What Is Cancer?

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accountable care, best practices, evidence based care, health, innovation, jay walker, mind the gap, oncology, stephen wilkins, tedmed, wellness

By Gregg A. Masters, MPH

It’s been a while since Dr. Just has been able to put pen to pad and update you on his journey (and their is lots to tell from group mergers to a continuing drama with EHR implementation) into social media and a ‘transition’ to full to part time practice in a multi-site community oncology practice. More soon from Dr. J aka @chemosabe1 – at least I’ve been told.

Meanwhile, below is a clip producer by Jay Walker the curator of TEDMED and noted Professor of Medicine and Engineering at the University of Southern California Keck School of Medicine and Viterbi School of Engineering oncologist David B, Agus, MD well worth a view!

Also, we had a great session today on ‘this week in oncology’ chatting with Stephen Wilkins the publisher of ‘Mind The Gap’ blog. You can listen here.

 

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The Advent of Cancer Immunotherapy: Addressing Unmet Needs Part 1

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cancer, evidence based medicine, health, immunotherapy, innovation, integrative oncology, managed care, medical education, wellness

By Gregg A. Masters, MPH

The following is provided via the video series at the American Journal of Managed Care on ‘The Advent of Cancer Immunotherapy’, part 1 of a 3 part series:

 

In a discussion moderated by Dr. Peter Salgo, Drs. Jeffrey Weber, Michael Kolodziej, and Daniel J. George share their insights and perspectives on the rise of cancer immunotherapy, and its significance during a time in which cancer is recognized as the “new global pandemic” that has killed more than 600,000 US persons in 2012 alone.

 

For original source link, click here.

@IBMwatson and the Future of Oncology Care

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cancer, digital health, FutureMed, genomics, health, IBM Watson, Marty Kohn MD, oncology, wellness

By Gregg A. Masters, MPH

Another of the highlights of FutureMed 2013 was the track on ‘the future of oncology’. In addition to the promise of favorably impacting both the early diagnosis and thus treatment outcomes for pancreatic cancer via the discovery of Jack Andraka, Ronald Levy, MD of Stanford wove a beautiful narrative of hope and promise that might best be represented by the following quote:

My dream is to get rid of chemotherapy and do it with the immune system..

Dr. Levy’s concluding slide outlined the visioned future for oncology:

Meanwhile one could not be but immensely inspired by the clinical decision support and powerful AI platform demonstration detailed by Marty Cohn, MD. Witness ‘IBM Watson Demo: Oncology Diagnosis and Treatment’ developed in conjunction with Memorial Sloan-Kettering Cancer Center:

Biometric Monitoring Systems: A Role for Monitoring & Managing Cancer?

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bimetric scoring systems, ces 2013, digital health, health, michaeal singer, Quantified Self, vitality analyzer, wellness

By Gregg A. Masters, MPH

There is considerable (and growing) attention focused on the emerging role of ‘quantified self’ tools to improve our overall health status, enhance access, improve outcomes while also lowering the total cost of health care. At the recently concluded CES 2013 Conference and Exposition a Forbes article posed the following question:

CES 2013: The Year of The Quantified Self?

If you’ve not heard of the ‘Quantified Self‘ movement you will. Their website is chock full of information and health apps for the curious and motivated. The recent blog post: Future Normal: Quantified Self Tools at the Apple Store hints at the new normal now in sight. Or as overheard several times on the Silicon Valley circuit for at least the last three years and oft credited to William Gibson:

The future is already here. It’s just not evenly distributed yet

So in this entrepreneurial frenzy and resultant sea of digital health apps all chasing the holy grail to define and manifest a healthier America, much attention has rightfully focused on the capture, reporting and sharing of meaningful biometric data to maintain health, improve health literacy, better inform doctor/patient communications and ultimately support improved health outcomes.

Against this background, now ponder the following xPrize-esque(?) question:

Imagine if you could have a conversation with your body on a cellular level. What if you asked your cells, how am I really doing? Am I healthy? Is my treatment working? Is there anything I could be doing better?

And consider the following reply:

‘The Vitality Analyzer, an FDA approved Class II over-the-counter medical device that electrically measures your health, is a simple tool that helps you answer those questions. Based on well established technology, the Vitality Analyzer measures your health collecting information about your body’s cells and then translates it to a numeric score; your Vitality Index a global health indicator.’

Sound interesting, if not a bit of an over the top claim to make? it did to me. So on the Wednesday, January 30th 2013 broadcast of ‘This Week in Oncology‘ we’ll chat with the inventor Michaeal Singer and dive deeper into the peer reviewed science supporting the ‘well established technology’ cited above.

To state the obvious, at least from the point of view of cancer patients wondering what is happening at the cellular level minimally in between those routine or non-routine follow-up visits to the oncologist, if this metric can reliability report on the underlying state of health or to the contrary tumor pathogenesis, this is the kind of ‘biomarker’ information most cancer patients would want to have.

China: A report from the journey

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cancer, digital media, evidence based medicine, integrative oncology, medical education, oncology, participatory medicine, physician, social media, Traditional Chinese medicine, wellness

By Richard Just, MD

China is nothing like I imagined! The evolution of healthcare mirrors major events in Chinese history.  Traditional Chinese Medicine (TCM) dates back 5,000 years when the first documentation appears.  What is currently called TCM goes back 3,000 years, and was essentially passed from one generation to the next.  Another factor that resulted in fragmentation of medical practices was that China was a feudal society whose states were constantly at war with each other.  The emergence of the Qin state resulted in a single state system with a single script and standardized weights and measures.  But their reign was so oppressive it lasted only 15 years, overthrown by the Han Dynasty in 210 BC.  During this time fragments of the Great Wall were fused into one continuous structure, and the underground mausoleum of the terra-cotta warriors was constructed near modern day Xi’an which was China’s capitol at that time.

In my mind, China was still a monolithic society under a Communist regime and TCM was available to the masses while western medicine was for the ruling class.  Well that’s not exactly the case.  Prior to 1949, there had been a widening chasm between those who had access to healthcare and most everyone else who didn’t.  When the Party came to power, most workers were employed by the government and had access to healthcare.  All through the Cold War era, the only major leader who never left his country was Mao.  He was mainly concerned with unification of the country and building a strong infrastructure.  Many lesser officials did interface with the West, and when they returned with different ideas, the Cultural Revolution (1966-1976) ensued.

We all know that intellectuals, including doctors, suffered.  But Mao realized he needed some physicians to treat the population.  He also realized that TCM needed to be standardized so it could be disseminated to as many doctors as possible.  In this process, much of the practice of TCM was changed in China, but it continued as it had been practiced for 3,000 years in Japan.  In 1980, with the end of the Cultural Revolution, two policies were instituted that have resulted in major changes in society:

1. One child per family rule:  There are certain exceptions to this rule.  But, in general, if a family has more than one child they are fined, heavily.  And, if the practice continues, a sterilization procedure results.
2. Opening up China to western ideas and businesses:  One of the first businesses allowed into China was health insurance.  Hard  to believe but true.  What has resulted is a system resembling ours.  Government employees and  officials  have  government insurance, which is essentially free.  They have access to everything necessary for their care, and it is funded by taxing the entire population.  Non-governmental employees buy private health insurance which generally covers 70% of  costs, leaving 30% out-of-pocket.  These policies consume a  good  chunk of income, and are renewed for 25 years after which all costs are covered by Social Security and the government.  Again these funds derive from taxes.  Parents pay for healthcare of their children, and rural farmers who can’t afford insurance are eligible for something like Medicaid/MediCal with “bare-bones” coverage.  This latter situation is also not free.  Obviously, most young people prefer a government job.  These are hard to come by unless you know someone, and contribute to his “Red Pack.”  This is the local phrase for payola or bribe.

Does this sound familiar?  I found no one who felt the system was fair.  But I didn’t speak with a government official.

Meanwhile, my wife and I had a personal experience with TCM.  Prior to our trip, Dee Dee fractured two metatarsals in her left foot.  This was healing when we left.  But, I’ve dubbed China as the country of stairs.  Lots of walking and climbing.  This time both feet and ankles were extremely painful and swollen when we boarded the Yangtze River cruise.  Fortunately, there was a doctor on board who saw her the next day.  Her treatment consisted of acupuncture, acupressure, placement of antifungal patches on the tops of her feet and cupping.  Not what I learned in training.  It was recommended that she soak her feet and legs up to mid-calf level each night in very warm to hot water for 20-30 minutes.  The whole process lasted one hour and cost 550 yuan, equating to roughly 90 USD.  She was much improved by the following morning.  That afternoon, Dee Dee had a second treatment.  Both treatments were very painful, especially when the needles were inserted.  It turns out Chinese needles have a much larger bore than those used in the U.S.

We listened to a lecture on TCM given by the same doctor.  TCM involves not only acupuncture, acupressure and cupping, but also herbal medicine, Qigong, and Tai chi.  He discussed the use of TCM modalities in treatment of migraine and other headaches, motion sickness and back pain.  Every morning, the same Dr. John Lee gave Tai chi lessons on board, which we both attended.  The only excursion Dee Dee has missed was to the temples at Fengdu which involved over 500 stairs and inclined walkways.

Now for the big question:  “Is there any role for TCM in the treatment of cancer?”  He said that TCM is of little benefit in treating or preventing cancer, but may have some benefit as an adjunct to surgery or other conventional treatments.  More on this when we reach Shanghai.

More To The Henrietta Lacks Story

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cancer, clinical trials, elder wisdom, epatients, evidence based medicine, health, Henrietta lack, medical education, medicine, physician, physicians, research, social media, twitter, wellness

By Richard Just, MD

A few weeks ago, my wife and I attended “A Conversation With David ‘Sonny’ Lacks” at the California Center for the Arts, Escondido.  The event was a sellout with 900 attendees.  As it turns out, most of the colleges and universities in San Diego County designated “The Immortal Life of Henrietta Lacks” as the book discussed by students and faculty this past academic year.  The conversation was sponsored by California State University, San Marcos.  As an added bonus, Mr. Lacks’ daughter appeared with him on the podium.  I had previously attended a similar lecture with the author, Rebecca Skloot, at UCSD.

The story of Henrietta Lacks can be viewed from several vantage points.  As a medical oncologist, and Chairman of the Investigational Review Committee as well as Medical Director of the Research Institute at Palomar- Pomerado Health, ethics in medical research certainly occupies a position of paramount importance to me.  In fact, the book is being discussed locally primarily from this perspective.  Ms. Skloot points out that obtaining ‘Informed Consent’ from patients to do research on their tissue was not required, nor was it considered, in 1951 when Mrs. Lacks’ biopsy was obtained for research purposes.  Mr. Lacks stated he did not feel the family should receive financial compensation for using her tissue for research purposes.  But, Henrietta and the family should have been told that her cells were going to be used for research purposes, what the research involved, and knowledge of the results.  In other words, essentially informed consent as we now require in all patients undergoing clinical trials.

On the other hand, he did feel that the family should receive financial remuneration from the companies that commercialized his mother’s cells by selling them to labs around the world.  This proposal seems fair.  To date, no financial restitution has occurred.

But despite all this, Mr. Lacks maintains an air of dignity that engenders respect.  Throughout the evening, there was no expression of anger or hostility; no complaining.  When asked if he thought that racial discrimination played a role in how they were treated, Mr. Lacks said no, people of all races were treated the same at that time.  Sonny said that although no one from Johns Hopkins has ever formally apologized, they have honored his mother in other ways.

Sonny Lacks was 3 years old when his mother died.  So, he has no direct recollection of her.  In fact, the picture on the front of the book is the only picture of Henrietta in existence.  All that he and his daughter know about her they learned from his older siblings and Ms. Skloot’s research for the book.  When Henrietta was treated, Johns Hopkins was the only hospital in the state of Maryland that treated the uninsured.  Fast forward to the present and this sore is still festering in our country.  Mr. Lacks stated that he recently required stents placed in his coronary arteries on an urgent basis and he, like all the members of his family, is uninsured.  This brought an audible gasp from the audience.  He said he had $100,000.00 in unpaid bills, and he opined that health care should be a right as it is in other countries, not a privilege for only those who can afford it.  This elicited a vigorous round of applause from the audience .  I would add that the number of people in the U.S. who can afford access to healthcare is dwindling also. [Editor’s Note: For specific discussion on the impact in the Black community, see: ‘Blacks See Largest Decline in Health Insurance Coverage.’]

The closest we have to universal healthcare provided by government is Medicare and Medicaid (MediCal in California), see: ‘Medicare: The Basics.’  I recently crunched the numbers in my own situation at age 70 to decide whether or not to convert from my medical group’s health plan (since I’m still working to full Medicare coverage.  Plan A is free and mandatory at age 65.  But I needed Plan B, a Medicare Supplement Plan and Medicare Part D for prescription drugs.  Part B involves an annual fee of $140.00 + monthly premiums of $99.00 + something called “Modified Adjusted Gross Income” (MAGI).  The IRS now sends Medicare a report of my income and a graduated monthly charge is added to my premium.  The monthly total amounted to $259.70.  Added to that is the cost of the Supplement and Medicare Part D.  Then the out of pocket expenses including cost of drugs in the donut hole and now you’re talking “real money.”  Of course, you can opt for a Medicare HMO but choices are limited. So for effect, I will quote myself (drum roll please!):

My conclusion was that being insured does not equate to being covered, and I needed to be a CPA to figure this out.  So, I stayed with my group health plan.

The most poignant moment of the evening occurred when Henrietta’s granddaughter was asked how she felt her grandmother should be remembered.  Her answer:

The gift that keeps on giving.

Not a dry eye in the room.

Cancer Survivorship

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12 steps, cancer, digital media, epatients, evidence based medicine, health, innovation, medical education, medicine, oncology, recovery, twitter, wellness

By Richard Just, MD

The fact that the term “Cancer Survivorship” is now part of our vocabulary is a testimony to advances made in management of these diseases.  Most cancer survivors, however, are not unscathed by the experience.  As I tell my patients, they won’t be entirely as they were before treatment.  How these issues are dealt with varies from person to person.  But, awareness that chronic problems may persist long after treatments end signals that even though we’ve won the battle, the war is not necessarily over.  We may need to address problems in the physical, mental/emotional and/or spiritual spheres.  After all, quality is as important as quantity.

Certainly, health care professionals are well trained to deal with physical issues.  Attempting to address the totality of needs in an organized manner is a recent phenomenon.  Certainly, in thinking about programs that have been successful in supporting people mentally, emotionally and spiritually, 12-Step Programs come to mind.  The Steps are compelling as they are for anyone affected by the disease alcoholism, including the alcoholic (A.A.) and the “caregiver” (Al-Anon).  Substitute “cancer” for “alcoholism.”  The value of The Steps is that they provide a guideline through the process of recovery.  In fact, I prefer the designation “recovery” over “survivorship” as it implies an ongoing process with relapses and remissions along the way.

At first glance, the verbiage doesn’t seem to be appropriate.  But, The Steps suggest four primary ideas:

• “We Are Powerless Over the Problem of Alcoholism.”  This notion of powerlessness is difficult for healthcare professionals, especially physicians, to accept.  The intention is that we as individuals have no ability to change attitudes and behaviors of others, but we do have control over ourselves.  Think the Serenity Prayer:

God, grant me the serenity to accept the things I cannot change, Courage to change the things I can, And the wisdom to know the difference.

In fact, this is a very empowering concept that releases each of us from worrying about issues that don’t concern us and address our energies to our own lives.

• “We Can Turn Our Lives Over to a Power Greater than Ourselves.”  Many find the idea of a Higher Power difficult to embrace, while others already believe in a Power greater than themselves, but feel that “God has deserted” them.  Both viewpoints hinder recovery as they tend to foster a victim mentality.  Personally, I dislike the designation “cancer victim” for this reason.

The slogan:  “Let Go and Let God” can also be very liberating, recognizing that The Higher Power is in charge of our lives and we are not victims.  The 11^th Step provides details:

Sought through prayer and meditation to improve our conscious contact with God as we understood Him, praying only for knowledge of His will for us and the power to carry that out.

• “We Need to Change Both Our Attitude and Our Actions.”  Both the cancer and its treatments can  result in distorted thinking.  Some are left with severe fatigue and pain; others with long-lasting memory deficits called chemobrain.  Anxiety and depression are not uncommon.  The possibility of recurrence is always present.  Some become angry and blame their situation on others.  Obviously, these behaviors can be self-destructive and ruin relationships.  In these difficult situations, a useful tool in 12-Step programs is sponsorship.  Having someone who has lived through similar circumstances and recovered always there for support and guidance is crucial for recovery.

• “We Keep the Gifts We’ve Received by Sharing Them with Others.”  Probably the most important concept.  Several studies have shown that participation in cancer support groups improves outcomes.  But many patients still are reticent to join.  Some prefer the privacy of one-on-one sessions with a therapist.  On the other hand, they lose the personal experiences of people who have experienced what they’re experiencing.  One compromise is to have a mentor or sponsor who has personal knowledge of the treatment guide the patient and family through the process.

For this reason, 12-Step programs rigidly subscribe to anonymity to encourage participation in meetings and sharing experiences with others.  The most important item in the success of these programs has not been identified, but several reports have suggested sharing at meetings as the major one.

I’m thrilled that we’re talking about Cancer Survivorship these days.  The fact that more people are living longer is very gratifying.  Therefore, formally addressing quality of life issues is the logical next step.  Incorporating 12-Step program concepts into Cancer Survivorship Programs, proven successful in other diseases, merits serious consideration.

Happy New Year!

Tags

cancer, epatients, medical education, medicine, mentoring, oncology, participatory medicine, social media, twitter, wellness

As opposed to last New Year, I’m beginning 2012 relatively peacefully.  I’ll take a little laryngitis and bronchitis rather than last year’s open heart surgery anytime.  Early in my recovery I had more time to read, which was a plus since reading is one of my favorite hobbies.  While reading my e-mail a few days ago, I noticed a Medscape review of books recommended for physicians.  Included were two books I read: The Emperor of All Maladies; A Biography of Cancer (1) by Siddhartha Mukherjee and The Immortal Life of Henrietta Lacks (2) by Rebecca Skloot.  I agree with Dr. Bruce Cheson who thought so much of these books he gave copies of each one to his fellows at Georgetown.  They read like historical novels, confirming that truth is sometimes stranger than fiction.

But after the “Must Read” list, one item caught my attention that resonated with me:  “Doctors’ Bucket List:  20 Things to Do Before You ‘Kick the Bucket’ “. The idea is derived from the movie starring Jack Nicholson and Morgan Freeman.   I’ve practiced hematology and medical oncology for 36 ½ years after 2 years of fellowship following 4 years of internship and residency in internal medicine.  That’s 42 ½ years in medicine, almost 2/3 of my life, dealing with everyone one else’s mortality, but devoting only a small amount of energy to mine.

After surgery, my surgeon said he got me 10-15 (or was it 15-20) more years.  The implication was to make the most of it.  Next Friday is my 1 year anniversary from surgery.  So far, the cow aortic valve and the 3 coronary artery grafts are doing well.  It’s hard for me to believe, but in 1 month I will be 70 years old.  So there’s no time like the present.  Citing Caroline Adams Miller, MAPP, a certified professional coach, “The list should consist of things you plan to attempt and want to reach for so that you leave behind the imprint you wanted to have.”  It is advised to set specific goals that move you beyond your comfort zone.

I was encouraged to realize that, without actually writing anything down, I had started the list.  My wife and I are planning a trip to China for both business and pleasure.  She will practice her Tai Chi and hopes to attend a psychology conference.  I am planning to visit hospitals and clinics to educate myself in Traditional Chinese Medicine.  Since we have the beginnings of an Integrated Oncology Program in our practice, future affiliation may be possible.

Speaking of reaching outside my comfort zone, blogging and podcasting were new to me 8 months ago.  I am enjoying this new technology more as I’ve gained experience with time.  Gaining knowledge in new technology certainly is exciting and keeps me young.  Same for research.

It’s now 2012.  I have places to go, things to do and people to see before I kick the bucket.  By the way:  the origin of the phrase “kick the bucket” is unclear.  One theory is that people hanged themselves by tying a noose around their necks, standing on a bucket and kicking the bucket away.

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Metastasis

Tags

cancer, epatients, evidence based medicine, health, medical education, medicine, metastasis, oncology, participatory medicine, social media, wellness

Throughout my career in oncology, I thought I was communicating difficult concepts to patients and families relatively well.  Recently, my wife and I visited our daughter in Salt Lake City over Thanksgiving.  Catherine is an extremely accomplished blogger and video broadcaster.  So when she commented on my blogs, I paid attention.  Her (constructive) criticism was my use of some medical terminology which she didn’t understand.  More surprising to me was the example she cited:  “metastasis.”   Like others I recalled in the past, she had trouble pronouncing the word.

My wife, Dee Dee, is a psychotherapist with training in psycho-oncology and hypnotherapy.  She is adept in psychosocial support for patients and families.  So when she spoke, I listened.  Hearing the above, her input was that many patients and family members have little understanding of what cancer is.  Since the ability to spread (metastasize) from the organ where cancer started to another organ or region of the body is what defines cancer (malignancy), and a benign growth does not have this capability, metastasis deserves further comment.

Cancerous cells can spread by one of three routes:

1. By direct extension locally to adjacent structures.
2. To regional lymph nodes that drain the primary organ.
3. To sites distant from the original growth, implying spread through the bloodstream.

Using breast cancer as an example, fibro-adenoma is a benign growth that appears as a smooth, round lump felt on breast examination or visualized on mammography.  Contrast this with ductal carcinoma-in-situ (DCIS), which is malignant but is confined to the tubes connecting milk glands to the nipple which has not invaded into the surrounding breast yet.  DCIS usually presents with tiny calcium spots on mammograms, not an actual lump.  Finally, infiltrating (invasive) ductal carcinoma (IDC) appears as a breast lump usually hard and irregular that can spread by all three routes listed above.

The mainstay of treatment for over seven decades was the radical mastectomy as championed by William Halsted at Johns Hopkins in the 1890’s.  This procedure was based on the theory that breast cancer spread locally and to regional lymph nodes, mostly in the axilla (armpit), before it invaded into the bloodstream and spread to distant sites far from the breast itself.  Therefore, if the entire cancer was removed surgically with wide margins of normal tissue before the last event occurred, patients should be cured.  Likelihood of cure was also increased if lymph nodes were not involved yet.  In my training years, it was not uncommon for a woman to feel a lump, call her physician who admitted her to hospital that night for surgery the following morning, telling her that if she woke up without a breast she’d know she had cancer.

Analysis of 7 decades of experience with radical surgery revealed if a woman experienced a long remission she possibly did not need such a disfiguring operation; and conversely, if the disease had already spread through the bloodstream the procedure would be of no benefit.  To test these concepts, Dr. Bernard Fisher of the University of Pittsburgh, started a clinical trial comparing radical mastectomy with simple mastectomy or lumpectomy + radiation therapy.  Since benefits of all 3 procedures proved to be essentially equal, there was no need for radical procedures.  Also, whether or not regional lymph nodes were involved with metastases proved important in estimating prognosis.  If nodes were free of disease, 5 year disease free survival was 80%; if nodes contained metastases, this figure fell by about 30%.  But the question arose:  “If Halsted’s theory as to how breast cancer spread (first to lymph nodes, then to the systemic circulation) was correct, why weren’t 100% of women with node negative disease cured?”  This lead to the notion that some breast cancers have already metastasized at the time of diagnosis, and benefit could only be obtained by treating with something that permeated every organ in the body, i.e., chemotherapy, used as an “adjuvant” (to give a boost) to loco-regional treatments.

In conclusion, one of the reasons Halsted’s attempt to cure breast cancer with radical surgery failed was an incomplete understanding of the process of metastasis.  No amount of local therapy, be it surgery or radiation therapy or both would cure a patient whose malignant cells had bypassed regional lymph nodes and gained access to the systemic circulation.

The Avastin Story: It Ain’t Over ‘Til the Fat Lady Sings

Tags

Avastin, cancer, CME, digital media, epatients, innovation, participatory medicine, pharma, physician, social media, twitter, wellness

After 5 months of deliberation, FDA Commissioner Margaret Hamburg, the final arbiter in the Avastin hearings, decided to revoke approval of the drug in patients with metastatic breast cancer.  At first blush, this event would seem to end the story.  But not so fast!  Even though Avastin cannot be marketed for this indication, it still can be prescribed “off label” as oncologists have done in the past for many agents.  And, this ruling doesn’t affect its use for other indications including colon, lung, kidney and brain cancers.  Medicare will continue to reimburse for Avastin use in breast cancer patients.  But response of private insurers has been variable so far.  All of the above has a familiar ring to it.  The situation is almost exactly the same as it was when hearings ended in June.

We have extensively covered these hearings and the articles on which this decision is based in prior blogs and radio broadcasts.  The data clearly documented that no complete remissions were achieved and, therefore, there were no cures.  In the Wall Street Journal report (WSJ; Saturday/Sunday, November 19-20, 2011, pp. B1-B2), Rep. Sue Myrick (R., N.C.) is quoted as saying:  “When a drug can help save patients’ lives, they should be able to do that affordably.”  Her point was that this decision may result in denial of coverage.  But stating that Avastin saves the lives of breast cancer patients implies a cure, giving thousands of women false hope.  Yes, I’ve personally treated many breast cancer patients with Avastin.  Some have lived months longer than they would have without it.  Rarely years.  But none have been cured.

Coverage of the FDA’s decision has been rapid and extensive.  This morning’s AMA Morning Rounds provides an excellent compendium of what’s been published or aired so far.  I found the last 2 cited sources especially interesting, providing a “point-counterpoint” perspective:

“WSJournal critical of FDA move.  The Wall Street Journal (11/19, Subscription Publication) argued that the FDA’s requiring credible, objective evidence is a subjective standard and criticized the government for interfering with patients’ choices.  The Journal argued that the FDA and medical journals dislike the accelerated approval process for medicines and that its decision isn’t based on Avastin’s side effects but an effort to convey a message that the agency is in charge of pharmaceutical development.  The Journal asserted that the FDA was ignoring the real world and should have allowed Avastin to remain on the market while more was learned about it.”

“FDA decision applauded.  On a blog in Forbes (11/19), Matthew Harper wrote, ‘the FDA decision is the right one, and, more than that, it’s actually good for the drug industry.’  According to Harper, the opposite decision ‘would have made scientists who work at the regulator or who advise it on expert advisory committees more reluctant to give accelerated approvals at all.’  Furthermore, ‘we’re not going to beat cancer by lowering the bar.’  Harper notes, ‘that Avastin costs $80,000 for the average breast cancer patient, and Roche pockets the money whether it works or not,’ adding, ‘we can’t afford to fight cancer with weapons that don’t both shrink tumors and prolong patients’ lives.”

Recognizing these divergent opinions are being read and heard by our patients and their families and friends, how do we advise them about Avastin’s appropriate role in breast cancer, if there are any?    Thoughts of two respected breast cancer researchers, Joyce A. O’Shaughnessy, M.D. and Hope S. Rugo, M.D., are reasonable.  They are stated in the OncLive issue; Vol 12 No 9, 9.11, pg 18:  “Insights on Avastin:  Patient Selection Is Key.”  This selection process should obviously identify both those patients most likely to benefit and those most likely to suffer adverse reactions:

1. At this point in time, we haven’t identified biomarker(s) predictive for response.  Preliminary data suggesting that levels of VEGF-A may identify a subset of patients potentially responsive to Avastin is apparently being investigated.  Until such a marker is identified, it is reasonable to recommend weekly, low dose Taxol + Avastin 10 mg/kg IV q2wks. for aggressive tumors, e.g., triple negative disease.  We have the option of hormonal therapy in addition to chemotherapy for ER+/PgR+ patients, and Heceptin and chemotherapy for HER-2+ patients.
2. By avoiding Avastin in patients at increased risk for complications (recent surgery, planned surgery in the near future, diverticulitis, active body wounds, or uncontrolled hypertension at baseline), safety of administration can be improved.

Don’t blink.  We probably haven’t heard the last of this evolving story.  But that’s as it should be.  Nothing in medicine is exempt from testing to see if it can be done better.