CDC Cancer TweetChat

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cancer, CDC, epatients, medicine, oncology, social media, survivorship, Tweetchat, twitter

By Gregg A. Masters, MPH

On Tuesday June 19th, 2012 from 2:00 to 3:00 PM Eastern the Center for Disease Control’s (CDC), aka @CDCgov, Division of Cancer Prevention and Control aka @CDC_Cancer  hosted a ‘Tweetchat’ on cancer survivorship. Subject matter experts including Blythe Ryerson, MPH and Dr. Elizabeth Rohan moderated the session and answered questions posted via the Twitter hashtag #CDCcancerChat.

The stats tracked represent Tweets posted to #CDCcancerChat hashtag in the 24 hours before and during the actual Tweetchat and certainly represent an impressive potential reach of the message!

The ‘Cancer Survivorship’ Tweetchat began with the following Tweets:

Below are  the influencers:

 

 

 

 

 

 

The last series of ‘long tail’ Tweets are represented below:

Clearly we are early in the application of social and/or digital media to influence, shape if not resolve many lingering chronic healthcare financing, delivery and public health concerns. Kudos to the CDC!

For recent timely topical reflections from @chemosabe1 aka Dr Just, click on ‘Cancer Survivorship.’

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Western Meets Eastern Medicine: Or Ying Meets Yang?

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cancer, clinical trials, CME, digital media, epatients, evidence based medicine, innovation, integrative oncology, medicine, pharma, physician, research, Traditional Chinese medicine

By Richard Just, MD

In today’s China, both eastern and western medical philosophies and practices exist relatively harmoniously.  Patients with minor, usually self limited problems are treated initially with a seven day course of seven liquid herbal preparations taken each day.  If symptoms subside, usually treatment is discontinued.  If improved but not resolved, formula may be modified.  If worse, regimen can be changed and/or referral to specialists arranged.  There are hospitals that practice purely eastern or only western medicine.  But it is becoming more frequent to find hospitals that integrate both disciplines.  Chronic conditions, like cancer, tend to be treated with western techniques, with Traditional Chinese Medicine (TCM) used in a supportive or complementary role.

I was somewhat surprised to hear that the 2 largest cancer problems are breast cancer and liver cancer (mainly the former but not the latter).  Before I left, one of my patients had brought an article to my attention about a low incidence of breast cancer in China  compared to the West.  This may not be the case.  Primary liver cancer, hepatocellular carcinoma), has long been the number one cancer in frequency in the world due to a high incidence of hepatitis, especially in Asia.  This results in chronic active hepatitis, cirrhosis and, finally, cancer.  Even though we stayed at 5 star hotels, we didn’t brush our teeth or rinse our toothbrushes with tap water, and avoided ice.  Sanitation, or lack of it, is an issue.

Everywhere in China, especially big cities, there are forests of skyscrapers.  Private homes are essentially nonexistent as the government owns all the land.  New construction is ubiquitous, so cranes are numerous.  Many of these apartment spaces are empty due to high prices, and those that are bought or rented are shared by several families.  Same with kitchens and bathrooms.  Public bathrooms may lack toilets and simply be holes in the ground.  In some buildings, one bathroom per floor exists.  We saw the interiors of 3 residences.  First, the home of one of four of the farmers that first discovered the terra-cotta warriors outside Xi’an.  Clean.  Very little furniture as you buy empty spaces which you have to furnish yourselves.  But several generations of the family lives there.  Second, a more modest quarters of a woman in the old section of Beijing.  Bathrooms were down the road apiece.  The last was a tiny, single room in what used to be the French Concession section of Shanghai.  Five people slept on one cot.  No mystery why hepatitis and liver cancers are still issues.

Another surprise is lack of mention of lung cancer.  Cars everywhere.  Their gridlock is continuous and called “rush days”.  Mist or fog (mostly pollution) gives a surreal appearance to the landscape of high rises.  Seemingly everyone coughs.  Lots of spitting.  A perfect setup for respiratory problems including lung cancer.  There are several hospitals in major cities devoted to respiratory diseases, however.

An excellent article appeared in the Wall Street Journal, Tuesday, April 3, 2012, pg D4, entitled “Chinese Medicine Goes Under the Microscope” by Shirley S. Wang.  The main topic is a clinical trial studying a four herb combination, called huang qin tang in China and PHY906 in this trial, in combination with chemotherapy to see if effective in reducing side effects of chemo (nausea, vomiting, and diarrhea).  If so, patients might be able to tolerate higher doses of chemo with better results.  Trial design and quality control are issues when doing studies such as these:

One challenge with using herbal medicines is that the ratio of the chemicals they contain isn’t consistent when plants are grown under different conditions.  After testing various suppliers, Dr. (Yung-Chi) Cheng ended up creating a biotechnology company sponsored by Yale called PhytoCeutica to carefully monitor growing conditions to ensure plants from different batches were pharmacologically consistent and to continue clinical development of the compound.

Finally, an article that appeared in the China Daily entitled “There’s More to Life Than Money” by Cai Hong, a senior writer for the paper, cites the first World Happiness Report   released by the Earth Institute last month.  Not surprisingly, the top 4 rated are northern European welfare states:  Denmark, Finland, Norway and the Netherlands.  China doesn’t make the top 100.  One of the benchmarks evaluated is health:

……Increased insurance coverage has not yet been effective in reducing patients’ financial risks, as both health expenditure and out-of-pocket payments continue to rise rapidly.  And there are many reports of disgruntled patients and their relatives attacking the medical staff in hospitals.  Reform of public hospitals is essential to control health expenditure because such institutes deliver more than 90% of the country’s health services.  But Health Minister Chen Zhu said the cost of improving care remains an obstacle, and China is looking to other nations for cost-effective solutions.

While this notice appeared in the WSJ this last weekend:

U.S.-China Pharma: Some big pharmaceutical firms are partnering with Chinese companies in trying to discover the next blockbuster drug.  This Philadelphia conference will include venture capitalists and such Western firms as Novartis and Abbott Labs. Wednesday-Thursday, Hub Cira Centre.  Regular admission:  $1,799.00.

I find it interesting that both the U.S. and Chinese governments are investigating hospitals for price gouging in the sale of drugs. Further, given the emerging cost and access pressures they’re witnessing, might mainland China by eying the health system reform experiment underway in Taiwan?

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.

More On Screening: Barrett’s Esophagus

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Barrett’s Esophagus, cancer, CME, epatients, GERD, medical education, medicine, oncology, participatory medicine, patients, physicians, research

By Richard Just, MD

Recently, a friend of mine asked me for medical advice concerning his condition, Barrett’s esophagus.  When the diagnosis was initially made, he was advised he would require annual screening endoscopies with random biopsies.  But, on his last visit, my friend was told he didn’t need another procedure for 5 years, with no explanation.  “What’s up?”  Since he had a copy of the biopsy report (not with him, but at home), I advised he read it and look for the word dysplasia.  Wikipedia defines dysplasia as

maturation abnormality.

So far, I haven’t heard back.  But this stimulated me to review current recommendations on the subject.

Between 2-3 decades ago, there was a sudden increase of adenocarcinomas (“glandular cancers”) of the lower esophagus usually in Caucasian males.  This event was noticeable in that the usual esophageal cancers were a different cell type, squamous cell carcinomas, that tended to occur in Black males.  Adenocarcinomas appeared to be correlated with gastroesophageal reflux disease (GERD), while squamous cell carcinomas (SCC) are associated with smoking and alcohol consumption.  These are tends, not absolutes.  GERD causes irritation of the cells of the lower esophagus resulting in conversion of the cell type (metaplasia) from squamous cells to columnar cells, the definition of Barrett’s esophagus.  Barrett’s, in turn, can progress to low grade dysplasia, high grade dysplasia, and adenocarcinoma.  Thus, it has been proposed that patients with at least weekly GERD symptoms (heartburn, regurgitation, and dysphagia, meaning difficulty swallowing) that have been present for at least 5 years, and who have multiple risk factors for esophageal adenocarcinoma including white ethnicity, male sex, older age, obesity and long duration of GERD undergo screening for Barrett’s esophagus.

Management of Barrett’s esophagus involves 3 major components:

1. Treatment of GERD:  Recommended to be initiated prior to surveillance endoscopies to minimize confusion caused by inflammation in diagnosing dysplasia.  Not thought to reduce incidence of esophageal adenocarcinomas.
2. Endoscopic surveillance:  If no dysplasia found, next scope in 3-5 years.  Follow up for low grade dysplasia is 6-12 months  For intensive endoscopic surveillance of high grade dysplasia, scope every 3 months.
3. Treatment of high-grade dysplasia:  Recommendations can include esophagectomy, endoscopic ablative therapies, and endoscopic mucosal resection in addition to intensive endoscopic surveillance.

Since the above recommendations were updated in 2011, my assumption is that no dysplasia was discovered on any of the 3 studies and risk of progression to cancer is low.  For the general population of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma is 0.5% per year.  Contrast this with 5-8% per year in patients with high grade dysplasia.  The risk for low grade dysplasia falls somewhere between these 2 extremes.

I’ve written previously about the limitations and risks of mass screening techniques, e.g., mammography for breast cancer, PSA testing for prostate cancer and PAP smears for cervical cancer.  The same applies to screening endoscopies for Barrett’s esophagus.  The procedure carries with it risks, including perforation and bleeding.  It’s also not very comfortable to have a hose snaked down your throat so that pre-anesthetics are sometimes necessary, creating more risk.  Random biopsies are performed because it’s sometimes difficult for the endoscopist to identify areas of dysplasia from just metaplastic cells, leading to falsely negative results.  In his new book “The Creative Destruction of Medicine”, Dr. Eric Topal opines “We’re not very good at detecting and fighting cancer.  The mass screening model, as with mammography or prostate specific antigen (PSA) testing……..is enormously expensive and leads to an untold number of false positive results and more unnecessary biopsy procedures.  Doing serial sensitive scans like PET or CT would likely make this problem worse, both by increasing the false positives and incidental findings and by exposing individuals to ionizing radiation that itself causes cancer.”  The use of innovative technologies such as circulating tumor cells (CTC), genomics (circulating DNA and RNA) and wireless sensors including implanted nanosensors are described.  Obviously, hope runs high that at least some of these techniques will be validated so that the ultimate goal, prevention, is achieved.

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!

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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

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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

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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.

When Less is More – Part II

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cancer, clinicaltrials, epatients, medicine, oncology, participatory medicine, pharma, research, twitter, value based medicine, wellness

In my last blog, I discussed the rationale behind and evidence supporting the United States Preventive Services Task Force’s (USPSTF) recommendation to discontinue routine PSA screening for prostate cancer.  Exceptions might be made in circumstances where men are at high risk.  In 2009, the USPSTF found that screening mammography offered no benefit to women in their 40’s.  Previously, screening was recommended every other year between ages 40-50.  Now it is suggested that women between 50-74 years of age be screened every other year rather than annually.  Pushback to all of these recommendations has been “animated” to say the least.  Finally, the annual PAP smear for cervical cancer has been challenged.  Rather than annual exams, the proposed change is every 3 years.

In her New York Times article of October 29, 2011 entitled:  “Considering When It Might Be Best Not to Know About Cancer”, Gina Kolata asks “What changed?”  Her conclusion is that new information is now available.  In regard to breast cancer, mammography finds the cancer in 138,000 women per year.  But between 120,000 to 134,000 have cancers that already are lethal, or cancers that are so indolent they require no treatment.  In the same article, the chief medical officer of the American Cancer Society, Dr. Otis Brawley, states the way we look at screening has also changed.  “No longer is it just, Can you find the cancer?…..Now it is, Can you find the cancer, and does finding the cancer lead to a decrease in the mortality rate?”  Factor in possible harm that can result from screening, e.g, surgical procedures for benign conditions, and increase in cost, resulting in a benefit/risk ratio that is upside down.

While researchers and clinicians are approaching screening from multiple angles, annual mammography has assumed an almost unassailable status from our patients’ point of view.  To many, screening is equated with prevention of cancer, which is untrue.  Tiring of hearing the unsubstantiated claim that “a mammogram saved my life,” Dr. H. Gilbert Welch and Brittney A. Frankel from Dartmouth conducted an analysis estimating a woman’s 10-year risk of developing breast cancer and her 20-year risk of death.  Their calculations included the added value of early detection and benefits from improvements in treatment.  It was concluded that of the 60% of women whose breast cancer was detected by mammography, only 3-13% were helped by the test.  This amounts to 4,000-18,000 women per year out of a total of 230,000 women diagnosed with the disease.  Conversely, of the 138,000 patients found to have breast cancer as a result of screening mammography, 120,000-134,000 are not helped by the test.  In turn, these numbers pale when put in the context that 39 million women have mammograms each year in the U.S.  So, when they did the numbers, claims that mammography saves lives really are untenable.  The paper by Welch and Frankel was published online on October 24, 2011 in the Arch Intern Med.2011.476.

For abstract, click here.

I agree with my colleagues that some women are helped by screening but the numbers are very low.  Also, the premise that early diagnosis saves lives has been somewhat diminished by improvements in treatment of aggressive and even advanced cancers.  Mammography has certainly improved our ability to diagnose breast cancers earlier as reflected by the marked increase in incidence of carcinoma in situ, i.e., pre-invasive cancer.  And these are not lethal cancers.  Do these facts justify the $5 billion spent on mammograms annually?  I think not.  But the reality is until these recommendations become standard of care, I doubt that many physicians would be brave enough to adopt these as policy in our litigious society.  That’s the sad truth.

Drug Shortages: A View From The Trenches

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A few weeks ago, I had a discussion with Kris Ghosh, MD one of our local GYN Oncologists, (listen here).  We talked specifically about Doxil, the usual second line treatment for recurrent ovarian cancer.  We agreed that the lack of availability of the drug does limit options for these patients, with further increase in already heightened anxiety levels for patients and families.  Add to the mix the increase in stress levels of oncologists and our staffs trying to handle one more insult to a broken healthcare system.  In one patient who was due to start treatment I was able to substitute topotecan (Hycamptin).  Fortunately, she is responding and tolerating the agent very well. We had put her name on our list of patients who were waiting for Doxil when it became available.  So I was able to use the drug allocated to her for another patient with multiple myeloma. The only agent that had controlled his disease was Doxil. I guess the problem worked out well in these cases, but it appears that this shell game is going to become routine.  The question arises:  “Is this the harbinger of rationing cancer care?”

In my residency training in the late ‘60’s/early ‘70’s, I rotated through the Nephrology service when hemodialysis was relatively new.  Just like today, demand for the procedure far outstripped supply.  One of the factors taken into consideration in a negative way was anyone whose renal failure was due to diabetes.  That’s a lot of people!!  Obviously, we were very uncomfortable being put in that predicament.  Hindsight personalized this for me since my maternal grandfather died of sepsis after amputation of one of his legs for diabetic gangrene, my father died of every complication of diabetes and was hemodialyzed for 2 ½ years before his death, and I have type I diabetes and am on an insulin pump but fortunately no signs of renal impairment, yet.  I’m sure my father would never have been treated during my training years.  I’m sure our cancer patients experience similar anxiety and fear when faced our current dilemma.

Causes of shortages are multifactorial.  In Doxil’s case, the manufacturing plant in Alabama was struck by lightning during the tornado earlier this year.  Hard to believe but that’s the story.  Obviously an unpredictable Serious Adverse Event (SAE).  However, most of the chemotherapy drugs in short supply are older agents, e.g., bleomycin, cisplatin, cytarabine, daunorubicin, doxorubicin, etoposide, leucovorin/levoleucovorin, mechlorethamine, thiotepa, and vincristine.  Many are now off patent and therefore priced lower as generics; so not as profitable.  In some cases manufacturing of the drug was stopped in anticipation of newer and, of course, more expensive replacements.  One of the predictable side effects replacing old, cheaper drugs with newer, more expensive agents is pushback from payors who deny coverage/payment.  We then get on the authorization-denial-authorization-denial merry go round many times leading to a teleconference with the medical director of the health plan.  All this takes time and can delay treatment for quite a while, adversely effecting results.  Especially when used with curative intent and when there are no good substitutes, this is unacceptable.  Another complication is the emergence of a “gray market” where drugs from questionable sources pass through unknown hands to our offices at up to 10 times the usual price.  In the ‘90’s we called this brown-bagging.  Trying to keep inventory straight as to which drug from what source belonged to whom was an added challenge.

From the above, it is obvious that health care is big business.  An invaluable source of health care information is, therefore, the Wall Street Journal.  In last weekend’s edition I learned that “Roche Holding AG has stopped delivering its drugs for cancer and other diseases to some state-funded hospitals in Greece that haven’t paid their bills.”  This policy may extend to Spain, Portugal and Italy.  Patients had to purchase chemotherapy from private pharmacies and bring them back to hospitals for administration.  In the US, we find ourselves in a similar situation in that we can’t afford to purchase some drugs for our patients.  So drug shortages are a global issue involving different causes requiring different approaches directed to specific problems.

I found two articles helpful in defining the problem and proposing possible solutions:

1. Link, M., et. al.:  Drug Shortages Threaten Patient Health and Safety; HemOnc today, vol 12 no 15, August 10, 2011, pg 1, 10-12.
2. Johnson, P.E.:  Drug Shortages:  Impact and Strategies; JNCCN, vol 9 no 8, August, 2011, pp 815-819.