Although the symptoms vary a little, heartburn mostly causes a distinct “burning” pain, often with bloating. These arise from an upward assault of stomach acid that illogically moves north into the esophagus. This is opposite of the way things should be; hydrochloric acid made in the stomach should flow south, where it ultimately gets neutralized by an alkaline “buffer” solution produced by the pancreas. Acid only goes north because of an incompetent or relaxed barrier or “sphincter” at the junction between the stomach and the esophagus.

Although heartburn can be severe and lead to serious complications, the truth is that most heartburn gets promptly better with TUMS or Rolaids or Maalox or something that is anti-acid. By the time the Purple Pill was developed, there were other prescription medicines like cimetidine or ranitidine and lansoprozale available for tougher cases of heartburn. Although the Purple Pill may be slightly superior in some patients, the truth is that it is not dramatically better. The Purple Pill is not a breakthrough medication.

When the Purple Pill People decided to go straight to the masses via television, millions of viewers became convinced that 1) their heartburn is a dangerous symptom and needs to be treated, 2) the best way to treat heartburn is with a prescription medicine, and 3) the best medicine is the Purple Pill.

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As a result of this ad campaign, sales of the Purple Pill hit the ceiling. Despite professional guidelines and restrictions from insurance companies and millions of doctor hours spent giving advice about alternatives to prescription medication, the Purple Pill - an unbelievably safe medicine - became a blockbuster hit. An also-ran, me-too medication became a pharmaceutical superstar.

The other pharmaceutical companies quickly learned the Purple Pill Lesson, and the floodgates opened. From Viagra (for you know what) to Enbrel (for rheumatoid arthritis), audiences have been bombarded by drug ads. And the ads run in all time slots and during all events, from Oprah to NASCAR.

The industry’s defense for this practice - which I believe has been bad for medicine and public health generally - goes along the lines of “We are educating the public about their health.” And I suppose some good has occurred. Profits from the Purple Pill sales support research into other drugs, some of which might actually be future breakthrough drugs.

But there have been interesting side effects of the Purple Pill marketing phenomenon, one of which involved Phil, a 40-ish father of three elementary school kids. Phil came in for his yearly physical a couple of weeks ago.

Doctors do an orderly inquiry into bodily functions called a “review of systems,” and I plunge into it with my patient. I go from top to bottom, starting with headache and ending with leg symptoms.

“Having any bowel or bladder problems?” I ask Phil, who is seated on the exam table dressed only in a blue-dotted hospital gown. He looks comfortable despite the air conditioning draft coming in over his head.

“No,” he answers, and shakes his head casually.

My next, usual question for men, follows: “A lot of men would like to discuss sexual function with me,” I ask him.

“Not a problem for me so far, doc,” he answers, and he gives me a smile. “But from all the ads, I know a lot about those Viagra medicines.”

I stop, and look at him closely, not sure what he means. His smile turns rueful, as if he regrets something.

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The reappearance of these drugs in the news, however, is a reminder of one of the most highly questionable marketing practices in the pharmaceutical industry. The promotion of these pills may be legal, but it’s still hazardous to our health care system, costing consumers billions of dollars a year.

Proton pump inhibitors (PPIs) have been used for several years, helping to treat millions of people suffering from heartburn and gastroesophageal reflux disease (GERD). Previous research has shown that these drugs limit the ability of the body to absorb calcium, causing some worries about long-term use and osteoporosis. So, this new study, which links long-term use of PPIs to an increased risk of hip fracture, may have implications for the treatment of these diseases.

“PPIs are very popular and osteoporosis is very common, so we were compelled to look at this link,” said Dr. Yu-Xiao Yang, a gastroenterologist from the University of Pennsylvania School of Medicine

Osteoporosis is caused when too little calcium is consumed or the bones cannot absorb enough calcium to keep them strong, causing an increased risk of fracture. But while wrist fractures can be the result of a bad fall or a combination of a fall and the weak bones caused by osteoporosis, hip fractures are almost always a result of weak bones. Yang, also looked at only hip fractures because they are relatively common among the elderly population and cause long hospital stays, disability and even death in over 20 percent of cases.

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For the study, Yang and colleagues analyzed data from over 145,000 patients in England over the age of 50. The participants included people who used PPIs for varying lengths of time, as well as those who had never used the drugs.

Those patients who had used PPIs for more than a year had a 44 percent higher risk of hip fracture than those who had never used the drugs. And the largest risk was seen in those patients who used high doses of the drugs for more than a year—more than double over people who never used PPIs. The results of the study were published in the Journal of the American Medical Association.

“We observed that PPI therapy is associated with a significantly increased risk of hip fractures, with the highest risk seen among those receiving high-dose PPI therapy,” said Yang.

However, Yang notes that his results don’t mean that patients should stop taking PPIs.

“These drugs have revolutionized our ability to treat reflux diseases and for many patients they are almost lifesaving,” he said. “So, this population shouldn’t stop using them.”

Yang recommends that all patients on PPIs speak with their doctor about ways to reduce their risk of hip fractures and osteoporosis. This may include adding more calcium to your diet or taking supplements. Since the study showed that the people on the lower doses of PPIs had the lowest risk of osteoporosis, trying a lower dose of the drug may also be a recommendation.

“If you have to use PPIs, always use the lowest effective dose,” said Yang

But officials at the Food and Drug Administration played down the heart worries, saying that other studies suggested no such risks. The F.D.A. will need another three months to complete a thorough analysis of the drugs’ safety, the officials said in an announcement on Thursday.

In the meantime, doctors and patients should continue to prescribe and use the drugs as before, the officials said.

AstraZeneca, the maker of Prilosec and Nexium, released a statement saying that it agreed with the F.D.A.’s preliminary assessment. “Therefore, patients should not change their medication in the light of the study data,” the company said.

The F.D.A.’s preliminary message is part of a new agency strategy to be far more forthcoming about possible public health risks, even ones agency officials largely dismiss.

The agency came under criticism in recent months for failing for more than a year to alert the public to studies that suggested that Avandia, a medicine prescribed for Type 2 diabetes, may increase the risks of heart attacks and angina.

Agency officials initially dismissed concerns about Avandia’s safety, but a panel of experts voted overwhelmingly on July 30 that the risks were real.

“It’s hard to know if this will play out similarly until we have completed our analyses” of Prilosec and Nexium, said Dr. Paul Seligman, the agency’s associate center director for safety policy and communication.

Concerns about Prilosec and Nexium began on May 29 when AstraZeneca sent the F.D.A. the results of a 14-year study of the treatment of reflux disease that compared patients taking Prilosec with those who underwent surgery.

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Within a year of the study’s inception, patients taking Prilosec were more likely to have heart attacks, heart failure and heart-related sudden death than were those who underwent surgery. The effect continued throughout the study, the drug agency said.

A second, continuing study of Nexium found similar risks early in the trial, but this effect seemed to go away as the trial continued, the agency said.

The Prilosec study suffered from several weaknesses that could have led to a false suggestion of a risk, the agency said. Patients who underwent surgery tended to be younger and healthier than those who took Prilosec. And 14 other Prilosec studies found no heart risks, it said.

“Based on everything we know now, F.D.A.’s preliminary conclusion is that the observed difference in risk of heart attacks and other heart-related problems seen in early analyses of the two small long-term studies is not a true effect,” the agency said in a written statement.

The parallels with the Avandia situation are striking, demonstrating the difficulty of trying to assess drug safety issues.

In the case of Avandia, a combined analysis of more than three dozen short-term studies revealed a heart risk, but the drug agency largely dismissed this result when a continuing long-term trial did not find such a risk. With Prilosec, a long-term trial suggested a heart risk, but the agency dismissed the finding because 14 briefer studies were more reassuring.

Prilosec and Nexium, which are nearly identical, are part of a class of medicines known as proton pump inhibitors that resolve heartburn by reducing the stomach’s production of acid. Among the other drugs in this class are Prevacid, Protonix and Aciphex.

The F.D.A. has asked for safety data from the makers of all proton pump inhibitors. Dr. Seligman said.

The agency’s announcement about Prilosec and Nexium was the earliest public warning that it had ever made during a safety review, Dr. Seligman said.

“We were cognizant from the earliest submission about whether and how we should say something,” Dr. Seligman said.

What I find interesting is that Ephron answers questions (from Oprah and members of the audience) by “quoting” almost verbatim from the book. It doesn’t sound like she’s quoting, though. You’d only know if you’ve read it.

I am disappointed because I thought she’d have more up her sleeve than that. I mean, this is the woman who wrote When Harry Met Sally, Sleepless in Seattle, and Heartburn (to name a few modern masterpieces) for goodness’ sake. Still, although I’ve heard it all before, I laugh. The woman has perfect comic timing.

Heartburn, by the way, is a novel based on Ephron’s divorce from Carl Bernstein (the Washington Post journalist who, with Bob Woodward, broke the Watergate presidential scandal in the 1970s). Just months away from delivering their second son, Ephron (Rachel in the book) finds out that her husband is having an affair. It’s heartbreaking, but Ephron manages to make you laugh about it. What’s funniest (both ha-ha as well as bizarre) is how a seemingly intelligent man like Bernstein could have (if you believe Ephron) behaved like a complete ass.

Anyway, if you’ve ever had to deal with a donkey in man’s clothing, Heartburn is a must-read. The movie, starring Jack Nicholson and Meryl Streep, is also pretty good.

Back to I Feel Bad About My Neck and Other Thoughts on Being a Woman. I do not feel bad about my neck, but I’m certainly not over the moon about various other body parts. This book is, of course, not about necks per se. It’s about how we women are never happy with the way we look. However, Ephron herself has problems with her neck. She appears on Oprah with a scarf wound round it and, watching her, I wonder the whole time what on earth she is hiding.

We know about necks, though. We’ve noticed wattles on our grandmas and grandpas. I feel bad about my thick waist and have done so ever since I had one, which is practically forever. But I have never considered my neck. This is probably because I don’t have a problem neck. Ephron writes that one of her biggest regrets is “that I didn’t spend my youth staring lovingly at my neck. It never crossed my mind that I would be nostalgic about a part of my body that I took completely for granted.”

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I guess I should start staring lovingly at my neck from now on.

Ephron’s neck is just one chapter in this collection of essays about the trials and tribulations of being a woman of a “certain age”. She writes about hating her purse, about her life as a serial monogamist, about maintenance (or “Pathetic Attempts to Turn Back the Clock”), about falling in love (with an apartment), about falling out of love (with Bill Clinton), about the joy of reading (my favourite chapter – surprise, surprise).

There’s a list of all the things she wishes she’d known as a younger woman: nothing on it surprised me, which probably means I am no longer a young woman.

The book ends with thoughts on death. I have re-read this chapter a couple of times. It’s very funny and extremely moving, and just a tiny bit depressing. It would probably be much more depressing if you were in your 60s and above, or if you were ill.

Death seems unreal when you’re young. It might even seem glamorous. Or romantic. The older you grow, the more you realise that death is the least of your worries. Dying is the real problem. If only we could all slip away peacefully in our sleep, fully moisturised and wearing our best silk nighties. Oh, the horror of a painful death. A long, lingering, conscious and painful death. Incontinent. Ga-ga. Drooling.

And so, you close the book in a thoughtful mood. You consider death. You consider being happy about your nice neck. You think that no matter how ridiculous you look in a bikini now, you might later regret not ever having worn one. You consider death. You feel happy that you are not dead and not dying. You consider life. You count your blessings. Including your neck.

Yes, that education and entertainment was paid for through advertising. Product manufacturers were very careful about the programs they sponsored because they would suffer in the retail market if the program material was found to be offensive by the TV audience. Both the programs and the advertising were respectful of public decency and morals.

Fast forward to today. Not only have we substituted clean, wholesome entertainment with bawdy programming; it appears product sponsors no longer fear the wrath of consumer ire. We have turned our “family rooms” into theaters our parents would cringe to enter.

Particularly disheartening is the amount of time and dollars spent on drug advertising. Drug advertising panders to almost any bodily function that doesn’t belong in polite company. And, it exposes our children to a philosophy that every one of life’s ills can be remedied by taking a time-release capsule.

Adults often succumb to that siren song of relieving all of life’s pain and trivial inconveniences by taking a pill. We not only attempt to relieve life’s aches and pains with medications but also “fix” problems that would better be discussed with one’s doctor.

Is it any wonder that our outrage to the use of both licit and illicit drugs has been numbed?
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Perhaps we should encourage our drug providers to spend more time on educating the medical community on the merits and hazards of various medications and less time trying to convince the public that all of their woes will be solved by the latest drug.

Direct-to-consumer advertising on TV raises the issue of drug safety
Dr. Tom Doerr, internist and co-founder of Purkinje, a maker of electronic prescribing software

The U.S. is one of only two industrialized countries that allow drug ads on television. The other is New Zealand. Americans see an average of 9 drug commercials per day.

Drug manufacturers rightfully want to maximize their shareholders’ profits. These commercials clearly are designed to create a favorable impression of their newest and most profitable drugs. What you won’t see on these ads are specifics about which patients the drug might actually benefit, the magnitude of the benefit, comparisons with other treatment options, the frequency of side effects and especially the cost.

What the consumer may not recognize is that many of the drugs promoted have marginal — if any — advantages over older drugs that cost much less.

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Who hasn’t seen a Nexium commercial? Does the average consumer know that the patient’s outcomes with this new medication are virtually the same as the over-the-counter and much less expensive Prilosec OTC?

More important, newer products are less well studied, and it is often only years later that side effects become completely known.

The arthritis drug Vioxx was heavily advertised but later removed from the market because it increased the risk of heart attacks. There are hundreds of lawsuits pending about Vioxx.

These ads force physicians to take time away from discussing other important aspects of care and teach patients why the drugs they see advertised on TV are not appropriate for them.

Direct-to-consumer marketing increases the use of more expensive drugs that have a limited track record of safety.

Patients should rely on doctors and pharmacists, not TV spots, to pick drugs.
Kenneth W. Schafermeyer, professor of pharmacy administration, St. Louis College of Pharmacy

Pharmaceutical companies spent more than $4 billion on direct-to-consumer advertising in 2004. According to a 2006 Government Accountability Office report, drug company spending on this advertising increased twice as fast from 1997 through 2005 as spending on physician education or research. This advertising has paid off — for every $1 spent on direct advertising, companies reap an additional $4.20 in sales.

Ads have focused on treating symptoms of chronic conditions such as impotence, arthritis and allergies. Relying on emotional appeals, many ads describe benefits in vague terms with a limited amount of evidence to support their claims.

The ads stimulate patients to seek the advertised medications, and physicians tend to accommodate these requests. From 25 to 30 percent of prescriptions are thought to be initiated by patient requests.

Though many physicians accommodate patients’ requests for advertised drugs, about 80 percent believe this advertising encourages patients to seek treatment they do not need.

There are, of course, two sides to the issue. Proponents say direct-to-consumer advertising provides useful information that promotes early diagnosis and treatment of conditions that would otherwise be under-treated. Opponents argue it encourages overuse of prescription drugs and reliance on the most costly treatments instead of less expensive alternatives.

So what should consumers do? Instead of insisting on an advertised drug, patients should ask a qualified professional — a physician or pharmacist — for complete and balanced information about a particular medication.

Heartburn occurs when excessive amounts of stomach acid reflux into the esophagus, according to the ACG.

The college offers the following information about heartburn:

* Besides being uncomfortable, heartburn can also be a sign of a serious problem called gastroesophageal reflux disease (GERD). Symptoms of GERD include burning chest pain, regurgitation of bitter or sour liquid, difficulty swallowing, and excessive clearing of the throat.

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* Left untreated, persistent heartburn/GERD symptoms can lead to severe complications such as esophageal strictures or a precancerous condition called Barrett’s Esophagus. In rare cases, people with persistent heartburn/GERD develop esophageal cancer.
* Eating smaller meals, controlling your weight and avoiding tight-fitting clothes are all ways of reducing heartburn symptoms. Don’t lie down after meals, because that makes it easier for stomach contents (including acid) to back up into the esophagus. Do not eat for three to four hours before you go to bed.
* Common heartburn triggers include: smoking, caffeine, chocolate, peppermint, fatty and spicy foods, and tomato sauces.
* Pregnancy increases the risk of heartburn/GERD symptoms. That’s because pregnancy puts greater pressure on the stomach and causes increased production of the hormone progesterone, which relaxes the lower esophageal sphincter muscle, which can allow more acid to reflux into the esophagus.
* See a doctor if you: have heartburn two or more times a week; don’t get lasting relief from medication; have difficulty swallowing; have unexplained weight loss; experience reflux symptoms lasting more than a year.

By Paul McDougall
InformationWeek
.;8 16, 2007 01:23 PM

IBM said Monday it secured a $1.4 billion deal to provide technology services to Anglo-Swedish pharmaceutical company AstraZeneca.

Under the seven-year arrangement, which extends an existing contract, IBM will provide IT infrastructure management services to AstraZeneca locations in 60 countries. The services will include server and storage hosting, desktop management, network maintenance and management, and help desk support. AstraZeneca will maintain its application development services in-house.

Richard Williams, CIO at AstraZeneca, said in a statement that the deal will let the company “focus its efforts on adding value to its scientific, commercial and supply operations, thereby helping the company to deliver more medicines that make a meaningful difference to patients.”

AstraZeneca is the manufacturer of Nexium, a drug for heartburn and acid reflux disease that’s widely known as “the purple pill.”

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The agreement is a key win for IBM’s services unit, given that it comes at a time when an increasing number of large pharmaceutical companies are tapping offshore vendors for their technology needs. In March, GlaxoSmithKline outsourced clinical data management for new drug development to India’s Tata Consultancy Services. To fulfill the contract, TCS is building a new data center in Mumbai devoted exclusively to its Glaxo work.

In November 2006, Eli Lilly & Co. outsourced a range of clinical data management services to TCS.

The contract also is the latest in a string of significant outsourcing wins for IBM in Europe. So far in the second quarter, the company has announced services agreements with Royal and Sun Alliance in the U.K. for between $400 and $500 million and Banque Cantonale Vaudoise in Switzerland for $460 million. IBM also signed an $84 million deal with Spanish wind energy company Iberdrola during the period and a $354 million contract with Monte Paschi Bank in Italy.

A. A small number of people with long-term gastroesophageal reflux disease, where stomach acid refluxes into the esophagus, develop Barrett’s esophagus.

Acid reflux changes the cell structure in the esophagus. The normal lining of the esophagus looks like tile; the medical term is stratified squamous epithelium. In patients with Barrett’s esophagus, the lining looks more like shag carpet. It’s termed intestinal metaplasia with goblet cells.

Barrett’s esophagus doesn’t present unique symptoms, other than what patients typically experience with GERD: Heartburn, a burning pain or discomfort behind the breast bone in the chest; or acid regurgitation, a bitter or sour-tasting fluid coming up into the throat or mouth. About 40 percent of patients with Barrett’s esophagus do not perceive their gastroesophageal reflux at all.

The reason Barrett’s esophagus matters is that patients with at least 3 centimeters of Barrett’s esophagus lining have a 30- to 125-fold increased risk of esophageal cancer compared with the general population. Patients with shorter segments of Barrett’s have a somewhat lower risk. Doctors treat patients with long- and short-segment Barrett’s the same.

Although the cancer risk figures initially sound frightening, the overall risk of cancer in persons with Barrett’s esophagus is low. Only 3 to 10 percent of people with Barrett’s esophagus will develop cancer.

Our best indicator of the seriousness of Barrett’s esophagus is the degree of dysplasia found on a biopsy. Dysplasia is the Greek word for change. Higher grades of dysplasia indicate that the cells are more abnormal.

The symptoms of reflux (heartburn and acid regurgitation) can be controlled with medications, surgery and lifestyle changes. However, neither medicines nor surgery has been shown to lower the cancer risk in patients with Barrett’s.

The usual lifestyle recommendations for controlling reflux symptoms apply to patients with Barrett’s esophagus. Cut back on caffeine (coffee, tea, soda, chocolate), alcohol, tobacco, mint and fatty foods. It is best to avoid lying flat within four hours of finishing a meal. One should consider sleeping with the head of the bed elevated.

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Beyond these lifestyle changes, there is a range of treatment options. Some are approved by the Food and Drug Administration, and others are considered experimental. The best approach will depend on the patient’s health and the degree of dysplasia.

Barrett’s esophagus is a complex process. When we have a patient with a new diagnosis of Barrett’s, the education session to cover options takes about 90 minutes. To ensure that you are doing everything possible to manage the condition, I’d recommend a full educational session with a physician well versed in this condition.

– Yvonne Romero, MD, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

Too busy to get old

Physical activity as the elixir of youth might seem like old news, but there’s a new twist, according to a recent issue of Mayo Clinic Women’s HealthSource. For the best chance of a long, healthy life, marathon training is not required, but staying busy and active might be.

Research published last year found that any activity that contributed to energy expenditure in older adults may help prolong life. Such activities can include household chores such as vacuuming, mopping the floor, washing windows, lawn work, caring for children or adults, walking or volunteering.

The study, published in the Journal of the American Medical Association, tracked 302 adults between the ages of 70 and 84 for six years. Participants who had shown the highest energy expenditures had about half the mortality risk of those with the lowest energy expenditures.

Although researchers don’t have all the answers about how daily activities affect longevity, it’s heartening to know when people are “too busy” for exercise, staying busy around the house, at work or in the community may contribute to a longer, healthier life.

A: Both table salt and sea salt are sodium chloride. Though table salt has been refined down to almost pure sodium chloride, any difference in sodium content is likely to be negligible on a weight-for-weight basis.

The key difference between the two might be iodine content.

Table salt is a readily available source of iodine. Manufacturers began adding iodine to table salt in the 1920s to prevent goiter (enlargement of the thyroid gland) caused by iodine deficiency.

Sea salt may have less iodine than table salt, though iodized forms of sea salt might be available.

Iodine deficiency is becoming more common, perhaps because more people are shunning the salt shaker as a way to limit sodium intake. (One researcher hypothesizes that low iodine intake might increase the risk of heart disease.)

Sea salt is a viable alternative to table salt as long as you’re getting adequate iodine from the diet (e.g., iodine-rich seafood) or a multivitamin. The latter generally provides the RDA for iodine (150 mcg).

Be aware that sodium chloride is added to many processed foods as a flavor-enhancer and preservative, particularly if you’re on a low-sodium diet. Note that the sodium chloride used in processed foods is not iodized.

Hypertension (high blood pressure) guidelines typically recommend restricting sodium intake to two to three grams daily.

Don’t get salt (sodium chloride) and sodium confused. For example, five grams of sodium chloride provides two grams of sodium.

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A little known factoid: Higher sodium intake increases your calcium needs. As sodium intake climbs, more calcium is lost in the urine.

Q: My husband and I enjoy your column in the Sun Herald and find it helpful in trying to get the necessary vitamins in our aging lives. We are both 65 and I have been diagnosed with osteopenia. A recent column mentioned that Nexium could impair the absorption of calcium. Does over-the-counter Prilosec have the same effect? We take Prilosec as well as calcium and vitamin D3.

A: Osteopenia indicates bone loss and might be thought of as pre-osteoporosis.

Calcium compounds are most efficiently absorbed when stomach acid is high. This is the reason for the general recommendation to take calcium supplements with meals. Food increases stomach acid secretion.

Prilosec (omeprazole), like Nexium, reduces stomach acid and so may impair the absorption of some calcium supplements.

However, as I said in the prior column, this is mainly a theoretical consideration. There doesn’t appear to be any evidence that, under ordinary circumstances, these drugs reduce levels of calcium in the blood.

Diminished stomach acid is more likely to affect the absorption of calcium carbonate than calcium citrate. However, calcium citrate contains only about half as much calcium as calcium carbonate, so you would have to take more of a citrate product to get the same amount of calcium.