Infectious Diseases
Seasonal Flu and Swine Flu Updates
10.16.2009
Judge Halts Mandatory Flu Vaccines for Health Care Workers
By Sewell Chan AND Anemona HartocollisDaniel Barry for The New York Times Dr. Richard F. Daines, the state health commissioner, issued the vaccination requirement in August.
Updated, 1:27 p.m. | A judge on Friday morning halted enforcement of a New York State directive requiring that all health care workers be vaccinated for the seasonal flu and swine flu.
The temporary restraining order by the judge, Thomas J. McNamara, an acting justice of the State Supreme Court in Albany, is likely to add to the growing debate about the flu vaccine.
Justice McNamara scheduled a hearing on the case for Oct. 30.
On Aug. 13, the state health commissioner, Dr. Richard F. Daines, through the State Hospital Review and Planning Council, issued a regulation ordering health care workers to be vaccinated by Nov. 30 or face fines.
Dr. Daines said at the time:
Questions about safety and claims of personal preference are understandable. Given the outstanding efficacy and safety record of approved influenza vaccines, our overriding concern then, as health care workers, should be the interests of our patients, not our own sensibilities about mandates. On this, the facts are very clear: the welfare of patients is, without any doubt, best served by the very high rates of staff immunity that can only be achieved with mandatory influenza vaccination – not the 40-50 percent rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur every flu season. Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated themselves, while also allowing the institution to remain more fully staffed.
Terence L. Kindlon, a lawyer for three nurses who sued the state, asserting that the order violated their civil rights, said the judge’s ruling was a victory. New York was the only state in the country to mandate vaccinations for health care workers, he said.
The nurses — Lorna Patterson, Kathryn Dupuis and Stephanie Goertz — work in the emergency room at Albany Medical Center, a regional trauma unit.
“These are not libertarians, they are not lefties, they are not right-wing lunatics,” Mr. Kindlon said of his clients in a phone interview on Friday. “They are health care professionals, and they think the vaccination is not going to be good for them. They have no confidence that either the seasonal flu vaccine or H1N1 vaccine is going to do any good for them.”
Justice McNamara consolidated the nurses’ suit with two other lawsuits, brought by the New York State Public Employees Federation and the New York State United Teachers Union, which also challenged the regulation.
Mr. Kindlon said of his clients: “They basically were being administratively ambushed. This regulation came out of the Health Department during the dog days of August. People weren’t aware of it until September. Then they were suddenly advised that the drop-dead rate for receiving the vaccination from the state was Nov. 30.”
The hospital imposed its own deadline — mid-October — for vaccinations for its employees, Mr. Kindlon said.
The state is all but certain to fight the lawsuits and seek enforcement of the mandate. At a legislative hearing on Tuesday, Dr. Guthrie Birkhead, a state deputy health commissioner, defended the mandate, saying, “Health care settings are no different than any other setting where vaccination is the most effective method of preventing influenza.”
The issue of mandatory vaccinations has divided health care workers and even experts. The New York State Nurses Association, for example, has been monitoring the situation but not taken an official position against the requirement.
The Public Employees Federation, which has about 5,000 members covered by the regulations, said it encouraged its members to be vaccinated against the flu but opposed making the vaccine a condition of employment.
Patricia Finn, a lawyer for Suzanne Field, a nurse from Poughkeepsie, N.Y., who has filed a lawsuit in State Supreme Court in Manhattan challenging the mandatory vaccinations, said on Friday that her case would proceed despite the Albany restraining order, but added about the temporary restraining order:
We’re absolutely thrilled about it. I’m very pleased that the whole process has been slowed down. That’s what we’re so concerned about, the process of vaccinating. It’s not like getting your teeth cleaned; it’s pretty serious. It shouldn’t be taken lightly. So we were happy about this.
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Giving babies Tylenol may blunt vaccines' effects
By Marilynn Marchione ASSOCIATED PRESS
Giving babies Tylenol to prevent fever when they get childhood vaccinations may backfire and make the shots a little less effective, surprising new research suggests.
It is the first major study to tie reduced immunity to the use of fever-lowering medicines. Although the effect was small and the vast majority of kids still got enough protection from vaccines, the results make "a compelling case" against routinely giving Tylenol right after vaccination, say doctors from the U.S. Centers for Disease Control and Prevention.
They wrote an editorial accompanying the study, published in Friday's issue of the British medical journal, Lancet.
The study only looked at preventive use of Tylenol -- not whether it is OK to use after a fever develops.
Tylenol or its generic twin, acetaminophen, is widely recommended as a painkiller for babies. Many parents give it right before or after a shot to prevent fever and fussiness, and some doctors recommend this. The CDC's vaccine advisory panel says it is a reasonable thing to do for children at high risk of seizures, which can be triggered by fevers.
However, fever after a vaccine isn't necessarily bad -- it's a natural part of the body's response. Curbing fever, especially the first time a baby gets a vaccine, also seems to curb the immune response and the amount of protective antibodies that are made, the new study found.
It was led by military and government scientists in the Czech Republic and was done at 10 medical centers in that Eastern European country. It involved 459 healthy infants, 9 to 16 weeks old, who were getting vaccines against polio, pneumonia, meningitis, whooping cough, tetanus, hepatitis and other childhood diseases.
Half were given three doses of Calpol, or paracetamol -- a Tylenol-like brand sold in Europe -- during the first day after vaccination. The others were given nothing besides the vaccines.
Babies given the painkiller were significantly less likely to develop a fever -- 42 percent versus 66 percent of the others -- and very few in either group developed a high one.
However, lower rates of protective antibody levels from several vaccines were seen in the group given the drug. Levels remained significantly lower in this group after booster vaccines, given when the babies were 12 to 15 months old.
Next, the researchers looked at 10 other vaccine studies and found some supporting evidence that using Tylenol to prevent fevers at the time of vaccination may curb immune system response rates. The same may not be true of using the drug to treat fevers after they develop.
The research was sponsored by Belgium-based GlaxoSmithKline Biologicals, which makes all the vaccines used in the study. Some authors have financial ties to the company, including owning stock in it, and Glaxo had a role in reporting the results.
Even with the fever-lowering drugs, more than 90 percent of children in the Czech study achieved protection from the various vaccines after the booster dose, so the effect of lower levels of antibodies on any individual might be small, Dr. Robert Chen and two other CDC doctors wrote in an editorial.
Yet the consistency of findings from other studies makes "a compelling case against" routine use of fever-lowering medicines during immunization, they write.
It's not known if Tylenol or other painkillers might reduce vaccine response in adults, but they are less likely to develop a fever after vaccination or to be so bothered by it, said Dr. John Treanor, a vaccine specialist at the University of Rochester Medical Center in Rochester, N.Y., who had no role in the study.
Tylenol is the only member of the family of over-the-counter pain relievers that is not a nonsteroidal anti-inflammatory drug, or NSAID.
"There's been speculation for a long time that the use of NSAIDs might have an effect" on antibody production after vaccination, but this is far from proved, Treanor said.
Given that so few children develop high fevers after vaccines, skipping the meds unless fever develops "may be the way to go," he said.
Vaccines and Preventable Diseases:
Fatal Exemption: Relationship Between Vaccine Exemptions and Rates of Disease
Dr. Paul Offit's Commentary as published in Wall Street Journal
January 29, 2007 On January 20, the Wall Street Journal published a commentary written by Paul A. Offit, MD, director, Vaccine Education Center, and chief, Division of Infectious Diseases, Children's Hospital of Philadelphia (CHOP). The commentary originally appeared in the December 2006 issue of the email newsletter Parents Pack, which is a publication of the Vaccine Education Center.
Dr. Offit's commentary discusses the findings presented in a paper published in the Journal of the American Medical Association (JAMA) on October 11, 2006. The commentary as printed in Parents Pack is reprinted below in its entirety.
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Last month [October 2006] the Journal of the American Medical Association (JAMA) published a study that received little attention from the press and, as a consequence, the public. The study examined the incidence of whooping cough (pertussis) in children whose parents had chosen not to vaccinate them; the results were concerning.
Vaccines are recommended by the Centers for Disease Control and Prevention (CDC) and professional societies, such as the American Academy of Pediatrics. But these organizations can't enforce their recommendations; only states can do that—usually when children enter day care centers and elementary schools—in the form of mandates. State vaccine mandates have been on the books since the early 1900s; but aggressive enforcement of them didn't occur until much later, born from tragedy.
In 1963 the first measles vaccine was introduced in the United States. Measles is a highly contagious disease that can infect the lungs causing fatal pneumonia, or the brain causing encephalitis. Before the measles vaccine, measles caused 100,000 American children to be hospitalized and 3,000 to die every year. In the early 1970s, public health officials found that states with vaccine mandates had rates of measles that were 50 percent lower than states without mandates. As a consequence, all states worked toward requiring children to get vaccines. Now every state has some form of vaccine mandates.
But not all children are subject to these mandates. All fifty states have medical exemptions to vaccines, such as a serious allergy to a vaccine component. Forty-eight states also have religious exemptions; Amish groups, for example, traditionally reject vaccines, believing that clean living and a healthy diet are all that are needed to avoid vaccine-preventable diseases. And twenty states have philosophical exemptions; in some states these exemptions are easy to obtain, by simply signing your name at the bottom of a form; and in others they're much harder, requiring notarization, annual renewal, a signature from a local health official, or a personally written letter from a parent.
The JAMA study examined the relationship between vaccine exemptions and rates of disease. The authors found that between 1991 and 2004 the percentage of children whose parents had chosen to exempt them from vaccines increased by 6 percent per year, resulting in a 2.5-fold increase. This increase occurred almost solely in states where philosophical exemptions were easy to obtain. Worse, states with easy-to-obtain philosophical exemptions had twice as many children suffering from pertussis—a disease that causes inflammation of the windpipe and breathing tubes, pneumonia and, in about twenty infants every year, death—than states with hard-to-obtain philosophical exemptions.
The finding that lower immunization rates caused higher rates of disease shouldn't be surprising. In 1991 a massive epidemic of measles in Philadelphia centered on a group that chose not to immunize its children; as a consequence nine children died from measles. In the late 1990s, severe outbreaks of pertussis occurred in Colorado and Washington among children whose parents feared pertussis vaccine. And in 2005 a 17-year-old unvaccinated girl, unknowingly having brought measles back with her from Romania, attended a church gathering of 500 people in Indiana and caused the largest outbreak of measles in the United States in ten years; an outbreak that was limited to children whose parents had chosen not to vaccinate them. These events showed that for contagious diseases like measles and pertussis it's hard for unvaccinated children to successfully hide among herds of vaccinated children.
Some would argue that philosophical exemptions are a necessary pop-off valve for a society that requires children to be injected with biological agents for the common good. But as anti-vaccine activists continue to push more states to allow for easy philosophical exemptions one thing is clear, more and more children will suffer and occasionally die from vaccine preventable diseases.
When it comes to issues of public health and safety we invariably have laws. Many of these laws are strictly enforced and immutable. For example, we don't allow philosophical exemptions to restraining young children in car seats or smoking in restaurants or stopping at stop signs. And the notion of requiring vaccines for school entry, while it seems to tear at the very heart of a country founded on the basis of individual rights and freedoms, saves lives. Given the increasing number of states allowing philosophical exemptions to vaccines, at some point we are going to be forced to decide whether it is our inalienable right to catch and transmit potentially fatal infections.
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To access Dr. Offit's article from Parents Pack, go to:
NOTE: Dr. Offit's Wall Street Journal commentary, titled "Fatal
Exemption," is available to the paper's online subscribers at http://www.wsj.com
To access the abstract of the JAMA article ("Nonmedical Exemptions to School Immunization Requirements: Secular trends and association of state policies with pertussis incidence"), go to: http://jama.ama-assn.org/cgi/content/abstract/296/14/1757
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New York state is battling mandatory vaccination of healthcare workers. MNA is following their struggle closely. To date vaccination has NOT been mandated by the MDPH or any hospitals I am aware of. Feel free to contact me with questions or information about vaccine mandates.
Just fyi, DHCFP (MA Dept of Healthcare Finance and Policy) has posted the most recent financials for MA acute care hospitals (FY09 Q3) on its website at the following url address:
The 5th line down, “Total Surplus/Loss” is the hospital profit or loss figure that MNA follows closely—that’s the figure that hospital staff would get beat over the head by their administration about.
