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Three Things You Don’t Know About Drug Trials

Friday, April 18th, 2008

1. It pays to be a middle-aged white male.
When it comes to new drug trials, white men under 65 seem to be in high demand. That’s despite the fact that other people develop deadly diseases – and more often than this population. One study found that ony about 10% of cancer-study participants were African American or Hispanic, despite the fact that these groups make up more than 25% of the general population. Or how about this: nearly 60% of cancer diagnoses are in people over 65…but cancer trials typically include no more than 25% people in that age range.

This information comes to us from Baylor College of Medicine, where researchers were concerned that older people are rarely included in trials, even though most of the drugs being tested will be used primarily by them. Older people can be more prone to side effects and drug toxicities, so even FDA-approved drugs are coming to with unknown consequences. Same for women, who generally weigh less than men, and who absolutely have different hormonal makeup – drugs may not impact them the same way, yet they are less likely to be included in trial groups.

But since drug companies are allowed to design their own trials and choose participants, this problem may not be solved in the foreseeable future. After all, if you were a Big Pharma executive, would you want to test your billion-dollar profitmaker on old sick people or younger stronger people?

2. Cutting them short may short-change us.
It sounds (on the surface at least) like a good thing – stopping promising trials for innovative cancer therapies early so they can get to patients sooner. But the ugly truth is that the practice definitely benefits the drug companies more than cancer patients. Especially with cancer drugs, cutting trials short means there is no data about long-term survival outcomes – and isn’t that what patients are really looking for?

Italian researcher Giovanni Apolone looked into prematurely-stopped trials conducted between 1997 and 2007. According to Apolone, “If a trial is evaluating the long-term efficacy of a treatment, short-term benefits, no matter how significant statistically, may not justify early stopping.” More disturbing, Apolone discovered an alarming trend: the results of trials are being increasingly used in marketing applications, suggesting “a commercial component in stopping trials prematurely.”

3. Drug companies “edit” their findings, then hide the original data.
Case in point, the new, improved Merck-Vioxx scandal. New evidence suggests that Big Pharma giant Merck knew as early as 2001 that Vioxx was deadly, but chose not to present that information to the FDA when they were trying to get their prescription painkiller approved. They skated a very thin ethical line when they decided to remove certain patients from the trial pool, including patients who died after they stopped taking Vioxx, even though their deaths may have been attributable to the drug.

The raw trial data showed deaths in the Vioxx group were nearly 3 times higher than in the placebo group. When Merck presented trial information in their FDA approval packet, they edited those findings. By excluding patients who died after their course of Vioxx treatment, the drug appeared much less dangerous.

The kicker: According to New Scientist (a British scientific magazine), public health researcher David Egilman uncovered another hushed-up study called Protocol 906. That experiment found that Vioxx caused nearly double the side effects of Celebrex (made by Pfizer), another drug in the same family. In that paper work, he actually came across an email from one Merck employee to another saying…

“…this is a very serious result and you will hardly be surprised by the idea of keeping this VERY TIGHT for the moment.”

Posted in Big Pharma, Dangerous Drugs, Studies, Drug Trials | 2 Comments »

Court-Sponsored Fraud…or Murder?

Tuesday, April 8th, 2008

Let me get this straight: A drug harms us, and we can’t sue the drug company because the drug was FDA-approved. Or, as I like to put it, the government has decided it’s ok for the drug companies to hurt us as long as they make plenty of money at it.

It was bad enough when this ridiculous “preemption” law (preempting us from suing) had the spirit of protecting genuine unforeseen errors – unforeseen due to insufficient testing, of course. But now there’s a case of actual intentional fraud going on. FRAUD! Intentional FRAUD! And it’s possible that the preemption law may still apply.

Here’s the case. According to the New York Times, my old Big Pharma buddy Johnson & Johnson seems to have purposely lied and covered up damaging information in order to sell a drug they KNEW was mislabled and potentially deadly. In fact, this drug was literally deadly for at least 50 women. Other consequences were slightly less dire, like strokes and heart attacks. And ALL of these dangerous drug side effects could have been prevented if the company hadn’t lied because they wanted to sell more. To me, that sounds like they should be charged with murder, or negligent homicide, or some other punishable felony.

The drug in question was a birth control patch, called Ortho-Evra, which was supposed to deliver an even lower dose of estrogen than low-dose birth control pills. But the company (again, according to the Times) KNEW that the patch, in fact, delivered a much higher estrogen dose. And they KNEW that the dose actually delivered was known to cause complications like strokes and heart attacks. And they lied about how much estrogen the patches contained, telling the public they contained 40% less estrogen than they actually delivered. Their own studies, one from 1999 and one from 2003, clearly showed that the estrogen dose of the patch was higher than that of the pill…but they told no one about it at the time.

Finally, in November 2005, the FDA realized something was amiss and issued a warning: “exposes women to higher levels of estrogen than most birth control pills.” The patch’s labeling was changed…and prescriptions for it plummeted. See, virtually no women would knowingly subject herself to that kind of danger to wear a patch instead of taking a pill. And virtually no reputable doctor would prescribe that dangerous dosage to his patients. But no one knew about the danger before November 2005…except the caring folks at Johnson & Johnson.

So, now, a group of more than 3,000 is trying to sue the corporation. And in true Big Pharma fashion, the corporation is trying to make sure the case dies a quick death – under the “our drug was FDA-approved” exemption.

I say the courts should absolutely let this FRAUD case in. I say the judges should find in favor of the hurt, sick and dead women, and declare J&J guilty of fraud, negligence, and homicide…and sentence them all to a year on the Ortho-Evra patch.

Posted in FDA, Big Pharma, Dangerous Drugs, Lawsuits | 2 Comments »

How to Murder Your Husband (or Wife)

Thursday, April 3rd, 2008

These days, you don’t need to hire a hitman to knock off an annoying spouse with a hefty life insurance policy. Nope, you can get rid of your spouse – permanently – without doing anything illegal at all. All you have to do is encourage him (or her) to try a drug that’s been approved by the FDA in the past few years. Because these days, “FDA-approved” often means “may have deadly consequences.”

Think I’m kidding? Bextra. Vioxx. Avandia. Ketek. Singulair. Vytorin.

Any one of these drugs might do the trick. Well, not any one…you can’t get Bextra or Vioxx anymore. The FDA finally cottoned to the dangers - after the number of patient deaths grew too high to ignore - of these COX-2 inhibitors and they were taken off the market.

Now Avandia and Ketek have black-box warnings, but you can still get them. Singulair and Vytorin are under investigation, but you can still get them. And there are dozens of new drugs in the approval pipeline, all just waiting to be prescribed before someone notices they’re potentially deadly.

The days of the hitman are over. There’s a new danger in town – and this one is probably covered by Medicare.

Posted in FDA, Dangerous Drugs, Quick Hits | 1 Comment »

A Singulair-ly Bad Drug?

Friday, March 28th, 2008

It’s all over the news: The FDA is looking into the possiblity that asthma/allergy drug Singulair causes suicidal thoughts and actions. For a change, they’re telling us at the front-end of the investigation (which they expect will take at least 9 months to conduct), giving people a chance to stop taking the drug NOW instead of waiting almost a year to find out they should have stopped taking it NOW.

My guess is that the FDA will find this drug can cause extreme mental disturbances. And that’s because I’ve seen it in action. About four years ago, our pedicatrician prescribed Singulair for my then four-year-old son. A couple of days later, he started hearing a dog-man’s voice in his head telling him to do things. The pediatrician took him off Singulair right away – she told me it had probably caused his “auditory hallucinations.”

And hallucinations is just one of the possible known side effects of Singulair. More already-admitted side effects (as per Merck’s own labeling) include anxiousness, depression and – yes, you read it on their own label first – suicidal behavior. That’s right…this comes directly from their own patient information circular, just a small sample of a very long list of possible side effects:

behavior and mood related changes [agitation including aggressive behavior, bad/vivid dreams, depression, feeling anxious, hallucinations (seeing things that are not there), irritability, restlessness, suicidal thoughts and actions (including suicide), tremor, trouble sleeping]

Imagine how bad it really is if Merck has – on its own, without being forced – updated it’s labeling to cover these horrific side effects. Don’t wait for the FDA to discover what Merck is already admitting.

If you take Singulair, talk to your doctor today about other treatment possiblities. And if you’re interested in a safe, natural approach to keeping allergy and asthma symptoms under control, check out the HSI archives.

Posted in FDA, Big Pharma, Dangerous Drugs | 2 Comments »

UK KOs Big Pharma

Wednesday, March 26th, 2008

If that was only a small subset, experts wonder what other data might be out there.

That was the line in this AP article that most drew my attention. It’s referring to the fact independent researchers looked through the data provided to the FDA by GlaxoSmithKline for drug approvals…and found that antidepressants are largely ineffective. GSK responded by saying that the researchers conclusions didn’t mean much as they were only at “a small subset of the data available.”

If that doesn’t show that the drug company carefully chose the data they presented to the FDA to get their drugs approved, I don’t know what will. And, apparently, the UK government agrees with me – even if the US government remains firmly on the side of Big Pharma. The UK government feels so strongly, in fact, that they’re planning to force drug companies to share more complete data when they conduct clinical trials.

The lynchpin case here is about a drug called Seroxat, produced by GSK. It turns out that this antidepressant can raise the suicide risk in teens by 600%. And that the drug company appears to have purposely withheld the information from the government and the public.

Of course, the company denies doing anything wrong. Their spokesman said, “We firmly believe we acted properly and responsibly.”

Well, sure. They skated within the fine line of the law. Legally, they only have to report problems found in a drug when that drug has been used as officially recommended. And since the Seroxat was only officially recommended for use in adults, the company bears no responsibility for reporting data when the drug was prescribed for teens.

GSK has made their position quite clear – they will follow the strict letter of the law, when it comes to product disclosures. Obviously, we can’t count on Big Pharma to do the real right thing, just the officially proper action. So, clearly, the law needs to change.

U.S. Congress – are you paying attention?

Posted in Big Pharma, Dangerous Drugs, Studies | No Comments »

Fosamax & Femur Fractures

Monday, March 24th, 2008

This just in, folks. According to a newly published study, Fosamax – the drug millions of women take to strengthen their bones – may cause “unusual femur fractures.”

What’s so unusual about these femur (a.k.a. thigh bone) fractures, you ask? Well, they were all caused by falls of standing height or less – meaning these people didn’t fall off ladders or down a flight of stairs. In fact, according to the senior study author, the women were “basically doing nothing” when their legs broke. The breaks also formed atypical horizontal patterns. And it turns out that 37% of the women who experienced these fractures had been taking Fosamax for years, most for at least seven years. Talk about a product not working as expected!

Here’s what else the brilliant (sarcasm alert) study author, Dr. Joseph Lane, had to say, according to the Medline report. He believes that women taking this medication should keep taking it, and these findings shouldn’t cause them alarm. And he’s quoted as saying “This is a great drug that does wonderful things. Bisphosphonates have dropped the rate of hip fractures.”

So, unusual femur fractures are less important than hip fractures? Not to me! I like all of my bones to be unbroken and in good working order. Which is why I would never take a drug like Fosamax. Especially when this news comes on the heels of an FDA warning back in January that the drug also seems to cause severe bone pain. Oh, and a severe pain in the wallet, as a one-month supply runs $83.99 on Drugstore.com.

I prefer to strengthen my bones the Spreen way, courtesy of HSI Panelist Dr. Allan Spreen. His natural solution for building and maintaining bone is the right mix of nutrients. Most people load up on calcium and stop there – but, as Dr. Spreen tells us, calcium can’t do the job alone.For proper absorption of calcium, your body also needs plenty of magnesium as well as manganese, boron, silica, strontium, usually digestive enzymes, often additional betaine hydrochloride, and ALWAYS vitamin D. For more safe, natural – and relatively inexpensive – ways to strengthen your bones, check out the HSI e-Alert archives at http://www.hsibaltimore.com/

Posted in Dangerous Drugs, Natural Remedies, Osteoporosis | 1 Comment »

Protecting Profits, Killing Patients

Sunday, March 16th, 2008

Remind me, please? Who is the FDA working for? And who is protecting us from dangerous drugs that may be killing us?

We all need protection against greedy drug companies pushing unnecessary and dangerous drugs on us – but endstage cancer patients need even more protection. Those patients are the most willing to try anything, just to gain a little time or feel a little better. And the fact that they may be treated with a drug that we know can make them worse, and actually steal time from them – that’s unconscionable, disgusting, infuriating, and some words that I’m not allowed to post on this website.

I’m talking about anemia drugs that we now know are horrific choices for cancer patients: Procrit, Aranesp and Epogen. The FDA has already cost Big Pharma a few hundred bucks (they made them relabel the products with stronger warnings), and it looks to me like they don’t want to cut more deeply into their buddies’ profits – because they’re NOT taking these sometimes deadly drugs off the market. In fact, the AP article I just read lead with this line:

“Federal advisers said anemia drugs sold by Amgen Inc. and Johnson & Johnson should be sharply restricted to a segment of cancer patients - a recommendation that could cost the companies millions.”

How about the fact that it could cost the cancer patients what’s left of their lives? But, hey, no worries. The FDA advisory panel wants to restrict the use to a particular segment of patients – limiting use to only those “with uncurable forms of cancer.”

The article is full of infuriating information:

The limits, proposed Thursday by a Food and Drug Administration panel, were the latest blow to three blockbuster medications already plagued by concerns over increased risks of death and tumor growth.

The recommendation was not as restrictive as some on Wall Street had feared, and shares of Amgen climbed by nearly 5 percent in afternoon trading. Many analysts said the panel could have recommended halting the drugs’ use in all chemotherapy patients, endangering as much as $1 billion in Amgen sales.

Earlier on Thursday, FDA staff told panelists there is no definitive evidence that the blockbuster anemia drugs are safe when used as recommended.

Amgen and J&J representatives argued Thursday that the problems cited by FDA have been inconsistently reported across dozens of studies. And they pointed out that only studies involving higher-than-recommended dosing levels showed significant safety risks. The companies outlined a large-scale study Thursday to try and answer whether anemia drugs hasten death and tumor growth when used according to the current label, but results won’t be available for at least five years.

On top of all this, the FDA doesn’t even have to follow the recommendations of the advisory panel. They could choose not to limit the use of these drugs at all. And, based on their Big Pharma-loving track record, I think they’ll do just that – nothing.

What I think they should do: Make the Big Pharma execs test the drugs on themselves. They’re already rats, why not make them lab rats?

Posted in FDA, Big Pharma, Cancer, Dangerous Drugs | No Comments »

Think You’re Drug-Free? You’re NOT!

Monday, March 10th, 2008

Did you know that every time you take a drink of tap water, you’re taking drugs? And I’m not just talking about flouride here. Anticonvulsants, antidepressants, antiobiotics…and that’s just a few of the As!!

The AP just published an article about pharmaceuticals found in municipal water supplies. Not just floating around in the reservoirs, but in the actual water you’re drinking, cooking with, and bathing in. And every time you connect with that water, you’re taking in low levels of drugs. Which drugs and how many – well, no one is being directly forthcoming about that. But count on this: It’s a lot of different drugs, and more than you should be getting.

This is some seriously scary stuff – alarming, really. And it’s worse than it sounds, because not every municipality tested their water for drugs. And the ones that did, well only the drugs they’ve specifically tested for will be reported. Some water supplies contained dozens of different trace pharmaceuticals – Philadelphia, for example, turned up 56 different drugs in their drinking water. 56!

Yes, this is scary, and overwhelming. But it does have its funny moments, as reported in the AP article. Here are a few of my favorite lines:

Arlington, Texas, acknowledged that traces of a pharmaceutical were detected in its drinking water but cited post-9/11 security concerns in refusing to identify the drug. [O]fficials in Emporia, Kan. refused to answer AP’s questions, also citing post-9/11 issues.
(Right…because Arlington, TX and Emporia, KS are known terrorist target cities, and not disclosing drug findings protects their citizens from…what exactly? )

Water sampled downstream of a Nebraska feedlot had steroid levels four times as high as the water taken upstream. Male fathead minnows living in that downstream area had low testosterone levels and small heads.

Ask the pharmaceutical industry whether the contamination of water supplies is a problem, and officials will tell you no. “Based on what we now know, I would say we find there’s little or no risk from pharmaceuticals in the environment to human health,” said microbiologist Thomas White, a consultant for the Pharmaceutical Research and Manufacturers of America.

“It could be that the fish are just exquisitely sensitive because of their physiology or something. ”

Confidence about human safety is based largely on studies that poison lab animals with much higher amounts.

“I think it’s a shame that so much money is going into monitoring to figure out if these things are out there, and so little is being spent on human health,” said Snyder.

Excuse me, but how is this issue not related to human health? We’re prescribed too many drugs. Those drugs end up hitting us a second time through the water supply – along with dozens of other drugs. Antibiotic-resistant bacteria are breeding like never before. And the paltry amount of money governments are spending to find out if our most basic need is safe – that’s not critical human health spending? Now I’m really afraid.

Posted in Dangerous Drugs, Prescriptions, Water | No Comments »

Creating Generation Rx

Sunday, March 2nd, 2008

Contrary to what you’ve been led to believe, Nexium is NOT a wonder drug…except maybe in the sense of “I wonder why anyone would take it.” That includes babies, for whom this destructive drug has now been approved by the FDA, an agency that seems to do more horrible and stupid things every day.

The latest travesty is the approval of Nexium for kids aged one to eleven who have “acid reflux disease.” Nexium is a proton-pump inhibitor (PPI), a drug that decreases stomach acid production. Sounds like a great plan - treat acid reflux with a drug that reduces acid. But doing that is a BIG mistake.

Here’s what they’re not telling you: Putting kids on Nexium (or any PPI for that matter) practically ensures that they’ll be drug users for life. This drug actually suppresses their bodies’ natural stomach-acid producing mechanisms – and no one can digest food properly without stomach acid. If you can’t digest your food, you can’t properly absorb the nutrients…and who needs nutrients more than growing children?

Another thing they’re not telling you: Acid reflux is not caused by too much stomach acid. Rather, it’s caused by a weak LES (lower esophagus sphincter), the flap that’s supposed to close after food has passed down so that nothing can pass back up. When the LES is working right, nothing is going to come back up, no matter how much acid you have in your stomach. When it’s not working well, though, even a tiny amount of acid could cause great discomfort. So suppressing much-needed stomach acid is not the solution…in fact, it can make the LES even lazier, causing more acid to flow up. That, in turn, makes people seek out even stronger acid suppressants – and the real problem is never addressed.

Finally, Nexium comes with some very lovely side effects. (You didn’t think this drug was side-effect free, did you?)
· headache
· diarrhea
· dizziness
· abdominal pain
· nausea
· gas
· constipation
· dry mouth
· sleepiness
And, of course, even the side effects usually lead to additional drug use. Kid’s got a headache? Give him some Motrin. Can’t sleep? Try a Benadryl. More drugs, more side effects, more drugs. Luckily, there’s a much better way to deal with this problem.

Believe it or not, there’s a ridiculously simple, cheap, side-effect free way to help a child who appears to be suffering from acid reflux: Acidophilus. That’s right, acidophilus supplements (use the powder form – the liquid tastes awful) protect the esophagus without killing off any acid, and kill the pain of reflux almost immediately. The trick with acidophilus capsules is that for treating reflux, it’s best to open the capsule and let saliva carry the powder down your throat to your stomach. (If your child won’t do that, try mixing it up in some apple sauce.) And you don’t have to worry about dosage, since acidophilus supplements represent a sample of the billions of ‘good guy’ bacteria that you want in the GI tract.

You can find acidophilus easily at most health food stores. The best ones to get are those in the refrigerated section. Look for labels that say billions of CFU (colony-forming units). Give your child about 1/4 teaspoonful right before meals and bedtime, plus anytime he experiences the burning feeling.

Posted in FDA, Dangerous Drugs, Natural Remedies | No Comments »

Drug Approval Reaches Ridiculous Low

Monday, February 25th, 2008

Cancer patients often suffer horribly, clinging to the hope that a treatment will give them more time. So when a new drug gets approved, or an old drug learns new tricks, cancer patients gather hope. And when that hope is betrayed because of money or politics, it’s just disgusting. Congratulations, FDA – you’ve just given breast cancer patients false hope, and the chance to suffer through a newly-approved treatment for absolutely no reason.

That’s right. Despite a thumbs down from their advisory committee, the FDA has just given existing lung and colon cancer drug Avastin a new lease on life – Genentech’s (the manufacturer) financial life that is, not the lives of the patients the drug is approved to help. The drug does not prolong the lives of breast cancer patients. The drug does not cure breast cancer. It does not appear to improve quality of life for breast cancer patients. And when the advisory panel voted down the approval of this drug for breast cancer, they indicated (according to the AP) that “the drug’s benefits did not outweigh toxic side effects.” Which, by the way, include high blood pressure and death.

So how did the FDA get around all this negativity and approve the drug anyway? Well, there’s evidence that Avastin does slow down tumor growth…for the lovely low price of $100,000 a year. Slower tumor growth could theoretically give breast cancer patients a little more time, time in which a better treatment could be discovered…though that doesn’t help the six patients (from the Avastin group) who died during the trial. (Did I mention that death is a possible side effect of this drug?)

Some people (like the idiots at the FDA) consider this to be good news for breast cancer patients. With news like this, who needs enemies?

Posted in FDA, Cancer, Dangerous Drugs | 1 Comment »