Wendy Harpham on Healthy Survivorship

Relieving Major Depression in Cancer Patients

An Oncology Times article caught my eye: "Relieving Major Depression in Cancer Patients: Specific 'Biopsychosocial' Method Found Useful."  It reviewed a study that addressed the impact of an intervention developed to treat depression, reduce stress and help patients develop coping strategies.

Problems with Generics

Did you know that when you take a generic drug, you essentially forfeit the ability to sue the company making the drug for damages if you experience an adverse event?

Revoking FDA Approval: Conclusion

The FDA revokes approval of Avastin for breast cancer. What's a survivor to do?

Revoking FDA Approval: Right or Wrong? - Part IX

In my last post, I asked, "Why not, at least, make Avastin available to breast cancer patients who are doing well on it?"

Revoking FDA Approval: Right or Wrong? - Part VIII

The case of the FDA revoking approval of Avastin for the treatment of breast cancer is complicated by the urgency of the need for better therapies. We’re not talking about treatments to decrease the sniffles of the common head cold. At issue is a drug to help patients who are suffering -- and dying -- from metastatic breast cancer.

Revoking FDA Approval: Right or Wrong? - Part VII

Let's tease apart some of the sticky-wicket issues of FDA approvals and revocations. For one, how does the FDA measure success?

Revoking FDA Approval: Right or Wrong? - Part VI

In light of recent events in my personal life forcing uncharacteristic delays between posts, I'll review briefly what I've discussed so far before continuing the discussion about the FDA's recent revocation of approval Avastin for treatment of breast cancer.

Revoking FDA Approval: Right or Wrong? - Part V

Now let's look at the players who influenced the FDA's decision to revoke approval of Avastin for breast cancer. The complex process requires a book-length manuscript to fully explain. Rather than abandon my effort, here are the bare bones:

Revoking FDA Approval: Right or Wrong? - Part IV

My last post provided an outline of the FDA's approval process. I cringed while writing it, knowing 250 words couldn't capture the investment of time, people and capital. 

Revoking FDA Approval: Right or Wrong - Part III

In my November 28th and December 3rd posts I introduced the media storm regarding the FDA's recent revocation of approval of Avastin for the treatment of breast cancer. Today I'll provide an overview of the FDA approval process to help us talk about the controversy.

Revoking FDA Approval: Right or Wrong? Part II

To judge the FDA's recent revocation of approval for Avastin for breast cancer, let's go back to basics. What is the job of the FDA?

Revoking FDA Approval: Right or Wrong?

Recently the FDA revoked approval of a best-selling drug, Avastin, for treatment of breast cancer. Ever since, arguments for and against the removal have been voiced in blogs and major media by a wide variety of people with different points of view. Let's look at some of the issues in the context of Healthy Survivorship.

Your Medical Mind

My recent posts have discussed some of the difficulties of modern medical decision-making in the context of PSA testing for prostate cancer. A new book by Harvard oncologist Jerome Groopman and Harvard endocrinologist Pamela Hartzband offers help to Healthy Survivors: Your Medical Mind: How to Decide What is Right for You.

My Bad?

My August 6th post shares a report on a new technology for breast cancer screening. I confess: I did not check out the story.

From Promise to Disaster

Patients are not Healthy Survivors if they believe the promises of charlatans. What about patients who receive treatment from of team of professionals at a major university in a clinical trial that turns out to be based on wrong information?

The Pro-Diabetes Board

In 2006, leaders in the state of Washington created the Health Technology Assessment (HTA) program to evaluate the cost-effectiveness of various medical therapies. With our country facing a huge budget deficit, what could be better than determining which treatments are worth paying for?

A Fighting Spirit

A NYTimes op-ed piece entitled A Fighting Spirit Won't Save Your Life concludes, "Linking health to personal virtue and vice not only is bad science, it’s bad medicine."

Rare Cancer Initiatives

My recent posts are about the trouble of defining "rare cancers." The attention these cancers are now getting gives Healthy Survivors many reasons for hope.

Ultra-Rare Cancers

My recent posts discuss the trouble with the adjective "rare" when talking about types of cancer. What's a researcher, clinician or patient to do?

Good news for Healthy Survivors! Now, along with ultra-strong hairsprays and ultra-rich ice-creams, we have:

"Why Me?" -- Part II

I'm an outlier. Of all the patients diagnosed in 1990 with Stage III follicular lymphoma, I'm one of a small minority who are still kickin'. Why me?

Today I am not asking "What in the grand plan of the divine explains my extraordinary survivorship?" Rather, I'm asking "What is it about my physical body and/or my particular cancer that I've had a much-better-than-average response to the treatments?"  

The Future of Cancer Research

In "The Cancer Sleeper Cell," oncologist Mukherjee shares his insights about the future of cancer research.

Abigail's Alliance

On my recent post about clinical trials, commenter Steve Walker wrote, "The Phase III trial is being run primarily to satisfy the rigid, formulaic and in many cases scientifically obsolete requirements imposed by the FDA's Office of Oncology Drug Products for most cancer drugs...." 

Is the randomized clinical/controlled trial (RCT) obsolete?

Testing a Fast Track to Rx

Recently, I've pointed out the clashes between business and ethical considerations and beween clinicians' obligations to their individual patients and to the method that leads to advances. What if researchers can find ways to satisfy both the science and today's patients?

The Problem with Accelerated FDA Approval

In Phase I trials researchers test an experimental treatment in a few patients for the first time. The purpose is NOT to see if the treatment kills cancer cells, but only to:

• evaluate the drug's safety
• determine a safe dosage range
• identify side effects

What if the patients in a Phase I trial experience shrinkage of their tumors? Should this speed up FDA approval of the trial drug?

Anguished Debate on Witholding Rx for the Control Arm

My last post introduced a dilemma regarding modern clinical trials: Is it ethical to randomize some patients to the "control arm" of a trial where they will NOT receive the trial drug?

According a NYTimes article, one particular trial of a therapy (called PLX4032) for malignant melanoma "ignited an anguished debate among oncologists about whether a controlled trial that measures a drug's impact on extending life is still the best method for evaluating hundreds of genetically targeted cancer drugs being developed."

Witholding Rx in Clinical Trials

Sunday's NYTimes ran an article tackling a complex ethical dilemma in cancer care: The witholding of treatment in clinical trials. Because I was treated in 3 clinical trials in the 1990s, the topic is close to my heart.

Researching Clinicial Trials

People who hear my story often say, "You had an advantage getting into those clinical trials, because you were a doctor with connections." Given the paucity of patient-centered resources in 1993, this was true. 

Today a plethora of excellent resources can help patients and families learn about clinical trials and find any available trials that might be right for you. Resources include:

The Treatment Option You May Be Missing

As a scientist, I credit clinical trials with advancing our understanding of cancer and ability to treat it effectively. As a patient, I credit clinical trials with playing an essential role in my survival. 

From both perspectives it troubles me greatly that only ~3% of adult cancer patients participate in clinical trials.

Healing Open Notes

What can clinicians do to ensure that chart notes are healing -- or at least not harmful -- to patients who choose to review them?

Not Waiting for Answers

How can Healthy Survivors get good care -- the first criterion of Healthy Survivorship -- if the data needed to make sound choices in their particular situation is not yet available?

Late Effect of Radiation - Qualified

We need to revisit a prior post, so I can qualify what I said. On my June 22nd post, I mentioned the high incidence of changes in the carotid arteries in patients who received radiation years earlier. But I didn't provide any details.

Reacting to Post-radiation Risks

How did I go from rattled to relaxed in a matter of hours after learning about my risk of carotid disease due to radiation therapy I received 18 years ago? First, by putting the piece of information in perspective, as outlined in my last post. Second, by making a plan of action.

Late Effect of Radiation

Many of my friends and family assume that the further away I get from the mini-mantle irradiation I received in 1992, the more I can relax about my developing any complications of that treatment. Not so.

Cancer Survivorship Research: Recovery and Beyond

What a three days I've had here at the 2010 Biennial Conference. While packing my suitcase for the return home, I'm thinking about all I've heard.

Wendy in Washington

Tomorrow begins a conference entitled "Cancer Survivorship Research: Recovery and Beyond." And I have a job to do.

Breakthrough Melanoma Drug: Hope or Hype?

NBC News health correspondent Robert Bazell introduces his report on a sensational new drug for the treatment of melanoma.

But then he explains that the new drug --  ipilimumab -- improves life expectancy from 6 months to 10 months. And it works well in only 20-30% of patients, the other 70-80% of patients showing no benefit at all. And it carries serious side effects, such as colitis and rheumatoid arthritis.

Is the fanfare hype? Are we celebrating too soon?

Placebos -- The Magic Cure

Your doctors evaluate your pain and conclude it is due to something benign (i.e., you don't have cancer, a broken bone or other health-threatening condition). Then they give you a prescription for a placebo. Should you sue these doctors? Or thank them?

PSA Conundrum

Imagine being diagnosed with cancer and having your doctor recommend you not undergo treatment and, instead, "Watch and wait."

What? Do nothing but watch and worry?

Calling all Patients!

Will someone please explain this to me: Clinical trials are the modern tool for finding truths about preventing and treating cancer. Yet our system puts obstacles in the path of clinicians who might participate in designing and running trials and in the path of patients who might enroll in trials.

Faltering Cancer Trials

Faltering Cancer Trials should get everyone's attention. The NYTimes Opinion piece opens, "The nation's most important system for judging the clinical effectiveness of cancer treatments is approaching 'a state of crisis.'"