying to get approval.

    Methinks many times it’s all about the $$$ and job opportunities!

  5. Joan
    FL
    Reply

    I believe my primary physician is a very smart man. All the medications he gives me have been on the market for many years and are what you would call tried and true. What reason would the FDA have for fast tracking medications. Unless it is something new for cancer, or another major disease, there is no reason except the PIG PHARMA may be pushing them. There are so many older medications that I would rather take one of those than one of the new ones that can cost hundreds of dollars a year.

    Another thing the FDA does is pull an older drug off the market to be sure it’s ok….give me a break.!!!! When they put it back on the market it gets classified as a new drug and can cost hundreds of dollars when before they removed it the price was $4 a month. I have a friend that is taking Armor thyroid for many years. It had done wonders for her, she lost weight and was feeling great. The FDA pulled it for testing. She went on the synthetic thyroid and had a seisure. So she tried a different manufacturer and had another seizure.

    When the Armor became available it was $400 a month. She paid it because her insurance said they wouldn’t …then because of the seizures her Dr was able to get the price down and she pays $40 or so a month…still to high. She became very I’ll when she had no thyroid meds to take. Now at 80, she is doing quite well. I had been on synthetic thyroid for many years and was a large woman. 200 lbs. I never ate much and had a healthy diet so we couldn’t find what the problem was. I was also tired all the time and losing my hair.

    About a year ago, my Dr said “I’d like you to try Armor thyroid to see if it helps you feel better. I at this point would agree to anything but I trusted him so was anxious to try it. I had no part D, it was too expensive, more than if I paid cash. I was worried about the price because of my friends problem. I started taking the new thyroid about a year ago. After being on it for about two weeks I started feeling good. I was more energetic, I wanted to do things. I called the Dr and told him how good I felt and thanked him. When I went for my regular visit about 2 months later I had lost 10 lbs!

    I was very happy. Now, I continue to feel better, my weight has gone from over 200 to 145. Not losing the weight fast is good. The only thing is the appearance of my body. I’m 77 and had been heavy for so long that my skin has stretched. My legs and stomach look awful. Thank goodness it can be covered with clothes. My Dr is very happy with my progress. When I go to see him both he and the nurse just smile. I look so much better and…I had to buy new clothes. The Armor costs me $18 a month.

  6. Garry TM
    Reply

    An important article. Fast tracking drug approval may help a few needing urgent help, but I think it likely that far more will be injured -or worse-by inadequate testing.

    And with any drug, old or new, I suggest always asking the doctor the NNT number. [Number needed to treat.] Or, the number may be researched on line. This is a way of estimating the likelihood of receiving benefit from a particular drug.

  7. J C
    Reply

    So ”you say” people want a MAGIC BULLET to stop all illnesses & diseases? Are you kidding me ? What an understatement maybe for the high percent of people who really trust in what the FDA ”says” they are all about. I want the USDA, HHS, CDC & NIH come out against the APPROVALS of FDA’s that they call SAFE / GKAS on all forms of M S G, ASPARTAME, & other chemicals, additives & preservatives like NITRATES & NITRITES in our foods & drinks.

    Any if not all of these things can also be found in drugs, especially neurological drugs. Generic names are the WORST where most brand names that are always 1000X’s higher in cost, do not have the EXCTIOTOXINS in the drugs they make for the most part. All generic names have some form of ASPARTAME in every neurological drug & other drugs as well including the OTC ones. METALS are found in them all & OTC drugs. TOOTHPASTES except for a few brands that are not P&G products I do not use. So trash the MAGIC BULLET theory. We want first honesty from FDA & other health agencies, CDC & NIH which we’ll never get in my lifetime & the same can be said for you with such a fantasy myth of A MAGIC BULLET we want, instead of SAFE DRUGS, SUPPLEMENTS, DRINKS & FOODS to have daily in our lives.

    This is why Jesus Christ said,,, This kind can only be healed by prayer and fasting. No MAGIC BULLET / TOXIC FOOD OR DRUG there. Do the real FACT CHECK on all neurological diagnosis that has been done since 1980 in this country. And a span too from 1955 to 1980. No magic bullet is needed when you see how MONSANTO & the DRUG INDUSTRIES are killing people with APPROVAL & $UPPORT by congress in the past 80 years.

  8. Lisa
    NC
    Reply

    The FDA is just another regulatory agency pressured by corporate greed. Which is why I classify FDA as Fraud & Deception Administration.

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