Tuesday, March 31, 2009

Post #17 Autism Top Exec Quits Because She Doesn't Think Vaccines Cause Autism

The media/publicity pendulum continues to swing the other way (in the correct direction!) with Allison Singer, the executive vice president of communications and awareness at Autism Speaks, conceding that vaccines are not linked to autism.

She advocates using public research money to further delineate the genetic role of autism in lieu of further studies searching for a link to vaccines - "Dozens of credible scientific studies have exonerated vaccines as a cause of autism," she wrote in a statement. "I believe we must devote limited funding to more promising avenues of autism research."

Mrs. Singer is not a scientist or a doctor. However, she is the mother of an autistic child and through the organization Autism Speaks, Mrs. Singer has had contact with some of the brightest minds and studies delving into this delicate issue.

It takes no small amount of courage for her to break stride with her former group by essentially exonerating any causal link between vaccines and autism. In short, the evidence must have overwhelmed her.

Newsweek Interview Below. . .

Newsweek Web Exclusive
January 16, 2009


The warfare over vaccines and autism is heating up yet again.

This week, Alison Singer, the executive vice president of communications and awareness at Autism Speaks, one of the nation's leading autism advocacy groups, announced her resignation, citing a difference of opinion over the organization's policy on vaccine research. "Dozens of credible scientific studies have exonerated vaccines as a cause of autism," she wrote in a statement. "I believe we must devote limited funding to more promising avenues of autism research."

Singer, who has an 11-year-old daughter with autism, joined the organization when it launched in 2005. Singer praised Autism Speaks and its founders, Bob and Suzanne Wright, but said she could no longer work for a group that supports spending limited resources on vaccine research.

Calling Singer's resignation "disappointing and sad," Bob Wright says more authoritative research needs to be conducted on the safety of vaccines given to children under 2. "We all know that autism has genetic causes, but it's highly associated with environmental factors we can't get our hands around," says Wright. "Vaccines fall into that category."

NEWSWEEK's Claudia Kalb spoke with Alison Singer about her resignation.

NEWSWEEK: Describe Autism Speaks.
Alison Singer: Autism Speaks is an amazing organization. It has really been a privilege for me to work there. Autism Speaks has raised so much awareness of autism and has supported literally thousands of families around the world. I could not be more proud of Autism Speaks and the work that we've done.

But you disagree with their vaccine position?
In general, I disagree with a policy that says, "Despite what this study shows, more studies should be done." At some point, you have to say, "This question has been asked and answered and it's time to move on." We need to be able to say, "Yes, we are now satisfied that the earth is round."

What do you believe the science shows?
There are more than a dozen studies that show no causal link between the MMR [measles-mumps-rubella] vaccine and autism, and thimerosal [a mercury-containing vaccine preservative] and autism. Over and over, the science has shown no causal link between vaccines and autism. My feeling is that if there was an unlimited pot of money at the NIH [National Institutes of Health] from which to fund autism science then it would be fine to say let's study it more. But we don't have that. We have very limited resources and every dollar we spend looking where we know the answer isn't is a dollar we don't have to spend where we might actually find new answers. In general, yes, more research is always better than less. But again, we have limited dollars to spend and we have to use our limited money wisely in ways that are likely to yield new information for families.

How confident are you in the studies that show no vaccine-autism link?
I've read the studies and I've talked to many doctors. One thing that has been a hugely wonderful part of being at Autism Speaks is that I've been able to consult with the top scientists in the field. We work with the top minds. I think that there's this feeling [among some parents] that the vaccine decision is a choice between, "Do I want to risk measles or do I want to risk autism?" That's not a good characterization. We know for a fact that the measles vaccine reduces the risk of getting measles. One choice is backed by science, one choice isn't.

Where would you like to see the research money go?
I think the genetics work has the potential to point us toward important answers. When we can determine which proteins are associated with various genes we can start to understand the mechanism of action that causes autism. Once you understand the mechanism of action, you can start to look for targeted therapies. I would also focus on prenatal exposures. What is a mom exposed to during pregnancy with regard to hormones or maybe medications or even pesticides? Or what's happening in the environment? During flu season, people are more prone to infections so we should look at the incidence of viral infections, flu, hormonal fluctuations and toxins in the environment for both mother and baby.

How is your daughter doing now?
Jodie has benefited tremendously from applied behavioral analysis therapy. She has learned to have some actual communicative speech. She's able to make her wants and needs known. That's really a breakthrough. For three years, she was in private school that focused intensively on language. She gained enough skills to be in a special class in a public middle school. She's not mainstreamed, but she's able to be in that large environment. So she's making great progress.

What do you think caused your daughter's autism?
Jodie had difficulties from the day she was born. She cried constantly, she had difficulty feeding, difficulty sleeping. She was diagnosed in the first few days as having "failure to thrive." I also have a brother diagnosed with autism. He's 44. My first cousin has a son diagnosed with autism. I strongly believe that there is a genetic component.

What do you say to the families who believe their child's autism was triggered by vaccines?
It's very hard because people feel very strongly and love their families so much. But not all opinions are created equal. Some are based on fact and science and some are not. Do you remember when Jenny McCarthy went on Oprah? She said she doesn't need science. Her science is at home and his name is Evan. That's not science.

Here's another story. A few weeks ago, Jodie went to the pediatrician. She had Tdap [tetanus-diptheria-pertussis] vaccine, a flu shot and a vaccine against meningitis. The next day her teacher remarked to me that Jodie was much more attentive and participated in class much more than usual. Her gym teacher said that for the fist time Jodie was able to compete in an obstacle course. Should I start pontificating that vaccines are a great treatment for autism? Of course not, that's not science. That's called coincidence.

Some families want more money spent on services for people with autism. Thoughts?
I think that's true. There's a growing number of people with autism and they're going to need services and supports. We really need to think about autism as a lifespan issue. We need to start planning now for our children's future.

What about federal health officials? Some scientists have critiqued them for not being outspoken enough about vaccine safety. Do you agree?
I think the media has to start to change. In our culture, we love celebrities. We need to listen to experts and not actresses. The media culture, feeling compelled to give both sides of an argument has lent a legitimacy to the anti-vaccine movement that is very over-weighted. They're a small number of people with very loud voices. The vast majority of parents of children with autism are very supportive of the importance of vaccines. I've had hundreds of emails in last 24 hours from parents supporting me. The media need to show both sides to make it look like both sides are equal. One side is backed by evidence, one side is not.

I think the government needs to be more vocal and I think scientists have to be more vocal. Scientists are an interesting group. They are very reluctant to speak to the media. There needs to be change in that culture. Scientists need to be more comfortable speaking out about the good science being done. I think when we see the scientists speaking out more, we will see a change.

In an interview in 2006, you said, "I am planning to stay at Autism Speaks until the day we find a cure." Now what?
Now I'll revise that to say I plan to stay in autism advocacy. I plan to take all the energy and passion that I committed to Autism Speaks and apply it elsewhere in the autism advocacy community. I'm certainly not going to be leaving. If anything, I hope to be more vocal.

Will you become more vocal on the vaccine issue specifically?
I think by talking to you today I already have.

Wednesday, March 25, 2009

Post #16 Malpractice: Wash Your Hands or Risk a Lawsuit

I was cleaning out some of the interesting articles that I have collected over the past year and came across one of my favorites from the Wall Street Journal 2008 (posted below). The essential premise of the article is that certain nosocomial (hospital-acquired) infections can be 100% averted if proper hygiene regimens are followed - beginning with, of course, hand washing.

Certain facts in the article jump out at me:

1. Nearly all hospital infections are avoidable when doctors and staff clean their hands and rigorously practice proper hygiene and other preventive measures.

2. Since October of 2008 (according to the article) Medicare no longer reimburses hospitals for nosocomial infections following orthopedic or heart surgeries.

3. Beth Israel Medical Center in New York City hasn't had a central line (a large IV placed in a major blood vessel) bloodstream infection in the cardiac intensive care unit in nearly 3 years!

Bottom line: Infections can be avoided with good hygiene beginning with hand washing. This is important not just in the O.R. but in every aspect of healthcare.

A great additional read is an entire chapter dedicated to hand washing in Atul Gawande's book Better.

Wall Street Journal August 14, 2008
By BETSY MCCAUGHEY
On July 30, a jury awarded over $2.5 million to James Klotz and his wife Mary in a medical malpractice lawsuit against a heart surgeon, his group practice and St. Anthony's Medical Center in St. Louis, Mo. In 2004 Mr. Klotz, now 69, was rushed to the hospital with a heart attack and a pacemaker was surgically implanted. He developed a drug-resistant staph infection called methicillin-resistant Staphylococcus aureus (MRSA). It was so severe that he underwent 15 additional operations, spent 84 days in the hospital and lost his right leg, part of his left foot, a kidney and most of his hearing.

This verdict should send a warning to physicians, hospitals and hospital board members. Until recently, infection was considered an unavoidable risk. But now there is proof that nearly all hospital infections are avoidable when doctors and staff clean their hands and rigorously practice proper hygiene and other preventive measures.

Hospital infections will cause the next wave of class-action lawsuits, bigger than the litigation over asbestos. The germ that Mr. Klotz contracted, hospital-acquired MRSA, infects about 880,000 patients a year and accounts for only 8% of all hospital infections. Hospital infections caused by all kinds of bacteria sicken millions.

The Klotz verdict is not the first sign that hospitals are in a new legal environment. In 2004, Tenet Healthcare Corporation agreed to pay $31 million to settle 106 lawsuits by patients who contracted infections after heart surgery at Palm Beach Gardens Medical Center in Florida. Since then, numerous lawsuits have been filed against hospitals in Florida, Kentucky and elsewhere by infected patients. Hospitals being sued are saying that their infection rates are within national norms. But for most infections, the only acceptable rate is zero.

Medicare calls certain device-related bloodstream infections, urinary tract infections and surgical infections after orthopedic and heart surgery "never events." Starting in October, Medicare will stop reimbursing hospitals for treatment of these infections. Hospitals will be barred from billing patients for what Medicare doesn't pay, forcing them to take a loss. Next year Medicare will add other types of infections to the list of "never events."

The evidence justifying Medicare's new policy is compelling. Central line bloodstream infections, caused by the contamination of certain devices, are preventable. Hospital patients in intensive care are commonly medicated through a tube inserted into a vein. The risk is that bacteria will invade the tube and enter the bloodstream. Rigorous hygiene, including clean hands, sterile drapes, and careful cleaning of the insertion site with chlorhexidine soap, can keep bacteria away from the tube.

Beth Israel Medical Center in New York City reports that it hasn't had a central line bloodstream infection in the cardiac intensive care unit in over 1,000 days. Dr. Brian Koll, chief of infection control there, explains that the key is using a checklist that doctors and nurses must follow. Implementing the checklist cost $30,000 and saved $1.5 million in treatment costs. Lives saved: priceless.

Other hospitals -- from Johns Hopkins Medical Center in Baltimore to Sutter Roseville Medical Center in Sacramento -- have reached the goal of zero central line bloodstream infections. No wonder Medicare calls these infections "never events." Why should jurors reach a different conclusion in a lawsuit?

We have the knowledge to prevent infections. What has been lacking is the will. A recent survey from the patient-safety organization Leapfrog found that 87% of hospitals fail to consistently practice infection prevention measures. Insurance companies that sell liability coverage to hospitals could change that by offering lower premiums to hospitals that rigorously follow infection-prevention protocols.

To be sure, lawsuits are not the best way to improve patient care. Many verdicts are unjustified, and few truly injured patients find a lawyer to take their case. Still, the coming wave of lawsuits, as well as financial incentives from Medicare and insurers, will fight complacency about hospital hygiene.

Ms. McCaughey, a former lieutenant governor of New York State, is chairman of the Committee to Reduce Infection Deaths.

Tuesday, March 10, 2009

Post #15 An Allergy Update

If you (or your loved one) suffer from allergies and you want some good evidence-based facts - keep reading. This particular blog entry is a bit tedious as I have tried to include a complete amount of information on allergies (their causes, the tests to diagnose, and treatment).

The article (published in August of 2008) posted below is essentially a doctor's CliffsNotes on allergies. It is a practice guideline reviewing a vast amount of articles and research on allergies; the actual article is 84 pages long with a bibliography of 998 articles. The task force has made the article user friendly by summarizing the essential 109 points that the group wanted to highlight.

You ask, "How essential can a list of 109 items be?"

Excellent question.

I have further pared down the article from 109 points to the 40 most essential "essential points" that the lay person would be interested in.

Each recommendation is listed with a letter demarcating the strength of evidence supporting the "essential point's" statement. For example an "A" indicates relatively strong evidence, with each lower letter grade representing lesser strength.

However, take careful notice that a weaker letter does not mean the statement is any less true; it simply denotes that currently, the body of evidence supporting the statement has not been fully flushed out in strong clinical studies (which may or may not happen in the future).

The take home points (with a sprinkling of my spin on things) are these:

1. Allergies are complex and can be confused with COLDS as they present very similarly. Treatment however is different. Colds cannot be treated (for the most part), allergies can be treated (more on this below).

2. Testing for allergies can be done by skin tests or blood tests. Generally, the skin tests are more sensitive and preferred.

3. Common sense: Avoid the things that make you allergic. A few allergen specific recommendations are listed below. For example, if you have a pollen allergy, track pollen counts and avoid the outdoors accordingly.

4. Intranasal corticosteroids (Flonase, Rhinocort, Nasonex) are the most effective medication class for controlling symptoms of allergic rhinitis.

5. Antihistamines (intranasal and oral) are also good to control symptoms. For the most part, second generation oral antihistamines (Claritin, Zyrtec, Allegra) are preferred over the first generation oral antihistamines (Benadryl) because they are less sedating.

6. Most allergy medication brands are interchangeable in terms of effectiveness, i.e. Claritin, Zyrtec, and Allegra are all equally effective.

7. In general, regardless of the cause of the allergy (whether it be pollen, dust mites, pets, etc.), the battery of medications used will be the same. Therapy only deviates when allergen immunotherapy (weekly allergy shots) are necessary. Thus, it is probably only necessary to visit the allergy specialist when medication therapy has been exhausted and the patient potentially requires either exact identification of the offending allergen (in order to better avoid the cause) and/or desires to initiate allergen immunotherapy.

8. For cases, uncontrolled by above said medications, it is probably time to see the allergist.

9. The key is to expect reasonable control of symptoms and not a cure and gear therapy towards achieving that goal.

The article's key points posted below. . .

The diagnosis and management of rhinitis: An updated practice parameter
Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, et al. J Allergy Clin Immunol. 2008 Aug:122(2).

These parameters were developed by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma and Immunology; and the Joint Council of Allergy, Asthma and Immunology.

Classification of recommendations and evidence

Category of evidence

Ia. Evidence from meta-analysis of randomized controlled trials
Ib. Evidence from at least 1 randomized controlled trial
IIa. Evidence from at least 1 controlled study without randomization
IIb. Evidence from at least 1 other type of quasi-experimental study
III. Evidence from nonexperimental descriptive studies, such as comparative studies
IV. Evidence from expert committee reports or opinions or clinical experience of respected authorities, or both
LB Evidence from laboratory-based studies.
NR Not rated.

Strength of Recommendation

A Directly based on category I evidence
B Directly based on category II evidence or extrapolated recommendation from category I evidence
C Directly based on category III evidence or extrapolated recommendation from category I or II evidence
D Directly based on category IV evidence or extrapolated recommendation from category I, II, or III evidence

ESSENTIAL POINTS

Burden and epidemiology of rhinitis
10. The influence of early childhood exposure to infections, animals, and secondary tobacco smoke on the development of atopy and allergic rhinitis is still unknown. C

ALLERGIC RHINITIS

Pathogenesis
13. The symptoms of allergic rhinitis result from a complex allergen-driven mucosal inflammation caused by interplay between resident and infiltrating inflammatory cells and a number of vasoactive and proinflammatory mediators, including cytokines. Sensory nerve activation, plasma leakage, and congestion of venous sinusoids also contribute. C

Associated allergic conjunctivitis
19. Intranasal corticosteroids, oral antihistamines, and intranasal antihistamines have similar effectiveness in relieving ocular eye symptoms associated with rhinitis. A

Infectious rhinitis
24. Viral infections account for as many as 98% of acute infectious rhinitis and the majority of rhinitis symptoms in the young child. Routine nasopharyngeal cultures when bacterial infections are suspected do not add diagnostic value. C

TESTING FOR SPECIFIC IgE ANTIBODY

Skin Testing
39. Skin tests are the preferred tests for the diagnosis of IgE-mediated sensitivity. The number of skin tests and the allergens selected for skin testing should be determined on the basis of the patient’s age, history, environment, and living situation, such as area of the country, occupation and activities. D

In vitro asaays for specific IgE
40. The precise sensitivity of specific IgE immunoassays compared with skin prick/puncture tests is approximately 70% to 75%. Immunoassays have similar sensitivity to skin tests in identifying those patients with nasal symptoms elicited after natural or controlled allergen challenge tests. C

41. Interpretation of specific IgE immunoassays may be confounded by variables such as potency of allergens bound to solid support systems, cross-reactive proteins and glycoepitopes, specific IgG antibodies in the test serum, and high total IgE. D

43. Nasal smears for eosinophils are not necessary for routine use in diagnosing allergic rhinitis when the diagnosis is clearly supported by the history, physical examination and specific IgE diagnostic studies but may be a useful adjunct when the diagnosis of allergic rhinitis is in question. C

46. The measurement of total IgE and IgG subclasses for the diagnosis of allergic rhinitis has limited value and should not be routinely performed. C

MANAGEMENT OF RHINITIS

Environmental control measures
52. The most common allergic triggers for rhinitis include pollens, fungi, dust mites, furry animals and insect emanations. B

53. The types of pollen responsible for rhinitis symptoms vary widely with locale, climate, and introduced plantings. B

54. Highly pollen-allergic individuals should limit exposure to the outdoors when high pollen counts are present. B

57. Clinically effective dust mite avoidance requires a combination of humidity control, dust mite covers for bedding, high efficiency particulate air (HEPA) vacuuming of carpeting and the use of acaricides. B

58. Avoidance is the most effective way to manage animal sensitivity. D

59. Cockroaches are significant cause of nasal allergy, particularly in inner-city populations. C

PHARMACOLOGICAL THERAPY

Oral antihistamines
63. There are important differences among the second-generation antihistamines in regard to their sedative properties: fexofenadine, loratadine, and desloratadine do not cause sedation at recommended doses; loratadine and desloratadine may cause sedation at doses exceeding the recommended dose; cetirizine and intranasal azelastine may cause sedation at recommended doses. A

64. Among the newer, nonsedating antihistamines, no single agent has been conclusively found to achieve superior overall response rates. C

Intranasal antihistamines
66. Intranasal antihistamines are efficacious and equal to or superior to oral second-generation antihistamines for treatment of seasonal allergic rhinitis. A

69. Intranasal antihistamines are generally less effective than intranasal corticosteroids for treatment of allergic rhinitis. A

Oral and topical decongestants
70. Oral decongestants, such as pseudoephedrine and phenylephrine, are α-adrenergic agonists that can reduce nasal congestion but can result in side effects such as insomnia, irritability and palpations. A

71. Oral and topical decongestants agents should be used with caution in older adults and young children, and in patients of any age who have history of cardiac arrhythmia, angina pectoris, cerebrovascular disease, hypertension, bladder neck obstruction, glaucoma, or hyperthyroidism. C

72. Topical decongestants can be considered for short-term and possibly for intermittent or episodic therapy of nasal congestion, but are inappropriate for regular daily use because of the risk for the development of rhinitis medicamentosa. C

Over-the-counter cough and cold medications for young children
73. The efficacy of cold and cough medications for symptomatic treatment of upper respiratory tract infections has not been established for children younger than 6 years. Because of the potential toxicity of these medications, the use of these over-the-counter (OTC) drugs generally should be avoided in all children below 6 years of age. A

Intranasal corticosteroids
74. Intranasal corticosteroids are the most effective medication class for controlling symptoms of allergic rhinitis. A

75. In most studies, intranasal corticosteroids have been shown to be more effective than the combined use of an antihistamine and leukotriene (LT) antagonist in the treatment of seasonal allergic rhinitis. A

76. Intranasal corticosteroids may provide significant relief of symptoms of seasonal allergic rhinitis when used not only on a regular basis but also on an as-needed basis. B

However, as-needed use may not be as effective as continuous use of intranasal corticosteroids. D

77. When comparing the available intranasal coriticosteroids, the overall clinical response does not appear to vary significantly between products irrespective of the differences in topical potency, lipid solubility and binding affinity. C

78. Intranasal corticosteroids may be useful in the treatment of some forms of nonallergic rhinitis. A

79. Intranasal corticosteroids when given in recommended doses are not generally associated with clinically significant systemic side effects. A

80. Although local side effects are typically minimal with the use of intranasal corticosteroids, nasal irritation and bleeding may occur. Nasal septal perforation is rarely reported. B

Oral corticosteroids
81. A short course (5-7 days) of oral corticosteroids may be appropriate for the treatment of very severe or intractable nasal symptoms or to treat significant nasal polyposis. However, single administration of parenteral coritcosteroids is discouraged and recurrent administration of parenteral coritcosteroids in contraindicated because of greater potential for long-term corticosteroid side effects. D

Oral anti-leukotriene agents
85. Oral anti-LT agents alone, or in combination with antihistamines, have proven to be useful in the treatment of allergic rhinitis. A

87. There is evidence that topical saline is beneficial in the treatment of the symptoms of chronic rhinorrhea and rhinosinusitis when used as a sole modality or for adjunctive treatment. A

Allergen immunotherapy
88. Allergen immunotherapy is effective for the treatment of allergic rhinitis. A

89. Allergen immunotherapy should be considered for patients with allergic rhinitis who have demonstrable evidence of specific IgE antibodies to clinically relevant allergens, and its use depends on the degree to which symptoms can be reduced by avoidance and medication, the amount and type of medication required to control symptoms, and the adverse effects of medications. A

90. Allergen immunotherapy may prevent the development of new allergen sensitizations and reduce the risk for the future development of asthma in patients with allergic rhinitis. B

SPECIAL CONSIDERATIONS

Pregnancy
100. A sufficient amount of human observational data has now been accumulated to demonstrate safety for second-generation as well as first-generation antihistamines. C

104. Intranasal corticosteroids may be used in the treatment of nasal symptoms during pregnancy because of their safety and efficacy profile. C

105. Immunotherapy for allergic rhinitis may be continued during pregnancy but without dose escalation. C

Consultation with an allergists/immunologist
109. Consultation with an allergist/immunologist should be considered for patients with rhinitis who have inadequately controlled symptoms, a reduced quality of life and/or ability to function, adverse reactions to medications, a desire to identify the allergens to which they are sensitized and to receive advice on environmental control, or comorbid conditions such as asthma and recurrent sinusitis, or when allergen immunotherapy is a consideration. C