Unemployment Affecting Possible Compliance Risks

By: Gary Miller, CIS Associate
garymiller@cis-partners.com

With unemployment on the rise, so is the demand for prescription drug assistance from clinics all over the country. “There is no comparison to the demand we’re seeing that I can recall,” says Ken Trogdon, Welvista’s CEO. (Welvista is a Columbia, S.C.-based mail-order pharmacy that collects and supplies free medications from a dozen different pharmaceutical companies.) Like many other similar organizations, Welvista saw its patient-assistance applications nearly double in January. Luckily for these organizations, they have been able to keep up with demand due to an influx of additional samples being supplied by more and more physicians across the country. The Dispensary of Hope, a Nashville-based not-for-profit that supplies free prescription drugs to people with no coverage and low incomes, depends largely on physicians to send in surplus prescription samples from drug-industry reps that would otherwise soon expire.[1]

With this new influx of inventory, and greater demand for the products, a large window for possible non-compliance has opened with it. With clinics handling more drugs then they ever have before, and having a greater need for a quick turnaround to meet the rising demand; clinics may not be equipped to properly meet all the regulatory requirements outlined by the FDA in 21 CFR 203.39 for drug sample donations. Currently, the FDA is in the process of revising the regulation as it pertains to free clinics, to relieve the clinics of some burdensome tasks they were previously required to perform. However, the FDA does provide a suggested guidance to the clinics, and reserves the right to exercise enforcement of the guidance at its own discretion. The “Guidance for Industry Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics,” specifically states that the:

FDA, in the exercise of its enforcement discretion, does not intend to object if
a free clinic fails to comply with § 203.39(b), (d), (e), (f), and
(g). For the most part, these subsections focus on recordkeeping
requirements. FDA does, however, expect free clinics to comply with §
203.39(a), (c), (h), and (i). For the most part, these subsections focus
on ensuring the integrity of samples stored and dispensed by clinics, and should
not be too onerous for free clinics to comply with and still operate
effectively.[2]

With this unprecedented flow of drugs in and out of the clinics, this will be a good test for the clinics and the FDA to see how strictly regulations will, or even can, be followed. This opens up some opportunities for CIS as well, to provide their services to look into these regulations and activities. To be able to provide recommendations and process improvements to ensure all parties involved are safe and happy.

Sources:

1. As More Lose Jobs and Coverage, Free Drugs are a Booming Business; Posted by Vanessa Fuhrmans, February 19, 2009
http://blogs.wsj.com/health/2009/02/19/as-more-lose-jobs-and-coverage-free-drugs-are-a-booming-business/

2. Guidance for Industry Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), March 2006
http://www.fda.gov/CDER/GUIDANCE/5519fnl.htm

Vendor Credentialing: Genius or Scam?

By: Alaina Anderson, CIS Manager
alainaanderson@cis-partners.com

Sales Representatives in the Pharmaceutical industry aren’t being cut any slack. Thousands have lost their jobs and the trend continues. The new PhRMA Code and various state laws have put restrictions on interactions with healthcare providers. And just recently I heard of another hurdle: vendor credentialing.

As a compliance specialist, I think the concept is great. Basically, to ensure vendors who are entering hospitals have appropriate training (e.g., patient privacy) and vaccinations, a third party vendor conducts this check and provides access to the hospital by issuing identification badges. The hospitals sign up for the program, but to avoid anti-kickback issues no money is exchanged. These programs are funded by the vendors, who pay the credentialing service provider to participate and gain access to the hospitals.

Now if I’m a hospital or a patient, this sounds pretty good. I’d like to know that not just any vendor can enter a patient area without proper training or vaccinations. As a hospital, it is a lot of work to check each vendor representative’s credentials and keep records of them. So a free service is pretty awesome. But some of these vendor credentialing service providers offer a greater range of services than others.

There are a lot of mixed opinions regarding these vendor credentialing services. Some of the individual’s I’ve spoken with indicate “they are a joke; there is no consistency.” Other feedback I’ve heard is some of these service providers require certificates of training, but there is no check as to what the content or scope of the training was.

Sales Representatives, especially who service inner city hospitals, are running into these vendor credentialing service providers. In order to gain access to a hospital they must pay a fee, submit their credentials, and in return they may access the hospital with, of course, no guarantee of business.

To be honest, I don’t think hospitals have the extra cash to sit around reviewing and filing the credentials of all of their vendors. But will hospitals begin to absorb the cost of these programs via a mark-up to the products and services they do purchase?

Regardless, it does seem like good practice to ensure those who enter patient areas are appropriately trained and vaccinated. But maybe we just need to employ some standards to really gain all the benefits this service has the potential to offer.

Sources:
http://www.nci-cg.com/blog/post/Vendor-Credentialing-Distributor-Perspective-Bill-Vitez.aspx
http://www.hpnonline.com/inside/2008-04/0804-CBS.html

Electronic Medical Records and the Economic Stimulus Bill

By: Suma Kallurkar, CIS Senior Manager
sumakallurkar@cis-partners.com

Among the many provisions in the approximately $787 billion economic stimulus bill that the US House and Senate came to agreement on recently, one very interesting one is a $19 billion provision to implement a national Health Information Technology (HIT) system for use by doctors and hospitals. In other words, we are talking about the implementation of an electronic medical record system – an issue that the health care industry has long been considering and debating. With the current Obama administration pushing for this modernization of health care technology, we may finally see an electronic medical record system be adopted in the near future.

Many of us have experienced receiving a not-so-legible hand-written prescription from a doctor that could be mis-interpreted by a pharmacist. I recently experienced a social security number notated incorrectly on official medical papers, and in turn manually corrected. It is obvious that one of the most significant benefits of electronic medical records is the reduction of such errors. When it comes to notating drug and treatment information, such errors can be fatal. An electronic medical record system would achieve significant efficiencies in health care by significantly reducing administrative errors and their associated negative health outcomes.

Proponents of electronic medical records believe that improvements in health care can also be achieved by the sharing of medical information that such technology would facilitate. An electronic medical record system would allow for faster and easier communication of a patient’s medical history, current prescription drugs, treatment regimen, etc. between doctors and hospitals. Such easier and faster sharing of information can allow health care providers to make more informed and faster decisions in treating a patient.

On the reverse side, opponents of an electronic medical record system (as being advocated in the stimulus bill) worry that easier access to medical information will infringe on a patient’s right to privacy. Many fear that businesses will be able to access patient health information and use it for sales and marketing purposes. Strong concerns also exist about the government having access to patients’ records and interfering in medical decisions made between doctors and patients. However, the bill agreed upon between the Senate and House calls for stronger privacy law to protect personal medical data from wrongful use.

On February 17, 2009 President Obama signed the $787 billion economic stimulus bill into law. How the money will be spent, and how quickly it will affect Americans, remains to be seen; however, the implementation of an electronic medical record system was indeed a significant component of the final stimulus bill. If we ensure the protection of patients’ health information against misuses, then an electronic medical record system adopted on a national basis should indeed result in significant improvements in quality of health care and billions of dollars in cost savings. Achieving such efficiencies in health care could be a key component in getting the economy back on the right track.

References:

http://www.speaker.gov/newsroom/legislation?id=0273#health

http://www.bloomberg.com/apps/news?pid=20601087&sid=aOQrsih0y1BU&refer=home

http://www.foxnews.com/politics/first100days/2009/02/11/critics-says-stimulus-gives-government-say-health-care/

http://blog.hittransition.com/

A Cry for Uniformity

By: Chrissy Spicer, CIS Senior Manager
chrissyspicer@cis-partners.com

As states issue regulations one-by-one to promulgate requirements related to pharmaceutical marketing activities, manufacturers in the industry have been challenged to uniformly satisfy the state requirements in their compliance programs. In the future, it is expected that more and more states will continue to issue regulations; at the same time, the push for transparency in interactions with physicians will continue to shape the agenda of the new administration.

Now more than ever, Corporate Compliance Departments have revisited their compliance programs, including their codes of conduct, policies & procedures, training programs, and monitoring & auditing plans. Although the future may hold uniformity in some of the market disclosure rules, other new state requirements around corporate compliance programs will need to constantly be reevaluated to ensure alignment within the organization. The codes of conduct adopted by states like California, Nevada, and Massachusetts are great examples of this lack of uniformity.

In California Codes SB 1765, the regulation states:

(a) Every pharmaceutical company shall adopt a Comprehensive Compliance
Program that is in accordance with the April 2003 publication "Compliance
Program Guidance for Pharmaceutical Manufacturers," which was developed by the
United States Department of Health and Human Services Office of Inspector
General (OIG). (b) Every pharmaceutical company shall include in its Comprehensive Compliance Program policies for compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) "Code on Interactions with Health Care Professionals," dated July 1, 2002. The pharmaceutical company shall make
conforming changes to its Comprehensive Compliance Program within six months of
any update or revision of the "Code on Interactions with Health Care
Professionals."[i]

In this example, California applies the guidance published by the OIG and PhRMA Code in establishing rules for pharmaceutical manufacturers conducting business in California.

On January 30, 2008, regulations promulgated by the Nevada State Pharmacy to implement AB 128 required “a written marketing code of conduct which establishes the practices and standards that governs the marketing and sale of its products.”[ii] Adoption of the most recent version of the Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America (PhRMA) satisfies these requirements. If a manufacturer chooses not to adopt the PhRMA code, then a marketing code of conduct must be submitted and approved that addresses the following:

1. The basis for interactions;
2. Informational presentations by or on behalf of a manufacturer;
3. Third-party educational or professional meetings;
4. The use of consultants;
5. Speaker training meetings;
6. Scholarships and educational funds;
7. Educational and practice-related items;
8. Independence of decision making; and
9. Adherence to the marketing code of conduct.

In summary, Nevada suggests the adoption of the PhRMA code; however, if a different code is adopted, then Nevada must approve that marketing code of conduct.

Lastly, Massachusetts will be issuing a Marketing Code of Conduct that will go into effect July 1, 2009. The Marketing Code of Conduct is currently being drafted; it will address the same activities outlined in the PhRMA Code, but with heavier restrictions. [iii]

To summarize, the requirements related to establishing a marketing code of conduct:

1. California: The OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers and PhRMA Code are mandated requirements for pharmaceutical compliance programs.
2. Nevada: The adoption of the PhRMA Code as established, or if the manufacturer develops a marketing code of conduct, then the Code needs to be reviewed and approved by Nevada.
3. Massachusetts will develop and issue a code of conduct that must be followed.
In the end, manufacturers have found themselves starting with the OIG Guidance as a foundation, and slowly integrating the additional or more restrictive requirements state-by-state. It does not look like the future holds any promises for providing a federal law that preempts all state laws for the adoption of a marketing code of conduct, requirements for a compliance program and marketing financial disclosures.

Sources:
[i] California SB 1765
[ii] Nevada State Board of Pharmacy Compliance Packet for Manufacturers, Wholesalers of Drugs, Medicines, Chemicals, Devices, or Appliances
[iii] Massachusetts Part I. Title XVI, Chapter 111N., §2. Marketing Code of Conduct; Adoption; Prohibited Practices

More Advertising Woes Wrack the Industry

By: Grete Dudek, CIS Associate
gretedudek@cis-partners.com

While watching Grey’s Anatomy a few weeks ago, an interesting advertisement came on. It was for Yaz, the most popular birth control pill in America, and it began with, “You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads.” After pointing out the difference between PMS and PMDD, the ad mentioned a wide variety of side effects, including “Yaz contains DRSP, a different kind of hormone that for some may increase potassium too much, so you shouldn’t take Yaz if you have kidney, liver or adrenal disease…” At the end, I thought to myself, “Wow. That was weird.”

My curiosity was answered when I came across an article while reading the New York Times on February 10 about the ad. (1) I discovered that Bayer’s advertising troubles started in 2007, when the FDA sent them a warning letter regarding non-disclosure of the risks involved in taking Baycol. Something similar happened again in 2008, this time with Yaz. According to the warning letter issued in October of 2008 by the FDA, “[t]he TV Ads are misleading because they broaden the drug's indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug.” (2) The two direct-to-consumer ads “misled consumers into thinking that Yaz treats premenstrual syndrome and promoted the contraceptive as a treatment for types of acne that the drug is not approved to treat.” (3)

“Bayer’s 2008 marketing of the oral contraceptive Yaz violated the terms of the 2007 agreement by not disclosing the uses the Food and Drug Administration (FDA) has approved for Yaz.” (4) Because of the popularity of Yaz, the FDA required Bayer not just to discontinue or correct the advertisements, but to embark on an unusual campaign to set the record straight.

“Bayer agreed last Friday to spend at least $20 million on the campaign and for the next six years to submit all Yaz ads for federal screening before they appear” (1). The ad campaign began on February 9 with the ad I saw, which was put out to set the record straight. This ad is much clearer about what Yaz is and is not approved for, and listed more side effects than I’ve ever seen televised. In addition to submitting ads to the FDA prior to their appearance, Bayer must also comply with all changes suggested by the FDA.”(4) The “director of the FDA’s Division of Drug Marketing, Advertising, and Communications, added, ‘This is a great example of collaboration between the FDA and state Attorneys General…. This significantly benefits the public by ensuring that consumers are not misled about information relating to their health.’” (4) In their print ads as well, Bayer must clearly disclose what symptoms can be treated with Yaz.

Sources:
1. http://www.nytimes.com/2009/02/11/business/11pill.html?_r=1&ref=health
2. http://www.fda.gov/cder/warn/2008/YAZ_wl.pdf
3. http://news.moneycentral.msn.com/provider/providerarticle.aspx?feed=ACBJ&date=20090209&id=9593063
4. http://www.mass.gov/?pageID=cagopressrelease&L=1&L0=Home&sid=Cago&b=pressrelease&f=2009_02_09_bayer_settlement&csid=Cago

Articles of the Week!

Courtesy of Debbe Saez, CIS Senior Manager
debbesaez@cis-partners.com

Sanofi-Aventis and AZ Launch YouTube Sites
http://pharmexec.findpharma.com/pharmexec/Marketing/Sanofi-Aventis-and-AZ-Launch-YouTube-Sites/ArticleStandard/Article/detail/582363?contextCategoryId=43753

CDC: 'Young invincibles' have significant health concerns
http://www.cnn.com/2009/HEALTH/02/17/cdc.young.people/index.html

FDA Bill Would Strengthen Agency's Regulatory Authority
http://www.aafp.org/online/en/home/publications/news/news-now/government-medicine/20090217fda-bill.html

Another State Banning Medical Promos?
http://www.corporatelogo.com/hotnews/minnesota-banning-medical-promos.html

FDA approves brain-zapping device to relieve OCD
http://www.usatoday.com/news/health/2009-02-19-fda_N.htm


Enjoy, and have a great weekend!
The PCB

The Infamous Fourth Wave: The Sasquatch of the GP Compliance World

By: Steven Moore, Business Development Director
stevenmoore@cis-partners.com

“The first rule of Fourth Wave, is you do not talk about Fourth Wave.” - Unknown

So it’s Saturday AM and I am reflecting upon another great, successful conference for our industry, the IIR MDRP Conference in be-a-utiful Baltimore, MD. There was a lot of talk about the Waves and where everyone fits in. For those of you playing along at home, the new folks to the blog, and as a refresher, here is the definition of Waves 1 through 3:


The First Wave:

The First Wave is the dinner wave. This is where we all break bread together, share some drinks and laughs, and try to talk a little shop --- but not so much that we lose sight of the importance – fun. Most everyone can jump in and join the First Wave --- and enjoy themselves thoroughly. Thankfully, this year I had the pleasure of sitting next to one of CIS’s founding partners, Jim Collins. He watched me say ‘yes’ to about 27 appetizers for the table as we ordered drinks and pricey wines. Perhaps there is a reason he says I set my career back a little bit more at each conference. Or maybe it is because of the subsequent Waves… We shall see.

Anyway, once dinner is over the First Wavers make their exit. They generally yawn and tell you they have work or that they have to speak the next day, thank you and head to bed. This is the Wave I long to be a part of some days --- that is, until the Second Wave starts…


The Second Wave:

The Second Wave is the after dinner drinks crew. This Wave usually congregates at the hotel bar or another one nearby. There are drinks and laughs --- high fives and cheers --- yawns and tears. About an hour and a half into this session, the Second Wavers pronounce they have had enough, or that they are “too old for this,” and make their prompt exit. Chris Cobourn lumps himself into the Second Wave and, generally speaking, he does fit into this area. You will know when the Second Wave is coming to an end when you hear someone say, “Shots!” This is the moment when all remaining Second Wavers run to the nearest exit or elevator. This is also when you find out if anyone is ready to graduate to Third Waver status, or if they realize it’s far past their bedtime and scamper away.


The Third Wave:

To some it’s legend or myth --- to others, it’s a tiresome reality. The Third Wave is when things really get cranking. The time frame is generally between 12:30 and ? You would think that most Third Wavers are the young GP protégés who still have a bit of the college life in their memories --- but you would be wrong.

Third Wavers come in all shapes, sizes and ages. Third Wavers do not discriminate when it comes to welcoming a fellow Third Waver into the fray. We are a proud group of people who enjoy a good time so much that we actually try to make sure the night never ends. We laugh and skip around town to the beat of our own drum. We get back home and wake up our roommates and get 3 hours of sleep, only to wake up and go at it again early the next morning. Third Wavers are not lore --- in fact, they are quite real, and their claims the next morning are true. You’ll know when you see one by the looks of them. They will be drinking coffee, doing stretches or calisthenics, telling stories, and sometimes, staring at the ceiling wondering if there are any sharp butter knives nearby.

So with that recap, I think it’s time to provide some framework around what a Fourth Waver would be --- IF, and I mean IF, one actually existed.


The Fourth Wave:

In my opinion, I think that IF there was a Fourth Waver, they would do things that you just wouldn’t expect. They would be things that really seem out of their normal daytime character. They would go on stage and play drums and make a dueling piano bar whole. They would get up on tables around town and shake things that shouldn’t necessarily be shaken. They would show up at places when the normal cover charge of $20 is now $2, because the establishment realizes that there are 12 people inside and it will be the easiest $2 per person they ever make. They would make sudden right turns on the walk home. They would form circles and have an individual GP dance competition. They would talk about making calendars and who would be AMP or COT. They would forget to pay bar tabs. They would lose their sport coat, belt or even their sweater. They would declare that their main goal would be to become the Director of Beer or Director of Goose for a fine establishment. They would text in their own codes.

In fact, they may even be seen wearing GP Geek T-Shirts over their button down and taking Shirley Temple shots filled with whipped-cream, provided by prospective clients.

So there you have it. A theoretical framework of what a Fourth Waver WOULD look like.

(DISCLAIMER: Any resemblance between myself and the"mythical" Fourth Waver are purely coincidental...)

For Your Space,
Steven.
*

IIR - A New Forum for Discussion

By: Chris Cobourn, VP of Regulatory Compliance
chriscobourn@cis-partners.com

I would like to thank everyone who participated in this year’s IIR Conference in Baltimore, in both our Full-Day Advanced Government Programs Workshop (which ran concurrent to MDRP 101), as well as our open Panel Discussions Thursday and Friday. We have received very positive feedback from participants on the panels as well as attendees, and we look forward to continuing this tradition in the future, so look for the 3rd Annual Advanced GP Workshop next February!

Our goal was to create an environment to foster open dialog between the many people involved in Government Programs, including agencies, auditors, consultants, lawyers, and industry professionals. We had a number of issues to discuss, developed from our work with clients, CMS, the OPA and the VA. We also hit on hot topics like TRICARE, and the potential impact the new administration could have on the industry (especially with Medicare Part D plans, Dual Eligibles, and the 340B Program Improvement and Integrity Legislation).

As you know, the GP community is a small and close knit group. We all know each other by first name, and most of us have been doing this for some time. CIS felt that what the community really wanted, and needed, was an open forum for meaningful dialog. I felt really positive about the conference last week, and I welcome your input or feedback so that we can continue to develop and build upon forums like this.

CIS heard lots of great information at the conference, and is currently writing Blog and PCX Newsletter articles on topics including (but not limited to) Medicaid Restatements, Penny Pricing, and Inpatient vs. Outpatient Assumptions, so keep an eye out for those articles in the coming weeks! Tomorrow we'll have Business Development Director Steven Moore's take on the "Infamous Fourth Wave..." Stay tuned!

Also, many of you had the opportunity to meet Dave Rice at the CIS booth. Dave will be starting with CIS in March, leading our Federal Contracting offerings. We look forward to Dave joining the team!

Thank you again
Chris

How Leadership Styles Influence Your Culture of Compliance

By: Joe Calarco, CIS Senior Manager
joecalarco@cis-partners.com

Managing compliance activities in a Clinical Operations group was an implicit expectation. Ensuring compliance with government regulations, corporate policies and departmental performance metrics all required routine oversight. As a result, keeping staff engaged and vested in company outcomes was a top priority. This required the ability to create a productive and responsible work climate.

This sounds simple enough, yet every corporate culture I have been a part of has struggled to consistently establish such a climate. In fact, most employees speak of such peak engagement as a fleeting experience incapable of being sustained. Interesting, more research is starting to quantify the financial impact of employee engagement [1]. Allow me to take you back to your Introduction to Psychology class and discuss how traditional leadership styles may impact both employee engagement and compliance efforts.


Participative Leadership

Involving employees in the identification and resolution of compliance challenges will heighten engagement. Such dialogue also allows leaders to justify the importance of compliance efforts (e.g. risk mitigation, improved resourcing/productivity, etc.) in the context of the company’s mission and strategy while affording staff the ability to report on situations they face in their day-to-day activities. This approach has been called “participative” or “collaborative”[2] and should be utilized in a majority of situations. The positive outcome from this approach should be twofold: 1) more productive/content employees and 2) better risk management. The improved risk management comes from employee willingness to speak up on potential concerns, thus reducing the number of surprises that may catch an organization off guard.

I once had a colleague say to me, “If I practice participative leadership, I will constantly have people in my office whining”. So let me set the record straight, participative leadership does not mean being a push over or hanging out your therapy shingle. As the leader, you still have the decision-making authority and may not always implement advice or address a concern of staff. What remains vital is for staff to feel they can come to you with their concerns and/or ideas.


Authoritarian and Delegative Leadership

The alternative to participative leadership is authoritarian or delegative leadership[2]. Authoritarian leadership has its time and place in any corporate culture when one needs to handle a crisis. When teaching communication workshops I tell my participants that I do not seek input from my four-year-old regarding his desire to play in the street. Some situations simply require a call be made quickly and not be questioned. Most employees respect this no matter how unpleasant it may feel at the time. However, if used as the primary approach to staff interactions, the authoritarian style will lead to what I call “morale compliance failures”. Staff will quickly learn to not question authority, and thus stop letting you know of any potential concerns. Worse, they may stop caring completely and allow compliance risks to go unnoticed.

The delegative style leaves the decision making responsibility solely up to the staff. I would equate it to a ship without a rudder. Without any guidance from leadership, staff at best will guess correctly sometimes and at worst surprise leadership with a significant compliance problem.


Leadership and effective communication styles are critical to a successful compliance program and should be tailored to the compliance culture your organization wants to create. Feel free to contact a CIS consultant to discuss strategies to create your collaborative culture of compliance.



Sources:

[1] Towers Perrin (October 22, 2007) Towers Perrin Study Finds Significant "Engagement Gap" Among Global Workforce
http://www.towersperrin.com/tp/showdctmdoc.jsp?url=HR_Services/United_States/Press_Releases/2007/20071022/2007_10_22.htm&country=global
[2] About.com:Psychology Lewin’s Leadership Styles
http://psychology.about.com/od/leadership/a/leadstyles.htm

Articles of the Week!

Courtesy of Justin Wutti, CIS Senior Associate
justinwutti@cis-partners.com

It's been a big week for transparency. Not only as it pertains to manufacturers, health care reform, and the revised Sunshine Act, but also as it affects Executive Salaries for firms who take bailout money, the Peanut Corporation of America and how much information it must provide to the FDA when it finds salmonella in its product, and Tom Daschle's short-lived nomination to take over as Secretary of HHS. (That actually does pertain to pharma. How could Daschle effectively monitor physician payments when he can't even keep track of his own income, which just happens to include money for pricey speaking engagements? Don't get me started.)

In any event, transparency is a big deal, so Senior Associate Justin Wutti has compiled some Articles of the Week, outlining the more relevant ways it might affect you. Thanks Justin!

- Dana Zelig, Senior Associate and PCB Editor

Articles of the Week:

"Pharma Beats Sunshine Act to the Punch"
http://pharmexec.findpharma.com/pharmexec/News/Pharma-Beats-Sunshine-Act-to-the-Punch/ArticleStandard/Article/detail/580863?contextCategoryId=43753

"Orthopedics Firms To Lose Oversight, Keep Payment Controls"
http://money.cnn.com/news/newsfeeds/articles/djf500/200902111528DOWJONESDJONLINE000844_FORTUNE5.htm

"AAFP Expresses Concerns About Revised Physician Sunshine Act"
http://www.aafp.org/online/en/home/publications/news/news-now/professional-issues/20090209sunshine-act.html

"PPAI Urges Action to Preempt the Physician Sunshine Act"
http://www.corporatelogo.com/hotnews/ppai-urges-action-against-promo-legislation.html

*

The Sunshine Act... It's Only a Matter of Time

By: Dana Zelig, CIS Sr. Associate and PCB Editor
danazelig@cis-partners.com

As described in Matt Hotz’s article, “Transparency and its Implications for Pharmaceutical and Medical Device Manufacturers,” transparency is going to be an increasingly important theme in new government laws and regulations, including those monitoring pharmaceutical and medical device manufacturers. The most relevant example is the bill by Senators Chuck Grassley and Herb Kohl, which has recently been revised and resubmitted as the Physician Payments Sunshine Act of 2009 (S. 301, 111th Cong.).

The Sunshine Act has been drafted in an attempt to require all manufacturers of drugs, devices, biologics and medical supplies to report any payments to doctors and group purchasing organizations (GPOs) that could influence their decisions to purchase, prescribe, and endorse these products. As described in the Act:

The term ‘payment or other transfer of value’ means a transfer of anything of
value and includes… any compensation, gift, honorarium, speaking fee, consulting
fee, travel, services, dividend, profit distribution, stock or stock option
grant, or ownership or investment interest. [1]

The Pharmaceutical Research and Manufacturers of America (PhRMA) are also paying attention to the money spent on physicians. PhRMA’s updated “Code on Interactions with Healthcare Professionals for 2009” limits the amount of money manufacturers can spend on meals, promotional items, and speaking engagements for doctors.[2] This coincides with Grassley and Kohl’s desire to limit the influence manufacturers have on physicians. As explained on PhRMA’s website:

The Code is based on the principle that a healthcare professional’s care of
patients should be based, and should be perceived as being based, solely on each
patient’s medical needs and the healthcare professional’s medical knowledge and
experience.[3]

On the heels of the new PhRMA Code, which took effect on January 1, 2009, Grassley and Kohl introduced their revised Sunshine Act to the Senate with some significant changes from the 2007 version of the bill (S. 2029, 110th Cong.).[4] For example, the 2007 version required reporting of any payments totaling at least $500 per recipient per calendar year, and the 2009 version lowered the threshold to $100. The new version also increased the maximum penalties for failing to report, from $5,000 to $10,000 for individual payments, and from $50,000 to $150,000 for annual submissions. In addition, “The current version of the Sunshine Act requires the Secretary to submit each year to Congress a report of the information provided to the Secretary aggregated by manufacturer and a description of any enforcement actions taken.”[5] These revisions could mean serious changes for manufacturers if the bill is passed.

But how will the revised Sunshine Act serve to increase transparency and effectively monitor the influence manufacturers have over physicians and GPOs? Senator Grassley ties it all together nicely:

Shedding light on industry payments to physicians would be good for the
system. Transparency fosters accountability, and the public has a right to
know about financial relationships. Patients rely on their doctors' advice.
Taxpayers spend billions every year on prescription drugs and medical devices
through Medicare and Medicaid. They also fund tens of billions of dollars of
medical research each year, and the doctors conducting that research have a big
influence on the practice of medicine.[6]

Despite the proposed merits of transparency, however, the Physician Payments Sunshine Act is one Senators Grassley, a Republican from Iowa, and Kohl, a Democrat from Wisconsin have long been unsuccessfully trying to push through Congress. But pharmaceutical and device legislation is gaining traction in President Obama’s new era of transparency, and Senator Grassley is confident that the revised Sunshine Act, which would establish penalties as high as $1 million a year for non-compliant manufacturers,[7] will soon be a reality, saying:

Since we first introduced the bill, there has been a groundswell of support from
every corner. Patients want to know that they can fully trust the relationship
they have with their doctor. I am confident this legislation will pass during
the 111th Congress.[8]

In anticipation of the bill’s eventual approval, many manufacturers have already taken steps to proactively report payments and incentives provided to physicians. However, some large manufacturers have met with setbacks, finding that reporting dollars spent on lunches, honorariums, grants and speaking fees would be easier if records had been consistently maintained across their various divisions.[9] If meeting internal reporting goals has proven difficult for manufacturers, they can expect even more pressure if the revised Sunshine Act passes as anticipated. The Act would set a reporting deadline of March 31, 2011 for all manufacturers of drugs, devices, biologics, and medical supplies.


[1] The Physician Payments Sunshine Act
http://aging.senate.gov/letters/ppsabill2009.pdf

[2] PhRMA Code on Interactions with Healthcare Professionals
http://www.phrma.org/files/PhRMA%20Marketing%20Code%202008.pdf

[3] PhRMA.org
http://www.phrma.org/code_on_interactions_with_healthcare_professionals/

[4] Senators Grassley and Kohl Introduce a Revised Version of the Physician Payments Sunshine Act of 2009
http://www.ebglaw.com/showclientalert.aspx?Show=9667

[5] Senators Grassley and Kohl Introduce a Revised Version of the Physician Payments Sunshine Act of 2009
http://www.ebglaw.com/showclientalert.aspx?Show=9667

[6] Grassley, Kohl Continue Campaign To Disclose Financial Ties Between Doctors And Drug Companies
http://www.medicalnewstoday.com/articles/136470.php

[7] The Physician Payments Sunshine Act
http://aging.senate.gov/letters/ppsabill2009.pdf

[8] Grassley, Kohl Continue Campaign To Disclose Financial Ties Between Doctors And Drug Companies
http://www.medicalnewstoday.com/articles/136470.php

[9] New Rules on Doctors and Medical Firms Amid Ethics Concerns
http://www.nytimes.com/2009/01/24/business/24device.html?_r=3&pagewanted=2

Health Care Reform, Economic Stimulus, and Transparency

By: Matt Hotz, CIS Compliance Specialist
matthotz@cis-partners.com

The top priority of the Obama administration is undoubtedly the stabilization of the economy. A casual observer might conclude, therefore, that health care reform would have to wait until the economy was stabilized, postponing the implementation of legislation that would bring greater transparency to the pharmaceutical and medical device industries. A closer look at the administration, though, reveals that the President and his advisers consider health care reform a necessary and inextricable component of long-term economic stability.

The incoming head of the Office of Management and Budget (OMB) Peter Orszag clearly stated his position on the relationship between the nation’s economic future and health care reform on the blog he maintained while serving as director of the Congressional Budget Office (CBO):

Although this [health care reform] may not seem immediately relevant given our
current difficulties, it will be crucial to address the nation's looming fiscal
gap -- which is driven primarily by rising health care costs -- as the economy
eventually recovers from this current downturn.

This view is not unique to Orszag. According to Ezra Klein at The American Prospect, Jeanne Lambrew, “aggressively framed health reform as a response to the fiscal crisis,” at the Academy Health National Health Policy Conference in January. Lambrew, who was profiled here on the Pharma Compliance Blog in December, is the Deputy Director of the newly minted Office of Health Reform (OHR), and could be taking on a larger role in the administration in the wake of Tom Daschle’s withdrawal from consideration for the top job at OHR.

This sentiment, that health care reform and long-term economic stability are inseparably linked, is not limited to health policy professionals: Senate Finance Chairman Max Baucus (D-MT) made this linkage a recurring theme of his speech at the Academy Health National Policy Conference, and the President himself listed health care reform as one of the key elements to American economic recovery during his inaugural address. These strong words are leading to strong action: 20% of the funds included in the economic stimulus package will be directed towards health care.

The state of the economy is clearly the administration’s top priority, and health care reform is viewed by the administration as vital to the state of the economy. The administration’s attention and the openness and accountability provisions in the economic stimulus package will bring a culture of transparency with them. Pharmaceutical and medical device manufacturers that have not adopted transparency in their own corporate culture will stand out as contrarian once the administration targets health care reform in earnest, which could happen this year.

Transparency and Its Implications for Pharmaceutical and Medical Device Manufacturers

By: Matt Hotz, CIS Compliance Specialist
matthotz@cis-partners.com

Transparency is a hot topic these days, not just in the pharmaceutical industry, but for all industries facing new regulations under the Obama administration. Due to the attention being paid to transparency legislation and its potential implications, we at the PCB have put together some articles to describe how these changes might affect you. I officially declare this week "Transparency Week!"

Regulations requiring disclosure of physician payments by pharmaceutical companies and medical device manufacturers have been developing for years. Several states have already passed their own versions of these so-called sunshine laws, and at the federal level, the first iteration of the Physician Payment Sunshine Act was introduced in the Senate in 2007. The 2009 incarnation of the Physician Payment Sunshine Act was released by Senators Herb Kohl (D-WI) and Charles Grassley (R-IA) two days after the inauguration of President Obama.

The concept motivating these laws is transparency, and in government, it applies to much more than payments made to physicians by pharmaceutical companies. But what does transparency mean in this broader context? In short, transparency means conducting government business openly; transparency involves making everything from government processes to legislative deliberations to financial data available to anyone who wants to see it. Transparency enables oversight of the workings of government, and this oversight, in theory, makes government less susceptible to corruption. A famous quote from Supreme Court Justice Louis Brandeis illustrates the idea behind open government so well that its inclusion in any discussion of transparency is all but mandatory:

Publicity is justly commended as a remedy for social and industrial diseases.
Sunlight is said to be the best of disinfectants; electric light the most
effective policeman.

President Obama has employed transparency as one of his recurring themes since his general election victory in November 2008. During his inaugural speech, in a passage about federal spending, the President stated that:

Those of us who manage the public's dollars will be held to account -- to spend
wisely, reform bad habits, and do our business in the light of day -- because
only then can we restore the vital trust between a people and their government.

The new administration’s commitment to transparency was formalized in a pair of memos issued on January 21, 2009. The first memo addresses the Freedom of Information Act and states that “all agencies should adopt a presumption in favor of disclosure” for all decisions involving the Freedom of Information Act (FOIA). The second memo is titled Transparency and Open Government, and it explicitly announces the Obama administration’s attitude towards government and its relationship with the public.

The prominence of transparency as a dominant theme of the nascent Obama presidency is a call to action for pharmaceutical and medical device manufacturers. As the concept gains traction, it will be applied more broadly. Sunshine laws addressing physician payments will likely become stronger, and legislation requiring disclosure far beyond the scope of physician payments will likely follow.

Clearly, companies looking to mitigate their audit risk should try to anticipate the types of regulations and standards likely to be implemented in the near future. Consequently, companies should develop compliance strategies for any potential regulations and standards which would necessitate investments of time, resources, or both. These steps, though, will no longer be sufficient. In an environment that values transparency, the attention of regulators, industry watchers, and the public will be drawn to companies that choose to disclose as little as necessary to maintain compliance. Companies should take steps now to foster an atmosphere of transparency across their entire corporate culture.

Physician Social Networks: Opportunities for Pharma

By: Jess Ebert, CIS Compliance Specialist
jessicaebert@cis-partners.com

With the updated and enhanced PhRMA Code on Interactions with Healthcare Professionals taking effect in January 2009, pharmaceutical companies are no doubt finding it more difficult to effectively market their products. No longer being able to provide entertainment, recreation, or any of the other fun stuff (pens, mugs, note pads, etc.) is sure to have an impact on the way that companies sell themselves. That said, pharma companies need a more efficient way to get their name out there and remind physicians that, free meals and vacations aside, they still have something to offer.

A great area to target that is perhaps overlooked is physician online social networks. It’s exactly what it sounds like; an online community exclusive to healthcare professionals, where they can share their knowledge with each other, discuss important topics and emerging trends, ask questions, and provide new insights into medications and devices. The most popular sites are Medscape, Sermo, and SocialMD, just to name a few.

On January 20, 2009, Manhattan Research, a pharmaceutical and healthcare market research company, released a physician analysis titled “Physician Online Communities: Physician Social Networking and the New Online Opinion Leaders.” The analysis focuses on the characteristics of physicians, such as their specialty and pharma company interactions, currently using, or interested in using, online social networks. This analysis should be of interest to pharma companies looking for a new marketing angle, as it revealed that physicians participating in an online network write a mean of twenty-four more prescriptions in a week than non-participating physicians[1].

What’s the reason for this? Research shows that it may be the work of an “opinion leader”. An opinion leader in a physician online community is generally a physician who has a significant medical background, holds academic titles at medical schools, and has contributed to peer-reviewed publications[2]. General practitioners prescribe the most drugs, but often request the opinion of a specialist who has more knowledge than they do, when making prescribing decisions. Therefore, if the opinion leader can be targeted and detailed by a pharma company, it is likely that the information would be passed along to many more general practitioners.

With 60% of physicians already using or interested in using online networks, there is big potential in directing marketing efforts to opinion leaders, as their influence on those who seek their advice could have a huge impact on sales.

To read an excerpt from the “Physician Online Communities: Physician Social Networking and the New Online Opinion Leaders” analysis and for more information about it, visit:
http://www.manhattanresearch.com/products/Research_Modules/Physician/physician-online-communities.aspx
1. http://www.drugs.com/news/physician-social-networkers-prescribers-more-likely-engage-pharma-15701.html
2. http://globaltechforum.eiu.com/index.asp?layout=rich_story&channelid=3&categoryid=7&title=Social+networks+impact+the+drugs+physicians+prescribe&doc_id=10534

Roll Up Your Sleeves... and Hold Onto That Job!

By: Katie Lapins, CIS Senior Compliance Consultant
katielapins@cis-partners.com

These are dark days in pharma/biotech... The economy has continued to sputter, regardless of the actions of politicians and CEOs, despite the prayers of workers at risk. I’ve tried so hard to not “go negative,” but the time has come for me to admit the reality of our times. If you’re reading this blog, you’ve most likely noticed it, too. The numbers are staggering to me – I didn’t expect them to be so high. According to Fierce Biotech, layoffs in the pharma/biotech world are unprecedented, and they are affecting large and small companies alike.

If you’re like me, all of these layoffs (and the overall economic environment) create just a bit of uncertainty and nervousness. Many people have little control over the financial situation of their employer, so the only area in which most have some semblance of control is in what I call their own “professional strategies.” This concept is discussed in the latest issue of Money magazine, which provided the following recommendations:

1. Stand out and step up. Complete assignments on time, volunteer to take on additional work and make sure your boss (and your boss’s boss) know your contributions.

2. Be a money-maker. Find ways to save money or to bring in more revenues. Even if you’re not a sales rep, identifying a cheaper vendor or more efficient way of doing something is a valuable contribution.

3. Don’t be a downer. Try to keep a positive attitude and make an effort to be a team player. Another good recommendation is to avoid those who seem to constantly complain. Bad attitudes can be contagious.

4. Increase your value. If you’re the only person who knows how to do something, it’s a bit harder for your company to eliminate you and/or your position (but not impossible!). Learn more; broaden your area of expertise, even if it is on your own time.

5. Go beyond your job description. Most people are expected to work harder these days, so you can either complain about it, resist it (see #3 above), or you can look at it as an opportunity (see #1 above).

6. Make a sacrifice. If you’re paid more than others or have superb benefits, offer to forgo a bonus or salary increase if the company is facing difficult times. (This is described as the riskiest of the options and I definitely agree. I thought about leaving it out in case my boss reads this but decided I didn’t meet the requirements!)

I realize that these strategies won’t always save a job. However, none of them will make you more likely to lose your job. And if you do find yourself back in the job market, they will help make you more competitive.

Despite the bad reputation currently held by the pharma/biotech industry, it is one I am proud to be a part of, because of its dedication to eradicating illnesses, treating diseases, and saving lives. So, for all the unfortunate individuals who have lost their jobs during this downturn, and for the rest of us worried about what tomorrow may bring, I sincerely hope that recovery for our industry, and for our country, comes soon.


Sources:
(http://www.fiercebiotech.com/tags/layoffs?utm_medium=nl&utm_source=internal&cmp-id=EMC-NL-FB&dest=FB)

Rosato, D (2009, February). Fireproof Your Job. Money, 38(2), 81 – 84.

My Super Bowl Glog

FRIDAY, January 30, 2009

Friday, 1/30, 6:00PM: So CIS has an internal ‘box pool’ going on where the two last digits of the half time score and final score are winners. Of course, since gambling is illegal in the illustrious and mind-blowingly well-written CIS Handbook, the half time winner gets a CIS notebook and pen and the final score winner gets a 3 hour Government Programs 101 Training courtesy of GP Practice Lead Chris Cobourn. Therefore, there are clearly no winners and no CIS Handbook violations. (For the record and for fun throughout the game, I have: Steelers 0, Cardinals 1; Steelers 7, Cardinals 6; Steelers 6, Cardinals 8; Steelers 3, Cardinals 9; and Steelers 4, Cardinals 5). I’m calling Steelers 17, Cardinals 6 at half-time and a final score of Steelers 27, Cardinals 16 for the final score. Then, God willing, I’ll have a notebook to take a lot of notes for my GP 101 Training.

SATURDAY, January 31, 2009
10:33AM: Last year my wife and I were distraught that the name Plaxico was snatched away as a unique name for our first born. This year, we just chatted about the odds of Anquan also being taken. We’re obviously cursed.

4:34PM: I was watching a little golf on CBS on Saturday and found out that the Mean Joe Greene Coke commercial is being retired and can’t win the “Best Super Bowl Commercial” on their show tonight. Troy Polamalu will be taking his place in a ‘re-filming’ of the commercial. Nice touch, and Title IX appropriate, that they decided to use a little girl from a shampoo commercial this go around.

4:34PM and 3 seconds: My boss is a huge Steelers fan.

Random Thought: Does Phil Mickelson need a “Bro” or “Manzier”?

8:57PM: Mean Joe Greene was supplanted by the 2008 Rocky Clydesdale theme from last year. Because I think it’s important for writer’s to always stand by their words, this was my exact review from last year’s Super Bowl Glog:

“7:13PM (2008) - Bud commercial using horses, a dalmation and a Rocky theme. Fantastic. Best ad of the Super Bowl thus far. A-. There's still an A and A+ out there!”
SUPER BOWL SUNDAY, February 1, 2009

Random Thought: Is Kurt Warner old enough to be my Dad?

6:54AM: I’m going for the Cardinals not because I hate the Steelers or like the Cardinals, but because I like the underdog. That’s why I like myself so much.

11:12AM: The Cardinals were 8-8 this year. If they win the Super Bowl it would be as impossible as the New England Patriots making the playoffs without cheating.

3:21PM: Taking another walk with the wife. It’s 53 degrees in Media, PA on February 1st. I
wonder what that pesky groundhog will say tomorrow…

6:00PM: Watching golf and marveling at the fact that Super Bowl coverage began at 1PM this afternoon. Did anybody really watch all of that??? By the way, Kenny Perry just made a bad bogey on 18 to force a playoff with Charley Hoffman. Much like last year, 99.9% of you care more about just about anything else.

6:13PM: ‘Duplicity’ with Julia Roberts. Nope.

6:15PM: Kurt Warner just won the “NFL Man of the Year” award for his Habitat for Humanity efforts. Good for him. He’s still old.

6:16PM: Faith Hill sings “God Bless America”. I wonder if Carrie Underwood is bitter that Faith has the spotlight on Super Bowl Sunday. (Few of you will get that and a part of me is ashamed to have written it).

6:18PM: The crew from US Air Flight 1549 enters the field. I don’t have a joke here. It just wouldn’t fly.

Random Thought: What will the pharmaceutical industry’s presence be like this year during the ads?

6:19PM: Jennifer Hudson. B-.

6:28PM: Heads.

6:28PM and 1 second: YOU KNOW IT! (So the NFC has won the coin toss 12 times in a row. That’s amazing.)

6:32PM: Kick off --- FINALLY!!!! The Cardinals’ kicker makes the tackle at the 28 yard line or so --- good for him!

6:38PM: Touchdown Steelers. That was scarily easy. Oh wait. We have a review coming…

6:39PM: Bud Light’s Drinkability commercial with a guy ending up getting thrown out of the window for suggesting that they stop drinking Bud Light at every meeting. C. Mostly because “Drinkability” is a stupid ad campaign. If you drink it, it should be drinkable. I’m Steven Moore and I approve this message.

6:42PM: 4th down! Review says NOPE for the touchdown. 3-0 Steelers. That will help the Steelers get to 17 at half time for me.

6:44PM: Bob Dylan and Will.I.Am commercial. Nicely done. Pepsi gets the first B of the night.

7:00PM: End of the first quarter. 3-0 Steelers. That was a fast and relatively boring quarter.

7:01PM: Mr. & Mrs. Potato Head Ad. B.

7:05PM: Go Daddy.com commercial with Danica Patrick. Interesting to see that her racing talent can be combined with her racy talent.

7:08PM: 10-0 Steelers. On our way to 17-6, but I have to say that this game is headed in a bad direction.

7:11PM: So the Clydesdale fetches a bigger stick than the Dalmatian. Cute, but I thought they were friends. B.

7:13PM: The Budweiser Clydesdale’s are the theme it seems. So the male Clydesdale finds the female and jumps over the Grand Canyon in the process. I’m trying to figure out how this makes me want to drink a Budweiser --- just like a horse fetching a giant stick? Oh, that’s right, because it’s drinkable. C+.

7:21PM: Touchdown Cardinals --- Ben Patrick out of The University of Delaware. The same school as my beautiful wife is getting her PhD! 10-7 Steelers and my first half hopes of winning a notebook are waning.

7:31PM: My wife and I just spent 15 minutes reviewing the numbers on the block pool and figuring out how I could win. That’s how exciting this game has been.

7:33PM: Hyundai Genesis commercial with Mercedes, BMW and Lexus executives pronouncing Hyundai correctly. I absolutely love the ‘in your face’ style of this commercial. B.

7:36PM: E*Trade Baby Commercial. Our favorite baby from last year and his friend baby singing Mr. Mister. “Take these broken wings…” B+. I laughed out loud.

7:39PM: CIS. Complianceability. (Brought to you by Grey Goose vodka)

7:43PM: TeleFlora commercial with talking flowers saying, “Nobody wants to see you naked.” “You have an ugly mug.” I get the point, but that’s like having a car commercial where the car crashes.

7:47PM: Apparently pigeons love Cheetos too. Eatability. C+.

7:53PM: 100 yard interception return for a touchdown by James Harrison! Wow --- the longest play in Superbowl history! That changes the complexity of this game. Thanks Einstein. 17-7 Steelers. Congrats to Justin Will for having 7 and 7. Enjoy your CIS Notebook and Pen. Jerk.

7:57PM: “The President set the terror level at Brown because I have to change my pants.” From the preview for the movie Monsters versus Aliens movie. Very nice. (Movie previews don’t get grades).

8:31PM: Took a shower at half time because I have to travel to our Raleigh, NC office tomorrow. How was Bruce?

8:33PM: John Madden says, “If the Cardinals had lost Anquan Boldin, it would be a big loss.” This just in: If Tiger Woods gets hurt, others have a chance.

8:36PM: Beer commercials 8. Drug commercials 0. Wait --- isn’t alcohol a drug?

8:37PM: Denny’s is giving away a Free Grand Slam breakfast.

8:40PM: Another Budweiser Horse commercial. I’m still gonna grab a martini. (A.K.A. Stevetini)

8:48PM: Terrible Rouging the Passer call on Cheesberger. It’s football, not figure skating.

8:54PM: For the first time in the history of the NFL, there was a “Roughing the Holder” call. I repeat: a “Roughing the Holder” call. What a stupid play and call. The odds of the holder scoring a touchdown after the ball was kicked were…

8:58PM: CareerBuilder.com and Monster have both had advertisements. Have they seen the unemployment numbers?

9:01PM: Coke Commercial with the bugs --- A-. That was an amazing commercial. The graphics and feeling of it were both fantastic and so very ‘Coke’ (I’m a marketer in a past life). That commercial is in the lead for me.

9:05PM: Usama Young of the New Orleans Saints was selected as the NFL’s best story for a Super Bowl Ad. Great to see him make it so far with the first name ‘Usama’. It’s almost as if you could be President of the United States of America with the middle name Hussein. Perhaps it’s because Usama has USA as the first three letters…

9:12PM: Yawn.

9:18PM: So the new Coke commercial with Troy Polamalu was far worse than simply copying the original commercial with Mean Joe Greene --- which is the best I’ve ever seen. The concept of Coke Zero having the same taste as Coke is like the people who think driving a Camry is like driving a Lexus. D.

9:26PM: Larry Fitzgerald is amazing. What a catch! 20-14 Steelers.

9:33PM: I love MacGyver. Best TV show ever. However, that was a horrific Pepsuber commercial. D.

9:41PM: James Harrison punches a guy and hits a guy hard while he’s done. Shameful. Cardinals should get the ball back for that nonsense and he should be tossed out of the game.

9:42PM: Almost a safety --- that would have killed my hopes for a 21-20 Cardinals win and a FREE Government Programs 101 Training!!!!

9:45PM: A Safety!!!! Dangit. 20-16 Steelers. I need a 27-16 Steelers win here for me to get that GP 101 Training I oh so covet.

9:48PM: OH MY GOD!!!! 23-20 Cardinals after a remarkable TD by the MAN Larry Fitzgerald. What a game this has turned out to be!

10:00PM: WHAT AN INSANE CATCH!!!! I think he had it! Steelers 27-23.

10:10PM: The Steelers win and are the Super Bowl Champions. Good night. Troy Polamalu is a girl.

(John Jordan wins the FREE GP 101 Training. Congrats John. It will be the most fascinating 3 hours of your life)

For Your Space,

Steven.

stevenmoore@cis-partners.com