Saturday, August 25, 2007

Yoga The Best Way To Relieve Back Pain

Many people are turning to yoga. It may sound like a exercise fad. It might even sounded like a new age religion, but yoga is about purifying our body, mind and soul. It is a lifestyle. Yoga is an ancient cultural heritage of India and it derives from the Sanskrit with means “to unite.” It is a form of discipline which combines moral and mental refinement that leads to good health and longevity. It promotes a sense of well being that gives peace and positive outlook in life. Yoga is for young and old and doing Yoga is good for people who need back pain relief.

The back portion of our body is a structure made up of bone, muscles,soft tissues and nerves. You tend to rely on your back to be the workhorse of the body. The back can be particularly vulnerable to injury and pain. In fact, back pain is the most common reasons why people seek help from chiropractors, doctors and frequented the Spas for their massages as a form of a natural pain relief. Injuries due to overexertion and poor posture are among the most common why we developed back pain. Yoga is said to be a natural pain relief.\

But before tying yoga, it's best to get your doctor's “go” signal because there are back pains which is often a result of a bio-mechanical imbalance in spinal structures, Once you thoroughly discussed it with your doctor; then that was the time to find a good yoga teacher. That yoga teacher can advise you on how far you can go with the yoga exercises and can decide which is safe for your particular type of condition. But if yoga is done without proper instruction, back pain relief may become your next mantra.

The Kinds of Yoga Exercises For a More Meaningful Back Pain Relief

Pelvic Tilts – is a classic therapeutic exercise used to stabilized body posture by strengthening the core musculature.

Supported Bridge Pose - this pose elevates the pelvis.

Recline Big Toe Pose - this pose addresses postural problem with a gentle stretch to the hamstring muscle

Supine Spinal Twist – it gently twists your spine while you are laying on the floor

IT'S A BALANCING ACT

Doing yoga to as a natural back pain relief cultivates a balance between strength and flexibility of the muscles of the body. Yoga releases the tension in the muscles, therefore, improving back pain. A particular yoga style called the “hatha” is highly recommended and so does rest and restoration classes. The hatha yoga is main emphasis is on alignment and it also incorporates breathing techniques which serves as a stress relief.

Your Yoga teacher can help you out with the manual adjustments. After all, the very nature why most people are leaning towards yoga is because it is really good for those who have back problems. But don't forget that there is limits on what you can do while practicing yoga to as a back pain relief. Also try balancing yoga with the age-old practice of meditation which has been scientifically proven to maintain overall health and boost body resistance to some diseases.

Thus, yoga is one way to heal your back pains, it increases blood circulation, maintain a natural curvature of the spine which is crucial in avoiding lower back pain and an excellent therapy for sore back muscles, it helps reduces the risk of disability brought by back pain. However, if doing yoga increases your back pain that is the only time you should stopped until absolute back pain relief is achieved.

Sunday, May 20, 2007

Tension Type Headaches

Nothing can put you down as fast as a headache of any type - but tension type headaches, which are also called stress headaches often keep us from accomplishing things that we have set out to do. Tension headaches commonly come on in the middle of the day - when we need to be at our best - making it difficult to get our work done or live our lives normally in many cases.

Most sufferer’s of tension headaches report a constant dull ache on both sides of their heads. These headaches come on slowly, and gradually increase in intensity. A tight feeling in the head and neck may also be experienced. Sometimes the pain is only mild, and sometimes they are severe. Some people report that their tension headaches are worse than a migraine headache. As with most headaches, sensitivity to light is often reported as well.

Tests are not usually required to diagnose a tension headache. Most doctors recognize the problem when the symptoms are reported. However, if you experience tension headaches on a regular basis, especially when there is nothing going on that might cause regular tension headaches, your doctor may order x-rays, a CT scan, an MRI, or blood tests just to rule out other, more serious, possibilities.

How tension headaches are treated is usually determined by the frequency of the headaches. For occasional tension headaches, over the counter pain relievers are often used. You should always read the labels of any type of headache pain relief medication you choose, and do not take it for an extended period of time. If the headaches are not occasional, see your doctor.

For frequent tension headaches, over the counter pain reliever may not work, or may eventually stop working as your body becomes accustomed to the medication. Stronger pain relief medication will most likely be prescribed. You may also need to take anti-anxiety medications as well. Again, this will be determined by your doctor based on the severity and frequency of the headaches.

Because light tends to make tension headaches worse, you should wear a pair of sunglasses to reduce light rays. Sunglasses can often even prevent the headaches. There are companies that offer sunglasses designed specifically for headache sufferers. These sunglasses not only help prevent headaches, they also prevent headache pain from becoming worse.

It is important to know that as headache pain increases it becomes harder to treat the pain. Tension headaches should be treated at the first sign, not when the pain becomes worse. You can treat the headache, from the onset, by putting on sunglasses to reduce the light, taking pain reliever - even though the pain isn’t very bad, and by getting away from a stressful situation that may have caused the headache.

You don’t have to completely forget about the stressful situation, but you can get away from it for just a little while and relax a bit. In more serious cases, a vacation may even be required. Sometimes, stress can become overwhelming it does more than cause a headache. It can make us very sick, and cause high blood pressure as well! This, in turn, can lead to even more serious health problems.

Other treatments include taking a hot bath or shower and/or using heat or ice on your neck or head. Tension headaches can be prevented, again, by wearing sunglasses in bright light, and also by making sure that you get plenty of sleep at night. Regular exercise will also reduce tension headaches. Avoiding stressful situations also helps.

Again, if you have tension headaches on a regular basis, you should really seek the advice of your health care provider. Over the counter medication won’t always help in these situations, and it may even signal a more serious problem.

Thursday, May 17, 2007

Muscle Pain Relief: The Fastest Ways to Alleviate that Muscle Pain

Muscle pain is a normal experience for all of us; this could be blamed on a couple of reasons. Muscle pain can be due to overstretching the muscles or for some people, just because an advanced age. The muscle adjusts to the extended movement by causing microscopic tears in the tiny fibers of the ligaments and tendons. This is a natural response, but it requires that you give the muscles time to recover before the next session.

Most muscle pain is due to tension and overuse that may lead to inflammation. It is a severe condition that involves the connecting tissues that cover the muscles. For those in their prime, muscle pain may be because the muscles are weak already and can't withstand extended use.

Muscle pain syndrome could possibly affect either a single muscle or a muscle group. In select cases, the bodily location where a person senses the pain may not actually be where the pain generator is found. Professionals think that the actual location of the injury or the strain gives rise to the growth of a trigger point that, successively, causes pain in an alternate area. This particular pain feeling is regarded as referred pain.

A condition like this evolves from an injury or excessive strain on a certain muscle or muscle group, tendon or ligament. Other possible causes may include:

•Injury to inter vertebral disc•
•Injury
•Illness
•General fatigue/stress
•Repetitive motions
•Over usage of muscles
•Medical conditions such as heart attack and stomach irritation
•Some prescription medications

Because muscle pain has become a common problem for most everybody, the search for an effective and fast relief for muscle pain is common. An effective muscle pain remedy may come from a number of methods. A few methods include a hot shower or ice applied directly to the soreness, these usually are a great way to feel relief fast, albeit temporary. Somewhat helpful muscle relief comes from non-prescription drugs like ibuprofen, naproxen sodium, or even aspirin. Even stronger prescription medication could be used including Carisoprodol, Cyclobenzaprine, Soma and Skelaxin.

If you are looking for some great muscle pain relief methods every time you experience muscle pain, here are some useful tips which you can follow:

1. Do the RICE method (rest, ice, compression and elevation). Most athletes do this to avoid injury during practice. All you have to do is rest your sore muscles for 48 hours. During rest time wrap some ice cubes in a thin cloth and apply it to the affected area of your body for 20 minutes at a time.



2. muscle and also remove carted off lactic acid because muscle waste can be a great contribution to pain.

3. Seek some help from your medicine cabinet. Take aspirin or ibuprofen to reduce the pain for at least half an hour.

4. Massage the affected area. Rub some warm cloth to the affected area. Stop rubbing that location if it makes the pain worse. A massage usually is a fairly good method for relief; it can be very comforting and helpful if done by a knowledgeable masseuse.

5. Balm soreness. Use liniment containing menthol under heat pads on the painful area.

Also, here are list of effective pain relievers that can be of great help to you too.



1. MSM (Methyl Sulfonyl Methane)

This is used around the world for aching joint pain relief. Remember that most of these muscle pains are caused by inflammation. Inflammation is often a build up of toxins inside the joints, muscles and body fluids. MSM makes the walls of individual cells more permeable which makes it much easier for the cells to eject toxins and absorb nutrients.

2. EMU oil

This very closely associated to the natural oils found in the human body, which makes it easily absorbed into the skin. Since emu oil is so easily absorbed it will not leave a greasy feeling and goes quickly to the source of the pain. Emu oil also helps to relax the muscles.

3. Arthro-Pain Cream

This is especially effective when you are having trouble sleeping due to pain. This is odorless and will not stain your clothing. Arthro-Pain cream is specially formulated to be alkaline to help the nutrients be easily absorbed into the body and to help the body detoxify.

4. Muscle Relaxants

Muscle relaxants like Carisoprodol (Soma) (buy Soma at online pharmacy ) will remedy the stiffness and pain from strains, injuries, muscle spasms and sprains. These muscle relaxors will provide major comfort for soreness or pain from these conditions. Remember to consult with a doctor first.

If you have already tried many of the muscle pain relief methods mentioned above and nothing works, follow-up with your doctor. He or she may prescribe a temporary prescription medication similar to Carisoprodol or recommend another remedy suited especially for you. If left untreated, simple muscle pain can lead to a more serious injury, as in all things with your body, consulting a doctor is still the best idea.

Thursday, May 10, 2007

Antidepressants for pain in rheumatic conditions

ain is the main symptom of many rheumatic and inflammatory conditions, and when it cannot be controlled effectively with analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), or opioids, additional treatment with an antidepressant may be helpful, the authors comment. Although the use of antidepressants is increasing for conditions such as fibromyalgia, rheumatoid arthritis, spondylarthropathies, and osteoarthritis (OA), there are questions concerning the use of these drugs. For instance, does the analgesic effect depend on the antidepressant effect? When is such treatment appropriate and how long should it be continued?

In an attempt to answer some of these questions, the authors reviewed the medical literature (from 1996 to 2002) and also drew on expert opinion within the group. The panel comprised seven rheumatologists, one psychiatrist, and one neurologist; two of the members were also pharmacologists. They present the document as "a starting point for discussion" and designed it to be "flexible enough to gain practical acceptance in different countries."


Tricyclics are first choice for analgesia

The analgesic effects of antidepressants have been demonstrated most convincingly for tricyclic antidepressants (TCAs), such as amitriptyline, but the evidence is "conflicting" for selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, the authors note. The analgesic effects appear to be independent of the effect on mood; pain relief is usually observed within one week of starting treatment, whereas the antidepressant effect usually occurs after the first two weeks. But side effects are similar whether the drugs are used to treat pain or depression.

Before initiating treatment with a TCA, the physician should check for orthostatic hypotension and perform an electrocardiogram, the group notes. In elderly patients starting TCAs, physicians should monitor blood pressure, cognition, and intestinal transit. No tests are necessary before initiation of treatment with an SSRI. Assessment of treatment efficacy should not be limited to pain evaluation but should also include functional evaluation, analgesic consumption, sleep evaluation (quality and duration), and psychological assessment. These should be started after one week of treatment.

The first choice of antidepressant for pain in patients who are not depressed is a TCA, initiated at low dose and then increased to the maximal-tolerated or minimal-effective dose. Antidepressant therapy should be integrated into a global management program along with nonpharmacological approaches, the experts write. There is no optimal duration, but treatment should last for at least four weeks before being stopped for lack of efficacy. After three to six months of remission, the dose may be gradually decreased; stopping abruptly may precipitate side effects (nausea, vomiting, trembling).


Rheumatic conditions

The experts also reviewed the clinical-trial data available for individual rheumatic conditions and add the following comments:

  • In fibromyalgia, TCAs are used at doses lower than they are for depression, probably because of the side effects of these drugs. Despite their widespread use, TCAs have only a moderate effect, and only a minority of patients display sustained, marked improvement. SSRIs are better tolerated but less effective, making it necessary to increase the dose to obtain significant pain relief.
  • For chronic low-back pain, tricyclic and tetracyclic antidepressants appear to moderately reduce symptoms independent of a patient's depression status. SSRIs do not appear to be beneficial.
  • In rheumatoid arthritis, amitriptyline, trimipramine, dothiepine, and paroxetine may have analgesic effects. In ankylosing spondylitis, amitriptyline may be useful in reducing symptoms. Low doses of amitriptyline (10-30 mg) may be sufficient to produce an analgesic effect.

None of the studies included in the review dealt specifically with OA, but a large study of older patients with arthritis (mostly OA) and comorbid depression found benefits that extended beyond the reduction of depressive symptoms and included decreased pain and improved functional status and quality of life.

The authors conclude that antidepressants are recommended as analgesics for fibromyalgia, especially TCAs, but they should not be first-line analgesic treatment in low-back pain, osteoarthritis, or inflammatory rheumatic painful diseases.

Music for pain relief

The efficacy of music for the treatment of pain has not been established.

Objectives

To evaluate the effect of music on acute, chronic or cancer pain intensity, pain relief, and analgesic requirements.

Search strategy

We searched The Cochrane Library, MEDLINE, EMBASE, PsycINFO, LILACS and the references in retrieved manuscripts. There was no language restriction.

Selection criteria

We included randomized controlled trials that evaluated the effect of music on any type of pain in children or adults. We excluded trials that reported results of concurrent non – pharmacological therapies.

Data collection and analysis

Data was extracted by two independent review authors. We calculated the mean difference in pain intensity levels, percentage of patients with at least 50% pain relief, and opioid requirements. We converted opioid consumption to morphine equivalents. To explore heterogeneity, studies that evaluated adults, children, acute, chronic, malignant, labor, procedural, or experimental pain were evaluated separately, as well as those studies in which patients chose the type of music.

Main results

Fifty – one studies involving 1867 subjects exposed to music and 1796 controls met inclusion criteria.

In the 31 studies evaluating mean pain intensity there was a considerable variation in the effect of music, indicating statistical heterogeneity ( I = 85.3%). After grouping the studies according to the pain model, this heterogeneity remained, with the exception of the studies that evaluated acute postoperative pain. In this last group, patients exposed to music had pain intensity that was 0.5 units lower on a zero to ten scale than unexposed subjects (95% CI: – 0.9 to – 0.2). Studies that permitted patients to select the music did not reveal a benefit from music; the decline in pain intensity was 0.2 units, 95% CI ( – 0.7 to 0.2).

Four studies reported the proportion of subjects with at least 50% pain relief; subjects exposed to music had a 70% higher likelihood of having pain relief than unexposed subjects (95% CI: 1.21 to 2.37). NNT = 5 (95% CI: 4 to 13).

Three studies evaluated opioid requirements two hours after surgery: subjects exposed to music required 1.0 mg (18.4%) less morphine (95% CI: – 2.0 to – 0.2) than unexposed subjects. Five studies assessed requirements 24 hours after surgery: the music group required 5.7 mg (15.4%) less morphine than the unexposed group (95% CI: – 8.8 to – 2.6). Five studies evaluated requirements during painful procedures: the difference in requirements showed a trend towards favoring the music group ( – 0.7 mg, 95% CI: – 1.8 to 0.4).


Listening to music reduces pain intensity levels and opioid requirements, but the magnitude of these benefits is small and, therefore, its clinical importance unclear.

Saturday, April 14, 2007

Natural Pain Relief drug - Eazol

Eazol can reduce the level of prostaglandins in your body. These compounds can cause the aches, pain and inflammation that make life miserable for so many people. Eazol helps to relax your muscles and to reduce swelling. It improves blood flow to areas such as the joints. The ingredients of Eazol work with each other, so that they're even more effective together than they are alone. And, they don't cause the sort of gastrointestinal irritation that can occur when you use many other kinds of pain reliever!

Active Ingredients:

White Willow (Salix species) (bark):
The bark of the stately white willow tree (Salix alba) has been used in China for centuries as a medicine because of its ability to relieve pain and to lower fevers. Early settlers in America found Native Americans gathering bark from indigenous willow trees for similar purposes. The active ingredient in white willow is salicin, which the body converts into salicylic acid. The first aspirin (acetylsalicylic acid) was made from a different herb containing salicin�meadowsweet�but works in essentially the same way. All aspirin is now chemically synthesized. It's not surprising, then, that white willow bark is often called "herbal aspirin". Although white willow is the species of willow tree most commonly used for medicinal purposes, other salicin-rich species are employed as well, including crack willow (Salix fragilis), purple willow (Salix purpurea), and violet willow (Salix daphnoides). These all may be sold under the label of willow bark.


Health Benefits: The salicylic acid in white willow bark lowers the body's levels of prostaglandins, hormonelike compounds that can cause aches, pain, and inflammation. While white willow bark takes longer to begin acting than aspirin, its effect may last longer. And, unlike aspirin, it doesn't cause stomach bleeding or other known adverse effects. White willow bark may help to relieve acute and chronic pain, including arthritis pain, headache, back and neck pain, muscle aches, and menstrual cramps. The effectiveness of white willow bark for easing these and other types of discomforts results from its power to lower prostaglandin levels. Some arthritis sufferers taking white willow bark have experienced reduced swelling and inflammation, and have eventually achieved increased mobility in the back, knees, hips, and other joints.

Lobelia (Lobelia inflata):This herb is named after the botanist Matthias de Lobel, a native of Lille, France, who died in London in 1616. The common name Lobelia also includes the species Lobelia siphilitica, Lobelia cardinalis and Lobelia chinensis, all of which are used interchangeably with Lobelia inflata. Lobelia is native to North America, and was both chewed and smoked by Native Americans. Lobelia root was used by the Iroquois Indians to treat syphilis, which is the source of the species name "siphilitica".

Health Benefits: One of the most useful muscle relaxants, Lobelia is rich in vitamin A, vitamin C, and manganese. An active ingredient in the lobelia plant, lobeline, stimulates nerves in the central nervous system. Lobelia is considered beneficial for treating mild depression, reducing inflammation and pain, easing muscle tension and calming the nerves. The primary chemical constituents of lobelia include piperidine alkaloids (lobeline, isolobeline), lobelic acid, chelidonic acid, glycoside (lobelacrin), essential oil, resins, and fats. The activity of Lobelia is dependent upon the liquid alkaloid, lobeline. Lobelia also contains gum, resin, chlorophyll, fixed oil, lignin, salts of lime and potassium, and ferric oxide. Lobelia may be used in many conditions in combination with other herbs to further their effectiveness.

Boswellia (standardized to contain 55% Boswellic Acid) (Boswellia serrata) (leaf): Boswellia, also known as boswellin or "Indian frankincense," comes from the tree Boswellia serrata, that grows in the dry hills of India. For centuries, traditional Indian healers have taken advantage of the anti-inflammatory properties of the tree bark's gummy resin, called salai guggal. Modern preparations made from a purified extract of this resin and packaged in pill or cream form are used to reduce inflammation associated with osteoarthritis and rheumatoid arthritis. Unlike conventional NSAIDs (nonsteroidal anti-inflammatory drugs) such as ibuprofen�the accepted treatments for joint inflammation�boswellia doesn't seem to cause stomach irritation. It also may be effective for back pain and certain chronic intestinal disorders.

Health Benefits: Research has identified specific active anti-inflammatory ingredients in this herb, which are commonly referred to as boswellic acids. In animal studies, these acids have been shown to reduce inflammation significantly in several ways. Boswellic acids deter inflammatory white cells from infiltrating damaged tissue. They improve blood flow to the joints. They also block chemical reactions that set the stage for inflammation to occur in chronic intestinal disorders such as Crohn's disease and ulcerative colitis. Boswellia may help to ease symptoms of osteoarthritis and rheumatoid arthritis. Boswellia can be taken internally as well as applied topically to affected joints to relieve inflammation associated with these joint disorders. This may lessen morning stiffness and increase joint mobility. In a study of 175 patients with rheumatic disorders such as rheumatoid arthritis, 122 participants experienced reduced stiffness and inflammation two to four weeks after starting on a boswellia regimen. Boswellia's anti-inflammatory properties can help to reduce aching and stiffness, especially when associated with low back pain. Although research indicates that boswellia is best taken orally for this purpose, creams appear to be soothing as well. Boswellia also appears to reduce the inflammation associated with ulcerative colitis and Crohn's disease, both painful intestinal disorders. It seems to accomplish this without the risk of further gut irritation associated with many conventional pain relievers. In a 1997 study of ulcerative colitis sufferers, 82% of those who took boswellia extract (350 mg three times daily) experienced a complete remission of their disease.

Wednesday, April 11, 2007

How Vioxx is changing US drug regulation

erck and Co now faces more than 6000 lawsuits involving the COX2 inhibitor rofecoxib, marketed as Vioxx. But no matter how these legal battles are resolved, the cases are already having an impact on how the pharmaceutical industry and government regulators do business. Todd Zwillich reports.

Merck and Co celebrated victory earlier this month after a New Jersey jury ruled that the company's anti-inflammatory drug rofecoxib (Vioxx) did not cause the heart attack of a 60-year-old postal worker. The verdict evened the score for the pharmaceutical giant, which in August lost a similar trial in Texas and was asked to pay US$253 million compensation.

The August case is under appeal, and Texas law will cut the award by 90%. But the company is just at the beginning of a series of Vioxx-based legal battles, which are expected to continue for years to come.

Plaintiffs have filed around 6400 lawsuits claiming that the cyclo-oxygenase 2 (COX2) inhibitor—which was pulled from the market in Sept, 2004—caused their heart attacks or strokes. Merck's overall liability in the lawsuits could reach $20–35 billion, according to analysts.

The company has vowed not to make any settlements, and instead promises to fight every case in court. It has already set aside $675 million for the effort.

But Vioxx's fallout goes well beyond Merck and its ledgers. Manufacturers facing mounting political pressure have now agreed to scale back advertising—an activity once staunchly defended by the industry. Meanwhile, the US Food and Drug Administration (FDA) has taken what some see as a defensive posture designed to avoid another safety debacle.

Merck is set to begin defending its third case at the end of November. Lawyers for the widow of Richard Irvin will try to show that the drug was responsible for the man's sudden cardiac death and that Merck officials knew of the risk while marketing the drug.

The case will be the first to reach federal court and will also test uncharted scientific ground. Irvin's widow claims that the drug caused his death after only a month of use. That is far shorter than the 18 months of average use it took for increases in cardiovascular risks to show up in Merck's trials.

“The autopsy shows the location of the clot and shows he had no prior significant heart disease problems. That makes our job easier”, Jere Beasley, the attorney representing the widow, Evelyn Irvin Plunkett, said in an interview.

Beasley points to anecdotal warnings Merck received as early as 1997 associating early use of the drug with cardiac death.

The company maintains that rofecoxib could not have caused Irvin's death. Increased risk of cardiac death in the Merck-directed APPROVe placebo-controlled trial did not reach statistical significance until 30 months of use, Bruce Kuhlik, Merck's vice president and associate general counsel, told The Lancet.

Merck stands by its pledge to avoid settling any cases. “We're committed to defending the cases on an individual basis, based on the science behind Vioxx and the individual risk factors that each individual patient has”, Kuhlik says.

Even if the plaintiff's strategy proves successful, it remains unclear what will be the impact on the overall dispensation of suits against Merck. 2 weeks before the federal trial opened, the New Jersey judge overseeing about half the total Vioxx caseload told attorneys that the next string of trials will focus only on plaintiffs who used the drug for 18 months or more.

The New Jersey victory proved to would-be plaintiffs that their suits against Merck will not be easy to win, says Robert Rabin, an expert in mass torts at Stanford Law School in California. The company is unlikely to ultimately stick to its pledge to fight each case, he says. At the same time, it pays in the short term for Merck to be as combative as possible.

“Sixty-four hundred cases are not going to be decided at trial individually. But it's not just 6400 cases if they started settling. Who knows how many other cases that would generate”, Rabin told The Lancet.

But the lawsuits reflect concerns over prescription-drug safety that go well beyond the courtroom. Other manufacturers are also reacting to allegations that they were too cavalier with safety in the rush to get promising new drugs to market.

As the Texas jury was nearing judgment against Merck in August, the Pharmaceutical Research and Manufacturers of America, the industry's main trade group, committed companies to withhold consumer advertisements of new drugs until physicians have been sufficiently educated about risks and benefits.

Pfizer Inc, the maker of COX2 drug celecoxib, marketed as Celebrex, and valdecoxib, marketed as Bextra, volunteered to ban consumer commercials for the first 6 months of drug sales. Bristol-Myers Squibb has said it will impose its bans for a year. Both were shorter than a 2-year moratorium on direct-to-consumer advertisements for new drugs called for by Senate Majority Leader and physician Bill Frist.

The major advantage of the COX2 inhibitors is their reduced risk of causing gastro-intestinal irritation and bleeding compared with non-selective COX inhibitors. But company advertisements were widely criticised for promoting the COX2 drugs to millions of patients who were not at risk for these side-effects. COX2 inhibitors do not offer an analgesia advantage over other anti-inflammatory pain killers.

“They've clearly gotten the message and tried to back away from (consumer advertising) discreetly”, says Alistair Wood, a professor of medicine and pharmacology at Vanderbilt Medical School in Nashville, TN, who chaired a 3-day series of hearings on COX2 safety in February.

Companies are also sensing that the FDA has reacted by making stricter demands on manufacturers, analysts say. Reports of increased suicidal ideation in patients taking antidepressants, defects in cardiac pacemakers, and political fury over the agency's unusual handling of a request to make an emergency contraceptive available without a prescription have all spurred the agency to avoid more mistakes, argues Michael Krensavage, a drug industry analyst. “It's a lot riskier for these companies to play games now than it used to be”, he says.

Krensavage says the new approach was in evidence in October when the agency demanded more safety data from Bristol-Myers Squibb and Merck before agreeing to approve muraglitazar, a jointly-developed type 2 diabetes drug to be marketed as Pargluva. The agency was concerned about data suggesting the drug could double cardiovascular risk, despite an 8-to-1 advisory committee vote backing the drug's approval only a month before.

Others expect any increased scrutiny to be temporary. That was the case in 1997 after fentermine-phenfluramine, the weight-loss combination known as fen-phen, was pulled from the market shortly before a wave of lawsuits connecting it to cardiac death, says Les Funtleyder, a health care analyst with the financial firm Miller Tabak & Co.

“Post fen-phen, things tightened up for about 18 months”, Funtleyder says. “This regulation tends to be cyclical. They'll tend to get tighter for a while and after we've gone a few years without a major safety scandal, they'll go laissez-faire again”, he says.

Steven Galson, director of the FDA's centre for drug evaluation and research, says that companies have become concerned about more FDA scrutiny and that officials may be looking more closely at industry applications. But he denied in an interview that the agency's decision-making process has changed.

“You can't avoid some of FDA's reviewers taking a harder look at safety info but that doesn't mean were going to be stricter in our safety decisions”, Galson said. “I object to the notion that there's any evidence that we've become stricter in the last few months.”

Kuhlik maintains that Merck has not altered the way it interacts with FDA. “I just don't see that changing”, he says.

The FDA has reacted in other, more obvious ways. The agency has vastly increased the amount of safety-report information it shares with the press and the public, regularly publicising minor drug-label changes and other safety information. An independent review of how the agency monitors drugs already on the market is underway, and over the summer the agency created a new board to help monitor drug safety.

Wood, who in 2002 was a candidate to take over as FDA commissioner, takes a dim view of the agency's recent moves. He likens the organisational changes to “shuffling the deck chairs on the Titanic” and says that the FDA should instead lower its threshold for compelling companies to conduct safety trials involving already-common side-effects like the heart attacks suspected with Vioxx. “The place to make the change is the FDA, not to ratchet up the tort system”, Wood says.