The Sunshine Act

 The Sunshine Act is about transparency; it is on the minds of Pharmaceutical and Biotech Companies (drugs & devices) since they are required to report Physician Payments starting in 2013, however, Centers for Medicare and Medicaid (CMS) have not yet published a final rule. The purpose of the Act is to make public financial dealings between physicians and Life Science (manufacturers) companies.  Another way of looking at the Act; ” The idea is that the more transparent the process, the more public scrutiny will steer all parties to better practices and will guard against questionable behavior” I am not an attorney but from my perspective the Physician Payments under scrutiny appears to be very broad, for example, the list below are some areas that need to be reported if the value (transfer) is more than $25.00 and if the manufacturer’s gross annual revenue is more than 100 million; I have found that these dollar amounts apparently are different depending on what/where/when information is read.  Please be aware that this list is not a complete compilation and the dollar amount may be questionable.

      Gifts

      Honoraria

      Research funding or grants

      Education, tuition for continuing-education

      Seminars

      Entertainment

      Charitable Contributions

      Direct Compensation for Serving as a Speaker for Medical Education Programs

      Consulting fees

      Ownership or investment interests

      Royalties

      Rebates

      speaking fees

      profit distribution

      stock or stock option grants

      Any categories of information the secretary(of Health and Human Services) determines appropriate

There is an article in Applied Clinical Trials http://www.appledclinicaltrialsonline.com  April issue title “Sunshine Act’s Impact” that is worth reviewing. The Sunshine Act is not new however drug and device companies are trying to decide how to implement the Act to obviously be compliant but not to negatively impact how the physician and key opinion leaders will interact with them; stay tuned for yet another final ruling as lawmakers work on making relationships and thus, financial transactions/disclosure initiatives more visible.

Drug Compliance in Clinical Trials

 Investigational drug compliance in clinical trials is an important determinant in the outcome of a trial. I often wonder when I read about the failure of a phase 3 pivotal clinical trial if subject drug compliance was a factor.  Of course, compliance is measured in various ways such as drug accountability and drug blood levels but there is no standard; the industry practice for disposition of drug is through maintaining drug accountability records. Compliance is difficult to measure but it should be assessed frequently during the course of a trial.  Audits of investigative sites revealed inadequate drug accountability records, missing or unaccounted for study drug, failure of a CRO to adequately monitor the study drug, lack of implementation of corrective actions for non-compliance of investigator, and  shipping invoices and drug accountability records reflecting more drug dispensed than received.  It has been reported by the FDA that poor to non-existent drug accountability is a top pitfall. An FDA inspector stated “any individual should be able to perform drug reconciliation at an investigative site within 20 minutes”. The aforementioned statement by the inspector is assuming that drug accountability records are well designed and error free. Also, drug is reconciled on an ongoing basis from initial shipment to final disposition. The records should reflect that the investigator maintained control over administration and distribution of study drug and that the investigator is in compliance with all regulatory obligations as they pertain to investigational drug; see ICH guideline for Good Clinical Practices E6 -  4.6.1 and CFR 321.60 – 312.64 for regulations regarding the control of investigational drug.

Drug Accountability

Drug accountability is not a priority for the investigational site monitor and often times it is documented in the monitoring report that drug accountability was not preformed due to time constraints. The clinical research associate (study monitor) is pivotal to ensuring that the investigative site’s drug administration and dispensing procedures are in place. Drug accountability is a priority for the FDA inspector and the site monitor should check the quality and accuracy of drug accountability frequently during the course of the clinical trial. In addition, the monitor should review records with the study coordinator/nurse and principal investigator to assure  drug accountability is being performed appropriately. Minor inconsistencies or deficiencies may be due to poor record keeping. However, major errors in drug records noted by an FDA inspector often times leads to the inspector exploring weather or not investigational drug was switched in an attempted to give active drug to certain subjects if a placebo arm was a part of the trial design, if lack of attention to detail impacted the overall quality of the data and the integrity of the study. Also, the inspector tries to determine if an intentional attempt to deceive occurred.

Although, this is a high level look at drug compliance/drug accountability in clinical trials it is worth noting that this is a concern for regulatory agencies. Many of you have a checklist for drug accountability and perform ongoing training at the investigative sites but it is important to pay adequate attention to this very important process.

Caregiving

Caregiving is terribly underrated but so very critical. More than 64 million Americans are caregivers. My mother is a caregiver for my father, my mother in-law is a caregiver for my father in-law and many are caregiver for their loved ones.  Caregiving can be a short-term responsibility but most of the time it is a long-term responsibility; The person being cared for is either in declining health, older adults and/or has a disorder or handicap which makes caring for themselves a challenge or just impossible.

Caregiving most often falls on the shoulders of females, approximately seventy-five percent of caregivers are women and many are juggling full-time jobs and parenting.  Also, studies suggest that caregiving takes a toll on the physical and mental health of the caregiver; financial problems, family relationships, friendships, quality of life and overall stress has been reported, as well as, having a negative impact on the caregiver. Even though caregiving has traditionally been a women’s role men are also caregivers and experience the same issues as women. However, men are most likely to hire someone to help them. Men are also faced with learning new skills to aid them as they become a caregiver. Check out these resources for caregiving support. Administration on aging (AoA) http://www.aoa.gov , http://alturl.com/b5ze5 and the caregiver magazine http://www.caregiver.com\magazine\index.htm. Sometimes just developing your own  support group of friends and other caregivers can be helpful.

CNN recently had a commentary on Compassion Fatigue in which the mental and physical challenges of the caregiver were discussed and self-help treatments were recommended. Of course, you can find many books dedicated to this phenomenon; check your local library or Amazon.

We so often focus on the caregiver but what about the person needing the care. It has been reported that the adult person needing care often feels guilty, full of anxiety, depressed by what they cannot  do and what the caregiver is doing and the sacrifices that are being made by the caregiver. What are the challenges you’re facing?

 http://www.kgdavisconsulting.com

Chronic Pain Management

Chronic pain such as headaches, lower back pain, joint pain/arthritis, or chronic pain caused by an underlining disease/disorder is the cross to bear for many people suffering from chronic pain. Chronic pain affects greater than 85 million adults in the U.S.. However, lower back pain is the most common complaint and of course, you can find a lot of information regarding lower back pain.  Many of us experience the following symptoms with regard to chronic pain,

• Mild to severe pain that does not go away
• Pain that may be described as shooting, burning, aching, or electrical that does not go away
•  A feeling of discomfort, soreness, tightness, or stiffness that does not go away

There is an organization and thus, a website worth checking out http://alturl.com/2cen7 . There is also a journal titled The Journal of pain and symptom management that is worth reviewing. How do you manage your pain? Is it through life style changes, exercise and/or Psyotherapy to help learn coping skills, as well as acupuncture? As you are probably aware, there are physicians that specialize in pain management however, not sure if this is covered by your health insurance.  If you have taken this approach what has your experience been?

Research specifically, chronic pain clinical trials are currently ongoing; go to http://www.clinicaltrials.gov to see what clinical trials are recruiting subjects and if they are worth you participating in. Several weeks ago I saw tips for the friend who wants to help a chronic pain suffer; the tips documented were not the typical tips you often see. I would like to share them with you.

• Avoid clichés and platitudes: I know how you feel
•  Offer to run easy errands
•  Don’t offer treatment advice
•  Cook a meal or two
•   Give massage gift certificates
• Offer to accompany your friend to doctor’s appointments

 To see the complete list of tips with further explanation go to http://alturl.com/m7acp. Many Medical Centers and Clinics have seminars/workshops on chronic pain management that you should check out.

 http://www.kgdavisconsulting.com

HIV/AIDS – where we are today

Unfortunately, we all probably know someone living with HIV/AIDS or has succumb to the disease especially in the early 1990s in the U.S.. June 2011 marked 30 years since we witnessed the HIV/AIDS epidemic. Although, it is no longer a death sentence and we have made great strides in the development and approval of drugs to treat HIV/AIDS the prevention and care of the disease are still challenging with some of the same issues today that we were burden with yester-year, and today there is still no cure. To view HIV/AIDS prevention and guidelines go to the National Prevention information Network (NPIN) http://www.cdcnpin.org In addition, you can also view the AIDS Research Program of the National Institute of Health (NIH) at http://www.oar.nih.gov

To address HIV/AIDS in the U.S in the 2013 Budget, President Obama proposed the following,

•  Continue to support HIV/AIDS research.
• Expand investments in prevention and care.
• Funds cross-cutting innovative efforts for care and prevention.
• Expand the Ryan White HIV/AIDS Program.
• Increase funding for HIV/AIDS prevention and service integration.
• Modernize the Housing Opportunities for Persons with AIDS (HOPWA) Program.
•  Continue to fight the stigma of HIV/AIDS.

The Fiscal Year 2013 budget’s HIV/AIDS elements can be viewed in this fact sheet from the White House: Fighting the HIV/AIDS Epidemic and Supporting People Living with HIV/AIDS

AIDS outside the United States

The fight against AIDS outside of the US has not been as successful but things are improving. Bill Gates and his wife Melinda through the Bill & Melinda foundation gave 750 million to help fight AIDS, TB and Malaria.  http://www.gatesfoundation.org. To date over 15 million Africans have died of AIDS and the number of Africans living with  HIV/AIDS is staggering. To find out more about HIV/AIDS in Africa go to http://www.avert.org\hiv-aids-africa.htm Another country struggling with the disease is India; over 2 million people are living with the disease. Go to http://www.avert.org/aidsindia.html to find out more about HIV/AIDS in India. Another country is on our minds due to the fact the population size is China. Although, millions have died from the disease and millions are living with the disease it’ prevalence is rather low, less than 1.0%. Go to http://www.avert.org/aidschina.htm to find out more about HIV/AIDS in China.

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Habits of Highly Effective People

I would like to focus on two of Stephen Covey’s habits from his book, 7 Habits of Highly Effective People. http://www.stephencovey.com The two habits I would like to discuss are,  Be Proactive and Begin with the end in mind. These two habits in my opinion are particularly important with regard to career transition, career growth, leadership, and personal branding.

#1 Be Proactive

Being Proactive in my opinion is viewing the “glass half full” and looking forward as you take responsibility for your choices; also, to act and not to react. Certainly, this is easier send than done particularly when faced with difficult circumstances. However, how we respond to circumstances is an important step in being in control instead of being controlled by negative circumstances. I try to follow this quote when dealing with difficult circumstances; “Lord may I accept the things I cannot change, change the things I can and have the wisdom to know the difference”.

In Stephen Covey’s book at the end of the discussion on the first habit, Be Proactive there is a list of Appreciation Suggestions that are worth reviewing if you have not already done so.

#2 Begin with the End in Mind.

Begin with the end in mind reminds me of the thought that you are probably aware of “only the plan  matters”; with unemployment as high as it is in the U.S. the plan is to get a job or keep the job you have. That being said, the ultimate goal is to start with a clear understanding of your goal/destination, in this case employment and then taking steps in the right direction. Stephen Covey suggest developing a Personal Mission Statement to help you realize the correct steps to take. Of course, a personal mission statement does not define the second habit, Begin with the end in Mind but what I does do is to help define your values and acknowledge your-self awareness. To help you to get started with your personal mission statement go to http://www.ehow.com search “personal mission statement”

I have merely scratched the surface with regard to habit #1 and #2 as identified in Stephen’s Covey’s book. If you have not already done so, it is worth reviewing Stephen Covey’s perspective.

 http://www.kgdavisconsulting.com

Risk-Base approach to monitoring of Clinical Trials

Some of you may also know remote monitoring of clinical trials as a Risk-Base approach to monitoring. In any event, risk-base monitoring does make many of us a bit uncomfortable including me because we have been taught that the method for evaluating study conduct including protocol compliance, patient safety and data review for each enrolled subject is by conducting frequent on-site monitoring visits. However, if you have worked with academic centers, cooperative groups, and government organizations the practice of on-site monitoring is not really embraced as it is in industry. On-site monitoring every 6 to 8 weeks has been an industry standard for decades, to deviate from the standard does cause a certain degree of stress. The FDA issued a draft guidance http://alturl.com/f6xww last year that certainly encourages Risk-Base Monitoring. The European Medicines Agency and Clinical Trial Transformation Initiative (CTTI) are supportive of the FDA’s approach but my question is, where does industry stand on this issue? I agree that advances in technology, namely electronic data capture (EDC) does allow for risk-base monitoring but is quality at risk? Is subject safety at risk? Will the FDA question/scrutinize a customized monitoring plan The FDA does make mention that risk-base monitoring may not be appropriate for early stage trials (Phase 1) and clinical sites needing more attention, at least the attitude is not “one size fits all”. The FDA has issued a record number of 483s and warning letters in 2010/2011, will risk-base monitoring cause the FDA to be more vigilant and aggressive in their enforcement of the regulations?

The cost savings for industry is staggering. That being said, I am certain that most companies will embrace Risk-Base monitoring but “buyer beware”. It is easy to prioritize the cost savings as # 1 rather than quality or compliance however, I am sure that the FDA will demand 100 percent compliance. In my opinion, a detailed monitoring plan that is followed and of course, updated will be even more critical.

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“What Color Is Your Parachute”

What Color Is Your Parachute by Richard Bolles has been in print for 4 decades but it also has been updated and revised annually. In any event, What Color Is Your Parachute is as relevant today as it was those decades ago.  In my opinion, the book is much more than a job hunting book, it’s about really finding out who you are and getting out of your comfort zone. We all have that “zone” we feel most comfortable in, we do not feel stressed, and we don’t need to make “Change” our friend. However,  job hunting or career transitioning in 2012 and moving forward will continue to be about getting out of your comfort zone; we can accomplish this by taking baby steps at first and then taking risks. I certainly do not mean the kind of risks that would be unethical, immoral or the kind of risk that would put your health or life in danger; I’m referring to the kind of risks that would help you develop or improve upon your survival skills with regard to job hunting and more importantly running your Life. We know of risk management for an organization but perhaps, we need to think of it in terms of ourselves and develop a risk matrix where we evaluate the  probability and the consequence of the event on a scale from 1 to 10, where 1 is low and 10 is high.  Some examples of events would be,  starting a new career, starting your own business, going back to school, doing an internship, volunteering, or relocating to a different geographical area. To get started I would recommend utilizing a risk matrix software which you can download for free at http://www.freedownload3.com\software\risk_matrix_software.html , you will have to adapt it for your personal needs but it’s an example to follow.

Strategizing is risky business but it is essential to grow and see the possibilities in your life. Today we need plan A, B & C; we should have the foresight and flexibility to initiate any plan at any time if we have to make an unexpected turn/change. The rationale to having plans in place is that we can make that “go, no go decision” sooner and not continue on the same unsuccessful path; as they say, the definition of insanity is doing the same thing over and over again and expecting a different outcome.

 I would recommend reading chapter 13, self-inventory. In my opinion, a self-inventory will help define who you are and the value you bring to the table. Of course, “What Color Is Your Parachute” is a book worth reading in its entirety, the book is for both the job hunter and for the person trying to identify their purpose and mission in life.

 http://www.kgdavisconsulting.com

Apps and Clinical Trials?

In this electronic era it is just assumed that there are apps to assist with and to help improve the implementation and maintenance of clinical trials, to connect patients with a clinical trial, to connect the patient with the physician, to help physicians in finding the right clinical trial for their patient, to plan, forecast, as well as track patient enrollment in a clinical trial. Of course, there are apps that will do most of the aforementioned. As I am sure you are aware, there is an app for your iPhone, iPad, blackberry, and other mobile devices. Check out these articles. http://alturl.com/64z7j and  http://alturl.com\4tt3y. If you have not already done so,  you can  also find information on the U.S. National Library of Medicine website http://www.nlm.gov/mobile/. With regard to clinical trial management platforms such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Microsoft SharePoint just to name a few, they have been around for years and are in need of redesign to address the functional gaps that exist.

As we work through this explosion of electronic information/aides, industry is looking for guidance from the Food and Drug Administration. However, there is not a guideline with regard to the management of clinical trials on mobile devices but hopefully FDA will be forward thinking and put something in place soon. There is a guidance that was proposed last year with regard to consumers and health information, the guidance can be found at http://alturl.com/ynjdf. In my opinion, the FDA should employ an expert who can focus solely on mobile device apps for the Life Science space specifically, the management of clinical trials, perhaps, they have a person(s) but I could not find such an expert on their staff.

The future of Healthcare is an open agenda ready for us to fill in the blanks. See an article in the Wall Street Journal titled A Doctor in your Pocket http://alturl.com/whruy. The Healthcare Industry is certainly taking the lead with regard to utilizing the latest technology; see reports in Technology Review magazine published by MIT. http://alturl.com/6s68p and  http://alturl.com/gdxcc

The Biotech/Pharmaceutical industry is trying to contain the rising cost of drug development; in my opinion, it would be quite impressive if industry could be innovative enough to propose a unique process particularly with regard to early stage clinical drug development that would dare all of industry to be different but of course,  insuring that CDER & CBER mission is not in conflict.

 http://www.kgdavisconsulting.com

Drug Development in 2012

In 2011 the primary focus with regard to drug development was the rising cost of drug development, increased development & sale of generic drugs, and drug patent expiration. “In Fiscal Year 2011 the FDA approved 35 drugs that offered important advances in treatment for hepatitis C, late-stage prostate cancer, lupus, drug resistant skin infections, pneumonia, and other serious and life-threatening diseases”. Go to http://www.fda.gov to obtain a complete list of 2011 drug approvals. In 2012 it will be great if the FDA can surpass the number of drug approvals that occurred in 2011. With regard to issues in the drug development space that perhaps were a threat in 2011, will remain a threat in 2012. However, I would like to add the need for greater innovation which will be a positive for drug development. Specifically, the need to have an innovation process in place/implemented at Biotechnology/Pharma companies including a dedicated budget. And of course,  top management’s ability to encourage innovation by their employees will be need to be successful. Check out an article in Forbes magazine titled “Innovation Resolutions 2012″ http://alturl.com\yskhu. Forbes magazine also identified the best large Pharmaceutical companies of 2011 with regard to their top share price but it would be great if these Pharmaceutical companies were also recognized for their innovative practices; see Forbes article http://alturl.com/kv588. In addition, for the small biotech companies that are in the clinical space perhaps, we could tie innovation to the amount of financial backing that they receive from Venture Capitalists.  In my opinion, if we take this approach we may be able to better address the need for an innovative approach to drug development

  In an effort to keep the cost of drug development down  we saw partnerships with Contract Research Organizations (CRO) and Big Pharma. Will we see more partnerships between Pharmaceutical companies? See article in Fierce Biotech http://alturl.com/mzdzy. I think there will be increased collaboration between academia and industry, as well as, an increase in conducting basic research by academia in 2012. In my opinion, innovation will be an important part of development, we recognize that we cannot continue to develop drugs the way we have been doing so and contain costs. Will AstraZeneca’s misfortune force a change in the current drug development process? See the article in Business week. http://alturl.com/rqoii.

 The mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. The current drug development and drug approval process can be found on the FDA website http://fda.com. In my opinion a change in the way drugs are developed will not affect CDER’s mission.

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