May 29, 2007

Corrupt Drug Regulator Sentenced to Death

Zheng Xiaoyu, who served as director of China’s Food & Drug Administration from its founding in 1998 until mid 2005, was sentenced to death after investigation showed that he had accepted bribes to allow the selling of what he knew to be dangerous drugs that killed at least 10 people.

Our media treats this like it was another example of Chinese excess.

But you have to ask yourself: why does our legal system land so heavily on the person who shoots a gun or drives a getaway car, while giving a pass to the executive who approves the fraudulent study used to approve the dangerous drug or who decides to hide the in-house data that shows his company's drug is causing people to die unnecessarily?

The person who has a heart attack after taking Arcoxia is just as dead as the person shot by a drug dealer. The person who dies of ketoacidosis caused by Zyprexa is just as dead as a person stabbed in a parking garage.

But despite a long history of drug company executives approving the submission of fraudulent research data and constructing well-financed campaigns to get doctors to misprescribe dangerous drugs with fatal side effects, even after these effects were known to the drug company, there is not a single case of a drug company executive going to jail for the deaths he has caused.

By the same token, the individual physicians who received huge sums from drug companies to put their names on research papers that had been prepared by drug company marketing departments--studies with which the well-paid doctors had no involvement except to lend their prestige when it was time to publish them--- have not been pursued for fraud, either, though this practice was endemic in the medical industry until very recently when some brave people in the medical community finally blew the whistle on the practice.

Again, why is it not fraud to take money for putting your name on a study you did not conduct?

As long as our system allows people to get away with murders when they cause these murders when acting for a corporation, and as long as the people who are corrupted by these entitities are held blameless for the results of their collusion, drug companies will continue to lie, bribe, and subvert regulators, physicians, and anyone else who will ensure that their billions of dollars of profits continue to roll in.

The Chinese are sacrificing their corrupt official here because they fear they're going to lose the billions their food and drug industry currently earn them around the world. One rather yearns to see just the tiniest sign that maybe someone in the U.S. might be held accountable for the venal corrupt behavior that pervades our drug regulation system. A month in prison would be a huge improvement over the current scheme where the executive who knowingly approves strategies that result in the unnecessary deaths of thousands retires with tens or even hundreds of millions of dollars that he earned from his actions.

May 27, 2007

My Agenda: Why I Crusade against Dangerous Drugs

As a result of my postings about Avandia and Actos I've been accused by the moderator of the American Diabetes Association discussion board (in a private email) of having an "agenda." Well, I do have one-- it is keeping people healthy. And as long as the American Diabetes Association continues to give patients advice that damages their health, my "agenda" will annoy them.

The ADA's latest move was this: As soon as the news of Avandia's possible lethal side effects was broken by the far-from-hot-headed New England Journal of Medicine, the ADA immediately announced to the major media that patients should keep taking Avandia. This response was so swift that it is not possible that anyone at the ADA had actually analyzed the findings published by the NEJM--findings, which were, as it turned out, found to have been confirmed by independent studies run by the FDA. Clearly, the interests of the ADA's Big Pharma contributors, once again, trumped those of us poor schnooks with diabetes.

But because I do write about dangerous drugs a lot and ask a lot of questions, publicly, about new drugs, so that it is understandable that people might think that I do have an "attitude," I would like to explain why I have spent the last couple years collecting research data about the drugs prescribed to people with diabetes and posting warning about the drugs that can be dangerous.

Contrary to what you might think, I do not categorically think all drugs are bad. What I do think is that most drugs approved in the last decade are poorly understood, and that many of them do have serious and even lethal side effects that people ought to know about before they take them.

A serious side effect may only affect .01% of all the people who take a drug, but when a million people take a drug, that is 1,000 people, and if you are one of those unlucky 1,000, you are going to wish that someone had prevented it from ruining your life. At a minimum, you are going to wish that someone had told you that the side effect could happen and which people were more likely to experience it, so that it wasn't, as is so often the case, a complete and ugly surprise. But our current system of drug regulation ensures that you are very unlikely to know anything about any drug side effect no matter how serious that only affects a couple thousand people.

I learned this the hard way. I suffered a permanent side effect--loud and permanent ringing in my ears--after being given a prescription NSAID, Clinoril/Sulindac, 10 years ago by a doctor who wasn't aware that this side effect was possible. Even worse, I had a warning sign--an early episode of ringing in the ears which went away when I stopped the drug--which I reported to my doctor, who nevertheless assured me that I should just take a lower dose of the drug. I did, and 1/2 of one more pill was all it took to leave me with a lifetime of shrill squealing ears.

When my tinnitus struck, I was told by my doctor that my reaction to this drug was "extremely rare." But when I researched it, I discovered this wasn't true. There were other people all over the web who had undergone the same experience as I did, and even some in my local area. The problem was that each of their doctors thought that their experience was "rare" and did not report it to the FDA. So while hundreds of people around the country developing permanent tinnitus as a result of the drug I took and those closely related to it, doctors continue to prescribe it and ignore any early warning signs their patients might report. And people continue to develop permanent tinnitus from it.

That's why my mission now is to make sure that people can learn what the latest information is about dangerous side effects of the drugs they take, so that if they do experience an early warning sign, they'll be able to stop the drug before it goes on to cause permanent harm.

This should be what doctors do, but since doctors are too overwhelmed to be able to take the time to keep up with the research on the hundreds of conditions they treat and rely almost entirely on the drug companies to "educate" them about the dozens of new drugs that come on the market, those of us in the patient community must step in and do it ourselves.

The truth is that the information about the side effects of any drug less than a decade old is very incomplete. The drugs most people take now are approved after being tested for only two or three years in clinical trials in human populations. But if we judged the safety of cigarette smoking using 2 years of data, we'd conclude that cigarettes were a perfect diet aid which improved mood. It's only when you look at the results of 10 years of smoking data that you start seeing the cancer, lung disease and heart attacks.

The new drugs on the market are also in many cases more complex than those of the past. Like Avandia, they have been engineered to work on enzymes and receptors found throughout the body whose functions outside of their impact on blood sugar are often not well understood. To get a new drug approved, a drug company only has to submit data that shows that the new drug is effective for a single purpose. They do not have to investigate its effect on the many other organs throughout the body that use the same receptors and enzymes. They have to report on side effects found in more than 1% of people taking the drug, they must check how the drug interacts with a couple well known drugs that affect specific liver enzymes , and they must run some basic, but by no means comprehensive, tests for carcinogenicity. That's it.

Once a drug is on the market it will take a long time until even the most dangerous long term side effects are discovered, because the drug companies have ensured that there are no effective system in place to track after-market experience. A person with diabetes who dies of a heart attack, well, that's not likely to be reported as a side effect because people with diabetes are expected to die of heart attacks. You need to look at carefully screened data covering many thousands of people to detect "excess" deaths attributable to a diabetes drug. Not so surprisingly, after the experience with Vioxx and now Avandia, once they have gotten a new drug through the approval process, it is likely the big drug companies are never again going to fund the large expensive studies that might reveal the hidden cost of their profitable drugs.

So that's my "agenda." Getting the word out about stuff that can really hurt you. I don't earn a penny from any of my diabetes activities. You'll find no drug company ads on my site, unlike those of many better known diabetes bloggers. But I do hope that if you visit What They Don't Tell You About Diabetes you might just find a nugget of information that will help you live a longer, healthier life.

May 22, 2007

Countering Big Pharma Lies about Avandia

A reader protests that the TZD drugs, though they do cause people with diabetes to gain weight, redistribute the weight away from the abdominal area, where it is associated with insulin resistance, to other places on the body.

Well, this was part of the drug company hype used to promote the drug. They couldn't get away from the fact that this drug for a disease that is worsened by obesity increased obesity, so they came up with the idea that it created "good obesity."

Nonsense.

Here's the study, conducted by researchers from the Mayo Clinic, that showed that Actos (very closely related to Avandia) does not change the amount of visceral fat or redistribute fat the way the drug companies claim. The drug changes the waist hip ratio (the basis of that claim) by enlarging the hips by growing new fat cells.

http://care.diabetesjournals.org/cgi/reprint/26/11/3148
Effects of Pioglitazone Versus Diet and Exercise on Metabolic Health and Fat Distribution in Upper Body Obesity. Samyah Shadid, MD and Michael D. Jensen, MD (Mayo Clinic). Diabetes Care 26:3148-3152, 2003

And there is more troubling data about where those new fat cells are coming from. It turns out that in response to TZD drugs, the precursor cells that are supposed to be turning into bone are, instead, turning into baby fat cells. This is not new news, but it isn't something the drug company PR machine has let you know about. Here's a study that explains how Avandia does this. It is one of several studies linking TZD drugs with osteoporosis, especially in the older women most at risk for it.

Rosiglitazone impacts negatively on bone by promoting osteoblast/osteocyte apoptosis.
Soroceanu MA,Miao D,Mai XY, Su H,Goltzman D, Karaplis AC. J Endocrinol. 2004 Oct;183(1):203-16.


The reaction to yesterday's news was swift and predictable. The ADA and the American Heart Association (both heavily funded by Big Pharma) told patients to keep taking the drug while muttering about further studies being needed. The most recent news wire report says that Glaxo's own studies showed a 30% rise in heart attack risk. Months ago.

Reuters Story:Glaxo's own meta-analysis also showed Avandia risk

Why is the ADA telling patients to keep taking this drug? Am I the only one who sees irony in the way that ADA and AHA tell patients to take expensive Statin drugs for which the research, despite decades of searching, does not show clear evidence that they decrease heart attack risk in people who have not already had a heart attack, yet they tell patients to keep taking Avandia now that there is a lot of research suggesting that Avandia does raise the risk of heart attack and heart attack death risk significantly?

A drug that makes obese people fatter, increases the risk of heart attack, increases the risk of heart failure, increases the incidence of osteoporosis and bone fractures in women, and increases the risk of a blinding condition is NOT a drug anyone should be taking.

And yes, these drugs do lower blood sugar slightly (A1cs come down around 1%) but the point of lowering blood sugar is to decrease the incidence of complications, the most significant of which, for people with diabetes is heart disease.

Big Pharma's claim, "We have to give people a drug that gives them heart attacks to save them from heart attacks," is right up there with the Vietnam claim, "We had to destroy the village to save it."


May 21, 2007

DREAM STUDY: Avandia Kills People

As reported by the New York Times today. The DREAM study, which Glaxo, the manufacturer of Avandia ran to prove that Avandia would improve the health of people without diabetes so they could sell it to everyone else, instead found this:

"...patients taking Avandia had 66 percent more heart attacks, 39 percent more strokes and 20 percent more deaths from cardiovascular-related problems. That outcome, Dr. Nissen [writing in the New England Journal of medicine] wrote, “virtually precludes the possibility of an overall benefit and suggest [sic] an unexpected mechanism for harm.”

http://www.nytimes.com/2007/05/22/business/21drug-web.html?hp

There are already quite a few studies showing that Avandia and its evil twin, Actos, don't do much for blood sugar. What they do do, very well, is grow new, permanent, fat cells (just what someone with diabetes needs!)They also cause water swelling (edema) which can lead to the macular edema which can cause blindness, and in older women they lead to osteoporosis. It has been known for a few years that these drugs appear to cause heart failure. All these side effects have been documented in multiple studies, not just one.

But this expensive drug has been on the market, racking up profits for its maker, since 1999. It has taken 8 years for the nastier side effects to become publicly known. Several of the troubling side effects, including macular edema, were documented on my What they Don't Tell You About Diabetes web site more than a year before they appeared in the mainstream medical press. You can read detailed discussions of what the research shows about all the oral diabetic drugs at http://www.phlaunt.com/diabetes/14045911.php

The next time you reach for a brand new drug your doctor tells you will regenerate your beta cells, ask him how long it has been on the market and how much he knows about side effects reported after the drug was released. Until a drug has been on the market for 7 or 8 years, you can be pretty sure that information about any serious side effects has been suppressed by the drug company.

And Glaxo has made enough money from Avandia by now that even if it did kill a bunch of people to whose families they might have to pay damages, the billions the drug earned made it worth it.

Note, that the guy blowing the whistle in the NEJM is also the guy who nailed Vioxx.

May 18, 2007

UKPDS found Many More Complications in Type 2 than Type 1 at 7% A1c

A visitor commented on the previous post with the remark that a Type 1 might have great difficulty achieving the 7% A1c safely. That could lead into a whole nother debate about what is a safe blood sugar target for people with Type 1, but that is a debate that would be more appropriately conducted between people with Type 1, which I am not. So I'll leave it alone.

But that comment made me want to focus on another very important point about the UKPDS study. The UKPDS study was an attempt to duplicate the DCCT study which first came up with the finding that lowering the A1c to 7% resulted in a significant drop in microvascular complications.

The important thing to realize--which your doctor may not know--is this: The DCCT study only involved people with Type 1 diabetes. The UKPDS study was an attempt to do the same thing with a population of recently diagnosed people with Type 2 diabetes. It found was that people with Type 2 had a much higher incidence of microvascular complications at the 7% A1c level than had the Type 1s involved in DCCT.

Though there was an improvement in the incidence of serious complications between those with 7% A1cs and those with 9% A1cs in the UKPDS, the improvement was much less pronounced in the Type 2s than it had been for DCCT's Type 1s. Far more Type 2s with 7% A1cs had serious retinopathy, kidney damage, nerve damage, etc than did the Type 1s with that A1c.

The reason for this is most likely that people with Type 2 usually have elevated blood sugars for at least a decade before they are diagnosed. During that decade, uncontrolled high blood sugars wreak a lot of damage on nerves, capillaries, and the retina. In contrast, people with Type 1 get diagnosed very swiftly because they go into a health crisis, so they don't have that decade of insidious damage to contend with when they get back into control.

In addition, because people with Type 2 diabetes often have very high levels of circulating insulin, due to insulin resistance, they may be more prone to experiencing damaging tissue changes, thanks to that high insulin level and the production of other hormones associated with insulin.

If doctors would look at people's blood sugar after a meal, instead of screening for diabetes using only the fasting plasma glucose test, people with Type 2 diabetes (and quite a few of us with milder forms of MODY) would get diagnosed before the high blood sugars after every meal had a chance to destroy our organs. Sadly, they don't.

I am still getting mail from people whose doctors tell them to ignore blood sugars over 200 mg/dl after every meal because their fasting blood sugar is under 125 mg/dl and hence they are, in the doctor's mind, not diabetic. So it's pretty clear to me why almost 1/2 of all "newly diagnosed" type 2s already have at least one significant, diagnosable diabetic complication--usually early kidney damage or neuropathy.

But because Type 2s already have microvascular complications, they need to lower their blood sugar much more dramatically to prevent those complications from getting worse. There is much anecdotal evidence that achieving 5% A1cs can repair neuropathy and early kidney changes, but the blood sugars associated with the 7% A1c are not going to do that.

May 17, 2007

Misunderstanding UKPDS - 7% is NOT a Good A1c.

The ADA board is full of people with A1c test results over 7% whose doctors tell them they are doing fine. They aren't. The doctors who tell them this are as irresponsible as if they told them not to worry about a "touch of cancer."

My guess is that uneducated doctors think an A1c near 7% is "fine" because they've only read the one line summary of the findings of the UKPDS. That "25 words or less" version is that people with Type 2 Diabetes who attained A1cs of 7% reduced the incidence of complications.

What this summary statement ignores, is that UKPDS also showed that, while the rate of complications in the population with A1cs of 7% was better than that in the population with A1cs of 9%, people with those 7% A1cs still developed microvascular complications at a very significant rate, and, even more importantly, they had not decreased their likelihood of dying from a heart attack or stroke.

Here's what the actual findings published in the British Medical Journal said:
Each 1% reduction in updated mean HbA1c was associated with reductions in risk of 21% for any end point related to diabetes . . . No threshold of risk was observed for any end point. [i.e. this stayed true as the A1cs continued to drop] . . .Any reduction in HbA1c is likely to reduce the risk of complications, with the lowest risk being in those with HbA1c values in the normal range (<6.0%)."

Does this sound to you like 7% is a good A1c? I don't think so.

Even more significant is that other studies show that to decrease the incidence of cardiovascular "incidents" i.e. heart attack and stroke, you need to lower A1c far below 7%.

The chart below, derived from the huge EPIC-Norfolk study makes it very clear that the risk of heart attack DEATH has already doubled at an A1c 6%. (from Medscape New Avenues for Complicated Patients with Type 2 Diabetes and Hypertension) The chart graphs the risk of death from various causes for various A1c levels. CHD: Coronary Heart Disease. CVD: Cardiovascular Disease (includes stroke).




Could any doctor who looked at this data complacently tell a patient that an A1c of 7.3% was fine?

Clearly, the only A1c that is truly "fine" is 5% or less. Many of us can't get there. I sure can't. But the 5%s are a whole lot better than the 6%s and with the 7 times higher risk of death at the 7% you'd have to be crazy to be complacent about an A1c that high.

If this is all making you nervous, don't despair. I know literally hundreds of people who have brought their A1cs into the 5% range, often starting from as high as 13%. The tools you use are cutting back on your carbohydrate intake until you can get under 120 mg/dl two hours after every meal and, if carb restriction isn't enough, well chosen meds, including the one drug that always works for people with diabetes: Insulin.

Normalizing blood sugar saves lives. It can be done. It must be done. And if your doctor won't help, find a new doctor. It isn't his eyes that will go blind, his feet that will get amputated, or his heart that will give out when you take his outdated and dangerous advice!

May 11, 2007

Diabetics Poorly Served by Ignorant Family Doctors

I get a lot of mail from people who read my "What They Don't Tell You About Diabetes" site. They have been to the doctor, but they have no idea what is going on with their health. Many of them, like me, are not overweight but have very high post-meal blood sugars, often into the mid 200 mg/dl range or higher. Some can't get any treatment at all, because their fasting bgs are near normal though after every meal they go way, way up.

Some are being put on drugs that aren't doing anything for their blood sugars and when that doesn't help, they're put on drugs that an educated doctor should know won't work for someone who has no response to the earlier drug. Some are being put on expensive new drugs that are not supposed to be given to people newly diagnosed and are not being given the cheap drugs with the long track record of safety that should be the first drug started. And others are on 20 year old 70/30 insulin regimens which are giving them continual hypos but have never heard of basal/bolus insulin treatments!

What is the common thread here? It's pretty obvious: it's family doctors who don't consider diabetes a condition that requires the services of a specialist. Family doctors who have only a very rudimentary knowledge of diabetes. Family doctors who learned about diabetes 30 years ago in school and whose only education in diabetes care since then has been provided by the pretty ex-cheerleader drug company reps. And who, if the drugs they prescribe don't work, just shrug and send the patient away without answers--though with a hefty bill.

What these doctors do know seems to be mostly what are the latest, hottest, new drugs that have the highest profit margin for the drug companies. Not what those drug's real side effects are. Not which patients it is appropriate to prescribe these drugs for. And certainly not what much cheaper drug is much more likely to lower their blood sugar better.

And when it comes to the people who are not 300 lb Type 2s with a family history of Type 2, these doctors are more than clueless. I ran into this myself, when the doctor at Kaiser Northeast told me my 240 mg/dl blood sugars were "nothing to worry about" since my fasting bg was under 126 mg/dl. But that was 9 years ago. And yet, every day, I'm hearing from so many people who have clear cut signs of genetic diabetes or of early LADA (a sl0w form of autoimmune that strikes adults) and whose family doctors have never heard of either condition and have never suggested that they see a specialist.

This is scary.

These aren't people who are imagining they have something serious going on. One lady developed gestational diabetes several weeks into the pregnancy (as did I) not at the 5th month as is usual and is diabetic now, though not obese. Her doctor doesn't seem to know about MODY. Another is being told she is normal based on a 5.0% A1c but she had a very recent Glucose Tolerance Test with a blood sugar well 200 mg/dl 3 hours after the start of the test. Her doctor doesn't seem to know that anemia can make an A1c test result worthless. Someone else was diagnosed with a fasting bg over 300 and is not on medications, just self-treating with herbs.

I hear from thin people who have kids diagnosed as Type 1, parents diagnosed as Type 2, and whose doctors have never mentioned genetic diabetes to them when they show up with diabetic blood sugar. With that kind of family history, their child may not be a Type 1 at all, they might have one of the genetic forms of diabetes that can be treated with pills. But these family doctors don't know about genetic diabetes so they just tell them they're type 2 themselves, prescribe pills, and that's that. And then there are the people with the A1cs over 8% whose doctors tell them to watch their diet and give them no other treatment.

There's something wrong when a person like me, who isn't a doctor and doesn't particularly want to be a doctor, seems to know more about appropriate diabetes treatment--as defined by current practice standards set by the ADA, AACE and other professional organizations--than the family doctors who people rely on for treatment.

But if you wonder why the incidence of diabetic complications just keeps getting worse and worse, and why the typical American patient's A1c is worse now than it was 10 years ago (according to the NHANES study), well, there's your answer.

Family doctors who don't keep up with the details of diabetes treatment as provided by education sources OTHER than cute little drug company sales chippies really hurt a lot of people with diabetes!

May 4, 2007

Healthy Whole Grains are like Healthy Filter Tip Cigarettes

Some poor victim, I mean patient, just posted on the ADA forums about a visit to the nutritionist where, having brought his A1c down from 12% to 5.8%, he was chided for not eating enough carbs!

In particular, he was told to eat 8 servings of grain each day.

I know, I know. By now I should be inured to this kind of stupidity, but reading something like this still does very bad things to my blood pressure.

The idea that people with diabetes should eat "healthy whole grains" is derived from a bunch of studies where people eating whole grains were compared to people eating junk food and found to have slightly better blood sugars. These studies are almost all funded by the companies that sell grain in one form or another. When people with diabetes eat those "healthy grains" their blood sugars may be slightly better than those eating marshmallow fluff, but their blood sugars are still much higher than is consistent with health.

This is very much like those studies that showed that filter tip cigarettes were healthier than unfiltered cigarettes. They look good until you notice that smoking any kind of cigarette causes cancer and heart disease at rates that are completely unacceptable.

But while researchers have compared the health of people who smoke with people who don't, you won't find large, well funded studies where people with diabetes who eat little or no grain of any kind are compared to people who ate these universally recommended eight servings of grain each day.

Nor will you find long term studies where they track the development of diabetic complications against grain intake over a decade. Why? Well, for starters, because such studies take a lot of money and almost all food-related research is funded by companies that sell the food being studied. It's in their interest to do small, sloppy studies, and to publicize the results of those studies only when they make their products look good. So yes, a study may "prove" that whole grain Cheerios are a "healthier" breakfast than sugar frosted flakes, but just about anything rich in protein is far better than either. Just don't wait for General Mills to fund that study.

I am old enough to remember when doctors all smoked and there were commercials on TV touting the brand that doctor's preferred. I probably won't live long enough to see the demise of the oxymoron "healthy grain".

Fortunately, you don't have to take any dietary advice on trust. Get out your meter and test those "healthy" grains. See what they do to your blood sugar. If you can stay at normal levels, eat them. If not, how about a nice cheese omelet. Afraid of the cholesterol? Relax. Eating cholesterol has no significant impact on your lipids a.k.a. Cholesterol. It is eating starch and sugar that raise the bad kinds of blood lipids.

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A visitor suggested I put in a link to back up my statement about the ADA's main contributors including a lot of junk food companies.

This was discussed and documented in an earlier post on this blog complete with link to the ADA's largest contributors and some information about what they sell:

ADA Nutritional Guidelines--Keeping Diabetics Diabetic