pharmaceuticals

  1. China starts to act on shoddy drugs

    China starts to act on shoddy drugs

    I've always believed that the dangers of China's shoddy manufacturing practices and seeming lack of health standards is probably far worse than anyone realizes - especially in China. Remember that in spite of the rapid economic growth and apparent Westernization of China, this is still at its core an old-school Cold War era dictatorship with rigid government controls. So bad news about things that happen inside the Communist "worker's paradise" is usually squelched.

    But the recent tragic earthquake in China and all the media hype of the upcoming summer Olympics in Beijing have suddenly shined a spotlight on China. And maybe that's putting China on its best behavior. The recent news that the deaths of six patients who had all received a blood-based drug in a hospital has resulted in an unusually rapid and intense response by Chinese regulators. Could this be the first outward sign that China is following through on its pledge to rein in and clean up its pharmaceutical industry?

    According to The New York Times, tens of thousands of crates of unsafe pharmaceuticals have been distributed within China over the last few years at an unknown cost in death and illness. And as much as I bellyache about the FDA and the money and influence wielded by Big Pharma, our system is a shining example compared to how things are run in China. The system there is rife with corruption, and the cost of doing business regularly includes bribing government regulators to turn a blind eye to safety violations.

    One thing that could help China clean up its act swiftly is the decisiveness (and ruthlessness) of their system. Case in point: after the former chief of the Chinese equivalent of the FDA admitted that he and his family had accepted gifts valued at more than $850,000 from drug companies, he was executed. We don't need a system that goes that far, but some good, old-fashioned accountability would be nice for a change.

    I'm sure this isn't the last we've heard about this, and I'll stay on top of the story. We may as well get all the news about China we can while they're opening up the place to hordes of foreign journalists for the Olympics. But I'm sure it's all an act, and that as soon as the Olympic flame is extinguished in China, the media blackout will again descend. Remember: even Nazi Germany managed to put on a happy face when the 1936 games were held in Berlin.

    In the meantime, just keep buying American whenever possible - especially when it comes to pharmaceuticals.

    Do antibacterial wipes spread superbugs?

    I've told you in the past that a hospital is one of the most UNnsafe places you can be. Viruses and bacteria like nothing more than to take up residence there, and unfortunately, doctors and nurses are all too willing to keep them alive and kicking. At least, that appears to be the case, since so many hospital workers seem averse to washing their hands.

    I've also suggested to you that an easy way to cut down on the spread of harmful bacteria could be to use antibacterial wipes. Docs could clip a pack onto their belt - right next to their pager - and give their hands a thorough wipe down as they make their way to their next patient. It wouldn't slow them down at all.

    But a recent study by microbiologists from Cardiff University in Wales is suggesting that using antibacterial wipes might not be such a good idea after all. Could I have been wrong about this? Let's take a look

    According to British researchers, disinfectant wipes could actually be SPREADING drug-resistant bacteria, not killing them. The researchers studied two hospitals and concluded that that, while the wipes did kill some bacteria, it left others alive and could actually carry the bacteria from one surface to another.

    But here's the rub: The researchers found that health care workers clean multiple areas near patients with these wipes - bed rails, monitors, tables, and more. Instead of killing the germs, they're probably just picking them up and pushing them from place to place - making them spread faster.

    The researchers offered this solution: "We found that the most effective way to prevent the risk of MRSA spread in hospital wards is to ensure the wipe is only used once on one surface."

    That's exactly what I've been saying all along. The one surface they should be used on is your hands - the real culprits in the spread germs. So forget about wiping down every surface in sight. Stick to making sure your hands are germ-free, and the rest will take care of itself.

  2. The FDA's hit parade of big "oops" stories

    The FDA's hit parade of big "oops" stories

    The FDA has all the usual flaws that go hand-in-hand with any government bureaucracy. The difference is that when the FDA fouls up, people die. The organization has been getting a lot of flak lately, from more than just me.

    It's about time people started to notice.

    Most of the FDA's critics recognize, as I often point out to you, that the Administration's failures are rooted in its close ties and associations (often financial) with the medical industry. A perfect example of this conflict of interest is the 1992 Prescription Drug User Fees Act, which requires the FDA to approve or deny new drug applications by major pharmaceuticals within a certain time - or else they have to refund "application fee" monies paid by the pharmaceutical companies. Obviously, the rush job isn't doing anyone any good.

    The FDA has approved too many drugs that ultimately had to be pulled from distribution due to serious side effects - i.e., THEY WERE KILLING PEOPLE. Even the government's own General Accounting Office determined that the process set in motion by this act has coincided with an up-tick in the percentage of drugs that ultimately needed to be withdrawn from the market. Coincidence? Hardly.

    After ranting and railing so often against the FDA, I just wanted to remind you all of some of the Administrations' biggest gaffes. While major drugs being pulled from the market are worthy of lead stories on the 11 o'clock news, too often the stories about "minor" drugs that get pulled are tucked away in places where they're easy to miss unless you're me, who lives for this sort of stuff.

    Here's the FDA's "hit parade" of big "oops" stories.

    1. Vioxx - I'm sure you're familiar with this infamous anti-inflammatory. Merck had to pull Vioxx off the global market in 2004 after a clinical study demonstrated that it significantly increased the risk of cardiovascular "events" such as heart attacks and strokes.
    2. Bextra - Like Vioxx, this prescription painkiller caused an increased risk of heart attack and stroke. Pfizer pulled it off the market in the U.S. a year after the Vioxx fiasco in 2005.
    3. Cylert - Abbott pulled the Attention Deficit Hyperactivity Disorder (ADHD) drug off the U.S.
      market in 2005 after the FDA discovered 13 cases of liver failure. Turns out that Cylert patients have a 25-percent higher rate of liver failure compared to the general population.
    4. Baycol - This cholesterol-lowering drug caused users to suffer from a much higher rate of rhabdomyolysis - a debilitating muscle ailment that can be fatal. There were 31 reported deaths that were directly linked to Baycol, and it was yanked off the market in the U.S. in 2001.
    5. Palladone - This slow-release narcotic painkiller by Purdue Pharma was pulled off the market in the U.S. in 2005 because it was found to cause side effects like depression and even coma when mixed with alcohol.

    This small handful of examples of FDA foul-ups within recent years (there are more - this list could've been much longer) should serve as a wake-up call for every single one of us. In spite of the FDA, neither food nor drugs are any safer.

    FDA leaves cancer-causing foot gel on the market

    Even the most seemingly innocent drugs can carry fatal side effects. The FDA just announced a study showing that the foot gel Regranex could be causing cancer. And yet, amazingly, Regranex is still on the market!

    The prescription foot gel is manufactured by Johnson & Johnson and is often used by diabetics who develop leg and foot ulcers that are difficult to heal.

    Apparently, diabetics who'd been prescribed the gel three or more times were at increased risk of death from cancer. With incredible gall, the spokesperson for J&J insisted that Regranex is safe when used as directed. What? This is a topical foot gel-if these people are applying it to the sores on their feet and legs, they ARE using it as directed. Should any foot gel be capable of giving you CANCER!? Does this make sense to you?

    Obviously there's more to this story. But if I were you, I wouldn't wait for the FDA to do the banning - ban Regranex from your medicine cabinet immediately.

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