drug warnings

  1. New drugs are untested

    What you don't know can kill you

    You have to wonder what it takes for new drugs to get rejected these days.

    The FDA has sped up drug approvals, shaving years off the process and accepting smaller and shorter studies -- and even the agency admits it approves many of these new drugs before we know all the risks.

    So they order new studies on the drugs after they're approved.

    You know... the kinds of studies they should have demanded in the first place.

    Just don't hold your breath waiting for the results of those studies -- because as one new analysis shows, Big Pharma is in no hurry to get them done.

    Of the 85 clinical trials ordered by the FDA for 20 drugs approved in 2008, 60 percent are still missing. And in some cases, we've been told not to expect that information until 2020.

    Yes, 2020 -- a full 12 years after the drugs were approved.

    But the studies completed so far show exactly why this "approve first" approach has the power to hurt or even KILL patients -- because they've led to new warnings for nine of the new drugs, including black-box warnings for five of them.

    That's the most serious warning of all -- and if patients knew of those risks first, they may not have swallowed a single pill.

    And that, of course, is the real reason so many of these studies have been delayed, postponed and otherwise dragged out: New data means new warnings... and new warnings could hurt sales.

    If only they cared half as much about patients as they do about profits.

    It's as clear a sign as any that the new drugs approvals process isn't working for you.

    If anything, it's working against you -- turning you into an unwitting guinea pig anytime you swallow a new drug (including "new" drugs that have been on the market for years).

    That's why it's essential to trust your health to a doctor who isn't quick to pull out his prescription pad -- a doctor who sticks to the basic principle of the most effective treatment that's least likely to cause harm.

    Unfortunately, you won't get that at a typical mainstream medical clinic these days, where insurance companies set the rules and doctors are often paid advisors to the drug industry.

    For that, you'll need to visit a holistic medical doctor.

    If you're in Southern California, I can help. Contact my clinic for more information or to make an appointment.

    Not in the area? I'm also available to offer advice over the phone. Call 855-DOC-MARK for more information, or to schedule a consultation.

  2. FDA admits drug safety record falls short

    Feds admit to missing drug problems

    Imagine NASA patting itself on the back over the discovery of a new asteroid -- but only after it crashed into the planet and wiped out Los Angeles.

    It's crazy, but that's exactly what the FDA's been doing lately.

    Up to 50 percent of all drug side effects -- including dangerous and even deadly risks -- aren't spotted until after a drug has been approved by the agency and given to millions of Americans.

    It's a shameful and downright embarrassing track record for any agency charged with drug safety -- but the FDA seems to think the fact that they eventually spot those risks is worth bragging about.

    In a new report with the comically ignorant title of "Advances in FDA's Safety Program for Marketed Drugs," the FDA says it's required 385 post-market studies and made 65 changes to drug labels to reflect new safety guidelines since 2008.

    Here's an idea: How about requiring those studies before a drug is approved, so the label won't have to be changed at all -- because we'll already know most, if not all, of a drug's risks?

    Apparently, that's asking too much in today's "approve first, ask questions later" environment.

    What's even more amazing is that the new report doesn't even hint at the agency's other huge problem with approved drugs -- and that's the fact that they often wait years to act even when they do learn of new risks.

    Case in point: Statins.

    Earlier this year, the FDA required a new warning for statin labels saying the drugs can cause diabetes, memory problems, confusion, and serious muscle pain.

    We've known about those risks for years now. One friend of mine, a retired doctor, has battled neuropathy pain since taking statins a decade ago. And the diabetes risk was exposed in a major study four years ago.

    Yet the FDA is only just getting around to revising the warning label.

    And if you think that's bad, just wait -- because this is about to get a whole lot worse.

    I'm sure you've heard plenty about all the gridlock in D.C., but there's one area where both parties have been able to work together. In a rare act of bipartisanship, Congress is getting ready to make it easier for new drugs to reach the market quicker than ever.

    That's something to think about next time you read about a newly approved drug -- and how "safe" it's been shown in studies "so far."

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