Wednesday, October 31, 2007

In the Pursuit of Health & Wellness -- Is Alternative Medicine Complementary?

Not long ago, I received a notice regarding a 14-day belly-fat study sponsored by Curves and the Health & Wellness Center of Alexandria, Virginia. I was curious to sample the services and facilities of Curves, so I responded to the advertisement. Also, a belly-fat study sounded like an excellent complement to the medical advise of my rheumatologist.

During a routine visit in September, my rheumatologist inquired as to my exercise level and food choices. My initial reaction was one of guilt for becoming increasingly sedentary. However, my very smart rheumatologist quickly changed the focus of the conversation. She explained that abdominal fat (adipose tissue) produces specific proteins or cytokines (TNF-a and Interleukin-1) which are involved in systemic inflammation (as is associated with rheumatoid arthritis).

Some of the newer drugs for RA, including Enbrel, Humira, and Remicade, work to counteract interleukins and TNF-a. However, MS patients are restricted from using these drugs due to MS-like neurological side effects. Thus the non-pharmaceutical, anti-inflammatory prescription for reducing the production of these cytokines is to focus on reducing abdominal fat through exercise and nutrition.

This puts me, the patient, in charge of using alternative or natural methods to control the symptoms and dangerous effects of chronic disease. I'd say that I'm fortunate in that several of my doctors welcome an integrative medicine approach to disease management; however, my health insurance doesn't. For example, I do not have insurance-covered access to licensed dietitians or physiotherapists, although their guidance and expertise would be invaluable in helping to limit the effects of chronic disease. Unfortunately, you must be diabetic to have dietitian services covered by insurance and the only approved treatment for obesity is the extreme solution of gastric-bypass surgery.

The Patient as CEO of Personal Health and Wellness

In an ideal patient-centered healthcare system, the individual (ie. patient, consumer, client, CEO of one's own body, whatever you prefer to call yourself) should seek to obtain the most accurate and appropriate information available with which to make decisions regarding his/her choices in achieving a healthy body or treating a specific disease or disorder.

Although the CEO of a corporation does not need to obtain an education or degree in electrical engineering to run a company which uses computers, modern lights, or copy machine technology, he would be wise to harness the expertise of those who do have the knowledge and skills to maintain the desired electrical or technical systems required to facilitate the functions of the corporation.

Likewise the patient does not need to have a medical degree to be wise enough to seek guidance and care from a qualified, educated, and licensed medical or health professional.

License vs. Certification

In general, a license is a government-issued permission allowing the recipient the privilege to conduct business or engage in an activity which is otherwise prohibited. A licensing board determines the conditions and limitations which must be met to allow participation in certain professions or activities. Certification differs from licensing in that it is not issued as a permission to engage in certain activities. Certification serves to set standards, educate practitioners, increase competency, and to verify completion of a specific course of study.

The difference between license and certification can be significant when the patient-CEO is seeking the advise of a qualified healthcare practitioner. For example, consider the difference between dietitian and nutritionist.

Dietitian vs. Nutritionist

Dietitians have a Bachelor's degree specializing in foods and nutrition, and have completed an accredited internship at a hospital, or a graduate degree associated with an accredited hospital. They must pass a national registration exam and maintain their registration through continuing education. As dietitians are members of a regulated profession, they are held accountable for their conduct and the care they provide.

The term 'nutritionist' is not a professionally-regulated term and there are no minimum qualifications for an individual to call himself a nutritionist. Some nutritionists may give their businesses fancy names like "The National Nutrition Clinic" or "International Nutrition Center," but the truth is anyone can open up shop as a 'nutritionist' -- including the 16 year-old kid at the health food store.

What is Complementary and Alternative Medicine (CAM)?

According to the National Center for Complementary and Alternative Medicine (NCCAM), a component of the National Institutes of Health, CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. Conventional medicine is medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses. Some health care providers practice both CAM and conventional medicine.

While some scientific evidence exists regarding some CAM therapies, for most there are key questions that have yet to be answered through well-designed scientific studies -- questions such as whether these therapies are safe and whether they work for the diseases or medical conditions for which they are used. The list of what is considered to be CAM changes continually, as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge.

  • Complementary medicine is used together with conventional medicine. An example of a complementary therapy is using aromatherapy to help lessen a patient's discomfort following surgery.
  • Alternative medicine is used in place of conventional medicine. An example of an alternative therapy is using a special diet to treat cancer instead of undergoing surgery, radiation, or chemotherapy that has been recommended by a conventional doctor.
  • Integrative medicine combines treatments from conventional medicine and CAM for which there is some high-quality evidence of safety and effectiveness. Integrative medicine neither rejects conventional medicine nor accepts alternative therapies uncritically.

As part of the Department of Medicine at the University of Arizona Health Sciences Center in Tucson, the Program in Integrative Medicine seeks "to lead the transformation of healthcare by creating, educating, and actively supporting a community of professionals who embody the philosophy and practice of Integrative Medicine." Alongside the concept of treatment, the broader concepts of health promotion and the prevention of illness are paramount. Currently, there is no accrediting agency with the authority to endorse a comprehensive education in integrative medicine.

Integrative Medicine is not without critics as is evident in this post by Panda Bear, MD, this post at Respectful Insolence, and this post by The Physician Executive. And Musings of a Dinosaur discusses CAM here, here, and here. I would like to suggest that much research is being done which explains, or at least supports, the beneficial claims of some alternative approaches, including nutrition, acupuncture, deep tissue release, and others.

A book which I have found to be both highly educational and somewhat practical is "Prescription for Nutritional Healing" by Phillis A Balch, CNC and James F. Balch, MD. Research at NCCAM confirms many of the nutritional claims presented in this book now in it's 4th edition.

Back to the Curves/Health & Wellness Center Study

When I answered the advertisement, the woman on the phone told me that I needed to attend a Seminar on Monday night before beginning the study. Since I teach lessons every weeknight, I could not attend but was scheduled an appointment to see the doctor instead. I was told that the doctor would want to conduct a pre-study analysis which seemed reasonable to me.

At the Health & Wellness Center, a video of a lecture was playing in the waiting room. I found that a little annoying while trying to concentrate on filing out all of the paperwork and then reading the handout of recommended dietary guidelines. During the appointment, an assistant measured my weight and height (I was not asked to remove my shoes), asked for a urine sample in a non-sterile container (no instruction given or disinfectant wipes provided for a 'clean catch' sample), took my blood pressure while laying down and then while standing upright (no time elapsed to allow arm to recover between pressure readings), and finally a Heart Rate Variability test while laying down and then standing up (I was told this registered my heart's ability to respond to stress).

While waiting for the doctor, I continued to read the literature provided and make note of the posters and notices placed on the walls. One large poster illustrated the acupuncture points used in Traditional Chinese Medicine. [I have a friend who is an acupuncturist and her treatments have helped me tremendously in dealing with pain and stiffness.] However, no diplomas or certifications were prominently displayed in Dr. Berg's office.

One of the first things that the doctor discussed after introducing himself was the urine test which showed a pH level of 7.0 and elevated leukocyte level. I was told that my pH was completely neutral which needed to be addressed and that the elevated leukocyte level indicated a possible urinary tract infection. The first thing I asked was "what is a normal pH level for a regular person and then what is a normal pH level for someone who takes the medications I do?" It was at this point that the doctor looked down at my forms and replied, "Oh, you are taking a lot of medications. What are these for?"

The red flag began to rise.

I referred to the form where I had carefully listed each medical conditions including multiple sclerosis and rheumatoid arthritis. I also stated cheerfully that, yes, I had double-dipped in the autoimmune pot. Then the doctor showed me a graph which illustrated the results of the Heart Rate Variability test. Apparently, my heart did not show optimum strength and resiliency. The doctor explained it was like 'I had one foot on the gas pedal while the other foot was on the brake pedal.'

The doctor further explained that I likely had problems with my adrenals and thyroid. He encouraged me to attend the next seminar he was offering on Saturday morning in order to get the full amount of information I would need to complete the study. I agreed to attend. But I'll tell you now that if the advertisement had mentioned a Seminar, I would not have responded. Due to recent experience at unrelated seminars (1,2), I have become quite suspicious of such offerings.

At The Seminar

At the Seminar, Dr. Eric E. Berg discussed the influence of hormones on the storage of body fat as is discussed in his recently published book, "The 7 Principles of Fat Burning." To accompany the book, Dr. Berg has made available an online software program, called the "Fat Burning Tracker," which purports to track the hormonal influences of specific foods and activities. It was at the seminar that I first learned Dr. Berg is a chiropractor, a minor detail which had been glossed over until this point.

During the demonstration portion of the seminar, Dr. Berg illustrated a system of muscle-testing various points on the body to locate energy blockages which help to determine weakness in a correlating endocrine system. After further research, I have identified Dr. Berg's technique as Contact Reflex Analysis (CRA), a system of analysis using reflex points on the body and muscle testing which seems to be rooted in the theories of Applied Kinesiology. CRA is not widely accepted in conventional medicine as is evident in this article by Stephen Barrett, MD - "Contact Reflex Analysis is Nonsense."

Also during the seminar, I browsed the "7 Principles" book and noted that much of the material seems to have been taken from Guyton/Hall - "Textbook of Medical Physiology" and Faigin - "Natural Hormonal Enhancement". To promote and ensure the success of this latest book, Dr. Berg employed the services of Gilleard Market Research. I have to admit that the 'Fat Burning' site is very snazzy and presents an interesting approach to educate the user on the interactions of nutrition, hormones, and health.

The Health and Wellness Center and BRT

The Health and Wellness Center is owned and operated by Dr. Eric Berg, D.C. He is a Certified Doctor of Chiropractic by the Virginia and California Boards of Medicine. [California license expired in 1995.] Dr. Berg is the developer of the Body Restoration Technique. The Northern Virginia center is the main training and intern location for over 1,000 healthcare practitioners around the world. The practitioners working at The Health and Wellness Center have been hand-picked and have achieved master-level certification in the BRT technique. When a client comes to our office, we consult them and recommend the best method approach using foods, exercise and nutrition. Our policy is that we never take on a patient who we can't help.

Although Eric Berg does have a valid license to practice Chiropractic Medicine issued by the Virginia Department of Health Professions, its current expiration date is March 31, 2008. Dr. Berg has been under investigation by the State Board of Medicine regarding his unique techniques and has been instructed to "cease and desist the use of, and any and all advertising pertaining to, BRT, NAET, CRT, ACG" among additional requirements to keep his license.

Here's a selection of techniques and certifications referenced in Berg bios:

Various Websites dedicated to the work of Dr. Eric Berg:

Here are various concerns expressed online by others regarding adjacent businesses headed Dr. Eric Berg and Karen Berg (his wife):

Personal Take-Aways

First of all, I don't wish to get involved in a discussion regarding the teachings or techniques of Scientology or the practices and techniques of trained Chiropractors. However, I do see some validity and benefit to Acupuncture and Traditional Chinese Medicine and I have found huge relief in the unique deep-tissue massage and range-of-motion techniques of Thai Yoga Massage. Finally, I hope that all readers can agree that our choices of food and exercise affect our health and well-being.

However, if medical professionals and health insurance companies continue to avoid involvement with scientifically-sound integrative medicine treatment options, it is reasonable to think that more patient-CEOs will unwittingly seek the guidance of self-proclaimed 'experts' on any number of specialties and treatment modalities.

Regarding the dietary guidelines of the belly-fat study, I have proactively decided not to make drastic changes in my diet (such as drinking a cranberry juice/lemon juice/apple cider vinegar concoction) which may or may not put undue strain on my liver. As it is, my blood is monitored regularly to detect any potential problems with liver functions caused by pharmaceutical medications. I don't need to make things worse.

Wednesday, October 24, 2007

Study Shows Protein Linked to Male Infertility - Implications for Potential Birth Control Drug

Picture the healthy sperm. Valuable DNA stored in the head is propelled by a powerful tail on the quest to create life bigger than itself. Once the sperm reaches the egg, a battle of strength and strategy ensues. The egg is protected by a tough outer shell which the sperm must penetrate. If the sperm is successful in breaking through that barrier, cellular union and division begin, creating the magic of new life.

But what if the sperm isn't powerful enough to break through the shell? What if the sperm has the density of, say, a water balloon or a bag of sand? What if the mighty sperm doesn't possess the force of a battering ram?

For sperm to become a battering ram, it must "compress into a tight ball before springing into action." In the nucleus of the sperm cell, strands of DNA are wrapped around spools of protein called histones. Chemical tags, such as methyl groups affixed to the histones, govern how tightly the DNA can be compacted.

Scientists at the University of North Carolina at Chapel Hill have identified a gene crucial to the sperm's ability to "scrunch up tightly enough" to penetrate the egg. In this study, mice genetically engineered to lack this crucial gene had smaller testes, a significantly lower sperm count, and were infertile. In addition, the few sperm that were produced by these mutant mice displayed significant morphological defects, including abnormally shaped heads and immobile tails.

"In order for sperm to be able to enter the egg, the sperm chromatin has to be tightly packaged," said Yi Zhang, Ph.D., Howard Hughes Medical Institute investigator and professor of biochemistry and biophysics in the UNC School of Medicine. "It must become like a dense ball, so that when it hits the egg, it can penetrate. And in order for this DNA to be tightly packaged, the histone proteins must be replaced by other basic proteins."

In their experiments, Zhang and his colleagues explored the function of the enzyme Jhdm2a which is a histone demethylase. Histone demethylase enzymes activate genes by snipping molecules called methyl groups from histones. Histone proteins make up the "smart stuffing" in chromosomes-the core of proteins around which the DNA winds so that it is packaged compactly.

The research team, led by Howard Hughes Medical Institute investigator Yi Zhang, published its findings online in Nature on October 18, 2007. Zhang and his colleagues at UNC collaborated on the studies with researchers in the Laboratory of Reproductive and Developmental Toxicology at the National Institutes of Health. The research was funded by the Howard Hughes Medical Institute and the National Institutes of Health.

The researchers focused on the function of Jhdm2a because earlier studies had indicated that the gene for this protein is highly active in the testis and that Jhdm2a protein levels are highest during sperm maturation. The studies show that if this key protein is missing, the genetic material, called chromatin, does not condense normally, a process which is necessary for fertilization to be successful.

Zhang said that although their study was done in mice, it might well have implications for understanding some forms of human infertility. "Because this gene has a very specific effect on the development of functional sperm, it holds great potential as a target for new infertility treatments that are unlikely to disrupt other functions within the body."

Drugs that affect the Jhdm2a enzyme might have clinical use. "A small molecule that enhances the enzyme's activity could be a useful fertility drug in cases where compromised function of the gene has caused infertility," Zhang said. "On the other hand, a small molecule that inhibits the enzyme's activity could be a potential birth control drug."

Zhang and his colleagues are now looking for mutations in this gene in infertility patients, and are also interested in identifying the partners or cofactors in the cell that help this gene do its job. "Although a number of histone demethylases have been identified, very little is known regarding their biological functions, particularly in the context of whole animals," said Yuki Okada, Ph.D., a postdoctoral fellow in Zhang's laboratory and lead author on the study.

Study co-authors include Greg Scott, Manas K. Ray and Yuji Mishina from the National Institute of Environmental Health Sciences.

Rx Outreach Rocks! Great Assistance Program for Generic Medication; PhRMA's Billy Tauzin at it again

Rx Outreach -- "A Safe, Affordable, and Easy Way to Get the Medicines You Need"

I just have to say that Rx Outreach truly does provide a valuable and easy service to patients, unlike some other more highly promoted programs (ie. PPArx).

After being denied a request for additional assistance in receiving my MS medication last summer (2006), I began an extensive search of prescription assistance programs and trudged through the lengthy application process. At the time, a number of my other medications were not yet available in generic form, but they are now.

With the increased availability and use of generic medications, patients' options have been expanding and innovative programs have been cropping up to serve those patients. Wal-Mart's $4 Live Better Prescription Program has sparked competition in other large retail stores including Target which has established it's own $4 Prescription Program.

To date, none of my generic medications are included on the $4 lists at Wal-Mart or Target, but they are available through Rx Outreach with a reasonable handling fee. Rx Outreach, a program of Express Scripts Specialty Distribution Services, Inc., currently provides 129 generic medications to eligible patients (income below 250% FPL) with an easy-to-complete application form.

According to the customer service agent I spoke with this summer (2007), the program was established in 2005 to assist uninsured and underinsured patients. Since many of the patients they help are elderly, Rx Outreach has designed an extremely easy application process. Amazingly, the only proof required for income eligibility is YOUR WORD.

Imagine assistance program which honors the "honor system."

The refill process is simple. I received a Refill Reminder letter in the mail.
"We are sending you this letter to let you know that it is time to refill the following medication(s)." If you choose to refill by phone, an automated system is available 24/7 and customer service is available monday-friday. To refill by mail, simply use the form provided and include payment in the enclosed envelope (no need to add postage.)

Throughout the process, each customer service agent I have spoken with has been friendly and helpful. I am extremely please with their service.

Rx Outreach is managed by Express Scripts Specialty Distribution Services, Inc. (ESSDS), a fully licensed mail order pharmacy that is committed to making the use of prescription drugs safer and more affordable. It is not an Internet pharmacy. ESSDS manages more than 55 patient assistance programs (PAPs) for major pharmaceutical companies, serving millions of individuals.

ESSDS developed Rx Outreach to provide a safe, affordable, and easy way for people of all ages to get medicines they need. The program offers prescription medicines to uninsured individuals and families, as well as those who have limited prescription drug coverage.

On a slightly related topic:

I think that it is disgusting that Pharmaceutical Research and Manufacturers of America (PhRMA) is using the tragedy of the California wildfires to promote their sham of a service, Partnership for Prescription Assistance (PPArx). I have spoken before about PPArx and not much has changed.

When I called their number this summer, I was 'assisted' by a man who didn't really speak English at all. In fact, we had to resort to spelling everything in 'alpha, beta, charlie, echo' lingo. Now just think about most medications....that's extremely tedious at best.

Then I waited....and waited...and waited...and finally received their specially-prepared 'package' almost two months later. Ironically, the 'package' omitted applications for programs which I knew were available (I was instructed to contact the program directly for more information) and included applications to programs for which I knew I was not even remotely eligible.

What a waste of time, energy, and resources.

Here's PhRMA's recent press release:

Help For California Fire Evacuees Possible
Through Partnership for Prescription Assistance

Washington, D.C. (October 23, 2007) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin issued the following statement regarding the California wildfires:

“Californians who have been affected by the recent wildfires -- and who are uninsured or underinsured -- should know that help getting the medicines they need may be available through the Partnership for Prescription Assistance. The PPA, sponsored by America’s pharmaceutical research companies, is dedicated to helping Americans who lack adequate health care coverage. Now, as residents of southern California face the destruction being caused by these wildfires, the PPA is offering to help qualified patients get assistance even faster.

“Struggling Californians who are having trouble getting the medicines they need may find expedited help through PPA’s disaster relief program by calling the PPA’s toll-free number [info redacted]

“Since April 2005, the PPA has helped more than 4.3 million uninsured or underinsured Americans – including 250,000 in California – find programs that provide prescription medicines for free or nearly free. It helps patients in need obtain access to more than 475 public and private patient assistance programs, including 180 programs offered by pharmaceutical companies. The PPA can also help Californians find out about programs offered by the state, such as Medi-Cal, Healthy Families and Access for Infants and Mothers.

“In addition, the PPA provides information on nearly 10,000 free healthcare clinics and has connected more than 163,340 patients with clinics and healthcare providers in their communities.

“Through the PPA, America’s pharmaceutical research companies are continuing to make tremendous inroads by assisting struggling Americans who need it most, and this is especially true during California’s time of need.”

More than 1,300 national and local organizations, including the American Academy of Family Physicians, American Cancer Society, Easter Seals, National Urban League and the National Association of Chain Drug Stores, are working with America’s pharmaceutical research companies to help spread the word about the PPA.

Health Affairs Summit in DC - Nov 1, 2007

Thanks to Joe Paduda for reminding us that the Health Affairs -- 2007 Health Policy Summit is taking place next Thursday at the Ronald Reagan Building and International Trade Center, Washington, D.C.

For those who may not know, I live inside "the DC Beltway" and although my interest in health policy is recent, I would love to attend. Not being a professional in health policy, is it possible to attend as a "fly on the wall"? Even if it were allowable for an individual to attend, the registration fees are beyond my budget.

Does anybody have any ideas?

$950 - Standard Summit Registration
$500 - Nonprofit/Academic Summit Registration
$250 - Government Summit Registration

Please note: Registration for the Summit and Gala closes on October 25, 2007. There will be no onsite registration available.

Generic Biotech Drugs -- The House Energy and Commerce Committee meeting to consider establishing a Regulatory Pathway for Follow-On Biologic Drugs

"The Access to Life-Saving Medicine Act — introduced by Congressman Henry Waxman (CA)would provide a statutory pathway for the Food and Drug Administration (FDA) to review and approve generic biologic therapies."

The cost of biological multiple sclerosis treatments — $16,500 to $29,000 each year — can unfortunately force many people to stop their prescribed therapy because they just cannot afford it. More affordable, generic options for this fast-growing and expensive category of drugs are not yet available. Many people living with MS and other diseases depend on biological drugs to sustain or improve their quality of life. For MS, those therapies include Avonex, Betaseron, Copaxone, Novantrone, Rebif, and Tysabri.

It is the case too often that prescription assistance programs are insufficiently funded, have extremely strict eligibility requirements, or simply do not offer assistance for these biologic drugs due to the extreme cost. Listen to a recent NPR broadcast on this issue (transcript provided below). It includes the story of Donna Gosbee of Wyoming who lives with MS and her struggle to afford therapy.

Biologic (also known as biological or biotech) drugs are produced from living cell cultures rather than synthesized chemically. The generic drugs that are currently available are synthetically exact copies of the brand name original, based on a precise chemical composition. Generic versions of biologic drugs, on the other hand, would need to allow for nuances in the cell cultures while meeting certain parameters that are strict enough to ensure they are just as safe and effective as the originals.

The U.S. Senate has passed legislation that would establish a course for approving safe, effective, affordable, and comparable versions of biologic therapies for MS and other diseases. Unfortunately, the House still has not yet taken up a similar bill. Members of the House of Representatives will be meeting this month to talk about creating a pathway for the approval of follow-on biological drugs. Reports indicate that members of the House Energy and Commerce Committee will meet on October 31 to discuss the issue.

It is imperative that the House Energy and Commerce Committee take action on this bill, where Congressman John Dingell (MI) and the rest of the committee will help shape the final legislation. The time for Congress to take action is now. The Access to Life-Saving Medicine Act — introduced by Congressman Henry Waxman (CA) — would provide a statutory pathway for the Food and Drug Administration (FDA) to review and approve generic biologic therapies.

Take a minute to write your Representative today. Ask them to move forward with the Access to Life-Saving Medicine Act (H.R. 1038). Congress can provide the FDA with a pathway for approving safe, effective, and lower-cost versions of biologic drugs. And give people living with MS and other diseases more affordable options for therapy.


History of the Access to Life-Saving Medicine Act (H.R.1038)

On February 14, 2007, Rep. Waxman, Rep. Jo Ann Emerson, and Rep. Frank Pallone, Jr., along with Senators Charles E. Schumer and Hillary Rodham Clinton introduced H.R. 1038, the “Access to Life-Saving Medicine Act,” which will establish a process through which the FDA will be able to approve lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals. Other original co-sponsors are Reps. Rahm Emanuel and Mazie Hirono, and Senators David Vitter, Susan M. Collins, Patrick J. Leahy, and Debbie Stabenow. Biotech drugs, which are produced from living cell cultures rather than synthesized chemically, are among the fastest growing and most expensive components of the nation’s drug bill. Currently there is no statutory pathway for biotech drugs, and manufacturers of biotech drugs can charge monopoly prices, indefinitely.

Generic drugs (first made possible under the 1984 Hatch-Waxman Amendments) have been extremely successful in bringing down the high cost of prescription drugs. Generic drugs save patients and payers $10 billion a year. But there is no generic competition for one of the fastest growing and most expensive category of drugs: so-called biotech drugs, also known as biological drugs or biopharmaceuticals. It is common for these drugs to cost tens of thousands of dollars a year, even after patent expiration. Many patients are now denied access to these important drugs because even the co-payments can reach thousands of dollars a year. And the sky-rocketing cost of biotech medicines is imposing increasing burdens on employers, insurers, and the federal government. Introducing fair competition for biotech drugs is essential to keep these life-saving treatments affordable.
Press Release - Rep. Waxman's Statement - Background on Biologics - Bill Summary - Quick Summary - Bill Text - Letters of Support


NPR Health & Science: All Things Considered, August 9, 2007

Are Generic Biotech Drugs Coming Soon?
by Joanne Silberner

Correction: At the time this story aired neither the House nor Senate had voted on legislation. There have been two hearings in subcommittees of the House of Representatives, and a Senate committee has approved legislation.

All Things Considered, August 9, 2007 · While Congress is away this month, House and Senate staffers are working on a bill aimed at helping patients who rely on innovative biotech drugs that can cost as much as several thousand dollars per month.

Generic versions of the drugs would surely be cheaper, but opponents of generic versions say that making sure the knockoffs are safe and effective may be trickier than it sounds.

Donna Gosbee, 51, came from Wyoming to Washington, D.C., to attend a meeting of the Multiple Sclerosis Society. She is using a walker.

"I never know from one day to the next until I put my feet down on the floor whether I'm going to be able to walk," Gosbee says.

Gosbee was diagnosed with multiple sclerosis four years ago.

"The doctors put me on one of the biologics, Betaseron," she says. "I've been on it for three years now and this drug costs $1,500 a month."

The government helps Gosbee with some of the cost, but she's worried the help won't always be there. So she came to Washington to lobby Congress.

Lobbying for Change

"I'm going to talk to Wyoming legislators to try to convince them that medications are just out of reach of the normal person," Gosbee says.

A generic could significantly cut her medical bill. At, for example, the generic version of the statin drug, Mevacor, is only one-third of Mevacor's price.

But Gosbee's drug is manufactured very differently — by living, bioengineered cells.

They make molecules that are much bigger than most conventional drugs, and a lot more complex, says Roger Williams, CEO of U.S. Pharmacopeia, a nonprofit organization that sets standards for drug manufacturers.

"If I showed you on a page the molecular structure of a biologic, it might cover two pages just of carbons and nitrogens and hydrogens and oxygens," Williams says.

In contrast, he says the structure of many conventional drugs fill less than half a page.

Williams says making conventional drugs is like snapping together Tinker Toys. You add one chemical after another, and the manufacturer is very much in control.

Making a biotech drug is more like farming. You start with a living cell, then keep the temperature, the nutrients and other growing conditions just right. Just as wheat grown from a different seed stock or under different conditions will produce slightly different grain, different versions of biotech drugs can vary — even when made by the same company.

The Process of Biotech

In Gaithersburg, Md., a company called MedImmune makes the biotech drug Synagis. The drug fights a virus called RSV that can kill premature babies.

Just getting into MedImmune takes work — you have to put on gloves, booties and a double set of what look like surgical scrubs.

You must also go through multiple airlocks. Sterility is important for conventional drugs, too, but it's especially important here. If bacteria or viruses get into the cell cultures, they could disrupt the manufacturing process and wind up in the final drug.

Workers take large beakers of living cells in culture from a refrigerator. The cells go into gleaming metal vats the size of small cars.

"This is the start of our bioreactor train," explains Tony Luttrell, MedImmune's vice president.

There are enough pressure monitors and temperature gauges and pipes to make a science-fiction movie proud.

Conventional manufacturers use temperature gauges too, as well as vats filled with buckets of chemicals.

But these biotech vats hold mouse cells, each one loaded up with human DNA. The human DNA is directing the cells to produce a particular protein — an antibody that can fight RSV.

If you want to make a copy of MedImmune's drug, you would have to insert some human DNA into mouse cells in a precise way — a way that will produce that protein. It's a real challenge.

"One little genetic change, one little change in the way the protein is configured or the way the proteins fold onto each other may have an effect on how it actually acts in the clinic," Luttrell says.

Then you have to be really careful about how you grow the cells, Williams says. For example, temperature can make a big difference. Look at albumen — the protein in egg whites.

"If you take egg white and cook it, that's OK to eat, but it's no good to the chicken anymore," Williams says.

Generic Outlook

Williams thinks some biotech drugs could be made generically. But the only way to know for sure that a different version would be just as safe and effective is to perform lengthy and expensive testing in animals or people — something that's not required for conventional generics.

There have been two hearings in subcommittees of the House of Represenatives, and a Senate committee has approved legislation. Staffers are now working to develop legislation that can win approval.

But don't hold your breath — companies that make brand name drugs are still adamant that testing in people should be required.

Patients and generic companies waiting for less expensive drugs aren't happy either. Both bills would make generic companies wait 12 years before they could market a cheaper drug, not much different from conventional generics, but a long time when you're spending several thousand dollars a month to fill a prescription.

Copyright 2007 NPR

Saturday, October 20, 2007

Genetics -- Improving Health Care

In March 2006, an article by Erika Jonietz, "Getting Personal about Drugs," appeared in Technology Review. The topic of discussion -- the use of genetic testing to alter physicians' prescription writing decisions.

Getting Personal about Drugs

The age of "personalized medicine" has arrived, but chances are your doctor doesn't know it yet. Existing tests can analyze patients' genetic makeup to provide guidance on whether certain drugs--such as codeine, antidepressants, and even some cancer medications--will help them, harm them, or do nothing. And a host of even newer "pharmacogenetic" tests are now in the pipeline.

But the existing tests aren't widely ordered by doctors, a fact that bothers David Flockhart, chief of clinical pharmacology at the Indiana University School of Medicine. Flockhart, who has developed genetic tests to help guide the prescription of diabetes and high-blood-pressure drugs, says doctors are generally uneducated about the availability of such tests. But he predicts that that will change if the U.S. Food and Drug Administration recommends that doctors test two specific genes in all patients prescribed a widely used anticoagulant.

  • Technology Review: In November, an advisory subcommittee you sit on recommended genetic testing for patients being prescribed warfarin, a drug used to treat blood clotting and stroke. Why did you make this recommendation?
  • David Flockhart: If the FDA accepts the commendation, this will mean that it suggests everyone prescribed this valuable medication receive a genetic test at the start of warfarin treatment in order to ensure less costly and medically simpler treatment courses in which patients have fewer bad bleeding episodes and reach a stable, effective dose more quickly. It will bring pharmacogenetics for the first time to thousands of
    general practitioners and family practitioners.
  • TR: But the FDA has already approved a number of genetic tests to guide prescriptions. Aren't doctors using them?
  • DF: No. The big, big market is going to be in doctors' offices and hospitals, but it's really only now starting there. A major problem is going to be educating physicians who are, as yet, relatively uneducated about the availa­bility of genetic tests to guide some of their prescribing decisions.
  • TR: How long will that take?
  • DF: Every one of the large clinical-­testing labs is jockeying for position to try to exploit the large, anticipated growth in this kind of testing. The movement of these tests into the clinic will happen gradually with fits and starts.... Demand will kick in within a year or two, as patients realize the power of these tests. That will be the biggest driver.
In September 2007, an article by Steven Reinberg, "Drug Industry Seeks Tests to Spot Side Effect Risks," appeared in HealthDay introducing a newly formed non-profit organization called the International Serious Adverse Events Consortium (SAEC). The Consortium, which includes seven of the biggest Pharma giants, will study how DNA and genetic markers may account for the serious adverse reactions some patients experience to a prescribed medication.

Drug Industry Seeks Tests to Spot Side Effect Risks

Seven major pharmaceutical companies are banding together to develop genetic tests that predict which patients will have adverse side effects from drugs.

The group, a nonprofit organization dubbed the International Serious Adverse Events Consortium (SAEC), will conduct two studies, one to look at drug-related liver toxicity and the other aimed at a rare drug-related skin condition called Stevens-Johnson syndrome.

"SAEC's focus is to identify and to validate DNA variance or genetic markers that are useful in predicting a drug-induced serious adverse event," Arthur Holden, the chairman of the group, said during a midmorning teleconference Thursday.

The findings of the consortium could have an impact on improving the ability of patients to safely use existing drugs, Holden added. "We hope it will improve the productivity and
effectiveness not only for those who develop drugs but for those who regulate drug development," he said.

"The immediate goal would be to develop a test that could identify who will have a problem with a drug before they get it," said Dr. Paul Watkins, director of the General Clinical Research Center at the University of North Carolina in Chapel Hill.

"The ultimate goal is to look at the genes that are causing the susceptibility and work back to figure out how we can design drugs differently so that no one would have that problem," he added.

"The two drug reactions that are being studied, Stevens-Johnson and liver toxicity, are very common reasons for problems with drugs either being restricted, not being developed, not being approved or being pulled off the market," said Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer at the U.S. Food and Drug Administration.

"This effort is part of personalized medicine -- personalized safety -- that will make treatments safer by understanding individual benefits and risks," she added. "This will help in
the development of drugs both in avoiding these side effects in the future and maybe developing tests to help identify people at high risk," she said.

Findings from these studies could lead to the FDA requiring genetic tests to determine risk before the drug is prescribed, Woodcock added.

A recent survey found that most Americans are more concerned with drug safety than with speeding more medications to the

Members of the consortium include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Pfizer, Roche, Sanofi-Aventis and Wyeth. In addition, the FDA will consult on the design and conduct of SAEC studies.

The actual research will be done at academic centers in Europe and the United States.

The results of the studies will be made public domain, and none of the companies will have early access or be allowed to patent the findings. When the results are made public, any company can develop and sell the genetic tests that predict side effects.

SAEC is one of several consortiums formed by the pharmaceutical industry to conduct basic research. One of the first was started in 1999 and was headed by Holden. That consortium looked for DNA variations among people. Their data were also put into the public domain.

The Associated Press' Linda A. Johnson also covered the announcement, "Drug Makers, FDA Partner on Drug Safety." According to Arthur Holden, the consortium's chief executive, the project could bring breakthroughs that change patient care in as little as five years. Holden envisions that an individual's standardized profile of key genetic variations could be checked before he is put on a new drug that has known, gene-related risks. Holden said, "employers and insurers now spend far more on hospitalization of patients harmed by serious adverse effects than what genetic tests would cost once they are common."

Drug Makers, FDA Start Global Partnership to Make Drugs Safer

A rare collaboration of top pharmaceutical companies, regulators and university researchers has begun attacking one of the toughest problems in medicine: why severe drug side effects strike a small percentage of patients.


Pharmaceutical companies have a lot at stake. Serious adverse reactions during testing generally doom experimental drugs, and ones that surface after a drug is on sale often lead to it being pulled from the market or having its use restricted.

"If you can prevent these types of reactions, it's going to have a significant impact on health care," because adverse drug effects cause considerable illness and death, said Raju Kucherlapati, scientific director of the Harvard Medical School-Partners Healthcare Center for Genetics and Genomics, who is not
involved in the project.

Holden envisions people getting standardized profiles of key genetic variations, which then could be checked before they are put on a new drug that has known, gene-related risks. He said employers and insurers now spend far more on hospitalization of patients harmed by serious adverse effects than what genetic tests would cost once they are common.


Dr. Franklyn Prendergast, director of the Mayo Clinic's Center for Individualized Medicine, said that given the clear evidence that genetic variations put some patients at high risk of bad drug effects, he is sure the project will have a big impact. He added that making its findings available to scientists worldwide will help "profoundly" in related research.

Holden said the participating drug companies together have put up millions of dollars to fund the work. Other partners include Columbia University, which will coordinate and analyze data, plus the European Agency for the Evaluation of Medicinal Products and two academic consortia in Europe, called Diligen and Eudragene.

The SAEC is also discussed on Pharmalot, "Pharma and Academia Form Consortium to Study Side Effects and Genetics," and the Wall Street Journal Health Blog, "Drug Makers Gang Up on Side Effects."

Fortunately, big pharma is not the only source of research for genetic testing to benefit patients' health and lives. In October, the Howard Hughes Medical Institute (HHMI) announced the addition of 15 physician-scientists to their team of investigators nationwide. (See "Improving Patient Care through Science: The Howard Hughes Medical Institute adds 15 Patient-Oriented Researchers")
“These 15 physician-scientists are changing the way we think about and treat a variety of diseases,” said HHMI President Thomas R. Cech. “The impact of their research is already being felt by people suffering from malaria in Africa, by those with post-traumatic stress disorder in the United States, and by people worldwide with leukemia or lung cancer. As a group, they have demonstrated extraordinary creativity and innovation.”

One of the newly appointed HHMI investigators is Vivian Cheung, M.D., Associate Professor of Pediatrics and Genetics at the University of Pennsylvania School of Medicine and The Children's Hospital of Philadelphia. Ultimately, Cheung would like to see genetic tests become an essential component of medical care.

“My dream is that eventually everyone will have a genetic test done, so we'll know how best to treat that person.”

Dr. often frustrated about how little knowledge in basic research has been translated into patient care. She is especially interested in a disorder called ataxia telangiectasia, a genetic disease that first appears in young children. It presents particular challenges to doctors because children with the disease—characterized by neurological problems, immunodeficiency, and cancer—can react very differently to treatment. “Many patients suffer side effects from the therapy we give them,” she says. “How do we make sure we do more good than harm?”

Cheung wants to create a genetic tool that will give physicians
the information they need to make better decisions. Such a test, built from genetic data from her own studies, would predict a patient's response to the most commonly prescribed therapeutics to “guide physicians and patients in selecting therapeutic options and designing preventive care,” she says.

“When you walk into a doctor's office, you want the doctor to look at all your relevant risk factors, not just whether you
smoke and other matters of lifestyle, but also risk factors that differ by gender, by family medical history, even by ethnic group,” says Cheung. “We're starting to see genetics play a role
in that process, but it's not a major focus of most medical practice.”

Cheung wants to change that. Genetics should be a “foundation of predictive and preventive medicine,” she says, not just a “medical subspecialty.”

Cheung studies the effects of genotype—the sequence of DNA letters on a person's chromosomes—on phenotype—a person's observable traits. But the phenotypes she studies are unusual. She uses DNA microarray technology to measure the expression levels of genes in a cell. “Gene expression is a very convenient phenotype, because we can take a large number of measurements quickly using microarrays,” she says. “And
understanding gene expression has a direct impact on disease, since disease is almost always associated with an aberration of gene expression.”

Cheung and her colleague Richard Spielman at the University of Pennsylvania have done a large study linking differences in DNA sequences to differences in gene expression. Using extensive genetic data collected from families and from the International HapMap Project, which has catalogued genetic differences among people from Asia, Africa, and Europe, they identified thousands of places in the genome that affect gene expression. Many of these regulatory regions are quite distant from the genes they help control.

Now Cheung's group is working to apply this knowledge directly to medical practice. They are studying how gene expression changes in response to various therapeutic agents, such as drugs and radiation, in cells from different individuals. They then connect the differences in responses that they observe to sequence variations in the regulatory regions.

The result will be a map of regulatory regions that can be used to predict how a person will react to a given drug or treatment.
Cheung wants to use information from this kind of basic science research to guide diagnosis and treatment of diseases so that a doctor will no longer have to start a patient on one drug and wait for a reaction to decide whether to continue the drug or try something else.

Ultimately, Cheung would like to see genetic tests become an essential component of medical care. “My dream is that eventually everyone will have a genetic test done, so we'll know how best to treat that person.”

So what does this mean for patients, insurers, and employers?

Once everybody has had their standard genetic tests done, which will certainly be included in our universally-accessible electronic medical records as part of improved health IT, how will those results be used?

Will insurers find a way to charge higher premiums based on your genetic make-up? Will the elimination of severe adverse drug reactions create a system of severe adverse selection problems in acquiring insurance?

Will employers discriminate, ...I mean manage risk..., based on the potential cost of your future healthcare needs?

Will patients make choices based on the implications of their genetic code?

Will "individualized medicine" negate the efforts of agencies in establishing standard protocols and strict requirements for "evidence-based" care? Will managed care dictate availability of care or treatment based on DNA?

More importantly....Will medicine become safer for the patient?

Inquiring minds want to know...

Thursday, October 18, 2007

Health Wonk Review is Up at Healthcare Economist, October 18, 2007

This week's edition of the Health Wonk Review, hosted at the Healthcare Economist, is overflowing with useful information.

Can there be too much of a good thing, you ask? The posts have been narrowed into a few, easy-to-use categories:


  • Politics: S-CHIP, the Candidates and Conservative Health Scientists
  • From Aspen to San Francisco to México
  • Health Insurance and WTC Safety
  • Microsoft’s Health Vault
  • Money’s Influence on Physicians: Comments on physician profit motive, the NIH, and managed care.
  • Health care Effectiveness: Preventive Care, Midwives and Comparing American and European Health
  • Who are you?

And I'm happy to say my post "When Should Taxpayers Pick Up the Tab?" is included.

Wednesday, October 17, 2007

Senator Sanders says "We Can Do Better Than This" and Bush says that Congress isn't listening to him

President Bush just completed one of his Thursday press conferences.

Near the end of the conference, he had not been asked about his SCHIP veto so he brought it up himself. This was after his mentioned that he is NOT part of the Legislative Branch, but that he can only URGE Congress to pass bills, which the Administration helps to design and approves. He referred to the many veto threats he proposed while Republicans were in control of Congress, but explained that they listened to his threats and decided to work with him. Bush touts the Medicare Modernization Act as an excellent example of the Administration's fulfillment of promises to improve benefits to Seniors. I have my own opinions on Medicare Part D and fail to see it as 100% effective in truly helping seniors with drug costs and access, but it has been beneficial for pharmaceutical companies.

Regarding SCHIP, he reiterated that stupid argument about six states who spend more on adults than children under SCHIP and the misleading argument regarding increasing coverage to those earning $83,000. Somebody really should have given him unbiased FACTS regarding how the program HELPS those who do truly need help!! He also mentioned the vast number of children who are covered by Medicaid (sorry I don't have the number on hand), but Medicaid coverage excludes children from SCHIP eligibility (at least in Virginia.)

What is utterly frustrating about the SCHIP veto is the apparent disregard by the Bush administration for the increasing struggles of lower-middle-class families in our current economy. If you are earning more than the median household income in your community, I imagine you are more financially equipped to make choices which reflect your sense of personal responsibility or personal enjoyment. You have more freedom of choice.

In a recent article in the Washington Post, Vote Nearing in Battle Over Kids' Health Care, Christopher Lee details the experience of one Maryland family who benefits from an SCHIP program and describes some of Bush's objections to the bill.
The president has repeatedly criticized the proposed expansion as an excessive governmental intrusion into health care that would siphon middle-class families away from private insurance. He favors a more limited $5 billion increase, for total funding of $30 billion over the period, although recently he said he might be willing to go higher. Bush believes the program should focus on serving children from families that earn less than twice the poverty level: $34,340 for a family of three and $41,300 for a family of four.

I live in Fairfax County, VA, where the median household income is $94,500 and the median income in the greater Washington, D.C., area is $78,978. If a family of four living in Fairfax County is earning $41,300, twice the poverty level, that family is surviving on an income which is 56% below the area's median income. Then complicate manners further regarding housing in the area. "The median new-home price in the region's largest jurisdiction [Fairfax County, VA] is $960,000, and the average monthly rent for a two-bedroom apartment is $1,306, according to county data." It would be reasonable to deduce that a family earning up to 400% FPL might be considered upper-middle-class in Shawnee, Oklahoma. But that same family living in Fairfax County would definitely rank towards the lower end of the income spectrum.

What is becoming more apparent is the disparity of wealth and poverty in this country. And policy which is limited to the needs of an extremely small range of families, those earning between 133% and 200% FPL, is very narrow indeed. And it seems to me that the most narrow policies are usually the least effective in achieving their stated purpose.

I agree with the several points put forth in Senator Sanders' article found on Huffington Post: "We Can Do Better Than This"
Let's be very clear. A vicious and premeditated class warfare is being waged today against the American middle class. Poverty is increasing and tens of millions are working longer hours for lower wages. Meanwhile, the richest people have not had it so good since the 1920s, and the gap between the very rich and everyone else is growing wider. For the first time in the modern history of our country it is likely that the younger generation will have a lower standard of living than their parents as the American Dream becomes an economic nightmare. The time is long overdue for members of Congress to look beyond the needs of their wealthy campaign contributors and begin addressing the issue of income and wealth disparity.

Today, disgracefully and despite all the rhetoric of "family values," the United States has, at 18 percent, the highest rate of childhood poverty of any major country. Since George Bush has been president, nearly 5 million more Americans have slipped into poverty, 8.6 million have lost their health insurance, 3 million have lost their pensions and median family income has declined by about $2,500. So much for the president's "compassionate conservatism."

And to try to be fair and balanced, I'll provide a link to an opposing view which was left in the comments section of the above article.

"Senator Sanders Lives in a Dream World" by Johnny Galt.

Tuesday, October 16, 2007

Kaiser Family Foundation offers New Online Tool to Compare 2008 Presidential Candidate Health Care Proposals

NEW!!: 2008 Presidential Candidate Health Care Proposals: Side-by-Side Summary

This online tool allows users to customize side-by-sides by selecting as many as four candidates for comparison that can then be formatted into a printer-friendly pdf. The tool summarizes positions in four overall categories of access to health care coverage, cost containment, improving the quality of care and financing.

This side-by-side comparison of the candidates positions on health care was prepared by the Kaiser Family Foundation with the assistance of Health Policy Alternatives, Inc. and is based on information appearing on the candidates websites as supplemented by information from candidate speeches, the campaign debates and news reports. The sources of information are identified for each candidates summary (with links to the Internet). The comparison highlights information on the candidates' positions related to access to health care coverage, cost containment, improving the quality of care and financing. Information will be updated regularly as the campaign unfolds.

Republican Candidates -

Only three Republican candidates have announced formal healthcare proposals.
  • Rudy Giuliani
  • Mike Huckabee
  • Mitt Romney
The following Republican candidates have not announced formal healthcare proposals.
  • Sam Brownback
  • Duncan Hunter
  • John McCain
  • Ron Paul
  • Tom Tancredo
  • Fred Thompson

Democratic Candidates -

Six Democratic candidates have announced formal healthcare proposals.
  • Hillary Clinton
  • Christopher Dodd
  • John Edwards
  • Dennis Kucinich
  • Barack Obama
  • Bill Richardson
The following Democratic candidates have not announced formal healthcare proposals.
  • Joe Biden
  • Mike Gravel

For commentaries on each of the candidates' healthcare proposals, peruse the excellent articles by Robert Laszewski at Health Care Policy and Marketplace Review.

For additional links to detailed analyses of the Presidential candidates on a variety of topics, go to 2008 Race to the White House - Is U.S. Healthcare a Priority?

Saturday, October 13, 2007

When should Tax Payers Pick Up the Tab?

Zagreus Ammon over at The Physician Executive asked me a good question after I commented on his post regarding the recent blogger SCHIP 'FOOD FIGHT' (my characterization).

He wanted to know my thoughts regarding taxpayer-subsidized health benefits. More specifically how I might propose to establish appropriate financial thresholds at which an individual (or family) would be required to sell assets (or spend down resources) to continue to be eligible for benefits from programs, such as Medicaid or SCHIP.

He thought that my experience with being ‘caught in the web of chronic disease’ and subsequent frustrations in navigating 'safety net' programs might afford me some greater insight. Well, let’s see.

A Primer on Medical Assistance in Virginia

FAMIS - Family Access to Medical Insurance Security (SCHIP)

  • FAMIS Plus is Medicaid for Children. To qualify family income must be at or below 133% FPL (2007: $18,308 for family of 2, $27,465 for 4, $36,722 for 6). No resource evaluation is required.
  • FAMIS is a state/federal program which provides low-cost health insurance for children in families whose income is 133% to 200% FPL (2007: $18,308-$27,308 for 2, $27,465-$41,300 for 4, $36,722-$55,220 for 6). The child must not have health insurance (some exceptions apply) and is not eligible for a state employee health insurance plan. No resource evaluation is required.
  • FAMIS Select is a program which helps families pay for private or employer-sponsored health coverage. To be eligible, family must have at least one child enrolled in FAMIS. Families can choose between FAMIS or FAMIS Select benefits. The eligible family will receive up to $100 per enrolled child to help pay for family health insurance coverage, although a minimum employer premium contribution is required. The amount received from FAMIS Select can not exceed the family's share of coverage premiums. No resource evaluation is required.
  • For pregnant women, Virginia has FAMIS MOMS program. To be eligible, income must be at or below 185% FPL (2007: $25,327 for you and unborn child) and you must not have access to a state employee health plan. No resource evaluation is required.
DMAS - Department of Medical Assistance Services (Medicaid)
  • Full Medicaid Coverage is available to enrollees who are 65 or older, blind, or disabled as determined by SSA and have income at or below 80% FPL (2007: $8168 for 1, $10952 for couple). Or be an SSI enrollee with resources less than $4000 for individual or $6000 for couple.
  • Limited Medicaid Coverage is available to enrollees eligible for Medicare Part A with resources less than $4000 for an individual or $6000 for couple. If income is below 100% FPL (2007: $10,210 for 1, $13,690 for couple), medicaid pays Medicare Part A & Part B premiums and all amounts for coinsurance and deductibles which medicare doesn’t pay. If income is less than 135% FPL (2007: $13,784 for 1, $18,482 for couple), medicaid pays Medicare Part B premiums. If disabled, working, with income less than 200% FPL (2007: $20,420 for 1, $27,380 for couple), medicaid pays Medicare Part A premiums.
  • If income is below 135% FPL, you may be eligible to receive a Medicare Part D Subsidy. For full subsidy, resources must not exceed $6000 for individual or $9000 for couple. For partial subsidy, resources must not exceed $10,000 or $20,000 respectively.
  • A Work Incentive (WIN) program, called Medicaid Works, is available to disabled enrollees, under 65, who are employed or wish to be employed. Initial eligibility requires income below 80% FPL and resources limited to $2000 for individual or $3000 for couple. Continued participation requires that all earned income must be deposited into a WIN account, maintaining $2000 minimum balance. This program allows the disabled Medicaid recipient to earn income up to $40,905 and to accumulate resources up to $27,577. Any amounts deposited into IRS-approved accounts do not count against resource limits and will not affect continued eligibility. Examples of IRS-approved accounts include IRA, MSA, MRA, education accounts or independence accounts.
  • If the Medicaid Works enrollee is unable to continue working, he may switch to traditional Medicaid. Resources accumulated in WIN accounts will not count against current eligibility and the enrollee will have one year to dispose of excess funds before impacting continued eligibility. Resources accumulated in IRS-approved accounts will not count against current or future eligibility.
  • Health Insurance Premiums Payment (HIPP) Program is a Medicaid program which reimburses some or all of an enrollee's share of employer-sponsored group health insurance premiums when it is determined to be more cost-effective to do so.

Useful Definitions:

  • Income includes earned income, such as wages, and unearned income, such as Social Security, retirement benefits, veteran's benefits, child support, etc.
  • All resources and assets MUST be reported, including money on hand, in the bank, or in a safe deposit box; stocks, bonds, CDs, trusts, and pre-paid burial plans; cars, boats, life insurance policies, and real property. Not all resources are counted against eligibility, including your personal residence, one vehicle, and resources necessary to self-support.
  • Spenddown - If you meet all Medicaid requirements, but have excess income, you can reduce your excess income by incurring medical expenses, placing you in Medically Needy group. A deductible, or spenddown amount, is calculated for a six-month period (2007: $1557-$2335 for 1, $1982-$2815 for couple). Current and some old unpaid medical bills can be used as deductions against the spenddown amount. Coverage starts only after the spenddown amount is reduced to zero, and runs through the end of the spenddown period, after which you can reapply for another period of coverage.

My thoughts on government (taxpayer-funded) programs

Regarding the Frost family in Baltimore:

  • If they lived in Virginia, the only two issues affecting FAMIS eligibility include low family income (below 200% FPL, 2007: $55,220 for family of 6) and lack of access to employer-sponsored or state employee health insurance plans. The application form does not require documentation related to the value of their personal residence, bank accounts, business property, or general monthly expenses. In the FAMIS Select program, the Frosts would be eligible to receive up to $400 monthly to apply towards private insurance or their share of employer-sponsored group health insurance premiums. This program would place the Frost's medical care and expenses within the private insurance sector, not the public Medicaid system.
  • In this scenario, I believe that means-testing is irrelevant. The potential monthly subsidy to a low-income family is a great incentive to participate in the private healthcare system, assuming insurance is available to them, and to be responsible for all associated copays, coinsurance, and deductibles. This is truly a step-up not a hand-out. But if the family is not reporting all of their earnings in order to qualify, then they've got a bigger problem than receiving medical benefits.

Regarding seniors who shelter assets:

  • After reading much of the regulations surrounding the valuation or exclusion of resources for medicaid applicants, I am not convinced that one spouse would be able to squat on a Park Avenue apartment so that the other spouse could receive nursing home benefits, a situation which Megan McArdle eludes to at Asymmetrical Information. In Virginia a 1994 amendment invalidates the provisions in inter vivos trusts which provide for the suspension, termination or diversion of income of an irrevocable trust in the event that the grantor applies for Medicaid or needs medical, hospital or long-term care. The trustee must distribute the principal and interest to the potential medicaid applicant while only $25,000 will be exempt from the provisions. Here I believe that it would be seriously irresponsible for a couple who 'squat' on a Park Avenue apartment to not have Long Term Care Insurance.
  • Regarding wealthy families who establish complicated trusts to protect their assets and to avoid taxes, transfer costs or capital gains on investments, I believe this is a much larger problem which is beyond the scope of the current discussion of government-subsidized programs. Although I acknowledge that the wealthy in this country do pay a substantial chunk of the dollars paid in taxes, I believe that the ratio of assets, income, and taxes paid is seriously out of proportion if you consider the same ratios throughout all income levels.

For years, my grandmother paid premiums for long-term care insurance. But my aunt retired early and she, along with my father and other siblings, chose to care for her in her home and paid for part-time nursing care at home. Now my grandmother didn't earn alot, but she was smart and responsible with her money. She was the personal bookkeeper for an affluent family in Oklahoma City and was great with numbers. If dementia had not settled in and if she had known her children were spending their own money and wasting her long-term care benefits, she would have given them serious "what for." After she passed away in 2003, there was practically nothing left of great value to split between her four children. One of the home nurses had stolen her jewelry, the children had spent the balances of her accounts, and the house which was jointly owned by the children (a change of deed which occurred almost 15 years ago) had become my aunt's personal residence and is worth about $55,000 at most. This just illustrates that even families of lesser means do not consider government programs to be an appropriate entitlement.

Finally a little Something about My Situation

First of all, my challenge to qualify for and obtain assistance in covering medical costs has not required me to enroll in any of the above programs.

  • I am not disabled.
  • I am 39 (which is under the age of 65).
  • I am employed (self-employed as musician).
  • I 'choose to save' to prepare for a secure financial future.
  • I maintain a debt-free status (paying bills in full each month).
  • I have no student loan debt or mortgage debt. I received substantial scholarships and fellowships which the majority of college costs. I have not purchased a home, although I was saving for that purpose.
  • I have private health insurance in an individual (non-group) plan.

So why do I have trouble paying for medications?

  • My prescription benefit is capped at $1500 annually, which I discovered AFTER submitting a prescription for a $21,000 MS medication. Two years ago, someone asked me - "Will your insurance pay for it?" My naive answer was - "Well, I think so, but I don't know what my copay will be. I guess I'll find out."
  • My insurance would not pay for this medication and bounced my case to the pharmaceutical company's benefit investigations department which determined I was not eligible for any state or federal programs. The pharmaceutical company referred me to NORD (National Organization for Rare Diseases) who administrates their assistance program, as well as many other programs. The application to NORD required proof of income (paystubs, tax returns, etc) and financial assets (bank statements, pension statements, etc), listing of property assets (home, car, etc), and details of monthly expenses (mortgage and loan payments, food and shelter, utilities, insurance premiums, etc).
  • November 2005, I applied submitting the most recent tax return (2004) which showed $32,696 AGI. (I had not been deducting retirement contributions from taxes so as to show higher income to improve credibility to potentially purchase a home.) Although I had a separate 'business' and 'personal' subaccounts within the solitary bank account I have had since childhood, the total balances were determined to be 'personal' by NORD. Although I am self-employed and file Schedule C, certain business deductions were non-allowed by NORD and were 'added back into' by income for eligibility consideration, including the modest $200 spent on concert attire and depreciation amounts related to musical equipment. With this information NORD awarded me 50% assistance which meant 6 months of medication would be provided after which I would be responsible for the full expense.
  • I was told that I could appeal this decision after completing 2005 taxes which I did showing $27,321 AGI. I also documented that during the previous six months, expenses exceeded income by $10,390, the result of decreased income and increased medical expenses. My appeal was denied and I was told that without great debt (ie. mortgage or student loans) I was expected to spend excess savings (ie. retirement money and savings for a downpayment). The woman I spoke with also mentioned that I was not even spending the minimum of what they allowed in their calculations for food and shelter and so I was fortunate. So fortunate and financially responsible that I was expected to pay the remaining $10,000 out of savings for this one medication, in addition to all medications after reaching my insurance policy's $1500 limit which ran out in June 2006.
  • This denied appeal marked the beginning of a long search for non-government assistance programs which propose to help with prescription costs. I discovered several copay programs which had closed their MS programs due to insufficient funding. The Patient Access Network Foundation provides disease-specific assistance for lower-income individuals who have insurance, but they denied me because my income exceeded their limit by approximately $5000, although my immediate need was in excess of $10,000. I won't bore you with the LONG list of applications and denials, but it was rather discouraging.
  • So February 2007, I reapplied to NORD for assistance - this time armed with $19,417 AGI, medical expenses of $15,542 in 2006, and segregated personal, business, and retirement accounts. Additionally, I sent my application by certified, signature-required mail to the director of NORD's Copaxone assistance program. This time I was quickly approved to receive Copaxone free for 12 months. But I still have to go through the same process next spring, and the next spring, and so on, during which I cannot risk earning or saving too much for fear of becoming disqualified. And I still exhausted my prescription coverage in July this year, so I'm on my own to pay for meds until January 2008.

My situation does not belong on the books of government-subsidized programs. My argument is with the federal and state regulations which allow a private insurance company to arrange benefits for self-employed persons such that the beneficiary will be unprotected from catastrophic medical expenses. My argument is also with the business practices of pharmaceutical companies, who are allowed to exploit their blockbuster drugs and price-gauge individuals suffering from chronic illness, in order to improve their market share and profit margin.

I've written just a little about my personal experience in previous blogposts. Please feel free to browse through all such articles and leave a comment.