How to Reverse Fatty Liver

Two recent studies have come up with some useful information about what it takes to reverse nonalcoholic fatty liver disease.

This is a condition where fat accumulates in the liver. It is often considered "benign"--that is not associated with any adverse health effects. But in rare cases it can lead to liver damage and, very rarely, this damage may lead to liver failure.

Fatty liver disease is caused by--or found in association with--the taking of certain medications, gastric bypass surgery, high cholesterol, high levels of triglycerides in the blood, malnutrition, metabolic syndrome, obesity, rapid weight loss, toxins and chemicals, such as pesticides, Type 2 diabetes, and Wilson's disease.

The drugs reported as causing fatty liver include total parenteral nutrition, methotrexate (Rheumatrex), griseofulvin (Grifulvin V), tamoxifen (Nolvadex), steroids, valproate (Depakote), and amiodarone (Cordarone).

However, most people with Type 2 diabetes who develop fatty liver probably develop it because of exposure to the very high triglycerides that result from uncontrolled high sugars.

If you are diagnosed with fatty liver, you will probably be told that losing weight will reverse fatty liver, and this appears to be true.

The two studies I want to discus here tell us two things: how much weight you have to lose to reverse your fatty liver and what the most effective diet might be for doing that.

How Much Weight Loss Reverses Fatty Liver

The first study Orlistat for overweight subjects with nonalcoholic steatohepatitis: A randomized, prospective trial. was another drug company supported trial that hoped to prove that the drug, Orlistat, which blocks the digestion of fat would reverse steatohepatitis, which is the term for the inflammatory liver condition that develops in some people with fatty liver.

In fact, the study found that Orlistat neither enhanced weight loss or made any positive changes in the laboratory markers relating to the inflamed liver. However, what it did discover was that when patients managed to lose weight--using any technique--their liver disease improved. Beyond that, the study quantified how much weight loss was needed to achieve this.

Their findings were these:

...subjects who lost 5% of body weight over 9 months improved insulin resistance and steatosis [liver inflammation], and those subjects who lost 9% also achieved improved hepatic histologic changes [liver cell changes visible on microscopic exam].

In short, inflammation started to recede when 5% of the starting weight had been lost and when subjects lost 9% or more of their starting weight and maintained that loss over a period of nine months, the damage that had been done to their livers started to improve.

This is good news, because it turns out that 10% to 20% of starting weight is about as much weight as most people can lose without obsessional dieting, so it's good to know that losing only 20 lbs when you weigh 200 lbs though it isn't enough to make you comfortable wearing a bikini, is enough to reverse any liver damage you might have sustained.

Which Diet Burns Liver Fat Best?

The second study is Alterations in hepatic glucose and energy metabolism as a result of calorie and carbohydrate restriction.

To understand this study which is quite technically complex, I'd suggest you read the article about this study that was posted on Diabetes in Control: Low-Carb Diet Burns More Excess Liver Fat Than Low-Calorie Diet.

In brief, this study assigned 7 overweight people to a low calorie diet, 7 overweight people to a low carbohydrate diet, and used a group of 7 lean people eating normally as controls. Though the numbers are very small, that is because of the high expense of the techniques employed. And I already like this study, because of the inclusion of controls. This is a factor so often lacking in diet studies.

After two weeks, they studied their livers using advanced imaging techniques. They found that the liver behaved differently in people on a low carbohydrate diet. To quote Diabetes in Control,

“We saw a dramatic change in where and how the liver was producing glucose, depending on diet,” said Dr. Browning. Researchers found that participants on a low-carbohydrate diet produced more glucose from lactate or amino acids than those on a low-calorie diet. “Understanding how the liver makes glucose under different dietary conditions may help us better regulate metabolic disorders with diet,” Dr. Browning said.

In addition,

people on a low-calorie diet got about 40 percent of their glucose from glycogen, which is comes from ingested carbohydrates and is stored in the liver until the body needs it.

The low-carbohydrate dieters, however, got only 20 percent of their glucose from glycogen. Instead of dipping into their reserve of glycogen, these subjects burned liver fat for energy. [emphasis mine]

This latter finding is the one of most interest to those with fatty liver disease. The doctors who conducted the study believe it may point to the superiority of eating low carb diet when attempting to reverse fatty liver disease and will be doing more research to look into this.

By the same token, if you don't already have fatty liver disease, eating the low carbohydrate diet that has been shown repeatedly to lower triglycerides may prevent you from developing it.

FDA Approves Apidira SoloStar Disposable Pen!

I just read in Diabetes in Control that the FDA has finally approved the disposable Apidra pen.

I've been using Apidra for almost six months and for me it is by far the most phyiological fast acting insulin. Injected at the time I eat, it peaks exactly when my food peaks, and it's gone in about 2 hours. If I eat something that digests slowly, I may split my dose and do another small booster shot at 2 hours.

Until now, Apidra was only available in vials or cartridges that you use with the huge somewhat clumsy OptiClick pen. I like that the Opticlick displays the dose you've injected for a few minutes. But I don't like that if anything goes wrong with the pen you have to get a new one, in my case, from a doctor as the pharmacies don't stock them here, which could leave you high and dry if it broke during a weekend.

This availability in the new disposable pen makes Apidra more competitive with Novolog, too. The pen is the same one used for Lantus--though I never understood why you would need to dispense once a day insulin via pen. Especially since most people using Lantus use large enough doses that they'd go through a pen in a few days.

Unfortunately, the insurers in my region don't cover pens unless you are blind, and my own insurer doesn't cover Apidra at all. But when a new product like this is released, doctors get a lot of free samples, so if nothing else, more people may be trying Apidra and perhaps the drug reps will turn their intensive marketing efforts to getting the insurance company to cover Apidra along with Novolog and Humalog. It doesn't cost any more than they do.

Study Identifies Virus Linked to Both Type 1 and Type 2 Diabetes

Last week's Science News directed my attention to a fascinating new study. I could not find the actual study posted online, but I did find this excellent article provided by the UK NHS which gives more information about it than you will find in the abstract when it comes out:

NHS: Diabetes Linked to Virus

This study replicated findings of an earlier study linking the finding of enterovirus on autopsy in human pancreases of people with Type 1 diabetes but not those without it. The enterovirus is a stomach virus that causes vomiting.

This new study went beyond the earlier study in quantifying how frequently this virus was found in people with and without Type 1 diabetes and looking at where the virus was found in the pancreas.

The researchers used sophisticated techniques to hunt for viral proteins in the pancreases of 72 young people diagnosed with diabetes who had died on average 8 months after diagnosis and of 39 children who had died at the same age who did not have diabetes.

They found that 61% of the children recently diagnosed with Type 1 diabetes showed signs of pancreatic infection with the enterovirus. Furthermore, when they looked at where the protein was being expressed, they discovered that it was being expressed almost entirely in the beta cells found in the pancreas islets that further testing showed had been still producing insulin at the time of death. The researchers also found an antiviral protein, PKR in these same islets.

In contrast, only about 8% of the pancreases of children who had died of other causes were found to have viral proteins from enterovirus, and their pancreases did not have any antiviral PKR protein in their islets.

This association of the virus and the anti-viral protein is very interesting, and may suggest an explanation for why, even though we know there is a genetic profile associated with Type 1 diabetes, some people with that profile get Type 1 and others do not. This is true even in identical twins, which has always suggested that there must be some environmental factor that causes someone with a certain genetic make-up to develop Type 1.

But, as they say on the infomercials, That's Not All!

These brilliant researchers went on to use the same techniques to examine the pancreases of a group of adults who had been diagnosed with Type 2 diabetes and then compared them with the pancreases of a group of adult controls who did not have Type 2 diabetes. Here's what they found: Forty percent of the pancreases from adults with type 2 diabetes contained the enterovirus protein. But it was found in only 13% of the normal adult pancreases. The incidence of enterovirus in pancreases of people diagnosed with Type 2 was three times higher than in those without it.

They did not, apparently, check the Type 2 pancreases for the antiviral protein PKR. That is a shame because it would be important to know if the people without Type 2 diabetes who harbored enteroviruses in their pancreases also lacked the PKR that was lacking in those children with enterovirus in their pancreases who did not develop Type 1 diabetes.

The most important thing about this study is that hints very strongly that both Type 1 and Type 2 diabetes may be related to infection with this common gut virus.

Though it is important that the study confirms the earlier finding that the virus is linked to Type 1 diabetes and found that further implication of the PKR anti-viral protein, finding the link between enterovirus and Type 2 strikes me as being the real news here--one that appears to have eluded those writing the reports about this study in the media.

If you've been reading my blog and web site you know that I'm convinced that Type 2 diabetes is no more "caused by obesity" than Type 1 is. There is a huge amount of evidence accumulating that suggests that while "prediabetes" is common among people who are overweight, people, no matter how overweight do not develop full fledged Type 2 diabetes unless they have one of dozens of specific underlying genetic conditions that have been linked in research study after research study with Type 2 diabetes. Even then, as was the case with Type 1 genes, you need some environmental factor to turn the genetic profile into actual diabetes.

We already knew from other research, that these environmental factors may include exposure to pharmaceutical drugs like Zyprexa and some SSRIs, exposure to pesticides or PCBs, and plastics like Bisphenol-A. Now we have found another possible culprit. A common virus your children are likely to bring home from elementary school.

The good news is that it may be possible to create a vaccine against this particular virus and if that happens, it might eliminate one factor that pushes beta cells towards failure.

The Supreme Court Hands Patients a Win!

From Reuters:

WASHINGTON, March 4 (Reuters) - The U.S. Supreme Court on Wednesday ruled against the drugmaker Wyeth in a closely watched case, holding that pharmaceutical companies can be held liable for harm from medicines which carry warnings approved by federal regulators.

By a 6-3 vote, the high court ruled that labeling approvals by the U.S. Food and Drug Administration does not preempt state laws and shield companies from legal damages as part of liability claims.

This is huge. If this case had gone the other way, the same drug companies that get their drugs approved by the FDA by submitting cherry picked studies and heavily massaged data, the FDA run by executives who go right back to the drug industry when they leave the FDA, would have been protected from lawsuits from those patients their drugs harmed.

Instead, the court ruled that the company still has a responsibility to protect the people who use their drugs no matter what the FDA says.

WILD CHEERS!

While the business press is treating this as a victory for trial lawyers, it is worth noting that trial lawyers don't take cases unless someone has been seriously maimed or killed. If they are maimed or killed by a drug because the company that provides that drug omitted to mention that the drug could maim or kill in the information it gives doctors, the drug company should pay a price. It will be far less than that paid by the victims of their negligence.

The real benefit of this decision is not for trial lawyers. It is for you, the patient. The drug companies have known all along about the studies they have kept hidden from the FDA and from the public. They also know how the data has been massaged to hide certain findings when they earned product approval. We saw this when Avandia's connection with heart attack finally was made public many years after the company had suppressed this information. We just saw this in the case against the makers of Seroquel who also hid data showing their drug to be less effective than older drugs and more likely to cause diabetes in people who otherwise would not have gotten it.

Now thd drug companies whose drugs' hidden dangers have not been revealed have been put on warning. They will be subject to ruinous law suits if they don't do something to protect the public against the dangers that they already know their drugs present.

Like, for example, the likelihood that Januvia's inhibition of DPP-4 is turning off the tumor suppressor gene you need to survive prostate cancer, melanoma, lung cancer, and ovarian cancer.

There are studies that could be done to determine if this is the case. They have not been done. The only screening done currently when the FDA approves a drug, to rule out that it causes cancer, is screening to see if the drug causes cancer in test tube cells or rodents. No one is saying Januvia causes cancers, only that it turns off our cancer fighting mechanism.

Most of us develop one or two cancerous cells many times throughout our lifetimes, but our tumor suppressor genes kill them. There is no research to see what happens to people harboring one or two cancerous cells when you give a drug that turns off the anti-cancer genes, and that is exactly what Januvia is doing.

It may take ten years until the Januvia-related cancer epidemic becomes evident. At least, with this latest Supreme Court case decided, the company selling it, whose scientists must know of the tumor suppressant features of DPP-4 will not be able to say, "The FDA approved Januvia, so we're off the hook."

Extremely Bad Science: HEART2D "Proves" Fast Acting Insuiln is Worthless

Sometimes you see a study published that is so poorly conceived it leaves you wondering how lab chimpanzees were able to take over the department that ran the study and how they got into the journal office that published it.

The most recent study that falls into this category was published in this month's Diabetes Care.

Effects of Prandial Versus Fasting Glycemia on Cardiovascular Outcomes in Type 2 Diabetes: The HEART2D trial

It is very important that you pay attention to what is wrong with this study, because it is yet another study whose outcome is going to be used to justify denying you the care that could prevent you from developing complications.

The idea behind this study was to see if lowering post-meal blood sugars would be more effective in preventing heart attacks than using a strategy of lowering fasting blood sugar alone.

Okay. That sounds reasonable. Why am I trashing this study?

Here's why: The study took a group of people who had already had a heart attack. It assigned them to two groups. One received three shots a day of Humalog (Lispro). The other received either 2 shots a day of NPH or one shot of Lantus.

Do you see the problem with this study? Of course you do! They gave no basal insulin to the people who were given the post-meal insulin. But all these people started out with very high A1cs which tells you that their fasting blood sugar control was shot. So when those three shots of fasting insulin wear off, their blood sugar will go right back up.

That, apparently, is exactly what happened. At the time the study was stopped both groups of patients had nearly the same average A1cs: 7.7 ± 0.1 (Humalog) and 7.8 ± 0.1% (basal insulin.) The people using fast acting only would have had their blood sugars rise any time they were in the fasting state. The people using basal only had their blood sugars shoot up any time they were in the post-meal state.

No group was given insulin to control their blood sugars in both states. Brilliant, eh?

Endocrinologists do not prescribe post-meal insulin alone. They prescribe it in combination with basal insulin. That researchers in a major study involving 1,115 patients were so ignorant that they set up their experiment in a way that violated everything doctors know about blood sugar control is criminal. That the editors of Diabetes Care considered this study worthy of publication is even more so.

Criminal? That's a strong word. But it is probably not strong enough. Because you can be certain this study will be used by insurance companies as "Evidence Based Medicine" that justifies withholding expensive fast acting insulin from patients.

In fact, all this study really proved is that if you maintain your blood sugar at levels high enough to produce a 7.7% A1c and already have severe heart disease you have a one in three chance of having another heart attack.

This is not news. EPIC-Norfolk data already showed conclusively, drawing on a huge number of study subjects, that people with A1cs well over 7% have three times the risk of heart attack as those with an A1c of 5.5%-6% and between 4 and 5 times higher than those with an A1c of 4-5.4%.

So in addition to proving that using fast acting insulin without basal insulin is ineffective in people with very high blood sugars. this study also proves only that allowing patients who have already had a heart attack to maintain average blood sugars at levels known to quadruple cardiovascular risk in anyone will not change their risk.

But try telling that to your insurer when they tell you they are no longer paying for your fast acting insulin because "studies show it doesn't do anything.

Court Case: How One Drug Company "Buried" Evidence Showing Its Drug Caused Diabetes

If you have a strong stomach, take a look at this news story:

AstraZeneca Seroquel Studies ‘Buried,’ Papers Show.

The data is coming out ten years after the malfeasance described here which resulted in the information being hidden from doctors that the expensive new drug, Seroquel, was less effective than older, cheaper drugs, and that there was solid evidence that it caused both weight gain and diabetes.

As many of you have learned the hard way, the diabetes that the atypical psychotic drugs like Seroquel causes may be irreversible. It is probably not caused by the weight gain experienced in people who take these drugs, as the story suggests. Instead, as is so often the case, the weight gain probably occurs after it breaks something that causes blood sugars to rise high enough to increase insulin resistance.

What's really tragic here is that people took Seroquel because the company hid the data suggesting it was less effective than halperidol, an older drugs whose problems were well understood.

But my reason for highlighting this study is not just because of what it shows us about how Seroquel was marketed, but because it alerts you, once again, to the techniques that have been used by all the drug companies selling expensive new drugs and makes you aware of how far they are willing to go to convince doctors to prescribe these new drugs to you even when they have internal documents warning that these drugs may not be effective and that they may do patients harm.

Because it takes at least a decade for the real problems with widely prescribed drugs to become evident enough that drug makers are forced to surrender internal documents to the court, it will be another 8 more years until the public learns about the mismarketing of today's new drugs. Between now and that time, hundreds of thousands of people will experience irreversible, life-altering side effects from ineffective drugs that in some cases will end their lives prematurely and in others, as is the case with Seroquel, will add other chronic disorders to their health burden.

But because so much ugly truth has leaked out about the drugs of a decade ago, there is a change in how drug companies are operating. Today's drug company will commit errors of omission rather than squelching of results. If you don't do a study looking into something that a reasonable scientist would assume should be investigated, given how a drug affects the body, you won't end up with a result you have to hide.

So you won't be seeing studies looking to see if people taking Januvia have a higher rate of cancer if they keep taking this drug longer than the 18 months that acceptance trials lasted, even though the mechanism by which Januvia works is known to shut off tumor fighting genes. This is true, even though there was a slight hint in acceptance testing that even in 18 months cancers were rising in people taking Januvia. The company cleverly spun the way it reported tumors so that this finding was obscured.

Several non-drug company researchers who work with DPP-4, the protease suppressed by Januvia, have told me that this is a valid concern and one that should be investigated. But given the role drug company money pays in research today, no university is going to sponsor research of this kind. They are too dependent on that drug company money which would be shut off were they to blow the whistle on this highly profitable new family of drugs.

You have only to look at how the maker of Avandia threatened the university that employed the researcher who tried to blow the whistle on Avandia's relationship to heart attack, to see the power of this threat. Avandia's heart attack risk stayed hidden and the researcher was muzzled. Few universities can afford to defend lawsuits threatening $4 billion dollar damages.

Read about the $4 Billion Law Suit Used to Muzzle the Avandia Whistle Blower HERE.

By the same token, you won't find much new research looking into the incidence of blindness in people who took Avandia or Actos for more than a decade, though we now know it increases macular edema. You won't find studies that follow people who took Avandia or Actos for 15 years to see how many of them end up in nursing homes with broken hips, though we know these drugs increase the incidence of serious osteoporosis in older women.

Drug companies pay for most drug studies, and they have learned from what happened to Avandia to avoid doing any studies of already successful, approved drugs that might turn up anything troubling.

And even when they do conduct studies they are careful to avoid asking any questions but those where they already know the answer. When testing the effects of powerful new statins, for example,they don't include measures of cognitive function, before and after people spend five years on the drugs, because if they were to do so, they'd have to let you know that whatever benefits these drugs have are countered by their tendency to cause cognitive problems in older people.

Bottom line: Be wary. Don't believe everything you read in published studies because the data has often been analyzed in ways that obscure important findings, or the study design itself or the selection of study subjects may have been tinkered with to provide a result that would boost sales. Remember that negative studies often do not get published.

Take as few pharmaceutical drugs as you possibly can. When possible take older drugs that have survived the test of time, whose real side effect profile is known, and which are out of patent so that there is no financial motivation for companies to promote them with tricks.

A Place for Patients in the Health Care Discussion?

I have a grave concern that the discussion about health insurance reform taking place at the highest levels of government it taking input from everyone but us, the patients.

Insurers, doctors, and drug companies are involved. So are organizations like the American Diabetes Association. The latter present themselves as if they were advocates for patients, but those of us who have been involved in diabetes advocacy for any amount of time know that this is not, in fact the case. This organization and others like it (American Heart Association, American Cancer Society) raise money from patients, but primarily serve the needs of those who profit from patients: drug companies, food companies, and doctors.

Because there is no organization of patients--most of whom are too sick or overburdened with just getting through daily life to spend their time in political activity--patients are at serious risk.

For example, the idea that "evidence based medicine" is the solution to cost cutting means that the poorly designed and badly conducted studies that "prove" that testing blood sugar is useless for people with diabetes may mean that you won't be given test strips any more. The studies that "prove" that lowering A1c is worthless--again poorly designed and sloppily conducted, may keep you from getting the drugs you need. There are bad studies that show that insulin is worthless for Type 2s. There are studies that pretty much prove that you would be better off going to a Witch Doctor than an MD for help with diabetes.

And if health reform goes in the direction it looks like it may be going, the witch doctor may be the only doctor your new health care will pay for you to see. With a huge co-pay.

I am really worried about this.