October 2006
Unless, you’re willing to risk your life to cure the sniffles
In what world is a sinus infection worse than dying from liver failure? It’s absurd, I know. But this is the kind of ridiculous trade-off the FDA thinks is entirely appropriate if you take the antibiotic Ketek. Let me tell you right now: If your doctor writes you a prescription for Ketek to treat a sinus infection or bronchitis…run! Don’t walk. And don’t look back.
Since this drug entered the U.S. market, at least four deaths have been linked to Ketek-related liver problems, not to mention at least 12 cases of liver failure, and at least 110 cases of liver injury. The numbers might not sound as alarming as the Vioxx news that hit every front page in the country. But, to be honest, there are usually far more unreported problems than reported ones. And if even one person died trying to fight a sinus infection it’s just too many. Period.
That’s unless you ask this drug’s maker, French drug giant Sanofi-Aventis. They seem to think this is a risk worth taking to clear up a case of the sniffles. And as crazy as it sounds, the FDA doesn’t seem to think it’s a bad idea either.
In fact, there’s been a lot of suspicion in the medical community that the FDA knowingly allowed fraudulent data to be used during the approval process of Ketek, even as doctors and scientists were already expressing concern about this drug. Hold on, it gets worse.
Even after the revelation that Ketek can cause liver damage, the FDA approved a clinical trial of Ketek to be used in (you’ll never believe this) babies. That’s right: babies. (After all, there’s no better patient than one who can’t talk about the pain they’re suffering.)
Fortunately they recently stopped that trial not long after some FDA officials came forward and spoke out against this drug. Thank God.
Payoff not worth the price
Yet, despite all the evidence that says otherwise, Sanofi-Aventis has sworn up and down (and so has the FDA) that the benefits of Ketek outweigh the consequences. WHAT!? I have never had a patient experience a sinus infection-or even a case of bronchitis-so vicious that I actually thought, “I would risk my patient’s life to make this go away.”
It amazes me that any company (even a profit-hungry drug manufacturer) would have the gall to make such a claim. But perhaps they’re just looking at different data than everyone else is. Because, based on what I’ve read, I can’t even believe that it’s still on pharmacy shelves.
What’s clear is that Ketek is more dangerous than other antibiotics out there (like the ones that don’t cause liver damage).
But, for some reason, the FDA has made a practice of defending itself from every Ketek critic out there, continuing to assert this drug’s relative safety, and defending its decision to keep this stuff on pharmacy shelves.
Even the one measly little alert the FDA actually did put out there doesn’t even warn people not to use the drug, and instead called the instances of liver damage “infrequent” and “reversible.” (In all my years of practice, I’ve yet to see one case of death that’s been reversible.) That’s not a warning.
Here’s a warning: DO NOT USE KETEK. Why was such a drug created in the first place?
Ketek is a ketolide antibiotic, a new subclass of the macrolide class of antibiotics, which includes well-known drugs like azithromycin (Zithromax), clarithromycin (Biaxin), and Erythromycin.
Macrolide antibiotics work inside your cell’s nucleus to prevent the production of proteins. And since bacteria need protein to survive, these drugs can slow down-and usually kill-a lot of the bacteria, helping you recover sooner. But eventually some bacteria get stronger and more resistant to certain antibiotics, which is why drug makers constantly need to invent new antibiotics.
Like I said earlier, Ketek was designed to treat acute bacterial sinusitis, mild to moderate pneumonia, and chronic bronchitis. It was also intended to counter a particular resistance problem that was occurring with other macrolide antibiotics, after -like always-a certain bacterial strain got too powerful.
It was a nice idea, in theory. But, in practice, it’s turned into a nightmare. And the nightmare started when Sanofi-Aventis first began testing the drug.
A quick fix, a cover-up, and the almighty dollar
We’re now learning that the studies submitted to the FDA don’t actually prove that Ketek does a better job than any other drug out there, unlike what Sanofi-Aventis is claiming. (“Fraudulent” is the term that a lot of people are using now.)
In fact, one French drug journal, Prescrire International, wrote: “Telithromycin (Ketek) is a needless addition to the other macrolides.” Needless? Try ridiculous.
It now looks like there might have been some serious flaws in how the company carried out its drug trials. One problem is that some of the trials were carried out overseas, where the standards for reporting are even less rigorous than our own stellar standards at the FDA. As a result, some deaths and illnesses may have gone unreported.
And the results of the study aren’t all that’s being called into question here. Some of the researchers actually conducting the study-many of them doctors who signed up their own patients-also proved to be less than trustworthy.
One of these doctors was addicted to cocaine, a fact no one discovered until he was arrested while holding his wife hostage at gunpoint. While they were arresting him, police found cocaine in his underwear.
Another doctor was actually disqualified (and even prohibited from taking part in any future clinical trials), as was another doctor, who’s been accused of 20 different violations against the study’s instructions. Finally, another doctor-who had the highest number of subjects in the study-was sentenced to five years in prison in March 2004, after being convicted of serious misconduct related to her medical practice.
These were the very people the FDA trusted to prove Ketek was safe and market-ready.
My black box warning to you
Obviously, not enough is being done to remedy this situation (or disaster, as I like to call it).
The FDA has recommended (not required) that the drugmaker put a black-box warning on its label, politely warning about the risk of liver failure. But even then there’s a caveat, with the FDA saying that a “bold-text warning” (notably less serious) may also be good enough.
Meanwhile, Aventis has sent out a “Dear Doctor” letter warning physicians that the drug could cause liver problems. If you’ve seen the paper-covered desks in a doctor’s office, you know how efficient that is. I feel safer already.
And none of that will stop doctors from prescribing it or patients from taking it.
The problem is that when it comes to liver failure, once the damage is done it’s often too late to fix it, no matter how closely a doctor monitors his patient, and no matter how many warnings you print on the label. And when that’s the case, the only course of action should be removing the drug from pharmacy shelves. Plain and simple.
And it’s not just your liver that’s at risk with this drug. At least 167 patients reported blurred vision-in some cases bad enough to interfere with the performance of daily activities-during the Ketek trials. These episodes started one to three hours after taking it and lasted up to 20 hours, mainly in women and children being treated for ear infections.
Meanwhile, it looks like the FDA is making itself busy saving face with claims that Ketek is safe when used as directed. Tell that to the families of the people who died or the people who suffered liver damage.
It would be much more honest to say: If you’re already at risk of dying from pneumonia, then Ketek might be worth the risk. But in any other case it’s just not worth it, especially when other proven remedies exist.
Obviously, the almighty drug company dollar has called the shots in this case-and most likely in many others. After all, Sanofi-Aventis invested hundreds of millions of dollars in Ketek and isn’t eager to see it gone-at least not until they turn a profit.
Unfortunately, the only people who know for sure why this drug keeps sticking around are tangled in a web of bureaucratic red tape and (most likely) deceit. The consequence is that all of us measly American citizens apparently aren’t entitled to know why our doctors are being allowed to keep writing prescriptions for a drug that could very well kill us.
This year, several newspapers got their hands on some internal e-mails in which three FDA safety officials waved a red flag before this drug was even approved. But guess what? The FDA ignored them all.
One of those safety officials, Dr. David Graham (the man who blew the whistle on Vioxx) wrote in an e-mail, “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where Telithromycin (Ketek) was concerned.”
How many more deaths and cases of liver failure will it take before it gets pulled off the shelves? Three more? Three hundred more? Three thousand?
What really makes me angry, though, is that there are still doctors out there buying into the propaganda and pulling out their prescription pads to write “Ketek” on them and then handing that prescription to a patient with the sniffles or bronchitis.
So much for that old doctor’s oath, “Primum non nocere.” English translation: First do no harm.
Editor’s note: As a loyal subscriber to America’s Country Doctor, you can access my archives, search for topics, and read my previous House Call e-mail updates for free by logging on at America’sCountryDoctor.com. I’ll give you alternatives to Ketek and other drugs that you can do without. Use the username and password listed on page 8 to receive this benefit today.
Immediate action required
After last month’s issue-when I told you about some symptoms not to panic over-I received a flood of letters from readers asking what symptoms actually should cause them to panic.
Well, just like some people worry about the slightest sniffle, others are too quick to cast off even the most serious symptoms as common and “no big deal.”
But, in reality, if you so much as suspect you might be suffering from one of these symptoms, it’s time to drop everything you’re doing and head straight to your doctor’s office-or possibly the emergency room-right now.
So here they are. I’m not going to even bother ranking them. The fact is, any one of these problems is a big cause for concern.
A “thunderclap” headache
This kind of headache may also be known as “the worst headache of your life.” It’s sudden, extremely painful, and it often comes with vision loss and an inability to focus. In medical terms, however, it might be called a subarachnoid hemorrhage (SAH).
In laymen’s terms, you might be bleeding into your brain, usually the result of a broken blood vessel. This is often the result of poorly controlled high blood pressure. It can also be an inherited problem, though that’s less common.
Doctors often allow milder cases, in which the bleeding stops on its own without brain damage, to heal without surgery. But severe cases are life-threatening and often require an emergency surgery to stop the bleeding. Doctors usually rely on a physical exam, plus emergency imaging techniques (like a CAT scan or MRI) to guide their decisions.
Here’s the catch: You’re not a doctor. So you may not know whether your case is serious or mild. Head to the emergency room-now.
“Elephant sitting on your chest”
This is the classic description of a heart attack
Of course, a heart attack can be associated with all sorts of pain, including abdominal pain, upper back pain, shoulder pain, and even (in some very rare cases) thumb pain.
But a heart attack can also be virtually painless, especially if you’re diabetic. (The high blood sugar associated with diabetes damages your nerves, making you less aware of pain.) And, unfortunately, without pain, shortness of breath, or sudden weakness, a diabetic has no way of sensing a heart attack. It’s just one of many reasons it’s important for diabetics to take extra good care of themselves.
When it comes to avoiding a heart attack, it’s crucial to know what your risk is-for instance, it’s higher if you’re a smoker, have a family history of heart disease, have high blood pressure, diabetes, are overweight, or if you’re just extremely stressed out.
Sudden loss of strength or feeling
A sudden numbness or loss of strength, especially when it’s located in just one spot-like your hand, foot, arm, leg, or face-could easily be a stroke. And, since the drugs that doctors use for treating a stroke only have a three-hour window of opportunity, it’s vital that you not delay one moment.
Strokes work in a fashion similar to heart attacks-a blood vessel gets blocked by a clot, often in a neck artery or the heart, which breaks off and travels up into the brain. This is known as an embolic stroke (an embolism is the bit that breaks off). The risk factors are similar to those for a heart attack, although high blood pressure is given greater emphasis. (Your brain has many tiny blood vessels that thicken and narrow in response to continuous pressure or wear-and-tear, blockage, and of course, stroke.)
Sudden, severe eye pain or vision loss
Sudden eye pain, vision loss, headache, haloes around lights, nausea, and vomiting, are all symptoms of acute closed-angle glaucoma. (Regular glaucoma, on the other hand, takes years to develop, unlike this form, which can develop quickly.)
This happens when the iris (the colored part of your eye) moves forward and prevents the free flow of the eye’s inner fluid, increasing the pressure inside your eye, and possibly causing irreversible damage to the optic nerve and visual loss.
Glaucoma is more common among elderly, female, and Asian patients. (Asians are more at risk because of their eye shape.) And, like most eye diseases, the damage caused by glaucoma is irreversible.
To make a long story short, this is a serious problem that warrants an immediate trip to an eye doctor or emergency room. Treatment usually consists of laser surgery to reduce the pressure in your eye, but the hope there is minimal. That’s why people with a family history of glaucoma should get regular eye exams every year.
Blood in your stool
Visible blood in your stool means you might be bleeding somewhere else in your gastrointestinal (GI) tract. Bright red blood could be hemorrhoids (painful and serious, but not life-threatening), a diverticular bleed associated with a weakening in the wall of the colon, a colon polyp, or colon cancer. And colon cancer-the most common form of cancer and more likely the older you get-is especially bad news.
The problem is that you don’t know which of these things it might be until you get checked out. This is why blood in your stool usually results in a prompt colonoscopy.
Dark-colored blood suggests that you’re bleeding higher up in your GI tract. Black stool, on the other hand, is usually caused by a bleeding ulcer way up in your stomach or duodenum (the portion of your small intestine attached to your stomach).
Either can be life- threatening and usually results in the urgent placement of a special scope through the mouth down into the stomach (called an endoscopy) for a look.
Colonoscopies and endoscopies sound scary and uncomfortable, I know. But you’ll be asleep through the whole procedure. And it could save your life.
Blood in your urine
While this symptom often means a kidney stone, it could also mean bladder or kidney cancer, at least until proven otherwise. If it’s a kidney stone, the affected side will probably hurt like the devil.
If your bleeding is light to mild, it could also just be a urinary tract infection, or an enlarged prostate if you’re a guy. Go to a urologist-it’s usually not an immediate emergency unless the blood flow is sudden and large. But if it is sudden and large, it’s time to worry.
When you go to the doctor (and you need to go soon), he or she will do blood work, look into your bladder with a special scope, and possibly check your kidneys with a CAT scan (or an MRI if nothing turns up in your bladder). These cancers are usually treatable with surgery and they don’t shorten your life expectancy.
A lump in your breast
Breast cancer has now assumed epidemic proportions. And although many conventional doctors downplay the roles of diet and exposure to environmental toxins, the scientific evidence is overwhelming. Genetics and family history are also very important.
Fixed, stony, hard masses are most likely cancer and should send you to your doctor as soon as possible. Rubbery and mobile masses that change in size through the month are probably benign, but they still require treatment. You should make your doctor aware of any mass in your breast. A benign mass can transform into a malignant cancer later on down the road.
If you are good about getting annual mammograms-which you should be-stagger them at six-month intervals along with your regular gynecological appointment, which should include a thorough breast exam. And make sure you get the practitioner who does your exam to show you how to do a proper self-exam-and then do one every month.
A lump in your scrotum
This is often symptomatic of testicular cancer, which is usually considered a young man’s disease (occurring primarily among guys between the ages of 18 and 35). But that doesn’t mean you’re too old to get it. Or to know someone who might be at risk.
Testicular cancer, if discovered early, is one the few truly curable cancers, with children and a normal love life still quite possible.
Even so, every year a few thousand unfortunate young men die because no one told them how to perform monthly testicular exams. In fact, half the young men I see don’t have a clue. Make sure the young men in your family do.
A mole that keeps getting larger
Most moles and freckles are harmless.
But when you have a mole that keeps getting larger, especially if it’s dark with irregular edges, it could be a melanoma, a form of skin cancer that can be quickly fatal if it spreads into the rest of your body.
Not all melanomas are the same, so skin doctors usually play it safe and biopsy anything that looks suspicious or has increased in size. Your best bet is to call attention to anything that worries you–freckles or moles–and to get an annual, full-body skin check by a dermatologist.
Severe abdominal pain
Sudden, severe, sharp, and unrelenting abdominal pain is usually so unbearable that you end up in the emergency room before you can even think twice.
You see, there are literally dozens of causes of abdominal pain. Doctors are always on the lookout for certain causes, especially those that could be deadly. Sharp, unrelenting, even unbearable abdominal pains could be signs of a perforated intestine, internal bleeding, or a bleeding ulcer, just to name a few.
Even milder pains can be tricky. Sometimes, milder pain that slowly increases, or comes and goes over time, could be the result of an underlying tumor. Certain cancers, including those in either your colon, kidney, liver, gallbladder, or ovaries, can all cause serious abdominal pain and tumors. Non-cancer causes are often ovarian cysts (in women of course), diverticulitis (a colon infection), an infected gall bladder or gall bladder stones, or a malfunctioning bladder (which is more common among elderly folks).
To be honest, any pain that’s worrisome to you is worth an immediate call to your doctor– whether it’s cancer or gas. ACD
The amazing benefits of grape seed extract
Most doctors will give you a laundry list of drugs you could take for heart disease prevention: Some might suggest aspirin. Others might tell you statin drugs are the only way to go. But in my mind, drugs shouldn’t play a role in prevention at all. After all, isn’t part of the point of prevention to avoid needing drugs in the first place?
That’s where grape seed extract comes in. Not extra vitamin C or vitamin E. Not even rhodiola. Not butterbur. I love them all, but it’s grape seed extract (GSE) that has my loyalty.
People first started noticing the health benefits of grape seed extract in the early 20th century, when studies showed that the French suffered fewer cases of heart disease than the rest of us. And the main link scientists found? They drank (and still drink) more red wine.
GSE can be found in green, red, and purple grapes. (The seeds of purple grapes have the highest quantities though, hence the name.) Just one dose of this stuff is chock full of antioxidant flavonoids that are up to 20 times as potent as the antioxidants found in vitamin C or vitamin E. These antioxidants are known for their role in preventing the oxidation that causes heart disease in the first place. And GSE’s higher potency of these antioxidants means this supplement is even more effective at fighting off “bad” LDL cholesterol, which eventually sticks to and injures your blood vessel walls (the end result often being heart attacks).
GSE has also been shown to support and protect collagen, the most abundant protein in your body. Now, you’re probably used to thinking of collagen as part of a surgical procedure for fuller lips, or an ingredient for lotions advertising firmer, tight skin. And I’m not going to lie: A lot of people are attracted to grape seed extract because of its reputation for promoting healthier skin, hair, and nails.
But, more importantly, it also plays a role in protecting your heart.
Collagen is the tough, fibrous stuff that helps keep the inner lining of your blood vessel walls intact. And the stronger your vessel walls are, the less likely you are to develop clogged arteries.
Like most supplements out there, GSE does have at least one side effect worth warning you about. It can actually cause blood thinning (not much, just a little), so if you’re already taking a blood thinner it’s best to talk to your doctor before starting it. (If you’re not taking a blood thinner, though, a mild blood-thinning effect can be a good thing and help to prevent artery-clogging blood clots.)
I recommend taking 200 mg daily for a month in order to quickly build up your tissue levels. After that, back off to a 50 or 100 mg dose daily. I like (and use) the Activin and Nature’s Way products myself.
Replace Neosporin with grape seed extract
This stuff isn’t just great for prevention. It also works wonders in everyday life.
For instance, recent studies have shown that grape seed extract can actually speed up the healing time for open wounds, cuts, and scrapes.
In one study, researchers found that grape seed extract actually enhances your body’s production of epidermal tissue and makes that tissue denser and stronger. And this stuff also helps rebuild connective tissue and repair blood vessels.
Navigating the supplement maze
Q. Several years ago I started taking Metamucil to clear up constipation. It worked like a charm, until lately. Now it’s stopped working altogether. I’m 62 years old, I take a 30-minute walk every day, I’m not overweight, and my diet is pretty healthy: Total cereal and a banana for breakfast, a cup of tea here and there, a sandwich (whole grain bread) and soup for lunch, and dinners of chicken, fish, rice, potatoes, and different vegetables.
Should I up my dosage of Metamucil or just quit taking it altogether and find something else?
–Jane Harmon, Staunton, Va
A. Before I go into how to fight constipation I need to address the possibility that it’s something more serious. A recent change in bowel habits that lasts more than a few days could be from underlying colon cancer. Tell your doctor immediately and get a colonoscopy, even if you’ve had a normal one within the last few years. But for now, let’s assume you’re just dealing with regular old constipation. And let’s start with your fiber intake.
Abundant fiber (more than the measly 25 g a day recommended by the government) derived from whole foods is the best way to ensure regularity.
Unfortunately, Metamucil doesn’t give you even a quarter of the fiber you need to be getting every day. In reality, this stuff has only 3 g of fiber per dose. Taking two doses daily, you get only 6 g of fiber. Add that to the fiber in your diet (probably about 15 to 20 grams a day, based on what you told me), and you’re still not getting enough.
In fact, 40 or 50 grams, every day, is closer to what you need. And the best place to get it is in your food.
However, that Total cereal you’re eating probably isn’t the best source. It most likely has only 2 or 3 g of fiber a serving, hardly enough to make a difference. Instead, try giving yourself an extra five or 10 minutes each day to cook a bowl of oatmeal, barley, or some other whole grain cereal. Muesli and unsweetened granola are both good options as well. Add a few sliced almonds and a half-cup of raspberries or blackberries, which are full of fiber. That’s more than 15 g of fiber, all of it from whole foods. Not a bad start to the morning, if you ask me.
Next, for a midmorning and afternoon snack, try a handful of nuts and raisins, prunes, or a small piece of fruit.
You should also be thinking about vegetables and colors. Add a tossed salad with tomato, peppers, carrots, and baby spinach to your daily diet. And include an extra steamed or lightly boiled vegetable from the broccoli family with your dinner. Try broccoli, cabbage, cauliflower, or kale at least three to four times a week (and preferably every day). Also make sure you drink enough fluid every day, at least 64 ounces.
If you need more help, try adding a tablespoon of ground-up flaxseed to your salad. Magnesium citrate (in capsule form, 400 to 800 mg daily) can also help by gently prodding your intestines to move food through faster. It’s safe and most of us don’t get enough magnesium anyway (it’s found in most fruits, vegetables, and nuts).
Some doctors say you don’t have to go every day, but I think that’s a load of … well, you know. You should actually be going two or three times a day-without straining.
The text contained herein does not constitute medical advice. America’s Country Doctor advises that you consult your own physician before acting on any recommendations contained within this publication.
Unless, you’re willing to risk your life to cure the sniffles
In what world is a sinus infection worse than dying from liver failure? It’s absurd, I know. But this is the kind of ridiculous trade-off the FDA thinks is entirely appropriate if you take the antibiotic Ketek. Let me tell you right now: If your doctor writes you a prescription for Ketek to treat a sinus infection or bronchitis…run! Don’t walk. And don’t look back.
Since this drug entered the U.S. market, at least four deaths have been linked to Ketek-related liver problems, not to mention at least 12 cases of liver failure, and at least 110 cases of liver injury. The numbers might not sound as alarming as the Vioxx news that hit every front page in the country. But, to be honest, there are usually far more unreported problems than reported ones. And if even one person died trying to fight a sinus infection it’s just too many. Period.
That’s unless you ask this drug’s maker, French drug giant Sanofi-Aventis. They seem to think this is a risk worth taking to clear up a case of the sniffles. And as crazy as it sounds, the FDA doesn’t seem to think it’s a bad idea either.
In fact, there’s been a lot of suspicion in the medical community that the FDA knowingly allowed fraudulent data to be used during the approval process of Ketek, even as doctors and scientists were already expressing concern about this drug. Hold on, it gets worse.
Even after the revelation that Ketek can cause liver damage, the FDA approved a clinical trial of Ketek to be used in (you’ll never believe this) babies. That’s right: babies. (After all, there’s no better patient than one who can’t talk about the pain they’re suffering.)
Fortunately they recently stopped that trial not long after some FDA officials came forward and spoke out against this drug. Thank God.
Payoff not worth the price
Yet, despite all the evidence that says otherwise, Sanofi-Aventis has sworn up and down (and so has the FDA) that the benefits of Ketek outweigh the consequences. WHAT!? I have never had a patient experience a sinus infection-or even a case of bronchitis-so vicious that I actually thought, “I would risk my patient’s life to make this go away.”
It amazes me that any company (even a profit-hungry drug manufacturer) would have the gall to make such a claim. But perhaps they’re just looking at different data than everyone else is. Because, based on what I’ve read, I can’t even believe that it’s still on pharmacy shelves.
What’s clear is that Ketek is more dangerous than other antibiotics out there (like the ones that don’t cause liver damage).
But, for some reason, the FDA has made a practice of defending itself from every Ketek critic out there, continuing to assert this drug’s relative safety, and defending its decision to keep this stuff on pharmacy shelves.
Even the one measly little alert the FDA actually did put out there doesn’t even warn people not to use the drug, and instead called the instances of liver damage “infrequent” and “reversible.” (In all my years of practice, I’ve yet to see one case of death that’s been reversible.) That’s not a warning.
Here’s a warning: DO NOT USE KETEK. Why was such a drug created in the first place?
Ketek is a ketolide antibiotic, a new subclass of the macrolide class of antibiotics, which includes well-known drugs like azithromycin (Zithromax), clarithromycin (Biaxin), and Erythromycin.
Macrolide antibiotics work inside your cell’s nucleus to prevent the production of proteins. And since bacteria need protein to survive, these drugs can slow down-and usually kill-a lot of the bacteria, helping you recover sooner. But eventually some bacteria get stronger and more resistant to certain antibiotics, which is why drug makers constantly need to invent new antibiotics.
Like I said earlier, Ketek was designed to treat acute bacterial sinusitis, mild to moderate pneumonia, and chronic bronchitis. It was also intended to counter a particular resistance problem that was occurring with other macrolide antibiotics, after -like always-a certain bacterial strain got too powerful.
It was a nice idea, in theory. But, in practice, it’s turned into a nightmare. And the nightmare started when Sanofi-Aventis first began testing the drug.
A quick fix, a cover-up, and the almighty dollar
We’re now learning that the studies submitted to the FDA don’t actually prove that Ketek does a better job than any other drug out there, unlike what Sanofi-Aventis is claiming. (“Fraudulent” is the term that a lot of people are using now.)
In fact, one French drug journal, Prescrire International, wrote: “Telithromycin (Ketek) is a needless addition to the other macrolides.” Needless? Try ridiculous.
It now looks like there might have been some serious flaws in how the company carried out its drug trials. One problem is that some of the trials were carried out overseas, where the standards for reporting are even less rigorous than our own stellar standards at the FDA. As a result, some deaths and illnesses may have gone unreported.
And the results of the study aren’t all that’s being called into question here. Some of the researchers actually conducting the study-many of them doctors who signed up their own patients-also proved to be less than trustworthy.
One of these doctors was addicted to cocaine, a fact no one discovered until he was arrested while holding his wife hostage at gunpoint. While they were arresting him, police found cocaine in his underwear.
Another doctor was actually disqualified (and even prohibited from taking part in any future clinical trials), as was another doctor, who’s been accused of 20 different violations against the study’s instructions. Finally, another doctor-who had the highest number of subjects in the study-was sentenced to five years in prison in March 2004, after being convicted of serious misconduct related to her medical practice.
These were the very people the FDA trusted to prove Ketek was safe and market-ready.
My black box warning to you
Obviously, not enough is being done to remedy this situation (or disaster, as I like to call it).
The FDA has recommended (not required) that the drugmaker put a black-box warning on its label, politely warning about the risk of liver failure. But even then there’s a caveat, with the FDA saying that a “bold-text warning” (notably less serious) may also be good enough.
Meanwhile, Aventis has sent out a “Dear Doctor” letter warning physicians that the drug could cause liver problems. If you’ve seen the paper-covered desks in a doctor’s office, you know how efficient that is. I feel safer already.
And none of that will stop doctors from prescribing it or patients from taking it.
The problem is that when it comes to liver failure, once the damage is done it’s often too late to fix it, no matter how closely a doctor monitors his patient, and no matter how many warnings you print on the label. And when that’s the case, the only course of action should be removing the drug from pharmacy shelves. Plain and simple.
And it’s not just your liver that’s at risk with this drug. At least 167 patients reported blurred vision-in some cases bad enough to interfere with the performance of daily activities-during the Ketek trials. These episodes started one to three hours after taking it and lasted up to 20 hours, mainly in women and children being treated for ear infections.
Meanwhile, it looks like the FDA is making itself busy saving face with claims that Ketek is safe when used as directed. Tell that to the families of the people who died or the people who suffered liver damage.
It would be much more honest to say: If you’re already at risk of dying from pneumonia, then Ketek might be worth the risk. But in any other case it’s just not worth it, especially when other proven remedies exist.
Obviously, the almighty drug company dollar has called the shots in this case-and most likely in many others. After all, Sanofi-Aventis invested hundreds of millions of dollars in Ketek and isn’t eager to see it gone-at least not until they turn a profit.
Unfortunately, the only people who know for sure why this drug keeps sticking around are tangled in a web of bureaucratic red tape and (most likely) deceit. The consequence is that all of us measly American citizens apparently aren’t entitled to know why our doctors are being allowed to keep writing prescriptions for a drug that could very well kill us.
This year, several newspapers got their hands on some internal e-mails in which three FDA safety officials waved a red flag before this drug was even approved. But guess what? The FDA ignored them all.
One of those safety officials, Dr. David Graham (the man who blew the whistle on Vioxx) wrote in an e-mail, “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where Telithromycin (Ketek) was concerned.”
How many more deaths and cases of liver failure will it take before it gets pulled off the shelves? Three more? Three hundred more? Three thousand?
What really makes me angry, though, is that there are still doctors out there buying into the propaganda and pulling out their prescription pads to write “Ketek” on them and then handing that prescription to a patient with the sniffles or bronchitis.
So much for that old doctor’s oath, “Primum non nocere.” English translation: First do no harm.
Editor’s note: As a loyal subscriber to America’s Country Doctor, you can access my archives, search for topics, and read my previous House Call e-mail updates for free by logging on at America’sCountryDoctor.com. I’ll give you alternatives to Ketek and other drugs that you can do without. Use the username and password listed on page 8 to receive this benefit today.
Immediate action required
After last month’s issue-when I told you about some symptoms not to panic over-I received a flood of letters from readers asking what symptoms actually should cause them to panic.
Well, just like some people worry about the slightest sniffle, others are too quick to cast off even the most serious symptoms as common and “no big deal.”
But, in reality, if you so much as suspect you might be suffering from one of these symptoms, it’s time to drop everything you’re doing and head straight to your doctor’s office-or possibly the emergency room-right now.
So here they are. I’m not going to even bother ranking them. The fact is, any one of these problems is a big cause for concern.
A “thunderclap” headache
This kind of headache may also be known as “the worst headache of your life.” It’s sudden, extremely painful, and it often comes with vision loss and an inability to focus. In medical terms, however, it might be called a subarachnoid hemorrhage (SAH).
In laymen’s terms, you might be bleeding into your brain, usually the result of a broken blood vessel. This is often the result of poorly controlled high blood pressure. It can also be an inherited problem, though that’s less common.
Doctors often allow milder cases, in which the bleeding stops on its own without brain damage, to heal without surgery. But severe cases are life-threatening and often require an emergency surgery to stop the bleeding. Doctors usually rely on a physical exam, plus emergency imaging techniques (like a CAT scan or MRI) to guide their decisions.
Here’s the catch: You’re not a doctor. So you may not know whether your case is serious or mild. Head to the emergency room-now.
“Elephant sitting on your chest”
This is the classic description of a heart attack
Of course, a heart attack can be associated with all sorts of pain, including abdominal pain, upper back pain, shoulder pain, and even (in some very rare cases) thumb pain.
But a heart attack can also be virtually painless, especially if you’re diabetic. (The high blood sugar associated with diabetes damages your nerves, making you less aware of pain.) And, unfortunately, without pain, shortness of breath, or sudden weakness, a diabetic has no way of sensing a heart attack. It’s just one of many reasons it’s important for diabetics to take extra good care of themselves.
When it comes to avoiding a heart attack, it’s crucial to know what your risk is-for instance, it’s higher if you’re a smoker, have a family history of heart disease, have high blood pressure, diabetes, are overweight, or if you’re just extremely stressed out.
Sudden loss of strength or feeling
A sudden numbness or loss of strength, especially when it’s located in just one spot-like your hand, foot, arm, leg, or face-could easily be a stroke. And, since the drugs that doctors use for treating a stroke only have a three-hour window of opportunity, it’s vital that you not delay one moment.
Strokes work in a fashion similar to heart attacks-a blood vessel gets blocked by a clot, often in a neck artery or the heart, which breaks off and travels up into the brain. This is known as an embolic stroke (an embolism is the bit that breaks off). The risk factors are similar to those for a heart attack, although high blood pressure is given greater emphasis. (Your brain has many tiny blood vessels that thicken and narrow in response to continuous pressure or wear-and-tear, blockage, and of course, stroke.)
Sudden, severe eye pain or vision loss
Sudden eye pain, vision loss, headache, haloes around lights, nausea, and vomiting, are all symptoms of acute closed-angle glaucoma. (Regular glaucoma, on the other hand, takes years to develop, unlike this form, which can develop quickly.)
This happens when the iris (the colored part of your eye) moves forward and prevents the free flow of the eye’s inner fluid, increasing the pressure inside your eye, and possibly causing irreversible damage to the optic nerve and visual loss.
Glaucoma is more common among elderly, female, and Asian patients. (Asians are more at risk because of their eye shape.) And, like most eye diseases, the damage caused by glaucoma is irreversible.
To make a long story short, this is a serious problem that warrants an immediate trip to an eye doctor or emergency room. Treatment usually consists of laser surgery to reduce the pressure in your eye, but the hope there is minimal. That’s why people with a family history of glaucoma should get regular eye exams every year.
Blood in your stool
Visible blood in your stool means you might be bleeding somewhere else in your gastrointestinal (GI) tract. Bright red blood could be hemorrhoids (painful and serious, but not life-threatening), a diverticular bleed associated with a weakening in the wall of the colon, a colon polyp, or colon cancer. And colon cancer-the most common form of cancer and more likely the older you get-is especially bad news.
The problem is that you don’t know which of these things it might be until you get checked out. This is why blood in your stool usually results in a prompt colonoscopy.
Dark-colored blood suggests that you’re bleeding higher up in your GI tract. Black stool, on the other hand, is usually caused by a bleeding ulcer way up in your stomach or duodenum (the portion of your small intestine attached to your stomach).
Either can be life- threatening and usually results in the urgent placement of a special scope through the mouth down into the stomach (called an endoscopy) for a look.
Colonoscopies and endoscopies sound scary and uncomfortable, I know. But you’ll be asleep through the whole procedure. And it could save your life.
Blood in your urine
While this symptom often means a kidney stone, it could also mean bladder or kidney cancer, at least until proven otherwise. If it’s a kidney stone, the affected side will probably hurt like the devil.
If your bleeding is light to mild, it could also just be a urinary tract infection, or an enlarged prostate if you’re a guy. Go to a urologist-it’s usually not an immediate emergency unless the blood flow is sudden and large. But if it is sudden and large, it’s time to worry.
When you go to the doctor (and you need to go soon), he or she will do blood work, look into your bladder with a special scope, and possibly check your kidneys with a CAT scan (or an MRI if nothing turns up in your bladder). These cancers are usually treatable with surgery and they don’t shorten your life expectancy.
A lump in your breast
Breast cancer has now assumed epidemic proportions. And although many conventional doctors downplay the roles of diet and exposure to environmental toxins, the scientific evidence is overwhelming. Genetics and family history are also very important.
Fixed, stony, hard masses are most likely cancer and should send you to your doctor as soon as possible. Rubbery and mobile masses that change in size through the month are probably benign, but they still require treatment. You should make your doctor aware of any mass in your breast. A benign mass can transform into a malignant cancer later on down the road.
If you are good about getting annual mammograms-which you should be-stagger them at six-month intervals along with your regular gynecological appointment, which should include a thorough breast exam. And make sure you get the practitioner who does your exam to show you how to do a proper self-exam-and then do one every month.
A lump in your scrotum
This is often symptomatic of testicular cancer, which is usually considered a young man’s disease (occurring primarily among guys between the ages of 18 and 35). But that doesn’t mean you’re too old to get it. Or to know someone who might be at risk.
Testicular cancer, if discovered early, is one the few truly curable cancers, with children and a normal love life still quite possible.
Even so, every year a few thousand unfortunate young men die because no one told them how to perform monthly testicular exams. In fact, half the young men I see don’t have a clue. Make sure the young men in your family do.
A mole that keeps getting larger
Most moles and freckles are harmless.
But when you have a mole that keeps getting larger, especially if it’s dark with irregular edges, it could be a melanoma, a form of skin cancer that can be quickly fatal if it spreads into the rest of your body.
Not all melanomas are the same, so skin doctors usually play it safe and biopsy anything that looks suspicious or has increased in size. Your best bet is to call attention to anything that worries you–freckles or moles–and to get an annual, full-body skin check by a dermatologist.
Severe abdominal pain
Sudden, severe, sharp, and unrelenting abdominal pain is usually so unbearable that you end up in the emergency room before you can even think twice.
You see, there are literally dozens of causes of abdominal pain. Doctors are always on the lookout for certain causes, especially those that could be deadly. Sharp, unrelenting, even unbearable abdominal pains could be signs of a perforated intestine, internal bleeding, or a bleeding ulcer, just to name a few.
Even milder pains can be tricky. Sometimes, milder pain that slowly increases, or comes and goes over time, could be the result of an underlying tumor. Certain cancers, including those in either your colon, kidney, liver, gallbladder, or ovaries, can all cause serious abdominal pain and tumors. Non-cancer causes are often ovarian cysts (in women of course), diverticulitis (a colon infection), an infected gall bladder or gall bladder stones, or a malfunctioning bladder (which is more common among elderly folks).
To be honest, any pain that’s worrisome to you is worth an immediate call to your doctor– whether it’s cancer or gas. ACD
The amazing benefits of grape seed extract
Most doctors will give you a laundry list of drugs you could take for heart disease prevention: Some might suggest aspirin. Others might tell you statin drugs are the only way to go. But in my mind, drugs shouldn’t play a role in prevention at all. After all, isn’t part of the point of prevention to avoid needing drugs in the first place?
That’s where grape seed extract comes in. Not extra vitamin C or vitamin E. Not even rhodiola. Not butterbur. I love them all, but it’s grape seed extract (GSE) that has my loyalty.
People first started noticing the health benefits of grape seed extract in the early 20th century, when studies showed that the French suffered fewer cases of heart disease than the rest of us. And the main link scientists found? They drank (and still drink) more red wine.
GSE can be found in green, red, and purple grapes. (The seeds of purple grapes have the highest quantities though, hence the name.) Just one dose of this stuff is chock full of antioxidant flavonoids that are up to 20 times as potent as the antioxidants found in vitamin C or vitamin E. These antioxidants are known for their role in preventing the oxidation that causes heart disease in the first place. And GSE’s higher potency of these antioxidants means this supplement is even more effective at fighting off “bad” LDL cholesterol, which eventually sticks to and injures your blood vessel walls (the end result often being heart attacks).
GSE has also been shown to support and protect collagen, the most abundant protein in your body. Now, you’re probably used to thinking of collagen as part of a surgical procedure for fuller lips, or an ingredient for lotions advertising firmer, tight skin. And I’m not going to lie: A lot of people are attracted to grape seed extract because of its reputation for promoting healthier skin, hair, and nails.
But, more importantly, it also plays a role in protecting your heart.
Collagen is the tough, fibrous stuff that helps keep the inner lining of your blood vessel walls intact. And the stronger your vessel walls are, the less likely you are to develop clogged arteries.
Like most supplements out there, GSE does have at least one side effect worth warning you about. It can actually cause blood thinning (not much, just a little), so if you’re already taking a blood thinner it’s best to talk to your doctor before starting it. (If you’re not taking a blood thinner, though, a mild blood-thinning effect can be a good thing and help to prevent artery-clogging blood clots.)
I recommend taking 200 mg daily for a month in order to quickly build up your tissue levels. After that, back off to a 50 or 100 mg dose daily. I like (and use) the Activin and Nature’s Way products myself.
Replace Neosporin with grape seed extract
This stuff isn’t just great for prevention. It also works wonders in everyday life.
For instance, recent studies have shown that grape seed extract can actually speed up the healing time for open wounds, cuts, and scrapes.
In one study, researchers found that grape seed extract actually enhances your body’s production of epidermal tissue and makes that tissue denser and stronger. And this stuff also helps rebuild connective tissue and repair blood vessels.
Navigating the supplement maze
Q. Several years ago I started taking Metamucil to clear up constipation. It worked like a charm, until lately. Now it’s stopped working altogether. I’m 62 years old, I take a 30-minute walk every day, I’m not overweight, and my diet is pretty healthy: Total cereal and a banana for breakfast, a cup of tea here and there, a sandwich (whole grain bread) and soup for lunch, and dinners of chicken, fish, rice, potatoes, and different vegetables.
Should I up my dosage of Metamucil or just quit taking it altogether and find something else?
–Jane Harmon, Staunton, Va
A. Before I go into how to fight constipation I need to address the possibility that it’s something more serious. A recent change in bowel habits that lasts more than a few days could be from underlying colon cancer. Tell your doctor immediately and get a colonoscopy, even if you’ve had a normal one within the last few years. But for now, let’s assume you’re just dealing with regular old constipation. And let’s start with your fiber intake.
Abundant fiber (more than the measly 25 g a day recommended by the government) derived from whole foods is the best way to ensure regularity.
Unfortunately, Metamucil doesn’t give you even a quarter of the fiber you need to be getting every day. In reality, this stuff has only 3 g of fiber per dose. Taking two doses daily, you get only 6 g of fiber. Add that to the fiber in your diet (probably about 15 to 20 grams a day, based on what you told me), and you’re still not getting enough.
In fact, 40 or 50 grams, every day, is closer to what you need. And the best place to get it is in your food.
However, that Total cereal you’re eating probably isn’t the best source. It most likely has only 2 or 3 g of fiber a serving, hardly enough to make a difference. Instead, try giving yourself an extra five or 10 minutes each day to cook a bowl of oatmeal, barley, or some other whole grain cereal. Muesli and unsweetened granola are both good options as well. Add a few sliced almonds and a half-cup of raspberries or blackberries, which are full of fiber. That’s more than 15 g of fiber, all of it from whole foods. Not a bad start to the morning, if you ask me.
Next, for a midmorning and afternoon snack, try a handful of nuts and raisins, prunes, or a small piece of fruit.
You should also be thinking about vegetables and colors. Add a tossed salad with tomato, peppers, carrots, and baby spinach to your daily diet. And include an extra steamed or lightly boiled vegetable from the broccoli family with your dinner. Try broccoli, cabbage, cauliflower, or kale at least three to four times a week (and preferably every day). Also make sure you drink enough fluid every day, at least 64 ounces.
If you need more help, try adding a tablespoon of ground-up flaxseed to your salad. Magnesium citrate (in capsule form, 400 to 800 mg daily) can also help by gently prodding your intestines to move food through faster. It’s safe and most of us don’t get enough magnesium anyway (it’s found in most fruits, vegetables, and nuts).
Some doctors say you don’t have to go every day, but I think that’s a load of … well, you know. You should actually be going two or three times a day-without straining.
The text contained herein does not constitute medical advice. America’s Country Doctor advises that you consult your own physician before acting on any recommendations contained within this publication.
Posted in Newsletter.
