Archive for November, 2009

Thanksgiving Thoughts on Fertility Challenges

November 25th, 2009

Challenges to the process of conceiving a child are not usually mentioned among the top things to be thankful for when one goes around the dinner table on Thursday, but after 2 years and counting of walking this rocky road to motherhood I realize that I have several things on which I’d like to express gratitude.

  1. I give thanks for greater knowledge and appreciation for the miracle of my female body and the reproductive process. I would be embarrassed by how little I knew if the average women knew any more.  It is a disservice to women that we are not taught more and earlier.
  2. I give thanks for a stronger marriage and an enhanced appreciation for my husband’s strength, sensitivity, love, and the great gift he has given me of a safe place to pour all my disappointment, frustration, and fears.
  3. I give thanks for doctors who listen and truly practice medicine. Reproductive endocrinology is as much art and science and requires a level of personalization physically and emotionally that is not necessary in other specialties.  Also, there is as much unknown as known.  I am grateful for finally finding a physician with the humility and skill to meet me where I am and work with what my body can do.
  4. I give thanks to God.  Fertility is faith. Faith that my body is innately fertile. Faith that diligently seeking God’s plan for my life is worthwhile in itself. Faith that as I draw nearer to Him He draws nearer to me.

The Real Death Panel: USPSTF and Breast Cancer

November 17th, 2009

In today’s Annals of Internal Medicine and splashed across the front pages of many major newspapers are the shocking new recommendations of the U.S. Preventive Services Task Force (USPSTF) that:

  1. Women should not begin routine mammograms until age 50 (instead of the current age 40)
  2. Women should not be taught to do monthly self-examinations
  3. Physician/clinical breast exams have insufficient evidence of benefit.

Was there a new study that changed their minds? No, just some computer modeling.

Did this modeling show that lives would be saved?  No, annual mammography for all women beginning at age 40 reduced the death rate from breast cancer by 15%, yes, fifteen percent.  According the American Cancer Society in 2009, among women younger than 45 – 6, 460 were diagnosed with in situ ( confined to the breast) cancer; 18,640 had invasive breast cancer; and 2,820 died.  These women and their families don’t matter? Apparently mammography saving lives is not a persuasive argument for these folks.

The justification of the USPSTF and its supporters – false positive readings of earlier screening may cause anxiety and 33/1000 women may have an unnecessary biopsy.

Now I don’t take this lightly.  I was diagnosed with high grades of dysplasia (cellular changes on their way to becoming cancerous) and have had multiple biopsies of various body parts in my 20s and the “anxiety” of a false positive (the false parts later leads to relief) does not even come close to the joy of being alive.

What is the U.S. Preventative Services Task Force for if they’re not for prevention?  They’ve recently torpedoed prostate cancer and Peripheral Arterial Disease (PAD) screening.  Economists may say that they are for evidence-based public health policy, I see rationed care and justification for reduced insurance reimbursement.  Talk about a death panel.


Annals of Internal Medicine – USPSTF recommendations   on breast cancer screening

American Cancer Society response to USPSTF recommendation

USPSTF Information including Membership

National Breast Cancer Coalition supports new recommendations

A Patient’s Perspective on Day 2 of the FDA Public Hearing on Social Media

November 13th, 2009

Since I have great confidence in my fellow bloggers and all the fabulous Twitterati who followed today’s second day of the FDA Public Hearing on Social Media to provide detailed summaries of the day, I will take a different direction and offer my perspective as a patient on the hearing and the FDA’s  as well as pharmaceutical companies’ roles in social media.

I’ve been on branded prescription medication since I was 13 and first diagnosed with ulcerative colitis (inflammatory bowel disease), more for primary sclerosing cholangitis (autoimmune liver disease), more post-liver transplant, well you get the gist, so I have experienced my share of side effects and even a few adverse events and NOT ONCE did I think to make a report to the FDA.  NOT ONCE. Now I’m often chided for not being the average patient, but that further strengthens my argument here.  I’ve presented at NIH and not thought to report, I’ve worked with pharmaceutical companies and never thought to report, I’ve been a member of the Alliance to Strengthen FDA since it’s first year and never thought to report.

Why not? Well, my key concerns at the time were self-centered – what is going on? What is causing this? How can I make it stop?  For many of these answers I do turn to the Internet first, for context –is this normal? expected? will it resolve on its own? is there something simple I can do? —  but for resolution I ask my physician, because only in coordination with my doctor can I make the necessary adjustments or stop taking the medication. Reporting to FDA was not going to change my treatment.  It could have, in retrospect, changed treatment for others in even a more impactful way than sharing my experiences have changed treatment for fellow patients in social media and regular social environments.

Today’s hearing has impressed upon me how much we need a broadscale public relations campaign for FDA MedWatch or whatever new simplified reporting format takes its place.  (And yes, the federal appropriations, not user fees, to allow FDA to  do its many jobs.) Patient forums abound with people who not only want to help themselves, but help all patients standing with and coming behind them.  Social media and online reporting of patient experiences, good and bad, with medications can be a powerful force for improving healthcare by providing information for physicians, public health researchers, as well as regulators to access.

And Pharma – I am interested in the FDA-approved language and data (safety and efficacy)on the branded medications I take being easily accessible on the Internet and understandable.  I am not interested in pharmaceutical advertising, being approached by a pharmaceutical representative, or any overt contact of any kind.   I am happy to have them listen and correct grave misinformation if they believe that the particular forum is not sufficiently self-policing. Medication is not like shoes. I am happy to look at shoe advertising, talk to shoe people, and if the president of Zappos would like to come to my house, I’d bake him a cake.  I take medications because I need them and I’ve worked out a plan with my health care professionals of what, when, and why I will take them.  I welcome tools and information to boost my understanding, adherence, and coping, but I’d prefer if it came through a medical society or patient organization (even if pharma sponsored, I’d feel that it has been reviewed and tailored by people with interests more aligned with mine).

Bottom Line: I’m not as afraid of health social media because I believe in the intelligence, passion, persistence and generosity of my fellow patients (and I still believe in doctors). FDA has a strong role in ensuring that information by regulated entities (under their control or influence) is accurate and meaningful ( my preference over exhaustive) and that reporting mechanisms when there are negative interactions with that material or the products are well known, convenient, simple to fill out andsend.  Pharmaceutical companies and other regulated entities should listen more than talk and only interact to provide value to patients, as defined by patients.

A Patient’s Perspective on Day 1 of the FDA Public Hearing on Social Media

November 12th, 2009

First and foremost, thank you HealthCentral, for hosting the afterparty. I admit, though, that this is the 1st time I’ve left a great cocktail party to go blog.

Overall Impression: Very well done and informative.  Presentations were thoughtful and most included data.  Too many PR agencies battling to promote their digital agencies and have the sexiest graphic explaining the extent of pharmaceutical responsibility. Companies with thinly veiled “please don’t kill my business model” presentations advocating to preserve sponsored links. Consistent results from research on patient and physicians Internet usage was reassuring.  Commonsense consensus across presentations on regulated entity accountability for content in proportion to the extent of their control.

Best Presentation: WEGO Health

Just when I had given up on  hearing the patient’s viewpoint, WEGO Health gave us the actual words of health activists (top 10% of engaged patients who create and interact with content and fellow patients across multiple platforms).  WeGO Health activists welcome pharmaceutical company participation in social media (as do I) IF companies bring value to the table.  90% think that companiesalso have a responsibility to correct misinformation about their branded products and yet realize that it is impossible to monitor all mentions on the Internet. Regulation of the pharmaceutical and device industries should not come at the cost of participation.  The full survey can be requested at

Best Presentation Title: Envision Solutions “Health Searchers: Blind, Irritated, & Impatient”

Scariest Presentation: VuMedi

VuMedi creates communities for the 80-85% of surgeons (he used orthopods as an example) who perform the majority of surgery types only once or twice a year a way to learn the surgery the night before the scheduled procedure or exchange comments with higher volume proceduralists.

Worst Presentation: National Research Center for Women & Families

I have a great deal of respect for this organization and so I was so disappointed by their call for the FDA to issue more regulation and more severe penalties for pharmaceutical interactions on the Internet, completely out of step with the flexibility that almost all others outlined.  The presentation also reflected a great paranoia about potentially ghostwritten content (“I don’t know who’s paying for this content” —  take 10 seconds to google and look for the company name in the corner or do 1-click.) and Wikipedia. (Really, is the FDA supposed to do something about Wikipedia?)

Most Intriguing Solution: FDA seal of approval symbol for credible sites (PhRMA and others)

Interesting Factoids:

  • 83% of Internet users searched for health information (Pew Internet survey)
  • 13% of hospitals use social media (Acsys Interactive)
  • 78% of condition sufferers go online (comScore)
  • 36% of consumers who view online product information then go seek a physician (Google)
  • 27% of consumers who view online product information change their behavior (Google)
  • 4.6 Billion (with a B) searches on health keywords in the US in last 3 months of 2007 ( Google)

Key Takeaways:

  1. Social media should be important to FDA and Pharma because it is important to patients and physicians.
  2. Patients welcome pharma and device participation in social media if they lead with value not branded message.  Patients first!
  3. Regulated entities should be held accountable for content in proportion to their control whether on their own  or 3rd party sites but their responsibility for independent content and content changed by independent entities should be limited or none.
  4. Full prescribing information with risk and benefit should not be more than 1 click away from branded product related commentary on pharma-controlled or collaborative sites.  Amount and proximity of fair balance information should reflect audience and potential space limitations of medium.

Full information about the FDA meeting can be found at