|Issue #28 - January 2005|
Welcome to this issue of Naturopathic News, issue #28. 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.
COX-2 DRUGS OVERPRESCRIBED FOR YEARS
The now-infamous pain relievers known as Cox-2 inhibitors were overprescribed by MDs long before their current problems came to light, a new study concludes. The research, published in the Jan. 24, 2005 issue of the Archives of Internal Medicine, finds that many people may have been paying more than needed and may have been unnecessarily exposed to side effects.
Most of the growth in Cox-2 use between 1999 and 2002 came among patients who were least likely to benefit, namely those without a high risk of gastrointestinal (GI) complications, according to the study. Cox-2 inhibitors were developed for patients who had gastrointestinal problems with over-the-counter pain relievers, such as aspirin, ibuprofen, and naproxen.
While traditional nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, and naproxen increased the risk of gastrointestinal bleeding and stomach ulcers over the long term, the Cox-2s, introduced in 1999, supposedly minimized this risk while providing the same amount of pain relief.
The first downside, however, was that the new drugs cost 10-to-15 times as much as their older cousins. The second downside came to light over time as it was found that these drugs were no easier on the gut than the cheaper drugs they had replaced. Then, in September 2004, Merck & Co., which makes Vioxx, removed the Cox-2 drug from the market after indications that it increased the risk of heart attacks. There have since been similar concerns about Celebrex and Bextra, although those drugs are still on the market.
The current study, which began before the controversy erupted, used national surveys of patient visits to their doctors' offices to compare NSAID and Cox-2 prescriptions with treatment guidelines.
Cox-2s were prescribed for all types of patients, although the guidelines specified that patients with "low" or "very low" risk of GI problems receive traditional NSAIDs. In 1999, 12 percent of patients at very low risk (1.7 million people) received Cox-2 prescriptions. That number rose to 40 percent of low-risk patients (7.6 million) in 2001 before turning down slightly in 2002. Sixty-three percent of the growth in Cox-2 use was in patients with lower levels of risk. The remaining 37 percent came from the high-risk patients.
In general, much of the growth may have been spurred by direct-to-consumer advertising. "Perceptions of benefit are one of the key drivers to the speed with which a new innovation diffuses throughout a population," said Dr. G. Caleb Alexander, senior author of the study and an instructor of medicine at the University of Chicago. "Heavy marketing and promotion of these drugs may have contributed to a greater perception of benefit than actually existed."
GP: In other words, the drug companies hyped these drugs; MDs went for it, and consumers paid the price—some with their lives. If you know of anyone still using Celebrex or Bextra tell them there ARE alternatives. Ones that don’t carry the side effect of heart attack or stroke.
CANCER THE TOP KILLER FOR THOSE UNDER 85
For the first time, cancer has surpassed heart disease as the top killer of Americans under 85, health officials said Jan. 19, 2005.
The news is contained in the American Cancer Society annual statistical report, released Wednesday. In 2002, the most recent year for which information is available, 476,009 Americans under 85 died of cancer compared with 450,637 who died of heart disease.
That trend actually began in 1999, but "this is the first time we've looked at this by age," said Ahmedin Jemal, a cancer society epidemiologist and main author of the report.
Those under 85 comprise 98.4 percent of the population, said Dr. Eric Feuer, chief of statistical research for the National Cancer Institute, who also worked on the report.
That means that only the very oldest Americans continue to die of heart disease more than of cancer, a trend that is expected to reverse by 2018, said Dr. Harmon Eyre, the cancer society's longtime chief medical officer.
A third of all cancers are related to smoking, and another third are related to obesity, poor diets and lack of exercise — all factors that also contribute to heart disease.
GP: You may read some convoluted story about how this trend is good news. That somehow we are beating back heart disease and next we’ll beat back cancer. However, the truth is not so rosy. The same factors that contribute towards cancer contribute to heart disease—diet, exercise, lifestyle, etc. Once you’re dead does it really matter whether you died of the #1 cause or the #2 cause—if educated choices could have made a difference in the first place?
SUPPRESSED RESEARCH—THIS IS SCIENCE?
The Food and Drug Administration has given a whistle-blower scientist permission to publish data indicating that as many as 139,000 people had heart attacks that may be linked to Vioxx, the scientist's lawyer said Monday, January 03, 2005.
Dr. David Graham, who works in the FDA's office of drug safety, has said he was not allowed to publish his data questioning the safety of Vioxx, a pain medication principally used to treat osteroarthritis. Additionally, an FDA official sent email messages to the medical journal Lancet trying to persuade the journal not to publish the data.
Citing its own safety concerns, manufacturer Merck voluntarily pulled Vioxx from the market in late September 2004.
Graham testified in November before a Senate committee that the FDA fumbled in its handling of safety concerns around Vioxx and had mishandled concerns about five other widely used drugs. He contended that FDA has an inherent conflict of interest that triggers "denial, rejection and heat" when safety questions emerge about products it has approved.
The FDA denies the allegations, and controversy over the agency's role continues.
But the question of publication of the Vioxx data appears to be settled. The FDA told Graham that he could go ahead and publish his research, which shows that 88,000 to 139,000 people have had heart attacks that could be linked to Vioxx, with 30 percent to 40 percent of them fatal, said Graham's attorney, Tom Devine.
The report will be resubmitted to the Lancet, a British medical journal, which is expected to publish it, Devine said. Lancet editor Richard Horton has been sharply critical of the FDA as well.
Devine, legal director of the Government Accountability Project, said the FDA go-ahead is a positive sign.
"For the short-term at least, the FDA has decided to stop suppressing controversial research on Vioxx," he said.
GP: I don’t know about you but the FDA’s actions rile me. Since when does the FDA have the power to break the law and prevent the release of research that we have paid for with our tax money? Makes me want to know what else they are suppressing and why. It took 30,000+ people to die before this secret got out. How many will die next time?
LIFESTYLE INTERVENTION CUTS CARDIAC RISK WITHOUT DRUG THERAPY
In a new study, a 12-week lifestyle intervention helped an ethnically diverse group of adults with hypertension, hyperlipidemia, and hyperglycemia reach their goal risk factor levels without using drug therapy.
These results "refute the notion that intensive lifestyle intervention is not worth the effort," lead author Dr. Neil F. Gordon, from St. Joseph's/Candler Health System in Savannah, Georgia, and colleagues report in the December 15th, 2004 issue of The American Journal of Cardiology.
The results are based on a study of 2390 adults who participated in the lifestyle program involving an initial health assessment followed by the generation of risk factor goals and lifestyle changes designed to achieve these goals.
Participation in the program was associated with a significant improvement in blood pressure, cholesterol profile, glucose levels, and body weight among subjects with abnormal values at baseline. Moreover, in a subset of 700 patients with no know atherosclerotic cardiovascular disease, the intervention was linked to a significant reduction in Framingham 10-year risk scores for heart disease.
"Therapeutic lifestyle changes can generally be implemented less expensively than most medications and, unlike single-drug therapy, favorably affect multiple risk factors," the authors point out. Thus, the current findings could have important implications for healthcare payers, which often do not reimburse for such lifestyle interventions.
GP: For years, drug companies, along with most medical practitioners, have denigrated the effectiveness of lifestyle changes in relation to prevention of serious disease. This important study is an important step in the effort to reverse that trend. The next time your MD wants to give you a drug for one of these diagnoses ask them if they’ve reviewed this study. Help them help you (and others in the same situation).
MEDICAL MALPRACTICE BILL SHIELDS DRUG COMPANIES
The medical malpractice bill backed by President Bush would prevent consumers from seeking punitive damages from the makers of Vioxx and Celebrex, two popular pain medications recently linked to increased risks of heart attacks and strokes, according to legal experts on both sides of the issue.
While Bush often touts the medical malpractice proposals as a prudent way to stop frivolous lawsuits against doctors, the bill's less-discussed liability protections for pharmaceutical companies such as Merck & Co., the manufacturer of Vioxx, is a boon to the huge pharmaceutical industry.
The drug company provision has been in the Republican House bill, which Bush supports, for months, but after the Vioxx and Celebrex reports, the bill's opponents are making the provision a key argument against the Bush plan. Supporters privately say the legislation may have to be changed to win approval.
"I am sure it gives opponents a pretty good bludgeon," said former representative James C. Greenwood (R-Pa.), who sponsored the bill, which passed the House but not the Senate. It must be reintroduced this year.
Merck withdrew Vioxx on Sept. 30, 2004 after reporting that the painkiller increased the chance of a stroke or heart attack. Pfizer Inc., the maker of Celebrex, reported last month that in one study, its pain medication increased the risk of heart attack if taken in high doses. Pfizer has not pulled Celebrex from the market because it says there is conflicting research on the side effects. Critics charge that both companies sold the drugs despite warnings about side effects.
Both companies would be shielded from punitive damages -- those jury awards that often reach into the millions of dollars to punish wrongdoing -- if the medical malpractice plan becomes law.
The bill would protect pharmaceutical companies from punitive damages as long as they met Food and Drug Administration standards to win approval of their drug. Merck and Pfizer received FDA approval for their drugs, and both say they followed FDA requirements.
In a statement, Todd A. Smith, president of the Association of Trial Lawyers of America, said, "President Bush unashamedly advocates legislation that would protect insurance industry profits and prohibit any punishment for the makers of dangerous drugs like Vioxx."
GP: I fail to see why drug companies should be protected from punitive damages if they allowed their drugs to be marketed even though they knew of the potential danger. As consumers we should at least have the opportunity to seek redress.
CHRISTMAS CAROLS FOR THE DISTURBED
GP: Better late than never.
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.
Gregory Pais, ND, DHANP