Posted by rob on March 31, 2005 under Uncategorized | 
Purpose. Safety-net clinics’ use and assessment of patient-assistance programs (PAPs) were studied.
Methods. A multistate telephone survey was conducted on the basis of issues identified during 10 case-study interviews of safety-net clinics serving primarily uninsured and publicly insured patients. Interviewed were pharmacists and other staff taking primary responsibility for helping patients apply to PAPs.
Results. Of 339 survey candidates, 215 provided complete interviews (63% response rate). Ninety-three percent of the completed interviews were with clinics in California, Texas, and Florida. Forty percent of the clinics reported that at least 75% of their patients lacked drug insurance coverage. There was a significant positive relationship between a clinic’s likelihood of using PAPs and the percentage of its patients lacking drug coverage. PAPs consumed 12 hours of pharmacist time per month and 99 hours of other staff time per month. Clinics most frequently cited program requirements changing without notice and unrealistic income-documentation rules as potential barriers to PAP use and indicated that consistent eligibility criteria and standardized application procedures were needed.
Conclusion. A survey of safety-net clinics indicated that PAPs help fill a major gap in health insurance coverage but that consistent eligibility criteria and application procedures are needed.
Index terms: Charity; Data collection; Economics; Health-benefit programs; Industry, pharmaceutical; Pharmacists; Prescriptions; Sociology; Time studies
http://www.ajhp.org/cgi/content/full/62/7/726
Posted by rob on under Uncategorized |
She’s back.
Brittany Randle suited up for the Ceres High varsity girls soccer team for the first time this season on Thursday in Modesto. The senior defender returned to the field a month after being diagnosed with chronic myelogenous leukemia. Her cancer went into remission.
“I think it’s a miracle,” said Ceres coach Randy Cerny. “I figured she was lost for the season.”
Randle started at sweeper against the Downey Knights. She was just as effective despite her lack of stamina. Randle asked for her first and only breather midway through the first half.
“This is something I was really hoping for,” she said.
Randle was granted medical clearance on March 18.
Her parents, head coach and athletic director also approved of the comeback.
“They’re excited for me because they know how much it means to me,” Randle said.
Said Cerny: “The best thing for Brittany is to get her on the field. We feel we’re not going to put her at any physical risk as far as her disease.”
Randle began treatment on Feb. 17. She has taken one Gleevec tablet a day since being diagnosed. The medication has brought her white blood cell count down considerably, from 109,000 to 3,500.
“It’s a little bit below normal but it’s still good,” Randle said.
Added Cerny: “I need to find out what company makes that medicine and buy some stock.”
So how many games will Randle be able to participate this year?
Randle said she has no idea.
“I’m anemic because of the medication,” she said. “That’s going to make it harder but I’m still going to play.”
Said Cerny: “It’s always going to be Brittany’s decision.”
In April, Randle will visit UC San Francisco Medical Center for a third time for further testing. There’s still a possibility Randle might need a bone marrow transplant.
“I have to wait it out and see,” she said.
Randle wants to tryout for the Fresno State women’s soccer team in the future.
“That’s always been her dream, to go on to college and play soccer,” Cerny said. “If anyone can go on and still achieve that, it would be somebody like Brittany Randle.
“She’s smart enough and has the ability. She can do just about anything she wants to do.” – By DALE BUTLER / Staff Reporter of The Ceres (Calif.) Courier
http://www.mantecabulletin.com/articles/2005/03/31/ceres/sports/sports02.txt
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Jia Liu of Austria vies with Martina Safran from Slovenia during their match at the European Championships in table tennis in Aarhus.
Posted by rob on March 30, 2005 under Uncategorized |
A salamander takes a walk shortly after a downpour in a wooded area on the outskirts of Rennes.
Posted by rob on under Uncategorized |
March 29, 2005: 3:40 PM EST
By Aaron Smith, CNN/Money staff writer
NEW YORK (CNN/Money) – Big drugmakers look poised to reap the benefits of the FDA’s recent guidelines encouraging the biotech industry to develop “targeted” drugs.
The Food and Drug Administration published guidelines last week calling for drugmakers to make products targeted at specific populations. This combination of pharmaceutical manufacturing and genetics is known in the industry as pharmacogenomics.
The idea is to create and prescribe drugs with a patient’s genetic profile in mind, skipping the standard “hit-or-miss” approach.
“ImClone, Genentech, Novartis: They have more experience and they have more resources to spend on technologies and products like this,” said Sena Lund, analyst for Cathay Financial.
The FDA’s recognition of this relatively new science is a also potential boon to smaller drug development companies like Celera Genomics (Research), which mapped the human genome, and deCode (down $0.33 to $5.71, Research), which genetically mapped the Icelandic population, according to industry officials and analysts.
“The publication of the guideline is very helpful to us because it focuses attention to this area of pharmaceuticals and it defines the path for registration of these new products,” said Celera CEO Kathy Ordonez.
“[The FDA guideline] is a clear sign to the medical community, the financial community and the industrial community that this is an accepted way now,” said Kari Stefansson, CEO of deCode.
But it may be a while before small drug companies and biotechs can reap profits from targeted drug development. Spokesmen for Celera and deCode said their companies have pharmacogenomic drugs in the pipeline, but they could be years away from entering the market.
Meanwhile, some drugmakers are already making money off targeted drugs and they have additional products in the test phase.
In its guideline, the FDA said the new science has already led to several major drugs, including Herceptin, a breast cancer treatment made by Genentech (down $0.26 to $56.64, Research), Erbitux for colorectal cancer by ImClone Systems Inc. (down $0.48 to $34.85, Research) and Gleevec for leukemia by Novartis AG (down $0.25 to $46.80, Research).
Herceptin was Genentech’s third biggest-selling drug last year, bringing in $483 million. Erbitux, ImClone’s only drug, went on sale last year and generated about $261 million in sales. And Gleevec is one of Novartis’ blockbusters, with sales of $1.6 billion, out of $18.5 billion in pharmaceutical sales last year.
ImClone spokesman David Pitts said his company had five more targeted oncology drugs in the pipeline: Two are in human testing, with two more expected to enter human testing this year and a fifth to enter testing early in 2006. “If they do what they’re expected to do, they could supplant the chemotherapy regimen,” said Pitts.
The FDA guideline comes as welcome news to biotech companies, particularly the smaller firms, as it will help streamline their drug approval process.
The guideline will help small biotech companies that are “looking for some guidance as to how they might develop these novel treatments,” said Geoff Porges, an analyst for Bernstein & Co. “They’re likely to benefit by having a clearer path to market, lower development costs and a potentially more accelerated development time.”
Biotechs also stand to benefit from the FDA’s new stance of approving drugs for limited populations, said Winton Gibbons, analyst for William Blair & Co. Gibbons said this was the case with Genentech’s development of Herceptin, tailored towards specific types of breast cancer.
“[The FDA will] give you a broad approval even if it only works in a sub-group,” said Gibbons.
Celera spokesman David Speechly said the genetic testing will make a customer “more inclined to pay money for a drug that they know is going to work” and allow them to skip sometimes unpleasant or harmful drug therapies.
Gibbons at William Blair owns 120 shares of Genentech. The other analysts interviewed do not own shares in the companies discussed and their firms do not conduct banking with these companies. 
http://money.cnn.com/2005/03/29/news/midcaps/fdaguideline/
Posted by rob on under Uncategorized |
Parmar S,
Smith J,
Sassano A,
Uddin S,
Katsoulidis E,
Majchrzak B,
Kambhampati S,
Eklund EA,
Tallman MS,
Fish EN,
Platanias LC
The precise mechanisms by which imatinib mesylate and IFNalpha exhibit antileukemic effects are not known. We examined the effects of IFNs or imatinib mesylate on signaling pathways regulating initiation of mRNA translation in BCR-ABL expressing cells. Treatment of IFN sensitive KT-1 cells with IFNalpha resulted in phosphorylation/activation of mTOR and downstream activation of p70S6K. The IFN activated p70S6K was found to regulate phosphorylation of S6 ribosomal protein, which regulates translation of mRNAs with oligopyrimidine tracts in the 5′-untranslated region. In addition, IFNalpha -treatment resulted in an mTOR- and/or PI3′kinase-dependent phosphorylation of 4E-BP1 repressor of mRNA translation on sites that are required for its de-activation and dissociation from the eIF4E-complex. In contrast to the effects of IFNs, STI571 suppressed p70 S6K activity, consistent with inhibition of BCR-ABL mediated activation of the mTOR/p70S6K pathway. Moreover, the mTOR inhibitor rapamycin enhanced the suppressive effects of STI571 on primary leukemic CFU-GM progenitors from CML-patients. Taken altogether, our data demonstrate that IFNs and STI571 differentially regulate PI3′-kinase/mTOR-dependent signaling cascades in BCR-ABL-transformed cells, consistent with distinct effects of these agents on pathways regulating mRNA translation. They also support the concept that combined use of STI571 with mTOR inhibitors may be an appropriate future therapeutic strategy for the treatment of CML.
http://www.hubmed.org/display.cgi?uids=15790787
Posted by rob on under Uncategorized |
Chronic myelogenous leukemia (CML) is a clonal hematopoietic disorder caused by the reciprocal translocation between chromosome 9 and 22. As a result of this translocation, a novel fusion gene, BCR-ABL, is created on Philadelphia (Ph) chromosome, and the constitutive activity of the BCR-ABL protein tyrosine kinase plays a critical role in the disease pathogenesis. Imatinib mesylate, a selective BCR-ABL tyrosine kinase inhibitor, was first given to a patient with CML in June 1998. Since then, it has continued to demonstrate remarkable efficacy in treating patients with CML. Based upon the results of early phase I and II studies, a phase III study (IRIS Study) that was randomized to first-line imatinib (400 mg/day) or to standard treatment with interferon+low-dose Ara-C, was conducted on 1,106 patients newly diagnosed (within 6 months) with chronic-phase CML. After median follow-up of 30 months, imatinib showed significantly superior tolerability, hematologic and cytogenetic responses (major cytogenetic response, 90%; complete cytogenetic response, 82%), and overall survival (95% without censoring allo-HSCT). Although imatinib is the first-line therapy and has changed the paradigm of CML treatment strategy, questions remain as to the meaning of cytogenetic and molecular response, curability, optimal dose, and relation with allo-HSCT.
http://www.hubmed.org/display.cgi?uids=15791812
Posted by rob on March 29, 2005 under Uncategorized |
Competitors of the women’s 10 kms Scratch Race prepare their final sprint at the 2005 UCI Track Cycling World Championship in Carson, CA. Olga Slyusareva of Russia won the gold.
Posted by rob on March 28, 2005 under Uncategorized |
NEW HAVEN, Conn., March 28 /PRNewswire-FirstCall/ — VION PHARMACEUTICALS,
INC. (Nasdaq: VION) announced today that it commenced dosing the first patient
on the Phase III pivotal trial of its anticancer agent CLORETAZINE(TM)
(VNP40101M) in relapsed acute myelogenous leukemia (AML).
Susan O’Brien, MD, Professor of Medicine in the Department of Leukemia,
and principal investigator for the trial at MD Anderson Cancer Center
commented, “The therapeutic options for patients with relapsed acute
myelogenous leukemia are limited and unsatisfactory. Given emerging evidence
of CLORETAZINE(TM) (VNP40101M)’s anti-leukemia activity, MD Anderson is
pleased to be the lead institution for this global Phase III clinical trial.”
“Encouraging CLORETAZINE(TM) (VNP40101M) results in early phase trials
have also provided important leads in other malignancies,” said Frank Giles,
MD, Chief, Section Developmental Therapeutics, Department of Leukemia,
University of Texas, MD Anderson Cancer Center. “The launch of a pivotal
Phase III trial is an important milestone in the development of any drug; it
is especially gratifying to see an AML investigational agent go to Phase III
so rapidly” said Giles.
Alan Kessman, Chief Executive Officer, stated “We are proud of our
continued progress in the development program for CLORETAZINE(TM) (VNP40101M).
We consider the start of this pivotal trial as a major milestone
accomplishment for Vion. We are hopeful that the Phase III trial will prove
CLORETAZINE(TM) (VNP40101M)’s potential to bring a new treatment to patients
in first relapse AML, which is currently an unmet medical need.”
Vion recently reached agreement with the U.S. Food and Drug Administration
(FDA) on a Special Protocol Assessment (SPA) for this trial. The trial is a
double-blind, placebo-controlled randomized evaluation of an experimental
treatment consisting of Ara-C plus CLORETAZINE(TM) (VNP40101M) versus a
control arm regimen of Ara-C and placebo. This trial is designed to accrue
patients in first relapse whose first complete remission (CR) was more than
three months but less than twenty-four months in duration. Patients will be
stratified according to: (i) age, greater than or less than 60 years and (ii)
length of the first CR, more than or less than 12 months in duration.
The primary endpoint for the trial is the objective response rate, defined
as CR plus CRp (a complete remission with incomplete recovery of the platelet
count). Secondary endpoints include time to progression, duration of response,
overall survival and toxicity. An interim analysis is planned.
Vion Pharmaceuticals, Inc. is developing novel agents for the treatment of
cancer. Vion has two agents in clinical trials: CLORETAZINE(TM) (VNP40101M),
a unique sulfonylhydrazine alkylating agent, and Triapine(R), a potent
inhibitor of a key step in DNA synthesis. In preclinical studies, Vion is
also evaluating KS119, a hypoxia-selective compound from the sulfonylhydrazine
class, and heterocyclic hydrazones. For additional information on Vion and
its product development programs, visit the Company’s Internet web site at
http://www.vionpharm.com .
This news release contains forward-looking statements. Such statements are
subject to certain risk factors which may cause Vion’s plans to differ or
results to vary from those expected, including Vion’s ability to secure
external sources of funding to continue its operations, the inability to
access capital and funding on favorable terms, continued operating losses and
the inability to continue operations as a result, its dependence on regulatory
approval for its products, delayed or unfavorable results of drug trials, the
possibility that favorable results of earlier clinical trials are not
predictive of safety and efficacy results in later clinical trials, the need
for additional research and testing, and a variety of other risks set forth
from time to time in Vion’s filings with the Securities and Exchange
Commission, including but not limited to the risks discussed in Vion’s Annual
Report on Form 10-K for the year ended December 31, 2004. Except in special
circumstances in which a duty to update arises under law when prior disclosure
becomes materially misleading in light of subsequent events, Vion does not
intend to update any of these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.
COMPANY CONTACT: Vion Pharmaceuticals, Inc.
Alan Kessman, Chief Executive Officer
Howard B. Johnson, President
(203) 498-4210 phone
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/03-28-2005/0003285507&EDATE=
Posted by rob on under Uncategorized |
Gene project would seek keys to cancer
March 28, 2005
Federal officials are planning to compile a comprehensive catalog of the genetic abnormalities that characterize cancer, in hopes of discovering important new clues about how to diagnose, prevent, and treat cancer, according to a report in today’s issues of The New York Times.
The proposed Human Cancer Genome Project would be greater in scale than the Human Genome Project, which has already mapped the blueprint of the human genetic structure. Its goal woudl be to determine the DNA sequence of thousands of tumor samples, the Times reported, Researchers would look for mutations that give rise to cancer or sustain it.
The project’s proponents say a data bank of mutations would be freely available to researchers.
”Knowing the defects of the cancer cell points you to the Achilles’ heel of tumors,” Dr. Eric S. Lander, director of the Broad Institute, a research center in Cambridge, told the newspaper.
The project is projected to cost about $1.35 billion over nine years; funding sources are currently uncertain. The government would probably start with smaller pilot projects, officials said.
The proposal was presented last month to an advisory committee to the National Cancer Institute. It was drawn up by a group led by Lander and Dr. Leland H. Hartwell, a Nobel laureate who is president of the Fred Hutchinson Cancer Research Center in Seattle.
They and others say the time is right for such a project because the Human Genome Project has provided the human DNA sequence, with which tumor cells could be compared. In addition, the cost of such research is dropping. And discoveries of individual cancer-related genes have already helped lead to new drugs.
Boston.com / Business / Technology / Gene project would seek keys to cancer
Posted by rob on under Uncategorized |
March 28, 2005
Jen Christensen
Leukemia
Leukemia is a cancer of the bone marrow and blood that leads to an uncontrolled accumulation of blood cells. The disease can be classified as acute or chronic. Acute leukemia progresses very rapidly. It causes the formation of blood cells that aren’t fully developed, and thus, are unable to perform their natural function. Chronic leukemia progresses more slowly. This slower rate allows a greater number of normal cells to develop. Acute and chronic leukemia can be further divided into acute and chronic myelogenous leukemia and acute and chronic lymphocytic leukemia.
According to the Leukemia and Lymphoma Society, about 33,440 new cases of leukemia will be diagnosed in the U.S. this year. Acute lymphocytic leukemia accounts for about 3,830 cases of leukemia every year. It is the most common form of leukemia in children. Incidence is nine times higher in children one to four than in those 20 to 24. The other types of leukemia are most commonly diagnosed in late adulthood. About 11,920 cases of acute myelogenous leukemia are diagnosed annually. Annual incidence of chronic lymphocytic leukemia is about 8,190 cases and for chronic myelogenous leukemia, about 4,600 cases.
Lymphoma
Lymphoma is a type of cancer that develops in the lymphatic system. There are two main types: Hodgkin Lymphoma and Non-Hodgkin Lymphoma. The diseases are caused by an acquired genetic mutation causing excessive and uncontrolled growth of lymphocytes (specialized white blood cells).
About 62,250 cases of lymphoma will be diagnosed this year in the U.S. Roughly 7,880 cases are of Hodgkin lymphoma. It’s slightly more common in males than in females. Non-Hodgkin lymphoma is slightly more common than Hodgkin lymphoma. About 54,370 cases will diagnosed this year. As with Hodgkin lymphoma, males are affected slightly more often than females.
Leukemia and Lymphoma: Testing and Follow-up
To confirm a diagnosis of leukemia and lymphoma, doctors need to take a sample of bone marrow, the soft, spongy tissue inside larger bones. Testing is also done periodically after diagnosis to follow the effects of treatment and potential progression of the disease.
The most common site for bone marrow testing is the hipbone (posterior iliac crest). The skin in the area is cleaned and the patient is given a local anesthetic. Once the area is anesthetized, a small incision is made into the skin. A sharp, hollow needle is inserted through the incision, then into the bone. One of two types of tests may be performed. A bone marrow aspirate uses a syringe to withdraw a small amount of liquid within the bone marrow. This test is used to determine what types and how many blood cells are present in the bone marrow. The second test is a bone marrow biopsy. A slightly larger needle is inserted through the same space. The needle is rotated to cut and obtain a small specimen of bone. The needle is withdrawn and the bone sample is removed for analysis. A bone marrow biopsy can be used to look at the structure of the bone marrow.
After bone marrow aspiration and biopsy, a bandage is placed over the site to control bleeding. Patients may experience some degree of pain and discomfort after the procedure. There is also a risk of persistent bleeding and infection.
A Bone Marrow Blood Test
Patients with leukemia and lymphoma may require frequent bone marrow testing. Despite its necessity, many patients dislike the procedure because they may experience significant discomfort or pain.
But the days of frequent bone marrow testing may soon be over. Researchers at the University of Texas M.D. Anderson Cancer Center have developed a blood test that may provide much of the information obtained from the traditional bone marrow test. The blood test looks for molecular signs of the cancer within the blood. Researchers will look for the presence of certain proteins expressed on the surface of tumor cells, namely CD20, CD33 and CD52. In addition, the test will screen blood plasma for evidence of RNA and DNA that are specifically linked to leukemia and lymphoma.
The new blood test may not entirely replace the need for bone marrow testing. Researchers are hopeful it will greatly reduce the need for patients to undergo the painful traditional method of testing. The blood test has been licensed to Quest Diagnostics, Inc. Researchers hope it could be available by the end of the year.
AUDIENCE INQUIRY
For information about the test:
Quest Diagostics® – http://phx.corporate-ir.net/phoenix.zhtml?c=82068&p=irol-newsArticle&ID=665642&highlight=
For information on leukemia and lymphoma:
The Leukemia and Lymphoma Society, http://www.leukemia-lymphoma.org
WHOI – Healthbeat: Bone Marrow Blood Test
Posted by rob on under Uncategorized |
Thirty-four-year-old Melissa Curley is relying on the kindness of strangers in her battle against leukemia. Chemotherapy hasn’t helped the Northern Cheyenne woman defeat the life-threatening chronic myelogenous leukemia that doctors diagnosed nearly three years ago. So her hope now rests in a bone marrow transplant to restore her to health.
Posted by rob on under Uncategorized |
In Jerry’s diary for Sunday he mentions some of the things Dr. Talpaz said this week
about the tremendous progress that is being made in the treatment of CML. For those
of you who may be newly diagnosed and not aware of all of the new drugs in the pipeline
it will be inspirational to read.
Rob
3/27/2005 Sunday…Day 501:
“Dr. Talpaz says that with available treatments there will be very few patients who die from CML. He says that we have changed CML from a terminal disease with a life expectancy of only a few years to a truly chronic disease with a median survival approaching 25 years.”
“Dr. Talpaz speaks of many new CML drugs in the pipeline. In fact he has been asked to trial so many drugs that he can not possibly do trials on them all even though many look very good. By the way, he said that he and his research associates have developed a drug for the resistant T315I mutation and they are trying to bring it to trial. This makes about 5 new T315I drugs that I have heard about.”
http://www.newcmldrug.com/diary_interface/Results/Diary.asp
Posted by rob on under Uncategorized |
A hummingbird flies in a garden of Mexico City.
Posted by rob on under Uncategorized |
A hummingbird flies in a garden of Mexico City.
Posted by rob on March 27, 2005 under Uncategorized |
A couple walk in the sea and enjoy the sunset on Patong beach, in the Thai resort island of Phuket
Posted by rob on under Uncategorized |
Faith helped, no matter what decision loved ones finally made
By JENNIFER NEJMAN
Daily Record/Sunday News
Sunday, March 27, 2005
Donna Webb remembers nearly the exact words she asked the doctor at Johns Hopkins Medical Center three summers ago.
Is this going to prolong Andrew’s life or make him better?
Her 15-year-old son had chronic myelogenous leukemia. A bone marrow transplant cleared his body of cancer, but a complication developed.
A machine had been helping the Red Lion Area Senior High School student breathe, but his body was doing the work as it received purer oxygen, Donna Webb said.
As Andrew grew weaker, doctors told his family they could hook him to a respirator that would take over his breathing.
“The inevitable was going to happen, it just wasn’t going to happen as fast,” Donna Webb said.
Donna and her husband Mike Webb of Brogue had to make a decision.
* * *
It’s a choice families may face at any time.
Sometimes, the situation presents itself unexpectedly — a loved one is injured in a car accident or has a massive stroke and doesn’t have a living will.
Other times, the choice is expected and can be planned for through discussions with family, or the patient has created a living will to outline what she would like done when certain medical situations occur.
Terri Schiavo, the brain-damaged Florida woman whose husband and parents are fighting over her future, had no living will. So when her husband and parents disagreed about what she would have wanted, it went to the courts — something local health-care professionals say is rare.
Beyond the political and legislative implications of Schiavo’s case is the universal question at its core.
It’s a question someone might answer differently than her spouse, her father, her child.
How do you personally define life? If you can breathe, but can no longer think, do you still consider yourself alive? At the end of your life do you want to be made comfortable as your body shuts down or do you want interventions to keep your basic functions going as long as possible, even if your reasoning has stopped?
* * *
In April 2001, while Andrew Webb was playing lacrosse, a ball whacked him on the hip. A large lump of blood swelled to his skin’s surface. The next month, doctors diagnosed Andrew with chronic myelogenous leukemia.
About a year later, Andrew underwent a bone marrow transplant. The transplant went well. But in late July 2002, doctors learned Andrew had Graft vs. Host disease, a serious complication of the transplant.
Andrew required emergency surgery. Donna Webb remembers telling her son he needed to communicate what was happening in his body.
“He always said, ‘We will do what we have to do and if it’s not enough, it’s not enough,’” Donna Webb said.
Doctors told the family the end was near. The family had called relatives and friends, bringing probably 100 people to the hospital.
Andrew said his goodbyes. A few days before he died he ate a plate of yellow Jell-O — his first true meal in weeks.
Then, something changed and his body began to shut down. The day he died, Andrew called his mother over and said he was ready. She told him not to be scared.
The 15-year-old boy said, “‘Mom, I’m not scared.’”
Donna Webb remembers how Andrew’s body had thinned to 100 pounds, how he looked like a skeleton. She believes near the end he lost his brain function but that his heart was strong and beat on.
“He wouldn’t have wanted to survive if he wouldn’t have been Andrew,” Donna Webb said. “Who wants five or 10 more years, if you’re going to be terrible.”
They didn’t take machine off that helped him breathe, but used it to trick his brain, so he would be comfortable and wouldn’t gag from a complete disconnect, she said.
For a minute Andrew opened his eyes and blew his mother and father a kiss.
Donna Webb had never watched anyone die. In his final moments, she believes she watched Andrew’s spirit leave his body — the coloring drained from his body, moving from his head to feet.
She said her faith helped her arrive at the decision. For months, the family had prayed for him to recover, but believe he is in a place away from suffering now.
“I have no doubt where he is,” Donna Webb said. “I have no doubt I will see him again.”
* * *
On Friday, Betty Mialki of West York turned off the television so she would not have to listen to people talk about Terri Schiavo’s case anymore.
Betty and Len Mialki’s daughter Shelley Mialki died at the age of 17 on June 26, 1998. She had been riding her bicycle when she was hit by a car.
A few days before she died, Shelley had a conversation with her father about organ donation. She also had checked the box on her driver’s license form. Shelley’s organs helped six or seven people, Betty Mialki said.
The decision Betty and Len had to make at the end of Shelley’s life was not complicated, Betty Mialki said.
Shelley’s brain had swelled out of control and her brain stem was severed. Doctors told the family Shelley was brain-dead, she said.
If Shelley had brain activity, the family, most likely, would have kept her alive, Betty Mialki said.
“What’s happening in Florida is very upsetting,” she said. “My whole family is pro-life.”
Betty Mialki said she believed denying Schiavo nutrition was wrong.
“As a parent I can understand what those parents are going through, and I would have done anything to keep my daughter alive,” she said.
* * *
People have different opinions concerning how they want to die — whether they want to be in a hospital attached to tubes or in their home, said Dr. James Sioma, a family physician and geriatric doctor.
Sioma is the medical director of AseraCare Hospice, an organization that sees its role as helping individuals die comfortably.
Dying is natural; the body knows what to do, he said.
All people are different. Some eat and drink until the end, while others stop eating, he said.
Near the end of a person’s life as functions shut down, the body takes in fewer calories, he said. Sioma said giving the body fluids can fill the lungs and make a person feel like they are drowning.
“When (people are) dying, they don’t feel thirst or hunger like they do when they are healthy,” he said.
Family members’ instincts may be to feed a person by having a feeding tube inserted because family members feel like they are doing something to help the person, Sioma said.
“Feeding a dying person is a cruel thing to do,” he said.
Kathy Redding, coordinator for the Hanover/Spring Grove VNA Hospice Program, which serves southern York County and Adams County, said disputes over placing feeding tubes in patients don’t usually happen when a patient is in hospice.
But the association has seen situations where a family insists on having a feeding tube inserted, causing the person’s lungs to fill with fluid and legs to swell as the person dies.
When patients come to hospice, they are dying of specific conditions — unlike the Schiavo situation — and the purpose is to make them comfortable, not to extend their lives, Redding said.
She attributes the lack of disputes in her program to the educational work her nurses do to answer families’ questions.
“It’s a scary time for families,” she said.
Some hospice patients have living wills. Others choose to do one when they enter hospice, but it is not a requirement in order to receive services from the visiting nurse association program.
Sioma pointed to the importance of creating a living will to detail whether a person wants CPR, feeding tubes or diagnostic testing. That way the person will be able to die the way she wants, not the way someone else thinks she may want to die.
“You get legal battles — the person who suffers is the patient,” Sioma said. “The death is prolonged and it’s not fair to the patient.”
Reach Jennifer Nejman at 771-2026 or jnejman@ydr.com.
|
http://ydr.com/story/main/63016/
Posted by rob on March 26, 2005 under Uncategorized |
Cuban Catholics walk in procession for the streets of the Havana, March 25, 2005
Posted by rob on under Uncategorized |
Tighter controls are needed to root out bogus patient groups
London Zosia Kmietowicz
Patient organisations need to be more tightly regulated to protect the public from bogus groups and undue influence from the pharmaceutical industry and other funding bodies, MPs heard last week.
Setting standards on transparency and accountability would help to distinguish legitimate patient groups from those set up by drug companies to promote awareness of a specific condition and drugs to treat it, said witnesses at the fourth public hearing of the health committee’s inquiry into the influence of the pharmaceutical industry.
There are more than 200 national patient groups in the United Kingdom and many rely on funding from the pharmaceutical industry, especially if they are concerned with less emotional and more mundane matters which do not attract the public gaze, said Melinda Letts, chair of the committee of medicines working group on patient information.
http://bmj.bmjjournals.com/cgi/content/extract/329/7478/1307-a
From Patient Activism to Astroturf Marketing
by Bob Burton and Andy Rowell
“So what does PR stand for?” asked Nancy Turett, the president and global director of Edelman Health. “It stands for powerful relationships. The heart of PR is third-party credibility,” Turett wrote in Pharmaceutical Executive in September 2002.
“Third-party messages are an essential means of communication for validating scientific credibility, for legitimizing products, for building brand and disease awareness, and for building defenses against crises,” Turett wrote. “As advocates develop louder voices, pharma companies must forge alliances and win allies.”
AIDS and the Rise of Activism Marketing
Until the late 1980s, healthcare PR concentrated on cultivating doctors and wooing government regulators. That began to change in part due to the emergence of AIDS activism. In 1987 the US-based AIDS Coalition to Unleash Power (ACT UP) raised citizen-led health activism to new levels, using civil disobedience protests to embarrass drug companies for profiteering, regulators for slow approval of new drugs and governments for inadequate research funding.
For drug companies, AIDS activism presented both a challenge and a new marketing opportunity. “Our strategy was not to try and reach every AIDS activist . . . So we tried reaching out to a few and have them work as ambassadors,” recalls John Doorley, the head of corporate communications at Merck Pharmaceuticals in the early 1990s.
Doorley, now teaching corporate communications at Rutgers University in New Jersey, devised Merck’s strategy for managing AIDS activism. He established a corporate advisory committee, took members on plant tours and rewrote clinical trial consent forms. When ACT UP San Francisco members planned to protest against Merck, advisory committee members came to the company’s rescue. “They called the guys in San Francisco and said, ‘You go to any other company you want to, but not Merck,” Doorley recalled in an interview with PR Week.
In the ensuing decade, drug companies realized the potential benefits of investing in patient groups. In January 2000, Urch Publishing, which offers “business intelligence and information for management in biotechnology, pharmaceuticals and chemicals companies,” issued an $800-per-copy report titled Patient Groups and the Global Pharmaceutical Industry. “The perception that industry-patient group collaborations can lead to unwelcome publicity is the principal reason holding many potentially fruitful relationships back,” wrote Fred Mills, a UK-based former pharmaceutical industry executive. “Despite this, groups are biting the bullet and some of the early efforts at partnerships have been very worthy and mutually beneficial.”
Teri Cox from the New Jersey-based Cox Communication Partners expressed similar enthusiasm in a September 2002 issue of Pharma Executive. Industry-patient “partnerships,” she wrote, could “influence changes in healthcare policy and regulations to expand patient access to, and coverage for, earlier diagnoses and treatments . . . recruit participants for clinical trials” and “speed the development and approval process for new therapies.” Better still, an alliance with a non-profit group can deter inquisitive journalists. “Without such allies, a skeptical journalist may see a company’s messages as self-serving and describe them as such to their audiences,” Cox wrote.
“There are no better, more credible advocates for maximising access to a therapy than the patients who are going to benefit from it,” explained Emmanuella Dekonor and Simon Taylor from the PR firm of GPC International in a guide to working with patient groups that was published in 2002. However, they acknowledged that there would also be “potential areas of conflict” including “price–they will always think it is too high” and “profit–companies should not be making profit out of illness.”
Of course, profit is exactly the reason why drug companies seek to foster patient-industry partnerships. Mills says that “disease awareness” campaigns often result in “a large increase in sales.” A good example, he says, is “Zeneca, which was responsible for the creation and sponsorship of ‘Breast Cancer Awareness Week.’ It would be reasonable to assume that the programme also did nothing to harm sales of tamoxifen either!” Now Breast Cancer Awareness Month (BCAM) events every October raise huge amounts of money for breast cancer research.
Some breast cancer activists are wary of industry’s embrace. Barbara Brenner, the executive director of Breast Cancer Action, believes drug company sponsorship of breast cancer awareness has skewed the priorities of some groups into researching a medical “cure” and away from real preventative measures–such as reducing environmental exposure to pesticides. “Real prevention . . . means we figure out what is causing illness and we eradicate those causes. You don’t hear BCAM saying that,” she said.
Brenner points to the dual role of drug companies manufacturing both breast cancer drugs and pesticides as one reason for the silence about non-drug prevention. Aventis, for example, manufactures Bromoxynil for use on genetically modified cotton. Up until October 2000, Zeneca manufactured the pesticide Acetochlor, which generated annual sales of up to $300 million.
Winners and Losers
Partnerships between drug companies and non-profit groups are now touted as “win-win” deals, but the reality is that consumers of drugs have quite a bit to lose. Salli Nathan edited Blood Ties, a book about the experiences of HIV-positive women in Australia. She believes media hype about HIV drugs exaggerated benefits and understated the “really toxic” side effects. “Each new wave of drugs–especially through the mid- to late 1980s and early 1990s–has been greeted with a huge waves of optimism and enthusiasm, with good cause. But then there has been disillusionment and distress when the drugs haven’t been the cure that the hype had lead people to expect,” she stated.
Drug companies also view partnerships with patient groups as a way to gain a competitive advantage over rivals. Dekonor and Taylor candidly acknowledge that drug companies “may be reluctant” to help partners gain “accelerated access to the next generation of treatments (i.e., in a competitor’s pipeline).”
When a PR crisis emerges, such as withdrawal of drug approval, companies seek to turn third-party “partners” into corporate shields. A key task in a crisis is to “deploy third parties to advance your cause,” explained Maxine Taylor, the director of corporate affairs at Lilly UK. Third parties should be called on, she suggested, “to share the spotlight if possible, or indeed to divert the spotlight of media attention from you.”
Wyeth’s Women
One possible example of this strategy occurred in July 2002 when the US National Institutes of Health (NIH) announced that it was abandoning its study of the effects of Prempro, Wyeth’s market-leading hormone replacement therapy (HRT) drug. NIH had originally planned an eight-year trial of the drug, but it only took five years to accumulate conclusive evidence of increased health damage to women who use the drug over time. The announcement was reported with shock in media outlets around the world, which had long been accustomed to glowing reports of HRT.
Women’s health and consumer groups welcomed the decision, but the announcement precipitated a crisis for Wyeth, which had a 70% share of the HRT market and earned $900 million annually from sales of the drug. Its share price plummeted, and plaintiff lawyers filed a class-action lawsuit.
Support, however, came from the Washington, DC-based Society for Women’s Health Research (SWHR), which condemned the NIH decision and distributed op-eds and letters to newspapers around the country. Reporting in Washington Monthly, Alicia Mundy noted that Wyeth and other drug companies are represented on the group’s corporate advisory board, but details of the group’s funding remain obscure. “Our attorney says it is confidential information that we don’t distribute,” Mundy was told when she inquired.
The SWHR website notes, however, that Wyeth has been a corporate sponsor of its annual fundraising ball at the Washington Ritz-Carlton. In fact, Wyeth underwrote the entire glitzy affair, which promoted Prempro so enthusiastically that one attendee complained it was “like they were doing an ad for Wyeth.”
Calls for Disclosure
Prevention First, a coalition of independent women’s health groups, testified before the US Food and Drug Administration (FDA) in May 2001 about the impact of behind-the-scenes corporate on public discussions of health issues. “The FDA should strengthen its requirement that all those who purport to represent a consumer point of view to the agency disclose whether they receive funding or other assistance from entities with economic interests at stake before they testify before the FDA,” it recommended.
Sharon Batt, a Canadian writer who has been involved in breast cancer groups since the early 1990s, believes that the “corrosive” effect of drug company funding means non-profit groups should be required to disclose potential conflicts of interest in all public communications. “Passive disclosure is clearly inadequate, and public disclosure shouldn’t be left to chance or personal choice,” she said.
In an article for Breast Cancer Action Montreal, Batt also challenges the description of drug company sponsorship of non-profit groups as a “partnership,” pointing out that “a partnership implies equality. The idea of a partnership between a grassroots community organization and the most profitable industry in the globe is patently absurd.”
Discussions of accepting funding from drug companies, she says, often creates divisions within non-profit groups. “There is also a lot of naivete and denial, just as with doctors and researchers who insist they can take whatever funds they want from drug companies and still do impartial work,” she told PR Watch.
http://www.prwatch.org/prwissues/2003Q1/astroturf.html
Posted by rob on March 25, 2005 under Uncategorized |
Myeloproliferative Disorders Associated with Tyrosine Kinase Mutation
Researchers from the UK have identified an acquired single point mutation as the probable cause of more than half the cases of myeloproliferative disorders. The details of this study appeared in the March 19, 2005 issue of the Lancet.
Myeloproliferative disorders currently include polycythemia vera, essential thrombocytosis and idiopathic myelofibrosis. The cause or causes of this group of diseases is unknown. In the past, patients with chronic myeloid leukemia (CML) were included in this group of diseases, but cytogenetic and molecular studies revealed unique cause of CML. Now a similar phenomenon may be occurring with other myeloproliferative disorders.
JAK2 is a tyrosine kinase that has a major role in cell proliferation. The hypothesis of this study was that mutated JAK2 could be responsible for myeloproliferative disorders. Researchers in the study performed molecular genetic studies in 73 patients with polycythemia vera, 51 with essential thrombocytosis, and 16 with idiopathic myelofibrosis. They found that 97% of patients with polycythemia vera had a sincle acquired mutation of JAK2 cytoplasmic tyrosine kinase. The same mutation was present in 57% of patients with essential thrombocytosis and 50% of patients with idiopathic myelofibrosis. They also found this mutation is all erythropoietin-dependent erythroid colonies and present in multipotent cells giving rise to both erythroid and myeloid cells. These authors suggest that identification of mutated JAK2 will assist in classification of myeloproliferative disorders and may provide insight into pathogenesis.
Comments: This study is important, as it could lead to specific therapies for myeloproliferative disorders similar to that observed with the development of Gleevec® for the treatment of CML.
Reference: Baxter EJ, Scott LM, Campbell PJ, et al. Acquired mutation of the tyrosine kinase JAK2 in human myeloproliferative disorders. The Lancet. 2005;365:1054-1061.
Myeloproliferative Disorders Associated with Tyrosine Kinase Mutation
