Posted on 02/19/2005 10:21:23 PM PST by neverdem
After a panel of medical experts gave a very cautious nod to the continued use of the painkillers Celebrex, Vioxx and Bextra on Friday, pain management experts said they expected to see the same caution transform the way the painkillers are prescribed from now on.
The drugs, which had been hugely popular for people with both short-term and chronic pain, will be prescribed much less readily, for a smaller group of patients, at lower doses and for shorter periods, the experts said.
"I am still very concerned about the cardiac risks of these medications," said Dr. David Campen, director of pharmacy services at Kaiser Permanente in Oakland, Calif., who led an effort to shift Kaiser patients off Celebrex and Vioxx and onto other painkillers. "If you can get away with a safer medication, you ought to."
But doctors expressed relief that they are likely to still have the drugs at their disposal.
"All of us have been reacting to the news as it comes forward, as to whether some of our tools will be taken off the market," said Dr. Raymond Gaeta, an anesthesiologist who directs Stanford's pain management clinic. "This is good news for patients over all. Clearly there are side effects with every medication, but it's really important to weigh the potential side effects versus the benefits for an individual patient."
On Friday the panel warned that all three drugs increased the risk of heart attack and strokes, although Celebrex is less hazardous than the other two, and recommended that the Food and Drug Administration place new warnings to that effect on their labels. But the experts also said the benefits to some patients outweighed the risks and concluded that the drugs should remain on the market. The agency usually follows the advice of its advisory panels.
While acknowledging the risks of the drugs, doctors pointed out that no drug was perfect for every patient. "As a physician, I like to have a choice of treatments, because people are different and some respond well to them," said Dr. James F. Fries, an arthritis specialist at Stanford University.
Dr. Sudhir Diwan, director of the division of pain medicine at New York-Presbyterian Hospital, said, "We all have found that these drugs can be very, very good in pain control and easy on the stomach," adding, "But it is true that we must do a better job of informing the public that these medications do have side effects."
Before prescribing any of the three drugs, doctors should carefully evaluate their patients' risk of heart problems, said Dr. Garret A. FitzGerald, a cardiologist at the University of Pennsylvania medical school, in Philadelphia, who was among those who spoke before the F.D.A. panel to warn of the drugs' risks. "Obviously one of the things to check is blood pressure," Dr. FitzGerald said. "And it's certainly wise to look at an echocardiogram to see if there is any impairment in cardiac performance." He said such drugs could help some patients with chronic pain who are prone to stomach irritation.
Anyone who has had a stroke or who has existing heart disease should be kept off the drugs, said Dr. Gaeta of Stanford, as should someone with obvious heart disease risk factors, like a diabetic smoker.
Unfortunately, many patients who are candidates for Celebrex, Vioxx and Bextra, because they are prone to stomach bleeding, are the same ones who are at risk for heart attack, said Dr. Campen of Kaiser Permanente. These patients tend to be older or have other health problems.
Doctors should also stick to low doses of the medications, said Dr. Fries, the Stanford arthritis specialist, noting that in the studies that have shown heart risks, patients took relatively large amounts.
Patients should take 10 milligrams of Bextra a day, rather than 20, he said, and 200 milligrams of Celebrex, rather than 400. And if Vioxx comes back on the market, it should be prescribed in 25-milligram doses rather than 50, Dr. Fries said.
(Merck withdrew Vioxx in September, after a study indicated it doubled the risks of heart attack and stroke, but an official told the F.D.A. panel that the company was now considering reintroducing it.)
Finally, doctors should avoid prescribing the three drugs for indefinite periods, said Dr. Diwan of New York-Presbyterian. Chronic pain typically ebbs and flows, he said, worsening when patients are very active or under stress. "When you are in pain for a few weeks, you take the drug, but when your pain is under control, you skip it for a few weeks, and then you lower your risk of problems," Dr. Diwan said.
Many patients can avoid taking Celebrex, Bextra or Vioxx altogether by switching to an older anti-inflammatory treatment like aspirin, ibuprofen (sold over the counter as Advil or Motrin, for example) or naproxen (available over the counter as Aleve). Some members of the F.D.A. panel were especially in favor of switching to naproxen, a drug that may help protect against heart attack and stroke, though not as much as aspirin does.
Celebrex, Vioxx and Bextra all belong to a class of drugs known as cox-2 inhibitors, which have come on the market since 1998. They block an enzyme called cyclooxygenase, or cox, as the older drugs do, but they block it selectively, leaving intact a form that helps protect the stomach lining. Thus, they are designed to ease pain and inflammation without irritating the stomach as readily as other anti-inflammatories do.
Research has indicated that Vioxx carries only half the risk of ulcers posed by older drugs. Theoretically, Celebrex and Bextra also protect the stomach, but no studies prove it.
At the height of the drugs' popularity, before their heart risks became widely known last fall, many people who were not prone to stomach distress took them.
Such people could switch to naproxen, ibuprofen or aspirin alone, doctors say. People who are vulnerable to stomach irritation or bleeding could take, in addition to anti-inflammatories, medications like Prilosec, Prevacid and Nexium, which block the production of stomach acids.
At Kaiser Permanente, many patients who in the past might have been given Vioxx or Celebrex are now prescribed anti-inflammatories that are somewhat gentler on the stomach than ibuprofen or naproxen - for example, nabumetone (marketed as Relafen) or etodolac (Lodine) - along with Prilosec, Dr. Campen said.
Some patients find that one drug works better for them, for reasons that doctors cannot necessarily determine. "Many people who took Vioxx were those for whom other medications had not worked," Dr. Diwan said.
One 71-year-old woman in East Brunswick, N.J., who has been taking Celebrex daily for five years, said it stopped the arthritis pain in her feet and ankles better than any other drug. The woman, who insisted that her name not be published, said she limited her daily dose to one 200-milligram pill, which limits the risk to her heart. "I don't overdo it," she said, "and I've never had any problems."
Cox-2 drugs are not thought to fight pain any better than aspirin, ibuprofen or naproxen do. Theoretically, the older anti-inflammatory treatments may even be somewhat more effective than cox-2 drugs because they are not as selective in the way they block cox, said Dr. FitzGerald of the University of Pennsylvania. But no study directly comparing the drugs' effectiveness has been done.
Nor has there been a large study comparing the safety of various painkillers. Dr. Robert Temple, director of the F.D.A.'s office of medical affairs, suggested to the advisory panel that such a study be done, to compare ibuprofen, naproxen, Tylenol, a cox-2 drug, diclofenac (another painkiller, sold as Voltaren) and perhaps also Tylenol with codeine, and aspirin.
"My main point is that there is really a very important need for more information about these drugs," Dr. Temple said.
The panel greeted Dr. Temple's proposal enthusiastically. One member, Dr. Thomas Fleming, a biostatistician at the University of Washington, calculated that such a study would need to include at least 10,000 patients on each drug and would need to follow them for three years in order to yield meaningful results.
But that would probably cost many millions of dollars. An executive from Pfizer, maker of Celebrex and Bextra, later said the company would like to participate in such a trial, but no one has yet offered to foot the bill.
Anahad O'Connor contributed reporting from New York for this article, and Gardiner Harris from Washington.
agree with your statements. Trial and error.
My neurologist sent me to two of them. I gave them their shot for six months. Then to the chiropractor came into the picture. Guess who is most effective at reducing the need for morphine usage? Yup, the chiropractor. I'll stay with him, thanks.
The error in your reasoning is your premise of illegality--which is not correct. No advertising promotes illegality, but promotes patients asking physicians for a prescription, an odious but legal practice.
A BBC program was devoted to the attempt by some homeopaths to collect the $1 million. They failed to prove their case. Here's the transcript.
Other Amazing Randi links:
interview
http://www.randi.org
Use the homeopathics on your infant, you'll avoid a lot of problems later on. They work much better on children, who aren't as metabolically burdened as adults are.
Explain scientifically how homeopathic medicine, which contains virtually no active ingredients, can possibly be more helpful for teething pain than a placebo, and I'll give it a try.
It's not my chart. It's the graphic that came with the story. I was surprised to see that it didn't reference any source, but in general, its recommendations appear to be cautious.
The following recommendations are from MedlinePlus:
Dosing—
The dose of acetaminophen will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of acetaminophen. If your dose is different, do not change it unless your doctor tells you to.
The number of capsules, tablets, teaspoonfuls of oral solution or suspension that you take, the amount of oral granules or powders that you take, or the number of suppositories that you use, depends on the strength of the medicine. Also, the number of doses you use each day and the time allowed between doses depend on the strength of the medicine. (If you use a solution or suspension, you must be able to do the arithmetic!)
For oral dosage forms (capsules, granules, powders, solution, suspension, or tablets) and rectal dosage forms (suppositories):
For pain or fever:
Adults and teenagers—325 or 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.The total dose should not be more than 4000 mg (for example, eight 500–mg tablets) a day.
Children—Acetaminophen dose is based on the child's age.
Infants up to 3 months of age: 40 mg every four hours as needed.
Infants 4 to 12 months of age: 80 mg every four hours as needed.
Children 1 to 2 years of age: 120 mg every four hours as needed.
Children 2 to 4 years of age: 160 mg every four hours as needed.
Children 4 to 6 years of age: 240 mg every four hours as needed.
Children 6 to 9 years of age: 320 mg every four hours as needed.
Children 9 to 11 years of age: 320 to 400 mg every four hours as needed.
Children 11 to 12 years of age: 320 to 480 mg every four hours as needed.
Here's the source URL: http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202001.html#SXX14
You may want to bookmark the homepage for the site, MedlinePlus, your tax dollars at work for a change.
I wasn't trying to debate. I was simply suggesting how a responsible court could argue for limiting advertising. If I brought up issues that you didn't disagree with me on, fine.
As for illegality, the point wasn't that the ads would be advocating criminal acts, so much as there would be a compelling state interest to deny the use of public airwaves (and subway advertisements, and freeway billboards, etc.).
Okay. As I said in my original post, I could be--and often am--wrong. The older I get, dangus, the more absolutist I am becoming, however, and "compelling state interest" just leaves me cold. If something is compelling (on a federal level, not a state level, I hasten to add), then the right of the government to act on it should be made explicit with an amendment. As the walking anachronism that I am, I believe that is what the forgotten 10th Amendment makes clear.
Relevant sections:
"The Congress shall have power... to regulate commerce ... among the several states, and ... To make all laws which shall be necessary and proper for carrying into execution the foregoing powers, and all other powers vested by this Constitution in the government of the United States, or in any department or officer thereof."
"The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people."
"The powers not delegated to the United States by the Constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people. "
The commerce clause is insidiously invoked to permit all sorts of enlargements of federal power. For instance Congress says, "we can force the states to apply a 55-MPH speed limit, because highways are used for interstate trucking."
But in this case, the issue is purely one of commerce, not of something else which may tangentially effect commerce, so the commerce clause is justifiably invoked, unless in the unlikely instance of a drug manufacturer deciding to manufacture drugs exclusively within a given state.
Don't be left cold by "compelling state interest." The Constitution nowhere mandates that there be a compelling state interest in regulating interstate commerce. *I* BELIEVE there should always be such a compelling state interest fo interfere with commerce, so I use the phrase. The reason it leaves you cold is it typically cited to override a freedom explicitly reserved for the individual, which is insidious. I use it here, merely to justify government action where there is NO right, explicitly or implicitly granted to the people, other than the general principle that the less government, the better.
Final thing I will say is that "compelling interest" was your phrase (quoting the government in many cases which uses it to do what they damn well please), not mine. I agree with you that there should be one for the government to act--within the bounds of enumerated powers only--at all.
But, your last sentence in wrong, wrong. Reread it. You say rights explicitly or implicitly granted to the people. That's not the Constitution. Rights are unalienable and granted by God. The Constitution tells what powers the government has and, supposedly, limits those powers. Don't ever make the subtle, but common and insidious, mistake of thinking our rights are granted by the Constitution. They ARE NOT. To repeat: our rights are granted by God. The Constitution guarantees that the government does not remove or harm those rights.
A few years ago, the accrediting agencies chose as their "pet project" pain UNDERtreatment. They all claimed it was a tremendous problem all through our health care system...if I remember correctly, they claimed that 65% of patients did not have their pain medication requirements "met".
Now, one half-assed study implicating a slight potential increase in vascular events among an already sick patient population if they take more than the recommended dosage of one medication for too long a period later, the new message is "proceed with caution".
Funny, I think I learned that many years ago in Medical School.
The more things change, the more they remain the same..
lol. It's hard to win, isn't it? Yes, I remember the clamor for and advent of the now ubiquitous pain scales.
Except the trigger points are really called enthesiopathies. T & S's maps are 25 years out of date.
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