November 15, 2011

I recently attended the FDA’s Clinical Investigator Training course in Washington, D.C..  This 3 day course covered regulations, ethics, experiment design, safety assessment , and clinical investigator expectations for conduct of clinical research studies supporting marketing registrations of new drugs, biologics, and medical devices.  FDA staff also reviewed submission of Investigative New Drug (IND) applications.

My key learnings were about experiment designs for conduct of clinical trials.  The randomized withdrawal experiment design is useful for studying diseases for which it is questionable to treat with a placebo for a long time period.  For diseases not appropriate (ethical) for treatment with a placebo, a non-inferiority experiment design was recommended.

When testing a new drug in volunteers, the dose for first-in-man (FIM) phase 1 studies is determined by applying a safety factor (usually 10 but variable depending on the drug class) to the no-observable adverse effect level (NOAEL) as defined by pre-clinical studies in animals.

This training course was excellent and provided very practical information that will be useful to me as a Principal Investigator in clinical research studies.

May 22, 2011

Healthcare reform is a major issue in the 2012 presidential campaign.  If a presidential candidate really wants to fix the healthcare problem in the U.S., he or she will support the following fundamental changes.

Repeal Obamacare: The implementation of the new healthcare law is filled with controversy.  Over 1,300 organizations to date have been granted waivers (exemptions) from the law.  Over half of these organizations are labor unions, and many are favorite businesses in the congressional districts of Representative Nancy Pelosi and Senator Harry Ried, the authors of the new law.  Why have so many waivers been granted?  Frankly, it’s the worst law ever developed in the history of our country.  Despite all the false promises better care at a lower costs, it has already INCREASED health insurance costs.  In addition, the new unconstitutional law will put physicians and small business owners out of business, cut Medicare service choices for seniors, and destroy the high quality of healthcare that we currently have.  Don’t believe this?  Go look at the 2011 Massachusetts Medical Society’s healthcare data under Romneycare.  It’s pathetic.  Obamacare is about increasing federal government control of the healthcare industry and not about providing affordable high-quality healthcare to citizens of the USA.  The Supreme Court should quickly escalate the litigation by a multitude of states against this horrific law and trash it as soon as possible.

People Should Buy Their Own Health Insurance Independently of Their Employer: Employers need to stop providing health insurance as an employee benefit.  Alternatively, employers should use these cost savings to pay their employees more money so they can independently buy their own health insurance coverage.  People should buy their own health insurance just like they do auto, home, and life insurance.  This is the major fundamental problem of our healthcare system. Big businesses get a tax break for providing healthcare benefits purchased for employees, while small businesses do not.  It’s completely unfair.  The solution is to give incentives (tax breaks) to U.S. citizens that buy their own health insurance.  This is a big win for business too, as they no longer have to manage employee healthcare planning and administration.  This solution also takes care of the “portability” issue with health insurance when an employee changes jobs, i.e. you won’t have to change health insurance companies if you change jobs.

Increase Competition Between Health Insurance Companies: How?  Health insurance companies should be allowed to sell coverage publicly in all states just like auto, home, and life insurance.  There should be no restrictions for health insurance sales between states.  I guarantee that health insurance prices would decrease if the insurance companies had to compete selling to consumers.  I’d be delighted to hear see a television advertising pitch for health insurance from the GEICO Gecko!

Decrease Healthcare Malpractice Litigation Costs: Let’s follow the successful lead of Texas and put a cap ($250,000) on all “non-economic damages” (quality of life) damages awarded in medical malpractice suits.  This should decrease medical malpractice insurance costs for doctors and fees for their services.

Decrease Health Insurance Costs: Health insurance costs are driven up when government mandates coverage of specific “luxury” items.  Everyone will not need hair plugs, breast reduction, or in vitro fertilization, so everyone should not be expected to pay for these services.  Health insurance coverage needs to be reformed to cover essential healthcare services and minimize costs.  In addition, if malpractice insurance costs for doctors decrease, they should be able to minimize unnecessary testing, procedures, and costs practicing “defensive medicine”.

Provide Healthcare for People That Really Need It: Realistically, approximately 15 to 20 million Americans (5 to 6 %) cannot afford healthcare services.  The federal government should provide these people vouchers to buy health insurance coverage.  The IRS should also allow tax deductions for physicians that provide free medical care for people that really can’t afford it.

This is a tough issue, but the debate had increased critical strategic thinking for solutions.  For the sake of our nation, I pray that our future government leaders will get it right.

March 20, 2011

I recently won the Biggest Loser weight loss competition in the fitness center at the Mason Community Center in Mason, OH.  I lost 17.8 pounds in 8 weeks which included a marvelous 10 day vacation trip to Maui.  People keep asking how I did it and for “my secret”.  I jokingly tell people that I slept with my dog and got worms!

The key for my weight loss success was understanding the factors that control your body’s metabolism.  The paradox that is most surprising is that you have to eat to lose weight!  Your body is like a furnace.  To produce heat, the furnace has to burn fuel.  Your body is the furnace, and your thermostat is your metabolic rate.  You are the proud owner of your house (your body), so you must control the thermostat (your metabolic rate).

To lose weight, you must increase your metabolic rate to increase breakdown (metabolism) of fat stored in the adipose tissues of your body.  To keep a furnace burning, you need to add fuel.  Turning up the thermostat adds fuel to the furnace and produces heat for the house.

For your body, food is fuel.  Eating food increases your metabolic rate (dah .  .  .  WINNING!).  You must eat to increase your metabolic rate, burn fat, and lose weight.  Now get ready for this.   When you don’t eat, your metabolic rate actually decreases to stop fuel consumption and maintain your blood sugar levels so that you don’t pass out.

You can also turn up your internal thermostat (metabolic rate) by increasing physical activity.  Depending on your age and condition, aerobic exercise and strength training are ideal physical activities for increasing your metabolism, but simple household chores and walking are effective too.  If you have any concerns about your health or physical ability, consult with a health care professional or fitness expert before beginning a physical activity program for weight loss.

Secret #1:  To lose weight, you have to eat small amounts of food several times throughout the day.  Breakfast (“break the fast”) is an absolute must meal, and you should eat something soon after you wake up and BEFORE you exercise to start the furnace, maximize your metabolic rate, and burn excess stored fuel (fat).  In general, you should have a small snack between breakfast and lunch and again between lunch and dinner.  Again, this stimulates the metabolic rate and decreases hunger between meals.  For lunch and dinner, it’s all about portion control.  As a general rule, an ideal serving portion of protein or carbohydrate foodstuffs should fit in the palm of your hand.  Obviously, to lose body weight, you should minimize fatty foods.  For my weight loss, I never ate after 7:00 PM and routinely had a cup of hot tea after dinner.   The warm tea helps warm the food contents in your gastrointestinal tract and aids digestion.  You should never eat late at night prior to bedtime if you wish to lose weight.  The old cliche, “Eat breakfast like a king, lunch like a prince, and dinner like a pauper”, is spot on for weight loss and good health.

Secret #2:  To maximize increases in metabolic rate and weight loss, exercise AFTER a snack or meal.  Increasing your metabolic rate (exercising) before a meal does not increase your metabolic rate as much as exercising after a meal.  The furnace burns fuel most efficiently when there’s adequate fuel to maintain the fire.  Exercise is a stimulator of your metabolic rate like air is to a charcoal fire.  Opening the fresh air damper vents on a charcoal grill is much more effective at stimulating burning of the charcoal if there are already a few flames and simmering coals versus when the burning has been dampened for some time by closed vents or water.  Skipping meals and fasting decreases your metabolic rate and is counter-productive for weight loss.

I sure feel great after losing almost 18 pounds.  There really are no secrets to losing weight, but I hope this information helps you understand the basic metabolic principles for weight loss.

Will Obamacare Really Decrease Healthcare Costs for Americans?

April 28, 2011

Will Obamacare really fix the problem and decrease healthcare costs for Americans?  Unfortunately, no.  To understand the root problem and how to best reform and improve healthcare in the U.S., it is helpful to reflect on the history of government healthcare entitlements.

During World War II, President Franklin D. Roosevelt created wage and price controls to help finance the war.  As a result, healthcare benefits for employees became popular in companies competing to hire workers.  In 1943, the IRS ruled that healthcare benefits paid by employers were tax exempt and resulted in the creation of the first “third payer system”  for healthcare by the U.S. government.

This ruling was (and still is) highly unfair to small companies and self-employed entrepreneurs.  Large companies purchased health insurance for their employees with pre-tax dollars, while small businesses and self-employed people had to pay for healthcare benefits for themselves and their employees with after tax dollars.

In 1946, President Harry Truman approved over $4 billion to build non-profit hospitals to provide charity healthcare for the poor.  In the mid-60’s, the President Lyndon Johnson’s administration created Medicare and Medicaid to provide healthcare for the elderly and poor, respectively.

Despite all of these government entitlement programs, President Richard Nixon recognized that healthcare delivery was in crisis  and created health maintenance organizations (HMO’s) to control costs.  The HMO’s were effective at decreasing healthcare costs, but they were very unpopular with consumers.

President Bill Clinton asked his wife, Hilary, to lead the development of a universal healthcare plan.  The Hilarycare plan required that people buy health insurance and that employers provide HMO healthcare insurance benefits to all employees.  As expected, Hilarycare was very unpopular and defeated by Congress.

Despite all of this government intervention, healthcare costs in the U.S. (as a percentage of income) has increased dramatically from 4.6% in 1946 to 7% in 1964 and 17% in 1997.  According to the Center for Medicare and Medicaid Services, the government will be responsible for 52% of healthcare spending by 2019 under Obamacare with a cost for implementation of almost $1 trillion according to the Congressional Budget Office.

Under Obamacare, Medicare’s budget will be cut by $575 billion.  Seniors will see their healthcare costs rise even more and the quality of their care suffer.  To compensate, Obamacare will expand Medicaid but shift more costs to the states.  Many states are near bankruptcy and cannot support this disastrous plan.

Bottomline, the U.S. government created our healthcare cost crisis by initiating a third party payer system.  Obamacare will ensure that the government plays a larger role in healthcare delivery in the U.S..  Obamacare will not decrease healthcare costs for Americans young or old.  It will simply make the problem much, much worse.

Portions of the above narrative were exerpted from The Truth About Obamacare by Sally C. Pipes, Regnery Publishing, Washington, D.C., 2010.

“I am excited to initiate this new product development work with an exciting new medical device at Community Research”,  said Dr. Weingand.  He added, “Community Research is an ideal partner for this upstream exploratory clinical research”. Here, you can view the press-release about this partnership.

Podcasts
Health Today talk radio show produced and hosted by Dr. Kurt Weingand and broadcasted on 55KRC (550AM) in Cincinnati, OH.

July 5, 2009 show with Carol Frankenstein, President of Biostart, discussing life-science innovation and new start-up companies and Richard Wendal, M.D., a urologist, discussing prostate cancer.

July 12, 2009 show with Robert Collins, M.D. discussing the Bethesda North Hospital, Cincinnati, OH and Cathy Creger-Rosenbaum, Pharm.D., CEO of Rx Integrative Solutions, Cincinnati, OH, discussing holistic medicines.

July 19, 2009 show with Mr. Ron Rohlfing discussing the new Westchester Medical Center, Westchester, OH, and Rita Numeroff, Ph,D, President of Numeroff & Associates, St. Louis, MO, discussing healthcare reform legislation.

July 26, 2009 show with David Morad, M.D. discussing the healthcare services of Group Health Associates, Cincinnati, OH and Thomas Tami, M.D., Cincinnati Sinus Institute, discussing sinus disease.

August 2, 2009 show with William Sietsema, Ph.D. discussing the clinical research services of Kendle International, Cincinnati, OH and Mr. Tom Anthony, an attorney and executive with Frost-Brown-Todd law firm in Cincinnati, OH, discussing health insurance.

August 9, 2009 show with George Atweh, M.D. discussing the Barrett Cancer Center at the University of Cincinnati Academic Health Center and Kathleen Havlin, M.D., Associate Professor of Medicine, University of Cincinnati Academic Health Center, discussing breast cancer.

August 16, 2009 show with Ms. Laurie Burman discussing services of the Hearing, Speech, and Deaf Center of Greater Cincinnati and Gina Hounam, Ph.D., discussing hearing loss.

August 23, 2009 show with Ms. Julie Isphording discussing mental health services at the Lindner Center of Hope, Mason, OH and Gary Sweeten, Ed.D., discussing mental health disorders.

August 30, 2009 show with Lynn Sprafka, R.N, discussing nurse advocate services at Healthcare Navigators, Cincinnati, OH and Carl Rafey, D.C. discussing chiropractic spinal manipulation.

September 6, 2009 show with Ms. Pamela Watkins discussing services at the Cincinnati Weight Loss Center, Westchester, OH and Bradley Watkins, M.D. discussing obesity and weight loss.

September 13, 2009 show with David Argo, M.D. discussing the healthcare services at Beacon Orthopedics, Cincinnati, OH and Peter Cha, M.D., an orthopedic surgeon, discussing knee surgery.

September 20, 2009 show with Rita Numeroff, Ph,D, President of Numeroff & Associates, St. Louis, MO, discussing healthcare reform legislation.

September 27, 2009 show with Tom Ernst, P.T. discussing the services of Oxford Physical Therapy and Matt Ernst, P.T. discussing physical therapy.

February 5, 2011

U.S. District Judge Roger Vinson of Florida recently ruled that the individual mandate clause that forces Americans to purchase healthcare insurance was unconstitutional and that the entire law must be declared void. This ruling was similar to the one given by District Judge Henry Hudson.

So what’s next? A final ruling by the U.S. Supreme Court is likely needed. Until this happens, these District Court rulings essentially make the new law null and void. The Obama administration has indicated they will appeal these U.S. District Court rulings, but they have not yet issued a stay to continue implementation the law. If the administration moves forward implementing the law without a stay, they are technically in contempt of the U.S. District court. Per these rulings, several states (Florida, Wisconsin, and Idaho) have canceled their plans to administer Obamacare. The states know that they can’t afford the additional massive transfer of Medicaid costs to state budgets, so they want no part of the fiscal disaster it will create from sea to shining sea. They also don’t want to waste precious state funds and employee time implementing a controversial law that may be nullified definitively by the U.S. Supreme Court.

In an unprecedented move, the Commonwealth of Virginia has motioned to expedite a hearing of this important legal case by the U.S. Supreme Court. The Obama administration will likely oppose this motion in support of an appeal and hope that the opportunity to appoint another liberal Supreme Court justice comes soon. It’s truly ironic that the late Senator Ted Kennedy’s (D-MA) life-long goal for nationalized healthcare legislation could be voted down by someone that shares the same surname, Supreme Court Justice Anthony Kennedy.

The U.S. House of Representative has voted to repeal the entire law, but the Senate rejected this bill. Fortunately, both the U.S. House and Senate voted to repeal one of the law’s worst components, a new IRS form 1099 reporting provision for business expenditures of $600 or more. Until the Supreme Court rules on this landmark case, we’ll likely see more efforts to dismantle this legislative beast piece-by-piece.

This unbelievable legislative fiasco shows that the majority of Congressional members didn’t read or understand the new healthcare bill before voting it into law. Members of Congress should be required to read every piece of legislation and understand it before voting. That’s their job! Until they do this, Americans will be stuck with legislative garbage that wastes billions of U.S. tax payer dollars and falls woefully short of helping the American people.

Anti-Cancer Technology White Paper:   Bexion Pharmaceuticals has contracted with SciComPro-LLC for scientific communications work on an exciting new anti-cancer technology (SapC-DOPS nanovesicles). “We’re delighted to have Dr. Weingand working with the Bexion team”, said Ray Takigiku, CEO of Bexion Pharmaceuticals. Takigiku added, “Kurt’s expertise will really help us communicate our exciting new development results effectively”. Weingand developed a new White paper on SapC-DOPS nanotherapy for Bexion Pharmaceuticals. For more information on this exciting new technology, visit www.bexionpharma.com.

Health Today Talk Radio Sponsorship:  SciComPro-LLC® produced a new talk radio program, Health Today, on Clear Channel Communications’ 55KRC (550AM) in Cincinnati, Ohio, July through September 2009.  The program was sponsored by BIOSTART.  Recorded broadcasts of 13 talk radio shows are available for streaming and podcasting by clicking on News and Media.  Dr. Weingand produced and hosted this informative new talk radio show that focused on health news, regional health care providers, and a topic of the week with an expert guest to answer call-in questions.  If you are interested in learning more about this talk radio program and sponsorship opportunities, contact  Dr. Kurt Weingand at kweingand@scicompro.com.