The FDA asked its Oncologic Drugs Advisory Committee to consider whether changes are needed to the agency’s policy on giving severely ill patients special access to cancer therapies that are not yet approved.

The panel will not make suggestions until its next meeting in March, said committee chairperson Stacy Nerenstone of Hartford Hospital’s Helen & Harry Gray Cancer Center.

Currently, a patient who is not eligible for a clinical trial of an experimental cancer prescription drugs can seek treatment with the same therapy through an individual investigational new drug (IND) application. The application must be approved by the drug company, and the FDA has to agree with the company that there is adequate evidence of safety and efficacy.

Grant Williams, medical team leader at the FDA’s Division of Oncology Drug Products, said several hundred patients a year get individual INDs. Many also get access to products in development through expanded access programs, in which pharmaceutical companies make their treatment available to hundreds or thousands of people at once while they complete clinical trials.

But drug makers often balk at making their products available through “compassionate use” programs, especially the individual IND. Several patients said they were stonewalled when they asked for individual access, with no clear policy explained.

“Companies must be clear and honest with the public about their policies,” said Robert Erwin, director of the Marti Nelson Cancer Research Foundation. He said there are many valid reasons why drug makers might deny access, but that they should not blame the FDA or do so without explaining the reasons to the patient.

Robert Spiegel, chief medical officer of Schering-Plough, said his company has made five drugs available through these programs. But, he said, Schering and other companies worry that opening up access will hurt their ability to get patients into clinical trials of the experimental product. They are also concerned that such programs will stress their capacity to provide the drug, and may compromise their ability to ensure safety.

With increasing media coverage of new therapies, some companies are being inundated with requests. Gerard Kennealey, vice president of oncology clinical research at AstraZeneca Pharmaceuticals, said the company has received 7,000 phone calls since May, when there was a spurt of upbeat stories about its non-small cell lung cancer drug Iressa.

“We stopped counting when we got calls from 12 Senators’ offices,” said Kennealey, noting that celebrities and politicians were among the many people pleading for the drug.

AstraZeneca set up an expanded access program, and now has 200 patients enrolled. But, said Kennealey, the company has been careful to limit distribution only to non-small cell patients, and only to those who had failed other treatments, and weren’t eligible for other trials.

The National Breast Cancer Coalition said expanded access programs were the only legitimate, fair, way to make experimental therapies available, but that they should not be the norm. Jan Platner, director of administration and programs for the Coalition, said individual INDs in particular tend to undermine research, and that there is no fair way to grant them. They also contribute nothing to scientific knowledge, she said.

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Both DeLapp and Dr. Janee Steinberg, medical director of the Advanced Cosmetic Laser Center in West Fort Lauderdale, Fla., say they have also had success with hypnosis.

“There’s lots of documentation for hypnosis that our bodies have energy we can tap into to fight infections,” Steinberg said. “For instance, I treated a 2 year old who had warts all over her eyes, face and mouth. I couldn’t bear the thought of putting her through the discomfort of surgery, so I decided to start with hypnosis. I told her I was giving her a special cream. She was to put it on her warts each night and say, ‘Warts, please go away.’ She surprised herself and me when she came back two weeks later and all the warts were gone. They have not recurred.”

Steinberg has also had positive results with Cantharone, the juice of the blister beetle.

Or you could always try Mark Twain’s method of burying a potato in your yard, among one of the hundreds of other old wives’ tales, such as rubbing the wart with a green banana peel, garlic or castor oil. It certainly can’t hurt.

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Unfortunately, the TV spots featuring Carter leave one with the incorrect impression that we know little about what causes the disease. While there apparently is a genetic component to pancreatic cancer leaving certain families at risk, what was not communicated in the Carter/Lustgarten ad is the reality that cigarette smoking is by far the leading controllable risk factor associated with the development of this form of cancer.

About 27,000 Americans are diagnosed each year with pancreatic cancer — and approximately the same number die annually from it. This type of malignancy is one of the deadliest forms of cancer.

Smokers are considered to be at twice the risk of nonsmokers, and the heaviest smokers at three times this risk (the Lustgarten Foundation Web site acknowledges this fact). Indeed, epidemiologists now estimate that 30 percent of the cases of pancreatic cancer can be causally linked to smoking (Individuals with cystic fibrosis or pancreatitis associated with heavy alcohol ingestion, are also at increased risk).

Interestingly, despite his family history, Carter has to date avoided pancreatic cancer — and he has never smoked. However, his sister, Ruth, brother, Billy, and mother, Lillian, were all cigarette smokers.

The tobacco industry is quick to argue that smokers are fully responsible for the health consequences of smoking — and “know all the risks.” But how many consumers are aware that smoking is a highly significant cause of pancreatic cancer and that this condition is almost always fatal?

If public service ads such as the one President Carter has done continue to communicate the message that the risks are largely unknown, we will miss an opportunity to give Americans the information they need to modify their lifestyle to reduce the risk of this deadly disease.

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“A lot of the controversy springs from the fact that we haven’t actually proven most of the claims for adding hormones,” said Love. Further, studies have shown that by adding hormones a woman is increasing her chances of getting cancer, especially of the breast, and of getting blood clots.

Why take something that could give you cancer, asks Seaman, the co-founder of the National Women’s Health Network, a member-supported organization that is a longtime advocate for women’s health. Based on her studies of problems associated with hormone use since the 1940s, she calls their inclusion other than on a short-term basis “unjustified.”

For his part, Thomas, in his practice as a reproductive endocrinologist, said, “I do see the benefits of hormone replacement therapy,” including for prevention of the problems of heart disease and osteoporosis.

What women need to make a decision, he said, is copious amounts of information and a balanced discussion of the pros and cons. He is currently working on a consensus paper that identifies whether women who are members of minority groups are getting adequate information on the use of hormones.

Thomas said about a quarter of the women in menopause are taking hormone replacement medication. About 50 percent of women who start hormones stop taking them within a year. Of those that continue, about two-thirds are women who are seeking estrogen because they no longer have ovaries that are producing any estrogen at all.

Lifestyle Changes
It’s important to stress that it’s never too late to begin making lifestyle changes to prevent serious medical conditions like heart disease and osteoporosis, said Marks, including the following:

Do not smoke.

Eat well: healthy foods and sufficient calcium intake.

Exercise: Walk, move your body.

Take care of your spirit: Reduce stress and do things you enjoy.

Alternative Treatments
Some of the areas in which women have chosen alternative methods include vitamin and mineral supplements, herbs and acupuncture.

The public is increasingly combining conventional medical treatments with alternative or complementary therapies, said Mark. She has formed a task force of federal agencies to look at this issue, specifically through CAMPS, a comprehensive study to assess what women 45 and older are thinking and doing in regard to menopause. The data that’s been gathered is now in the process of being analyzed.

“I think it’s important that we study not only the efficacy, but the safety,” Mark said. Over the past year, the NIH has created the National Center for Complementary and Alternative Medicine, and it is expected that high-quality studies will be generated on how good and how safe alternative techniques are for menopause as well as other conditions.

For now, she said, there is not enough information available to know about interaction between alternative and conventional therapies.

Evaluating the Options
As new research comes out on any of the issues of menopause, Mark said, one study may refute another, thanks to better design or other variables. “It’s an evolving process,” she said, and women need to understand the information generated in light of who they are as individuals.

One study that it is hoped will provide guidance is a large, randomized, controlled study undertaken by the Women’s Health Initiative to look at hormone replacement therapy and heart disease, osteoporosis and Alzheimer’s disease, said Love. However, it will not be completed until 2008.

In the meantime, women and the medical profession have a number of studies on hormone therapies, many of which seem to have conflicting information. One of the problems is that many of the studies, to date, have been based on observational data rather than randomized, controlled data, the methodology that guides the medical profession to identifying the gold standard in treatment.

One recent study published in the January 2000 issue of JAMA, The Journal of the American Medical Association, looked at more than 46,000 post-menopausal women. It compared the rates of breast cancer between those who took estrogen alone in hormone replacement and those who took estrogen plus progestin. Progestin had been added to the hormone mix several years ago in order to protect the uterus from the cancer-causing properties of estrogen.

One promising area of research is the use of SERMs, selective estrogen receptor modulators, or hormones that interact with specific parts of the body without having the potential of negative effects on other parts.

Love said the key to grasping what is best to consider doing in menopause and beyond is to understand, “This is a work in progress. We are finally doing studies that answer the questions.”

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The average age of menopause in the United States is 51.2 years, Thomas said.

Post-Menopause
This is the condition that remains for the rest of a woman’s years, and given current life expectancies, most likely that means a full third of her lifespan. Hormones continue to be produced in the body, though at a reduced level.

What Are the Symptoms of Perimenopause/Menopause?
Symptoms, said Love, are what make you think “you’re going crazy.” One of the defining aspects of perimenopause and menopause is “change and unpredictability. Your body is reshuffling and rebalancing and, in doing so, you don’t know what it’s going to do when.”

About a third of women have no symptoms, she said, another third have some symptoms, though not badly enough to do much about them, and another third are suffering and need some form of treatment. The most common symptoms include: hot flashes, night sweats, insomnia, weight gain, vaginal dryness and mood swings. However, there are many different symptoms that a woman may experience. In her book on hormones, Love lists about 40 of them.

Treatment Options
Do Nothing
You don’t have to do anything different as you experience menopause. Some women have no symptoms. Some who do have symptoms can control them through their usual coping mechanisms. In fact, said, Thomas, about 75 percent of women choose not to treat menopause medically.

Hormone Treatment
This has become the hottest topic of menopause. In the past 60 years, medical science has created the capability to add hormones, such as estrogen and progesterone, to the body through medication. The questions include: Is it necessary? Is it risky? What are the benefits?

There are two reasons generally given to take hormones. One is to relieve the symptoms of perimenopause and menopause. The other is to add higher levels of estrogen with the intention of protecting the body from some of the diseases associated with aging.

To frame the discussion, Love said it’s important to understand that the ovaries continue to make hormones well into a woman’s 80s, but at a lower level than during the child-bearing years. And given the needs of an older woman’s body, “That lower level may well be adequate.”

Since the body naturally stops making high levels of estrogen, by taking hormone medication, you are not so much “replacing” hormones as adding them. The vast majority of women do just fine with the levels of hormones their body produces naturally, Love said. Some, however, may want hormones to get over the hump of symptoms that are too difficult to deal with and can’t be eliminated by other means. The ovaries of some women may not be making enough hormones to sustain their needs in the post-menopausal period, or they may not have ovaries if they were removed in a hysterectomy.

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Three Stages of Menopause
Perimenopause
Perimenopause is the transition period from normal menstrual cycling to menopause itself, said Dr. Michael A. Thomas, director of the Center for Reproductive Health at the University of Cincinnati in Ohio. “It can take anywhere from two years to 10 years and can occur anytime after age 35.” It’s a process, he said, that’s different in every woman.

If a woman has her ovaries surgically removed, she does not go into a period of perimenopause, but goes directly into menopause. Chemotherapy also brings on menopause, although in some cases menstruation resumes after some time.

Perimenopause is typically a period when hormone levels fluctuate, often widely. Periods become irregular. There may be a great deal of bleeding, or very little. It’s a time, said Seaman, “of menstrual chaos.”

Love calls perimenopause “puberty in reverse.” You can feel really good one moment and low the next. Increasingly, she said, data is showing that the intense symptoms of perimenopause are caused by the shifting hormones. “You have your highest level of estrogen ever during perimenopause,” she said, as well as very low levels.

A woman can still be having a regular menstrual cycle at the same time that she starts to experience symptoms like hot flashes, vaginal dryness, mood changes and memory loss, Thomas said. And some of these symptoms are often mistaken for PMS or other conditions. Instead of being treated for hormonal fluctuations of perimenopause, women often end up with a prescription for antidepressants at this time. Studies to more accurately understand perimenopause are just getting started, he said.

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With scant details to work with, the image of this “change of life” loomed large — and ominous. What did it mean? What happened next? Would I change too?

Fast forward to today, where little is left to the imagination. Menopause has come out of its quiet place and into the public consciousness.

The numbers and the nature of the baby boomer women now in or entering menopause make it hard to hide. Roughly 4,000 women a day are reaching menopause, an unprecedented number, said Pam Boggs, education director of the North American Menopause Society, a nonprofit organization based in Cleveland, Ohio.

Further, “Baby boomers talk more about everything,” said Dr. Susan Love, author of “Dr. Susan Love’s Hormone Book: Making Informed Choices About Menopause,” (Times Books, 1997, $15). And menopause provides plenty of fodder for discussion, including lifestyle issues, stories of females who went through menopause in different times or cultures, and medical management through adding hormones.

The key questions for women today include: What do women really need to do to maintain a healthy mind and body as their chemistry changes? What should they draw from medical science and what can they take from nature to make this transition and the following years a positive experience? And what are the risk/reward trade-offs of following any given course?

What’s important to keep in mind, said Love, adjunct professor of surgery at UCLA in Los Angeles, Calif., and director of the Susan Love MD Breast Cancer Foundation, is that “Menopause is not a disease. It’s a natural, normal part of life, though not always a perfectly pleasant one.”

When it comes to deciding whether you want to treat symptoms or how you can prepare for healthy aging, “It’s a little less scary when you realize it’s your body and you’re not making a life-and-death decision,” she said. “You’re making a choice for prevention, and women are capable of making those kinds of decisions.”

There are no unequivocal answers that suit everyone. The issues of menopause are highly individual — timing of the changes, severity of symptoms, and pros and cons of treatment options.

The good news is you don’t have to wade through this alone. There’s plenty of information available, said Dr. Saralyn Mark, advisor at the Office on Women’s Health, senior advisor to NASA on women’s health issues.

“It’s a two-pronged approach,” said Mark. “First, you do need to establish a relationship with your health providers — nurse, nurse practitioner or physician — so that you can feel comfortable asking questions. I really believe it is a partnership, and there is no better place where you see that partnership at work than in the discussion of menopause.”

Next, Mark said, “Take active control of your educational process. Obtain knowledge in your own right — through books, research guides, the Internet, television. Do your own reading, at your own level and in the comfort of your home. You can gradually take in information and continue your active discussion with your provider.”

There is a challenge in the amount of information out there, with new data coming in every day. Make sure you know who the source of your information is, she said. If you get information from the Web, for example, question who has reviewed it and whether it is accurate. If information is from a company that may have a vested interest, keep in mind there might be a bias.

And as you get informed, stay positive. “Think of women in menopause as healthy women in their prime, with at least 25 years ahead of them that may be the most vigorous and energetic they’ve had,” said Barbara Seaman, co-author of “For Women Only!” (Seven Stories Press, 1999, $75), a guide to women’s health. In many cultures, she writes, “Menopause is anticipated as a rite of passage into a stronger, wiser time of life.”

Rather than just being an end of the ability to bear children, it’s the beginning of the rest of your life. Quoting anthropologist Margaret Mead, Seaman said to view these years as “the time of PMZ — post-menopausal zest.”

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Previous research suggests that very high acute doses of some painkillers have been associated with impaired kidney function.  Some small studies have suggested that chronic use of such medications might have negative effects on the kidneys. But the authors of the JAMA article note that some of these earlier studies had “significant methodologic limitations” that weakened the utility of their findings. Thus, Dr. Rexrode and colleagues used a very large, on-going study to evaluate possible negative effects of painkillers on kidney function.

The researchers investigated the use of analgesics by over 11,000 male physicians who were enrolled in the Physicians’ Health Study, which was conducted from 1982 through 1995. Participants completed annual questionnaires about personal characteristics such as weight, height, diet, tobacco and alcohol use, and medical history. At the end of the 14-year study period, the subjects also completed detailed questionnaires about their use of analgesic medications.

Study participants’ use of aspirin, aspirin-containing compounds, acetaminophen, acetaminophen-containing compounds, and other NSAIDs (non-steroidal anti-inflammatory drugs) were evaluated and compared with evidence of decreased kidney function.  Subjects provided samples of blood at both the beginning and end of the study period, which were used to evaluate how well the kidneys were working initially and 14 years later.

Dr. Rexrode and her colleagues examined two indices of kidney function and their association with analgesic use. The first index was the amount of creatinine, a waste product produced by muscle, in the blood. Higher than normal blood levels of creatinine suggest that the kidneys are not working efficiently to remove wastes from the blood. The second indicator of kidney function is called creatinine clearance, and is a more direct indication of how quickly the kidneys remove waste products from the blood.

In general, both blood creatinine levels and creatinine clearance indicated that kidney function decreased significantly with age in these healthy men, and thus all data were adjusted to take age into account. At baseline, only 460 subjects had elevated creatinine levels; there were no significant differences in analgesic use between these men and those who had normal blood creatinine. There were 1258 men whose creatinine clearance rates were below normal at baseline. These men reported significantly lower use of acetaminophen, but similar use of other NSAIDS, as men with normal creatinine clearance levels.

At the end of the study, the investigators calculated the risk of either elevated creatinine levels or decreased creatinine clearance for men who reported using up to or more than 2500 analgesic pills over the course of the study period. For acetaminophen, the relative risk of elevated creatinine was reduced by 17 percent in men who took 2500 or more pills.

For the other NSAIDs studied, there was no significant difference in risk. Similarly, for creatinine clearance there was no significant change in risk of elevation for any of the NSAIDs.

In their discussion, the authors comment that “Because analgesic use is so common, even small increases in the RR [relative risk] of renal [kidney] dysfunction could have a significant impact on rates of renal disease in the United States.”

In the January issue of the Journal of the American College of Cardiology, researchers from the Harvard School of Public Health and Harvard Medical School further confirm the relationship between  alcohol consumption and risk of death from cardiovascular disease, or CVD, and from all causes, as well.

Nearly 90,000 male physicians enrolled in the Physicians’ Health Study were subjects of the report. Initially, they were 40 to 84 years old, and were free of stroke, heart attack, cancer and liver disease. The subjects’ alcohol consumption was estimated from questionnaires they completed at the beginning of the study, and their health status was followed for 5.5 years. No attempt was made to determine whether the subjects consumed wine, beer or distilled spirits.

Compared with men who reported drinking alcoholic beverages never or rarely, those who consumed up to 14 drinks per week had an 18 percent to 26 percent lower risk of dying from any cause. These differences in risk of death were statistically significant. Most of this decreased mortality was due to a decreased risk of death from CVD — there was a significant 32 percent to 47 percent reduction in heart attacks.

Among the men who were light-to-moderate drinkers, the researchers found no association with death from the more common types of cancer, such as lung, colon or prostate cancer, or lymphoma or leukemia.

In their discussion of the results, researchers note that since their subjects were men, these results cannot be directly generalized to women. They added, however, that other large investigations have “found a similar … relationship between light-to-moderate alcohol consumption and mortality among women.”

Finally, the investigators emphasized that since excessive alcohol use is associated with increased risk of traumatic death and since the relationship of alcohol with various diseases is complex, alcohol consumption should not be considered a primary strategy to prevent disease. And, of course, there are certain populations — such as alcoholics or those with liver disease or ulcers — who should never drink. However, for healthy, middle-aged men, light-to-moderate drinking would seem a reasonable and not unhealthy way to celebrate the new millennium.

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Using affirmations can even make you younger, said Roizen. “It shouldn’t be that you have to have a heart attack to wake you up.” In his book and on his Web site, www.realage.com, he offers specific actions that can affect your body. “Start by doing things that are very easy,” Roizen said. “If you pick something too tough to do, it’s like a prison sentence. You want to break out of it.”

Instead, he recommends that you pick three or four things that are pleasurable for you to do that actually make a difference and set a goal for doing them. If you hate exercise, for example, do not pick exercise for your first challenge. It should come further along the line, after you have had some success with other easier habits. “Do it in small steps,” he said.

The form of your affirmation and your action is unique to you. “I change affirmations from patient to patient,” said Oz. “For example, if I’m operating on an athletic director, I use sports analogies. I think affirmations should be customized.”

And be specific. While it’s good to have confidence that you will live, it is not as useful to have a broad affirmation like, “I’m going to live.” Rather, he suggests making targeted requests for your mind and your body.

Oz’s affirmations for dealing with disease include:

I am calm in the face of adversity. I turn my fear into power and confidence. I am like a ship in difficult waters. I know it is choppy at times, but I stay the course.

I use my breath to get me through troubles. Through all the changes in life, my breath is always there. I take deep, concentrated breaths and I focus my mind on those breaths. They calm me and they help me heal. They increase my lymphatic flow, fill my airways and reduce the chance of pneumonia.

I am getting the best care that my team can provide me. I am supported by a team that includes my doctor, the staff and my family. I am getting good care because I am a loved person, a good person. And I am getting back all the loving that I have given.

I enter my special zone where time disappears, where I am totally focused and hyper-aware of events around me, but I am completely calm. It is the same space I occupy when I am doing what I love — listening to Chopin, playing my favorite sport — and it is from this zone that I take on the challenge of dealing with my surgery and other demanding moments of dealing with disease.

I take important lessons from the challenge of this disease. I am undergoing a trial and I am becoming a stronger person for the rest of my life. It is not bad luck, it is a chance to improve myself.
Health matters are not just about dealing with illnesses, but about preventing them. Roizen suggests more than 40 approaches that can be expressed in the form of an affirmation, including:

I take actions each day to help my body be as young and healthy as possible. I use my success in doing simple tasks, like flossing my teeth for healthy gums, to challenge myself to take on harder ones, like stopping smoking entirely.

I can control my blood pressure. I measure it and I follow through with whatever is recommended to lower it if it is too high, be it medication, diet or exercise.

I find a physical activity that suits me, and I do it. I can do 10 minutes of resistance exercises three times a week. I can take two 20-minute walks a day.

I reframe situations so that they are not so stressful for me. I reduce stress by joining a positive group where I can share with others.

I am a lifelong learner for my health. Every day I read a bit of health news. My education never stops.

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