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These simple diet and exercise tricks will cut about 100 calories. Try just two or three a day, and you’ll lose about 10 pounds in just 5 months!

Cut 100 Calories

• Replace mayonnaise on sandwiches with mustard.
• Cut out just one soft drink each day.
• Take the stairs instead of the elevator every time you’re in a tall building.
• Pick lean chicken breast rather than fatty steaks.
• Use balsamic vinegar dressing instead of Ranch or Thousand Island on your salads.
• Start your day with fifteen minutes of yoga or light stretching.
• Order an appetizer for your meal in restaurants.
• Take a brisk walk after dinner.
• Choose the kid’s fast food meal instead of the adult-size value meal.
• Make burgers and meatloaves with half meat and half black beans.
• Instead of potato chips, have baby carrots and celery sticks.
• When you watch TV, do sit-ups, jumping jacks and leg lifts during commercials.
• Double your vegetable portion at dinner and halve your meat serving.
• Have a white wine spritzer made with club soda instead of a Margarita.
• Pick broth-based soups over soups made with cream.
• Meet your friends for a hike instead of a movie.
• Eat a small green salad as your appetizer before dinner.
• Volunteer to walk dogs at your local animal shelter.
• Have sushi for dinner instead of ribs and French fries.
• Share a serving of dessert with a friend.
• Drink herbal tea instead of high-calorie specialty coffee drinks.
• Walk around the shopping center instead of driving.
• Serve sandwiches open-face.
• Switch to scrambled egg whites instead of a cheese omelet.
• Head to the playground with your kids and swing from the jungle gym.

Tradition to bent legs reigned in China for 1000 years, until it was banned buy Communists in the early 50’s.

They began to bent legs at age 4 and up to 12 years. It was a privilege of the rich, and in some areas also the poor. Terrible pain lasted for about 3 years, until the fingers are completely broke and wrap under the foot. Then the pain passed, and almost all can walk normally. However, many women could not walk far.

A girl without a wrapped foot could expect to be only a servant, while a girl with very small foot, even from very poor family, could get married well. Local matchmaker did not even ask about girl’s temper, can she cook, or how clever is she. They asked about her foot size.

Girls sewed shoes themselves. Each had 30 pairs or more, even the poor one.
Legs were not ever shown to anybody. Girls slept in the special shoes, which only husband could see. Bare feet were not seen by anybody.

When the Communists came and forced everyone to remove the bandages, it was even worse – without bandage the foot became to straighten with terrible pain, but never came to normal condition. Besides, girls were ashamed to have such legs – it was a sing of  not civilized woman.

HALF OF US AT RISK OF SWINE FLU; PRESSURE ON NHS AS EXPERTS SAY 50% OF POPULATION WILL SUFFER: WITH the Number of Swine Flu Cases Expected to Dramatically Rise in the winter, Health Reporter HELEN RAE Takes a Look at What Precautions Are Being Put in Place by the Local NHS.

HALF of the North East population could catch swine flu this winter and the virus could be here for up to five years, health experts have warned.

swine flu

Winter is always a challenging time for the health service and this year NHS organizations in the region have geared themselves up to deal with what could be their busiest year yet.
This year, on top of the swine flu pandemic, the normal winter seasonal flu will also arrive and the pressure on the NHS will be significantly increased as more people need care from their GP or local hospital.
In the past week 54,166 calls have been made nationally to NHS Direct. More than 75% of calls made to NHS Direct from the North East during this time were swine flu related.
Martin Wilson, director of NHS flu resilience in the North East, said: “The pressures of normal winter seasonal flu are something that the NHS is robustly prepared for as we deal with it every year.
“NHS North East organizations have been planning for this year’s winter seasonal flu since before last year’s even ended. In addition, over the past five years, we’ve been preparing for the arrival of a new flu pandemic which we knew would inevitably come, we just didn’t know when.
“The swine flu pandemic is now upon us and naturally there will be a much increased pressure across the NHS. Although we don’t know how many people will get swine flu in the North East, we’ve been planning for the past five years for a flu pandemic that could affect 50% of people in the region.
“This level of potential infection, combined with the number of people who could catch normal winter flu, means we are very keen for members of the public to understand both how they can help themselves and the NHS, as we move towards winter.»The best thing people can do is make sure they know how to look after themselves when they develop flu-like symptoms and then follow the necessary steps before contacting the NHS.
“First and foremost, people can reduce the risk of catching and spreading germs by covering their nose and mouth with a tissue when coughing or sneezing, throwing away the tissue straight away and washing their hands thoroughly with soap and warm water.
“Those who get unwell and develop symptoms should stay at home, rest, drink plenty of fluids and use over-the counter flu remedies or paracetamol to relieve symptoms as they normally would for flu.” The government’s medical chief Sir Liam Donaldson said a fuller profile of swine flu was emerging.
Twenty nine people with swine flu have died in the UK so far. Sir Liam said the disease was also likely to strike again in the years that followed.
“The virus will not just be here for one winter – previous pandemics have been around three, four, five years,” he explained.
The symptoms of swine flu are broadly the same as those of ordinary flu.
People should check symptoms online at www.nhs.uk or by calling the swine flu information line 08001 513 513 first and only contact their GP if they have a high temperature and at least two of the following symptoms: widespread muscle and joint aches cough headache blocked or runny nose sore throat vomiting watery diarrhoea cannot stop crying (only in children) Each autumn, from September, the NHS provides a free vaccine for the normal winter seasonal flu for the over 65s and people in the following ‘high risk’ groups: serious heart disease; serious lung disease, like emphysema, bronchitis, cystic fibrosis or asthma; serious kidney or liver disease; a long-term health problem, like diabetes; a weakened immune system eg from chemotherapy, radiotherapy or steroid treatment or HIV/Aids.
All NHS workers directly involved in patient care should also be vaccinated.
As the normal winter seasonal flu changes each year, the vaccine also needs to be changed to match the latest version of the virus which means people need to have the jab every year.
A swine flu vaccine is currently being developed but is not yet readily available. First supplies are expected to arrive in the UK in the autumn although it will take several months for a wider vaccination programme to be rolled out.
Mr Wilson added: “It’s absolutely vital that all those at risk, including all NHS staff, take up the normal seasonal winter flu vaccine when it’s available, as this will help to relieve some of the pressure on the NHS.” People should not call NHS Direct if they have a swine flu query, instead they should check symptoms online at www.nhs.uk or call the swine flu information line on 08001513513.

Stay at home, rest and drink plenty of fluids. Use over-the-counter flu remedies or paracetamol to relieve symptoms.
If still concerned and symptoms are not relieved, call your GP over the phone, who will make an assessment and may suggest a course of antiviral treatment, particularly for those with underlying health problems and in high risk groups such as those over 65, children under five, and pregnant women.
Nominate a healthy friend or relative who can collect the antiviral treatment.
DO NOT go to A& E or your GP’s surgery if you suspect you have swine flu, unless you are advised to do so by a healthcare professional. Help reduce the spread of infection by following basic hygiene rules: cover your mouth and nose with a tissue when you sneeze or cough, dispose of the tissue immediately and then wash your hands t h o r o u g h l y. In short – catch it, bin it, kill it.

buy tamiflu

Tamiflu / oseltamivir phosphate is probably the best medicine to treat / prevent flu.

REGULAR use of painkillers such as aspirin, ibuprofen and paracetamol could be dangerous, according to new research. The American study showed that men who took daily doses were about a third more likely to have high blood pressure, increasing their vulnerability to heart disease, strokes and kidney failure.

pain killers

But look in any typical household medicine cabinet and you are likely to find at least one type of over-the counter painkiller. Which type will depend largely on how susceptible the family is to the marketing hype that helps drive the half-a-billion-pound a year painkiller market.

So which products should you be using, and when should you be using them?

Here’s a guide to getting the most out of over- the- counter painkillers – HEADACHE Paracetamol (the cheapest nonbranded version you can buy) remains most doctors’ choice as a first-line painkiller for all types of headache.

As long as you stick to the recommended dose it’s about as safe as medicines get, and if you are only going to have one painkiller in your household then this should be it.

Avoid paracetamol preparations that claim to be more powerful, or fasteracting. Although theoretically beneficial, in practice additives like caffeine and codeine are unlikely to do anything other than lighten your wallet or purse.

Some people find ibuprofen (Nurofen, Brufen and Junifen) more effective but be careful if you are suffering with a hangover, or prone to indigestion – ibuprofen can upset a tender stomach.

BACK PAIN/ACHING JOINTS/PULLED MUSCLES Unlike paracetamol, ibuprofen has a mild anti-inflammatory action which may give it an edge in treating sprains and strains throughout the body.

Anti-inflammatory creams and gels (ask your pharmacist) can help, but the active ingredient is ibuprofen, or a related drug, and I remain to be convinced that they are anywhere near as powerful as taking the same products by mouth.

PERIOD PAINS Ibuprofen is likely to be more effective than paracetamol for treating the cramps associated with periods.

If you are going to take ibuprofen regularly for three to four days at a time, try to take it with meals to protect your stomach, and switch to paracetamol if you start getting indigestion.

Never take aspirin, as its blood-thinning properties can make the bleeding heavier. Aspirin does have its good points – it is cheap and powerful and it has a unique action on platelets, reducing the stickiness of blood, and offering significant protection against heart disease and stroke. But its sideeffects rule it out as an everyday painkiller, and certainly not for period pains.

EARACHE AND TOOTHACHE If anything, ibuprofen is slightly more powerful than paracetamol and if you have a serious bout of earache or toothache then you are going to need all the help you can get. I would start with ibuprofen (available in liquid form for children) and would even consider adding in paracetamol if the pain is severe (as it often is).

MIGRAINE Simple paracetamol is probably the best bet for milder forms of migraine but you can now buy a migraine-specific treatment without prescription.

Why did the esteemed Journal of the American Medical Association publish a paper showing that blockbuster anti-arthritis drug Celebrex is superior to a $7 bottle of ibuprofen, while the FDA maintains it isn’t? Because the scientists who wrote the paper–their expenses paid by Celebrex manufacturer Pharmacia–selectively omitted half their study data to make the boss’s drug look good.

The Celebrex case isn’t an aberration, according to Public Citizen’s Dr. Sidney Wolfe. “People are injured and killed as a result of incomplete data being published and studies being designed in the wrong ways,” he says. Corporate researchers attempt to prove marketing claims, not insure public health, critics say, so results are buffed or buried even if it means impeding doctors’ understanding of illness and health.

The problems, however, go beyond eager-to-please scientists and eager-to-earn corporations. Medical journals are themselves reliant on drug-industry largesse. As a result, they are ill equipped to exclude unsavory, publicity-seeking corporate research from their public platform.

In September, in an unprecedented joint editorial, editors of thirteen leading medical journals, including JAMA as well as The New England Journal of Medicine, The Lancet and The Annals of Internal Medicine, announced a plan to fight back. Along with previously required disclosures about funding, conflicts of interest and scientific contributions, they declared they would also require authors to confirm that their sponsors gave them independent access to data and control over their publication. (Even the standard disclosures required by hundreds of journals have had limited success. Tufts University’s Sheldon Krimsky analyzed the 1997 editions of more than 200 journals, finding that more than half hadn’t published a single disclosure, a percentage that is startling given widespread industry support and participation in biomedical research.)

“The pharmaceutical industry has academic clinical investigators in a corner,” explains Richard Horton, editor of The Lancet. Medical research on human subjects is poorly funded by the federal National Institutes of Health, Horton and others contend, because the agency favors the control and precision of laboratory science in which experimental subjects don’t have complicated needs and rights. The result, not surprisingly, is that academic researchers often turn to the drug industry for cash. Corporations now fund 70 percent of all clinical research conducted in this country. Most of this research is “careful, good work,” says former editor of The Annals of Internal Medicine Frank Davidoff. Even so, company sponsors see the academic work they fund as “marketing primarily, not scientific research,” he says.

The problems start when expensive, time-consuming clinical trials paid for by the corporations produce negative results that contradict marketing claims. “The academics want to be able to take that information and tease it apart, to look at the good parts and the bad parts too. But the pharmaceutical companies’ marketing departments are going to say they don’t want to report on the bad stuff,” says Dennis DeRosia, chair-elect of the Association of Clinical Research Professionals. In extreme situations, the struggle for control over data resorts to mudslinging and lawsuits. The Immune Response Corporation, for example, slapped a $10 million lawsuit on scientists it had hired to study its therapeutic vaccine Remune who wanted to publish results showing that Remune was ineffective. “I spent over $30 million,” the company’s president complained to the Baltimore Sun. “I would think I have certain rights.” The case was eventually settled out of court, and the study was published in the November 1, 2000, JAMA.

In such cases, journals’ new rules may help scientists negotiate better contracts with their industry sponsors. But there is no antidote to the problem of subtle, pro-industry bias toward positive results when scientists are more than willing to sign on. A case in point is the controversy over the recent study of Celebrex, funded by Pharmacia and Pfizer. “Super-aspirins” such as Celebrex and Merck’s Vioxx were developed to improve upon cheaper, over-the-counter remedies like ibuprofen by reducing the incidence of bleeding ulcers and other gastrointestinal side effects. With just a year of aggressive marketing to consumers (later condemned by the FDA as misleading), Celebrex sales leapt to $1.3 billion, even though FDA-required warning labels on the product stated that its advantage over ibuprofen–which costs about a third of what Celebrex does–was essentially unproven.

In September 1998 Pharmacia and Pfizer launched a study of more than 8,000 patients, overseen by industry scientists and hired academics from eight major universities, seeking to prove to the FDA that Celebrex deserved freedom from the stigmatizing warning labels affixed to competitors ibuprofen and diclofenac. The findings of the study were uninspiring. Celebrex patients developed ulcer complications more than twice as often as researchers expected, and this rate was statistically indistinguishable from the rate for patients taking the comparison drugs. But the study was a huge one, with thousands of patients and reams of data–surely some other conclusion could be made. And indeed, upon closer inspection, the researchers found that they could demonstrate a slight, qualified advantage for Celebrex if they left out the second six months of the study. A statistical anomaly–the faster dropout rate of susceptible patients in the comparison group–could shore up such a step.

While this move may have made Celebrex look marginally better than its competitors, it also diminished the study’s clinical significance. “People aren’t on these medications for six months; most are taking them for years on end,” says Dr. David Lichtenstein, a gastroenterologist at the Boston University School of Medicine. But what’s worse, critics say, is that the team’s September 13, 2000, JAMA paper on the study neglected to mention that portions of the data had been selectively omitted.

Those academics “had full control over the data and publication” of the study, Pharmacia’s vice president of medical affairs, Dr. John Fort, assured me. Perhaps so. But they also have industry ties even beyond those they disclosed publicly. What JAMA readers did not hear about is that one academic author is an epidemiologist mired in controversy over his claims that the doomed diet drug Redux was safe and effective while he was on the manufacturer’s payroll, another is a rheumatologist whose smiling face appears prominently on the Celebrex website, and a third is a partner in a venture capital firm.

A casting glitch raised the curtain on Pharmacia’s behind-the-scenes data manipulation. Upon request by JAMA editors, Lichtenstein and gastroenterologist Dr. M. Michael Wolfe reviewed Pharmacia’s paper and wrote a tepidly favorable editorial to accompany it. But six months later, Wolfe sat on the FDA committee that considered the study in its entirety–a vantage point from which Celebrex’s apparent advantage disappeared. He told the Washington Post he was “furious…. I looked like a fool.” The FDA rejected the label-change application. But the JAMA paper had already gone public, and by confirming the marketing hype, “probably ha[d] more impact than our labeling,” an FDA official told the Post.

Sometimes the unseen data are more alarming than the seen. Perhaps the most famous case dates back to 1978, when The New England Journal of Medicine reported that Ciba-Geigy’s gout drug Anturane had been found to reduce the incidence of fatal heart attacks in people who had suffered at least one previous heart attack. The finding was hailed by the New York Times as one of the most important medical advances of the decade–until the FDA alerted journal editors that they were rejecting the new use for the drug. While it did indeed reduce the incidence of cardiac deaths, it increased deaths overall.

Journal editors wring their hands over such debacles, but the reality is that medical journals must curry favor with drug-company marketing execs. “If we publish a study that finds positive results, then the industry is delighted and buys lots of reprints,” Lancet editor Horton confirms. According to insiders, The Lancet’s parent company, Reed Elsevier, contractually requires Horton to increase the journal’s revenues by 10 percent a year. Given flat subscription rates, that means increasing reprint revenues, which now exceed the journal’s subscription income, says Davidoff, the former Annals of Internal Medicine editor.

Most medical journal editors don’t muddy their hands with advertising decisions, but the companies and societies that pay their salaries are not above agitating for a bigger piece of the $5 billion drug-industry advertising pie–and forcing editors to make their pages as industry-friendly as possible. Reed Elsevier’s Excerpta Medica helps companies place positive articles about their drugs in top-tier medical journals, many of which are conveniently owned by Reed Elsevier. Last spring the American Medical Association and the Massachusetts Medical Society, publishers of JAMA and The New England Journal of Medicine, respectively, funded a study with little clinical application: It showed that ads in their journals’ pages more effectively boosted drug sales than expensive television spots aimed at consumers.

The Massachusetts Medical Society, which earns more than three-quarters of its income from journal revenues, pushes editors to be even more amenable to industry dollars, critics say. In a controversial 2000 move, for instance, the society replaced its independent-minded editors with asthma specialist Dr. Jeffrey Drazen, who had ties to more than twenty companies (which he said he would sever before assuming his new post). Drazen’s effusive praise for Sepracor’s drug levalbuterol, which he was paid to evaluate, was featured in company advertising materials and was later criticized as overstated by the FDA.

Given all this, the journals’ new rules are certainly a step in the right direction. But publishing rules alone won’t dam the tidal wave of industry dollars sweeping through medical research and publishing, with the very real risk of bias those dollars represent. Ultimately, clinical research must be supported with greater independent funding, and there should be federal rules that ban corporate participation in research the pharmaceutical industry does sponsor. Until then, public health is likely to continue to take second place to private gain.

FOR much of his life, a man takes his sexual performance for granted, so when he finds he can’t rise to the occasion it’s a frustrating and stressful experience.

lf the condition persists it’s called erectile dysfunction and may lead to depression and marital difficulties.

In most cases it is due to a physical factor such as high blood pressure, high cholesterol, smoking and diabetes – as well as a natural decline in sexual energy as men get older.

But now pills are available to help and there are several to choose from, as Dr Miriam explains.

VIAGRA was the first pill for erectile dysfunction and there has been a lot of hype about it – some true, some untrue.

Many men think Viagra increases sexual desire – it doesn’t.

It increases sexual response in those who have the capacity to respond, and the effects last for four to six hours.

For Viagra to work, a penis has to have adequately healthy nerves and arteries. A man of 80, for example, is bound to have some hardening of arteries even in the penis.

It may be worth a try if you have diabetes, but only half the diabetic men in tests had improvement in their erections.

Similarly, if your pelvic nerves or pelvic arteries have been damaged by an accident or by surgery, Viagra may not bring about an improvement. Here the success rate is only 40 to 50 per cent.

Is Viagra safe?

MANUFACTURERS say it shouldn’t be taken with heart drugs which include nitrates.

There are also side effects. The US Food and Drug Evaluation reported the most common were headache, flushes, upset stomach, stuffy nose, urinary tract infection, visual changes and diarrhoea.

STAY SEXY FOR HOURS

CIALIS is a new treatment but it isn’t an aphrodisiac and won’t increase sex drive.

It works in the same way as Viagra by helping blood vessels in the penis relax, allowing blood to flow in, resulting in an erection.

For Cialis to be effective, sexual stimulation is needed. Men who don’t have erectile dysfunction shouldn’t takeit. Both Cialis and Viagra appear to be similar in how effective they are, but Cialis works for up to 36 hours. This doesn’t mean a a man has an erection for 36 hours, because it only works when he is sexually stimulated. But he doesn’t have to worry about the effect wearing off quickly, so sex can be more spontaneous.

Cialis isn’t affected by food so it can be taken with a meal and remain effective.

In three studies between Viagra and Cialis, conducted in Sweden, Germany and the US, more than two thirds of men preferred taking Cialis.

It was also tested on about 350 men with diabetes and was effective in restoring erectile function in just over half of them. In men without diabetes it was effective in 80 per cent.

Cialis is available in two strengths – 10mg and 20mg. The maximum dose is one tablet per day to be swallowed at least 30 minutes before having sex.

Cialis is generally well tolerated but side effects can include headache and indigestion.

Less common side effects can be facial flushing, stuffy nose, muscle aches, dizziness and backache, all generally mild to moderate and short-lived.

As with Viagra, men taking medicines containing nitrates in any form shouldn’t take Cialis, to avoid a drop in blood pressure. Nitrates include the heart medicine nitroglycerine – GTN – and the long-acting nitrates used to treat angina.

Fatty food’s a disaster

LEVITRA allows some men to achieve erections 10 minutes after it’s taken, but normally leave 25 to 60 minutes before sexual activity. The effect lasts five hours.

Like the others, Levitra isn’t an aphrodisiac and its action is affected by eating a high-fat meal but not by drinking alcohol.

It comes in three dosage strengths – 5mg, 10mg and 20mg. Usual starting dose is 10mg with a maximum of one tablet per day.

Levitra is generally well tolerated but side effects may include headache, flushing, runny nose and indigestion, though these are generally mild to moderate and short-lived.

Men taking medicines containing nitrates in any form shouldn’t take Levitra.

TRIED’N TESTED

UPRIMA contains apomorphine and is a more old-fashioned treatment for erectile dysfunction.

You place the tablet under the tongue where it dissolves in about 10 minutes. If the tablet is swallowed whole, it won’t be effective. It isn’t an aphrodisiac so sexual stimulation is needed.

If you have any of these conditions you can’t take it: your partner is breastfeeding, you have unstable angina, you’ve had a recent heart attack, you have low blood pressure and any other medical conditions which make sexual activity dangerous.

If you get any side effects, speak to your doctor. Only your doctor should increase the dose.

Private practice

ALL drug treatments for erectile dysfunction are generally available on prescription for one treatment per week.

If you feel you need more tablets talk to your doctor.

Cialis and Levitra are also available more frequently by private prescription.

When you go private there may be a charge for the doctor’s time and you will have to pay for the prescription and the drug itself.

FOR further reading, Family Health, by Dr Miriam Stoppard, is available from Mirror Direct on 0870 07 03 200, price pounds 22.50 including postage and packing.

DRUGS for erectile dysfunction are available under the NHS only for men being treated for:

Prostate cancer (or if they have had prostate glands removed), kidney failure, spinal cord injury, diabetes, multiple sclerosis, single gene neurological disease, spina bifida Parkinson’s disease. polio, severe pelvic injury or radical pelvic surgery.

Men who were already receiving drug treatment for erectile dysfunction on Sept 14, 1998.

MAKE YOUR CHOICE

PILLS for erectile dysfunction are known as PDE5 inhibitors as they help to relax blood vessels in the penis, enhancing blood flow to it, causing an erection.

CIALIS LEVITRA VIAGRA

ONSET OF 20-60 mins 10-60 mins 20-60 mins ACTION

LENGTH OF 36 hours 5 hours 4-6 hours ACTION

When I lost my libido I knew it immediately. Not that there were physiological warnings beforehand. There were none. I had been going about as frisky as ever; I hadn’t been more tired at the end of the day. No, the first time it was a classic unexpected fiasco, as Stendhal called it. Suddenly sensation was gone; emphatically absent.

Still, what is one fiasco? When my husband and I were young and early in the habit of love-making, when I was unused to regular orgasms, I used to miss often. This thought–that I had a past of uneven accomplishment–didn’t occur to me until after the second fiasco. After a long lag, a second failure followed the first: the next time we tried to make love. After the second time I was eager for explanations and solace. In recent years I had never missed an orgasm twice in a row. That shouldn’t sound boastful: it certainly didn’t when I groaned to myself, over and over, “I’ve never missed an orgasm twice in a row.” Orgasm had become a matter of almost unconscious planning. If I’m not interested–if I’m seriously fatigued or angry or simply not in the mood (rather than just wound up)–we don’t try. When you’re long married and long-bedded, small nonverbal signs go a long way.

Q–I’ll call him Q–gives off his own silent signs as well. Some nights when I am feeling a little keen I’ll find him watching a late movie instead of coming to bed; and since he knows I need a lot of sleep, that’s a sign he wouldn’t be interested. Mutual forbearance–unless we are both fairly sure of success–goes far to explain why I have lovely sex with my husband. Not to make a fetish of orgasm, but it had been a fact of our midlife. The intensity varied, but it was firmly there. My libido had long felt as much a piece of my identity as the color of my eyes.

The second time I was worried. (The first time I simply fell asleep right away, tuckered out.) A list of possible causes emerged. There are days in any ambitious, involved life when ego-centered obstacles to pleasure mount up too high to leap over. No, I wasn’t angry at Q. If he had made me mad, we wouldn’t have been trying to make love at all. No, I wasn’t especially distracted, although my day had contained an editor’s letter refusing a submission. Sensitive to my own moods, I feel capable of knowing when the total jangle of the day has gotten so chaotic that it’s absurd to pursue any goal but sleep.

No, my day had not been stressful enough to serve as an explanation, no matter how darkly I retold its accumulated frustrations. We had alleviated a lot of them in the debriefing session that Q and I often held while driving home from work. Years ago we set up the habit of venting. I was then working for the haughtiest university in the world and Q was dealing with his own institutional malice. As soon as we get into the car, whoever is in higher dudgeon goes first. By the end of the session we have almost invariably located the enemies and hung them by their thumbs. That doesn’t necessarily mean we are calm enough afterward to manage sex. I see this turning into a commentary about labor under capitalism. Sex and work–or rather, impotence and the conditions of work–are subtly connected. (This might partly explain why the level of impotence in this country appears to be rising, especially among the young.)

This time, the second time, the failure was, starkly and utterly, mine. It was as though my body had been anesthetized, but only from the waist down. Sudden muscular tugs, gone. The slowly cumulating energy for sex, gone. Even the basic daily comfort of crossed legs–which I had complacently assumed would accompany me through life with or without Q–gone! Sensation didn’t come back the next day, or the next, or the next…. There was no sign that it might ever return.

So here was my body benumbed, for no reason I could guess. That your body has failed is perhaps the least-wanted conclusion in the explanatory repertory–worse for me than the idea of my mind in trouble. I would then have preferred to be depressed or angry rather than physically ill. Perhaps it’s because “the body” is so rarely uninfluenced by the mind that the idea of its having a life on its own is terrifying. My mind-body wanted to make love. I had never needed to know how much. When my body refused to perform in its wonted way, it threatened “me” the way illness or craziness might do. I failed to be me.

What saved our marriage early on, before I got the knack, was that Q either didn’t notice that I wasn’t coming very often, or else he expected it, as what girls were like. One sensational orgasm that he had provided long before we thought about marrying had reassured me that I was competent and heterosexual, and I just hung in there, waiting. That was fortunate, since after around 1,000 couplings I got into the habit. I could accomplish at worst a modest basic orgasm. We had floated on confidence–along with patience and delay–ever since. Over the years being able to count on orgasm has been another reward for getting older together. Obviously no one changes a winning formula much. My sensitivity, once aroused by the raptures of the missionary position, stayed virginally astounded by the same old same old. This has had the unexpected benefit of stretching our simple pleasures over many years, with only serendipitous minute variations. It still feels vanilla, but that’s a contented Puritan’s estimation. I can’t know, because not even my closest friends discuss such things.

I am no longer astonished by the idea that physiological compatibility can deepen over time. (I choose anonymity, in fact, not least to preclude becoming notorious for this marital-progress narrative.) Success in long-term monogamous relationships must actually be quite common. It is first-time lovers at any age who are ignorant about the mind-body of the particular other: particular sensitivities, tastes, dislikes; not to mention deeper apprehensions and phobias. And boys are encouraged to be selfish, ignorant, awkward. First times must be relatively dreadful, and any culture that idolizes them–as ours does–shows its fundamental Puritanism and youth-centeredness. Cultures truly interested in pleasure don’t romanticize inexperience. But we aren’t told any of this often enough, so the cliche that passion declines is harmfully fixed in people’s minds.

Time passed after the second fiasco. Quite a lot of time. I avoided occasions of sex because I didn’t want to fail again. Three times in a row would, I was sure, spell doom. (Believing that was itself a curse, making me afraid to try and postponing the trial more and more.)

But one night I felt I couldn’t evade Q’s puzzled persistence any longer. I was determined to make it work. It was a little late and I was a little tired but I relied on my old saw, “My orgasm is in my own power.” That maxim is usually helpful, but not when it goes wrong. It had become flippant instead of ancillary. The incipient excitement I counted on to grow to crescendo had utterly vanished. I couldn’t find it in any of its usual spots.

At least Q did not make it worse, by turning hypersolicitous, as if worried. This story is really not about him, even though sex is supposed to be a two-person affair. It always ought to be, and in mutually good sex it must be. But fiasco is not one of those happy cases. In that emergency you discover the ultimate solitude: solipsism a deux. With loathing.

This time I found myself drawing on that standby in times of solitary stress-relief, sexual fantasy. I used this rarely: when I went on trips alone, after stressful conferences, in impersonal hotel rooms. When my body works with Q, fantasy would be superfluous. A distraction. Various body parts are going off like timed fireworks and I would miss the display by looking elsewhere? Recurring to fantasy had been useful only at moments, say when I wanted to move from a trot to a canter.

I hadn’t paid attention to my sexual fantasies until a feminist discussion group in the mid- Eighties brought up the subject of where the imagery comes from. We dropped the scalding topic quickly, because no one wanted to expose her fantasies. Since the fiascos, I have slowly figured out where most of my imagery comes from: soft porn. Even though I’ve never watched a porn movie, images of sexualized domination are available in real life, from the teacher of my Southern second-grade class hitting a fat boy on his bottom with a ruler to Abu Ghraib. Similar visualizations turn up increasingly in the mainstream, TV and film. The repertory of behaviors is limited, so writers and directors ratchet up the sadomasochistic violence year by year.

But I didn’t understand that I had internalized so much of this until I taught myself to stop the action and review my fantasies as if they were an old movie. Some are. One scene derives from Godfather Part II; another from a sexist photo by an art photographer. Of course I don’t do any of this analysis while I’m cantering.

Fantasy took me to places I didn’t like to be. My fantasies–those I deployed on the occasions I am describing–used to occur in a wild garden. (One thing I still don’t know is where this setting came from, but it’s not Edenic. Far from it.) Remote parts of the garden were dimly lit and separated by total obscurity. Each site was linked to a different violent practice. The sadism I made go on there was graduated. There were other female bodies, but one, not recognizably “mine,” was the primary object.

Even as tension duly built in my solitary body, I would feel disappointed that sex is not always physical and pleasurable; degraded that my imagination needed to borrow from society’s much-handled store of images. Perhaps this distaste was related to my kind of feminism. The increasing dissemination of porn in this country is an unmistakable sign that a whole lot of people are suffering too many obstacles to pleasure: physiological failures or–perhaps worse–fear of failure, even in couples. Porn smelled rancid to me, stinking of this fear. Opposed to the male degradation of women required by actual porn productions, I felt ugly using fantasy dominators and victims for getting off. (Later I found a powerful essay about the masochistic side of this quandary by Sandra Lee Bartky.)

In the garden-movie I was also–this too took a long time to realize–the director of degradation. How bad was this? The surrogate men were not abusing any body but split-off versions of mine, presumably; and the activities went on only in my own mind, not for public consumption; and they did not cause me to regard Q’s body or my own with less affection and gratitude. Discovering all this about my mental life did not lessen my antipathy to commercial porn a whit; nor did it sharpen it. But those did not feel like saving distinctions. My aversion, not to mention my reflective disgust after I came, did not have a calm philosophical tone, like debates between pro-porn and antiporn feminists about what counts as sexual liberation. Having to have recourse to any of the distant sites was a misery, a different kind of failure.

On this third try I quickly found myself in the dismal far parts of the garden. Not in one at a time as usual, in a well-paced sequence, but in all of them in rapid fire, chaotic simultaneity. The Godfather scene didn’t work; nor the Bergman pastiche. Frenziedly trying for a location that worked, a rhythm to fall into, a sequence of S/M scenes that would take me over the top, my voyeur’s eye swept from one site to another, trying to escalate, failing in each, again and again. I didn’t know what caused this hysterical scampering of the images. Figures that had moved with grace when my body was working rhythmically halted, like a break in a jerky primitive film, and commenced the same vile gestures with mechanical rigidity. The most punitive images in my fantasy repertory jammed up against the introductory episodes, as I tried in vain to restart the movie. There was no progression. It was clockwork bedlam in por-nurbia. (How often does porn fail? Escalation means that more violent levels of stimulation are failing. Eventually, as D. H. Lawrence knew from his own experiences of impotence, you simply cannot have sex just in the head.)

I had humped to exhaustion. At least Q had come, at my suggestion. That was a relief. But I felt utter fatigue, mixed with a sense of wasted effort greater than any I had ever experienced in love-making. To find a similar experience of such numb futility I had to go all the way back to adolescence–to my first experiments at intercourse, with boys who were relative strangers. Or rather, to their clumsy sexual experiments on me. But those first times had, by contrast with my mid-adult state, less awfulness, because at seventeen I had no idea what I was missing or what good sex could be. I wasn’t even trying then. I was present out of ignorant passivity, not physiological volition, not to mention affection or love.

At that age, I had had only one sexual fantasy, of walking on a path through the woods clad only in a slip, fearful of being seen. Nothing else happened. The technique of turning that dread into excitement was unknown to me. Years later, someone whose name I can no longer remember had technically ended my virginity without producing in me the slightest sensation of pleasure. The comfort I derived from putting my hand between my legs before going to sleep seemed to have no connection with the useless groping of boys making out. What were boys for, sexually? I didn’t have a clue. Those boys didn’t know I had a problem, they thought the song was all about them.

Q was light-years from those narcissists. My husband, my lover, my partner in history. These were sentimental thoughts, unhelpful now. His concern hovered; the air was thick with it. I saw it would add to my abjection.

This time there was no doubt we were going to have to talk about it.

“There is something wrong,” I said in an especially calm voice. “I don’t know what it is.”

We had a slightly technical exchange.

“It’s probably some passing thing,” I said. “You can ignore it, you know; go on as if …”

“I can’t,” Q said without needing to reflect. “We’ve always climbed the mountain together. I can’t do it without you.” He explained a little bit more.

That was what mutuality was, to be sure. But I was filled with grief and terror. Without reasoning, I knew his attitude was a terrible danger to us. It was a critical moment. “We can’t let this become a big thing,” I said, leaching from my voice all the panic I felt lurking outside us, in the dark future. “We could let it become important. It could overwhelm us.” Like someone trying to soothe a strange dog, I achieved a firm tone of conviction. I felt as I were teaching an absolute truth, and that Q would have to believe me. “Have to” only in the sense that if he didn’t, or couldn’t, we were lost. If he panicked, we would never recover.

The close thickness in the dark dissipated. Q relaxed; slept. I was worn out; I did, too.

The next day, I told myself to put it out of my mind and work. And so I did. I read in the library, I made calls, I felt absolutely myself in the world: concentrated, attentive, efficient. The same upright posture, energetic walk. But every so often without warning I crashed. A sick feeling coming into my stomach meant I had had a thought labeled “the third time.” It was the same nausea that came over me after I was told that my father had lung cancer, when I was trying to forget it; succeeding, until heaving informed me that memory had flooded over.

“It’s the end of my marriage,” I thought. “We’re way too young to deal with this well.”

So that was it. Despite my firmness to Q, I had already concluded that I had become “impotent.” That was the word that came to me. (”Frigidity,” that old-fashioned word for women who had never been aroused, perhaps–when the term was accurate–because they had been anesthetized by patriarchal selfishness and contempt for their lack of phallus, didn’t come into my mind for an instant.) It was already in my head that I’d never recover. I assumed Q must already have reached the same conclusion. I must have somehow communicated it. When you have been married that long, it is harder to have secrets. Much harder. For the first time in our entire life, I regretted all the contiguity and sharing that had made him so sensitive to me. Our love had become a bitter joke, almost a tragic irony. Every strength was a weapon against us. A newer lover wouldn’t have known so exactly how different I was, and with a new lover I might have faked unobserved until it–whatever it was–ended and I got my normal body back.

For the first time I understood why men who are impotent become adulterers; it made perfect sense, however stupid and destructive. For myself, I discarded the option, because I jumped straight to how humiliating it would be to fail three more times with a new lover, and how hurtful for him. Whereas Q already knew, through the same mute communication, that it had nothing to do with him. How long he would believe that, however, or whether it would console him … He would think I had stopped loving him.

I would be washing my hands or picking up a cup and my stomach would churn as if my ship were collapsing into heavy seas; my mouth filled with bitter phlegm. I heard the final judgment, “Failure.” I thought, this is what those poor wilted men must feel. I felt unutterably sorry for us all. Even as I tried to deaden these feelings with routine, I was saying to myself, “This is despair.” I had forgotten that you could be in despair and use the word at the same time. And I thought, “This will never end now.” And then the moment passed and I was my same self until it walloped me the next time. “You’re a failure. This can’t end. There’s no help for you on this one.” I, who had never believed in “no exit” signs, absolutely had no response to this one.

Once I did think of consulting my doctor, but I cringed from the revelation that would be necessary. Writing this is possible for me now, even necessary; speech was then unspeakable. I could imagine his smooth, serious, practical face tensing from the effort not to reveal his surprise and discomfort. Moreover, I didn’t believe a doctor could help. Going to a therapist also seemed absurd: This wasn’t mental. My complete numbness unnerved me. I concluded, “This is so freakish they can’t have a remedy for it.” Nor could I imagine a friend to whom I would have the courage to tell this. None of my female friends had ever described their own impotence. Sympathy from the immune would be unendurable. If I had known at the time how widespread “impotence” is, I would still have thought, “But theirs can’t be as complete as this!” What was the point if lust was irrecoverable? “Lust.” I had never thought to use that word in connection with myself, but that was precisely what I had had and lost.

As it happened, over the previous four or five years I had been researching autobiographical accounts of male impotence written early in the twentieth century. I had never read a story of impotence written by a woman. I had also never come upon a story by a man or about a man where onset was both sudden and final. My isolation–from Q, from medical assistance, from my best friends–felt total. Because of something so chancy–something that, had I chosen it and called it celibacy, would have left my identity unimpaired–I had suddenly had all my stitches in the warp and weft of the world cut.

Even in despair there are degrees. In one of those frantic routines of discarding hope after hope, as I depressively saw it, I stopped taking a new medication I had just begun, an anti-cholesterol drug. And then in bed some nights later, when we were lying hand in hand, Q said, astonishingly, “Could it be those pills?”

“Hmmmm, that occurred to me…. I’ll call my nurse practitioner at the end of the week, see what she says,” I said, surprising myself by lying without premeditation. I had already called her complaining of “side effects,” and she agreed to my stopping without asking questions: “It will take twenty-four hours to wash the drug out of your system.” I was giving it a week, maybe ten days.

Q said, one night, haltingly, heartbreakingly, “I wouldn’t want you to … be at risk, you know, with your blood pressure…. I mean, just for me.”

“Oh,” I said instantly, with some harshness, with much tenderness, in truth, “It’s not for you.”

What saved us, in part, aside from holding hands, is that I never thought the cause was premenopause or perimenopause or whatever the ridiculous catchall diagnosis is that doctors rely on who can’t diagnose a midlife woman otherwise. If I had employed against myself the current version of the dread “magic marker” of the female life course, as Margaret M. Gullette calls it, that would truly have blocked all hope. In this emergency, however, a loony idea of Marie Stopes came to me. Marie Stopes was a British sex therapist who wrote books for crossover audiences. In the 1930s she wrote one on the male menopause, in response to letters she had been getting from men in their middle years who thought they had become permanently impotent. Everyone concerned believed in men’s midlife sexual decline; it was already a credo of the scribbling sexologists. Stopes didn’t have the courage to deny the male scientific wisdom of her day, but she wrote that the climacteric, although real, was temporary. It might last a year or so, but then it would vanish and libido would simply return. Why she alone of her contemporaries believed this, I cannot say. She provided no evidence of such cures. But, given that a midlife “climacteric” is itself an invention, her solution was not crazy but brilliant. A moratorium offered hope, however remote. This hope lightened my despair by maybe two degrees.

I was laughing at her and thinking, “I’ll kill myself before the year ends.” Another few months of this crashing pain in the gut and utter misery striking at unexpected moments, with the fear of losing my marriage underneath! But even two shades less darkness is better than nothing.

Of course I got my body back–indeed, not very long after I stopped taking the medication. Would I have told this story otherwise? But it wasn’t the anti-cholesterol drug that caused the impotence, because I’ve taken it since without bad effects. I’ll never know what caused those fiascos. I think I know what cured me, and it is related to not believing menopause was the problem. What I believed under all the misery is that my body like other bodies has a way of being that restores itself by nature, the way skin grows back after being cut. Sexuality is a piece of this. Of course I got my body back, with all the complacency that rushed back with it. I felt (knock wood!), “A fiasco might never happen again.”

Those times when sweet lovemaking doesn’t work, as I believe it would more often in a more secure world, are now once again blessedly rare. But I have been impotent again since then; once with Q for much longer. The difference is that we knew perfectly well what the external causes of anxiety and depression were; Q somehow knew that bodily closeness in hugs and kisses would help us through. And having once seen despair undone by keeping faith in the body, I waited, and I think Q waited, with trust.

The episode occurred several years ago, and if I hadn’t decided to write this for the sake of others I might have forgotten most of it, the way women forget the pain of childbirth. Except for the chaos at the dark end of the garden.

The one long-term difference impotence made in my life is that I have been changing my sexual fantasies by an effort of will. The humiliation of that dry hump the third time, hips driven into the air convulsively, lifting Q’s 165 pounds against gravity on the point of my clit, to the frenzied clash of porn tortures…. That moment was motivation enough. People believe that they can’t de-escalate the violence of the fantasies they direct and inflict on the shadow self. This belief is the road on which some even escalate to S/M actualization–a path that Pat (now Patrick) Califia has warned is fraught with peril for many people. There is a huge difference between fantasy and behavior, even though in my worst unhappiness over my porn fantasies I thought they were the same. S/M in real life was impossible for me, unthinkable for us. No, de-escalation was the only way.

It wasn’t easy, and I think anyone who struggles through any of the stages deserves credit. The whole process was enabled by feminism, and that’s a fact. Reading the Bartky chapter in Femininity and Domination called “Feminine Masochism and the Politics of Personal Transformation” gave me the vague ambition to be someone who tried to change her “unconscious.” And by then, I had somewhat prepared myself. I had slowed down masturbation from time to time enough to analyze its current imagery, even though focusing to analyze interfered with momentum and the discoveries often made me uncomfortable. But knowledge had brought some rewards: I knew fantasy had a history, in the sense that I had not always had the same pictures in my head; I knew the images had sources; I had identified some of my sources. The movie wasn’t entirely preconscious any more. (The good energy this process required was no doubt derived in part from my finally being able to appreciate my body both esthetically and physiologically. In midlife I had shed much of the self-hatred accumulated in adolescence, when girls are first exposed to the hypercritical gaze.)

Experimenting with fantasy was the next awkward slow hurdle, trying to replace sadomasochism with pleasanter pleasure. At first my imagination clung to the dread familiar because it had worked. It took experimentation to figure out how to avoid the rigidity, the desperation, and some of the sadism, without losing the visual aids that can help arousal at times when help is needed. One by one I have managed to take steps that make more of an agent of the faceless female figure who undergoes the adventures. At the beginning, safe outside the garden, a voice-over can now ask, “What would you like to do?” instead of “Hurry up now, it’s time.” On occasions when need invites me to speed into the violent darkness, even when with Q, I deliberately slow down. Thus I became kinder up to a point to that other, my surrogate, my ageless puppet, this recently avowed part of my self. Each step felt like a risk, but it wasn’t. On the contrary: Her body language often seems more eager. Some changes turned out almost to guarantee the surprise swoop toward crescendo.

Sometimes I still experiment when alone. I doubt I’ll ever experience the nirvana of reaching orgasm by myself through peaceful “oceanic” imagery, which some of Gina Ogden’s interviewees describe in Women Who Love Sex. But as I made these changes on the landscape of my arousal, the darkest parts of the garden disappeared, never to return. Now she can linger if she needs to in the early dreamy places, filled with warm pools, sensitive male fingers, easy time. To be sure, the question is asked by a powerful voice; the rule that she take charge seems as harsh as the more typical rules of porn. Yet what the voice with the authority of print calmly bids, over and over, is, “Go slow, stay in this part of the garden; enjoy this as long as you need; don’t rush, don’t let yourself be rushed.” It has no gender that I can recognize, being a voice from inside my own head, but on reflection seems feminist in its intentions. Now I make the repetitiousness of porn serve my sense of timing rather than pressuring it.

More recently, the surrogate female body goes into a theater with loges that is a prettier place. Before or after this change (I no longer remember), it came to trying to have women objectify male bodies, sauce for the goose. I was at first awed to be doing it to the gander, and then amazed and amused to be able to overcome the lack of habit. This had mixed results. In any case, when violence occurs late in the process of arousal, it now happens to figures far away–as if my self–conscious new postconscious were stating, “This is all a show.” Everything that happens is ultimately for the sake of the shiver that ends the play. I recognize the grip of goal-driven porn underneath the alterations.

Given our savage, impatient acculturations and current conditions, some sadomasochism still seems undoable. But who knows. So much has already changed, from my teens when I had so timid a fantasy life (and so benumbed a body), through the long period of my conjugal life when I was scarcely aware of my occasional recourse to repulsive fantasy, to these recent midlife recognitions and interventions inspired by feminist principle and theory. Sexuality is a long busy story. This is surely not the end of this aspect or any other of my sexual memoirs.

I wish such an essay had been available during my first despair, and I hope others will find themselves writing their own. It’s a new genre of autobiography that needs to be explored sensitively and critically.

The woman whose face is unseen has become more stubborn about her own satisfaction. Over this time, she has added flesh to her strong hips, muscle to her arms. When I am in doubt, she too resists. Sometimes she leaves the garden entirely. And the voice may be metallic but it wants to know only, courteously, “What would you like to do?”

The drug industry’s astronomical profits are rooted in government-funded research. Government policy needs to bring drug prices and research priorities down to earth.

Americans pay the highest prices in the world for prescription drugs. Drug expenditures in the United States have doubled since 1993 and are expected to double again by 2004, according to a study by the Health Insurance Association of America. Elderly people now spend more on medicine than on doctor bills. Many health plans have cut back on other benefits because of their rising drug bills. About one-third of seniors have no insurance and are therefore paying the highest, nondiscounted retail prices.

The pharmaceutical industry has one defense for the skyrocketing price of drugs: Private-sector labs are chiefly responsible for the breakthroughs in prescription drugs. Any efforts to limit drug prices, especially under a Medicare drug benefit, will short-circuit the medical revolution now underway.

Writing last year in The Wall Street Journal, Schering-Plough Corporation Chief Executive Richard Jay Kogan took aim at politicians and public-interest groups who mislead seniors and other consumers into thinking they can do something about the high cost of medicine. “To imply that increased drug costs come at patient expense is simply dishonest,” he said. “There is no other way to help people fight most diseases except through the introduction and widespread use of innovative drugs. Imposing price controls and access limits on drugs will only shift money from research and development to other parts of the health care system.”

Alan Holmer, president of the Pharmaceutical Research and Manufacturers Association (PhRMA), told the Senate Finance Committee that the industry’s cost of developing a new drug has now reached a staggering $500 million. Controlling the prices Medicare pays for drugs would mean the industry “would attract less investment money that could be used to discover and develop new medicines.”

It’s a tidy story, but it falls apart under scrutiny. Every independent study that’s ever looked at the sources of medical innovation has concluded that research funded by the public sector–not the private sector–is chiefly responsible for a majority of the medically significant advances that have led to new treatments of disease. Moreover, the drug industry’s expense for bringing those advances from lab to market is well below the $500-million claim. If one discounts the research clearly aimed at marketing and producing drugs whose contribution to public health does not exceed that of drugs already on the market, the assertion collapses on its face.

A Medicare drug benefit promises to be one of the hottest issues this fall. But adding a senior citizen drug benefit without first ensuring that Medicare pays reasonable prices for drugs would be like throwing gasoline on a raging fire. The government can structure a drug benefit that limits drug prices–without jeopardizing the search for tomorrow’s cures. But that will require overcoming the power of one of Washington’s most potent lobbies.

GOLDEN ENZYMES

Ed DeGrenier of Lombard, Illinois, discovered his two-year-old son Brian had Gaucher disease in 1991, shortly before Cambridge, Massachusetts-based Genzyme General came out with a treatment for the rare genetic disorder. For Brian, one of only about 5,000 Gaucher disease patients in the world, the introduction of Ceredase was truly a miracle.

People with Gaucher disease have a mutant gene that causes the body to fail to produce the enzyme that breaks down lipids (a fatty substance) in the blood. Their lipids build up in the liver and spleen, causing lung, kidney, and bone problems, and anemia. Before Ceredase and its successor drug Cerezyme, average life expectancy for people born with Gaucher disease was 41 years.

But the price tag for Brian’s miracle medicine has turned DeGrenier into an activist. His son’s fortnightly infusions cost over $8,000. His annual treatment fee has reached nearly a quarter-million dollars. DeGrenier writes letters to congressmen. He battles insurance company bureaucrats who are constantly seeking to cancel his son’s coverage and put him in a government-funded welfare program. And he’s read up on how Ceredase and Cerezyme came to be.

“This is government-developed technology,” he fumes. “This isn’t Genzyme working late at night to help sick people. The NIH [National Institutes of Health] did it. But as soon as the government transferred that intellectual property to the company, they lost all control over the pricing.”

Cerezyme sales generated $479 million in revenue last year, 70 percent of Genzyme’s total. The company cleared $223 million in pretax profits, more than twice the $98 million it spent on research and development, according to filings with the Securities and Exchange Commission. As is often the case in medicine, the science behind Ceredase and Cerezyme can be traced to the pioneering work of one person, Dr. Roscoe Brady, who’s been an employee of NIH since the mid-1950s. Winner of the prestigious Lasker Award for his life’s work, Brady and his teams discovered the genetic defect that caused the disease in 1964. He spent the next nine years purifying the enzyme glucocerebrosidase from human placentas. That gave him enough material to conduct a clinical trial on two patients. That paper was published in 1974.

At that point, he needed larger quantities of the enzyme to conduct trials on enough patients to determine its safety. Using NIH funds, he contracted with scientists at Tufts University to produce glucocerebrosidase. That proved challenging since ramping up bench science to large-scale purification stripped some of the activation and targeting components from the molecule. But after several more years of painstaking research, the purification problem was solved. “The solution to the problem was all done here at NIH” recalled Brady, who is now 76 and still conducts pioneering research in the field. “All Tufts did was give us large quantities of the enzyme.”

However, the scientists at Tufts recognized they were sitting on top of a gold mine. In 1981 they left academia to form Genzyme. The low-dose safety clinical trial then underway on eight patients had shown the drug to be remarkably effective in treating the one child in the experiment, but not very effective in the other seven adults. To observers it was clear that with proper dosing, a breakthrough drug was in the offing.

Once on their own, the Tufts scientists hired an economist, Henri Termeer, to run the company. Termeer raised $72 million from private capital markets to build a purification plant along the Charles River. That plant generated enough enzyme from placentas to conduct the efficacy trials that led to Food and Drug Administration (FDA) approval in 1991.

Genzyme’s reliance on public science wasn’t over yet, though. Purification from human placentas was difficult, costly, and time-consuming. Producing the molecule using recombinant engineering would be cheaper and faster. But for that, they needed the gene. Fortunately, that had been discovered by a scientist at the nonprofit Scripps Institute in California, also on NIH funding. Genzyme licensed the gene and in 1995 came out with the recombinant form of the drug. Despite the reduction in production costs, however, Genzyme never lowered the drug’s price when it moved from placenta purification (Ceredase) to the recombinant form of the drug (Cerezyme).

Genzyme’s reliance on publicly funded science is hardly unique. In May the Joint Economic Committee of Congress (JEC) released a study of public-sector research in health care in order to justify the large increases in NIH’s budget, which is $17.8 billion this year and is slated to rise 15 percent to reach $20.5 billion in 2001. (By comparison, PhRMA’s annual survey reports industry will spend $26.4 billion on research and development this year.)

The JEC pointed to a 1997 National Bureau of Economic Research study showing that public research led to 15 of the 21 drugs considered to have the highest therapeutic value introduced between 1965 and 1992. The JEC also cited a 1990 study by Robert Maxwell and Shohreh Eckhardt, “Drug Discovery: A Casebook and Analysis.” That study found that 60 percent of 32 innovative drugs would not have been discovered or would have taken much longer to discover without research contributions from government labs and noncommercial institutions.

The picture is the same when one reviews the results of the nation’s 30-year war on cancer, which has yet to reduce the overall death rate from the many forms of the disease. (While 62 percent of cancer patients can expect to live five years today compared to 35 percent in 1950, the incidence of the disease has risen dramatically; so the death rate of 126 per 100,000 today is no different than it was 40 years ago.)

Taxpayer-funded research is responsible for many chemotherapy agents. According to the National Cancer Institute (NCI) Web site, the NCI sponsored the investigational new drug applications for 50 of 77 anticancer drugs on the market as of the end of 1995. That work often extended right through to clinical trials. For instance, NCI sponsored 140 clinical trials for tamoxifen, which is produced by AstraZeneca for treating breast cancer.

The most frequently cited cancer drug story, and one worth repeating, is the development of paclitaxel (Taxol). The NCI spent 15 years and $32 million of taxpayers’ money to develop what is now the world’s most popular anticancer drug, used to treat breast, lung, and ovarian cancers. Bristol-Myers Squibb claims it spent $1 billion to bring it to market.

The drug generated an estimated $1.7 billion in sales for Bristol-Myers last year alone. Jamie Love of the Consumer Project on Technology (CPT), an indefatigable researcher on this subject and the main source for most press accounts that criticize the industry’s assertions about its research-and-development costs, has estimated the manufacturing cost of Taxol at around $500 per patient for up to an 18-month course of treatment. Yet Bristol-Myers sells Taxol to patients and their insurers for more than 20 times its manufacturing cost.

Most drugs for treating AIDS also owe their existence to government-funded research. Samuel Broder, the former head of NCI, and four government scientists laid out the government case in a bitter letter to The New York Times in September 1989 after the president of Burroughs Wellcome, now part of Glaxo Wellcome, asserted that his company had discovered and developed azidothymidine (AZT) on its own. AZT was the first effective treatment for slowing the AIDS virus’s impact. Broder, who is now chief medical officer at Celera Genomics in Rockville, Maryland, declined to discuss the sentiments he expressed while a member of the public sector, but Broder and fellow scientists wrote in the Times letter that

[t]he company specifically did not develop or provide the first application

of the technology for determining whether a drug like AZT can suppress live

AIDS virus in human cells, nor did it develop the technology to determine

at what concentration such an effect might be achieved in humans. Moreover,

it was not first to administer AZT to a human being with AIDS, nor did it

perform the first clinical pharmacology studies in patients. It also did

not perform the immunological and virological studies necessary to infer

that the drug might work, and was therefore worth pursuing in further

studies.

All of these were accomplished by the staff of the National Cancer

Institute working with the staff of Duke University…. They were doing

investigator-initiated research in response to a public health emergency.

Indeed one of the key obstacles to the development of AZT was that

Burroughs Wellcome did not work with live AIDS virus nor [did it] wish to

receive samples from AIDS patients.

THE INDUSTRY’S SILENT PARTNER: TAXPAYERS One reason the drug industry must rely on the public sector is that its own scientists play a bit part in basic biological research, which uncovers the building blocks of modern medicine. A 1997 National Science Foundation study of biomedical patents found that only 17 percent of key discoveries came from industry. The vast majority were generated by public, not-for-profit, and foreign labs.

Industry officials point out that their research budgets supply about 14 percent of research funding for the nation’s 125 academic health centers and thus are major contributors to basic research. But even there, industry-funded studies provide smaller returns than university research funded by NIH. David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital and a longtime student of industry-academic cooperation in medicine, points out that investigators who get two-thirds of their money from industry “publish less often and in less prestigious journals. By the measures of scientific productivity and quality, they are working at a lower level than their colleagues. The phenomenon of secondary science exists.”

I ran into this phenomenon last year while doing research for an expose on the pricing policies for Amgen’s Epogen, a biotech wonder drug used to treat anemia in kidney dialysis patients. The drug now costs Medicare over $1 billion a year. Two years ago, industry-financed scientists and lobbyists convinced regulators that patients do better when their red blood cell counts are near normal instead of slightly below normal. They deployed a host of industry-funded studies to make their case. Each small increase in red blood cell counts in dialysis patients costs the government hundreds of millions of dollars a year in additional Epogen payments.

And where did Epogen come from, anyway? The molecule, produced in the kidney, was first synthesized by University of Chicago microbiologist Eugene Goldwasser after 20 years of government-funded research. He never patented his discovery, even though he sent a letter to NIH in the late 1970s suggesting it might be a good idea.

PATENT MEDICINE

The government’s inability to track the uses of taxpayer-funded research continues to this day. The 1980 Bayh-Dole Act gave institutions and scientists that receive federal grants the right to patent and license their findings with commercial potential. The law was designed to speed up lab-to-industry technology transfer at a time when American industry was widely perceived as lagging behind its international rivals.

The government took steps to protect taxpayer interests in the process. The law required researchers to report their patenting and licensing activities to the government and gave federal agencies the right to purchase any products derived from government-funded research at a price free of licensing fees. But a General Accounting Office review of 2,000 biomedical patents issued in 1997 to 12 of the nation’s largest academic medical centers found the law has been honored mostly in the breach. Records were “inaccurate, incomplete, and inconsistent and … some inventions are not being recorded at all,” the report said. “The government is not always aware of federally sponsored invention to which it has royalty-free rights.”

Given the overwhelming evidence that government-funded research is responsible for a preponderance of medically significant knowledge, what justification can there be for the industry claim that it spends an average of $500 million to create a new drug? The figure is derived from a 1991 study by Joseph DiMasi and Louis Lasagna of the Tufts University Center for the Study of Drug Development, which is substantially industry-funded. The study pegged the figure at $231 million. The authors took the number of new drugs approved by the FDA and divided that number into industry research-and-development budgets, discounted for the length of time it took to bring a new drug to market. It has since been adjusted for inflation and the longer development times for new drugs.

Industry critics have long taken aim at the validity of the DiMasi-Lasagna numbers. CPT’s Love pointed out in 1993 in this magazine that two-thirds of the development costs came in preclinical research, much of it government-funded.

The industry story also downplays the fact that many “new” drugs aren’t medical breakthroughs. The FDA has rated applications to determine which proposed new drugs will get additional resources for expedited review. They rate new drug applications either as a “priority” which is defined as a “significant improvement compared to marketed products,” or “standard” which is a drug that “appears to have therapeutic qualities similar to those of one or more already marketed drugs.” The term of art for the latter is “me-too drugs.”

FDA statistics for the 1990s suggest that about half of industry research is aimed at developing me-too drugs. In 1999, 19 of 35, or 54 percent, of approved new molecular entities were given a priority review by the agency. For the decade, 134 of 311 new molecular entities, or 43 percent, approved for sale were rated a priority. “Is there a need for the 18th quinilone [a family of antibiotics]?” said Dr. Murray Lumpkin, deputy director for review management at the FDA’s Center for Drug Evaluation and Research. “It depends on how you define need. If a company needs a certain percentage of the market? I won’t comment.”

In a recent interview, DiMasi agreed that a substantial portion of industry research is aimed at developing drugs that provide little innovation for the nation’s medicine chest. Would it be fair to say that 40 percent of industry research and development is aimed at me-too drugs, I asked. “That’s a reasonable assumption,” he said.

Dr. Sidney Wolfe, the longtime head of Public Citizen’s Health Research Group, points out, “What is driving the pharmaceutical industry is the need to create new drugs to replace drugs that are already on the market but coming off patent. There are 80 products to treat high blood pressure; the next one to come on the market is likely to be more dangerous than what is already on the market.”

Industry lobbyists reject the charge that much industry research is, from a medical standpoint, unnecessary. “Incremental improvements in drugs have produced the vast majority of clinically important medicines introduced in the last 50 years,” an industry handout says. It cites a Georgetown University study showing that 72 percent of 39 me-too drugs in fact had clinical advantages over their competitors. Moreover, the new drugs lowered prices by introducing competition into the market, the handout says.

Again, the evidence is mixed. In 1997 SmithKline Beecham won FDA approval for carvedilol (Coreg), a beta blocker for congestive heart failure. SmithKline launched the drug with much fanfare and won a significant share of the crowded market. However, a study completed last year showed it was no more effective than metoprolol, a generic beta blocker on the market since 1978. Yet the new drug sold for three times the generic’s price.

In fairness, some searches for me-too drugs intended mainly to take market share from competitors or to replace older drugs coming off patent may yield clinically useful innovations. Some close cousins of rival drugs may in fact work better in some fraction of patients or may have lesser adverse effects for a given patient. In a world with infinite resources, such marginal research outlays would be defensible. But in the real world, they drive up drug prices and keep many patients from the drugs they need.

Research driven by scientific inquiry and public health goals, namely work funded by public agencies, is likely to produce a better use of scarce dollars than research driven by the entrepreneurial desire for market share. Drug companies have a legitimate role in bringing new medicines to market, but it would be better public policy to lower drug prices, even at the cost of deterring some private investment, and to rely more heavily on publicly funded research.

There’s another set of facts about consumer drug expenditures worth remembering: Drug firms’ vaunted research-and-development budgets are rivaled by their marketing campaigns. IMS HEALTH, which tracks the industry closely, reports that direct marketing costs for pharmaceutical firms totaled $13.7 billion in 1999 or 55 percent of their collective research-and-development budget that year. The fastest-growing industry expenditure is direct-to-consumer advertising, which leaped 40 percent to $1.8 billion last year.

Pharmaceutical firms’ research-and-development budgets are also dwarfed by their profit margins, which are by far the highest among U.S. industries. A Congressional Research Service report released last December showed that the pharmaceutical industry declared $24.8 billion in pretax profits in 1996, a year when the industry spent a total of $16.9 billion on research.

PRESCRIPTIONS FOR REFORM

No one doubts that the pharmaceutical industry has played a crucial role in the development of the drugs that are transforming medicine and prolonging many lives. Many path-breaking medicines came solely from industry labs, filled with dedicated scientists. The industry is instrumental in bringing the discoveries of government-funded researchers from the lab bench and the experimental clinic to market.

But that doesn’t mean they can’t do their jobs more efficiently and without imposing undue financial hardships. A good start is recently enacted legislation, sponsored by Representative Bernie Sanders of Vermont, to restore “reasonable pricing” clauses on any NIH-funded research that leads to patents and commercialization of drugs and medical devices. They were eliminated in the mid-1990s after industry lobbying. The problem, however, is that these clauses were never adequately enforced. We need legislation to ensure that publicly funded innovations are broadly available at moderate prices.

Government, or insurers who handle any new drug benefit for the elderly, should be given the power to negotiate bulk discounts with pharmaceutical firms. Democratic Representative Tom Allen of Maine has one such bill. The Clinton administration’s proposal gives that power to regional contractors. A better approach would be to empower Medicare to negotiate drug prices directly. Why should seniors pay the highest price for drugs when pharmacy-benefit managers and insurance companies are already negotiating discounts for their clients? In addition, drug companies should be required to conduct clinical trials for proposed new drugs, comparing the safety and effectiveness of these drugs against both placebos and existing alternatives.

Over the past century, the pharmaceutical industry’s evolution toward science-based medicine has largely been driven by public research and careful government regulation. It’s time for a new set of rules that will give Americans both affordable medicine and research priorities genuinely devoted to developing the next generation of cures.

INFLAMMATORY CLAIMS

The biggest blockbuster of 1999 was Searle’s Celebrex, an anti-inflammatory pain reliever that racked up sales of $1.4 billion in its first year on the market. A massive advertising and marketing blitz allowed it to steal market share from a wide range of nonsteroidal anti-inflammatory drugs (NSAIDs), including over-the-counter medications like ibuprofen that sell for a fraction of the price.

Yet this new class of pain relievers is no more effective than ibuprofen in curbing pain. What’s their attraction? Supposedly, the new drugs reduce such side effects as gastrointestinal bleeding and ulcers. A BusinessWeek piece reported as fact the industry contention that some 30 percent of NSAID users suffered gastric distress. But the package inserts mandated by the FDA say only 3 to 6 percent of users should expect gastric symptoms. And a recent study in Scotland that tracked more than 50,000 people over three years found that 2 percent of NSAID users were hospitalized for gastrointestinal problems after using the drugs for a prolonged period of time, compared to 1.4 percent of people who took no drugs at all.

A Wall Street Journal medical reporter recently repeated company claims that Celebrex and Vioxx could void a large portion of the 100,000 hospitalizations and 16,500 deaths caused by bleeding ulcers and other gastrointestinal problems associated with prolonged NSAID use. But according to the Centers for Disease Control, less than 6,000 Americans died in 1997 from all forms of gastrointestinal bleeding disorders, including ulcers. An academic study on the psychosocial causes of ulcers pointed out that Alexander the Great died at age 32 of acute abdominal pain after several days of binge drinking, presumably from a perforated ulcer. Surely a very substantial fraction of those 6,000 deaths came from causes other than pain relief medicine.

Nor has it even been proven that these new pain relievers will not cause similar gastric problems in the long run. The FDA required Celebrex and Vioxx to carry the same warning labels as other NSAIDs. Several industry-funded studies have appeared recently in academic literature, but even they have suggested the new drugs will eliminate only about one in four gastrointestinal bleeding incidents. “It’s still a question if they have less side effects,” said Raymond Woosley, director of Georgetown University’s Center for Education and Research on Therapeutics. “In trials, they were given in low doses. It may turn out that to take an equally effective dose of Celebrex or Vioxx you have to take higher than the recommended dose, and you also may have bleeding problems.”

MERRILL GOOZNER, professor of journalism at New York University, writes on a variety of business and economics topics.

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Taxpayers have surely noticed Madison Avenue’s recent interest in erectile-dysfunction medications. This week they learned why: They will be footing the Medicare bill for Viagra and similar drugs. The coverage of what are by and large lifestyle drugs seems all-the-more disfigured at a time of fiscal belt-tightening.

Medicare and other publicly funded programs are geared toward providing critical health coverage, not treating erectile dysfunction. Yet Medicare administrators have fairly pointed out that they were simply following the 2003 Medicare law by including Viagra, Cialis and similar medications. According to the law, a drug must be covered by Medicare if it is “medically necessary” and has been approved by the Federal Drug Administration. Sexual-performance drugs can also be used to treat enlarged hearts that can result from high blood pressure. Furthermore, there was no provision in the law excluding sexual-enhancement drugs from coverage, as there were for weight-loss and fertility drugs, barbiturates and non-prescription medications.

The potential for abuse is vast. “Bureaucrats, isolated from fiscal responsibility, have made a thoughtless decision that will accelerate Medicare’s demise,” said Tom Schatz, president of Citizens Against Government Waste. Wage earners help pay for Medicare through payroll taxes.

Doctors are also shielded from the concerns about public spending, and have wide discretion to decide just what is “medically necessary.” Meanwhile, it is becoming increasingly clear just how expensive the drug-benefit portion of Medicare will be. On Tuesday, Medicare chief Mark B. McClellan said the bottom-line cost of the drug benefits package is estimated to be $720 billion from 2006 to 2015. In September, he said the package would cost $534 over 10 years and the administration had originally said the cost would be about $400 billion. In light of that considerable and mounting sum, the potential abuse related to erectile-dysfunction drugs is all the more worrisome.

Congress will have to do more than worry, though. Lawmakers will have to broadly review the potential for waste under the 2003 law and consider if new legislation is needed to rein it in, even if this means more narrowly defining the meaning of “medically necessary.”