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Pharmaceutical companies can easily spend years—and more than $1 billion—bringing a new drug to market, in part because they can’t find enough patients to do the required testing of the compound. Such delays can cost up to $1 million a day, fritter away valuable months of patent protection, and allow rival developers to catch up. One remedy: pay hospitals to sift through the health records of their patients.

Five big drugmakers, led by Pfizer, are planning to use electronic health data gathered from patients of 13 hospital systems across New York State to help them identify and enroll participants in drug studies. The effort, which begins testing this month, is projected to make $75 million a year for the hospitals and save the pharmaceutical companies time and money in developing new products. “This is going to be a game changer, making medicine more of a science and less of an art,” says John Murphy, senior director of clinical analytics for Quintiles Transnational, which helps drugmakers conduct trials.

The program, called the Partnership to Advance Clinical Electronic Research, or PACeR, is among scores of such initiatives created nationally as medical providers, software vendors, and health data businesses seek ways to profit from the flood of clinical data now being gathered electronically. Besides Pfizer, companies helping fund PACeR include Merck, Roche, Johnson & Johnson, and Bayer HealthCare. Quintiles and Oracle are developing the system.

Federal law bars medical providers, hospitals, and insurers from disclosing identifying information such as names, addresses, and Social Security numbers. So drug companies that want to test a new product or compound would pay PACeR to query the records systems of participating hospitals to compile a list of patients who match a trial’s requirements. Each query would cost between $50,000 and $200,000.

Once they determine how many patients might qualify and where they’re located, and get approval from a local ethics board, the hospitals would contact the patients’ doctors. A drugmaker would have access to personal information only if the patient consents, says David A. Krusch, head of PACeR’s leadership team and director of medical informatics at the University of Rochester Medical Center. “There is no central database,” Krusch says. “We’re not dumping big buckets of de-identified data anyplace. Pfizer will not have a network connection, say, to the University of Rochester, or to any other participant in the network.”

Still, some civil liberties groups worry about data breaches and the potential for third parties to reconnect names to the data. “In a world where so much data is being retained, exchanged, and sold, being able to protect the privacy of individuals is a lot more difficult,” says Lillie Coney, associate director of the Electronic Privacy Information Center, a Washington-based advocacy group. Even data scrubbed of someone’s name and Social Security number can be “re-identified,” Coney warned, citing a 2006 case where AOL released information about people’s search queries, which others were able to combine with publicly available data to identify an elderly Georgia woman who had used her AOL account to research medical conditions.

Consumer and ethics groups who advised the New York project say they see patient benefits as long as confidentiality is protected. “One of the problems with clinical trials is it’s very hard to get the information out to the average physician, or to the average cancer patient being treated in the community,” says research scholar Karen Maschke of the Hastings Center, a bioethics group that consulted on PACeR. Maschke says that while she supports the PACeR concept, “I’m also a skeptic. There probably should be conversations at the national level about best practices for these endeavors to guard confidentiality.”

Such discussions are expected to increase around the country as the use of electronic health records increases dramatically over the next few years, spurred by $27.4 billion set aside in the 2009 U.S. stimulus to pay doctors and hospitals to adopt and use them.

Drugmakers are big potential customers of aggregated health data since drug development times have more than doubled in the past 20 years without a marked increase in the percentage of compounds successfully brought to market. “If pharmaceutical companies can make this happen faster and more cheaply, they’re big winners,” says C. William Schroth, a former consultant for the New York State Health Dept., who first broached the concept behind PACeR to a group representing New York hospitals and also to drug companies.

Doctors and hospitals liked the idea because it makes them more attractive research partners. It wasn’t a hard sale for Big Pharma, either: Every day of delay during a Phase 3 trial costs drugmakers more than $1 million, with an average delay of 90 days, says David Leventhal, director of clinical innovation at Pfizer, citing a Deloitte Consulting analysis. “Even if that number is only 25 percent right, it’s still a compelling message.”



The bottom line: A group of 13 New York hospitals will sell access to patient data to drugmakers for $50,000 to $200,000 per search.

Research by Carol Eisenberg


.
Quotes by readers of this article:


THEN, they probably have one of the HIPPA forms that you typically "sign without reading and will not treat you if you don't" sneaky forms that in the small print allows them to sell your personal data "for research purposes".
Quote from article: "A drugmaker would have access to personal information only if the patient consents, says David A. Krusch, head of PACeR’s leadership team and director of medical informatics at the University of Rochester Medical Center."

How does it stop?
Starts with getting the word out.
Starts with patients challenging their healthcare providers to see if their data is being "sold / provided for research" and requesting they sign whatever is necessary to make sure it isn't "released"! Make sure you get a copy of your "signed" refusal form "for your records (aka: protection)


Do you really need antibiotics?

Taking antibiotics when they are not needed may increase your risk of getting an antibiotic-resistant bacterial infection later on.  When antibiotics fail to work the consequences can include longer lasting illnesses, extended hospital stays and the need for more expensive and potentially toxic medications.  The discovery of modern antibiotics dates back to 1929, when British scientist Sir Alexander Fleming observed that a type of mold called Penicillim Notatum, could prevent the growth of Staphylococcus bacteria.  Ten years later, two other Scientist, Ernest Chain and Howard Florey, found a way to isolate the antibiotic penicillin and used it to treat soldiers for battlefield wound infections and pneumonia during World War II.  

By 1946 penicillin became available to the general public for treating bacterial infections including strep throat, pneumonia and scarlet fever.  Additional antibiotics such as sulfa drugs, streptomycin and tetracycline came on the market in the late 1940’s and early 1950’s, launching the age of antibiotic therapy.  The success of antibiotics was the most significant medical achievements of the 20th century, greatly reducing the incidence of illness and death from infectious diseases.  Unfortunately, over the years, many disease-causing bacteria have become resistant to antibiotic therapy, partly due to overuse, and misuse of antibiotics.   Antibiotic resistance has become a huge public health concern.  In the past, as bacteria became resistant to some antibiotics, new antibiotics came on the market.  In the 1970’s and 1980’s, there were a couple of new antibiotics introduced every year.  Unfortunately, today there are not as many antibiotics coming to the market because of the high cost of drug development, we are only seeing a few introduced to the market every decade.  We must be smarter about how we use the antibiotic drugs that are available.   Antibiotics only work on bacterial infections, not on the viruses that cause colds the flu, and some sore throats.  In numerous cases, patients pressure their physicians to prescribe antibiotics when their physician has explained to them that they most likely have a virus.  Some patients have become very angry and left the doctor’s office upset when antibiotics were not prescribed.  When taking antibiotic therapy, only your Physician, can prescribe the right antibiotic, for the right problem, in the right dosage, for the right amount of time.   Never flush your medications down the toilet, and discard them in the trash.  (That is a different story you will be able to read about later.)

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Oncology nurse Beth O'Brien administered chemotherapy to her father, Bill Dillow, who was diagnosed with Stage 4 lymphoma. He survived, and the experience challenged her and deepened her understanding of what families she works with go through.  Michele Dillow, her sister-in-law,  was so persistent, Beth O’Brien finally had to dig her heels in. No matter how much her sister-in-law enjoyed it, O’Brien saw no reason to become an oncology nurse. She was perfectly happy as a psychiatry nurse. After a year, though, “they called me and said they had an opening,” O’Brien said. “I got the job, and a week later, Dad was diagnosed. Ninety percent of me feels I was put there for a reason.”

 

Pain in the neck

 

“Actually, the symptoms started in about 1999,” said O’Brien’s father, Bill Dillow. They were garden-variety symptoms: fatigue, aches and pains. “I would get up and go to work and could hardly go.  There also were bouts of pneumonia. The day he was about to leave his puzzled doctor’s office in 2001, Dillow said, “I can’t move my neck.” A moment’s check of the lymph nodes there told the story. “Bill, I hate to tell you this,” his doctor said immediately, “but you’ve got cancer.”  A biopsy showed it to be Stage 4 lymphoma, a disease that was causing his immune system to shut down.  Within a whirlwind week, Dillow was seeing his oncologist, Dr. Daljeet Singh, and chemotherapy was ordered.

 

Prep

 

“Before he started chemo, I made him a care package,” said O’Brien, a 1997 graduate of the Community Hospital School of Nursing.  It had a thermometer, Tylenol, lotions, anti-nausea medicine. She didn’t want him to wake up in the middle of the night and not have what he needed on hand.  At the same time, her co-workers were wondering whether O’Brien was ready for what lay ahead. So was she.  “Part of me wanted to just be the nurse, part of me wanted to just be the daughter, and part of me wanted to be both,” O’Brien said. “Dr. Singh and I were just getting to know each other then, and I appreciated his willingness to help me be the nurse and help me be the daughter and help me distinguish between the two.” In addition, “my boss sat me down and said, ‘We need to work this out now,’ ” O’Brien said. The key question: “I need to know how you feel about it. Are you OK treating him?” O’Brien thought so, but was cautious. “For the first maybe two treatments, I was just a bystander,” she said. “Then I became more comfortable.” Her father, meanwhile, was becoming more uncomfortable.

 

Enduring the during

 

“Dr. Singh told me the cancer was aggressive so he was going to be aggressive,” said Dillow, now 70. “The second chemo is the one that really started putting me down. It was terrible.” Along with the hair, “you lose your peripheral vision. You can’t drive (because) you’ll run into things,” he said. Dillow soon ran into something he’d never faced. “I had sores from the inside of my mouth clear out the back,” he said. So that he could eat, he first drank a solution to numb his sore digestive tract. The food had no taste, Dillow said. But in doing his part, he was determined to be as aggressive as his cancer and its treatment. Said Dillow: “I ate everything that didn’t eat me first.” What’s said, 
what’s heard.  When cancer strikes, it’s only natural to want solid information and to know with some assurance how things will turn out. But that’s seldom in the cards. “We were told, ‘We hope this will be effective, but we’ll just have to wait and see,’ ” O’Brien said. They also were told what she since has repeatedly told others: “Every person responds to therapy differently.” As common as those messages are, O’Brien benefited from hearing them from the family’s side. “I was afraid,” she said. “It wasn’t because anybody said it was a death sentence. It was because it was my dad, and I saw him sick, and he had cancer. You immediately think he’s going to die.” As a professional, she had some reason for concern, too.  When her father began treatment, the immune-boosting drug Rituxan was relatively new to the market, and oncologists were on guard for a so-called “infusion reaction.”  “I was petrified” about that, O’Brien said.  Because of that concern, the drug was given in the hospital only and infused gradually over a 12-hour period.  Trials established it could be given out of the hospital setting and over a shorter period of time — but that was only later.

 

Bill of approval

 

In retrospect, O’Brien says that kind of uncertainty involving her father provided her with the best kind of training. “You take the same precautions with every patient,” she said. “But when it’s your family, it takes on a whole new meaning. You can imagine how careful I was.” Her precautions with her father started with the basics: asking if it was OK with him for her to treat him. And in that way, he was the ideal patient.  “I wouldn’t have had it any other way,” Dillow said. “She’s my daughter. I have confidence in her. She had to learn, she was new “I do that with the girls here,” he said, sitting in his daughter’s office at the Springfield Regional Cancer Center.  If he’s in for a blood test and it’s obvious a new technician is observing, “I’ll be saying ‘Why don’t you do it on me? You’ve got to learn,’ ” Dillow explained.  Part of it is his nature. But Dillow said part of it is the way he’s been treated by all the staff at the center . “You can be on the street, and these nurses, they’ll come and give you a big hug,” he said. “It’s close-knit.”

 

His lessons

 

During his nine-month course of monthly treatments, Dillow felt something else draw near.
When you’re facing death, you see a whole new light,” he said, even in light itself.

“One of the most simple (differences) is you get up in the morning and open the blinds and let the sunshine in.”  Other essentials surfaced, too. “My family — how important my family is to me,” he said. “And my faith. It’s just enlarged itself in me — my faith in God and in mankind.” Retired after a 30-year career at Navistar, Dillow said one plus of having cancer is “you do learn your body.” After his initial treatment ended successfully in 2002, he was in remission. But last year, “I was having a lot of back pain up in the lung area,” he said. He went in for tests, which revealed a slow-growing or indolent lymphoma, for which he was successfully treated with radiation and is again in remission.

 

Family history

 

After treating her father, O’Brien continued with four years of in-patient oncology nursing, then moved on to the research department at Springfield Regional Medical Center, where she directs the clinical trial program. “It’s professionally very interesting,” she said. “You’re on the cutting edge of cancer treatment, and there’s a sense of responsibility to see ... the treatments the patients are going through are safe, effective and up to date. And I still get to do one-on-one patient care.” In that regard, working with her father has made a difference.
“You walk into a patient’s room with the thought process: He doesn’t look just like my father, but I’m going to treat him like my father.” Or perhaps another family member.

 

Within a year of her father’s diagnosis, O’Brien’s brother, grandmother and an aunt were diagnosed with cancer. Another brother subsequently was diagnosed. All survive!.

 

As a result, O’Brien said she has “this sense that I’ve got to learn about this, I’ve got to know everything there is to know about cancer.” And when she says, “we have a very strong family history,” she seems to be speaking not of her family alone but of the wider human family as well.

 Written By Tom Stafford

 Photo by Bill Lackey


Joshua Clay, a 17 year-old from Lake Park, Ga., is a member of the Youth Advisory Council at GenerationOn, the youth enterprise of Points of Light. Clay, a homeschooled high school senior, combined his interests in the Spanish language and reading to develop a bilingual reading program for elementary school age children at local libraries and schools in his community. The program, Bilingual Adventures in Spanish and English, or BASE, encourages literacy and inspires cross-cultural communication among youth in his community.   What is the one thing humanity has tried to achieve, but has yet to obtain? The answer: world peace. Why does it seem to always slip through our fingers? Perhaps the answer is a lack of understanding between cultures. We acknowledge the presence of other cultures and customs in our world, but do we accept them? Some do and some most certainly do not. I have always strived to not judge people by their skin color or their beliefs. It doesn’t matter whether you are a Christian or a Muslim. It doesn’t matter whether you are Vietnamese or Mexican. It’s about your character and the actions you take throughout your life. In the past few years, I certainly feel that I have become more culturally aware. With a little faith and curiosity, cultural acceptance (world peace), could be just around the corner.

I have been blessed with the opportunity to learn a second language. I began studying Spanish four years ago and have never been so committed to anything in my entire life. I’ve decided that instead of just soaking up the wonderful language and not using it, I will apply it to the rest of my life. I hope to become a bilingual medical doctor or as called in Spanish “un médico bilingüe”. One of the greatest things I have gained from learning the Spanish language is the ability to not only speak with approximately half a billion people across the globe (especially the 6,000 within my own community), but also the ability to learn from each and every one of those 500 million souls.

Each week I volunteer time at a community center to teach Hispanic immigrants English. I have heard many stories of triumph, tragedy, culture and ideas beautifully foreign to me. I believe that through all of these conversations I have acquired a profound cultural education. I’ve come to find that in the terests in the  real world, it’s not knowing about things like Ontogeny Recapitulates Phylogeny that make you knowledgeable, but how much you know about people. It’s like the age old saying “I’m rich not because of money, but because of love.” I believe that everyone should be rich in the knowledge of other people, other cultures, and ideas. Perhaps if we were, then we would all be rich in peace and love, too.

Our differences make us unique. To some people this makes other human beings and cultures scary. Many fear what they do not know. That is why we don’t have world peace; we just don’t know. The differences can be very attractive as well; arousing the curiosity of a select few. It is because of this curiosity that we are making strides to peace and cooperation. We are learning. Where would we be without experts on Egyptian Society or Farsi translators for the United Nations? I still have a lot to learn about other people. We all do.
By Ronnie Cho


First Lady Michelle Obama has dinner with members of the Halls family at their home in Ocoee, Fla., Feb. 10, 2012. Kern Halls, 37, cooked a meal for the First Lady and his family based on the principles of "My Plate," a new USDA nutrition system that aims to replace the old pyramid system.