Pertussis vaccine proves effective in adults, adolescents

A vaccine to protect adults and adolescents against illness due to Bordetella pertussis infection--or whooping cough--has proved more than 90 percent effective in a national, large-scale clinical study, according to research results published in this week's issue of The New England Journal of Medicine.

The vaccine, researchers say, could be used to stem the increase in pertussis cases among adults and adolescents in the United States and thereby prevent the prolonged cough illness, which can result in hospitalization, pneumonia and cracked ribs in those populations. An important additional benefit of the vaccine may be to decrease transmission of the B. pertussis bacterium to infants, who are particularly vulnerable to severe illness, complications and death resulting from whooping cough. The illness annually affects 50 million people worldwide.

"During the 1990s, the number of reported pertussis cases among adolescents and adults more than doubled in the United States as the protective effects of earlier childhood immunizations have waned," says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, which funded the study. "This new study shows that an effective adult acellular pertussis vaccine is feasible and if routinely used could provide the U.S. population greater protection against the disease."

Known as the Adult Pertussis Trial, the 2.5-year study involved 2,781 healthy individuals between 15 and 65 years of age. Volunteers were randomly assigned to one of two similarly sized groups that received either the acellular pertussis vaccine or the control hepatitis A vaccine (Havrix). For purposes of the trial, pertussis cases were defined as illnesses with a cough lasting at least five days that occurred more than 28 days after vaccination and were confirmed through blood and nasal mucus testing.

Joel I. Ward, M.D., of the Center for Vaccine Research at the University of California, Los Angeles, led the multicenter clinical study. GlaxoSmithKline, based in Philadelphia, supplied both the pertussis test vaccine and the hepatitis A vaccine.

Ten confirmed cases of pertussis occurred during the trial--nine cases were among the individuals who received the hepatitis A vaccine. The researchers concluded that a single dose of the test vaccine was safe and 92 percent effective in protecting adolescents and adults against pertussis.

Although infants are routinely inoculated against pertussis through a series of three diphtheria-tetanus-acellular pertussis (DTaP) vaccines given in the first year of life, immunity has been shown to weaken after six to 10 years.

"The purpose of an adult pertussis vaccine is to prevent the disease in adults with the added benefit that it may help to put up a roadblock in the transmission of the disease, so that parents, grandparents and other adults are not unknowingly passing the disease along," says David Klein, Ph.D., of NIAID's Respiratory Diseases Branch.

In 2004, the highest number of U.S. pertussis cases was among individuals 10 to 18 years of age with roughly 6,500 cases reported, according to data from the Centers for Disease Control and Prevention. Infants less than six months old experienced the second highest number of pertussis cases last year, with an estimated 2,200 cases reported.

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NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.

Reference: JI Ward et al. Efficacy of an acellular pertussis vaccine among adolescents and adults. The New England Journal of Medicine 353(15):1555-1563 (2005).

Aromasin approved for adjuvant therapy of breast cancer

Pfizer Inc has received approval from the U.S. Food and Drug Administration (FDA) to market Aromasin® (exemestane tablets) for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer following two-to-three years of tamoxifen for a completion of five consecutive years of adjuvant hormonal therapy.
The approval was based on the Intergroup Exemestane Study (IES) which showed that patients who switched to Aromasin after two-to-three years of tamoxifen, for a combined total of five years of therapy, had 31 percent more protection from cancer recurrence than those who remained on five years of tamoxifen therapy.
This landmark study, published in the New England Journal of Medicine, established the superiority of switching to Aromasin rather than remaining on tamoxifen. Following its publication, the American Society of Clinical Oncologists and the National Comprehensive Cancer Network updated their guidelines to support the use of a new switch regimen using Aromasin adjuvant treatment.
"Pfizer is pleased to announce this treatment advance," said Dr. Joseph Feczko, Pfizer's chief medical officer. "This new indication for Aromasin provides women with a new treatment regimen that can significantly improve their chances of remaining breast cancer-free."
The IES trial involved over 4,700 postmenopausal women with estrogen-receptor positive breast cancer who were followed for an average of 35 months. Patients receiving Aromasin experienced a significant reduction in the risk for recurrence of the disease, compared to those continuing on tamoxifen. This reduction includes fewer local and distant tumors as well as new cancers in the other breast.

"This new approval for Aromasin clearly provides physicians and patients a more effective way of protecting against cancer recurrence compared to the current treatment practice of five years of tamoxifen therapy," said Dr. Stephen Jones, medical director at U.S. Oncology Research in Houston, Texas.
The most common side effects for Aromasin, which were mild-to-moderate, include hot flashes (21.2%), fatigue (16.1%) and arthalgia/ bone pain (14.6%).
Aromasin should not be administered to pre-menopausal women and women who are pregnant. Dose modifications should be considered for patients taking concomitant CYP3A4 inducers.
Breast cancer is one of the most common cancers occurring in women and the second leading cause of death from cancer in women, after lung cancer. Adjuvant therapy is treatment given following surgical removal of a primary tumor (the first tumor that occurs before it spreads to other parts of the body).
Last month, Pfizer received approval for adjuvant treatment in the European Union. Aromasin was approved in the United States late in 1999 for the treatment of advanced breast cancer in postmenopausal women whose tumors have stopped responding to tamoxifen. It also is approved for use in Europe, Japan, and South America. Currently, Aromasin is available in more than 50 countries around the globe.

ACTOS® shows significant benefits for diabetics

A study published in The Lancet shows that Takeda's ACTOS® (pioglitazone HCl), an oral glucose lowering medication, significantly reduces the combined risk of non-fatal heart attacks, strokes and deaths by an additional 16% on top of standard medication, such as statins, fibrates, ACE inhibitors, beta blockers, other glucose-lowering medications and anti-platelet drugs, in patients with type-2 diabetes with high risk of cardiovascular disease.
This means that for every 48 patients treated with ACTOS over three years one major cardiovascular event or death can be prevented.
"Seeing pioglitazone improve these cardiovascular outcomes (16% relative risk reduction) is an impressive result especially as these patients were already receiving standard treatments including the use of lipid-modifying drugs, anti-hypertensives, aspirin and other glucose-lowering agents," said Professor Ian Campbell, Consultant Physician at Victoria Hospital, Edinburgh, Scotland. He further commented, "We look forward to further analyses that I understand are being submitted to scientific meetings and to reviews of the results in the medical press during the coming year."
Dr Michael George, Managing Director of the Takeda European Research and Development Center commented, "In light of these excellent results Takeda is working on preparations for a label change for ACTOS."
Study design and results as presented at the 41st EASD meeting in Athens on September 12th 2005 PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) was a randomised, double-blind, placebo-controlled outcome study to determine the effects of ACTOS on mortality and morbidity associated with cardiovascular disease progression in more than 5,000 high-risk patients with type-2 diabetes when added to their standard treatment. Standard treatment included the use of anti-hypertensives such as ACE inhibitors and beta blockers; glucose lowering agents such as metformin, sulphonylureas and insulin; antiplatelet drugs such as aspirin and lipid-modifying medicines such as statins and fibrates.

The PROactive study focused on two key endpoints: a primary combination endpoint of seven different macrovascular events of varying clinical importance and a principal secondary combination endpoint of life-threatening events including non-fatal heart attacks, strokes and deaths.
The primary endpoint was reduced by 10% but had not reached statistical significance by the end of the study (p=0.095). However, the principal secondary endpoint of life-threatening events showed that ACTOS significantly reduced the combined risk of non-fatal heart attacks, strokes and deaths by 16% (p=0.027).
Data from the PROactive Study were presented at the European Association for the Study of Diabetes in Athens last month.
Additional PROactive study results of ACTOS showed:
HbA1c levels (a measurement of blood glucose control) were significantly reduced by 0.5% as compared to placebo (p<0.001).
Lipid profiles significantly improved by increasing HDL cholesterol ("good" cholesterol) by 9% more than placebo (p<0.001) and reducing triglycerides (a known cardiovascular risk factor) by 13% more than placebo (p<0.001).
The LDL/HDL cholesterol ratio ("bad" to "good" cholesterol) was significantly improved (p<0.001). A 2% increase in LDL cholesterol ("bad" cholesterol) was observed compared to placebo (p=0.003).
Systolic blood pressure was significantly decreased (p=0.03); median change of 3 mmHg as compared to placebo.
The PROactive study was also designed to further examine the safety of ACTOS in this high-risk patient group. The results demonstrated that adverse events reported in this study were consistent with the known safety profile. Known side effects of ACTOS, including weight gain, oedema, non-serious hypoglycaemia and heart failure, were observed more frequently in the ACTOS group compared to placebo group.

Humira receives FDA approval for psoriatic arthritis

Abbott Park, Illinois — Abbott announced that the U.S. Food & Drug Administration (FDA) approved HUMIRA® (adalimumab) for reducing signs and symptoms of active arthritis in patients with psoriatic arthritis, a chronic disease that combines the symptoms of arthritis, including joint pain and inflammation, with those of psoriatic skin disease, such as dry, scaly skin.
Psoriatic arthritis (PsA) is a serious autoimmune disease and few available treatment options address the potentially devastating combination of symptoms affecting both the skin and joints. Psoriatic arthritis is the first new disease indication for HUMIRA beyond rheumatoid arthritis (RA) and is one of the five autoimmune diseases Abbott is studying for HUMIRA therapy.
"The pain of psoriatic arthritis combined with the social stigma of its visible symptoms places a huge burden on people living with this disease," said Gail M. Zimmerman, president and chief executive officer of the National Psoriasis Foundation. "The symptoms can be debilitating and some patients experience diminished quality of life that may leave them feeling depressed and socially isolated. The HUMIRA approval brings another effective treatment option and hope for patients with this potentially devastating disease."
HUMIRA in Psoriatic Arthritis
The HUMIRA approval is based on results of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), which is the largest biologic trial in PsA. ADEPT studied 313 adult patients with moderately to severely active PsA who had an inadequate response to NSAID (non-steroidal anti-inflammatory drug) therapy. HUMIRA patients experienced significantly greater improvement in both joint and skin disease symptoms than placebo-treated patients at 24 weeks. Improvements in both skin lesions and joint symptoms were seen as early as two weeks after initiation of treatment and continued to improve over time.
Patients' arthritic symptoms also responded to HUMIRA, with nearly 60 percent of patients achieving ACR20 at week 12, one of the study's primary endpoints, and with a sustained response through week 24. ACR70, a more stringent response criterion, was achieved by nearly 25 percent of patients treated with HUMIRA vs. 1 percent of patients treated with placebo at week 24. American College of Rheumatology (ACR) scores measure the percentage of improvement in tender and swollen joint count and several other clinical measures.

"Clinical improvement in arthritic symptoms that can lead to disability as well as the pain and stiffness that keeps patients from functioning normally was rapid and significant with HUMIRA," said rheumatologist Philip Mease, M.D., Swedish Medical Center and University of Washington School of Medicine, Seattle, and lead investigator of the ADEPT study.
Clinical trial data from ADEPT showed the ability of HUMIRA to improve both the skin and joint symptoms associated with psoriatic arthritis. Among the 69 patients in the trial who had skin lesions involving greater than 3 percent body surface area (the palm of an adult hand represents approximately 1 percent of the body’s skin surface) who were treated with HUMIRA, three out of four achieved PASI 50 (75 percent), three out of five achieved a PASI 75 (59 percent) and two out of five (42 percent) achieved a PASI 90 response at 24 weeks, which reflects at least 50, 75 or 90 percent improvement in skin symptoms assessed by the Psoriasis Area and Severity Index (PASI).
The skin symptoms of psoriatic arthritis can severely affect patients' day-to-day lives," said dermatologist Kenneth Gordon, M.D., incoming co-director of Dermatology, Evanston Northwestern Healthcare. "The approval of HUMIRA gives patients access to a medication that can significantly impact skin symptoms and allow them to engage in everyday activities again, such as shaking hands when closing a business deal or going to a public pool."
After taking HUMIRA, my skin improved for the first time in years," said Annie Escalona, a native of Seattle and hiking enthusiast. "My joint pain kept getting better and my skin was much clearer. I can now wear a backpack, swim and enjoy activities I would have never dreamed of doing just a few years ago."
The recommended dose of HUMIRA for psoriatic arthritis is 40 mg every-other-week by subcutaneous injection (a shot beneath the skin), the usual dose used for HUMIRA in the treatment of moderate to severe RA.
The rates of adverse events and serious adverse events in the ADEPT trial were comparable with other HUMIRA RA clinical trials. Among patients taking HUMIRA, the most common adverse events (those affecting at least 5 percent of patients) were upper respiratory infection, nasopharyngitis, injection site reaction, headache and hypertension. The safety profile of HUMIRA in the ADEPT clinical trial was similar to that observed in the HUMIRA RA clinical trials.
Abbott simultaneously submitted applications with the FDA and the European Medicines Agency seeking approval to market HUMIRA to treat psoriatic arthritis and early moderate to severe RA in December 2004. Abbott also announced today FDA approval for HUMIRA for early RA and received European approval for psoriatic arthritis and early severe RA on August 8, 2005.

Depression Doubles Risk for Repeat Heart Attacks, Death

You may recall a blog I posted last month about research that linked smoking over a long period of time to a negative effect on one's cognitive abilities. Even if you don't care about your own mental faculties, you may want to stop anyway for the sake of your kids, according to a new study.
Exposure to environmental tobacco smoke, even at extremely low levels, is associated with decreases in certain cognitive skills, including reading, math, and logic and reasoning, in children and adolescents.
To measure exposure to environmental tobacco smoke, researchers measured levels of cotinine, a substance produced when nicotine is broken down by the body. Considered the best marker of environmental tobacco smoke exposure, cotinine can be measured in blood, urine, saliva and hair.
Reading, math and reasoning scores were highly related to environmental tobacco smoke exposure: The greater the levels of exposure as measured by cotinine levels, the greater the decline in reading and reasoning ability, even at extremely low levels of exposure, according researchers.
Three frightening sets of numbers for you to think about, or better yet, share with a loved one by e-mailing them this blog by using the e-mail to a friend feature on the top right-hand corner of this page:
More than 33 million children in the United States are exposed to levels consistent with the adverse effects seen in this study.
Forty-three percent of American children are exposed to environmental tobacco smoke in their own homes.
Eighty-five percent of children have detectable levels of cotinine in their blood.
EurekAlert January 4, 2004

Insane House Provision Protecting Big Pharma

You may recall a study I posted a while back about the considerable damage depression can do to patients who have already suffered a heart attack. Researchers found depressed patients have declining heart function after an attack, thus increase their risk of death.
A recent review of more than 40 realted studies confirmed those earlier results, as depression was found to double that risk of death or repeat heart disease in heart attack patients. Post-heart attack depression is indeed a common problem that affects nearly 20 percent of all heart attack patients.
Even more troubling: Researchers found the relationship between depression and a higher risk of death and disease REMAINED CONSISTENT despite a variety of ways to measure depression. Although unwilling to make recommendations or determine the exact link, the reviews all pointed to the same conclusion: One's risk of death or a second heart attack increased two-fold within two years after the first.
Life after a heart attack doesn't have to be a "death sentence," unless you perceive it to be. You can avoid "sudden death" by providing your body new tools to compensate for the bioelectrical short-circuiting that can cause serious disruption in many of your body's important systems. I've found energy psychology tools, like the Emotional Freedom Technique you can learn at home, can be very useful to battle stress as well as depression.
Science Daily January 5, 2004

Why Does Gender Influence Eating Disorders?

This week, Congress is debating the pros and cons of an unbelievably insane provision in a medical malpractice bill that would prevent consumers from suing pharmaceutical companies for punitive damages -- remember the toxic drug Vioxx -- as long as they met FDA standards to win approval of their drugs.

Their defense, according to a spokesman for the American Tort Reform Association: "If you have done everything the law requires, why should you be punished?" So, using that twisted logic, shouldn't marketing and selling drugs you know to be toxic be legalized?

Complete insanity folks!

If you think that's the only problem, here's the real kicker: The representative who sponsored the bill which passed in the House last year but not the Senate is now a former representative. James C. Greenwood (R-Pa.) now serves as president of the Biotechnology Industry Organization, a corporate trade association. Not so surprising, since former U.S. Rep. Billy Tauzin announced his intention to leave Congress to join the Pharmaceutical Research and Manufacturers of America (PhRMA), Big Pharma's chief lobbying group three weeks ago.

If you agree that this REPREHENSIBLE provision ought to be removed immediately, I strongly urge you to take action by getting in touch with your U.S. representative today. If you don't know how to reach him or her, this link will take you to a government-sponsored site that will help you do just that.
Washington Post January 5, 2005


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