Brenda Fulmer

FDA Fails in Many Drug and Device Reviews

A trio of studies published in the Journal of the American Medical Association (JAMA) finds that just because a drug or medical device makes it to market does not necessarily mean it’s been tested and is safe and effective beyond all doubt.

According to three published reviews, the same standards are not used to review drugs. Clinical trials may vary from one drug to the next. Early problems that arise in drug trials are often overlooked until after a drug is marketed and those problems appear in real life and we know from the debacle that is hip prosthesis and transvaginal mesh that clinical trials are not required at all for most medical devices.

Flowchart of the FDA's 510(k) process.

Flowchart of the FDA’s 510(k) process.

The problem is pressure from the manufacturers who want to get their products to market quickly with the least amount of resistance from the watchdog agency. Even those within the agency who want to protect the public often find themselves outvoted by the push to market.

One published review from Yale University reveals about one-third of drug approvals were based on one trial only. Incredibly, about ten percent of drug trials did not compare the medication to another one or a placebo.

And there is no consistency in clinical trials. The number of enrollees varied as did the duration of the trial. In the end the public, doctors and patients have no idea what evidence was considered before a drug is approved.

We already know that the majority of medical devices such as defibrillators and pacemakers, transvaginal mesh and hip prosthesis are approved based on an earlier model that is already being sold. Since 1979 there have been 5,829 device approvals that made it market based on being the “substantial equivalent” to another being sold even though the new device may have a different design or material.

Even with changes and even for permanently implanted medical device, a clinical trial was not required. The end result – life-threatening devices can fall between the cracks and make it to market. Devices such as the DePuy ASR hip, six makers of defective transvaginal mesh, the Medtronic Sprint Fidelis defibrillator leads and the St. Jude Medical Riata are examples of medical devices that were approved this way.

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2 Responses to FDA Fails in Many Drug and Device Reviews


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    Howard Sadwin says:

    even devices that have gone through “STRINGENT TESTING” in order to obtain PMA pre-market approval status by the FDA have fallen through the cracks.
    Point and case the Birmingham Hip or BHR.
    The FDA approved this device completely ignoring their own guidelines for PMA approval. ( single patient group controlled by the inventor, investigator, and at the time an employee of Smith &,Nephew, there were no patient consent forms signed acknowledging these folks were lab rat,the data retrieved from this group was hand picked, no IDE report was required, conditions of their PMA approval was never met by the manufacturer, whatever information was provided told you nothing,
    the investigator, inventor, employee (consultant) received 66 million pounds for his company. The only asset of value in this company was the BHR plus an additional 33 million pounds was given to this same individual upon the PMA approval of the BHR by the FDA. (CONFLICT of interest)This Smith & Nephew has been fined for a repeat offender of kickback laws. IF you read their own code of ethics Smith & NEPHEW STATES THEY DO not pay anyone to promote usage of their devices.
    When they tout statistics comparing the results of the BHR to other resurfacing devices, they fail to tell the public they are the only competition as the other 2
    PMA approved resurfacing devices (metal on metal) are off the market. So naturally their figures looks great when comparing their product to no other.
    The list goes on and on, it is time to put a stop to this type of exposure to innocent folks.
    The same inventor, wrote published articles in the UK discussing pseudo-tumors being of concern caused by use of metal on metal There was insufficient long term data from using these devices. The truth of the matter no one knew what would happen when the particles of metal entered the human blood. However the next year He sold out, he even forewarned Smith & Nephew they maybe jumping the gun by marketing the BHR without sufficient long term results. Today we are experiencing those results, for some folks complete devastation of their lives and the lives of loved ones. Some folks are disabled for life and who knows what the future health will bring.

  2. Pingback: Shouldn’t A Permanent Medical Device Implant Be Considered High-Risk? - Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts

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