In response to, "Group Seeks Grand Timeline," I wish to make a comment about the complete lack of safe access to the stage.
I am a member of Open Voices Community Choir and, in May we held a concert at the Grand Theatre. Another choir member and I had to take the risk of accessing the stage from outside using two very steep makeshift ramps that were provided by the Grand Theatre and laid over two sets of stairs because we both use wheelchairs. The grade was very steep and far exceeded the safety standards, but with the help of several men from the choir, we were able to use them without getting hurt.
I had to enter and exit the stage twice using those makeshift ramps. Once to go out during intermission, through the pouring rain to enter by the other door so I could use the washroom that was discussed in this article, and the second time, to leave for the night.
Both times I narrowly escaped injury. The first time I slid down the wet ramp, fish-tailing all the way, and came close to hitting the wall at the end. The men had to work hard to keep me from sliding off the side as well. The second time, I didn’t fishtail, but I hit the wall with a mild impact. I was not hurt. These scenes, and one of the men helping the other person out in a manual wheelchair, were captured on video and, out of frustration, were posted on You Tube.
It infuriates me to think that, once again, I had to take a risk because a request for accommodation at the time it would have been cheapest to fix, was ignored. I asked about making the stage accessible during the public input meetings prior to the renovations. This is because I had already been on the stage twice with the choir. There were 4 people in wheelchairs back then, so the choir graciously built a longer and safer ramp that could be put up to a side door, and it was donated to the Grand Theatre. Who knows where the ramp has gone now?
My request for an accessible stage was quickly shot down because I was told it would be too expensive and there would not be enough people with disabilities who want to get onto the stage.
What I'd like to know is what makes them think we wouldn't welcome an opportunity to finally take part in the performing arts? What better way to make friends and become more integrated in a community?
This blatant refusal to consider it was even more shocking because of its timing. The new Accessibility for Ontarian’s With Disability Act had just been passed. Standards were to be written and, as they were passed, enforcement dates were to be set, and the province would start to lay some pretty hefty fines.
On a moving forward basis and, after looking at some of the issues involved with fixing the stage, I want to first acknowledge that I saw, understood, and can appreciate, what some of the difficulties are in making the stage more accessible.
I then want to ask again, for safe access to the stage. It can be done. Consider the following:
- In the short-term, why not build another long portable ramp similar to what the choir had built so it can be used at the side door that is still there? It would at least guarantee safer access for those using a wheelchair.
- Why not raise funds with a fund-raising project so a porch lift could be bought and added to one end of the stage? It would then provide full indoor access. I don't recall seeing any barriers to prevent one from going up the aisle to access the rest of the theatre, including the accessible washroom.
- For a change room, why not use moveable walls, similar to those used in some Board Rooms, to create a temporary change room on demand? It would be cheaper than installing an elevator to the rest of the change rooms.
This is a dangerous suggestion because it would NOT be acceptable for the performing arts group to hold parties or leave a person excluded on stage by his or herself for very long. For this to work, it would have to become part of the norm for a group to adopt a practice of automatically finding an alternative room in which to hold these social events.
- I would not feel good about bankrupting the Grand Theatre or seeing the citizens of Kingston have to pay hefty fines for a mistaken understanding of what it means to accommodate a person who has a disability.
- Please ask those of us, who are more than willing to volunteer our time, to work with the experts to solve the problem. We live with the barriers each and every day and some of us even make it a hobby to research best practices so we can share knowledge of cost effective solutions which have been proven to work.
The list of high priority groups for H1N1 vaccine when it first arrives was developed based on the epidemiology of H1N1 in the United States, and is a list of those who have been shown to be at highest risk for complications from H1N1 or transmitting it to those at high risk. Health care workers, especially those with direct patient contact in hospitals, as well as EMS personnel, have been shown to be contracting H1N1 from patients as well as, most importantly, transmitting it to their patients who are at high risk for complications. For these reasons, they are on the list, along with pregnant women, everyone 6 months to 25 years of age, caregivers of those under 6 months of age, and those 25 – 65 years of age with underlying conditions.
Certainly, if non-EMS first responders fit into one of these other categories (such as being pregnant or having an underlying condition and being 25 – 65, etc), then we want them to be vaccinated in the first round.
We fully expect the H1N1 vaccine to be offered to everyone eventually. However, since it will be coming into the state in shipments, the US CDC has asked that we prioritize the vaccine during the first few weeks in those first shipments to those whom they define, through the epidemiology, as being at highest risk for complications and/or transmitting it to others.
I realize this prioritization will also result in some predicaments. For instance, I am not in a high-risk category, yet my children are. So, while I hope my children will be vaccinated in school during those first few weeks of the vaccine being available, I do not plan on getting the H1N1 vaccine until a few weeks later, when we expect there to be sufficient supplies for everyone. Likewise, a number of teachers will not be offered the vaccine for a few weeks, but the students they teach will.
Meanwhile, the seasonal (regular) flu vaccine will be available very shortly, and all first responders and others can obtain that vaccine, and we recommend they do so in September.
I hope this explanation helps. Dora
Most importantly, seniors (those over 64) are at risk for complications from seasonal influenza, and the vaccine for that is expected very soon. Seniors should arrange to have their regular (seasonal) flu shot very soon - preferably in September.
The H1N1 vaccine is expected to start arriving in mid-October. We anticipate that it will become available for everyone. However, since it will be arriving in shipments, US CDC has asked that the first few shipments be prioritized to those who are most commonly being severely affected by H1N1 infection such as pregnant women, children, nurses who work in hospitals, and EMS. Studies indicate that those over 64 seem to have some immunity to H1N1, which is probably why they are not being as commonly severely affected by the infection as young people are.
In Maine, we are planning a major focus on getting the first few shipments of vaccine to clinicians who care for pregnant women, schools, and hospitals. It is a Herculian effort to assure that those at high risk have access to the vaccine as well as to assure that everyone does eventually, but by working with many partners across the state - schools, home health organizations, health care systems and providers, emergency management, community organizations - I believe we can do this and do it well.
Thank you to all those who are assisting in this effort across the state! Dora
Dora Anne Mills, MD, MPH, FAAP
If you have any interest in finding the answers to any of these questions (and you definitely should), then check out the seven new fact sheets from APHA’s Get Ready campaign. These educational tools cover how to prepare for:
* H1N1 flu, often referred to as swine flu (PDF)
* earthquakes (PDF)
* floods (PDF)
* heat waves (PDF)
* power outages (PDF)
* winter storms (PDF)
* emergencies at work (PDF)
The new fact sheets are available in both English and Spanish. Use the information to educate yourself and your family, pass them out at a health fair, post them on campus or share them in the community. You can even add your group’s logo to the fact sheets on our Get Ready customization page.
Each of the fact sheets teaches you how to prepare for disasters, what to do during the actual emergency itself and how to respond after the crisis has passed. Help spread the word on how to deal with each of these ever-present public health hazards. Get ready and educate!
Is your face wider at your cheekbones than at your forehead or chin?
Source: A Girl and Her Hair, 1949
This blog was originally posted in 2009. Information contained in this blog is outdated. For current information about flu, please see www.maineflu.gov
On Friday, Aug. 21, US CDC reported 7,983 hospitalizations and 522 deaths nationwide from H1N1. As of Aug. 13, the World Health Organization reported 1,799 deaths from H1N1.
Maine has identified 360 cases of H1N1, which include 19 individuals requiring hospitalization and one individual who has died. Of Maine residents with H1N1, 60 percent have been under 25 years of age. The number of cases is only a barometer of community transmission, not of actual case counts, because not all people with infection are tested.
Good Health Habits Can Help Stop Germs
Prevention of H1N1 is most important, especially now that the virus is widespread in many parts of Maine. Covering coughs and sneezes with a tissue or sleeve, washing hands frequently, and staying home if ill with a fever are shared responsibilities of everyone in Maine, especially to protect people who are at higher risk for complications from H1N1 (http://www.cdc.gov/h1n1flu/vaccination/acip.htm).
H1N1 Preparedness Summit
Maine CDC/DHHS, Maine Emergency Management Agency, Maine Department of Education, and Maine EMS co-sponsored an H1N1 Preparedness Summit Aug. 20 at the Augusta Civic Center. With more than 1,400 in attendance, we believe this was the largest public health conference in Maine. Several presentations and handouts from the Summit are posted online, with additional materials coming soon. To access these materials, visit: http://www.maine.gov/dhhs/boh/maineflu/h1n1-summit.shtml.
Boston held an H1N1 Preparedness Summit on Aug. 21. Their materials can be found at: www.bphc.org/programs/infectiousdisease/infectiousdiseasesatoz/influenza/flusummit/Pages/Home.aspx
Seasonal Flu Vaccine:
US CDC recommends that all children ages 6 months to 18 years, as well as others in high-risk groups for seasonal flu, be vaccinated against this year. Vaccination for seasonal flu should begin in September, or as soon as seasonal flu vaccine is available, and continue through the flu season. (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0724a1.htm?s_cid=rr58e0724a1_e)
The seasonal flu vaccine is not expected to specifically protect against H1N1. However, with H1N1 and seasonal flu viruses both expected to be circulating, getting a seasonal flu vaccine early will help a person’s overall protection against the flu. Maine CDC expects H1N1 vaccine to arrive in the state in mid-October at the earliest.
H1N1 Vaccine:The H1N1 vaccine is not intended to replace the seasonal flu vaccine – it is intended to be used in addition to seasonal flu vaccine to protect people. At this point in time, there is no evidence that vaccinations will be mandatory. US CDC issued its recommendations regarding the use of H1N1 vaccine (http://www.cdc.gov/mmwr/pdf/rr/rr58e0821.pdf), which reiterates the groups that should be considered the highest priority to be offered the first available doses of vaccine. They are:
Pregnant women, because they are at higher risk of complications – especially in the second and third trimesters – and can potentially provide protection to infants who cannot be vaccinated;
Household members and caregivers for children under 6 months old, because younger infants are at higher risk of complications and cannot be vaccinated;
Health care and emergency medical services personnel, because infections among health care workers have been reported and this can be a potential source of infection for patients;
All people ages 6 months through 24 years of age:
Children ages 6 months to 18 years, because there have been many cases of H1N1 in children and they are in close contact with each other in school and day care settings, which increases the chances of spreading disease;
Young adults ages 19 through 24, because there have been many cases of H1N1 in healthy young adults, and they often live, work, and study in close proximity, and they are a frequently mobile population;
People ages 25 through 64 who have health conditions associated with a higher risk of medical complications from the flu, including those with asthma, COPD, diabetes, chronic cardiovascular disease, and people with compromised immune systems.
Vaccine Coordinators have been appointed for each Public Health District in Maine. Vaccine Coordinators will be one component of district leadership teams, which also include staff from the three Regional Resource Centers for Public Health Emergency Preparedness, and Emergency Management Agencies. These Vaccine Coordinators will be following up on discussions had at the Summit to plan for local vaccine distribution, and ensuring that people in the groups prioritized by US CDC (see below) are offered vaccine.
These Vaccine Coordinators are:
District 1 – York: Sharon Leahy-Lind, 490-4625
District 2 – Cumberland: Meredith Tipton (Interim), 592-5631
District 3 – Western Maine: MaryAnn Amrich, 753-9103
(Franklin, Oxford, and Androscoggin counties)
District 4 – Mid Coast: Jen Gunderman-King, 596-4278
(Waldo, Knox, Lincoln, and Sagadahoc counties)
District 5 – Central Maine: Sue Lee, 592-5634
(Somerset and Kennebec counties)
District 6 – Penquis: Debra Roy (Interim), 592-5633
(Penobscot and Piscataquis counties)
District 7 – Downeast: Mary Jude (Interim), 287-5182
(Washington and Hancock counties)
District 8 – Aroostook: Sharon Ramey (Interim), 592-5632
Tribal Vaccine Coordinator: Jerolyn Ireland, 532-2240, Ext. 15
Many resources for vaccination clinics have been posted on our Summit web site (http://www.maine.gov/dhhs/boh/maineflu/h1n1-summit.shtml) under the morning breakout for Organizers of Large-Scale Vaccine Clinics.
Guidance for Educators and Educational Settings
Continuity of Learning:Recommendations for the continuity of learning during school dismissals were issued by the Department of Education in collaboration with US CDC. These recommendations can be found at: http://www.ed.gov/admins/lead/safety/emergencyplan/pandemic/index.html
Institutions of Higher Education:
US CDC issued new guidance (http://www.flu.gov/plan/school/higheredguidance.html) that recommends actions that Institutions of Higher Education during the 2009-2010 academic year to decrease the spread of flu. The guidance includes additional strategies to use if flu conditions become more severe. The guidance in this document may change as additional information about the severity of the flu season and the impact of H1N1 become known. Detailed information on the reasons for these strategies and suggestions on how to use them is included in this report: http://www.flu.gov/plan/school/higheredtechreport.html.
A communications tool kit, including fact sheets, Q&As, sample letters, and posters is available at: http://www.flu.gov/plan/school/higheredtoolkit.html
All Residential Schools:
Updated guidance for Maine Residential Schools was issued Aug. 24 and can be found at: http://www.maine.gov/dhhs/boh/maineflu/h1n1/H1N1-Maine-Residential-School-Guidance-08-24-09.doc
Information and resources for Maine educators and school administrators is posted at: http://www.maine.gov/dhhs/boh/maineflu/swine-flu-2009-provider.shtml
Other New or Recently Updated H1N1 Guidance or News
The World Health Organization issued guidance for medical providers regarding the prescribing of anti-virals to treat H1N1:
How to Stay Updated
Weekly Updates: Check the Wednesday late afternoon updates on H1N1 in Maine on Maine CDC’s H1N1 website: http://www.maineflu.gov//
Health Alert Network: Sign up to receive urgent updates from Maine CDC’s Health Alert Network (HAN). The easiest and quickest way is to sign up is through the HAN Alert RSS feed at http://www.mainepublichealth.gov/ (midway down the center of the homepage).
Follow Maine CDC’s Updates:
Facebook (search for “Maine CDC”)
Maine CDC’s Blog (http://mainepublichealth.blogspot.com/)
H1N1 Conference Calls: Maine CDC will be holding conference calls on a variety of topics related to H1N1 over the coming weeks. Conference calls will resume after Labor Day. Check Wednesday Weekly Updates for schedule of topics and call-in information.
Consider Calling or Emailing Us:
For clinical consultation, outbreak management guidance, and reporting of an outbreak of H1N1 call Maine CDC’s toll free 24-hour phone line at: 1-800-821-5821.
General Public Call-in Number for Questions: 1-888-257-0990NextTalk (deaf/hard of hearing) - (207) 629-5751Monday - Friday 9 a.m. – 5 p.m.
Email your questions to: Sue.Dowdy@maine.gov
U.S. CDC H1N1 Recommendations and Guidance:
http://www.cdc.gov/h1n1flu/ and http://www.flu.gov/
Maine CDC H1N1 Website and Related Links:
Ataxin-7 Conserved Motifs Determine the Severity of the Neurodegenerative Disorder Spinocerebellar Ataxia Type 7 in Transgenic Mice and Influence Lifespan in Yeast
Spinocerebellar ataxia type 7 (SCA7) is an autosomal dominant, progressive neurodegenerative disorder whose characteristic features are cerebellar ataxia, dysarthria, and retinal cone-rod dystrophy culminating in blindness. SCA7 is caused by an abnormally long glutamine-coding CAG repeat in the SCA7 gene, which encodes the protein Ataxin-7.
Ataxin-7 contains several conserved motifs that may influence the toxicity of the glutamine tract. Among these are three conserved regions (conserved block I – III), two caspase-7 cleavage sites, a nuclear export signal and two monopartite nuclear localization signals (NLS). Previous investigations have shown that the caspase-7 cleavage site D266 is required for the full toxicity of the Ataxin-7 protein in cell culture. We generated SCA7 transgenic mice expressing a 92 CAG version of the human SCA7 cDNA, with and without a D266N mutation. Mice carrying the D266N mutation were protected from SCA7-like neurodegeneration, behavioral signs and shortened lifespan.
To further characterize the role of conserved motifs in SCA7 pathology, we generated SCA7 transgenic mice carrying point mutations in both C-terminal NLSs (KKRK -> KAAK). Previous work has shown that nuclear localization is an important step in the pathology of CAG repeat disorders. We observed that mice lacking C-terminal NLS activity were substantially protected from degeneration of the retina and cerebellum, SCA7-like behavioral signs and shortened lifespan.
Age is the primary risk factor for neurodegenerative disease. Even in the absence of overt disease, the aging brain shows histopathological and molecular changes reminiscent of neurodegeneration. To explore the link between neurodegenerative disease and aging, we have examined the replicative lifespan of Saccharomyces cerevisiae missing the SCA7 ortholog, SGF73. This strain exhibits an unusually long lifespan, which is dependent on the function of the NAD+-dependent deacetylase SIR2. We present evidence that the extended lifespan of the SGF73 null strain is due to the influence of Sgf73 on the activity of Sir2 and the histone deubiquitinase Ubp8. Furthermore, we show that the level of ubiquitinated H2B is elevated in an SCA7 transgenic mouse line, indicating that an alteration in Ubp8 activity may play a role in SCA7 pathology and that aging and neurodegeneration may share a common mechanism.
Allowing patients to control their own pain medication intravenously is four times more likely to cause the patient harm than other medications, a new study says.
The report, published in the December issue of The Joint Commission Journal on Quality and Patient Safety, shows that most mistakes involving intravenous patient-controlled analgesia (PCA) resulted from either human error, equipment issues or communication problems that led to the patient receiving the wrong dosage or drug. PCA errors also tended to be more severe — harming patients and requiring clinical interventions — than other types of medication errors.
“The entire PCA process is highly complex,” lead author Rodney W. Hicks, the UMC Health System Endowed Chair for Patient Safety at Texas Tech University Health Sciences Center in Lubbock, said in a news release issued by the journal’s publisher. “PCA orders must be written, reviewed, and then accurately programmed into sophisticated delivery devices for patients to be pain free. Such complexity makes PCA an error-prone process. Health care organizations should now plan to make the process safer.”
The five-year study uncovered more than 9,500 PCA errors. Patients were harmed in 6.5 percent of these incidents, compared to 1.5 percent for general medication errors.
In PCA, a computerized pump with a syringe of prescribed pain medication is hooked straight into a patient’s intravenous (IV) line. The patient can self-dose by pushing a button.
Hicks and his co-authors make three recommendations to reduce future PCA errors:
Simplify the equipment. Easier step-by-step setup instructions could cut down on programming errors by caregivers setting up the PCA machine’s dosage levels.
Use bar codes and keep an electronic medication administration record. Making a standard practice out of independent double-checks of the PCA orders, the product, and the PCA device could help prevent giving patients’ the wrong medication.
Design and use easy, standardized forms for PCA. Use of universal forms by pharmacists could correct communication issues in the process.
Painkillers Linked to Increase in Overdose Deaths
Deaths from overdoses of prescription drugs, primarily pain relievers, appear to be on the rise throughout the United States, new research suggests.
West Virginia, in particular, has seen a large increase in such unintentional deaths, say government researchers, who have uncovered patterns of “doctor shopping” for drugs and overdosing on medications not used as prescribed.
Scientists are developing an anti-AIDS pill that can be taken before sex and prevent transmission of the deadly disease.
The successful development of such a treatment would be controversial because it raises ethical questions about the circumstances in which the pill should be taken.
Experts in the disease, which claimed two million lives last year, are involved in scientific trials on antiretroviral drugs that already used to prevent transmission of AIDS from infected mothers to their babies during birth.
Scientists are hopeful that similar protection can be offered during sex.
Three trials of antiretroviral drugs are underway around the world. A report published in the Lancet claims they are “showing great promise” as experts meet in Mexico City for the International Conference on AIDS.
More research has to be done on the side-effects of the pill and the development of resistant strains of HIV before it is made available.
Controversy is bound to arise over who should take the pill and for what reasons. Globally, use would probably have to be restricted to those at greatest risk from AIDS such as sex workers or injecting drug users.
The pill could also have a major impact on the lifestyles at a time when experts have observed that promiscuity is on the rise.
“The party scene involving multiple sexual partners is definitely back in London and probably in most European cities,” said Sheena MCormack, a specialist in HIV prevention and reader in clinical epidemiology at Imperial College London, said.
“There is metrosexual mixing involving gay, bisexual and some heterosexual cases. We estimate new HIV infections in gay men are running at three per cent a year.”
She added: “People could pop a pill on a Friday night and be covered for a whole weekend.”
The trials involve 2,400 drug injectors in Thailand, 1,200 heterosexual men and women in Botswana and 3,000 homosexual men in America, Africa and Asia.
Experiments on primates suggest that the drugs are effective and can prevent the disease being passed. But their success in humans has yet to be proved, the Lancet report by Nancy Padian of Women’s Global Heath Imperative, San Francisco, said.
The trials use tenofovir, a drug currently used to treat AIDS, with a combination of other drugs.
Tenofovir (Trade name Viread) is an anti-HIV drug approved by the FDA (In October of 2001) to be used in combination with other HIV fighting medications. Viread belongs to a new class of drugs called Nucleotide Reverse Transcriptase Inhibitors (NtRTI). These are related to Nucleoside Reverse Transcriptase Inhibitors (NRTI) like zidovudine (AZT, Retrovir). The body converts Viread into a chemical that prevent HIV from reproducing in uninfected cells, but it does not help cells that have already been infected with the virus. As people with HIV lose CD4 cells - one of the immune system’s main defenses - they become more likely to get infections and illnesses.
The risks of two widely used asthma drugs outweigh their benefits for both children and adults, a U.S. Food and Drug Administration advisory panel said Thursday.
The health panel targeted GlaxoSmithKline’s Serevent and Foradil, made jointly by Novartis AG and Schering-Plough, for restrictions, but it excludedAdvair, Glaxo’s biggest-selling drug in the class of medications known as long-acting beta-agonists. It also left alone a fourth such drug, AstraZeneca’s Symbicort.
The health experts did not say that the use of Serevent and Foradil should be abandoned altogether. Instead, they said the medications’ labeling should be reworded to urge doctors to use the drugs along with an inhaled corticosteroid — as guidelines already recommend.
That may help explain why Advair and Symbicort were spared. Serevent contains just one active ingredient, salmeterol, while Foradil contains only formoterol. Advair is a combination of both salmeterol and fluticasone (an inhaled cortocosteroid), while Symbicort contains formoterol and another steroid (budesonide). All of these drugs relax airway muscles, letting asthma patients breathe more easily.
The controversy over these drugs has been going on for several years, with two FDA officials recently calling for banning the use of these drugs for anyone under 17. The results of studies noting a rise in asthma-related deaths by people using the medications have already resulted in a black-box warning that use could “increase the risk of asthma-related death.”
The advisory panel voted 10 to 17 on whether the benefits of Serevent outweighed its risk as maintenance therapy for adults, and voted 6 to 21 on the same question for adolescents ages 12 to 17, Dow Jones reported. Foradil received similar votes on the same questions: 9 to 18 for adults and 6 to 21 for adults.
The panelists were unanimous in voting that the benefits of the two drugs did not outweigh risks when used for children ages 11 and younger.
The announcement followed a two-day meeting on the issue by the expert advisory panel. The FDA is not obligated to follow the advice of its advisory panels but usually does so.
Speaking before Thursday’s decision, one expert said the problem is not with the drugs, but with their misuse.
“This is an over-interpretation of the risk without adequate consideration of benefit,” said Dr. Miles Weinberger, a professor of pediatrics at the University of Iowa. “However, there has been irresponsible marketing of the products, salmeterol and formoterol, and irresponsible prescribing by many physicians.”
“Since most patients with chronic asthma can be controlled with inhaled steroids alone, using these more expensive combination formulations as first line is inappropriate but strongly encouraged by marketing practices” of drug makers, Weinberger said.
In the panel’s first day of hearings on Wednesday, FDA officials themselves were split over the risks of the drugs.
One official told the panel members that more than 14,000 people may have died since 1994 after taking the drugs, while another suggested that an even greater number might have died without them, according to The New York Times.
Last week, two FDA officials, who work in the agency’s safety division, posted an assessment on the agency Web site, saying asthma sufferers of all ages should not take the medicines. But a third FDA official concluded that Advair and Symbicort are safe for adults, but that all four drugs should no longer be used by children 17 and younger, the Times said.
The panel was reviewing an FDA study of 110 trials that included 60,954 people and found an increase in asthma-related hospitalization, asthma-related intubation, and asthma-related death in asthmatic patients with the use of these drugs. The risk varied, however, depending on the particular drug studied.
For example, there were 20 asthma-related deaths, 16 among people taking long-acting beta agonists compared with four patients not taking these drugs. All the deaths were in patients taking Serevent, the FDA notes.
The increased risk wasn’t seen when a long-acting beta agonist was used along with an inhaled corticosteroid, the agency found.
The greatest risk appears to be among children aged 4 to 11; women also appeared to be at greater risk than men.
Weinberger thinks that long-acting beta agonists should be used only in combination with inhaled steroids.
“All trials of the combination of long-acting beta agonists and an inhaled steroid demonstrate substantial additive effect for patients not fully controlled on the inhaled steroid alone,” Weinberger said. “The sensible approach is to use the combination products only after inadequate control is observed with an inhaled steroid alone.”
For their part, the drugs’ manufacturers said they believe there is adequate evidence that their products are safe and effective when used properly.
In a joint statement issued after the panel voted, Novartis and Schering-Plough said both companies “remain confident in the safety and efficacy of Foradil.” The statement added, “Novartis and Schering-Plough strongly disagree with the Joint Advisory Committees view that the benefits of Foradil do not outweigh its risks in patients using it according to current product labeling for the maintenance treatment of asthma. We believe this opinion is inconsistent with clinical evidence supporting the benefit/risk profile of Foradil in patients not adequately controlled on other asthma-controller treatments.”
In its statement before the vote, AstraZeneca said the company “believes that Symbicort exhibits a favorable benefit-risk profile in patients 6 years of age and older. Symbicort offers an important therapeutic option for asthma patients who cannot be adequately controlled on other asthma controller medications [low- to medium-dose inhaled corticosteroids] or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.”
US drugmakers Pfizer Inc and Nektar Therapeutics on Wednesday warned of cases of lung cancer in clinical trials of their inhaled insulin Exubera.
The findings led Nektar to announce it was abandoning its search for a new marketing partner for the troubled drug, effectively signaling Exubera’s demise after entering the market in January 2006.
Pfizer, the world’s largest pharmaceutical company, announced last October it stopped marketing Exubera, saying it did not meet customer needs or the financial expectations of the company.
The rise in lung cancer apparently linked to Exubera led Pfizer to update the medication’s warning label to include information “about lung cancer cases observed in patients who used Exubera,” the company reported in a statement.
It said that over the course of the clinical trial, six out of 4,740 Exubera-treated patients developed lung cancer, versus one of the 4,292 patients not treated with Exubera.
An additional case of lung cancer in an Exubera-treated patient was discovered after the drug’s debut on the market following its approval by the US Food and Drug Administration.
The updated label states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were “too few cases to determine whether the development of lung cancer is related to the use of Exubera.”
“Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials,” Pfizer chief medical officer Joe Feczko said in the statement.
“We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies,” he added.
Nektar announced it was stopping all spending on the drug, including research and marketing.
“The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners,” said Nektar president Howard Robin on the company’s website.
Diabetes affects 230 million people worldwide, including 21 million in the United States, according to Pfizer. Exubera is a short-acting insulin breathed in through an inhaler that helps control high blood sugar in people with diabetes.
Pfizer warns Exubera patients about risk
Pfizer Inc. said Wednesday it is warning patients using its inhaled insulin product Exubera about the risk of lung cancer, leading Nektar Therapeutics to terminate its inhaled insulin programs.
Nektar had been Pfizer’s partner on Exubera from 1995 until Pfizer discontinued the drug in October 2007 after lackluster sales. Some patients continue to take the drug, however, including some enrolled in extended transition programs or clinical trials.
On Wednesday, Pfizer said it updated the U.S. product labeling for Exubera Inhalation Powder to include a warning about lung cancer cases observed in patients who used the inhaled insulin treatment.
Over the course of Exubera’s clinical trial program, 6 of the 4,740 patients treated with Exubera developed lung cancer, compared with 1 of the 4,292 patients not treated with the drug.
There was also a post-marketing report of lung cancer in one Exubera-treated patient.
The label notes that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the cancer is related to use of Exubera.
Pfizer said the data was reviewed by the company and the Food and Drug Administration.
Nektar said it will stop all spending associated with its inhaled insulin programs and will not incur any additional charges related to the action.
“The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners,” said Howard W. Robin, president and chief executive of Nektar, in a statement. “Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin.”
Generic Name: insulin inhalation
Brand Names: Exubera
What is Exubera?
Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.
Exubera is a rapid-acting form of human insulin that is inhaled through the mouth. It works by lowering levels of glucose (sugar) in the blood.
Ten years ago this month the lives of millions of men and women were changed almost overnight by the advent of a little blue pill — the first oral treatment for impotence.
Viagra, developed by accident by scientists at Pfizer Laboratories, was first approved for use by the US Food and Drug Administration on March 27, 1998.
“Originally, we were testing sildenafil, the active drug in Viagra, as a cardiovascular drug and for its ability to lower blood pressure,” said Dr Brian Klee, senior medical director at Pfizer.
“But one thing that was found during those trials is that people didn’t want to give the medication back because of the side effect of having erections that were harder, firmer and lasted longer.”
Since Viagra went on the market it has been used by 35 million men around the globe, and it took impotence off the taboo list, making it infinitely easier to treat.
Urologists’ waiting rooms became busier as news got round that the condition, which was rechristened with a new, scientific name — erectile dysfunction, or ED — could be treated with a triangular blue pill.
Previous treatments had involved surgically inserting a prosthesis into the penis, injecting a substance into the male sex organ or using urethral suppositories.
“Viagra brought a lot more people into the office because of the ease of treatment,” Dr Irwin Shuman, a urologist of 40 years’ experience in Washington, told AFP.
“In the old days, when we didn’t have much in the way of treatment, we would do a lot more evaluation, looking for answers as to why somebody had the problem,” he said.
In one test, men would be observed while sleeping to see if erections occurred.
Men who failed to get the usual five to six erections per night were deemed to have a physical problem, and those who did get nocturnal erections were said to have a psychological problem and were sent to see a sex counsellor.
So Viagra helped move impotence out of the psychological realm and into the world of physical illnesses. “What we have come to understand in the past 10 years is that ED is a vascular disease,” said Klee.
“What happens is veins and arteries that deliver and remove blood from the penis are not working the way they should, and Viagra allows those vessels to dilate and increase blood flow to the penis,” he said.
Dr Abraham Morgentaler, director of Men’s Health Boston, and associate clinical professor of urology at Harvard Medical School, hailed Viagra as a “benefit to medicine.”
But, he added, the drug has not delighted all those who took it.
“There are two truths to Viagra: for those who refill (get a new prescription), it’s wonderful and they’re happy,” Morgentaler told AFP.
“But a lot of people look to Viagra for personal happiness, thinking a hard penis can resolve relationship issues,” and they end up disappointed, added the doctor and author of the book “The Viagra Myth.”
Some patients say taking Viagra “does not correspond to the way they want to have sex,” Morgentaler said.
Viagra works best on an empty stomach or after eating a low-fat meal, the medication’s official website says. It kicks in about 30 minutes after being taken, works for four hours, and only with sexual arousal, the website says.
But it’s not the answer for everyone. Morgentaler said he had a 78-year-old patient in his office who “didn’t like the idea of programming sex. Guys, and often women, too, don’t necessarily want to compromise the ideal of sex as something magical, spontaneous, romantic.”
Morgentaler also spoke of the darker side of Viagra, which has evolved since it and two other ED treatments became easily available over the Internet.
“It’s the use of Viagra by healthy young men who don’t need it,” he said.
“These young men take a pill whenever they go out … Maybe because they are inexperienced or shy and Viagra makes them more confident, or maybe because they have inflated ideas about what sex is supposed to be like from seeing Internet porn, which they also have easy access to, and they want to heighten their feelings of masculinity,” he said.
“I am concerned — not that these young men will get addicted physically, but that they will become psychologically dependent on Viagra,” said Morgentaler.
“Sex is an entree into a relationship, and most often what we want from a relationship is to be loved for what we are.
“But some of these young men feel they have to take a pill to be acceptable, and I fear they are potentially missing the opportunity to have true emotional connections with a partner, based on reality, not mythology.”
Viagra celebrates its 10th birthday
The potency enhancing drug Viagra has been on the market for 10 years. In 1998, pharmaceutical company Pfizer introduced the erection drug that was to change millions of lives at a stroke. A solution to erectile dysfunction had been found, and the taboo surrounding impotence was largely a thing of the past.
The little blue pill that enabled millions of couples to reawaken their sex lives was discovered by accident, says sexologist Vera Steenhart of the Dutch Sexology Association. Pfizer was actually looking for a drug for the heart problem angina pectoris. The pills didn’t appear to be benefiting the test subjects, but they refused to give them back. Ms Steenhart:
“The manufacturers found this strange. On further investigation, they found the drug gave the male patients an erection. They were extremely happy about it.”
The forerunner to Viagra was developed to make blood vessels relax. The test subjects were given the drug to improve blood circulation to the heart to reduce the chance of heart failure. Viagra has the same effect on the penis. When the man is sexually stimulated, the blood supply is improved and it becomes easier for him to maintain an erection.
It’s a myth that the pill can produce an unwanted erection. The user does actually have to be in the mood, so Viagra has little or no effect if he is unwilling to have sex or feels anxious about it. In that case it would be more appropriate for him to have a good talk with his partner or pay a visit to a psychologist or sexologist.
Patients who receive free drug samples from their doctors end up having significantly higher out-of-pocket costs for their prescription drugs than people who don’t receive free samples, a new study finds.
In fact, patients who received free samples spent about $166 in out-of-pocket costs on prescription drugs in the six months before receiving the samples, $244 for the six months in which they received samples, and $212 for the six months following receipt of the free drugs, the study found.
But patients who didn’t get free samples spent about $178 on prescription drugs over six months.
“This is a curious finding because one would think, intuitively, that if you receive a free sample, one’s out-of-pocket prescription cost would be lower, not higher,” said lead researcher Dr. G. Caleb Alexander, an assistant professor of medicine at the University of Chicago Medical Center.
There are several possible explanations for the finding, Alexander said. One is that patients who receive free samples may be sicker than patients who don’t get samples.
“The second possibility is that patients who receive free samples may go on to receive and fill prescriptions for the very same medicine that were initially begun as free samples,” Alexander said. “We know that drugs that are available as free samples are those that are being widely marketed and promoted and these drugs are more expensive than their older, less promoted counterparts.”
The study findings are published in the March 24 issue of the journal Medical Care.
For the study, Alexander’s team collected data on 5,709 patients who had participated in the Medical Expenditure Panel Survey. The survey was done by the U.S. Agency for Healthcare Research and Quality and the patients were followed for up to two years.
Seventy-six percent of the patients had private health insurance. During the study period, 14 percent of them were given at least one drug sample. A total of 2,343 samples were distributed during the period, the researchers found.
Patients who received free samples were more likely to be younger and have private insurance, while patients with Medicaid were less likely to receive samples, the researchers noted.
The findings follow earlier research, reported in the February issue of the American Journal of Public Health, in which Harvard University researchers showed that more than 80 percent of free drug samples were given to wealthy and insured patients, not to uninsured and poorer patients.
Alexander said there are many ways doctors and patients can work together to reduce drug costs, but giving away free samples may not be the best one.
“Doctors and patients both should be encouraged to consider alternative ways to reduce patients’ out-of-pocket costs,” he said. “There are many other strategies doctors can use, such as prescribing a three-month rather than a one-month supply, such as using greater numbers of generic medicines, and discontinuing non-essential medicines.”
Dr. David Katz, director of the Yale University School of Medicine’s Prevention Research Center, said free samples aren’t designed to help lower drug costs, but rather to sell newer and more expensive drugs.
“Almost every clinician’s office is stocked with drug samples,” he said. “For patients and providers alike, these free drugs can take on the aura of Halloween goodies. Passing them out feels like giving a gift.”
But, Katz added, “free samples are by no means a long-term solution to high prescription drug costs. Rather, they are at least, in part, a marketing device, a chance to sample the wares.”
The pharmaceutical industry had this to say: “Free pharmaceutical samples are beneficial to patients of all income levels. Patients are able to try out a new therapy - gaining valuable first-hand experience of its benefits and side effects - without making a co-payment,” said Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president Ken Johnson.
“What’s more, contrary to statements made by critics, America’s physicians prescribe medicines based on a wide range of factors, not simply receipt of free prescription drug samples,” Johnson added in a prepared statement.
Free Drug Samples? Bad Idea, Some Say
Everyone loves freebies, and patients are no exception. So drug company sales representatives try to keep sample cabinets in medical offices well stocked with the latest medications, for doctors to dispense as the need arises.
Patients like going home with free samples because it saves them a trip to the drugstore and a co-pay, and doctors are happy to oblige, because samples help patients get started on treatment right away.
But now some leading academic medical centers are restricting the use of samples, and a smattering of physician practices are shutting down the sample cabinet. These critics say doctors should be choosing the most appropriate medication for a patient based on the best scientific evidence available — not just grabbing something from the office stash that happens to fit the bill.
“The doctor will say, ‘Here, start on this, and let’s see how it works,’ ” said David J. Rothman, president of the Institute on Medicine as a Profession, a research group at Columbia. “The question to the doctor is: If you didn’t have it in your drawer, would that have been your drug of choice?”
The crackdown on free samples comes amid growing concern about the close ties between physicians and drug companies. Critics like Dr. Rothman say physicians don’t realize the extent to which their medical judgment is influenced by their acceptance of the samples. They point to studies like a 2002 paper in the journal Annals of Family Medicine finding that the number of doctors who treated high blood pressure with the “first line” drugs recommended by national guidelines was low, but increased sharply when free samples were removed.
So far, the University of Michigan Health System has banned free samples altogether, and the University of Pennsylvania and Stanford University medical schools have prohibited staff members from accepting them (though samples can be given to Stanford’s pharmacy for use in free clinics).
Some medical groups and solo practitioners have also changed their policies. Dr. Jonathan Mohrer, an internist in Forest Hills, Queens, said he closed his sample cabinet in part because his office was overrun with sales representatives. “It was totally spinning out of control,” Dr. Mohrer said. “They were meeting each other and schmoozing in the waiting room — it was like a party.”
His office staff had to spend time arranging the cabinet, throwing out expired medications and rummaging around for the right drug. Patients were kept waiting while sales representatives were whisked in.
But there’s an upside to the samples. Using samples, a doctor can see if a patient can tolerate a new medication before the patient goes out and buys a 30-day supply. Physicians who treat poor people like to have samples on hand for them, and for uninsured patients.
Samples also provide patients with the convenience of one-stop shopping, said Dr. Hema A. Sundaram, a dermatologist in suburban Washington. “Usually a patient has waited some time to see a doctor and rearranged their whole working schedule, and then it may be another four or five days before they can fill a prescription,” she said. “They’re often busy, working people, with family responsibilities. I feel there shouldn’t be any further delay.” (Dr. Sundaram acknowledges that she is paid for speaking on behalf of drug companies.)
And many physicians say they like using samples because the sales representatives are an important source of medical education, helping to keep the doctors up to date on the latest therapies.
“Doctors who are shutting the door to sales reps are cutting themselves off from a lot of valuable information,” said Scott Lassman, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America, a trade association. “Sales reps can explain when it’s right to use a drug, when it’s not right to use the drug, which patients might benefit and which patients it might not work for.”
Some doctors are skeptical. “The sales reps are nice people, and they try to do a really good job,” said Dr. Judith Chamberlain, medical director of the Bowdoin Medical Group, a practice near Portland, Me., that banned samples this year. “But their job is to get you to use their product.”
A 1995 study in The Journal of the American Medical Association found that 11 percent of the statements drug company representatives made during presentations were inaccurate, and all of the inaccuracies were skewed in favor of their products.
The drugs promoted through free samples tend to be the newer medications that doctors are less familiar with, experts say. Some critics of samples say they prefer using older drugs anyway, because their side effects are better known. Critics also point out that helping poor and uninsured patients is not the intent of the sample distribution, and they add that developments like Medicare’s prescription-drug coverage, the proliferation of generic drugs and improvements in drug company patient-assistance programs have eased access to medication.
As for the bottom line, it’s not at all clear that samples save patients money. Critics say they may actually drive up the cost of health care in the long run, because the drugs being promoted are the most expensive brand-name medications. Since many conditions require lifelong treatment, the patient would have to buy the medicine sooner or later.
“You’re going to be paying more, because you’re taking the new, advanced drug,” Dr. Rothman said. “And you may have done just fine on the old-fashioned generic.”
Do free drug samples influence residents’ prescribing decisions?
When a pharmaceutical company puts drug samples into the hands of residents as a form of marketing, how does it influence their prescribing behavior? To what extent are treatment decisions based on which samples are available and further, what are the implications for patient care as well as resident education? While this is a frequently debated issue, there has been little objective data describing how drug samples affect resident physicians. In a study published in the August issue of The American Journal of Medicine, researchers from the University of Minnesota and Abbott Northwestern Hospital conducted a randomized study of 29 internal medicine residents over a 6-month period in an inner-city primary care clinic. Highly advertised drugs were matched with drugs commonly used for the same indication that were less expensive, available over-the-counter, or available in generic formulation. By random selection, half of the residents agreed not to use available free drug samples. The authors observed 390 decisions to initiate drug therapy in five drug class pairs.
In the latest research to cast a shadow on the safety of a popular bone-strengthening medication, researchers report that long-term use of Fosamax is associated with unusual fractures of the thigh bone.
The fractures were low-energy fractures, meaning that they all occurred from a fall from standing height or less, and the bone cracks were in an unusual horizontal pattern. About one-third of women with these types of fractures were on long-term therapy to prevent osteoporosis, the researchers noted. Of these women, two-thirds were taking Fosamax (alendronate), for an average of more than seven years.
Fosamax is a bisphosphonate, a class of drugs used to increase bone mass and reduce the risk of fracture in those who have osteoporosis.
“These were peculiar fractures that would occur when the women were basically doing nothing,” said the study’s senior author, Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Special Surgery at Weill Cornell Medical College in New York City.
Fifteen women were included in Lane’s analysis. The average time on Fosamax was 5.4 years before they experienced the unusual femur fracture. Of these 15, 10 women had similar, atypical fractures. These women had been taking Fosamax for an average of 7.3 years, while the remaining five had only been on the drug for an average of 2.8 years.
“Our results provide further evidence of a potential link between alendronate use and low-energy fractures of the femur,” the authors said in a letter reporting their findings, which is published in the March 20 issue of the New England Journal of Medicine. But, the authors acknowledge the limitations of their retrospective analysis and suggest that these findings need to be confirmed in a prospective study.
Lane said there are several theories as to how alendronate could be related to these fractures. One is that the drug slows down the development of new collagen, and he said new collagen is very strong. Another could be because there is slower bone turnover on the medications. That could mean there may be accumulated microdamage in the bone, making it more susceptible to fracture in certain women.
Lane said that women taking this medication should keep taking it, and these findings shouldn’t cause them alarm. “This is a great drug that does wonderful things. Bisphosphonates have dropped the rate of hip fractures,” he added.
Ron Rogers, a spokesman for Merck, which manufactures Fosamax, said, “Fosamax has not been associated with an increased risk of fracture at any skeletal site.” Rogers also noted that this study didn’t prove a cause and effect relationship between the drug and these unusual fractures, and that the researchers noted that 63 percent of women treated for low-energy fractures weren’t taking bisphosphonates at all.
Dr. Loren Wissner Greene, co-director of the osteoporosis and metabolic bone disease program at the New York University School of Medicine, agreed that this study has just pointed out an association between Fosamax use and these fractures, not proven a causal relationship.
Still, Greene said she believes these atypical breaks probably are related to the medication, although she added, “If this is a related complication, it appears to be very rare.”
Like Lane, she said, “Alendronate is still a very valuable drug in decreasing the risk of hip fracture.” But, she said, what would be helpful is a test that could identify who is in the sub-population that might have a problem on this medication.
Lane said that women who’ve been taking this medication for a long time and have test results that suggest low bone turnover, may want to take a “bone holiday,” and stop taking the medication for a year. But, he added, this shouldn’t be done on your own. “If you’ve been on alendronate for a long time, talk to your doctor,” he suggested.
The U.S. Food and Drug Administration in January issued an alert to physicians about the possibility of severe bone pain occurring as a result of bisphosphonate therapy. Additionally, last year Fosamax was also implicated in some cases of atrial fibrillation — a serious type of irregular heartbeat — though the FDA hasn’t found evidence to support this association.
Generic Name: alendronate
What is the most important information I should know about Fosamax?
Do not take an Fosamax tablet if you cannot sit upright or stand for at least 30 minutes. Fosamax can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.
Take the Fosamax tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.
Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an Fosamax tablet.
For at least the first 30 minutes after taking an Fosamax tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.
Some people using medicines similar to Fosamax have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.
What is Fosamax?
Fosamax is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Fosamax slows bone loss while increasing bone mass, which may prevent bone fractures.
Fosamax is used to treat or prevent postmenopausal osteoporosis and steroid-induced osteoporosis. Fosamax is also used to treat Pagets disease of bone.
Fosamax may also be used for purposes other than those listed in this medication guide.
What should I avoid while taking Fosamax?
Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking an Fosamax tablet. Do not lie down for at least 30 minutes after you take an Fosamax tablet.
What are the possible side effects of Fosamax?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Fosamax and call your doctor at once if you have any of these serious side effects:
- chest pain;
- difficulty or pain when swallowing;
- pain or burning under the ribs or in the back;
- new or worsening heartburn;
- severe joint, bone, or muscle pain; or
- jaw pain, numbness, or swelling.
Continue using Fosamax and talk with your doctor if you have any of these less serious side effects:
- mild heartburn or stomach upset;
- diarrhea, gas, or constipation;
- joint pain or swelling;
- swelling in your hands or feet;
- back pain; or
- dizziness, weakness, or headache.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Fosamax?
Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Fosamax. If you use these other medicines, do not that take them for at least 30 minutes after taking an Fosamax tablet.
Before using Fosamax, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.
There may be other drugs that can affect Fosamax. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.