Texas Doctors Lead Open-Notes Movement

Following a visit to your doctor, have you ever been:
- curious about what your doctor wrote in your file?
- unsure about what the doctor said?
- confused by medication instructions or anatomy terms you didn't immediately understand?

If so, raise your hand. You can't see me, but my hand is raised.

I was honored a few weeks ago when the Houston Chronicle contacted me and asked if I'd like to be interviewed for an article on MD Anderson Cancer Center's system which allows patients to access their own medical records. A Houston Chronicle reporter, Todd Ackerman, talked with me for about 30 minutes. Last week on January 17 2012, the article was published in the front section (page 6) of the Houston Chronicle. Yes, that's me in the picture. I'm pretty sure the photographer got my "good" side.

I won't repeat the article's contents, but the gist is that open medical records can reduce patient anxiety, improve patient/doctor communication, and save time. Here's a link to the article.

http://www.chron.com/news/houston-texas/article/Texas-doctors-lead-open-notes-movement-2575183.php

Enjoy.

Ed

Five Facets of Your Employer Health Insurance which may Surprise You

Health insurance purchased through your employer is an agreement between you and your employer to provide medical services and medications in exchange for payment premiums in the event such services or medications are required. It is similar to other types of insurance including automobile, homeowners, and life. One hopes they never have a need for the insurance, but if the need arises, one expects the agreement to be honored. From the time I entered the workforce in the mid 1970s to the time I left the workforce 30 years later in the mid 2000s, I always participated in and purchased health and life insurance through my various employers and didn’t give it much thought.

My journey into Cancer World has taught me a few lessons about health insurance worth sharing. The following points are some of my experiences and ones which I hope may help others.

#1: Black and white insurance company policy statements become grey areas once the bills begin to accumulate

Let’s begin with the basics, where do you find your insurance policy? Is it the few page description on your company’s website describing in-network providers, out-of-network providers, and co-pays? That’s a good overview and one that is useful to the vast majority of users and uses, but that is not your policy. The real policy is typically found in something called the “Summary Plan Description” or referred to as the SPD. My currently available Summary Plan Description is a 278 page document. To someone who hasn’t given healthcare insurance much thought, this document is intimidating. A brief somewhat comical side note is in order here. For about a year I tried to get the “full” plan document since what I had was the “summary” plan document. The “full” plan document turned out to be a 2 page agreement signed by an executive officer at my company. In short, I’m not sure what the word “summary” connotes in a 278 page document. But I digress.

In 2008, my SPD stated the following as a covered medical expense, “Prescription drugs approved by the Food and Drug Administration (FDA), used and sold in the U.S., and used for a medically accepted reason.”

My oncologist, a highly regarded and published physician at the cancer center rated number one in the country, prescribed a medication to me that in his opinion was medically necessary, was FDA approved, and was sold in the U.S. Based on the information in the SPD, the situation seemed pretty black and white to me. What do you think? What if you were in this situation?

I’ll make a long story short. My insurance company denied reimbursement for this FDA-approved medication. I spent weeks writing an appeal while sitting on some very expensive bills from my cancer center which my insurance company refused to pay. The denial interrupted my treatment plan. About two months after receiving the denial letter and working through the appeals process, my insurance company agreed to pay for past and future medication expenses for the drug which they had denied.

#2: Where an insurance policy states that the company reserves the right to amend, suspend, or terminate a policy at any time, this should be taken seriously

I don’t have any advice here. As such, this is more of a heads up than a facet of your policy which can be reasonably anticipated.

By way of example, my insurance company implemented a new policy in the middle of my cancer treatment specifically targeting the medication used in my treatment. Instead of calling me and giving me some warning about this new policy, they sent me a letter about a month after the policy was implemented denying payment for the treatment. This was after eight (or nine) treatments had already been reimbursed. But, not before two others had been administered. I have no insider knowledge, but it felt like a case of being singled out.

#3: In-Network and Out-of –Network providers are not always clear cut

If your health insurance is like mine, it may cover procedures received in a large medical institution or cancer center. Periodically, I received notices of use for an out-of-network provider even though the provider I saw was in an in-network institution. This in turn would kick-off a deductible and I’d be faced with a medical bill which was unexpected.

Two instances where this happened to me are as follows. A new cancer center employee was not fully registered as an “in-network” provider. She provided medical support to me as part of a team of people in preparation for one of my surgeries. It took a few months to straighten this out between my cancer center and my insurance company. The second instance was a bit harder to sort out. The cancer center had hired an independent contractor and that individual provided medical services to me. This resulted in another surprise and an unexpected medical bill. My cancer center took responsibility for this oversight and ended up writing off her expenses to me. But, it took time and effort to make this happen.

#4: The impact on your insurance when you enter into Long Term Disability is surprising

A book could be written on this subject area, but I’ll cover the highlights. This gets really confusing. Once one has been on long term disability for 2 years, Medicare takes over as your primary health insurance, regardless of your age. Surprise! And, depending on your employer’s supplemental insurance, you may or may not receive adequate healthcare coverage. I’m actually fortunate to have had a reasonable supplemental health insurance plan through the end of 2011. On January 1 2012 my supplemental insurance changed and the premium went up 400%. Sorry, that’s not a typo, 400%. It’s too early in the year to assess the impact of this change to my insurance coverage, but I’m already facing a need for a justification for a medication which in the past needed no prior authorization. The fun (and surprises) never end.

#5: Watch closely for changes which impose maximum reimbursement caps

This would most likely happen during an annual open enrollment period. This happened to me this past year. My prescription drug plan (PDP) which had no cap in the past changed to one with a maximum annual reimbursement cap. This created a lot of anxiety and stress knowing that my oncologist and I had just had an in-depth conversation on my chemotherapy medication and based on the new maximum reimbursement cap, I’d surpass the cap in April and face tens of thousands of dollars in out of pocket expenses. I had some lengthy and productive conversations with my company during the open enrollment period and the month following open enrollment. In the end, the cap was removed from the plan. I don’t know how many people this affected, whether or not my conversations had some impact on this decision to remove the cap, or whether the cap was an honest error on the part of my company to begin with. But, I do feel good about being an informed consumer and believe my discussions had some impact on the removal of this cap.

Conclusion

I realize this is a long post. The above are not the only issues one may face, but they seemed like the top 5 from my perspective. Here are my recommendations:

• Read and understand your Summary Plan Description (SPD) document
• Stay aware of medical plan changes that may impact your benefits
• Be diligent in assessing in-network and out-of-network service providers
• Keep good records (by date) of your treatment to support billing issues
• Watch for changes in coverage during open enrollment periods

If you have an insurance story you’d like to share publically, please send it my way. You can either post a comment or find my email address in this blog’s profile area. There are some good patient advocates groups that can help you work through your insurance issues, so you are not alone when the need arises. One such group which helped me recently was the Patient Advocate Foundation (PAF) at www.patientadvocate.org.

My last and most important piece of advice is to stay healthy and not need your health insurance benefits. Prevention is the best and least costly cure.

Happy and Healthy New Year Everyone,

Ed

December 13 2011 - My 5 Year Cancerversary

Happy Holidays.

Each year on December 13th I write a blog entry that is a reflection of a nadir in my cancer journey that took place on that date, now 5 years ago today. This year I had the privilege of sharing my cancer anniversary story in the University of Texas M D Anderson Cancer Center blog, Cancerwise. As such, please click on the link below to read today's blog titled, "It's Holiday Time - The Gift of Life" appearing in Cancerwise:

http://www2.mdanderson.org/cancerwise/2011/12/its-holiday-time-the-gift-of-life.html#more

In addition, for ease of reference I am including a link to each prior year Cancerversary entry from my blog.

2010
http://hncancer.blogspot.com/2010/12/december-13-2010-cancerversary-3.html

2009
http://hncancer.blogspot.com/2009/12/december-13-2009.html

2008
http://hncancer.blogspot.com/2008/12/december-13-2008.html

2007
http://hncancer.blogspot.com/2007/12/december-13-2007.html

Lastly, for those who would rather read my entry here without going out to the Cancerwise blog, here it is. But, it looks much nicer on the M D Anderson site.

It's Holiday Time: The Gift of Life

                                  

By Cancerwise Blogger on December 13, 2011 8:00 AM | Comments (0)

By Ed Steger

Ed Steger was diagnosed with head and neck cancer in 2005. After 36 radiation treatments, 2 years in palliative care and 5 surgeries he is now in remission. He blogs about living with head and neck cancer at www.hncancer.blogspot.com.

In order to give back to the medical team that saved him, Ed is currently a SPORE Patient Research Advocate at MD Anderson.

Today, Dec. 13, 2011, is my five-year cancerversary. I was originally diagnosed in April, at age 53, with stage III/IV head and neck cancer at MD Anderson Cancer Center. Throughout my cancer journey, the largest setback came five years ago today. Here's my story.

Difficult journey
Between April 2005 and December 2006, I had 36 IMRT radiation treatments, Taxol chemotherapy and four surgeries. One surgery that I often refer to as the "salvage surgery" lasted 12 hours and was followed by two terrifying days in the ICU and a week longer stay in the hospital.

At the time, it was either this surgical procedure or getting my affairs in order. After careful deliberation, driven largely by wanting to see my 12-year-old daughter grow up along with strong encouragement and support from my family, I chose the salvage surgery that took place on July 12, 2006.

It was an incredibly difficult surgery involving the removal of my left side jaw bone, a large section on my upper esophagus, part of my soft palate and a piece of my tongue.

If that wasn't enough, my tibia bone was cut from my leg to replace the portion of my jaw that was removed, necessitating a skin graft on the tibia area.

I recovered from this ordeal relatively quickly. By October, through a lot of determined, physical effort, I had the tracheotomy apparatus and feeding tube removed. By December, my life was getting back to normal.

Just six months after this major surgery, I was actually feeling great. To test myself, I made a trip out West to visit friends and enjoyed a round of golf on the beautiful Monterrey, California peninsula.

There was life after surgery.

Visit with my surgeon changed everything
A CT scan followed by a clinic visit with my surgeon on Dec. 13, 2006, changed all that. The scan revealed five inoperable hot spots. Once again, I was faced with getting my affairs in order. With help from MD Anderson's Palliative Care Unit, I prepared to let go of life and begin the process of dying.

But, as one who believes in having a Plan B, I also visited my MD Anderson oncologist.

One week later, I began an intensive chemotherapy regimen. During the next eight months, I had the proverbial kitchen sink of chemotherapy agents thrown at me: Cetuximab, Docetaxel, Cisplatin, Avastin, Tarceva, more Taxol, Carboplatin and GEMZAR.

It may sound random, but it wasn't. My oncologist and surgeon were monitoring me carefully and modifying my treatment based on my responses. Ten months later and after setbacks that required two relatively minor surgeries, I was declared as having no evidence of disease (NED).

The five inoperable hot spots literally melted away. That was in October 2007, more than four years ago! Two years ago, I was reclassified as being in remission.

So, this holiday season, I have the gift of life.

I was able to see my daughter graduate from high school last May and begin the next stage of her life as a beautiful young woman and a college freshman.

It has been hard, but it's so worth it.

I intend to keep moving forward and giving back, in my own unique way, to the community who made it possible for me to be here today. I am so very grateful for the untiring efforts of my medical team at MD Anderson.

For all those who have participated with me in this journey, including physicians, researchers, support staff and my spouse, family and friends, I wish you a happy holiday season and thank you with all that I have for this generous and unbelievable gift.

"You have cancer." What now? My Top 12 List (updated).

Two and a half years ago on March 19 2009 I wrote a similar blog entry. A link to that entry is at the bottom of this post. There is a revolution (see number 7 of 12 below) taking place in the world of cancer prevention, detection, and treatment. If you or someone close to you was recently diagnosed with cancer or are currently undergoing treatment, this list is for you. I've written about all of these topics before, but so much research and translational science work is coalescing, it felt like time for an update.

1. Know your cancer. The American Cancer Society (ACS) published a 68 page PDF containing a wealth of cancer information covering the year 2010. They estimated that there will be over 1.5 million new cancer cases diagnosed and almost 600,000 deaths (1,500 per day) in 2010. There is a marked increase in the 5 year survival rate when comparing a period in the mid 1970s (50%) to a period in early 2000 (68%). The document highlights 15 different types of cancers (many with multiple sub-types) listed along with cancers stratified along geographic, demographic, race, and ethic backgrounds. The document then delves into specific cancers. The more you know about your cancer, the better off you are in working with your medical team and making decisions about how to proceed. This document published by the ACS is a great starting point.

2. Use the Internet. This is such a powerful tool to research your specific cancer and discover the resources available. My focus is on head and neck cancer. So, by way of example, I've found the following web resources. 1) SOPHNC - Support for People with Head and Neck Cancer (www.sophnc.org). They have 108 support chapters throughout the US, many of which meet at least once a month. They also have the National Survivor Volunteer Network (NSVN) which matches patients and caregivers going through treatment with people who have already gone through similar ordeals. 2) The Oral Cancer Foundation (www.oralcancerfoundation.org). This is a non-profit entity designed to reduce suffering and save lives through prevention, education, research, advocacy, and patient support activities. 3) The Head and Neck Cancer Alliance (www.headandneck.org). This was formerly known as the Yul Brenner Head and Neck Cancer Foundation. Much of their effort goes into prevention and fund raising.

Most of these sites have Newsletters on up to date treatment breakthroughs, patient and caregiver forums, activities on how to become involved, and fund raising. For head and neck cancer, this list just touches the surface; there are dozens of other reputable sites (e.g., www.CancerCompass.com, www.redtoenail.org, www.beingcancer.net). Although I haven't focused my attention on other cancer types, I suspect that more pervasive cancers have an even greater treasure trove of support and information resources available.

3. Find the right cancer clinic. Cancer will kill over 600,000 people in the US this year. That is more than one death per minute, 24 hours per day, 365 days per year. Cancer doesn't take off for weekends or holidays. Finding the right clinic can help save your life. In my journey I've met enough people who either said, if I hadn't come here (referring to their current cancer center), I'd be dead now. On the other hand, I’ve known people who have passed away, in some cases unnecessarily, because they waited too long to find the right cancer treatment clinic. You want a cancer clinic that specializes in your type of cancer. Many clinics are fully prepared and qualified for plan A, but if plan A doesn't work, they are not going to be able to perform plan B. Plan B for them is referring you to a larger, better equipped center. For me, I’d rather start off with a clinic that can perform plan A, B, C, and D.

4. Find the right doctor(s) within the cancer clinic. I switched one of my doctors within my cancer clinic after the first year. I lost faith in my original doctor, so I asked to switch doctors. This is your life, and you should feel confident in the treatment prescribed. There are many options, and being an informed patient will help in choosing a path that is right for you.

5. Treat your core set of doctors as a team. Cancer is so complicated, one doctor is not enough. To be great, doctors specialize. In my case, the core team included an oncologist, surgeon, radiologist, and their physician assistants. They have been supplemented at times with other doctors who specialized in pain management, psychology, and other areas. You should understand how your doctors collaborate. For me, I liked knowing that each week my doctors gathered to talk about each patient, their treatments, progress, and next steps.

6. Understand your treatment and options. This means their probable success, timing, and life altering outcomes. Cancer is treated in slang terms as slash (surgery), burn (radiation), and poison (chemotherapy). These terms were not arrived at lightly. Many cancer treatments are as much art as science. Even the best doctors don’t have all the answers and field is constantly changing. They use their best judgment and if you are confident in your doctor, then you will have an easier time choosing the right paths.

7. Consider genetic testing. This is where the revolution is taking place and it may save your life. If your cancer center doesn't offer a genetic testing service consider a different cancer center or an independent testing laboratory. There are now many therapies which target specific genetic mutations. A great example of this is the EML4-ALK mutation in lung cancer. I've written about this before and you can search my blog or the Internet for more information on this specific mutation. The discovery of this mutation and the drug, Crizotinib, which has thrown a life line to about 7,000 lung cancer patients per year in the US is a remarkable success story for select patients, researchers, physicians, and pharmaceutical companies. In addition, Vanderbilt-Ingram Cancer Center has created a public database named My Cancer Genome at www.mycancergenome.org which currently lists six cancers including breast, lung, prostate, and melanoma where genetic mutations have been identified and based on a specific mutation, therapies have been shown to be effective in treating that mutation for that cancer. This whole field is causing an explosion of paradigm shifts within cancer centers, pharmaceutical companies, and even in the basic building blocks for how cancer is viewed. I'll touch on each of these areas briefly.

Cancer centers - MD Anderson Cancer Center recently announced the establishment of the Center for Targeted Therapies (CTT). See reference. The CTT's mission begins with hypothesis-driven research that identifies and validates targets; continues with the discovery, development and design of biological therapies and drug agents; and is followed by pre-clinical and clinical trials – with each step working toward the goal of personalized medicine. In an ASCO presentation last June, MD Anderson announced a goal of genetically testing each of their 30,000 patients annually within 5 years. In another example, the University of Pittsburgh Medical Center (UPMC ) recently announced that it will invest nearly $300 million to create the Center for Innovative Science, a research facility that aims to revolutionize the way treatments are designed for individual patients.

Pharmaceutical companies - Using Pfizer as an example, they created the drug Crizotinib for the treatment of the EML4-ALK mutation. Although this only addresses a small subset (4%) of people with non-small cell lung cancer, they made the investment and were successful in gaining fast track FDA approval for this drug on August 26 2011. In addition, Abbott Labs won speedy FDA approval for a test for this mutation. What is remarkable about this is the pharmaceutical company's recognition of the importance of how genetic findings will drive treatment approaches in the future. When one compares this to a drug like Lipitor, a cholesterol lowering medication and another Pfizer product having over five billion dollars in sales in 2010, it is this paradigm shift which is pushing even the largest drug companies to pursue drugs with relative small target populations. As a side note, a number of pharmaceutical companies offer assistance to those who can not afford an expensive chemotherapy agent. Talk to your cancer clinics business or clinical trial area for more information on this topic.

Basic building blocks for how cancer is viewed - Today, when one talks about cancer, they talk about lung cancer or breast cancer or prostate cancer, etc. The paradigm shift taking place in this area is talk about genetic mutations transcending specific cancer types. The American Society of Clinical Oncologists (ASCO) published a document last month which gives weight to this shift in thinking. I wrote about ASCO's document in my last blog entry and as such will not repeat myself here, but I predict that this shift is coming and there are cancer centers like MD Anderson, UPMC and Vanderbilt-Ingram which are embracing this shift. Then, there are the others. What is your cancer center doing in this field?

8. Understand clinical trials. Clinical trials are typically categorized as I, II, III, or IV. In a Phase I trial, the researchers are generally looking at the toxicity impacts on the human body. These trials are generally small with 10 or less humans. Phase II begins to assess drug efficacy. There may be varying dosages within a Phase II trial looking for the magic bullet and right balance between dosage and efficacy. Phase II trials are still primarily experimental and will be limited to a few hundred people. Phase III trials are where it goes mainstream. The research has proven that the drug can be tolerated (Phase I) and it has shown some promise (Phase II). A drug in a Phase III trial could include 1,000s of people across many different medical institutions and countries. They can take years to complete. One drug I’ve been interested in -- Crizotinib -- has been under study for about 4 years. There are currently 21 trials listed for this drug with a status of active, recruiting, terminated, or completed. Clinical trials have very specific inclusion and exclusion criteria. The http://www.clinicaltrials.gov/ website allows you to search among its 116,000+ trials taking place in 178 countries. This is a great resource. There may be a clinical trial out there for you.

9. Learn to live with uncertainty. As mentioned, for many cancers, treatment is as much art as science. It can take months for chemotherapy drugs to work or not work. It can be months between major tests. Some surgeries will require the surgeon to keep cutting until they find clean margins. They may not be able to tell you beforehand how much permanent damage there will be, how long the recovery time may take, or even if the surgery will be successful. I remember waking up after a major surgery. In the recovery room, the doctor was talking to the patient in the bed next to mine. He said, “I’m sorry, but the cancer has fully taken over several vertebrae and we were not able to remove it.” I could tell it had been a long, complicated surgery. I couldn’t see the patient as there was a curtain between us, but I could tell that the prognosis was bleak.

10. Understand your health insurance in depth. Read your health insurance document. Not just the guide, but the entire plan document. There are a lot of areas that become gray to one’s insurance company when the bills start coming in. What looked like a no brainer suddenly becomes a major issue. My insurance company has been reasonable, but not without a few major fights. Know your rights, stick up for them, and use the appeal process if you feel your rights have been violated. For those who have been paying insurance premiums for many years, it is an obligation (contract) for the insurance company to support your needs should they arise.

11. Take charge of the cancer. To the extent possible, don’t let the cancer control your life. There are drugs and therapies that can help you manage chronic, acute, and psychological pain and issues. Take advantage of these resources and make the most out of your current situation.

12. Understand the impact of your cancer on family and friends. Cancer can create stress in relationships. It can also create bonds. Sometimes cancer impacts close family and friends more so than the cancer patient. It has certainly impacted some of my relationships -- some for the better, and some for the worse. This impact can be more powerful than the cancer itself.

I hope sharing this information is helpful. If you would like to comment or add to the discussion, please post a comment. If you have ideas for other discussions or topics, please let me know.

References

"You have cancer." What now? My top 10 list (from March 19 2009)
http://hncancer.blogspot.com/2009/03/you-have-cancer-now-what-my-top-10-list.html

ACS 2010 Statistics
http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-026238.pdf

MD Anderson Center for Targeted Therapies
http://www.mdanderson.org/education-and-research/research-at-md-anderson/early-detection-and-treatment/centers/center-for-targeted-therapy/index.html

UPMC Announcement
https://www.dtmi.duke.edu/news-publications/research-news/upmc-to-build-300-million-center-for-innovative-science

FDA Crizotinib Approval
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm269856.htm

Abbott Labs ALK mutation test
http://www.genomeweb.com/blog/abbotts-alk-mutation-companion-dx-finds-home-ahead-schedule

Lipitor sales information
https://www.google.com/search?sourceid=navclient&ie=UTF-8&rlz=1T4DKUS_enUS214US215&q=lipitor
.

Panomics

Panomics is a word I've been hearing in oncology lectures and reading about in oncology-related materials, but when Googling it, it had no clear definition. This week I received an email from the American Society of Clinical Oncologists (ASCO) with a link to a document titled, "Accelerating Progress Against Cancer - ASCO's Blueprint for Transforming Clinical and Translational Research." A link to the document is at the bottom of this blog entry. Within this document, the word PANOMICS is used to refer to, "the combination of genes, proteins, molecular pathways, and unique patient characteristics which together drive the disease [cancer]." This document far exceeded my expectations as to deep thinking and actually does provide a roadmap for winning the war on cancer. It should be a must read for everyone in the cancer field - clinicians, researchers, and administrators. It's easy to read and short, but puts forth three simple guiding strategies.

It starts off compellingly by asking the reader to envisioning what the "patient" experience will look like in the future by tying together their genetic profile, all known medical information about that individuals at the touch of a button, and faster and smarter clinical trials. All this points clinicians to targeted therapies which have been shown to work in patients with a similar profile and steers them away from those therapies which have shown no benefit. The document talks about the importance of biomarkers and the leveraging of patient health information systems. It also lists three strategies to reach the goal of curing cancer. I won't articulated them here, but for those who are interested, please click on the link below and begin reading about wining the war on cancer.

Take care,
Ed

ASCO Article:

http://www.asco.org/ASCOv2/Department%20Content/Cancer%20Policy%20and%20Clinical%20Affairs/Downloads/Blueprint.pdf

Timeline of Cancer Progress - Explore 40 years of advancement in cancer treatment, detection, and prevention (a very cool interactive website referenced in the above document):

http://www.cancerprogress.net/
.

Meltdown

I was at my cancer center today for two reasons. First, to have my obturator adjusted. Wearing it created enough pain that I stopped using it at the expense of loss in the quality of my speech. Some adjustments were made and I have a follow up appointment next week to assess whether or not a new device is required. Second, I began a volunteer role as a patient research advocate a few months ago. My primary responsibility to date has been to attend a one hour meeting each month.

While at the cancer center, a man of about 50 years old was pushed by me in a wheel chair. He was having a complete meltdown. It's not often that one sees a grown man cry. Cancer is a terrible disease. It's been 4 plus years, but I've been there on at least four occasions. I remember each one vividly. I'll share one here briefly. It was on September twelth four (or five) years ago today. I was in the chemotherapy unit scheduled to receive some very toxic substances. A nurse was making attempt number four at getting an IV line going. First one arm then the other, then the back of my hand when the other usual suspect areas didn't work. It was also the anniversary of my mom's death. She died at age 72 after a 6 month battle with lung cancer. The world felt pretty crummy right about then between the poking, the anticipation of toxic substances, and my mom's death from lung cancer. I lost it and had a good hard cry. I don't know anything about the man in the wheel chair today, but I know that cancer can have that affect of you.

Mom - rest in peace, thinking of you today.

Love,
Ed

Today's FDA Avastin Decision

There's a lot of news out there about the FDA's 6 to 0 vote today recommending that Avastin not gain full approval for treating women with metastatic breast cancer. This case has been watched closely by both drug companies and cancer patient advocate groups. The final decision for withdrawing full approval rests with the FDA Commissioner, Margaret Hamberg. According to one news source, that decision will be rendered later this summer.

I've followed this issue closely. I'm not going to comment on the accelerated approval process granted by the FDA which allowed on label use of this drug sooner than later. With some fear of upsetting people who sided against the FDA, based on what I've read and after careful consideration, the FDA panel is making a sound recommendation.

I base this on the assumption, which I believe to be true, that the NCCN (National Comprehensive Cancer Network) Compendium will continue to list Avastin as a treatment option for breast cancer. This compendium is used by many insurance companies and Medicare to determine which treatments will be reimbursed. The panel's recommendation and ultimate decision to remove the breast cancer approval will not prevent doctors from prescribing Avastin to their breast cancer patients. In addition, Avastin is a serious drug with potentially deadly side-effects (internal bleeding). Unfortunately for patients, Genentech, and our hope for a cure, Avastin showed only marginal benefit in two recent studies. There are many, myself included, that for some people Avastin is the answer and our medical community is hard at work to find the bio-markers which show which patients have the greatest chance of success without endangering women who will not benefit.

Today's recommendation is a win for patients, doctors, and the FDA. Patients will continue to have access to this treatment regimen, insurance companies will continue to pay for the treatment, doctors will still be able to prescribe it to patients who they believe it will benefits, and the FDA is protecting the American people against unnecessary risks.

In closing, I credit my medical team who had the foresight to treat me with Avastin (in off-label use for head & neck cancer) with significantly prolonging my life although I can't prove that it was the Avastin that did the trick. I wish the two recent Avastin breast cancer studies on which the FDA panel based their recommendation had shown great benefit for breast cancer patients, but they didn't.

Lastly, I apologize to anyone I may offend for having sided with the FDA on this one. It is not about the money, it is not about death panels, it is not about Obama care; it is about the science.

Take care.