Part 3 of 3 [Part 1, Part 2]

The Emperor's Invisible Suit

There was once a very vain Emperor whose main interest was to wear elegant clothing. He had a coat for every hour and often changed his clothes several times a day since his greatest pleasure was to show them off to his people. Everyone knew of his vanity and fetish for fine clothing and two scoundrels decided to take advantage of it.

They introduced themselves at the palace gates as two very fine tailors who had invented an extraordinary method to weave a cloth so light and fine that it was barely visible. In fact, it would be invisible to anyone too stupid or incompetent to appreciate its superior quality. The chief of the guards sent for the court chamberlain who notified the prime minister, who ran to bring this incredible news to the Emperor.

The two fake tailors were summoned and told him, "Besides being invisible, your Highness, this cloth will be woven in colors and patterns created especially for you." The Emperor couldn't resist this and gave them two bags of gold coins in exchange for their promise to start work at once in a special room in the palace and inquired as to what equipment was needed.

They asked for a loom, silk, gold thread, all of which was immediately procured and they pretended to start working at a furious pace. The Emperor was convinced he had made a great deal: in addition to getting a new extraordinary suit he would also discover which of his subjects were ignorant and incompetent. A few days later, he asked his old, trusted and wise prime minister to check on how the suit was coming along. The two thieves proudly displayed their accomplishments, stating, "Here, Excellency, admire the colors, feel the softness!"

They reassured him that they were almost finished but needed considerably more gold thread. The old man bent over the loom and tried to see the fabric that was not there. He could feel the cold sweat on his forehead. "I can't see anything," he thought. "If I see nothing, that means I'm stupid! Or, worse, incompetent!"

If the prime minister admitted that he didn't see anything, he would be discharged and disgraced. "What a marvelous fabric! I'll certainly tell the Emperor and get more gold thread," he told them. The two thieves visited the Emperor to take their final measurements and as they bowed while being ushered in, they pretended to be holding a large roll of fabric. They showed it to the Emperor so he could appreciate the beautiful colors and feel how fine it was.

The Emperor, who felt and saw nothing, felt like fainting, but fortunately, the throne was right behind him and he sat down. The measurements were taken and the tailors began cutting the air with scissors and sewing it with threadless needles. After evaluating the situation, the Emperor realized that no one could know that he did not see the fabric and felt better, since nobody could find out that he was stupid and incompetent. He had to strip down so the new suit could be draped on him and he could view the results in his full-length mirror. He felt embarrassed but was relieved that none of his court seemed to be. "Yes, this is a beautiful suit and it looks very good on me," the Emperor said trying to look comfortable. "You've done a fine job."

All his subjects soon heard about the fabulous suit and clamored to see it so it was necessary to arrange a ceremonial parade in which he stood in his carriage. A group of dignitaries walked at the front of the procession, anxiously scrutinizing the faces of the people who were pushing and shoving to get a better look. Each one marveled at the beautiful colors and fine fabric loud enough for everyone to hear lest they reveal their stupidity and incompetence, until a little child peeked into the carriage and shouted, "The Emperor is naked". His father tried to quiet him but soon everyone cried, "The boy is right. It's true. The Emperor is naked." The Emperor realized the people were right but couldn't admit it and continued the parade with a page holding his imaginary mantle behind him.

The new invisible and imaginary disease of prehypertension proposed by JNC-7 seems somewhat similar. This is not to imply that its authoritative proponents are dishonest. Although acting in good faith, there is reason to believe they may have been unduly influenced by others with their own private agenda.

Is JNC-7 Déjà Vu All Over Again?

The law requires that all important federal rules, including guidelines that affect the public, must be written and promulgated according to the Government Code. This code mandates formal selection of a committee, pre-announcement of all meetings, open meetings that encourage testimony from all interested parties as well as written records, all of which must be preserved in a special docket.

Everything is then reviewed in order to provide a written discussion of all the relevant evidence leading to the final rules or guidelines that must be published in the Federal Register. In addition, if the published guidelines are not consonant with a logical review of the evidence presented, the recommendations may be overturned by legal action.

Since the new JNC-7 guidelines seemed to fall under these rules I accessed the Federal Register but was unable to find anything relevant. When I contacted the Government Printing Office to inquire about this I received a reply confirming they had no JNC records and was referred to a NIH web site. This was remarkably reminiscent of how the National Cholesterol Education Program (NCEP) for the detection and treatment of high cholesterol had operated. The first NCEP report issued in 1988 was timed to coincide with the introduction of Mevacor, Merck's new cholesterol lowering drug. In an unprecedented action it was released directly to the public, weeks before doctors could read the scientific information on which it was based. The last set of revised guidelines in 2001, which tripled the number of Americans advised to take statins, was also publicized prematurely.

In both instances, the guidelines were published in the Journal of the American Medical Association but not the Federal Register. There was no public notice of any meetings, the meetings were not open to the public, public input was not solicited, and detailed records and testimony of committee meetings were not kept. The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC) has followed the same format in order to bypass Government rules and regulations.

When NIH officials were questioned about this they explained that the cholesterol and hypertension guidelines were written by a non-government committee of experts that they had selected and were therefore not subject to the Federal Register regulations. This despite the fact that they are presented by government spokespersons at government press conferences and are promoted in the media here and abroad as the latest government guidelines. The new JNC-7 report made its debut at a special session of the American Society of Hypertension Annual meeting in New York. This took place on the same day in May as the National Heart, Lung, and Blood Institute Press Conference was held in Washington and coincided with appearance of the JNC "Express Report" on the Journal of The American Medical Association web site.

My personal suspicion is that powerful pharmaceutical interests were behind much of this, as well as making May National Hypertension Month. Although JNC-7 reverted to the previous advice that inexpensive diuretics were the first choice it also emphasized that "Most patients with hypertension will require two or more antihypertensive medications to achieve goal pressure."

A Novartis spokesperson lavishly praised the report in a press release emphasizing that "Inadequate control of blood pressure has become a public health crisis. We are encouraged that new approaches recommended by JNC-7 will provide impetus for improvement." That's hardly surprising. Novartis, with its 73,000 employees in 140 countries and U.S. sales of $21 billion per year has all the hypertension treatment bases covered. They manufacture Lopressor, a beta blocker, Lotensin, an ACE inhibitor, Diovan, an angiotensin II blocker, Lotrel, a combination ACE inhibitor and calcium channel blocking agent, as well as products combining these with a thiazide diuretic.

Despite all the hoopla, many physicians were not as enthusiastic. Some were skeptical that the new guidelines offered anything that was either new or helpful. Several prominent authorities on hypertension denounced it as being based on conclusions that were not only unwarranted but also misleading.

Some Thoughts on Pharmaceutical Finagling and Future Hypertension Research

The full study will not be published until the fall and the report in the "JAMA Express" raised some eyebrows. This feature is designed for rapid dissemination of new breakthroughs, for which JNC-7 hardly qualified. The journal's peer review process time for this is 24-48 hours and all 33 JNC authors would have had to respond within 72 hours. This seems doubtful but that wasn't the only complaint.

The recommendation for diuretics as first line therapy were largely based on the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study conclusions that many disagreed with. ALLHAT results were also reported early in the JAMA Express and some feel that anything dealing with statins receives this preferential treatment. This holds true for other respected peer reviewed publications such as Lancet, which has also expedited statin studies despite the fact that they show nothing new or significant. Conversely, it is very hard to get anything negative about statins published, even when the data is solid. Perhaps this has something to do with the enormous revenues publications derive from statin advertisements.

John Laragh, director of the Cardiovascular Center at the New York Presbyterian Hospital-Cornell Medical Center, founded the American Society of Hypertension, is editor-in-chief of its journal, and past president of the International Society of Hypertension. He is one of the world's leading authorities on hypertension because of his delineation of the renin-angiotensin-aldosterone system, which landed him on the cover of Time magazine. I grew up with John, we have been personal and professional friends for well over 50 years, and he was a founding Trustee of The American Institute of Stress.

I was tempted to ask him about his opinion of the new guidelines, but didn't have to. His objections to this and the ALLHAT study were vividly detailed at a press conference and were summed up by his colleague, Larry Resnick, as essentially "garbage".

Laragh believes that patients with high renin hypertension are more prone to have complications than low renin salt sensitive hypertensives and respond better to drugs other than diuretics. Björn Folkow, another authority and recipient of the Hans Selye award and numerous other honors has emphasized the role of stress, the sympathetic nervous system and catecholamines.

However, I suspect both these good friends subscribe to the decades old "mosaic theory" that hypertension rarely has a single cause and can result from dysequilibrium in the above and other contributory components. Researchers are now focusing in on our old friend inflammation as a cause that may explain its link with coronary heart disease, obesity, diabetes and other disorders. Inflammatory cytokines like Interleukin II released by deep abdominal fat cells that contribute to insulin resistance and metabolic syndrome are increased in hypertension and both angiotensin II and aldosterone have been found to promote inflammation. Increased CRP levels were reported in newly diagnosed untreated hypertensives at the same meeting and another paper showed a correlation between elevated CRP and hypertension complications--so stay tuned!