Cholesterol Control Without Diet!
The Niacin Solution

       The book points out that H stands for "healthy," while L stands for "lousy." This memory device is not elegant, but it works. Let's always remember that niacin reduces bad cholesterol and increases good cholesterol. No other drug shares these characteristics.

       Definitely! The Coronary Drug Project (CDP) was the first-ever nationwide cooperative study of drugs and heart disease. It was conducted between 1966 and 1974 in 53 centers from Massachusetts to Hawaii. The participants, 7,700 men between 30 and 65 who had already had one or more heart attacks, received either placebo capsules or one of four drugs capable of altering cholesterol and/or triglycerides. Two of the four drugs were dropped during the study because they caused adverse effects, including more heart attacks, than the placebo. Of the two drugs which finished the study (at least five years in every participant), the other drug did not improve the heart attack and stroke rate; only niacin had a favorable effect on all the endpoints.

       Niacin reduced both heart attacks and heart attacks by about 25%. It reduced cardiovascular surgery by a whopping 46%! And it also reduced cardiovascular hospitalization and all hospitalization.

       Yes. This required a survey nine years after the end of the study, in which the statisticians contacted all 53 centers with a single question: who is still alive and who has died? When they sorted out these results according to drug groups, all of the other drugs had the same death rate as the placebo. Niacin had reduced the death rate by 11%, even in these high-risk patients who had already had at least one heart attack when they enrolled, an average of 15 years earlier. (The men were now between ages 45 and 80!) The statisticians calculated that niacin had added an average of 1.63 years to each man's life, which means that for some the added survival was much more than this average.

       The CDP used a fixed dose of niacin, which was the usual starting dose, recommended by the Canadians and used in early studies at the Mayo Clinic and in Madison. In practice, we follow the cholesterol levels (which were kept from the doctors handling the CDP participants) and adjust the dose accordingly. Our earlier work had shown that at least 50% of patients required a larger dose as the CDP dose (sometimes twice as much) for the best cholesterol control. If the CDP dose had been even 50% larger, the results would have been even better. In a way, the cards were stacked against niacin in the CDP, but it had an outstanding record in spite of this.

       There are two important reasons. First, niacin has never had any "commercial push" behind it. Ever since I first worked with it, niacin has been a generic drug. No company can patent it and make large profits from its exclusive sale. This keeps niacin inexpensive. No sales representative comes to physicians' offices to tell of niacin's distinctive advantages, its long safety record, or its low cost. Other companies spend millions of dollars on advertising campaigns, aiming for larger shares of the multi-billion dollar market, even though their products have less impressive records and high price tags.

       Until recently, diet advocates had always held positions of authority in opinion-making bodies such as American Heart Association and National Institutes of Health. Their bias in favor of diet thoroughly brainwashed the media, which in turn brainwashed the public, including the medical profession. Furthermore, the food industry has a huge vested interest in foods advertised as beneficial for cholesterol problems. I know researchers who believe that there has been a conspiracy between some dietary advocates and the food industry. I don't think they ever sat down around a table and conspired, but over the years they have trumpeted the party line about diet so loudly that the media and the public didn't realize there was any other way.

       When most people hear "cholesterol," they automatically think "diet." My book points out why this is far from the truth. Diet is such a weak and ineffective for cholesterol management that it should be forgotten, except as a weight control measure. The only way to reduce excessive weight (which is an epidemic problem in the U.S.) is to control calories on an ongoing basis.

       The National Cholesterol Education Program (NCEP) of National Institutes of Health (NCEP) advises a trial of diet before adding a drug. But they are getting more realistic. Their 1988 guidelines specified a six-month trial of diet, and if not successful in the first three months, making the diet stricter. If any doctors really followed this plan, it must have made a lot of patients leave follow-up and never obtain effective treatment with a drug, because no one likes diet and no one likes an unsuccessful result. Two months is long enough to see whether diet will help. In their 1993 guidelines, NCEP changed the dietary recommendation to an unspecified (shorter) period, then using a drug when the diet fails to achieve the goals of treatment.

       A doctor must always know the expected side effects and any potential toxic effects of any drug he prescribes. He also needs to differentiate between nuisance effects and serious effects. The several cholesterol-control drugs on the market can be safely managed by physicians who know the necessary precautions and carefully supervise their use.

       What bothers me is the diet advocates' implication that diet has no side effects or toxic effects. It has both. The "toxic effects" are the heart attacks and strokes that occur when diet proves to be ineffective in cholesterol control. "Side effects" of diet include sentencing people to low-fat, high-fiber programs they neither want nor need. But the worst and most widespread "side effects" are the worry, concern, and guilt which people have been taught to feel when thinking about food, buying food, cooking and eating food. None of this is necessary! When you consider how many millions of people have been subjected to these "side effects," it would be no exaggeration to call the diet advocates' position a criminal conspiracy, as some do.

       In the early 1960's, before the CDP, the National Institutes of Health (NIH) decided that there was plenty of evidence that it was better to have a lower cholesterol than a higher one. Proposing to find out whether treatment of high cholesterol levels really made a difference, they formed committees to determine the feasibility of a diet-heart study and a drug-heart study. The Drug-Heart committee, of which I was a member, decided that there sere several drugs ready for such a trial and proceeded with their trial, the CDP. The Diet-Heart committee decided on a two-year feasibility trial at six centers.

       The two-year Diet-Heart Feasibility Trial really showed that most people would not follow any diet with significant fat and cholesterol restriction very well, even when special foods (not generally available then or now) were provided, along with repeated dietary counseling and what some one has termed "an enthusiastic team of exhorters." Furthermore, it didn't make much difference in cholesterol levels if they did. The study was too short to tell anything about rates of heart attacks, strokes, or deaths. They simply tried about six different diets to see whether people would follow them. Despite these negative findings, the diet advocates declared the study a success and advised a massive nationwide study. Fortunately, NIH did not accept this suggestion, and did not fund a larger study.

       The most important message of the book, repeated time after time, is this: Niacin is not a do-it-yourself drug. It requires knowledgeable medical supervision. In short, you need a doctor who is good at using niacin.

       The definition of a doctor good at niacin: one who has read my book. I advise the patient-reader to buy another copy of the book and present it to his/her doctor. The cost is not great; it is less than one saves in one month by using niacin rather than one of the best-selling but expensive drugs, the statins.

       Yes and no. It does have side effects, as all drugs do, but in most instances they do not limit its use if the doctor is good at niacin. Everyone who takes plain niacin experiences a flush, consisting of a warm feeling with redness of the face and upper body, sometimes accompanied by itching or a slight rash. At first this occurs with each dose lasting 20 to 30 minutes each time, but flushing usually decreases over the first several days of treatment. It disappears, for all practical purposes, in an average of three to four days.

       Yes, by taking a single aspirin tablet each morning, or by using a time-release (slowly absorbed) niacin preparation, or both. Plain niacin should always be taken with meals. It is also a good idea to avoid hot beverages at first, until the flush is no longer a problem.

       There can be. But before going into specifics, let me remind everyone: although niacin is available over-the-counter as a "nutritional supplement," in doses used for cholesterol control, it is a drug which should not be taken without supervision by a knowledgeable physician. It is particularly important not to change from plain niacin to a time-release preparation in the same dosage. This is approximately the equivalent of doubling the dose, which can cause serious problems.

       Yes, but not as serious as the liver effects, and most can be easily managed. Nausea may occur, but the doctor good at niacin handles this by changing the dose or the type of niacin preparation. The book discusses this and other side effects, which are less frequent and usually less significant.

       Again, the lack of "commercial push" and the extravagant promotional campaigns by manufacturers of other cholesterol-control drugs which have dominated the market in recent years. The competing companies brush off niacin as "hard to take because of side effects" and offer their expensive products, which lack niacin's distinctive advantages, at costs of $50 to $220 per month. Compare this with niacin's average cost of $8 to $10 per month. In a situation which usually requires continuing treatment for a lifetime, such a difference quickly multiplies into great financial savings for the patient whose doctor is good at using niacin.

       Yes. I don't mean to depict niacin as a total outcast. In its first detailed statement on diagnosis and treatment of cholesterol disorders, the NCEP (National Cholesterol Education Program) designated niacin and bile-sequestrant resins as the "first-line drugs" to use if dietary management proves inadequate. They selected these drugs because of their long safety records and proven ability to reduce not only cholesterol levels but also heart attacks. The 1992 NCEP guidelines reiterated the same choices and added one class to its list of "major drugs."

       In 1993 they advised reducing LDLC to less than 100 in persons who have already had a heart attack, stroke, coronary bypass surgery, angioplasty (stretching a narrowed spot in an artery), or other arterial procedure, including surgery on neck or leg arteries. Levels this low have been shown not only to retard new cholesterol deposits but also to decrease existing plaques. For persons with no artery event but with two or more risk factors for coronary disease, they advised LDLC levels below 130. For those with no event and fewer than two risk factors, they accept LDLC below 160; I like to see it below 130 in everyone.

       NCEP also pointed out that HDLC levels below 35 increase the risk of heart attack and other artery disorders and should be raised to higher levels. They did not give a specific target; I customarily aim for 45 or higher. As we said before, niacin is the only drug (or measure of any type, including diet and exercise) that both raises the HDLC and lowers LDLC.

      With the advent of the statin drugs, the 2001 NCEP guidelines changed dramatically. The guidelines were flawed in several ways. They continued to emphasize diet, which doesn't work. If diet reduces LDLC at all, the reduction is negligible, about 5%. And diet also reduces HDLC just as much, a bad thing!

      Worst of all, the 2001 guidelines strongly advised use of statins, almost to the exclusion of other drugs. When they do mention niacin, they call it "nicotinic acid," an old term that sounds bad and that readers might not recognize as a synonym for niacin. Each time they mention niacin, they couple it with fibrates and label them "triglyceride drugs." They do not mention that niacin reduces LDLC, raises HDLC, lowers triglycerides, reduces Lp(a), reduces VLDLC (very low-density lipoprotein cholesterol--which turns into LDLC and which they recommend as a target to be reduced), and favorably alters subfractions of both LDLC and HDLC. No other drug approaches this performance list. The panel also failed to mention that the statin drugs do only one of these things well (reduce LDLC).

      Early in 2000 the NIH coordinator for the large NCEP panel (about two dozen members) told me that the panel was beginning to work on new guidelines. I sent copies of the first edition of Cholesterol Control Without Diet to each member. The 2002 guidelines showed that, as a group, they had not read or did not understand the distinctive advantages of niacin. Another factor, of course, might have been the strong activity of statin manufactureers in paying cholesterol experts. In a footnote to the 2002 guidelines, six members of the panel acknowledged that they had received moneys from statin companies. At least two others failed to acknowledge such support, although my files contain published papers in which they acknowledged financial support from drug companies that market statins. The current, second edition of the book discusses this matter in more detail.

      In July, 2004 a smaller panel (nine, including the coordinator) issued an even more disgraceful set of guidelines. An Associated Press release reported that they had reviewed five recent studies (all statin-sponsored) and advised even lower LDLC levels as a goal of treatment. In 2001 NCEP had advised keeping LDLC below 130 in persons with no previous coronary or other event but below 100 for anyone with such a previous event. I was comfortable with those figures. In 2004 the small panel, through a convoluted reasoning process, used five recent studies to recommend LDLC below 70 for anyone with "high risk of coronary disease." More comments on these unwise and dangerous guidelines appear later in this report (after the Bill Clinton paragraph). Two days after the original AP story, another AP story revealed that eight of the nine panelists (all except the coordinator) had been paid by statin manufacturers.

       Lp(a) -- pronounced "LP little a" -- is an abbreviation for "lipoprotein (a)," a part of the LDL family which has been found to be especially related to heart attack and stroke when the body produces too much of it. The only measure which reduces it effectively (if you exclude use of estrogenic hormones in postmenopausal women) is niacin. It is not necessary to do the expensive measurement of Lp(a) in everyone if the doctor uses niacin as his drug of choice for most lipid disorders. He just knows that this level, if too high, is being reduced by niacin as it corrects other problems with cholesterol and triglycerides.

       That's up to the patient. If he/she needs to lose weight, the only way to do so is by limiting calories. One part of reducing calories is to reduce intake of fats, higher in calories than either carbohydrate or protein. I do not restrict eggs because studies have shown they have no effect on levels of cholesterol or lipoproteins, and they are a good source of protein.

       I emphasize that the main factor in determining your blood cholesterol is what the body factory is doing, not what you eat. Many people had heard that the body manufactures its own cholesterol (about 80% of it) but had never heard it put that way. The setting of the body factory is inherited and, if unsuitable, can best be changed by drugs for cholesterol control. The drug that does everything right is niacin.

       If one wishes to try a careful diet for a couple of months, I have no objection. However, the patient should understand that whatever he/she eats during this trial period must be the diet he/she is willing to use for a lifetime. Diet may lower total and "bad" cholesterol (the largest fraction), but in many patients it does not. Or it may lower these only during periods of weight reduction. When persons learn that since the late 1950's there has been a drug, niacin, which reduces total and "bad" cholesterol while raising "good" cholesterol (which diet does not do), most people prefer to take medication and continue to enjoy eating as they please.

      Over the years there have been convincing studies showing that persons will not follow sufficient changes in diet to meet the goals of treatment. These are discussed in the book. An excellent community study in California showed that diet reduced total cholesterol by a trivial amount (about 5%) and lowered HDLC ("good" cholesterol) as much as LDLC ("bad")--not a desirable change.

      In a nutshell: diet just doesn't work. If any part of your cholesterol profile is in an undesirable range, you have inherited a body factory that is responsible. Treatment must change the body factory. This requires medication. The book explains, for doctors and patients alike, why niacin is far preferable to the billion-dollar statin drugs.

       Niacin has a fifty-year safety record. Of the best-selling "statins," the first one was marketed in 1987; Others were introduced in 1991, 1993, 1997, and 1998. Early in 1997 one of the drugs introduced in 1991 was found to have a serious interaction with several commonly used drugs, including antidepressants and erythromycin. This hazard applies to some, but not all, of the statins.

       Doctors at Stanford and University of California at San Francisco have raised the question of cancer from long-term use of statins. They point out that these drugs are carcinogenic (cancer-producing) in rodents at doses 2 to 30 times those used in humans. They also point out that known cancer-producing agents, like tobacco and asbestos, take 20 to 40 years of exposure before the cancers appear. They specifically advise against use of statins in younger people, but it seems wise to consider their reasoning when choosing a drug for cholesterol control in every patient.

     Bill Clinton's coronary bypass surgery has heightened interest in coronary surgery. A radio talk show host asked Dr. Parsons how he would have handled Clinton's health problems if the ex-president had been his patient. The author replied that the book takes the position that heart attacks are preventable. He would hope that, if Clinton had been under his care over the years, all of his risk factors would have been so well controlled that he would have not reached the brink of a heart attack, requiring surgery.

     He reminded listeners that diet has so little to do with your blood cholesterol level that we might as well say that it has nothing to do with it. He then went on to say that Clinton's much-publicized penchant for fast foods had more to do with his weight than with his cholesterol level. The cholesterol level was inherited, as evidenced by his relatives' having premature heart attacks.

     Regarding the ex-president's stopping his statin drug when his cholesterol level came down, that was an unwise move. His doctors say Clinton will be taking a statin now. Parsons cited the new (July 2004) guidelines, written by a panel of experts who have been paid by the statin drug manufacturers in the past or currently. He pointed out that if the guidelines are implemented (and they will be, since most doctors are clueless on this matter), they will cost American consumers billions of dollars and will cause deaths.

     See next question and answer, Why are the new (July 2004) cholesterol guidelines unwise and dangerous?

     In July 2004 a panel of experts, meeting in Bethesda, Maryland, issued a new set of guidelines for cholesterol control. The previous guidelines (2001) had been forged by a panel of a couple dozen experts. This time there were just eight such experts, plus the NIH coordinator.

     The 2001 guidelines had advised controlling the LDL (bad) cholesterol to below 130 if you have not had a heart attack or other artery event and below 100 if you had already had such an event. After reviewing five new studies, done in recent years and sponsored by manufacturers of statin drugs ( Lipitor, Zocor, Pravachol, several others), they issued a new edict that recommended LDL below 70! And this was not just for those with a previous heart attack but for everyone "at high risk of heart disease." They advised using statin drugs to reduce LDL cholesterol to these levels.

     Treating all or most of these people with statins would start the drugs for millions of people and increase the dosage for millions already taking statins. This would deplete wallets by more billions of dollars and would cause deaths. Keep reading.

     That is a huge number of people! It includes smokers, those with high blood pressure (whether treated or not), those with abnormal lipid patterns other than too-high LDL cholesterol, diabetics, obese persons, and those without adequate physical exercise.

     Four days after the AP news story about the new guideline, another AP story appeared, revealing that all of the expert panel (excepting only the government coordinator) have received moneys from the manufacturers of statin drugs. Such payments take many forms: consulting or speaking fees, research money, or other support from companies producing statins, drugs that sell billions of dollars each year. The 2003 update of Cholesterol Control Without Diet! The Niacin Solution contains a chapter with more details of how FDA ( and in this case National Institutes of Health) repeatedly ignore federal law which states that experts with conflicts of interest may not serve on guidelines committees or advise regarding approval of new drugs.

     Let's go back to May 2001. About two years previously, Bayer had introduced a statin drug (Baycol), but in May 2001 they withdrew the product from the market, stating that it had caused 31 deaths in the US and more world-wide. After the withdrawal, the Washington watchdog group, Public Citizen, reviewed FDA records and found that the five statin drugs remaining on the market (Lipitor, Zocor, Pravachol, Lescol, and Mevacor) had caused 81 deaths. Later, Bayer admitted that the figure of 31 deaths had been inaccurate; the actual figure was at least 100. That adds up to at least 181 deaths from stains until mid-2001.

     How many deaths have occurred since then? There has been no further tally of deaths since then. I do not know why. I have notified FDA that it is their responibility to tally deaths since 2001 and bring that total to attention of the medical profession and the public. Thier reply was a beaurocratic response, saying that they will not do this, offering the desired data under the Freedom of Information Act. This wouldn't work since FOA applies only to data that are already on record--and FDA has refused to tally deaths since 2001. Any further requests for this important information have been met with equally negative results (such as a separate request for each drug, plus money to pay employees for time spent in such a review). Two later letters, emphasizing FDA's responsibility to protect the public, have met equally negative responses.

I have tried to get Public Citizen to tally deaths since 2001, from CD's of FDA records, as they did in 2001. To date their point man for such matters has explained their failure tofollow up with a current tally by saying, "The CD's are six months behind." [Well, then: Why not tally to the latest CD's and publicize the numer of deaths until then?]

     How do the deaths from statin occur? Many, perhaps most, persons who take statins suffer from muscle aches (myalgia). In Some, this becomes more severe and is accompanied by muscle tenderness (myositis). In a relatively small percentage, the process goes on to actual dissolving of muscles. The medical term for this is rhabdomyolysis--pronounced "rab-doe-my-ol-us-us." Doctors often shorten this in conversation to "rhabdo." Just remember that it means dissolving of muscles.

      Dissolving of muscles releases myoglobin from muscles into the blood. Myoglobin, like hemoglobin in red blood cells, was meant to be in cells, not floating freely in plasma. When myoglobin is in plasma, the kidneys filter it out of the blood. The problem is that this can block kidney tubules, which can lead to kidney failure and death. Nephrologists (kidney specialists) say that they see patients with "rhabdo" quite frequently and sometimes have to use dialysis to save their lives. Some are not so fortunate; then deaths occur. No one knows how many persons develop "rhabdo," placing their lives in danger. Nephrologists say that they see "rhabdo" so frequently that they do not bother to report it unless the patient dies.

     What drugs or foods can trigger rhabdomyolysis? Certain drugs, if taken with statins, can cause rhabdo, with its potentially fatal results. This happens because statins are mostly removed from the body by a liver enzyme called P-450. The book discusses this in some detail.

     Let's look at one possible scenario. Suppose you see a nose and throat specialist because of sinusitis, and he/she says, "The best drug for this is erythromycin. I'll give you a prescription." Maybe the doctor doesn't even know that you are taking a statin, or doesn't know that erythromycin is removed from the body by the same liver enzyme. If you take these two drugs together, the statin level in your blood goes sky-high. This may dissolve your muscles, shut down your kidneys, and cause death.

     A fair number of drugs are removed by the P-450 system. Strangely, so is grapefruit juice! I have recently read that taking a Zocor tablet with a glass of grapefruit juice is the same as taking 10 to 15 tablets with a glass of water! Not only may doctors be unaware of this P-450 enzyme interference; but other drugs will come along in the future with the same potential for serious harm.

     For a few weeks after the Baycol withdrawal, newspaper stories warned people, "If you have muscle pains while taking a drug in this group, stop the drug immediately and notify your doctor." Then those warnings no longer appeared. Of course, the fine print at the bottom of advertising pages (and fast talk at the end of TV commercials for statins) mentions muscle aching and advises, "Tell your doctor what other medications you are taking." In the author's view, these are not adequate warnings regarding a possible fatal complication. Public Citizen agrees. They recently pointed out that the FDA approved Crestor, the first new statin in several years, despite the fact that pre-clinical investigations (before the drug's approval for marketing) had shown several cases of muscle-dissolving and kidney failure (no deaths, fortunately). Crestor was the first statin drug to show these effects in pre-marketing studies. Public Citizen felt that Crestor should not have been approved, but FDA approved it. It is now being advertised heavily.

     In June 2005 FDA held hearings on the charge that Crestor is the most dangerous of all statin drugs and should either be taken off the market or accompanied by stern warnings about its hazardous potential. The author does not know the entire content of the hearings except that Sidney Wolfe, MD (Director of the Public Citizen Health Research Group) did testify. Obviously his evidence and recommendations were ignored by FDA, which took the position that the risk of rhabdomyolysis and death from statin drugs is small and Crestor was no more deadly than any of the others! (Sure, hundreds deaths from drugs taken by millions of people is a small percentage--but those hundreds of people are still dead!)

     Whether it is true or not, it appears that FDA has decided to take the side of the pharmaceutical companies, who desire to sweep hundreds of deaths under the rug, rather than the interest of the public--whom we had always believed it was FDA's mission to protect. A Public Citizen representative has told the author that each year FDA receives $150 million from the pharmaceutical industry, as part of their operating expense. Each person and organization must decide for themselves whether this sets up a conflict of interest or not. The fact that FDA uses experts to advise on approval of drugs that are paid by pharmaceutical companies and uses authors of guidelines that are also paid by drug companies is addressed in the book (pages 135-136).

     It was a better world when pharmaceutical companies were not permitted to advertise directly to the public. Cholesterol Control Without Diet! The Niacin Solution discusses the huge expenditure of pharmaceutical companies on direct advertising-and its effect on drug prices, a very important issue in all of our lives.