Tag Archives: drug studies

What drug researchers are hiding

Think the news media is untrustworthy? Try reading the medical journals.

Major studies are being retracted almost daily for everything from lousy data to outright fraud — and that’s just scratching the surface, because the studies that haven’t been retracted could actually be worse.

A leading medical journal says most of today’s studies are published without key data — omissions that could hurt or even kill patients as doctors unwittingly rely on an incomplete picture of a drug’s risks when they make treatment decisions.

BMJ recently published no less than seven papers on the problems with today’s research — but the biggest are those sins of omission.

One paper shows how quickly incomplete data can turn a snowball into an avalanche as research that combines data from earlier studies — called meta-analyses — ends up magnifying all those flaws and omissions.

Researchers reviewed 41 meta-analyses on nine different meds and found that 38 of them would have had different results if the researchers had access to the missing data.

Think about that next time your doctor offers you a med and cites some important-sounding study in a major medical journal.

In another paper, researchers checked to see how many studies complied with a rule that requires summaries of every single study to be posted on a government Web site, ClinicalTrials.gov within a year of completion.

They found that just 22 percent complied with this “mandatory” rule.

Looks like “mandatory” just ain’t what it used to be, but there’s a reason for that: When a study shows a drug doesn’t work or comes with too many risks, Big Pharma would rather sweep it under the rug — and researchers are often willing to grab a broom and help out.

One study a couple years back found that 85 percent of published company-funded studies found a benefit for the drug — an unbelievable success rate no doubt aided by the fact that only 32 percent of company-funded trials are even published in the first place.

You can probably find the other 68 percent in the nearest shredder. (Read more about why drug studies can’t be trusted here.)

Put it all together, and you get what an editorial in BMJ calls a “culture of haphazard publication and incomplete data disclosure” that makes any true risks-benefits analysis “almost impossible.”

I’d say we’re way beyond “almost.”

Posted in House Calls, Topic 1, Uncategorized.

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Diet drug fails another trial

They keep trying–and they keep failing.

Big Pharma has spent billions trying to create its dream drug: A pill that can help people safely lose a lot of weight.

But for patients who’ve taken the diet drugs that have come out so far, that dream has turned into a nightmare– because none of them work as advertised, and a new study links one of the most common weight loss drugs to an increased risk of heart attack and stroke.

The drug is sibutramine, but you may know it better as the prescription med Meridia. And while it’s been linked to trouble before, the new study offers some of the worst news yet.

Researchers randomly assigned 10,744 overweight or obese people with heart problems or type 2 diabetes to either Meridia or a placebo, and followed them for nearly 3.5 years.

And according to the study in the New England Journal of Medicine, patients taking Meridia had a 36 percent increased risk of a nonfatal stroke and a 28 percent higher risk of a nonfatal heart attack.

But instead of recognizing these dangers, the researchers appeared to downplay them. They practically celebrated the finding that Meridia didn’t seem to increase fatalities, and even said the drug should remain on the market as long as it’s kept away from diabetics and heart patients.

There’s just one catch: Many people who suffer from these conditions don’t know it.

Even if the researchers missed the point of their own study, it wasn’t lost on the journal’s editor. In an editorial published alongside the study, Dr. Gregory D. Curfman called Meridia just “another flawed diet pill” and said it’s time to pull the plug on this bad experiment.

Dr. Curfman wrote that Meridia users have a 1 in 70 chance of heart attack or stroke, and that risk shoots up to 1 in 52 if they’re already suffering from heart problems.

Not exactly comforting numbers.

European regulators were so concerned by those figures that they pulled the med off the market earlier this year based on the preliminary results of the trail–months before the study was even published.

A few steps behind (as always), the FDA will meet this month to consider making its own move on Meridia. And if the heart attack and stroke numbers don’t impress them, maybe the weight loss figures will: The new study found the average patient lost about 9 pounds, or 4.5 percent of their body weight.

That’s even lower than the ridiculous low bar set by the FDA, which considers any drug that reduces weight by 5 percent to be “effective.”

What’s more, sibutramine can also increase your blood pressure and pulse–two things many obese people already struggle to keep under control.

Other side effects include irregular heartbeat, allergic reactions, bleeding problems, restlessness, nervousness, dizziness, dry mouth and more.

But you don’t have to settle for any of those, because basic lifestyle changes will do far more for your body than any drug ever will–and teach you the good habits you’ll need to keep the excess weight off for good.

And that’s diet success by any measure.

Posted in House Calls.

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Shortened studies favor Big Pharma

Sooner isn’t always better… especially when it comes to drug research.

In fact, drug studies that end early–something that happens more often than you might think–tend to exaggerate the med’s effectiveness and miss dangerous side effects and complications, according to a new report.

Researchers compared 91 studies that were cut short to 424 comparable studies that went the distance, and found that the truncated trials overestimated the study drug’s effectiveness by an average of 30 percent.

In some cases, these shortened studies didn’t just make a drug look more effective than it really was… but also magically turned completely ineffective meds into working drugs, according to the study in the Journal of the American Medical Association.

That’s some parlor trick… but it’s just the research equivalent of smoke and mirrors.

Studies are supposedly cut short only when patients are in danger, or researchers get overwhelmingly convincing evidence of a drug’s effectiveness… but in reality, those latter cases are usually just an early spike in the data.

They know this, by the way. They know it–but still end the study early. After all, that’s how the drug companies that fund most of these researchers like it: Get in, get the result you want, and get out–fast. Shorter trials are cheaper, the drug gets to market faster and they can even switch the placebo patients onto the pricey new med.

And, as an extra bonus, a shortened study is also less likely to reveal any potential problems with the med.

That’s the kind of stock-boosting side effect Big Pharma really likes.

Dr. Victor Montori, author of the new study, called the practice misleading… but he’s being kind. Let’s call this what it really is: a dangerous lie.

These lies can have fatal consequences. For example, a study on beta-blockers was cut short when it found seemingly conclusive evidence that these meds can prevent heart attacks during surgery.

So docs began using them based on that conclusion–and who knows how many lives were lost… because a larger trial later on found that some patients on these meds had significantly higher death rates.

When that happens, we’re well beyond “misleading.”

These trials aren’t cut short by a couple of hours, days or weeks… in some cases, they end years ahead of time. The JUPITER trial on the statin drug Crestor, for example, was cut short by two years.

Two whole years!

It’s like walking out on a movie before the end… and missing the part where the villain rises up and kills the main character.

But this tragic ending wasn’t made by Hollywood. As the new study shows, it was brought to you by Big Pharma.

Posted in House Calls.

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Drug studies rarely bother to compare drugs

Next time you hear that a med’s been declared “effective” by one study or another, ask one simple question: “compared to what?”

The answer might surprise you… because a new review of major research on existing meds finds that most studies– the overwhelming majority of them, in fact–don’t compare the drug in question to other meds or treatments.

Kind of a big omission, don’t you think?

Researchers from the University of Southern California in Los Angeles examined 328 studies that evaluated existing drugs published between June 2008 and September 2009 in one of six major medical journals: Annals of Internal Medicine, Archives of Internal Medicine, the British Medical Journal, Journal of the American Medical Association, The Lancet and The New England Journal of Medicine.

Those are some pretty big names… but it looks like the biggest names don’t guarantee the highest standards. Of those 328 studies, just 104 of them actually compared the drug in the study to another drug or treatment. The rest compared the meds in the study to unapproved drugs or placebos.

And of those 104 studies, only 20 studies looked at safety issues.

That makes it a lot harder for doctors and their patients to make decisions when trying to choose a treatment. But guess what: Big Pharma likes it that way–everyone’s a winner when no one’s a loser.

Well, almost no one–you see, researchers also rarely bother to compare Big Pharma meds to non-drug alternatives, either. Just 11 percent of those 104 studies compared the drug to “other treatments,” a category that also included surgery.

True comparisons of a drug to a natural supplement are rare… and when researchers do bother to include a vitamin, they generally use only low doses of low-quality supplements, quietly stacking the deck in favor of the Big Pharma pill du jour.

That allows the mainstream to keep pretending that vitamins and other safe, natural supplements are completely unproven… but all it really means is that good research is harder to come by.

Those good studies are out there–and I’ll keep finding them for you. Keep reading House Calls and you’ll always know which studies have picked a proven treatment… and which ones are just more Big Pharma bluster.

Posted in House Calls.

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