Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2010

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period April - June 2010 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) April - June 2010

Product Name: Active Ingredient (Trade) or Product Class
Potential Signal of a Serious Risk / New Safety Information
Additional Information
(as of July 15, 2010)

Clindamycin injection (Cleocin)

Overdose due to labeling confusion/medication errors

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Dronedarone hydrochloride
(Multaq)

Torsade de Pointes

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Etonogestrel implant (Implanon)

Convulsions

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Everolimus
(Afinitor)

Hepatitis B reactivation

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Febuxostat
(Uloric)

Hypersensitivity

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Ferumoxytol injection (Feraheme)

Serious cardiac disorders

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

GnRH Agonists
(Androgen Deprivation Therapy)

Hyperinsulinemia, Arterial thrombosis

FDA Drug Safety Communication
FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Lanthanum carbonate (Fosrenol)

Intestinal obstruction

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Omeprazole products

Hypomagnesemia

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Simvastatin
(Zocor)

Muscle injury with 80mg dose

FDA Drug Safety Communication

FDA Patient Safety News, June 2010

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Saquinavir mesylate (Invirase)

Prolonged QT and PR Syndromes

FDA Drug Safety Communication
FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Tapentadol hydrochloride (Nucynta)

Convulsions, Hallucinations, Serotonin syndrome

FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Tetracycline products

Stevens Johnson Syndrome,
Toxic Epidermal Necrolysis,
Erythema Multiforme

FDA is continuing to evaluate these issues to determine the need for any regulatory action.

Trastuzumab
(Herceptin)

Neonatal pulmonary hypoplasia

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Mon, Aug 23 17:00 PM EDT

By Kate Kelland

LONDON (Reuters) - Scientists have found that vitamin D influences more than 200 genes, including ones related to cancer and autoimmune diseases like multiple sclerosis — a discovery that shows how serious vitamin D deficiency can be.

Worldwide, an estimated one billion people are deficient in vitamin D, and a team of scientists from Britain and Canada said health authorities should consider recommending supplements for those at most risk.

“Our study shows quite dramatically the wide-ranging influence that vitamin D exerts over our health,” said Andreas Heger of the Functional Genomics Unit at Britain’s Oxford University, who led the study.

Vitamin D effects our DNA through something called the vitamin D receptor (VDR), which binds to specific locations of the human genome. Heger’s team mapped out these points and identified more than 200 genes that it directly influences.

Vitamin D deficiency is a well-known risk factor for rickets, and some evidence suggests it may increase susceptibility to autoimmune diseases such as multiple sclerosis (MS), rheumatoid arthritis and type 1 diabetes, as well as certain cancers and even dementia.

With this is mind, the group looked at disease-associated regions of the gene map to see if they had higher levels of VDR binding. They found VDR binding was “significantly enriched” in regions linked to several common autoimmune diseases, such as MS, type 1 diabetes and Crohn’s disease, as well as in regions associated with cancers such as leukemia and colorectal cancer.

“SUNSHINE VITAMIN”

Sreeram Ramagopalan, of the Wellcome Trust Center for Human Genetics at Oxford University, said the results, published on Monday in the journal Genome Research, showed “just how important vitamin D is to humans, and the wide variety of biological pathways that vitamin D plays a role in.”

Most Vitamin D is made by the body as a natural by-product of the skin’s exposure to sunlight. It can also be found in fish liver oil, eggs and fatty fish such as salmon, herring and mackerel, or taken as a supplement.

Some experts say that up to half the world’s population has lower than optimal levels of vitamin D, and that about one billion people are actually vitamin D deficient. The problem is getting worse as people spend more time indoors.

A study published in March found that vitamin D is vital for activating the immune system’s killer cells, known as T cells, which remain dormant and unaware of threats from infections if vitamin D is lacking in the blood.

Ramagopalan said the latest study suggested vitamin D played a role “in susceptibility to a host of diseases” and that health authorities should consider giving supplements to pregnant women and young children as a preventative measure.

“Vitamin D supplements during pregnancy and the early years could have a beneficial effect on a child’s health in later life,” he wrote. “Some countries such as France have instituted this as a routine public health measure.”

There are no definitive studies on the optimal daily dose of vitamin D but some experts recommend 25 to 50 micrograms.

(Editing by Tim Pearce)

      Reason: This voluntary withdrawal is being conducted as a precautionary
      measure. In the interest of patient safety, Octapharma USA Inc. has
      initiated a voluntary market withdrawal of selected lots of octagam®
      [immune globulin intravenous (human)] 5% Liquid Preparation] as a result
      of an increased number of reported thromboembolic events, some of which
      were serious.

      Action: 1) Please check all product labels against the list of affected lot
      numbers.
      2) Do not take this product. Return any product from the withdrawn lots to
      the point of purchase or to your healthcare provider.
      3) Contact your physician if you have medical questions.

      Other Information: If you need assistance, please call Octapharma USA
      Medical Affairs Department at 360 990 4318.

Sunday, August 15, 2010

By Julie Steenhuysen

CHICAGO (Reuters) - A gene linked with the immune system may play a role in developing Parkinson’s disease, researchers said on Sunday, marking a possible advance in the search for effective treatments.

They said a gene in the human leukocyte antigen region or HLA — which contains a large number of genes related to immune system function — was strongly linked with Parkinson’s disease.

“That means the immune system probably plays a role in your body developing Parkinson’s disease,” said Dr. Cyrus Zabetian of the University of Washington and Veteran’s Administration Puget Sound Health Care System, whose study appears in the journal Nature Genetics.

Zabetian said there had been hints that the immune system may be linked to Parkinson’s disease, a neurodegenerative disease that affects 1 to 2 percent of people over age 65.

“This is the best evidence we’ve seen so far,” Zabetian said in a telephone interview.

The finding came from a large, long-term study of more than 2,000 Parkinson’s disease patients and 2,000 healthy volunteers from clinics in Oregon, Washington, New York and Georgia.

Parkinson’s sufferers have tremors, sluggish movement, muscle stiffness and difficulty with balance.

Researchers looked at clinical, genetic and environmental factors that might contribute to the development and progression of Parkinson’s disease and its complications.

“We found strong evidence that a gene within the HLA region is associated with Parkinson’s disease,” Zabetian said.

HLA genes play an important role in helping the body discern between foreign invaders and the body’s own tissues.

“We don’t know specifically which gene because there is a cluster of genes in that region, but it is the first really strong link that the immune system plays a role,” he said.

That may mean infections, inflammation or an auto-immune response play some role in the development of Parkinson’s disease, Zabetian said.

“What this allows us to do is to hone in on the immune system,” he said.

Although current medical treatments may improve symptoms, none can slow or halt the progression of the disease.

The study was funded in part by the National Institute of Neurological Disorders and Stroke, one of the National Institutes of Health.

(Editing by Vicki Allen)

Reuters Health

Professor Gregor Reid at the University of Western Ontario. A growing number of people have turned probiotics for a host of health reasons, including candida, digestion, brain development, diarrhea and boosting the immune system. THE CANADIAN PRESS/Dave Chidley

The organisms may help with many conditions, but vague labeling clouds benefits

Kathleen Goldhar tried for years to figure out what was causing her young daughter to suffer from persistent, sometimes agonizing stomach pains.

Since age three, the now seven-year-old girl had complained of intense cramps that would stick around for a couple of nights, subside and then return days or weeks later, usually when she ate.

With little insight from doctors, at least one trip to the hospital with cramps that caused the little girl to writhe in pain, and myriad tests producing no answers, the single mom took the advice of a nutritional consultant who recommended probiotics.

Ms. Goldhar began adding a powdered supplement to her daughter’s juice and within a couple of weeks noticed that her complaints diminished as the pain appeared to lessen.

“They seem to work,” she said from Toronto. “It does seem to be a digestion issue and she seems to be able to sort of handle her food better. Her stomach doesn’t hurt as much.”

Ms. Goldhar is one of a growing number of people who have turned to the bacterial critters for a host of health reasons, including candida, digestion, diarrhea, boosting brain development and boosting the immune system.

Probiotics are live organisms, usually helpful bacteria similar to those found in the human gut, that can change or restore the intestinal flora. They are present in such foods as sauerkraut, miso and fermented products, but can also be taken in pill or powder form.

There are billions of bacteria in the body – on skin, in the mouth, the intestines and other body parts – that can maintain general health by raising resistance to harmful bacteria.

The World Health Organization defines probiotics as “live micro-organisms which when administered in adequate amounts confer a health benefit on the host.”

The surge in popularity comes after manufacturers homed in on the category’s potential benefits and began adding them to everything from yogurt, infant formula and juices to bread, chewing gum and chocolate. They can even be found in some floor cleaners and aftershaves.

Marketers have claimed the naturally occurring bacteria can shorten the duration of colds, prevent diarrhea, overcome allergies and even reduce the risk of certain cancers.

But health experts say the hoopla over probiotics has overshadowed actual scientific proof that they improve health, leading to confusion for consumers deluged with claims about products containing the micro-organisms.

Gregor Reid, who specializes in the study of probiotics, was on the panel that created the WHO’s definition of probiotics and says many of the products claiming to contain them actually don’t – because the specific bacteria haven’t been proven in a human study to confer a health benefit.

“The majority of products on the market are not in fact probiotics,” said Dr. Reid, a University of Western Ontario professor and head of the Canadian Research and Development Centre for Probiotics at the Lawson Health Research Institute in London, Ont.

“When you call something a probiotic, there should be an expectation that it’s been clinically tested and shown to have a benefit, and unfortunately many products don’t. So the first step is getting companies to do the studies.”

The problem is that there are many different strains of friendly bacteria that perform many different functions. Most have not been proven to be effective in clinical trials.

For consumers, it’s not clear on food labels how much and what type of bacteria a product contains, making it difficult to know if the probiotics are best suited for a particular health ailment.

Only some companies, like yogurt maker Dannon, list the specific bacteria that have been shown in trials to help with certain health issues, like regularity and digestion.

The company settled a $35-million lawsuit last year with customers dissatisfied over health claims it was making about yogurt products, leading to more explicit labelling.

Some experts say that shouldn’t scare off consumers from using probiotics for conditions where there is some agreement on benefits, such as helping with some types of diarrhea, bowel regularity, colds and irritable bowel syndrome.

John Bienenstock, a professor of pathology and molecular medicine at McMaster University in Hamilton, said people have to look carefully at a particular product and determine exactly what it is.

“They have to look through the literature carefully, recognizing there is this problem of a lack of consistency of information and lack of consistency of products,” said Dr. Bienenstock, who’s also director of the Brain Body Institute.

“From a consumer point of view, it’s very important that when you go out and see what’s on the shelf, you know what’s on the bottle and what it can do… There are health benefits and there is hype.”

Regulatory agencies are trying to rein in the multi-billion-dollar industry, which saw consumer spending on probiotic supplements triple in the United States between 1994 and 2003.

The International Probiotics Association is planning a labeling scheme that would include a minimum bacterial count and an identification of the bacterial strain.

There is also a move afoot in Europe to control the claims with regulation that demands companies produce the scientific evidence to support their labeling.

Health Canada has developed a probiotics monograph, which includes detailed information on acceptable health claims, associated doses, source materials and required risk information.

It has also developed a guidance document that spells out when health claims can be made about food. The department website states that food products containing probiotics may have to remove the word if they’re not accompanied by “specific, validated statements about the benefits or effects of the micro-organism.”

Researchers say people need to scrutinize prebiotics just as closely. The sugar-type molecules are non-digestible foods that make their way through the digestive system and help good bacteria flourish. They are mostly found in carbohydrate fibres and can be taken in supplements or foods.

Dr. Reid said consumers have to research probiotic products themselves, using online sites like PubMed (www.ncbi.nlm. nih.gov/pubmed) to see what studies have been done to prove a company’s claims.

He would like to see it made easier to know the strain of bacteria, its properties, what it does, how long it lasts if it’s in powder form and where it goes in the body. Otherwise, he worries that skepticism over probiotics’ actual benefits will sully ones that have been scientifically proven to work.

“There needs to be more clinical evidence or companies need to stop calling their products probiotics,” he said.

“It shouldn’t be a fad. I think the ones that are properly scientifically documented will be here to stay, but the other ones hopefully don’t spoil it for everyone else.”

Robert Roos News Editor

Aug 5, 2010 (CIDRAP News) – The Centers for Disease Control and Prevention (CDC) is urging healthcare providers to be alert for influenza cases, following the reporting of two small outbreaks of influenza A/H3N2 in Iowa and scattered H3N2 cases in 11 other states.

Noting that sporadic cases and localized outbreaks of flu are detected every summer, the CDC said clinicians should consider flu as a possible diagnosis in patients with acute respiratory illnesses, including pneumonia.

In an e-mailed health advisory issued last night, the CDC said the number of reported H3N2 viruses in late June and July increased slightly over previous months. In early July, two small outbreaks confirmed by reverse transcriptase–polymerase chain reaction (RT-PCR) were confirmed in non-neighboring counties in eastern Iowa, the notice added.

The first outbreak included 4 of 13 members of a college sports team who became ill, the CDC said. The second one included 9 of 12 children in a child-care setting and one parent. Two patients in the first outbreak and one in the second have tested positive by PCR, and samples have been sent to the CDC for further analysis.

None of the patients had traveled recently, and there were no epidemiologic links between the two outbreaks, the CDC said.

However, a Jul 30 epidemiologic update from the Iowa Department of Public Health (IDPH) said several patients in the two outbreaks have “connections to travel outside of Iowa.” An earlier IDPH update, dated Jul 16, mentions two H3 flu cases in Johnson County.

In addition to the Iowa outbreaks, between Jun 20 and Jul 23 the CDC received H3-positive specimens from 11 other states and a “smaller number of sporadic samples” that tested positive for the 2009 H1N1 and influenza B viruses, the CDC notice said.

The CDC did not list the states that have reported cases, other than Iowa. However, the IDPH updates mentioned that H3 cases have been reported recently in Minnesota, Arkansas, Wisconsin, Pennsylvania, and Hawaii.

On the basis of hemagglutinin gene sequencing of four isolates so far, the CDC said, the viruses are expected to be similar to A/Perth/16/2009-like H3N2 viruses, a strain that’s included in this year’s seasonal flu vaccine.

“Perth-like H3N2 viruses were first identified in early 2009, but have not yet circulated widely in the United States,” the notice stated. Previous flu vaccines did not include this strain, so last year’s vaccine would not be likely to provide much protection against it, it said.

The CDC alert advises that treatment decisions should not be based on negative rapid flu test results, since rapid tests have only moderate sensitivity and also can yield false-positives. If laboratory confirmation is wanted, clinicians should order RT-PCR or viral culture.

“Clinicians should use empirical treatment with influenza antiviral medications for persons hospitalized with suspected influenza, and for suspected influenza infection of any severity in high-risk individuals, regardless of influenza immunization status,” the CDC said.

H3N2 viruses have been circulating since they emerged in the pandemic of 1968-69. But last winter they were largely crowded out by the pandemic H1N1 virus in the United States. Flu experts say that flu seasons in which H3N2 viruses predominate tend to be more severe than those in which seasonal H1N1 or type B viruses are dominant.

See also:

IDPH page with access to Jul 30 and Jul 16 epidemiologic updates
http://www.idph.state.ia.us/IdphArchive/Archive.aspx?channel=EpiUpdate

By TOM MURPHY (AP)

Health care reform hits another milestone next month, with new provisions that include a coverage expansion for young adults and restrictions on an insurer’s ability to impose annual coverage limits or to reject children with pre-existing medical conditions.

Insurance coverage that starts on or after Sept. 23 will have to comply with these changes and others that were put in place when President Barack Obama signed the health overhaul into law March 23. For most people, the changes won’t affect their plans until coverage renews in the weeks or months that follow. Here are the highlights:

_ Adult children up to age 26 will be able to receive dependent coverage with all individual and group policies.

_ Lifetime limits on the dollar value of insurance coverage will be prohibited. This refers to how much your insurance coverage pays out to cover claims.

_ Restrictions will be placed on annual limits for coverage, a practice that will prohibited in 2014.

_ Insurers will be prohibited from rescinding or canceling coverage except in cases where the customer commits fraud.

_ Insurers will not be able to exclude children from coverage because of a pre-existing condition, but they can require parents to sign up kids only during a fixed annual enrollment period to ensure they don’t wait until a child gets sick to buy coverage.

_ Insurers will be required to provide preventive care like immunizations or mammograms without charging co-pays or other forms of cost sharing. Some may not have to comply with this element if their coverage existed March 23 and has not changed substantially.

Individual plans that have so-called “grandfathered status” like this also will not have to immediately follow the new restrictions on annual coverage limits or eliminate their lifetime caps. Over time, most plans will lose their grandfathered status as they make changes in benefit designs, said Jennifer Tolbert, a health policy analyst with the Kaiser Family Foundation.

Tolbert said these early provisions of the new law focus in part on consumer protections.

“It’s basically improving the quality of coverage that people have,” she said.

However, insurers and benefits analysts have cautioned that these restrictions and coverage expansions will raise the cost of insurance for some customers.

Several provisions of the complex law started unfolding in the weeks after President Obama signed it. For instance, people with Medicare prescription drug coverage are receiving $250 rebates once they reach a gap in their coverage known as the “doughnut hole.”

Enrollment has started in some states for temporary insurance that will cover people with pre-existing medical conditions who have been uninsured for at least six months. Some small businesses that offer employee health coverage can seek tax credits that will apply for this year.

The law will continue to develop over the next several years. In 2011, insurers will be required to offer rebates if they don’t spend a minimum percentage of their premiums on medical costs. Details of that provision are still being worked out.

Some of the biggest reform provisions start in 2014.

By then, Medicaid will be expanded to reach more people. Most citizens and legal residents will be required to have health care coverage, and many will receive help from the government through income-based tax credits when they shop for coverage on health insurance exchanges.

Associated Press Writer Ricardo Alonso-Zaldivar in Washington contributed to this report.

Copyright © 2010 The Associated Press. All rights reserved

Survival tips for current and future caregivers

One day you may find that someone you care about — a spouse, parent, relative, or close friend — needs help negotiating the daily tasks of life. Perhaps that day has already come. Close to 49 million informal or family caregivers offer assistance of all sorts to adults in America, according to the National Alliance for Caregiving and AARP. Their efforts are vital to the lives of people struggling with illness, disability, or the changes that often accompany aging.

The spectrum of tasks that unpaid caregivers undertake is truly vast. Some, such as grocery shopping and cooking, are familiar to us all. Giving injections, changing bandages, calming an agitated parent suffering from Alzheimer’s disease, or helping a disabled partner get from the bed to the bathroom can be far more daunting. But through countless unheralded contributions like these, caregivers allow millions of Americans to continue to live as independently as possible.

Talking with your loved one

Discussing needs can be a prickly business. It may be easy for you to imagine what sort of help is necessary, but much harder to discuss it openly or come to an agreement with the person who needs care.

Ask the person in need of care to spell out what he or she believes would help. One way to open a conversation is to say: “I’ve wondered if you’re having any trouble with _______.” Or, “I’ve noticed it is getting harder for you to _______.” If offers of help are flatly declined, you might call in a second opinion about the need for assistance. Try talking to the person’s doctor or trusted relatives or friends. Their opinions may carry more weight than your own. Some doctors, particularly geriatricians, may be willing to schedule and attend a family conference to talk about what is needed. Geriatric care managers or social workers can also help facilitate these kinds of discussions and present a range of options.

Encourage forethought

Whenever possible, it helps enormously to plan ahead for certain types of assistance, such as good nursing home care and insurance coverage. You might start a conversation by saying: “I read about Medicaid planning in the news today. Do you know about this?”

Be sensitive

In many families, parents never talk to their children — even after they become adults — about finances or health problems. And it is hard to ask sensitive questions of a relative, spouse, or partner who already feels pressured from illness. Raising concerns about your own financial future can make it easier for you to ask your parent about his or her finances. The same tactic may work well for discussing end-of-life decisions. You may find that the person wants to acknowledge these issues. It can be a relief to talk frankly about troubling topics and share concerns rather than hiding them.

Honest talk for tough decisions

Certain topics — for instance, that an individual shouldn’t be driving or that it’s getting too difficult to continue caring for a person at home — are painful to discuss for everyone concerned. Even so, telling white lies or making promises that are impossible to keep can come back to haunt you.

No one ever wants to go to a nursing home, for example, but instead of pledging that this will never happen, it may be best to promise only that you will try hard to work out other solutions for as long as possible. If you know a nursing home is the best long-term option, it doesn’t help to suggest that such a move is just for a few weeks. When those weeks are over, the reckoning and sense of betrayal are impossible to sidestep. It’s better to acknowledge that these are hard, sad decisions replete with many layers of loss.

You might put these sentiments into your own words: “I know it’s very hard to even think about moving to a nursing home. But we can’t supply all the care you need anymore. I worry about you constantly, especially when I’m not available. I’ve tried really hard, but I can’t keep everything going. We need to think about finding a place where you’ll be safe and well cared-for all the time.”

If appropriate, you might mention concerns about your own health and well-being or worries about what might happen if you become ill or unable to offer enough care. A single conversation is rarely sufficient. Let the person you are caring for grieve the loss. Moving toward a solution is likely to take time and several discussions.

One thing to keep in mind in situations where judgments might differ is that people are often willing to assume a level of risk to their safety or well-being in exchange for autonomy and personal choice. If a loved one chooses to live in a situation that seems too risky to you, you might need the help of a doctor to determine decision-making capacity. If your loved one can fully understand the consequences of his or her decisions then you must abide by them, whether you agree with them or not.

Teens Escaped the weekend of July 16 to Bloomington, MN where they enjoyed a fun weekend with friends while learning about their Primary Immune Deficiency Diseases! Teens, young adults and parents all participated in interactive sessions throughout the weekend including:

In Tune with Your Immune System

Presenters:  Tamara Pozos, MD, PhD, Children’s Hospital of Minnesota & Jason Raasch, MD, Midwest Immunology

Treatment Options for PIDD 

Presenter:  Laura Hoyt, MD, Children’s Hospital of   Minnesota

Insurance:  What is it?  Why do I need it?  How do I get it?
Presenter:  Frank Quintieri, Baxter Healthcare

Taking Control of Your Healthcare 

Presenter:  Kristin Epland, FNP-C, Midwest Immunology

Taking Control of Your Life at Home and in School 

 Presenters: IDF Teen & Young Adult Council Mentors

Keeping in Touch – Common Ground
Presenter:  Elizabeth Ferguson, IDF Staff
In addition to participating in sessions, teens and young adults had plenty of time to meet others and make lifelong friends.  An outing to the Mall of America to play mini golf and enjoy rides at Nickelodeon Universe was a huge hit.  More than a few were doused with water on the log ride!
Teen and young adult attendees had a fabulous time as evidenced from these comments about the Escape:

• This was my first time attending the event, and I really enjoyed it!  I hope to attend many more of these. 
• I liked it!  Overall great experience!
• The Council is amazing!
• Really cool!  I will be going to more!

  While their teens and young adults were busy, parents had their own sessions to attend.

  Parents participated in the following sessions:

• Growing Up with PIDD

        Presenters:  Brian Rath & Elizabeth Hart, IDF Teen & Young  Adult Council Mentors

• Empowering Your Teen to Take Control of Their Healthcare

        Presenter:  Ralph Shapiro, MD, Midwest Immunology

• Insuring Your Teen
• Presenter:  Frank Quintieri, Baxter Healthcare
• Roundtable Discussion

         Presenters:  Ralph Shapiro, MD, Jason Raasch, MD, Kristin Epland, FNP-C,

          Midwest Immunology
Parents had this to say about the IDF Teen Escape:

• Extremely knowledgeable presenters, material presented in very easy to understand manner, Great ability to empathize with families/kids
• Really great to hear life stories from mentors/Council and talk with other parents
• Thanks! This is an awesome thing to do for our kids and their parents.
• We are jumping up and down we are so excited!!  Thank you so much!

This particular ‘musing’ is of interest to PIDD patients.

I left Dr Rob’s info in here just in case you would like to subscribe to his blog, AS WELL as to MY BLOG:)

A Letter to Patients with Chronic Illness

By: Dr. Rob  |  July 20, 2010

Note: The following post from my blog had an incredible response in the chronic pain community and across the web.  Clearly this is a very important issue and this letter touched a nerve that has largely been ignored.

Dear Patients:

You have it very hard, much harder than most people understand.  Having sat for 16 years listening to the stories, seeing the tiredness in your eyes, hearing you try to describe the indescribable, I have come to understand that I too can’t understand what your lives are like.  How do you answer the question, “how do you feel?” when you’ve forgotten what “normal” feels like?  How do you deal with all of the people who think you are exaggerating your pain, your emotions, your fatigue?  How do you decide when to believe them or when to trust your own body?  How do you cope with living a life that won’t let you forget about your frailty, your limits, your mortality?

I can’t imagine.

But I do bring something to the table that you may not know.  I do have information that you can’t really understand because of your unique perspective, your battered world.  There is something that you need to understand that, while it won’t undo your pain, make your fatigue go away, or lift your emotions, it will help you.  It’s information without which you bring yourself more pain than you need suffer; it’s a truth that is a key to getting the help you need much easier than you have in the past.  It may not seem important, but trust me, it is.

You scare doctors.

No, I am not talking about the fear of disease, pain, or death.  I am not talking about doctors being afraid of the limits of their knowledge.  I am talking about your understanding of a fact that everyone else seems to miss, a fact that many doctors hide from: we are normal, fallible people who happen to doctor for a job.  We are not special.  In fact, many of us are very insecure, wanting to feel the affirmation of people who get better, hearing the praise of those we help.  We want to cure disease, to save lives, to be the helping hand, the right person in the right place at the right time.

But chronic unsolvable disease stands square in our way.  You don’t get better, and it makes many of us frustrated, and it makes some of us mad at you.  We don’t want to face things we can’t fix because it shows our limits.  We want the miraculous, and you deny us that chance.

And since this is the perspective you have when you see doctors, your view of them is quite different.  You see us getting frustrated.  You see us when we feel like giving up.  When we take care of you, we have to leave behind the illusion of control, of power over disease.  We get angry, feel insecure, and want to move on to a patient who we can fix, save, or impress.  You are the rock that proves how easily the ship can be sunk.  So your view of doctors is quite different.

Then there is the fact that you also possess something that is usually our domain: knowledge.  You know more about your disease than many of us do – most of us do.  Your MS, rheumatoid arthritis, end-stage kidney disease, Cushing’s disease, bipolar disorder, chronic pain disorder, brittle diabetes, or disabling psychiatric disorder – your defining pain –  is something most of us don’t regularly encounter.  It’s something most of us try to avoid.  So you possess deep understanding of something that many doctors don’t possess.  Even doctors who specialize in your disorder don’t share the kind of knowledge you can only get through living with a disease.  It’s like a parent’s knowledge of their child versus that of a pediatrician.  They may have breadth of knowledge, but you have depth of knowledge that no doctor can possess.

So when you approach a doctor – especially one you’ve never met before – you come with a knowledge of your disease that they don’t have, and a knowledge of the doctor’s limitations that few other patients have.  You see why you scare doctors?  It’s not your fault that you do, but ignoring this fact will limit the help you can only get from them.  I know this because, just like you know your disease better than any doctor, I know what being a doctor feels like more than any patient could ever understand.  You encounter doctors intermittently (more than you wish, perhaps); I live as a doctor continuously.

So let me be so bold as to give you advice on dealing with doctors.  There are some things you can do to make things easier, and others that can sabotage any hope of a good relationship:

1. Don’t come on too strong – yes, you have to advocate for yourself, but remember that doctors are used to being in control.  All of the other patients come into the room with immediate respect, but your understanding has torn down the doctor-god illusion.  That’s a good thing in the long-run, but few doctors want to be greeted with that reality from the start.  Your goal with any doctor is to build a partnership of trust that goes both ways, and coming on too strong at the start can hurt your chances of ever having that.
2. Show respect – I say this one carefully, because there are certainly some doctors who don’t treat patients with respect – especially ones like you with chronic disease.  These doctors should be avoided.  But most of us are not like that; we really want to help people and try to treat them well.  But we have worked very hard to earn our position; it was not bestowed by fiat or family tree.  Just as you want to be listened to, so do we.
3. Keep your eggs in only a few baskets – find a good primary care doctor and a couple of specialists you trust.  Don’t expect a new doctor to figure things out quickly.  It takes me years of repeated visits to really understand many of my chronic disease patients.  The best care happens when a doctor understands the patient and the patient understands the doctor.  This can only happen over time.  Heck, I struggle even seeing the chronically sick patients for other doctors in my practice.  There is something very powerful in having understanding built over time.
4. Use the ER only when absolutely needed – Emergency Room physicians will always struggle with you.  Just expect that.  Their job is to decide if you need to be hospitalized, if you need emergency treatment, or if you can go home.  They might not fix your pain, and certainly won’t try to fully understand you.  That’s not their job.  They went into their specialty to fix problems quickly and move on, not manage chronic disease.  The same goes for any doctor you see for a short time: they will try to get done with you as quickly as possible.
5. Don’t avoid doctors – one of the most frustrating things for me is when a complicated patient comes in after a long absence with a huge list of problems they want me to address.  I can’t work that way, and I don’t think many doctors can.  Each visit should address only a few problems at a time, otherwise things get confused and more mistakes are made.  It’s OK to keep a list of your own problems so things don’t get left out – I actually like getting those lists, as long as people don’t expect me to handle all of the problems.  It helps me to prioritize with them.
6. Don’t put up with the jerks – unless you have no choice (in the ER, for example), you should keep looking until you find the right doctor(s) for you.  Some docs are not cut out for chronic disease, while some of us like the long-term relationship.  Don’t feel you have to put up with docs who don’t listen or minimize your problems.  At the minimum, you should be able to find a doctor who doesn’t totally suck.
7. Forgive us – Sometimes I forget about important things in my patients’ lives.  Sometimes I don’t know you’ve had surgery or that your sister comes to see me as well.  Sometimes I avoid people because I don’t want to admit my limitations.  Be patient with me – I usually know when I’ve messed up, and if you know me well I don’t mind being reminded.  Well, maybe I mind it a little.

You know better than anyone that we docs are just people – with all the stupidity, inconsistency, and fallibility that goes with that – who happen to doctor for a living.  I hope this helps, and I really hope you get the help you need.  It does suck that you have your problem; I just hope this perhaps decreases that suckishness a little bit.

Sincerely,

Dr. Rob