This weekly column offers opinions on the latest pharmaceutical industry news.

Imagine being prescribed a medicine when neither your doctor nor the manufacturer has any clue whether it will actually work — because the government never required it to be tested for effectiveness.

That’s not how things are done now, because federal law requires drugs to undergo clinical trial testing to gauge benefits and risks. But the incoming Trump administration may seek to undo a decades-old standard of evaluating drugs for effectiveness — to the detriment of every American who takes a prescription medicine.

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  • The FDA is a complete disgrace and blight on the Americn people.They accept millions in bribes from drug companies every year to approve and “fast-track” dangerous poisonous chemicals disguised as medicine. The problem is that the whole system is rigged and has been for over a hundred years. Big Pharma’s poisons don’t CURE anything!!!(except for antibiotics). There’s no money in cures.The whole pharmaceutical model needs to be replaced. It’s high time.It’s time to put to bed the whole “patent medicine” paradigm.This evil that has been foisted upon us has run it’s course. Enough lives have been sacrificed in the name of corporate greed. I hear that Jim O’neill “hates” the FDA,how it operates and what it stands for. I hope that is a fact. I sure do. It’s time for NATURAL CURES to have their day. I certainly hope that that is what this is leading us to.

  • You can’t separate safety from efficacy. You state in your article that most drugs are not safe. Actually all drugs have adverse effects. The question is whether a drug is worth the risk. It might be worth risking death if a drug can cure your cancer. But what if the drug is not effective? You need to know if the drug works in order to decide whether to take the risk. I am also not convinced it will be so easy to prove a drug is not effective using real life data. Not only is there the placebo effect, but there are also the vast propaganda resources of the pharmaceutical industry. Even with more stringent testing there are lots of drugs and procedures being used today that have little or no efficacy.

  • As far as this group is concerned if the drug generates a profit then it is effective.
    Everyone knows profit is more important then health or safety

  • Hopefully the next head of the FDA will recognize electronic cigarettes as harm reduction, and allow the industry to continue offering a product that is proven better than combustion cigarettes. The recent regulations placed on “vaping” products by FDA will kill innovation of a product that can save millions of lives.

  • The asininity of this article is perfectly exhibited in the first sentence. “Imagine being prescribed a medicine when neither your doctor nor the manufacturer has any clue whether it will actually work — because the government never required it to be tested for effectiveness.” The fantastic thing about this sentence is Silverman’s use of the passive phrase “being prescribed.” It clouds the issue of who actually is doing the prescribing. In this hypothetical, your doctor is the one prescribing the medication. Your doctor is in a good position to know about the effectiveness of a new drug. If he had “no clue” whether it would actually work he would not prescribe it to you unless he was completely incompetent. Imagine your doctor prescribing a medication to you saying “I have no idea whether this will actually work.” Would you accept that explanation and take the medication? I don’t think so.

    • You are the one being naive. According to a study cited by Dr.Atul Gawande, FORTY FOUR percent of oncologists admit to prescribing cancer drugs that they know won’t work because the patient DEMANDS the drug against all odds. Those drugs aren’t being prescribed based imagination, they are being prescribed for real.

    • How is a doctor in “a good position to know about the effectiveness of a new drug”? If you don’t have adequate information you can’t be in a good position to know anything even if you do have an MD after your name. Many physicians get most of their information about drugs from pharmaceutical company reps or drug company sponsored studies that they don’t critically analyze.

    • How is a doctor in “a good position to know about the effectiveness of a new drug”? If you don’t have adequate information you can’t be in a good position to know anything even if you do have an MD after your name. Many physicians get most of their information about drugs from pharmaceutical company reps or drug company sponsored studies that they don’t critically analyze.

  • On further reflection, I would like an engineer to lead the FDA, and especially, the device unit. They do not let planes fall out of the sky, or build bridges that collapse. They understand materials safety. They understand the concept of Precision Devices and Precision Medicine (testing to insure “right for you” and your allergies, immune system and genetics), making sure you get the right kind – not the wrong kind – of gas in your car. They look at the big picture and study all the data – the wall built between medical and dental records and health impacts would come down. Imagine the possibilities!

    In addition, FDA needs to reboot the Expert Advisory Panel system where specialists in an organ or body part review and make decisions about devices that are inserted in that organ or body part. To understand systemic impacts, all Panels should also include an allergist, immunologist, geneticist, functional medicine physician, and biologic dentist. You need all of the elephants in the room to consider benefits, risks, and ways to modify and limit risks of installing devices with 24/7/365 impacts on a genetically and medically diverse population.

  • I’m not sure how you would define the “right” person for the job. After all, Les Crawford was a horse doctor and a stock swindler.

    Let’s keep this party going!

  • The FDA has abrogated its responsibility to properly evaluate new drugs for efficacy, although it doesn’t do a bad job on safety. No new initiatives are required. Just dust off an oldie but a goodie as Marty McFly would say. Between 1938 and 1962, because of the massive number of new drugs approved and due to personnel shortages at the agency the FDA subcontracted efficacy reviews to the National Academy of Sciences under the DESI review program. Under this program drugs were classified as either effective, probably effective, possibly effective or ineffective. If the drug was found to be less than effective the manufacturer could submit additional data (“real world evidence”) to the New Drug Evaluation Office. If the decision was made to upgrade the product to “effective” status a notice was published in the Federal Register. If the drug was classified as “other than effective” the company was provided with a Notice of Opportunity for a hearing before an administrative law judge.

    Although the intent of the DESI review was to retroactively remove ineffective products from the market (almost 900 products were removed between 1968 and 1980) it could be re-engineered to approve drugs in a prospective way, with the FDA basically assuming the role of a rubber stamp agency with regards to efficacy.

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