Oliver Wendell Holmes recognized that it was nonsense back in 1842 when he wrote “Homeopathy and Its Kindred Delusions.” We long ago gave up the nonsense of trying to balance the four humors by bloodletting and purging, but the homeopathy Energizer Bunny is still marching on. What makes it so indestructible?
One reason is a lack of understanding about what homeopathy really is, even among health care providers. I recently heard about a nurse who thought “homeopathic” just referred to any mild natural herbal remedy. In case any readers are similarly confused, here’s a brief overview. Homeopathy was invented by Samuel Hahnemann in the late 1700s. It is based on the now-outdated principle that “like cures like,” and the lower the dose the better in homeopathy. If coffee keeps you awake, highly diluted coffee will put you to sleep. The more dilute the coffee, the better you will sleep.

To figure out what remedy works for what symptoms, you do a “proving” by giving a substance to healthy people and writing down every symptom they have for the next few days (without trying to determine whether the symptom was due to the substance or was just coincidental). You make a remedy by diluting that substance many times and shaking it (succussing) at each step. You look up a patient’s symptoms in a book listing all the different proving results, and you give him the remedy that best matches what ails him.

For one remedy, the book lists symptoms in 19 body systems, with entries such as this one: “Pain in back, with desire for some firm support. Every movement accelerates the circulation. Palms hot and perspiring. Nasal discharge or dry nose. Hangnails. Warts. Chill between 9 and 11 AM. Coldness of legs with congestion to head, chest, and stomach. Sleepy in forenoon. Dreams of robbers…” It goes on like that for pages. All of those symptoms were reported in provings by healthy people after they ingested Natrum muriaticum. That’s table salt. How could anyone seriously believe that table salt causes all those symptoms, or for that matter believe that a dilute salt solution could relieve all those symptoms?

How dilute? Serious dilution, as in comparable to one drop diluted in all the water on Earth. When they realized that no molecules of the original substance were left in most homeopathic dilutions, homeopaths rationalized that the water must “remember” what it had come into contact with — as in clusters of water molecules somehow holding the memory of their encounters with the allegedly curative substances. Unfortunately, homeopaths have failed to explain how water can remember what it’s supposed to remember, and forget all the other memories of coming into contact with various trace contaminants, elements, bacteria, and whatever else happened to float by at the time.

In homeopathy, any substance can be a remedy; even a non-substance. My favorite is “eclipsed moonlight.” I’ve been trying to find out how they collect it to prepare the remedy; no one’s talking. And then there was the homeopath who was selling homeopathic vaccines for smallpox and anthrax, which he said were made by diluting the real thing. I reported him to Homeland Security, because if he can get the real thing, so can terrorists. Jacques Benveniste is infamous for winning two IgNobel prizes for homeopathy studies: the first one couldn’t be replicated when proper blinding controls were used; in the second one, he claimed to have sent the electronic signature of the remedy over the Internet.

The Benveniste basophile degranulation study was a convoluted attempt to show that water could remember. It was supposedly replicated in other labs, notably by Ennis. Homeopaths are still citing these studies as evidence for the memory of water, but this is intellectually dishonest. In the first place, the studies are completely discredited by the fact that every attempt to repeat them with proper blinding has failed. When James Randi and a team from Nature visited Benveniste’s lab, his experiment stopped working. When Ennis’s experiment was repeated for Randi’s million dollar prize on the BBC show Horizon, it failed. If the experiment really worked under proper blinding conditions, someone could have easily won the million dollars by now.

In the second place, homeopaths don’t seem to realize that if the results of those experiments were valid, it would mean that homeopathy couldn’t possibly work as advertised. The effects went up and down with consecutive dilutions rather than steadily upwards, and it appears that they got a similar effect from a dilution as from the full strength solution, rather than getting the expected opposite effect.
Homeopathy is about as silly as it gets. Silly wouldn’t matter if it worked, but it doesn’t. People think it works because they get placebo effects and the homeopath keeps them entertained while they get better on their own.

One recent meta-analysis claimed to have found that homeopathy worked better than a placebo in general, but that it didn’t work better than placebo for any specific condition. I’m still trying to wrap my brain around that. That’s like saying broccoli is good for all people but it isn’t good for men or women or children. Other meta-analyses have been negative, especially the ones that looked at only the higher quality studies. A recent editorial in the British medical journal Lancet proclaimed “The end of homeopathy.”

Perhaps the most promising development is that Edzard Ernst, MD, has spoken out strongly against homeopathy. This is important because he was a practicing homeopath and the world’s first professor of complementary medicine. For the last 15 years he has led a team of researchers studying the evidence for alternative medicine, and he now concludes, “With respect to homeopathy, the evidence points towards a bogus industry that offers patients nothing more than a fantasy.”

Despite science and reason, homeopathy isn’t about to go away. It has some really good things going for it. When you visit a homeopath, he wants to know all about you. He gives you far more time and attention than your MD does. He picks a special treatment designed just for you. If it’s not working he has an explanation and something else to try next time. He’s always confident he can help you get better. Homeopathy is inexpensive. It has no side effects. It’s the ideal placebo. It’s great for the worried well and the hypochondriac. It’s great for those elusive symptoms scientific medicine cannot diagnose and cure. It’s harmless except in cases where patients are persuaded to forgo effective medical treatment, or when homeopathic vaccines are offered in lieu of real vaccines.

It’s popular in Great Britain where Queen Elizabeth uses it, Prince Charles promotes it, five homeopathic hospitals are still operating, and the National Health Service is paying a good chunk of its budget for it.

Let’s say you aren’t sleeping well. You could go to an MD and get a prescription sleeping pill that only works a little better than a placebo and has side effects, or you could go to a homeopath and get a placebo that has no side effects and is a lot cheaper. You’re probably better off with the placebo. Why don’t MDs prescribe placebos? Because it’s unethical: we don’t lie to patients; we can’t tell them a remedy is effective if we know it is no more effective than a sugar pill.

It’s easy to see how doctors could be persuaded that homeopathy works. Patients tell them they feel better. That’s why bloodletting and purging lasted so long: patients got better despite the treatment and the treatment got the credit. That’s why we have to do randomized controlled trials to make sure just as many patients don’t get better without treatment.

The arguments homeopaths use to support their beliefs would earn an F in a Logic 101 course. Here are just a few taken from “Presenting 50 Facts About Homeopathy” by Louise Mclean.

• Hippocrates said there was a law of similars. [Hippocrates also said all illness was due to an imbalance of the four humors.]
• Homeopathic provings are a more scientific method of testing than the orthodox model. [If you say something totally false often enough, someone might start to belief it.]
• There are more than 4000 homeopathic remedies. [None of which work]
• The exact substance in a homeopathic remedy is known, unlike most modern drugs where we are rarely informed of the ingredients. [What? We are informed if we know how to read!]
• Homeopaths treat genetic illness, tracing its origins to six main genetic causes: Tuberculosis, Syphilis, Gonorrhea, Psora (scabies), Cancer, Leprosy. [Geneticists would be surprised to hear this.]
• Homeopathy got better results than conventional treatment in epidemics of cholera and typhoid in the 19th century. [Only because 19th century conventional treatment did more harm than good. Today’s conventional medicine is a bit more effective.]
• Lots of people believe in homeopathy. [Lots of people believe in ghosts and angels, but that doesn’t make them real.]
• Big Pharma doesn’t want us to know how well homeopathy works. [Conspiracy theories are alive and well.]
• Queen Elizabeth never travels anywhere without her homeopathic vials of medicine. [And Madonna uses Kabbalah water.]

Arguments like these just highlight the intellectual bankruptcy of the homeopathic belief system. They would love to find scientific validation, but they reject science when it doesn’t support them. One repeated excuse is that the remedies are individualized so they don’t lend themselves to controlled trials. That’s just nonsense. A homeopath could prescribe individualized remedies and third parties could randomly dispense either what had been prescribed or a placebo control. Neither patient nor homeopath would know which the patient got.

Homeopathy was humbug in 1842. It’s still humbug today. That’s a diagnosis you can prescribe to everyone.

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To start with, this ancient Chinese treatment is not so ancient and may not even be Chinese! From studying the earliest documents, Chinese scholar Paul Unschuld suspects the idea may have originated with the Greek Hippocrates of Cos and later spread to China. It’s definitely not 3000 years old. The earliest Chinese medical texts, from the 3rd century BC, do not mention it. The earliest reference to “needling” is from 90 BC, but it refers to bloodletting and lancing abscesses with large needles or lancets. There is nothing in those documents to suggest anything like today’s acupuncture. We have the archaeological evidence of needles from that era — they are large; the technology for manufacturing thin steel needles appropriate for acupuncture didn’t exist until about 400 years ago.

The earliest accounts of Chinese medicine reached the West in the 13th century: they didn’t mention acupuncture at all. The first Westerner to write about acupuncture, Wilhelm Ten Rhijn, in 1680, didn’t describe acupuncture as we know it today: he didn’t mention specific points or “qi;” he spoke of large gold needles that were implanted deep into the skull or “womb” and left in place for 30 respirations.

Acupuncture was tried off and on in Europe after that. It was first tried in America in 1826 as a possible means of resuscitating drowned people. They couldn’t get it to work and “gave up in disgust.” I imagine sticking needles in soggy dead people was pretty disgusting.

Through the early 20th century, no Western account of acupuncture referred to acupuncture points: needles were simply inserted near the point of pain. Qi was originally vapor arising from food, and meridians were channels or vessels. A Frenchman, Georges Soulie de Morant, was the first to use the term “meridian” and to equate qi with energy — in 1939. Auricular (ear) acupuncture was invented by a Frenchman in 1957.

The Chinese government tried to ban acupuncture several times, from 1822 to the Chinese Nationalist government in World War II. Mao revived it in the “barefoot doctor” campaign in the 1960s as a cheap way of providing care to the masses; he did not use it himself and he did not believe it worked. It was Mao’s government that coined the term “traditional Chinese medicine” or TCM.

In 1972 James Reston accompanied Nixon to China and returned to tell about his appendectomy. It was widely believed that his appendix was removed under acupuncture anesthesia. In reality, acupuncture was used only as an adjunct for pain relief the day after surgery, and the relief was probably coincident with the expected return of normal bowel motility. A widely circulated picture of a patient allegedly undergoing open heart surgery with acupuncture anesthesia was shown to be bogus. If acupuncture is used in surgery today, it is used along with conventional anesthesia and/or pre-operative meds, and it is selected only for patients who believe in it and are likely to have a placebo response.

As acupuncture increased in popularity in the West, it declined in the East. In 1995, visiting American physicians were told only 15–20 percent of Chinese chose TCM, and it was usually used along with Western treatments after diagnosis by a Western-trained physician. Apparently some patients choose TCM because it is all they can afford: despite being a Communist country, China does not have universal health coverage.

There were originally 360 acupuncture points (based on the number of days of the year rather than on anatomy). Currently more than 2000 acupuncture points have been “discovered” leading one wag to comment that there was no skin left that was not an acupuncture point. There were either 9, 10, or 11 meridians — take your pick. Any number is as good as another, because no research has ever been able to document the existence of acupuncture points or meridians or qi.

Does acupuncture work? Which type of acupuncture? And what do you mean by “work”? There are various different Chinese systems, plus Japanese, Thai, Korean and Indian modalities, most of which have been invented over the last few decades: Whole body or limited to the scalp, hand, ear, foot, or cheek and chin; deep or superficial; with electrified needles; with dermal pad electrodes and no skin penetration.

Acupuncture works in the same manner that placebos work too. Acupuncture has been shown to “work” to relieve pain, nausea, and other subjective symptoms, but it has never been shown to alter the natural history or course of any disease. It’s mostly used for pain today, but the ancient Chinese maintained that it was not for the treatment of manifest disease, was so subtle that it should only be employed at the very beginning of a disease process, and was only likely to work if the patient believed it would work. Now there’s a bit of ancient wisdom!

Studies have shown that acupuncture releases natural opioid pain relievers in the brain: endorphins. Veterinarians have pointed out that loading a horse into a trailer or throwing a stick for a dog also releases endorphins. Probably hitting yourself on the thumb with a hammer would release endorphins too, and it would take your mind off your headache.

Psychologists can list plenty of other things that could explain the apparent response to acupuncture. Diverting attention from original symptoms to the sensation of needling, expectation, suggestion, mutual consensus and compliance demand, causality error, classic conditioning, reciprocal conditioning, operant conditioning, operator conditioning, reinforcement, group consensus, economic and emotional investment, social and political disaffection, social rewards for believing, variable course of disease, regression to the mean — there are many ways human psychology can fool us into thinking ineffective treatments are effective. Then there’s the fact that all placebos are not equal — an elaborate system involving lying down, relaxing, and spending time with a caring authority can be expected to produce a much greater placebo effect than simply taking a sugar pill.

There are plenty of studies showing that acupuncture works for subjective symptoms like pain and nausea. But there are several things that throw serious doubt on their findings. The results are inconsistent, with some studies finding an effect and others not. The higher quality studies are less likely to find an effect. Most of the studies are done by believers in acupuncture. Many subjects would not volunteer for an acupuncture trial unless they had a bias towards believing it might work. The acupuncture studies coming from China and other oriental countries are all positive — but then nearly everything coming out of China is positive. It’s not culturally acceptable to publish negative results because researchers would lose face and their jobs.

The biggest problem with acupuncture studies is finding an adequate placebo control. You’re sticking needles in people. People notice that. Double blinding is impossible: you might be able to fool patients into thinking you’ve used a needle when you haven’t, but there’s no way to blind the person doing the needling. Two kinds of controls have been used: comparing acupuncture points to non-points, and using an ingenious needle in a sheath that appears to have penetrated the skin when it hasn’t.

In George Ulett’s research, he found that applying an electrical current to the skin of the wrist — a kind of TENS (transcutaneous electrical nerve stimulation) treatment — worked just as well as inserting needles, and one point on the wrist worked for symptoms anywhere in the body.

Guess what? It doesn’t matter where you put the needle. It doesn’t matter whether you use a needle at all. In the best controlled studies, only one thing mattered: whether the patients believed they were getting acupuncture. If they believed they got the real thing, they got better pain relief — whether they actually got acupuncture or not! If they got acupuncture but believed they didn’t, it didn’t work. If they didn’t get it but believed they did, it did work.

A 2005 study published in the Journal of the American Medical Association compared the experiences of 302 people suffering from migraines who received either acupuncture, sham acupuncture (needles inserted at non-acupuncture points), or no acupuncture. During the study, the patients kept headache diaries. Subjects were “blind” to which experimental group they were in; the evaluators also did not know whose diary they were reading. Professional acupuncturists administered both the acupuncture and sham acupuncture treatments. Interestingly, although 51 percent of the acupuncture group showed a reduction in headache days by half (compared to 15 percent in the control group), but 53 percent of the sham acupuncture group had a 50 percent reduction in headache days!

Considering the inconsistent research results, the implausibility of qi and meridians, and the many questions that remain, it’s reasonable to conclude that acupuncture is nothing more than a recipe for an elaborate placebo seasoned with a soupcon of counter-irritant. You can play human pincushion if you want, and you might get a good placebo response, but there’s no evidence you’ll get anything more.

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Four years later they decided to have their first child. Then, Michelle went back on the pill, but she conceived and had a miscarriage. At that point they talked with a Christian medical doctor and read the fine print in the contraceptives package.

They found that while taking the pill you can get pregnant and then miscarry. They were grieved! They were Christians! They were pro-life! They realized that their selfish actions had taken the life of their child.

They prayed and asked God to forgive them, and to teach them to love children like He loves children. They asked God to bless them with as many children as He saw fit in His timing. Right after that Michelle got pregnant with twins!

To date they have been blessed with 17 children, (10 boys and 7 girls) Joshua, Jana & John-David (twins), Jill, Jessa, Jinger, Joseph, Josiah, Joy-Anna, Jedidiah & Jeremiah (twins), Jason, James, Justin, Jackson, Johannah, Jennifer (and #18 due in January 2009!).

Not be outdone . .

A Romanian immigrant has given birth to her 18th child in British Columbia, making her the province’s most prolific mother in 20 years.

Proud dad Alexandru Ionce said Saturday that his 44-year-old wife, Livia, gave birth on July 22. Their daughter Abigail weighed in at 7 pounds, 12 ounces (3.5 kilograms).

“We never planned how many children to have. We just let God guide our lives, you know, because we strongly believe life comes from God and that’s the reason we did not stop the life,” Alexandru Ionce said.

The couple immigrated to Canada from Romania in 1990 and now live in Abbotsford. Their 17 other children range in age from 20 months to 23 years.

Ionce said he did not know if the couple would have more children. The family now has 10 girls and eight boys.

“We would have liked a boy to be even,” he said. “We thank God all of them are healthy and happy.”

Alarmed health authorities in India’s Kottayam district have set up a sign dispelling rumors of a miraculous image in the sky and warning of the dangers of looking into direct sunlight.

Forty-eight cases of sight-loss, allegedly caused by photochemical burns on the retina, have been recorded at St Joseph’s ENT and Eye hospital in the region since Friday.

Despite warnings, and the potentially harmful effects of their actions, believers are allegedly still flocking to a hotelier’s house in Erumeli near where the divine image is said to have appeared.

“All our patients have similar history and symptoms… They have developed photochemical, not thermal, burns after continuously gazing at the sun,” Dr Annamma James Isaac, the hospital’s ophthalmologist said.

Even churches in the area have disowned the miracle after health officers and doctors approached the clergy.

The house where the miracle is said to have occurred has apparently been the subject of rumors for months.

The hotelier, who has since moved, had claimed that statues of the Virgin Mary in his house have been crying honey and bleeding oils and perfumes.

Hang on a sec – have you looked at the nutritional charts for this stuff? 200+ calories and over 34 7 grams of saturated fat? Holy Crap!

Anyway: Yes, the labels are turned to the camera in an unnatural way. Yes, the pawns smile an unnervingly robotic smile.

But Wait! The best part? It’s not even real coffee. It’s just a plastic simulation of iced coffee. From the Las Vegas Sun:

Two cups of McDonald’s iced coffee (BUY!) sit on the Fox 5 TV news desk, a punch-you-in-the-face product placement (BUY!) to chase down your morning news.

They’ve been on the Las Vegas station set for about two weeks, following the lead of a few TV stations across the country, and they’re still looking every bit as frosty and tantalizing (BUY!) as they were the first day you laid your eyes on them.

But wait, here’s the best part: They’re not real. Fake coffee on the real news, two plastic cups permanently filled with some kind of bogus drink. The anchors aren’t even supposed to acknowledge them, McDonald’s reps explain. That’s part of their genius, my little lambs! They get into your mind without you knowing it. So they just sit there, two logo-emblazoned plastic cups, percolating into the psyche. Made-to-scale models that weigh something like seven pounds each — refreshing, and bottom-line boosting!

Curious what’s in ‘em? From the McDonald’s website, these are the ingredients for a Vanilla Iced Coffee:

Premium Roast Coffee. Light Cream: Milk, cream, sodium phosphate, sodium polyphosphate, DATEM, sodium stearoyl lactylate, tetra sodium pyrophosphate, sodium hexametaphosphate, sodium citrate, carrageenan CONTAINS: MILK. Vanilla Syrup: Sugar, water, fructose, natural (plant source) and artificial flavor, caramel color (with sulfites), potassium sorbate (preservative), citric acid, malic acid, Ice.

And are you curious what those long, confusing words mean?

sodium stearoyl lactylate – a solid powder irritating to eyes and skin, and hazardous in case of inhalation.

tetra sodium pyrophosphate – when ingested it can cause nausea, vomiting, and diarrhea.

sodium hexametaphosphate – the Material Safety Data Sheet warns “do not ingest.”  Synonym of Sodium Polyphosphate (above).

More details on the rest of the ingredients over at this website.

Yummy, Yum, Yum! I’m Lovin’ It!

State police say they arrested a man early Tuesday whose blood alcohol level was 0.491 percent — the highest ever recorded in Rhode Island for someone who wasn’t dead.

Kobierowski, 34, of North Providence, was arrested after he drove into a highway message board on Interstate 95 in Providence, O’Donnell said.

After police arrived, Kobierowski had trouble getting out of the car, then grabbed it and refused to move, forcing troopers to carry him to the breakdown lane before taking him back to their barracks, O’Donnell said.

A breath test showed blood alcohol readings of 0.489 percent, followed by 0.491, O’Donnell said, the highest readings state officials could remember for someone who didn’t end up dead.

The legal limit in Rhode Island is 0.08. A level of 0.30 is classified as stupor, 0.4 is comatose and 0.5 is considered fatal, according to the health department.

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product – even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.

Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent.

The F.D.A. did not warn the public of the potential risks until November 2005 – six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.

“We have regularly disclosed data to the F.D.A., the medical community and the public in a timely manner,” Ms. Vanderham said. “Ortho Evra is a safe and effective birth control option for women when used according to the labeling.”

But Janet Abaray, a plaintiff’s lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities.

“Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies,” Ms. Abaray said.

A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.”

The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School.

Last month, at a trial over the schizophrenia drug Zyprexa, Dr. John Gueriguian, a scientist who worked at the F.D.A. for two decades, testified that the agency did not always ask for strong warnings even if it believed a drug was risky. Companies typically oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Dr. Gueriguian said.

“We at the F.D.A. know what we can obtain and we cannot obtain,” Dr. Gueriguian said. “We have many, many problems, and we have a management system – what we can’t obtain we will not ask.”

For years, top officials at the agency acknowledged that lawsuits could aid the agency’s oversight of safety issues. In the last decade, suits over Zyprexa, the withdrawn pain pill Vioxx, the withdrawn diabetes medicine Rezulin, the withdrawn heartburn medicine Propulsid and several antidepressants have shown that companies played down the risks of their medicines and failed to disclose clinical trials to the public even as they have aggressively marketed their drugs.

But now, the agency says a proliferation of lawsuits could lead to an overlapping patchwork of rules that would burden companies and might discourage patients from taking useful medicines.

The Ortho case, however, suggests that Johnson & Johnson, like other drug makers, is not always quick to tell the F.D.A. about potential problems with its medicines.

In 1996, the company told the agency it planned to develop the Ortho Evra patch in part because it would be likely to expose women to less estrogen than pills. The company suggested that the body would not break down hormones delivered via the patch as readily as the pill, so lower doses could be used to achieve contraception. And unlike the pill, which must be taken daily, the patch is changed weekly.

High doses of estrogen are known to raise the risk for blood clots that can cause heart attacks and strokes.

But a crucial trial completed in 1999 showed that the patch delivered 30 to 38 micrograms of estrogen into the bloodstream each day, according to company documents.

Because up to half of the estrogen in pills is lost in the digestive tract before it reaches the blood, the study suggested that the patch delivered an amount of estrogen that could be as high as a pill containing 76 micrograms of estrogen. In 1988, the F.D.A. banned birth control pills with more than 50 micrograms of estrogen.

But the study’s author, Dr. Larry Abrams, who has since retired from Johnson & Johnson, decided to apply a “correction factor” to the results of the 1999 trial, according to documents. He claimed that the patch actually delivered about 40 percent less estrogen than the trial results showed – about 20 micrograms a day.

Dr. Abrams made the change, according to his deposition, to adjust for the different ways the body metabolizes hormones from pills and patches. This adjustment was never part of the study protocol, a plan filed with the F.D.A..

“The judgment was made by the pharmacokeneticists at the time that in doing the calculation, it was probably appropriate to make that correction,” Bob Tucker, a lawyer representing Johnson & Johnson, said in an interview Thursday. “Later on when people looked at it in a different time frame, they concluded that probably the correction shouldn’t be applied.” The company mentioned its decision to use the “correction factor” only once in a 435-page report filed with the F.D.A., and then only in a complex mathematical formula. When the study was published in 2002, there was no reference to the alteration.

Mr. Tucker said that the F.D.A. was aware of the “correction factor.”

Clinical trials conducted before the patch was approved raised other red flags, as patients complained of breast soreness and nausea. “The side effects seem related” to high estrogen doses, one company scientist wrote in an e-mail message.

Two other studies, one conducted in 1999 and another in 2003, confirmed that the patch released more estrogen than the pill. Still, Johnson & Johnson delayed reporting those results to the food and drug agency, according to documents that have been made public in lawsuits.

After the patch was approved, the company marketed it as releasing 20 micrograms of estrogen to the blood every 24 hours, a figure it now acknowledges was inaccurate. It also acknowledges that the patch releases more estrogen than the pill but says that the estrogen released under the two methods cannot be directly compared.

The New York Times provided the drug agency with a copy of a court brief and asked whether agency medical reviewers were aware of the “correction factor.”

Rita Chappelle, an F.D.A. spokeswoman, replied, “At present, we are reviewing the allegations and cannot comment further at this time.”

Prescriptions for the patch grew rapidly after its introduction, reaching more than 900,000 by March 2004, according to data from Wolters Kluwer, a company that tracks prescription trends. But as the use of the patch rose, so did reports of side effects.

By 2004, after the death of Zakiya Kennedy, an 18-year-old college freshman in New York, food and drug officials had become concerned.

In November 2005, the agency announced that it had placed a warning that the patch “exposes women to higher levels of estrogen than most birth control pills.”

Since then, an epidemiological study has shown that women on the patch can have as much as double the risk of blood clots than those taking pills. And prescriptions for the patch have fallen 80 percent.

Still, lawyers for Johnson & Johnson say that patients should not be allowed to sue the company because the F.D.A. approved the patch and its label.

“F.D.A. is responsible for making those decisions,” said John Winter, a lawyer for the company.

Judge David A. Katz of Federal District Court for the Northern District of Ohio is expected to rule soon on whether any of the lawsuits against Johnson & Johnson can go forward.

In the fall, the Supreme Court will hear a separate pre-emption case involving Wyeth, another drug company. Chris Seeger, a plaintiffs’ lawyer who has about 125 Ortho Evra cases, said he expected the court to rule in Wyeth’s favor.

“Our lawsuits are the ultimate check against the mistake made by the government, or fraud made by the companies against the government, or just an underfunded bureaucracy stretched thin,” he said.