Kid’s Unlimited
March 3, 2005
Kid’s Unlimited is a monthly, or semi-monthly, newsletter of various articles, funnies, tidbits and opinions relating to our children and chiropractic. My opinions will always be in red and italicized. Please feel free to share the appropriate articles with patients, friends, and other chiropractors. I never buy any lists or put names on my email list unless the names were submitted to me directly. If you wish to be removed from my list, just reply with the word “remove” in the subject line.
Thank you… Together we will make a difference.
Well it has been quite some time since our last Kid`s Unlimited. I apologize for the delay. It has been a busy and eventful few months. I had something happen to me today that reminded me (once again) of why I am a chiropractor. One of my patients died yesterday. Mel was an intestinal cancer survivor a few years ago and started coming in with his wife last year. We had a great time. We laughed and joked with each other. We talked about chiropractic and true health. He referred friends in and would talk about our office throughout his community. Mel started having abdominal pains about 3 weeks ago. He was afraid, because it seemed like the pain he went through when he had cancer before. Interestingly enough, he was not afraid of dying. He was afraid of going through the same pain. Mel went to his M.D. about 2 weeks ago. They did an MRI and felt that he might have a blockage in his colon, so a biopsy was done. The biopsy was performed a week ago. The medics found cancer throughout his abdomen. He was placed in hospice on Friday and passed away Monday. Mel`s funeral service is tomorrow. His wife came in today, with their daughter, who flew in from California. Both of them sat and cried with me. They told me that Mel wanted me to know how much he loved me and loved coming into the office. His wife said that he had very little pain and felt that chiropractic helped him throughout his final time on earth.
Our job is the re-connection of the physical and spiritual and in the relationships we create along the way. I am truly blessed that Mel was a part of my life. I know that his family will continue to be a part of my life. I thank God every day for the opportunity to serve.
DRUG MAKER WITHHELD PAXIL STUDY DATA
ABC News Uncovers Documents Unknown to Regulators and Many Doctors
Dec. 10, 2004 - New documents uncovered by ABC News suggest GlaxoSmithKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk of suicidal behavior in some children taking the drug, as well as serious withdrawal symptoms when some patients stop taking Paxil.
The new documents obtained by the ABC News program "Primetime Live" have never before been made public. Earlier this year, the Food and Drug Administration ordered manufacturers to place a warning in bold print on antidepressants, alerting consumers that the drugs can cause suicidal tendencies in children and teenagers.
The FDA`s move raised the issue of how much antidepressant manufacturers knew about this increased risk and when. While Congress and the FDA have held hearings questioning GlaxoSmithKline and other drug manufacturers about suppressing studies that cast their products in a negative light, "Primetime Live" has obtained actual copies of GlaxoSmithKline reports from its own internal studies. In these studies, some children showed the same types of suicidal thoughts and behaviors that parents had for years claimed their children were exhibiting.
According to these documents, internal studies by GlaxoSmithKline concluded that Paxil had little or no effect in treating depression in children and adolescents. And as far back as 1997, the company was aware of studies reporting suicide-related behaviors in young patients taking the drug. In spite of this information, GlaxoSmithKline distributed a memo to its sales force in 2001 touting the drug`s "remarkable efficacy and safety in the treatment of adolescent depression."
See the memo.
Additionally, the internal documents reveal GlaxoSmithKline had scientific evidence Paxil could cause mild to severe withdrawal symptoms in some patients when they abruptly stopped taking the drug. A document the company distributed to sales staff referred to "withdrawal symptoms" and said they included problems like dizziness, nausea, fatigue, insomnia and nightmares, but advised the sales representatives to use the less-alarming term "discontinuation symptoms." The documents suggest GlaxoSmithKline`s sales strategy was to downplay this information in order to maintain its share of the billion-dollar antidepressant market. "This is about money," said Rep. Henry Waxman, D-Calif., who is on a congressional committee investigating antidepressant manufacturers. "This is not about science, because what they`re doing is withholding the scientific information, suppressing the studies that could have a negative impact on their sales and their profits."
Drug Maker Under Attack
In addition to the investigation by Congress, the New York attorney general`s office in June of this year leveled charges of consumer fraud against GlaxoSmithKline. The lawsuit alleged that the drug giant repeatedly concealed information about Paxil from doctors. The attorney general`s lawsuit noted that GlaxoSmithKline conducted at least five studies of Paxil`s use in children and adolescents, but the company only published one of these studies -- a decision at the heart of the controversy.
Central to the attorney general`s allegations were two Paxil studies for depression in children and adolescents. ABC News has obtained original documents from those studies. In one study, referred to by the company as Study 377, researchers noted some children exhibiting suicidal behaviors and attempts to kill themselves. Referring to that study and another, Study 329, an internal GlaxoSmithKline memo acknowledged that Paxil "failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures."
The same internal memo went on to identify a single goal: "to effectively manage the dissemination of these data in order to minimize any potential negative commercial impact." The document recommends that the company not seek government approval for Paxil`s efficacy or safety in treating depression in adolescents at that time because they believed that they would not get that approval and "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of [Paxil]." Finally, the memo concludes, "Positive data from Study 329 will be published in abstract and a full manuscript of the 329 data will be progressed." The results from Study 329 were ultimately published in the Journal of American Child Adolescent Psychiatry in 2001 with the conclusion "Paxil is generally well tolerated and effective for major depression in adolescents."
The New York attorney general criticized the publication of this article, saying, "Although it allowed the data from study 329 to be published, GlaxoSmithKline concealed and suppressed studies 377 and 701, which failed to show that [Paxil] was more effective than placebo in treating [depression] in children and adolescents." Nonetheless, a 2001 internal memo to the company`s sales reps touted the study as showing Paxil is "truly a remarkable product that continues to demonstrate efficacy" in adolescents.
See the memo.
GlaxoSmithKline says its reps were not supposed to discuss the memo with doctors and notes it was stamped "For representatives` information only," but the New York attorney general`s complaint charged that the company would only have sent the memo to its reps "to falsely characterize Study 329 in their communications with physicians." GlaxoSmithKline later settled the lawsuit, without an admission of wrongdoing, but paid a $2.5 million fine and promised to make all of its research available online.
GlaxoSmithKline defends its public disclosures regarding suicide risks, saying that in each individual pediatric study the numbers were too small to be statistically significant. GlaxoSmithKline also claims that it wasn`t until data were pooled from all antidepressant studies that the increased risk of suicide became clear. It and other drug companies also say there`s no way to prove that any individual suicide-related behavior was caused by the drug and not the patient`s underlying depression.
The makers of Paxil, Effexor and Zoloft said they have not endorsed the use of their antidepressants in children or adolescents. They also point out that during their pediatric trials no one actually committed suicide.
Downplaying Withdrawal Symptoms
Paxil belongs to a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Like other SSRIs, Paxil can cause withdrawal symptoms when patients stop using the drug. Until 2001 there was no clear warning or precaution in the prescribing information provided to doctors by GlaxoSmithKline. In prescribing information up to December 2001, the company only mentioned "withdrawal syndrome" as a rare potential side effect associated with the nervous system, but without explaining what "withdrawal syndrome" is. GlaxoSmithKline also mentioned spontaneous reports of "discontinuation symptoms," but explained these reports "may have no causal relationship with the drug."
But "Primetime Live" discovered an internal safety review dating from 1997 that provided scientific evidence from GlaxoSmithKline studies of withdrawal effects caused by Paxil. There was never any mention of these studies and the specific results in any of the official prescribing information made available to American doctors and patients. Starting in December 2001, GlaxoSmithKline included a precaution to make doctors and patients aware of some possible "discontinuation" side effects affecting "2 percent or greater" of patients based on studies. According to the 1997 review, one study found that 25 percent of patients taking Paxil in one experienced discontinuation symptoms (vs. 5.9 percent for patients taking a placebo). In a study of patients with major depression, 42 percent of the patients taking Paxil experienced one discontinuation symptom. GlaxoSmithKline told "Primetime Live" that "most of the individual studies have been made public either through publication in a peer-reviewed journal or presentation at a major medical meeting." But none of the medical experts contacted by "Primetime Live" knew about this data, and GlaxoSmithKline did not make those publications or presentations available, despite repeated requests.
Despite these studies, these documents reveal that GlaxoSmithKline instructed its sales force to downplay or minimize the negative effects of discontinuing Paxil from doctors A 1998 "business plan guide" for sales reps instructed them to "minimize concerns surrounding discontinuation symptoms." Sales reps were also told to explain to doctors that the "discontinuation incident rate is two in 1,000 patients." This rate is markedly different from the results of the studies in the safety review published nine months earlier.
See the Business Plan Guide.
In a company-sponsored education program for sales representatives, "withdrawal syndrome" was clearly defined as "a class effect that can occur when an SSRI is stopped abruptly. Symptoms may include asthenia, flu-like symptoms, fatigue, dizziness, nausea, and sleep disturbances (insomnia, vivid dreams or nightmares)." However, the next direction recommended reps avoid using the term: "instead of `withdrawal syndrome,` which implies addictive properties, try to refer to this phenomenon as `discontinuation symptoms.`"
One vivid reminder of the importance of Paxil to GlaxoSmithKline is found on a May 1997 sales memo. Sales reps are reminded, "Let`s face it in the end. [sic] The only thing the anxious and agitated patient will be saying is: `Where`s my Paxil!!!!!!`" The comment is illustrated by a cartoon of a screaming woman.
See the May 1997 sales memo.
As if to underscore the importance of Paxil to GlaxoSmithKline, another company sales document graphically explained why discontinuation is an issue. The answer: $1 billion, the total sales of Paxil and Seroxat (a related SSRI) as of September 1997. This statement is illustrated by a large, black money bag.
See the "money bag" memo.
A Publishing Coincidence In a 1997 memo, a public relations firm working for GlaxoSmithKline drafted a letter on the topic of discontinuation symptoms that was apparently intended for publication by a company spokesperson or possibly a physician. The memo explained that "complete duplication will look fishy if we decide to submit both. Are there other references we could draw on for the various drugs? At the very least, we can`t have the references appear in the same order." The draft letter listed three physicians as the intended senders, including Dr. Bruce Pollock of the University of Pittsburgh.
A letter by Pollock appeared in the October 1998 issue of the Journal of Clinical Psychiatry. Although Pollock`s letter was not the same as what the PR company drafted, it made nearly every point in the draft -- almost in the same sequence.
See the PR company`s draft letter and Dr. Pollock`s letter to the journal.
Pollock, who was on the company`s advisory board at the time, told "Primetime Live" he wrote the published letter and stands by its accuracy. He did say, however, he "could imagine a scenario where a representative from the makers of Paxil said, `Could you make this point?`" because it was well-known that he had studied Paxil in elderly patients. But he denied that he had any knowledge of intentions to use his letter in a marketing plan, or that he had any knowledge of the draft letter prepared by the PR firm that included his name. This published letter resurfaced once again in the internal memorandum obtained by "Primetime Live." The company`s 1998 business plan guide for sales reps cited Pollock`s letter as "an effective tool for addressing discontinuation."
GlaxoSmithKline declined to comment on these documents, saying "it is difficult to respond to court documents taken out of context." In court, they have said they provided adequate and complete warnings to physicians about the risks of withdrawal. In a letter to "Primetime Live," they also said the majority of patients who experience any symptoms have mild to moderate symptoms that are usually self-limiting within two weeks.
ABCNEWS` Greg Fisher, Kate Sheekey, Kim Launier and Marc Lallanilla contributed to this report.
Copyright C 2004 ABC News Internet Ventures
Healthy HABITS! – When smokers quit - What are the benefits over time?
Based on the U.S. Surgeon General’s Report on smoking cessation, here are some good reasons to quit smoking today:
20 minutes after quitting: Your blood pressure drops to a level close to that before the last cigarette. The temperature of your hands and feet increases to normal.
8 hours after quitting: The carbon monoxide level in your blood drops to normal.
24 hours after quitting: Your chance of a heart attack decreases.
2 weeks to 3 months after quitting: Your circulation improves and your lung function increases up to 30 percent.
1 to 9 months after quitting: Coughing, sinus congestion, fatigue, and shortness of breath decrease; cilia (tiny hair like structures that move mucus out of the lungs) regain normal function in the lungs, increasing the ability to handle mucus, clean the lungs, and reduce infection.
1 year after quitting: The excess risk of coronary heart disease is half that of a smoker`s.
5 years after quitting: Your stroke risk is reduced to that of a nonsmoker 5-15 years after quitting.
10 years after quitting: The lung cancer death rate is about half that of a continuing smoker`s. The risk of cancer of the mouth, throat, esophagus, bladder, kidney, and pancreas decrease.
15 years after quitting: The risk of coronary heart disease is that of a nonsmoker`s.
Friday, February 25, 2005 (SF Chronicle)
FDA painkiller panel advisers linked to pharmaceutical firms/10 members worked as paid consultants
Gardiner Harris, Alex Berenson, New York Times
Ten of the 32 government drug advisers who last week endorsed continued marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs` makers, according to disclosures in medical journals and other public records.
If the 10 advisers had not voted, the committee would have voted 12-8 that Bextra should be withdrawn and 14-8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9-1 to keep Bextra on the market and 9-1 for Vioxx`s return.The votes of the 10 did not substantially influence the committee`s decision on Celebrex, because only one committee member voted that Celebrex should be withdrawn. Eight of the 10 members said their past relationships with the drug companies did not influence their votes. The two others did not respond to phone or e-mail messages.
Researchers with ties to industry commonly serve on Food and Drug Administration advisory panels, but their presence has long been contentious. The agency has said that it tries to balance expertise --often found among those who have conducted clinical trials of the drugs in question or otherwise studied them -- with potential conflicts of interest.
The Center for Science in the Public Interest, an advocacy group in Washington that maintains a large database of scientists` industry ties culled from disclosures in medical journals and other public documents, analyzed the panel members` affiliations at the request of the New York Times. The center has been a frequent critic of the FDA and of the drug industry. The center`s analysis may understate the industry ties of the panel participants because some ties may not have been disclosed.
Dr. Sheldon Krimsky, a science policy expert at Tufts University, said such conflicts were common on FDA advisory panels. The FDA often conceals these conflicts, and studies have shown that, taken as a whole, money does influence scientific judgments, Krimsky said. He added: "FDA has to work harder to fill panels with people without conflicts, and if they feel they have the best committee, they at least ought to make it transparent." But Dan Troy, a Washington lawyer who was until last year the agency`s general counsel, said that finding knowledgeable experts without financial conflicts is difficult. Suggesting that such conflicts skew a panel`s decisions "buys into an overly conspiratorial view of the world," Troy said.
A spokeswoman for the FDA said that no one at the agency would comment on specific panel member`s industry ties. Before each of three meetings of the advisory board last week, an agency secretary read a statement absolving panel members of conflicts of interest because the committee`s agenda involved "issues of broad applicability and there are no products being approved."
The secretary also said, "The Food and Drug Administration acknowledges that there may be potential conflicts of interest, but because of the general nature of the discussions before the committee, these potential conflicts are mitigated." But the committee took nine votes -- three for each drug -- on whether Celebrex, Bextra or Vioxx hurt the heart, should continue to be sold and, if so, under what restrictions. These votes were deeply important to the three companies -- Merck, Pfizer and Novartis -- that came before the committee. Indeed, shares of Merck and Pfizer soared last Friday after the panel`s votes.
Ten members of the panel have worked in some capacity in recent years for Merck, the maker of Vioxx; Pfizer, the maker of Celebrex and Bextra; or Novartis, which is applying to sell Prexige, a very similar pill discussed by the panel, according to the public disclosures. Of the 30 votes cast by the 10 panel members on whether Celebrex, Bextra and Vioxx should continue to be sold, 28 favored the drugs. Among the 66 votes cast by the remaining 22 members of the panel, just 37 favored the drugs. The members with financial ties to the companies were 10 times more likely to favor the drugs as those without such ties.
THE VOTES ON PAINKILLERS: A SECOND LOOK
Ten of the 32 members of the panel that voted last week to advise the FDA against banning Bextra, Vioxx and Celebrex had financial ties with the companies that make these drugs. .
-- Should the following drugs be allowed to continue marketing?
Bextra (Pfizer)
Yes No
Total vote 17 13
Vote of those with financial ties 9----- 1
Vote of those with no known ties* 8---- 12
.
Vioxx (Merck)
Yes No
Total vote 17 15
Vote of those with financial ties 9 1
Vote of those with no known ties* 8 14
Panel voted 31-1 in favor of Celebrex. *Two abstained on Bextra.
Sources: F.D.A.; Center for Science in the Public Interest
New York Times
Study Shows Methylphenidate Linked to Chromosomal Changes
Released: Thu 24-Feb-2005, 14:00 ET |
http://www.newswise.com/articles/view/510069/
Description
A new study found that every one of a dozen children treated for attention deficit/ hyperactivity disorder with methylphenidate experienced a threefold increase in levels of chromosome abnormalities-occurrences associated with increased risks of cancer and other adverse health effects.
Newswise - In a small but startling preliminary new study, Texas researchers have found that after just three months, every one of a dozen children treated for attention deficit/hyperactivity disorder (ADHD) with the drug methylphenidate experienced a threefold increase in levels of chromosome abnormalities-occurrences associated with increased risks of cancer and other adverse health effects.
The researchers say that to their knowledge this is the first study addressing the potential chromosome-breaking effects associated with treatment of children with methylphenidate, the generic name for a group of drugs that includes Ritalin, Concerta, Metadate CD and others.
Methylphenidate is the most widely prescribed of a class of amphetamine-like drugs used to treat ADHD, with more than 10 million prescriptions written for it in 1996 alone. Between 1991 and 1999, United States sales of methylphenidate increased more than 500 percent.
Researchers at The University of Texas M.D. Anderson Cancer Center in Houston and the University of Texas Medical Branch at Galveston (UTMB) reported their detection of the chromosome abnormalities in the journal Cancer Letters. Their peer-reviewed paper is to be published several months hence, but the journal editors have made it available online in the journal`s "articles in press" section.
The authors said they undertook the study because, even though methylphenidate has been approved for human use for more than 50 years, "there are surprisingly few studies" in either animals or human beings "on the potential for serious side effects," such as causing mutations and cancer. In 1996, a report discussing several two-year-long animal studies showed that the highest levels of methylphenidate tested caused liver tumors in male and female mice. However, similar studies in rats showed no such tumors.
The new Texas study involved researchers drawing blood from children diagnosed with ADHD before they began taking methylphenidate in order to get a baseline level of chromosomal abnormalities. Three months after the children had begun taking the drug, the researchers drew the children`s blood and tested it a second time. Chromosomes are the bodies within cells that carry the genes and genetic information. All 12 of the children whose before-and-after blood cells were studied were treated with normal therapeutic doses of methylphenidate.
Most of the abnormalities found in the studied blood cells consisted of chromosome breaks "and a higher frequency of aberrations is reported to be associated with an increased risk of cancer down the line," said lead author Randa A. El-Zein, M.D., Ph.D., an assistant professor of epidemiology at M.D. Anderson who performed the blood studies using several techniques.
"It was pretty surprising that all of the children taking methylphenidate showed an increase in chromosome abnormalities in a relatively short period of time," El-Zein said.
UTMB Professor of Environmental Toxicology Marvin Legator, the study`s principal investigator and senior author, cautioned, "This study doesn`t mean that these kids are going to get cancer, but it does mean they are exposed to an additional risk factor, assuming that this study holds up." Of the 53 known human carcinogens, Legator said 48 could be detected using the chromosome analysis methods employed in this study.
El-Zein stressed that much larger studies at several medical centers are needed to confirm the results of this study and to answer other questions not addressed by it. One of these issues is the question of what happens when patients stop taking methylphenidate. "Do the levels of chromosome abnormalities go back to normal?" El-Zein said. "We don`t know."
Parents should respond cautiously to this preliminary study, El-Zein said, noting that there are few alternatives to methylphenidate for treating ADHD.
Asked what he would do in response to the study if his child were on methylphenidate, co-author Matthew J. Hay, a UTMB pediatrician who treated all the children who participated in the study, was equally guarded. "Twelve kids with one physician in one county is too small a sample to base a decision on," he said. "If my child were on the medication and were doing well, I wouldn`t take him off it" unless additional studies showed similar effects.
The Cancer Letters article by Randa A. El-Zein, Sherif Z. Abdel-Rahman, Matthew J. Hay, Mirtha S. Lopez, Melissa L. Bondy, Debra L. Morris and Marvin S. Legator can be found on the Web by clicking the "Articles in Press" button on ScienceDirect`s Cancer Letters page (http://www.sciencedirect.com/science/journal/03043835). PDF copies can be obtained by contacting the UTMB public affairs office at the email addresses or phone numbers above.
On January 27, 2005 after a bitter battle the Florida Board of Governors - who oversee the public colleges in Florida - voted down a proposed chiropractic school at Florida State University. Whether or not you supported the establishment of that school, there are some important lessons to be learned.
First, the allopathic medical profession has never understood or liked chiropractic and that has not changed. One had only to read the Florida papers to see that fact. Headlines and articles quoted members of the medical and associated scientific communities who referred to chiropractic as "pseudo-science," "voodoo," and even "deadly". What I have learned from these ignorant and vitriolic comments is that they don`t like us. That`s ok with me. Chiropractic was founded as a separate and distinct profession, and as such we have never needed their approval. What we need to do now is to stop seeking an approval that is never coming.
I know many chiropractors and chiropractic students who feel that if we just adopt the allopathic language, i.e. manipulation instead of adjustment, diagnosis instead of analysis, or call ourselves by the oxymoronic title of chiropractic medicine, that we can get into their private club. Wake up.
The FSU fight shows yet again the fallacy of that argument. Take heart because we are not alone. An acquaintance of mine, a board-certified osteopathic radiologist, was recently denied admission to a radiology fellowship at a prominent allopathic college in Philadelphia because "the program only admits MDs owing to their superior qualifications". If the DO`s - who have played the "let us in the club" game with the MD`s for years - are still not in, we should realize that we have no chance at all. It is time that we proudly view ourselves as the separate and distinct profession that we were founded to be.
The second key lesson in the FSU debate was the need for more chiropractic research. Proponents of the school promised it would be "evidence based," and that it would be a center for research. Opponents of the school said that chiropractic had no credible research to begin with, and that we were only seeking a school at FSU to provide a cloak of credibility for our disreputable profession. Evidence and research must proceed from a well-defined objective. Unfortunately, much of the evidence and research done under the banner of chiropractic has little or nothing to do with chiropractic. Many of the studies are done with an allopathic objective in mind. One of the frequent points of discussion in the FSU argument was whether the new college would teach "subluxation theory". The opponents decried subluxation theory as unscientific and lacking in both evidence and research. The proponents ran for cover and tried to find alternate language, promising that only proven concepts would be taught. Since we do not as a profession support a secondary industry, as the MD`s do the drug industry, we will never have the nearly unlimited dollars for research that they enjoy. For that reason we must allocate our limited resources carefully. We should divorce ourselves from the allopathic research objective and focus instead on researching chiropractic. We should spend our time researching the nature and effects of the subluxation, the affect of the adjustment on physiology, and the comparison of the various techniques employed. Doing that will not convince the MD`s of our value, but it will give our profession the courage and ammunition to stand up against the inevitable attacks. Instead of trying to deconstruct the historic principles and practices of chiropractic in a vain attempt to gain medical acceptance, let us work to prove constructively what we already know to be true - subluxations exist and their correction positively benefits human function.
BJ once said, "conflicts clarify". Perhaps this bitter conflict over the school at FSU will teach us some much needed lessons.
**************
Dr. Ralph Davis is a 1986 graduate of Sherman College of Straight Chiropractic. He has taught at Sherman College, Pennsylvania College,
and Palmer College of Chiropractic Florida. Dr. Davis is a member of the WCA and an Editorial Board member of the Journal of Vertebral Subluxation
Research. He is currently in private practice in Tampa, Florida.
Flu shots don’t save seniors` lives, study finds
Researchers say schoolchildren should be first in line for vaccine
The Associated Press
Updated: 4:01 p.m. ET Feb. 14, 2005
Led by National Institutes of Health researchers, the study challenges standard government dogma and is bound to confuse senior citizens. During last fall’s flu vaccine shortage, thousands of older Americans, heeding the government’s public health message, stood in long lines to get their shots.
“There is a sense that we’re all going to die if we don’t get the flu shot,” said the study’s lead author, Lone Simonsen, a senior epidemiologist at the National Institute of Allergy and Infectious Diseases in Bethesda, Md. “Maybe that’s a little much.”
The study should influence the nation’s flu prevention strategy, Simonsen said, perhaps by expanding vaccination to schoolchildren, the biggest spreaders of the virus.
No plans for new guidelines
However, the U.S. Centers for Disease Control and Prevention in
“We think the best way to help the elderly is to vaccinate them,” said CDC epidemiologist William Thompson. “These results don’t contribute to changing vaccine policy.”
The CDC currently recommends flu shots for people age 50 and over, nursing home residents, children 6-23 months, pregnant women, people with chronic health problems and certain health care and day care workers. When vaccine was scarce a few months ago, healthy people under 65 were urged to forgo the shot.
Although the study, published Monday in the Archives of Internal Medicine, looks at data from the whole
It’s also unlikely that a single study would trigger a change in policy, said CDC spokesman Glen Nowak.
But the former head of the nation’s vaccine strategy, Dr. Walter Orenstein, said Simonsen’s work “should make us think twice about our current strategy and (about) potentially enhancing it.” Orenstein is former director of the CDC’s National Immunization Program and now leads a program for vaccine policy development at
Schoolchildren first?
A shift to vaccinating schoolchildren, the age group most likely to spread the flu virus, is advocated by colleagues of Orenstein’s at Emory in a separate report to be published Tuesday in the American Journal of Epidemiology.
The NIH and Emory papers, one a highly technical statistical analysis of death data and the other a commentary based on field studies and mathematical modeling, come during a season that focused the nation’s attention on vaccine supplies.
As a vaccine shortage loomed last fall, the CDC urged shots only for the highest-risk groups. Most of the 36,000 people who die each year of flu-related causes are elderly and the nation’s strategy has focused on getting shots to them, as well as other high-risk groups.
Last week the CDC reported that about 59 percent of older Americans got shots in 2004, down from 65 percent in 2003. Based on her research, Simonsen doesn’t expect to see a corresponding increase in flu-related deaths this year, something that “can be seen as good news.”
The flu vaccine is less effective in the elderly than in younger people. It works, but not very well, said Ira Longini, a biostatistics professor at
While it’s smart for senior citizens to get their yearly flu shots because it can decrease their risk of getting sick, he said, a smarter government strategy would emphasize shots for children, ages 5 to 18. His statistical models show that strategy could save more elderly Americans from hospital visits and death.
`We simply have to change the policy`
“If we really want to make a difference and control influenza, we simply have to change the policy. We have to vaccinate large numbers of children,” Longini said.
He and his colleague Dr. Elizabeth Halloran write that if 70 percent of schoolchildren were vaccinated, the elderly would be protected without flu shots. The strategy would require 42 million doses of flu vaccine. Even during this season’s shortage, there were 57 million doses available, their report says.
Yearly flu shots have been recommended for people 65 and older since the 1960s and for those 50 and older since 2000. Vaccination rates have risen among seniors from 20 percent before 1980 to 65 percent in 2001, according to the NIH study.
Simonsen and her team of researchers could find no corresponding decrease in death rates. Their analysis took into account the fact that people are living longer and that more virulent strains of flu dominated the 1990s.
The CDC’s Thompson said Simonsen didn’t take into account the effect of a gradual lengthening of the average flu season over the decades. But Simonsen said that no matter what model she used to define a flu season, she came to the same result.
Older Americans should keep their risk in perspective, said Dr. Lisa Schwartz and Dr. Steven Woloshin, senior researchers at the VA Outcomes Group, a small group of researchers trying to promote the straightforward presentation of medical information.
For the average senior citizen, the annual risk of dying from the flu is low: about 1 in 1,000. They said senior citizens still should try to get flu shots, but shouldn’t panic if vaccine isn’t available.
URL: http://www.msnbc.msn.com/id/6969077/
Nation`s Health Spending Slows, but It Still Hits a Record
January 11, 2005
By ROBERT PEAR
WASHINGTON, Jan. 10 - The torrid pace of growth in national health spending cooled a bit in 2003, but the spending, at $1.7 trillion, topped 15 percent of the gross domestic product for the first time, the government said on Monday. Total health spending rose 7.7 percent in 2003, compared with an increase of 9.3 percent the year before, in part because of state cutbacks in the Medicaid program and a slower increase in drug spending. But it grew much faster than the economy as a whole, and now accounts for 15.3 percent of the nation`s output, the government said in its annual report on health spending.
"Prescription drug spending growth slowed more sharply than growth of any other service, increasing 10.7 percent in 2003, compared with 14.9 percent in 2002," said Cynthia Smith of the federal Centers for Medicare and Medicaid Services, the principal author of the report, published in the journal Health Affairs. Retail sales of prescription drugs totaled $179.2 billion in 2003, the government said. Though drug sales increased more slowly than in 2002, they are still growing faster than overall national health spending, the data showed. The figures indicated why drug costs remain a combustible political issue: consumers often pay a large share of the price. Prescription drugs accounted for 11 percent of national health spending, but 23 percent of total out-of-pocket spending by patients.
Consumers dipped into their own pockets to pay 30 percent of prescription drug costs - $53.2 billion of the $179.2 billion spent on prescription medicines in 2003. Consumers have much more extensive insurance for hospital costs; they pay just 3 percent of those costs from their pockets.
In the last decade, public spending on health care has grown somewhat faster than private spending, but in 2003, the reverse was true. Private spending rose 8.6 percent in 2003, after rising 9 percent the year before. By contrast, economists saw a sharp deceleration in the growth of Medicaid, the federal-state health program for low-income people. Medicaid spending rose 7.1 percent in 2003, to $267 billion, following growth of 12.1 percent the year before.
Spending on Medicare, the federal health program for the elderly and the disabled, grew 5.7 percent in 2003, to $283.1 billion, compared with an increase of 7.6 percent in 2002. Out-of-pocket payments were the only major source of health spending to increase faster in 2003 than in 2002, the administration said. Federal health officials offered two reasons: the number of people without health insurance is increasing, and employers who provide coverage are requiring workers to bear more of the costs.
In the last few years, Ms. Smith said, "employers have been more willing to pass on cost increases to employees by increasing co-payments for physician visits, requiring separate hospital deductibles and raising drug plan co-payments." Payments for private health insurance, in the form of premiums, increased 9.3 percent in 2003, compared with an increase of 10.6 percent in 2002, the report said. But benefits did not grow as fast as did the premiums collected by insurers. "Administrative costs and insurer profits accelerated as benefit growth decelerated," the report said. Mary Carol Barron, a health economist at the Department of Health and Human Services, said that "at least 34 states took measures to control Medicaid costs in 2003," typically by tightening eligibility or restricting benefits.
Factors contributing to the slowdown in the growth of drug spending included a smaller increase in the number of prescriptions; greater use of low-cost generic drugs; higher co-payments, which tend to discourage use of some drugs; and the conversion of Claritin, the popular allergy drug, to over-the-counter status. Consumer purchases from Canadian pharmacies, estimated at $1.1 billion in 2003, were not counted in health spending for the United States. American sales of generic drugs grew at twice the rate of brand-name drug sales in 2003. "When offered a choice, consumers opt for a generic drug almost 90 percent of the time in chain drug stores," the report said.
President Bush, campaigning for limits on malpractice lawsuits, said last week that "we have the best health care system in the world." But the United States devotes a much larger share of its economic output to health care than other industrial countries do. Among the 30 members of the Organization for Economic Cooperation and Development, the countries with the next largest shares, Switzerland and Germany, spend less than 12 percent of G.D.P. on health care.
Health spending continues to grow in most industrial countries, with rapid advances in medical technology and aging populations, even when economic growth is slow. Paul B. Ginsburg, president of the Center for Studying Health System Change, a private group that tracks health costs, said those trends could pose problems for the United States because of the way it finances health care. "Health insurance premiums are growing faster than what people earn," Mr. Ginsburg said. "Government health care spending is growing faster than federal revenues, crowding out other priorities."
The report said that health spending in the United States averaged $5,670 a person in 2003, up $353 from 2002. Hospital care accounts for nearly one-third of all health spending, and slower growth in spending for hospital services was a significant factor in the national trend. Hospital spending rose 6.5 percent in 2003, to $515.9 billion, following an increase of 8.5 percent in the prior year. Many states, wrestling with budget problems, froze Medicaid payments to hospitals. Medicaid spending on hospitals grew 5.3 percent in 2003, about six percentage points less than the year before.
Medicaid and Medicare alike curbed spending for nursing home care. Medicaid payments to nursing homes grew just 1 percent in 2003, to $51 billion, following an increase of 8.1 percent in 2002. Likewise, the government said, Medicare payments to nursing homes "increased only 1.3 percent in 2003, following three years of rapid growth that averaged 16.2 percent a year between 1999 and 2002."
http://www.nytimes.com/2005/01/11/politics/11health.html?ex=1110798291&ei=1&en=b68b5fa4c50f9628
ext season`s influenza vaccine will be changed to protect against a new strain of the virus that was first identified in California last month and that is spreading widely, a World Health Organization official said yesterday.
The new strain has been identified in more than 20 percent of influenza viruses isolated from patients in recent weeks and is expected to be the dominant one circulating in the Northern Hemisphere next season, said the official, Dr. Klaus Stöhr.
The strain, known as A/California/7/2004(H3N2), was first identified from a specimen from a patient who had influenza in Santa Clara County in September, said Dr. Carol Glaser , chief of the California Department of Health Services` viral branch in Richmond. The Centers for Disease Control and Prevention in Atlanta identified the strain as a new one in January, Dr. Glaser said.
Yesterday, at the World Health Organization headquarters in Geneva, a panel of influenza experts recommended inclusion of the California strain in next season`s vaccine. The panel meets twice a year to try to match the strains in the vaccine recommended for each hemisphere with those expected to be circulating there the next season.
Choosing the strains to include is largely scientific guesswork. But the panel has been wrong only once in the last 10 years, Dr. Stöhr, the health organization`s top influenza expert, said in a telephone interview.
The standard flu shot is composed of three strains of influenza virus. The California strain will substitute for A/Fujian, Dr. Stöhr said. The two other strains will remain the same: A/New Caledonia 20/99(H1N1), which has been included for the last six years, and B/Shanghai/361/2002, which has been included for two years.
The United States usually follows the health organization`s recommendations.
The idea is to introduce a new strain in the vaccine only when significant changes occur, Dr. Stöhr said, adding, "A/California is profoundly different from what has been circulating before."
The California strain is not related to the avian influenza strain that has killed hundreds of thousands of birds and a small number of people in Southeast Asia.
The vaccine is produced in sequential steps. The manufacturers start about January with the strain that they least expect to be changed, then move to the second strain. In a third step, they produce the newest strain, expected by the end of March. Then they produce the entire vaccine.
TO THE KIDS WHO SURVIVED the 30`s, 40`s, 50`s and 60`s
First, we survived being born to mothers who smoked and/or drank
while they carried us. They took aspirin, ate blue cheese dressing and didn`t get tested for diabetes.
Then after that trauma, our baby cribs were covered with bright colored lead-based paints.We had no childproof lids on medicine bottles, doors or cabinets and when we rode our bikes, we had no helmets, not to mention, the risks we took hitchhiking.As children, we would ride in cars with no seat belts or air bags. Riding in the back of a pick up on a warm day was always a special treat.
We shared one soft drink with four friends, from one bottle and NO ONE actually died from this.We ate cupcakes, bread and butter and drank soda pop with sugar in it, but we weren`t overweight because WE WERE ALWAYS OUTSIDE PLAYING! We would leave home in the morning and play all day, as long as we were back when the streetlights came on.
We would spend hours building our go-carts out of scraps and then ride down we forgot the brakes. After running into the bushes. We did not have Play stations, Nintendo`s, X-boxes, no
video games at all, no 99 channels on cable, no video tape movies, no surround sound, no cell phones,
no personal computers, no Internet or Internet chat rooms...........
WE HAD FRIENDS and we went outside and found them!
We fell out of trees, got cut, broke bones and teeth and there were no lawsuits
from these accidents. We made up games with sticks and tennis balls and ate
worms and although we were told it would happen, we did not put out very many
eyes, nor did the worms live in us forever.
Little league had tryouts and not everyone made the team. Those who didn`t had
to learn to deal with disappointment. Imagine that!
The idea of a parent bailing us out if we broke the law was unheard of. They
actually sided with the law!
No one was able to reach us all day - and we were O.K.
We drank water from the garden hose and NOT from a bottle.
This generation has produced some of the best risk-takers, problem solvers and
inventors ever! The past 50 years have been an explosion of innovation and new
ideas. We had freedom, failure, success and responsibility, and we learned HOW
TO DEAL WITH IT ALL! And YOU are one of them! CONGRATULATIONS!
Later, when the nurses were going through her meager possessions, they found this poem. Its quality and content so impressed the staff that copies were made and distributed to every nurse in the hospital.
One nurse took her copy to
Crabby Old Woman
What do you see, nurses?
What do you see?
What are you thinking
When you`re looking at me?
A crabby old woman,
Not very wise,
Uncertain of habit,
With faraway eyes?
Who dribbles her food
And makes no reply
When you say in a loud voice,
"I do wish you`d try!"
Who seems not to notice
The things that you do,
And forever is losing
A stocking or shoe?
Who, resisting or not,
Lets you do as you will,
With bathing and feeding,
The long day to fill?
Is that what you`re thinking?
Is that what you see?
Then open your eyes, nurse,
You`re not looking at me.
I`ll tell you who I am
As I sit here so still,
As I do at your bidding,
As I eat at your will.
I`m a small child of ten
With a father and mother,
Brothers and sisters,
Who love one another.
A young girl of sixteen
With wings on her feet
Dreaming that soon now
A lover she`ll meet.
A bride soon at twenty,
My heart gives a leap,
Remembering the vows
That I promised to keep.
At twenty-five now,
I have young of my own,
Who need me to guide
And a secure happy home.
A woman of thirty,
My young now grown fast,
Bound to each other
With ties that should last.
At forty, my young sons
Have grown and are gone,
But my man`s beside me
To see I don`t mourn.
At fifty once more,
Babies play round my knee,
Again we know children,
My loved one and me.
Dark days are upon me,
My husband is dead,
I look at the future,
I shudder with dread.
For my young are all rearing
Young of their own,
And I think of the years
And the love that I`ve known.
I`m now an old woman
And nature is cruel;
`Tis jest to make old age
Look like a fool.
The body, it crumbles,
Grace and vigor depart,
There is now a stone
Where I once had a heart.
But inside this old carcass
A young girl still dwells,
And now and again,
My battered heart swells.
I remember the joys,
I remember the pain,
And I`m loving and living
Life over again.
I think of the years
All too few, gone too fast,
And accept the stark fact
That nothing can last.
So open your eyes, people,
Open and see,
Not a crabby old woman;
Look closer . . . see ME!!
Remember this poem when you next meet an old person who you might brush aside without looking at the young soul within . .. . we will all, one day, be there, too!
March 17 - 20, 2005 Cancun, Mexico Georgia Chiropractic Council