|Issue #27 - December 2004|
Welcome to this issue of Naturopathic News, issue #27. It’s my goal to help you find natural solutions to health problems. This newsletter is one way to do that. The more educated you are about your health options the better able you will be to take control of your health.
NEARLY 1 IN 5 FDA SCIENTISTS PRESSURED
Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness, or quality.
The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency's ability to assess the safety of a drug.
The results of the survey, conducted by the Department of Health and Human Services' inspector general, appear to support some portions of the controversial November 2004 Senate testimony by FDA safety officer David J. Graham. The 20-year agency veteran told senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated.
Graham's testimony, at a hearing into the sudden withdrawal from the market of the arthritis drug Vioxx, put a spotlight on the FDA's safety and management record. Top FDA officials later criticized Graham's testimony as inaccurate and unscientific, but the survey results indicate that some other agency scientists share similar views.
"I think this provides evidence that among the reviewing scientists at FDA, their experiences mirror the testimony I gave before Congress," Graham said yesterday. "It also shows the unfortunate experience of many mirrors what happened to me when I tried to bring safety issues to my managers and the American public."
The survey, conducted at the FDA's request, found underlying concern and discord. For instance, 36 percent of scientists said they were only somewhat confident, or not confident at all, in the FDA's decisions regarding drug safety. When it came to drug effectiveness, 22 percent of scientists said they were only somewhat confident, or not confident at all, in the agency's decisions.
As described in the report, drug manufacturers reported significantly greater confidence in both categories.
Some of the most dramatic Senate testimony that Graham delivered involved what he described as efforts by FDA supervisors to silence him and pressure him to limit his criticism of the safety of some drugs. In the survey, 63 of 360 respondents - 18 percent - said they had been "pressured to approve or recommend approval for a [new drug application] despite reservations about the safety, efficacy, or quality of the drug."
Similarly, 21 percent of survey respondents said the work environment at the FDA's Center for Drug Evaluation and Research either allowed little dissent or stifled scientific dissent entirely.
The FDA drug reviewers were also highly skeptical of the agency's ability to monitor the safety of prescription drugs once they are on the market. In all, 6 percent said they were "completely confident," 28 percent said they were "mostly confident," 47 percent said they were "somewhat confident" and 19 percent said they were "not confident at all."
The report found that some FDA reviewers believed that the speeded-up process for reviewing drugs required by Congress was causing morale problems among overworked scientists. More than half of respondents said they did not think there was sufficient time to conduct an in-depth, science-based review in the six months required for drugs given "priority" status.
GP: In light of the recent well-publicized drug disasters this news is particularly dark and disturbing.
VIOXX DOUBLES HEART ATTACK RISK
On Sept. 30, 2004 drug-maker Merck & Co. announced the withdrawal of the anti-inflammatory drug Vioxx from the market due to a study they were conducting that shows patients taking the drug face twice the risk of heart attack compared to those in the test taking a placebo, especially those who had been taking the drug longer than 18 months.
“Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. It is also approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children,” says the FDA.
FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.
Merck withdrew Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo.
In June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke.
Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.
A wave of lawsuits has hit the courts in the United States, Canada and as far away as Israel. One lawsuit filed in Cook County Circuit Court alleges Merck knew about Vioxx's harmful side effects at least since the drug had been formally approved. Merck, argued one attorney, "intentionally tried to downplay the risks" until the evidence "was so overwhelming they had no choice."
The Vioxx example raises concerns about FDA's review process along with how long it took Merck to remove the drug from the market. Vioxx is the first prescription drug to be pulled from pharmacy shelves in three years for safety concerns.
GP: So, when a drug is known to cause heart attacks and strokes the FDA changes the label. Doesn’t that make you feel safe?
Dr. David Graham, associate director in the FDA's Office of Drug Safety, called the FDA's approval of arthritis drug Vioxx, "The single greatest drug safety catastrophe in the history of this country or the history of this world." Graham went on to cite the following statistic: A staggering 88,000 to 139,000 Americans suffered heart attacks and strokes as a result of taking Vioxx.
In addition to Vioxx, Graham named five other drugs that are putting the lives of the public at risk. The five drugs in question are:
Graham stated that the FDA's inability to protect Americans from another case similar to the Vioxx case was clear evidence that massive changes need to be implemented for the future protection of the public.
One of the regulatory changes Graham proposed was granting the Office of Drug Safety independent regulatory authority. Presently, safety officers are faced with a conflict of interest in the event they have to convince the Office of New Drugs that a drug is causing side effects. The conflict arises because the very group that approved the drug in the first place is also responsible for taking regulatory action against any post-marketing activities.
Tom Devine, Graham's lawyer, stated that Graham would be exiled from his duties of reviewing drugs and placed in the office of the commissioner. Devine described this position as "filling space under the scrutinizing watch of a babysitter."
CELEBREX CAUSES HEART ATTACKS
On December 18, 2004 the U.S. Food and Drug Administration advised doctors to consider alternatives to the pain reliever Celebrex in the wake of a study that showed it increased the risk of heart attack and strokes at high doses.
Pfizer Inc. said it would leave Celebrex on the market, although the same problems led Merck & Co. to withdraw its painkiller Vioxx from the market in September.
“We’re leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product,” Acting FDA Commissioner Lester Crawford said Friday. “We do have great concern about this product (Celebrex) and the class of products.”
Both Celebrex and Vioxx are a type of drug called cox-2 inhibitors. Vioxx was pulled from the market in September because it doubled patients’ risk of heart attack and stroke.
“I think the trial concludes the controversy about whether there is a class effect of these drugs. Now there is clear evidence of it,” said Dr. Garret A. FitzGerald, a cardiologist at the University of Pennsylvania. “You would need to believe the earth is flat if you thought this was just a coincidence.”
National Institutes of Health director Dr. Elias Zerhouni said that he ordered a full review of the more than 40 agency-supported studies involving cox-2 inhibitors.
News of the increased heart risk for Celebrex patients came in one of two long-term cancer prevention trials. The National Cancer Institute, which was conducting the study for Pfizer, said patients in the clinical trial taking 800 milligrams of Celebrex had a 3.4 times greater risk of cardiovascular events compared to a placebo. For patients in the trial taking 400 milligrams of Celebrex the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months. In the 2,000 patients study, 15 individuals taking 400 mgs, 20 patients taking 800 mgs and 6 patients on placebo suffered a cardiac-related death, heart attack, or stroke.
AVOID PFIZER'S BEXTRA
Doctors writing in a prominent medical journal on 12/23/04 recommended that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large study found the drug maker’s sister drug, Celebrex, doubled risk of heart attacks.
Both drugs are members of the so-called COX-2 inhibitor class of painkillers, which recently gained notoriety when Merck Inc. withdrew Vioxx in September after a study found it doubled the risk of heart attack and stroke.
A letter by doctors published in The New England Journal of Medicine's Dec. 23, 2004 edition said in light of Vioxx and negative signs on Bextra, Bextra should be avoided.
"To protect the safety of the public, we write to recommend that clinicians stop prescribing valdecoxib (Bextra), except in extraordinary circumstances," editorial writers at The New England Journal of Medicine wrote in an issue dated Dec. 23 but released early.
The authors of The New England Journal of Medicine letter are doctors at the Vanderbilt University School of Medicine. They said they made the recommendation in light of the long lag time between when evidence emerged on Vioxx and its withdrawal, coupled with two negative studies suggesting Bextra boosts heart problems in bypass patients by a factor of three.
STUDY USING PAIN RELIEVER ALEVE SUSPENDED
An Alzheimer's disease prevention trial was suspended on Dec. 20, 2004, after researchers said there were more heart attacks and strokes among patients taking Naproxen, an over-the-counter pain reliever in use for 28 years and commonly known under the brand name Aleve.
The study, involving some 2,500 patients, was to test whether Naproxen or Celebrex, both pain relievers, could reduce the risk of Alzheimer's disease among healthy elderly patients who were at an increased risk of the disease.
Officials at the National Institutes of Health said the study was suspended after three years when it was found that patients taking naproxen had a 50 percent greater incidence of heart attack or stroke than patients taking placebo.
Naproxen, a non-steroidal, anti-inflammatory drug, is sold under a variety of brand names, including Aleve, from Bayer and Naprosyn, from Roche.
Celebrex, a prescription drug, and naproxen are both commonly used to treat the joint pain of arthritis. Naproxen has been approved for sale, first as a prescription and then as an over-the-counter drug, since 1976. Celebrex is in the same class — COX2 enzyme inhibitors — as Vioxx, an arthritis drug recently taken off the market by its manufacturer after it was linked to an increase in heart attack and stroke.
Dr. Elias A. Zerhouni, the director of the National Institutes of Health, said the study linking heart attack to Celebrex last week was a major factor in deciding to suspend the Alzheimer's study. He said there was a question whether patients in the study would continue to take their medicine since they knew they might be taking Celebrex. Suspending the study, Zerhouni said, "is the prudent thing to do."
John Breitner of the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only preliminary data is available. But he said it suggests that among the 2,500 patients in the study, about 70 suffered stroke or heart attack. There were 23 deaths. There were 50 percent more of the cardiovascular events among patients taking naproxen than among those taking placebo, he said.
There are two important nutritional steps that may help the majority of people with pain. That is to start a high quality fish oil (cod liver oil) at this time of year and to stop sugar. Omega-3 essential fatty acids are precursors to mediators of inflammation called prostaglandins. In fact that is how Vioxx and other NSAIDs work. They manipulate prostaglandins. However, when you do it with drugs, there is frequently another price to pay like side effects that can lead to death. When you use natural methods like omega-3 fats and stopping sugar, the side effects are good health.
Remember that most commercially available cold liver oils or fish oils are unstable (basically rancid) after 20 days and are extracted from fish heavily contaminated with mercury and other poisons.
When arthritis is definitively diagnosed and there is joint cartilage degeneration it is sometimes possible to repair this damage. The use of high quality sources of glycosoaminoglycans (cartilage building blocks) can reduce inflammation and relieve pain.
Emerson Ecologics is a source both of essential fatty acids and joint support nutrients that I use in my practice.
Though nutrition and lifestyle factors are of paramount importance for pain due to any source—arthritis, migraines, allergies, headaches, menstrual problems, etc. I would be remiss if I didn’t mention my experience with homeopathy. When dealing with chronic disease of any type, it is always necessary to look at the whole picture, the whole person, in depth. Not just as a combination of problems—migraines, joint pains, and stomach distress—but as a culmination of mental/emotional/physical factors that have created the current state of health. When this is dealt with, through the use of the correct homeopathic medicine, true healing occurs on all levels and actual cure is the result. This is the goal of homeopathic treatment. To go beyond the symptom and help the individual get well.
If any of you would like to check out Emerson Ecologics online here is the address of their home page. http://www.emersonecologics.com/Main.asp. Here you will find information on herbal products and nutritional supplements as well as product specials. If you have any questions about these items feel free to email me.