Why shouldn’t we encourage women to perform self breast exams?

In May of this year, the daughter of one of my best friends died from breast cancer. She was 37, and had a Doctorate of Pharmacy from the University of Missouri. She had four children. The oldest is eight. She was pregnant with the fourth when she was diagnosed with breast cancer two years ago.

Last winter, the United States Preventive Services Task Force (USPSTF) updated its 2002 recommendations for screening mammography in women ages 40-49. The USPSTF also recommended that women under 40 should not be screened for breast cancer except under special circumstance. The USPSTF went on to recommend that women under 40 should not do self-breast exams (SBE) and that women under 40 should not be examined by their primary care physician for breast cancer, i.e. clinical breast exam (CBE).

The update included the following recommendations:

• USPSTF recommends against routine screening mammography in women ages 40 49;

• USPSTF recommends against teaching women how to perform BSE;

• USPSTF concluded that current evidence is insufficient to assess the additional benefits and harms of the CBE beyond screening mammography in women 40 years or older.
  

The new recommendations were based on information and statistics gathered from a structured literature search and meta-analysis of randomized controlled trials of breast cancer screening. Studies using mammography (film and digital), MRI, CBE, and BSE with breast cancer mortality outcomes published since 2001 were reviewed.1 Additionally, the USPSTF searched for updates to previously published trials that were used for their 2002 recommendation. Based on pre selected criteria, the USPSTF determined that a total of 8 trials provided data for the updated recommendation (updates to 1 study used previously and 1 new study). One of the studies dated back to 1963, while the others studies took place between the years of 1976 1982.

Clearly, one of the major problems with this meta-analysis is that the most recent trial that was included began in 1991 and the other trials began years earlier. The one “new” trial selected in the USPSTF’s analysis was the Age trial. This trial enrolled women from the United Kingdom, between the ages of 39-41, and the participants were then followed until age 48. Additional information came from a new publication based on results from a Swedish study that began in 1982!

Let’s discuss the Age trial that began in 1991. This study provided the largest number of control subjects for the analysis (106,956). The quality of this study was rated as ‘fair’ by the USPSTF due to the contamination in the groups not being described and 70% or fewer women attending screening across the trial.1 Furthermore, the USPSTF stated in their report that: “Also, its applicability to women in the United States is not clear, in light of important differences between mammography screening practices in the United States and United Kingdom.”

I have a hard time understanding how recommendations were made based on data from the early 1990s and from a country that has a different standard of care for screening mammography practices and other data that dates back into the 1960s.

Only 2 of the 8 trials selected for the analysis were conducted in North America. The USPSTF also failed to take into account the current trends of digital mammography and MRI. The USPSTF found that no trials have been published that evaluated the effectiveness of digital mammography or MRI in average-risk women.1 Antiquated data, differing standards of care, new technologies, did not however stop the USPSTF from moving forward and making recommendations that could adversely affect the lives of millions of women in the United States.

One thing I found surprising is the only number that has seemingly changed between the meta analysis conducted in 2002 and the meta analysis performed in 2009 is the number of screenings performed to prevent 1 breast cancer death. In the 2002 meta-analysis this number was 1792; in 2009 the number had increased to 1904.

Noteworthy is that in 2002, the USPSTF also provided the results when a Canadian study was excluded from the meta-analysis due to cited problems with the study. In 2002, without the Canadian study, the numbers decreased to 1385 screenings needed to prevent 1 breast cancer death. No such analysis was provided in the 2009 update.

In 2002, the USPSTF stated that there was no evidence that the BSE or CBE reduced breast cancer death rates. Needless to say, the flip side to this conclusion is that here is no evidence that BSE or CBE doesn’t’ reduce breast cancer deaths. One fact that is known is that BSE and CBE have in the past, and will in the future, identify some breast cancers. And in some instances, these early findings will lead to diagnosis, treatment and lives saved.

In 2009, the USPSTF recommend against teaching women how to perform a BSE. A study conducted in Russia, one which the USPSTF used as part of their recommendation, showed a “significant increase in the number of cases of breast cancer detected when BSE instruction was provided, however there was no reduction in all-cause mortality.”1

The USPSTF concluded that current evidence is insufficient to assess the additional benefits and harms of the clinical breast examination (CBE) beyond screening mammography in women 40 years or older. So, the USPSTF decided to get rid of CBE, currently a standard of care, based on what they describe as insufficient data.

Logic might lead some to conclude that even though the benefits of SBE and CBE cannot be quantified, lives are saved and exams should continue. This is true especially in women who are younger than 40, like my friend’s 37 year old daughter. Also, when breast cancer does occur in this younger group the results can be especially devastating. This sort of logic clearly did not play into the USPSTF’s recommendation.

To recap, the USPSTF cites a study, which demonstrated increased detection of cancer cases with SBE, the USPSTF concludes there is insufficient data to quantify the benefits, SO the USPSTF concludes women should not be taught BSE or given CBE.

Frankly, it appears to me that the USPSTF had a preconceived conclusion they were working toward before the analysis was even conducted and whatever the motivation for that conclusion was, it was not the improvement of healthcare or saving lives.

In addition to the USPSTF, there is another Federal Agency with over 50 years of experience making decisions that directly affects America’s healthcare. That Agency is, of course, the US Food and Drug Administration. Certain standards have evolved over the last half-century that the FDA expects (requires) for studies to be considered acceptable to be used for critical decision making that will affect the health and well being of US citizens. Some of these standards include such reasonable requirements as:

• There must be a representative sampling from the US population in the study;

• The data must come from a racial sampling similar to that in the United States;

• The data must reflect current standard of care in the United States;

• Foreign data must reflect current medical practice in the United States;

Meta-analyses are discouraged and when used for making decisions and the analyses must reflect the highest standards.

Clearly, the USPSTF have no such standards and adhered to none of the FDA standards described above. It just seems wrong to me that such a task force can make sweeping recommendations affecting the quality of healthcare in the United States and not be held to similar standards that pharmaceutical, biotechnology and medical device companies are held to when getting a new product into our healthcare system.

According to breastcancer.org, breast cancer incidence in women in the United States is 1 in 8 or roughly 13%. By age 30, approximately 1 in 229 women will develop breast cancer in the next 10 years, and by age 40, 1 in 68 women will develop breast cancer. (Source: American Cancer Society Breast Cancer Facts & Figures, 2005-2006.)

With those numbers in mind, I want to stress that I agree that large epidemiological studies can be extremely important to guide some healthcare decisions. But, at the same time, when decisions are made that will affect the lives and health of thousands to millions of people, an element of common sense needs to prevail. In light of the USPSTF recommendations, the questions still remain: Why shouldn’t we be encouraging women to perform self breast exams; why shouldn’t physicians continue doing clinical breast exams? I believe the data used by the USPSTF is outdated and based on old imaging standards and any recommendations based on that data are ill advised and should not be followed.

[1] Nelson HD, Tyne K, Naik A, Bougatsos C, Chan BK, Humphrey L. Screening for breast cancer: an update for the U.S. Preventive Services Task Force. Ann Intern Med. 2009 Nov 17;151(10):727-37.

How should we look?

Hello readers! We are currently considering if we should change our logo or not. We have narrowed down the designs to 5, and have created a survey for you to fill out and provide us with your opinions. There are 5 potential designs, including our current logo. New colors are not being considered at this time, so we have provided all the designs in our current color scheme, we hope this makes the comparisons more of an "apples to apples" kind of thing.

Please follow this link before Monday, March 1st, 2010 12:01 PM Eastern time. At that time, the survey will close and no further results will be accepted.

If you follow through to the end, you will have the choice of being entered for an American Express gift card for $50.00

//www.surveymonkey.com/s/RH5CHF5

Top take-aways from the FDA Social Media Hearings

Here is a guest blog from our Medical Illustrator, Amber Nicole Cannan. I know it is a little slow in coming, but we really wanted to get our past posts out there first.

Many people have provided excellent summaries of the events that happened at #FDASM, or as the FDA called it, "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (Document ID FDA-2009-N-0441-0001)." In the words of Jonathan Richman, "Catchy, right?"
Just a few that I enjoyed,
http://healthed.typepad.com/healthed-blog/ (what we didn't learn)
http://www.spectrumscience.com/blog/2009/11/17/the-fda-has-no-idea-what-to-do-about-social-media-%E2%80%93-day-2-of-the-fda-public-hearing/
http://creationinteractive.com/articles/lessons-fda-social-media-hearing/ (international implications)
http://blog.roskadigital.com/2009_11_01_archive.html
Ultimately, there were a few take-away points (opinions) that were made by several speakers:
1. Social Media is important. We knew that, but it appears as though the speakers were unsure that the FDA did.
2. Average Joe does not trust our industry. By preventing our use of social media, the FDA may be preventing transparency that the consumers and the agency want.
3. Companies want to provide fair balance, but believe that under current guidelines it is not possible to do effectively. Fair balance information is incomprehensible to those without medical backgrounds. The verbiage on it should change and be permitted to be "one click away" in order to track and understand when the vocabulary is effective and useful.
4. Adverse Event reporting should be made easier and more available to the consumer. The current Medwatch (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm) submission form is too long, and discourages compliance.
There were, of course, the nay-sayers, namely Dianna Zuckerman, President of the National Research Center for Women & Families and Steve Findley, a Senior Health Policy Analyst for Consumersunions.org.
Diana Zuckerman accused sites such as Wikipedia and Drugs.com as having "user-edited content” and “inaccurate or incomplete information.” Drugs.com responded in their blog and pointed out, with evidence, her inaccuracies, http://blog.drugs.com/2009/11/drugs-com-refutes-erroneous-claims/. Zuckerman later made some convincing points on AE on the second day, however they were overshadowed in most listener's ears by her lack of understanding of the media being talked about. Her most knowledgeable comment was probably, "(Reporting) links should be hard to miss, instead of hard to find."
Steve Findley felt that all restrictions on fair balance should be on web pages as it is in print media, stating that the space on the web is not restrictive. He is absolutely right. The space is not restrictive. I can easily place fair balance information on a drug 2020 pixels to the right of the advertising information. Most will not scroll their bottom scroll bar to the side to find it. But it is there, in the "unlimited" space on the same page. Of course, it is not obvious, or comprehensible.
Now that the Nay-Sayers are out of the way, let's talk about the ones we were watching for.
Yahoo's presentation sounded more like an advertisement, and they made no mention of their health pages. I was disappointed. Google provided an excellent solution on the search result advertisements that previously received warning letters from the FDA. (Though no mention of Side-wikis)

They also presented valuable statistics on the value of the information and click through rates since the warning letters.


The red line represents the date of the warning letters.

You can see the difference in the number of follow through to quality health information sites from before to after the letters. More users are now following the links to the purveying "snake oil" of our times. "This is potentially dangerous," was the general consensus from other presenters. Google also gave us the information that in the last three months of the year 2007 there were about 4.6 billion (That's the estimated age, in years, of the earth) searches on healthcare terms. These 4,600,000,000 searches were made by 111 million people and that the number is only going up.
PatientsLikeMe.com presenter, James Allen Heywood, had some very valid points, that he felt are being over-looked. He brought out the point about "how you say" vs. "what you say" in regards to consumer comprehension of potential side effects.
Heywood also mentioned that we have our amendment rights, namely- free speech. He used this argument not for the rights of pharmaceutical companies but he believes the consumer has the right to say what they feel about the product. If the government goes through and removes posts because they are "off-label" then Heywood feels they are interfering with that right. In addition, Heywood felt that heavily pushing side effect information on the consumer could influence the patient and doctor relationship in a negative way. Confused consumers could stop taking a medication for fear of side effects, without discussing the change with their primary care physician.
Compass Healthcare Communications' Peter Nalen and Maureen Miller brought up a a point about fair balance. They held the FDA accountable for tweeting about products that had been approved. They felt the FDA did not include the fair balance information about the drug in the tweet.

MISI Company's Kathleen Fourte and Alejandra Diaz made an interesting point. Not clicking through on a link to fair balance information would be like changing the channel before the end of a pharmaceutical commercial got to the fair balance information they are required to include. Sure, it is present, but consumers can listen to it, or change the channel.

ORC Guideline, Inc. 's Morris Whitcup made an amusing claim- that the internet is arguably the best invention since the Gutenberg Bible. He also showed survey results that said consumers feel there is too much risk information put forth by pharmaceutical companies and that 40% of consumers tune out that information on television.

HealthCentral's Christopher M. Schroeder said "At no point should a consumer have any confusion about the information that he/she is considering."

Sermo's Daniel Palestrant presented the information that the heaviest users of Sermo.com are the older, and busiest of physicians. They collected information that also indicated that those participating on Sermo are in the group that prescribes the most. Most of the doctors responding also said they were in favor of reporting Adverse Events online. They now have 111,000 physicians as part of their social networking group.

As a complete re-cap, I would like to give you this youtube.com link from WOMMA lawyer Tony DiResta. It is a re-cap of what occurred, in video.

At the end, Tom Abrams stated that "what we have heard is 'it's a different medium'" and that is a good sign. Abrams also asked, when Johnson and Johnson (JNJBTW) stated they were committed to providing accurate and timely information to the consumer, "how can we help you do that." This shows a deep interest (as if the hearing itself wasn't) in doing what is necessary and protecting the consumer.

In conclusion, I believe the FDA will be issuing some guidelines towards the end of 2010. What they will be, I do not know, but I know they have a great deal of work ahead of them. I also know, as a child of government workers, they will be working hours beyond what they are paid to do so. A special thank you should probably be given to Jean-Ah Kang, Special Assistant to the Director, DDMAC and CDER.

These are the FDA panelists at the hearing-
• Thomas W. Abrams - Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) - Center for Drug Evaluation, and Research (CDER)
• Kathryn J. Aikin - Social Science Analyst, DDMAC - CDER
• Rachel E. Behrman - Deputy Director, Office of Medical Policy (OMP) - CDER
• Gerald Dal Pan - Director, Office of Surveillance and Epidemiology - CDER
• Kristin Davis - Deputy Director, DDMAC - CDER
• David J. Horowitz - Assistant Commissioner for Policy, Office of Policy, Planning, and Budget - Office of the Commissioner
• Ele Ibarra-Pratt - Branch Chief, Advertising and Promotional Labeling Branch - Center for Biologics Evaluation Research
• Jean-Ah Kang - Special Assistant to the Director, DDMAC - CDER
• Sharon Kapsch - Chief, MDR Policy Branch - Center for Devices and Radiological Health (CDRH)
• Dorothy R. McAdams - Supervisory Veterinary Medical Officer, Division of Surveillance - Center for Veterinary Medicine
• Seth S. Ray - Associate Deputy Chief Counsel for Drugs and Biologics - Office of the Chief Counsel
• Robert Temple - Director, OMP - CDER
• Deborah Wolf - Regulatory Counsel, Office of Compliance - CDRH

(Images in this post were taken from Google's FDA presentation)

Clinical Trial Quality

Today we have a special guest blog from Steve Ehrhard, our Quality Assurance Director.
We all know about quality control. We experience the results of it in most everything we encounter. Did I get a good haircut? Are the apples fresh? Did the car get fixed correctly? Will the software actually do what I think it will do? Is the car going to get good gas mileage? There is a lot of activity going on behind the scenes to answer these questions.

When we think of quality, we think of it most often in two ways. First, is the service delivered to us error free or do the goods that we buy come to us without defects or problems? Second, does the product (goods or services) have the necessary design features to meet our needs? These two ideas, quality in the sense of design and quality in the sense of deficiencies, generalized by Dr. Joseph Juran and others, provides a means to both understand how to think about quality, and how to achieve it. That is, a business of providing goods or services must design the offering to meet needs and deliver it defect free.

Clinical trials have quality considerations. The drug or medical device that is being tested must be provided without defects or, in regulatory terms, adulterated or misbranded. It would be ethically wrong to subject a person to a drug or device that we knew was adulterated or misbranded. In a clinical trial, the drug or device has been designed to achieve a particular diagnostic, therapeutic or disease treating objective. That's, of course, what the trial is designed to confirm. International regulatory bodies have created rules to make sure drug and device manufacturers ensure a quality of design and flaws in the study are prevented.

Clinical trials also have "people" considerations. Are patients subjected to the safest protocols we can design? Is privacy protected (HIPPA)? Did the patient consent to participate? Regulations also require a number of actions and rules that a drug or device clinical trial sponsor must follow to ensure there are no exposures in the design of the trial and no problems with how it is conducted.

Certus International, as a Contract Research Organization, is in the business of managing clinical trials. Our product is information, and we have an extensive set of procedures and activities to ensure that our clinical trials are properly designed and executed. Clinical study protocols and plans undergo extensive analysis ensuring that objectives are clear, achievable and logical for drug or device testing. The design of data collection and analysis is carefully considered to make sure that the diagnostic or therapeutic effect of the drug or device can be discerned. Procedures at the clinical sites are designed to address how study subjects are treated and protected. During the trial, we review data extensively, as it is collected (called source data) verifying that it is accurate and precise (defect free) so that it is analyzed correctly.

Our quality objective provides a clinical trial sponsor with information about the drug or device that is trustworthy and reliable and can be the basis for ultimately approving for use in diagnosing or treating disease. The data we collect, and make sure is sound, through quality assurance, is eventually used to establish a drug or device's safety. In other words, quality assurance means helping people by making sure their drugs and devices are as safe as possible.

Self- Breast Examinations

Personally and professionally, the new recommendations issued by the AHRQ at http://www.ahrq.gov/CLINIC/uspstf/uspsbrca.htm cause me concern.

Approximately eight years ago, I was attending the Society of Nuclear Medicine meeting in Toronto. While there, the headlines in the Toronto paper extolled the government's new policy of dissuading women from doing self-breast exams.

It seemed to me, at the time, that the only reason for this decision was to reduce healthcare costs by reducing costs for mammograms and biopsies, while sacrificing the possibility of early detection of breast cancer.

It now appears the US Government has taken this a step further by not only dissuading self-breast examinations but also by recommending the end to mammography screening in women under 50 years old. Having been indoctrinated with the importance of self-breast examinations in medical school, and dealt with patients who found breast lumps that eventually turned out to be malignant; I believe self-breast exams are critically important for every woman, no matter how old. You can find some important, and easy to understand statistics on breast cancer rates here. Thank you to Imaginis for providing this information to the public.

I have never seen any medical argument against self-examination as not being one valid way for early detection of breast cancer unless it was ultimately driven by cost saving. In fact, if women do their own examinations, it is likely they will detect a change much earlier than a doctor might at a yearly physical.

As a researcher in breast cancer detection and imaging, I worry that this recommendation is only the tip of the iceberg as the US government takes control of our healthcare.

GetSocial

The Beginning

Social media is growing in popularity. I have been thinking of joining the craze for some time now, but due to perceived restrictions and general negativity about the Pharmaceutical industry, I have been hesitant. I now believe, however, that many of the Social Media restrictions placed on the industry have been self-imposed, and have decided to embark on a social media journey.

The hesitancy by our industry to dip our toes into the frigid waters of social media is understandable; especially because there have been little to no guidelines issued by the FDA in regards to what can or cannot be said. In addition, it can be a cold, crazy ocean out there with sharks waiting to eat you up at the slightest wrong move. Not to mention the millions of little fish that could be lead astray should the information you put out there be misinformed or worse- wrong all together. If the responsibility to the rest of the world, less informed about the industry of drug development, were not enough to keep you out of the water, the sharks definitely are.

Our industry is so used to strong guidance that the idea of embarking on unmarked, vastness of water that is social media is, in a way, scary. Granted, the FDA is now beginning to consider anchoring some buoys in some of the bays and coves with their hearing planned for mid-November, but with social media, even today, at the beginning of the same month, that is a long span of time. Social media does not have "hours" or reside only in one time zone. It is constant, practically omnipresent, in the modern world.

The hearing is scheduled to take place about 17,280 minutes from posting this blog. With 1,668,870,408 people with access to the internet, that is 28,838,080,650,240 people-minutes for someone to say something bad about your company or report an "Adverse Event." Those numbers can be really scary for a CEO like me, who just wants to protect his company and its reputation; ensure that the people that work for me can stay employed; and uphold social and personal values.

I have come to the realization that the conversation that I and other people in this industry have been avoiding is taking place, whether we are present or not. By not participating in the conversation we are being seen by those in the conversation as stuck up and unwilling to take part, or worse, secretive, greedy and dishonest. That is not what I am, nor my company.

Those with understanding in the industry need to be available to those without. In this way, we can ensure that the information out there is indeed valid and relevant. When the H1N1 virus first became the media firestorm that it now is, many misinformed individuals posted that you could get the "swine" flu from pigs (and other misnomers,) causing a great deal of confusion and a huge hit for the pig farmers. The greater travesty is that many still believe this. If more qualified individuals were present in the social media scene, perhaps many of these kinds of misunderstandings could be avoided.

So I will be here, with some friends as guest bloggers. First on Blogger, and then moving to our own URL, once my designer gets it up and running. I will post and comment on subjects I find relevant and be reading your blogs, collecting and distributing information that I hope you will find useful.