Ask Congress to Sponsor the #NeuroData Bill

The Neurological Diseases Act of 2015:

• Requires the Centers for Disease Control and Prevention (CDC)
• to enhance and expand infrastructure and activities to track the epidemiology of neurological diseases; and
• to incorporate information obtained through such activities into a statistically-sound, scientifically-credible, integrated surveillance system, to be known as the National Neurological Diseases Surveillance System.
• Requires the Department of Health and Human Services (HHS) to ensure that the System facilitates further research on neurological diseases.
• Requires HHS to provide for the collection and storage of information on neurological diseases, including the incidence, prevalence, and other information, such as demographics, risk factors, diagnosis and progression markers, to the extent practicable.
• Requires HHS to provide for the collection and storage of information relevant to analysis on neurological diseases, including epidemiology, natural history, and prevention of the diseases; the detection, management, and treatment approaches for the diseases; and the development of outcomes measures.
• Requires HHS to consult with individuals with appropriate expertise, including clinicians, epidemiologists, research scientists, health information technology experts, and representatives of national voluntary health associations that focus on neurological diseases and have demonstrated experience in research, care, or patient services.
• Requires HHS to make information and analysis in the System available to federal agencies and to the public, including researchers; and to ensure that privacy and security protections applicable to the System are at least as stringent as the protections under the Health Insurance Portability and Accountability Act (HIPAA).
• Authorizes Congress to appropriate $5,000,000 for each of fiscal years 2015 through 2019; and allows HHS to award grants to, or enter into contracts or cooperative agreements with, public or private nonprofit entities to carry out required activities.
• Requires that HHS submit a report to Congress within 4 years of enactment that shall include information on: the development and maintenance of the National Neurological Diseases Surveillance System; the type of information collected and stored in the System; the use and availability of such information, including guidelines for such use; and the use and coordination of databases that collect or maintain information on neurological diseases.

Please ask your elected officials to cosponsor and support increased research of neurological diseases.

Read this post in its entirety:

Encourage Congress to Support Research of Neurological Disorders

"National MS Disease Registry Act"

Have you ever questioned the NMSS estimate of 400,000 Americans living with multiple sclerosis?  I have.

Read -  ‘‘So How Many People in the US have MS?’’  -  Then come back here to continue.

In April, a bill was introduced in Congress which would provide us with an accurate accounting of the prevalence of MS in the United States in addition to much greater depth of information regarding the disease.

The bill is known as H.R. 5874 - the National MS Disease Registry Act and the following is a summary.

Congress makes the following findings:

1. Multiple sclerosis is a progressive, disabling disease that affects the brain and the spinal cord causing loss of myelin, damage to axons, and cerebral atrophy.
2. MS is a prime-of-life disease with an average age of onset at 30 to 35 years of age.
3. The causes of MS are not well understood.
4. There is no known cure for MS.
5. There are several drugs currently approved by the Food and Drug Administration for the treatment of MS, which have shown modest success in reducing relapses, slowing progression of disability, and limiting the accumulation of brain lesions.
6. More than 10,000 individuals in the United States are diagnosed with MS annually, and it is thought that more than 400,000 individuals in the United States have MS.
7. Studies have found relationships between MS and environmental and genetic factors, but those relationships are not well understood.
8. Several small and uncoordinated MS registries and databases exist in the United States and throughout the world.
9. A single national system to collect and store information on the incidence and prevalence of MS in the United States does not exist.
10. The Agency for Toxic Substances and Disease Registry (ATSDR) has established a series of small pilot studies, beginning in fiscal year 2006, to evaluate the feasibility of various methodologies that might be used to create a MS surveillance system at the national level.
11. The establishment of a national surveillance system will help—

• to identify the incidence and prevalence of MS in the United States;
• to collect data important to the study of MS;
• to produce epidemiologically sound data that can be used to compare with MS cluster information, data sets of the Department of Veterans Affairs data sets, and other information;
• to promote a better understanding of MS;
• to better understand public and private resource impact;
• to collect information that is important for research into genetic and environmental risk factors for MS;
• to enhance biomedical and clinical research by providing a basis for population comparisons; and
• to enhance efforts to find treatments and a cure for MS.

MULTIPLE SCLEROSIS NATIONAL SURVEILLANCE SYSTEM.

ESTABLISHMENT.—

1. IN GENERAL.—Not later than 1 year after the receipt of the Report, the [HHS] Secretary, acting through the Director of ATSDR and in consultation with a national voluntary health organization** with experience serving the population of individuals with multiple sclerosis, shall—

• develop a system to collect data on MS including information with respect to the incidence and prevalence of the disease in the United States; and
• establish a national surveillance system for the collection and storage of such data to include a population-based registry of cases of MS in the United States.

2. PURPOSE.—It is the purpose of the Registry to gather available data concerning—

• MS, including the incidence and prevalence of MS in the United States;
• the age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease; and
• other matters as recommended by the Advisory Committee.

ADVISORY COMMITTEE.—

1. ESTABLISHMENT.—Not later than 180 days after the date of the enactment of this section, the Secretary, acting through the Director of ATSDR shall establish a committee to be known as the Advisory Committee on the MS National Surveillance System. The Advisory Committee shall be composed of at least one member representing each of the following:

• National voluntary health associations** that focus solely on MS and have demonstrated experience in MS research, care, or patient services.
• The National Institutes of Health, to include, upon the recommendation of the Director of the National Institutes of Health, representatives from the National Institute of Neurological Disorders and Stroke, the National Institute of Environmental Health Sciences, and the National Institute of Allergy and Infectious Diseases.
• The Department of Veterans Affairs.
• The Department of Defense.
• The Agency for Toxic Substances and Disease Registry.
• The Centers for Disease Control and Prevention.
• Patients with MS or their family members.
• Clinicians with expertise on MS and related diseases.
• Epidemiologists with experience in data registries.
• Geneticists or experts in genetics who have experience with the genetics of MS.
• Statisticians.
• Ethicists.
• Attorneys.
• Other individuals, organizations, or agencies with an interest in developing and maintaining the MS National Surveillance System.

2. DUTIES.—The Advisory Committee shall review information and make recommendations to the Secretary concerning—

• the development and maintenance of the MS National Surveillance System;
• the type of information to be collected and stored in the System;
• the manner in which such data is to be collected; and
• the use and availability of such data including guidelines for such use.

3. REPORT.—Not later than 1 year after the date on which the Advisory Committee is established, the Advisory Committee shall submit a report concerning the Review that contains the recommendations of the Advisory Committee with respect to the results of such Review.

GRANTS.—Notwithstanding the recommendations of the Advisory Committee, the Secretary, acting through the Director of ATSDR, may award grants to, and enter into contracts and cooperative agreements with, public or private nonprofit entities for the collection, analysis, and reporting of data on MS.

COORDINATION WITH STATE, LOCAL, AND FEDERAL REGISTRIES.—

1. IN GENERAL.—In establishing the MS National Surveillance System, the Secretary, acting through the Director of ATSDR, shall—

• identify, build upon, expand, and coordinate existing data and surveillance systems, surveys, registries, and other Federal public health and environmental infrastructure wherever possible, including—
  

(i) the 2 MS surveillance pilot studies initiated in fiscal year 2006 by the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry;

(ii) the MS database of the Department of Veterans Affairs;

(iii) current MS registries, including the New York State MS Registry and the North American Research Committee on MS (NARCOMS) Registry; and

(iv) any other existing or relevant databases that collect or maintain information on neurological diseases identified by researchers or recommended by the Advisory Committee; and

• provide for research access to MS data as recommended by the Advisory Committee to the extent permitted by applicable statutes and regulations and in a manner that protects personal privacy consistent with applicable privacy statutes and regulations.
  

2. COORDINATION WITH OTHER FEDERAL AGENCIES.—Notwithstanding the recommendations of the Advisory Committee, and consistent with applicable privacy statutes and regulations, the Secretary shall ensure that epidemiological and other types of information obtained are made available to agencies such as the National Institutes of Health, the Department of Veterans Affairs, and the Department of Defense.

**For the purposes of this section, the term ‘national voluntary health association’ means a national nonprofit organization with chapters or other affiliated organizations in States throughout the United States.

AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2009 through 2013.

Price Gouging in Extremely Vulnerable and Captive Market

By 9:00 AM, the line of those waiting to enter Room 106 of the Dirksen Senate Office Building in Washington, D.C., had grown longer than the velvet rope gate established to organize such a line.

"What's being lobbied for today?" asked a congressional staffer who passed by the table covered with handouts of the witnesses' testimonies.

The topic of the morning was pharmaceutical "price gouging" from drug companies with effective monopolies within an "extremely vulnerable and captive market." Thus on July 24, 2008, Senator Amy Klobuchar (D-MN) opened the Joint Economic Committee hearing to discuss, "Small Market Drugs, Big Price Tags: Are Drug Companies Exploiting People With Rare Diseases?"

Even Before It Began

While a friend held my place in the waiting line, I was allowed to sit in one of the chairs at that press sign-in and handout-laden table. I asked the staffer sitting next to me, "Is this a larger turn-out than normal?" She laughed and told me that she had "never seen people line-up for a JEC hearing before."

From that chair, I was able to witness a public relations representative who arrived to leave fact sheets provided by one of the drug companies who was mentioned specifically. That company is Questcor Pharmaceuticals, Inc., who manufacturers the drug H.P. Acthar (r) Gel which is FDA-approved for the treatment of periodic flairs in multiple sclerosis. However, the drug is more commonly used in the treatment of Infantile Spasms (IS) which is a rare seizure disorder found in only an estimated 2000 infants each year in the United States.

The PR rep was told that someone else in charge would need to be asked, but I certainly asked to have a copy. After reading the fact sheet and when he returned to the table, I asked him some questions as well as introducing myself by name. But of course, he had no idea exactly how much I have researched Questcor's historical financial information.

Just a little later, a messenger from PhRMA, Pharmaceutical Research and Manufacturers of America, the industry's lobby firm, also came by the table with copies of a Press Release prepared to accompany today's hearing. Funny thing. She looked a lot like a drug sales rep. You know, that former cheerleader look.

But she couldn't stick around for the hearing as she was on her way to a different one, perhaps the one during which Medicare Part D Reform was discussed. Another funny thing about PhRMA - why is it that so many of their press releases tout "more than 300" drugs in development for name-the-disease-category, such as Mental Illness or Orphan Drugs.

Inside Room 106

A long conference table was facing Senator Klobuchar's seat upon which were three name tags, several bottles of water, and timing boxes which counted down the amount of time allotted for each witness to speak. I chose a seat on the second row so as to be able to hear the speakers better.

Joining me in attendance were 75-80 others in the room. Huge turnout I'm told for a Joint Economic Committee hearing. Staying to listen to the testimonies was Questcor's pr guy who sat a few rows behind me.

Senator Klobuchar opened the meeting by introducing the topic and thanking the three witnesses about to testify. On the docket were an academic economist from the PRIME Institute at the University of Minnesota, a physician who is the CEO/president of Children's Hospitals and Cinics of Minnesota, and a mother of an Infantile Spasm patient who was also in attendance.

Although I do believe that little Trevor slept for most of the event and only needed to be escorted out of the room once, upon returning he was happy enough with his bottle. Sitting next to his daddy and little baby brother was also Tobey, the big brother, who enjoyed some time on his Nintendo. Sorry, I didn't get a good look at what game he was playing.

Before excusing himself to attend another meeting, Senator Charles Schumer, Chairman of the Joint Economic Committee, presented a statement addressing the topic of the day. It is known that Senator Schumer has been "a staunch advocate of lower priced drugs and a competitive pricing market."

The Economist

Madeline Carpinelli, research fellow at the PRIME Institute which focuses its research on policy issues related to pharmaceutical economics and drug expenditures at all levels in the marketplace. Madeline explains that ordinary annualized price increases for branded drugs has been two to three times the rate of general inflation which has become routine.

"This rate of inflation is not necessarily acceptable, or even reflective of an economically efficient pharmaceutical market, but it has come to be expected in recent years."

The study at hand centers around drugs experiencing extraordinary price increases which was defined as "any price increase that is equal to, or greater than, 100% at a single point in time." This refers to a drug which doubles in price from one day to the next overnight. Primarily these drug products are not among the top 100-500 drugs on the market and the huge price increases may have been "flown under the radar" in small patient populations.

The Doctor

Dr. Alan Goldbloom is the president and CEO of Children's Hospitals and Clinics of Minnesota which is "the 7th largest pediatric heath care system in the nation." Dr. Goldbloom made clear that his testimony is not a rant against the entire pharmaceutical industry, but is focused on the practices of some specialty pharma companies and their questionable pricing of some older drugs now used in rare disease populations. His personal experience comes from two companies in particular, Ovation and Questcor, but notes that they are not the only ones and that this practice is not confined to pediatric pharmaceuticals.

Dr. Goldbloom discussed the drug indomethacin (Indocin) which was discovered over 30 years ago to be a safe and effective, non-surgical treatment of patent ductus arteriosus (PDA) found in some premature babies. Dr. Goldbloom testified that before Ovation purchased exclusive rights to Indocin (and several other drugs) from Merck in 2005, the cost of Indocin was just over $108 per unit, truly a low-cost alternative to surgery. But then in January 2006 the price jumped up 1278% to $1500 per unit.

"Indocin is an old drug. It has been on the market for more than three decades, so this dramatic price increase cannot be attributed to the high cost of research and development."

Presented was data on three other drugs which Ovation had purchased from pharmaceutical giant Merck and the amounts of price increases for these drugs which include Cosmegan (up 3437%), Diuril Sodium (up 864%), and Mustargen (up 979%). Please keep in mind that an extraordinary increase was previously referred to as being only 100%.

Dr. Goldbloom turned his attention to H.P. Acthar(r) Gel which experienced a 1410% increase in August 2007 from $1650 per vial to $23,269 per vial. I have previously discussed historical data related to Acthar and Questcor's justification for the rise in price.

After the close of stock trading today, Questcor released their 2nd Quarter Results in 2008 and held a conference call. I was unable to listen to the call at that time and will have to listen to the replay on their website later. Questcor reports Net Sales of $24.9 million and a profit margin of 91%. "We continue to successfully execute our Acthar-centric business strategy," said Don M. Bailey, President and Chief Executive Officer of Questcor in the Press Release.

It looks like Questcor had initially published a Statement Regarding the July 24 Senate Hearing on their website, but the item has been withdrawn and the link goes nowhere.

The Mommy

Danielle Foltz is mother to Trevor Foltz who at 7 1/2 months began exhibiting seizures which resembled "a newborn startle reflex." This was in November 2007 just before Thanksgiving. The Foltzes were preparing to return to their ministry work and home in Tanzania, East Africa when Trevor's jerky, odd movements were noticed. Danielle has shared their story on her blog Dear Trevor.

Originally the Foltzes insurance company denied coverage of Acthar stating that it is not FDA approved in the treatment of Infantile Spasms. Questcor filed an sNDA for that very indication in August 2006 but announced that they received a "not approvable" letter from the FDA in May 2007.

Mr. Foltz spent days on the phone with the insurance company fighting for coverage for Trevor. Mrs. Foltz called the Acthar patient assistant program but was told that it would take "a minimum of 3 business days" for the approval process and that approval was not guaranteed even in financial situations such as their's.

Ultimately treatment for Trevor was delayed six days before they were given the go-ahead to start treatment. Being quoted a price of $30,000 per vial the medication, and with a round of treatment for Trevor requiring 5 vials, the cost for medication alone approached $150,000 for their drug plan.

"Because ACTH must be injected into the thigh, a nurse had to teach us how to administer it once we went home. When she asked my husband if he was nervous about giving Trevor the shot for the first time, he answered that he was more nervous about holding $5000 in a single syringe. Or worse, dropping the vial!!"
Just imagine. With an insurance plan having 10-20% copays on medication, Trevor's treatment would cost $15,000-30,000 to the insured patient. Insurance policies can be structured in so many ways that it is very difficult to ascertain what the typical cost to the insured customer is. What I pay out-of-pocket is different from what you pay out-of-pocket which is different from what your neighbor pays out-of-pocket, all for the very same drug.

In Conclusion

It was fascinating to attend the meeting and learn a few things I didn't already know. It was a tiny bit frustrating to be sitting in the audience and know that I could supply much greater detail than was presented in such a short period of time. In fact, two of the drugs I take in relation to having multiple sclerosis were mentioned during the question/answer session.

• Effective Monopolies
• Vulnerable and Captive Markets
• Old Drugs - New Prices
• Orphan Designation
• Anti-competitive Behavior
• Price Gouging

These were the topics discussed today. Senator Klobuchar stated that this is only the beginning of the research to come. The Federal Trade Commission and the General Accounting Office have been asked to investigate further the business strategies and executive decisions which have led to such extraordinary price increases in recent years.

From 100% to 10,000%, drug prices in niche markets have soared
and ultimately we all pay for that. The question is - Who Benefits? and Who Suffers?

I look forward to following the developments of such research and the conclusions of the researchers.

After the hearing concluded, I spoke with Mr. Foltz before introducing myself to Ms. Carpinelli. Unlike the Questcor guy, she immediately knew who I was. "I've read your blog. It's great! And the research you've done... Going through and actually reading SEC filings... Impressive. I wouldn't do that. (lol)"

Well, then again. I'm an odd duck and heard for about the fourth time this week that I should start a secondary career. What do you think?

• Passionate Patient Advocate
• Financial Researcher and Analyst
• Strategy Consultant
  
• Freelance Writer/Author/Blogger

Which hat do you think might look good on me?

Transcripts and Video can be seen here.

Small Patient Population - Big Drug Prices

Information regarding Questcor and H.P. Acthar Gel compiled and analyzed by Lisa Emrich, blogger/writer at brassandivory.blogspot.com, multiple sclerosis patient and patient advocate with direct experience dealing with NORD and other patient assistance programs. Prepared for Senate Joint Economic Committee Hearing in support of Danielle Foltz's testimony.

Upon learning of the steep increase which Questcor Pharmaceuticals implemented in their lead drug, H.P. Acthar Gel on August 27, 2007, I became furious. Not because I am familiar with Infantile Spasms (IS), but because the families affected by IS will be facing an outrageous financial battle not too unlike my own financial battles stemming from multiple sclerosis.

Acthar was developed in the 1950's for the treatment of exacerbations in multiple sclerosis and became useful in treating the epileptic condition known as West Syndrome or Infantile Spasms. In 1997, the FDA recognized the need to continue manufacturing without interruption of H.P. Acthar Gel by Rhone-Poulenc for use in the treatment of Infantile Spasms.

For several months in 1996, Rhone-Poulenc stopped making Acthar because of manufacturing difficulties. A crisis resulted, with insufficient supplies to treat patients with West's syndrome and other diseases.
While the company worked with the Food and Drug Administration to fix problems in its plant, the nonprofit National Organization for Rare Disorders helped dole out the very limited supplies for emergency cases of infantile spasms and other conditions. "During the shortage, even some people with severe pain from rheumatoid arthritis couldn't get the drug in favor of babies with life-threatening West's syndrome," says NORD president Abbey Meyers.

In July 2001, Questcor acquired H.P. Acthar Gel from Aventis (formerly Rhone-Poulence) for the cost of $400,000. In November 2002, the FDA approved Questcor's application to extend the labeled shelf life of H.P. Acthar Gel from 12 months to 18 months. In October 2003, the FDA grants 'orphan drug' status to H.P. Acthar Gel for the treatment of Infantile Spasms. In November 2003, Questcor and IDIS enter into an exclusive agreement for distribution outside of the U.S. Between 2001 and 2005, Questcor made several strategic moves to consolidate Acthar manufacturing and distribution. In May 2004, neurologists from the American Academy of Neurology (AAN) and the Child Neurology Society (CNS) who specialize in diseases of the brain and central nervous system publish new guidelines presenting options for treating infantile spasms. A brief article regarding the new guidelines can be found here.

In February 2005, James Fares took the helm as CEO and proceeded to redirect Questcor to focus in the field of neurological disorders. Between May 2005 and September 2005, Questcor hires Craig Chambliss as Vice President of Sales & Marketing, Gregg Lapointe to the Board of Directors, and George Stuart as Chief Financial Officer. In October 2005, Questcor sells three of their products for $28.3 million earning them enough money to pay off much debt and focus on realizing their grand vision. In May 2006, Questcor acquires Doral(R) giving them a second product for the national neurology sales force. Ultimately the CEO's intent to revitalize the use of Acthar in MS market was not successful as IV Solumedrol is the preferred choice in treating multiple sclerosis flairs.

In August 2006, Questcor submitted an sNDA for FDA approval to include treatment of IS on the label of H.P. Acthar Gel. In December 2006, Questcor presents data on Acthar at the American Epilepsy Society annual meeting. On May 14, 2007, Questcor announced that the FDA did not approve the sNDA. One week later, Questcor CEO James Fares resigns. Followed by a number of colleagues in the months which followed.

Albert Hansen, Chairman of the Questcor Board of Directors, commented, "We appreciate Jim's service over the past two years and wish him well in the future. Our goal is to increase shareholder value through a continued focus on Acthar, consistent progress in our development pipeline, and a more rapid transition to profitability." Questcor will announce additional adjustments to its efforts shortly.

...a more rapid transition to profitability.”

During June and July 2007, Questcor makes strategic moves to consolidate supply by choosing Curascript, a subdivision of Express Scripts, as the sole distributor for Acthar. On August 27, 2007, Questcor board announces the New Strategy and Business Model for H.P. Acthar Gel.

UNION CITY, Calif.--(BUSINESS WIRE)--Aug. 27, 2007--Questcor Pharmaceuticals, Inc. (AMEX:QSC) announced today that its Board of Directors has approved a new strategy and business model for H.P. Acthar Gel(R), a natural form of adrenocorticotropic hormone (ACTH). This change may affect the usage of Acthar in the treatment of certain diseases, including multiple sclerosis (MS) and infantile spasms (IS), an extremely rare form of epilepsy. Specifically, Questcor will initiate a new pricing model, create an expanded safety net for patients using Acthar, and provide a group of Medical Science Liaisons to work with health care providers who are administering Acthar.

Don M. Bailey, Questcor's Interim President commented, "the goal of Questcor's new strategy is to make manufacturing and distribution of Acthar economically viable on a stand-alone basis, so that Questcor can continue to ensure the availability of Acthar for those patients who need it most and fund projects which can contribute to the growth of the company."

Acthar is currently approved in the U.S. for the treatment of MS exacerbations and other conditions. No drug is approved in the U.S. for the treatment of IS, a potentially life-threatening disorder that typically begins in the first year of life. However, pursuant to guidelines published by the American Academy of Neurology and the Child Neurology Society, many child neurologists use Acthar to treat infants afflicted with this condition. In June 2006 Questcor submitted a Supplemental New Drug Application to the Food and Drug Administration (FDA) and is currently pursuing formal agency approval for Acthar in the treatment of IS. Previously, the FDA granted Orphan Designation to H.P. Acthar Gel for the treatment of IS. As a result of this Orphan Designation, if Questcor is successful in obtaining FDA approval for the IS indication, Questcor will also qualify for a seven year exclusivity period during which FDA is prohibited from approving any other ACTH formulation for IS unless the other formulation is demonstrated to be clinically superior to Acthar. Questcor anticipates incurring significant additional costs in its further pursuit of a formal FDA-approved indication for Acthar in the treatment of IS.

The implementation of this new strategy includes a change in the method of distribution for Acthar and a significant increase in treatment cost. In addition, Questcor has changed its support program for health care professionals and reinforced its safety net for patients using Acthar. Questcor previously announced that the change in distribution from multiple distributors to a single specialty distributor is complete. Acthar is now being distributed only through its specialty distributor, Curascript. This new distribution system provides seamless support for Acthar including providing necessary information to health care providers and families, assisting with reimbursement, and distributing product faster. As of the end of July, this transition had virtually eliminated all Acthar inventories held by wholesalers. The new pricing is effective Monday, August 27 and brings Acthar in line with the cost of treatments for other very rare diseases. Based on Questcor's understanding of the usage of Acthar, the cost for a course of treatment could approach $80,000-$100,000.

Questcor acquired Acthar in 2001. Since then, to ensure that this drug remains available on a consistent basis for the patients who need it, Questcor has incurred significant costs to transfer and modernize Acthar's complex manufacturing process to assure continued compliance with FDA standards. Questcor net losses were $10.1 million in 2006 and $5.5 million for the first six months of 2007.

Questcor's new strategy is intended to create an economic model that will allow Questcor to support ongoing efforts to manufacture and distribute Acthar, to conduct any FDA-required studies, to continue development of QSC-001, and to develop or acquire other drugs or drug candidates for neurological disorders or for rare diseases.

Questcor continues to focus on the need to work with patients who are attempting to secure reimbursement from their insurance companies and has expanded its participation with the National Organization for Rare Disorders (NORD), an advocacy group for patients afflicted with rare disorders and a sponsor of patient assistance and co-pay assistance programs for patients who are otherwise unable to afford their treatments. The combination of the change to a specialty distributor, the availability of Medical Science Liaisons, the expanded participation with NORD, and existing government programs -- Medicaid and the federally-funded State Children's Health Insurance Program -- is intended to provide a safety net to make Acthar available to all patients who need it.

The term 'orphan drug' refers to a product that treats a rare disease affecting fewer than 200,000 Americans. The Orphan Drug Act was signed into law on January 4, 1983. The intent of the Orphan Drug Act is to stimulate the research, development, and approval of products that treat rare diseases. However, Questcor did not research and develop H.P. Acthar Gel, they purchased it from Aventis for $400,000 in 2001. But yet they want to bring the cost inline with other expensive drugs used to treat rare disorders which did result from huge R & D expenses.

Now the issue of 'rare diseases' is one which I do have personal knowledge. I have MS and I use an expensive self-injectable drug. The safety net for that drug is administered by National Organization for Rare Disorders (NORD), which is the same safety net Questcor uses for H.P. Acthar Gel. However, this 'safety net' has big holes and many families may likely fall right through. If you've read my other posts (at brassandivory.blogspot.com), you are aware that NORD finally awarded full assistance in receiving that $21,000 drug after my earnings sunk below $20,000. I do not know the details of the Acthar program, but if it is anything like the Copaxone program, the family's earnings will need to be below 200% Federal Poverty Level in order to qualify.

So with the August 2007 announcement, Questcor also claims that the price increase is necessary due to the company's net losses of $10.1 million in 2006 and $5.5 million for the first six months of 2007. The following information comes from research I conducted and published on my blog in October 2007. Some of the numbers were not made public at the time, so corrections have been incorporated.

...each time I contemplate the wonder of drug discovery and the ways in which I personally benefit from the investment in research, I am reminded that pharmaceuticals mean big business. Don't be fooled into thinking otherwise, especially when a company points to the bottom line when discussing the need to adjust business strategy and raise drug prices, as Questcor has done.

Since learning that Questcor raised the price for H.P. Acthar Gel, an injectable drug used primarily to treat the seizures associated with Infantile Spasms and the acute relapses of Multiple Sclerosis, I have been plagued with Questcor's justification for raising the price almost from $1650 to $23,265 per vial in August. Outrage spread quickly throughout patient support systems for families affected by Infantile Spasms and throughout the Multiple Sclerosis community.

What has been the PRICE OF ACTHAR?

Even the United Stated Securities and Exchange Commission (SEC) expressed concern in 2005 with the accounting methods Questcor applied in recording expenses related to the exchange or rebate of expired Acthar stock held by drug wholesalers. After Questcor reintroduced the distribution of Acthar through major drug wholesalers, thousands of vials (~5000) and over $4.5 million worth of drug expired in 2003- 2005 without reaching patients who may have benefited from its use. During this time period, Questcor recorded the value of these exchanges against gross revenue of product sales, which affects the company's perceived operating margin. Questcor's explanation to the SEC refers to the representation of company growth to please the investors. (Not being an accountant, I don't completely understand their justifications.) In addition to concerns over the exchange accountings, the SEC expressed difficulty in determining the assigned value of each vial of Acthar.

The SEC's correspondence can be read here:

In 2003, Questcor replaced/exchanged 2653 vials of Acthar valued at $2.3 million. The return rate for expired drug was 18-20% according to their annual report.

One vial = ~$867

In 2004 and 2005 combined, Questcor replaced/exchanged 2109 vials of Acthar valued at $2.228 million.

One vial = ~$1057

Using information provided in Questcor's annual reports, the following amounts may have been the per vial prices during 2003, 2004, 2004 amended, 2005, 2006.

• 2003: $867

• 2004: $928 (sales up 2%, demand up 7%, price up 7%)

• 2005: $1058 (sales down 2%, demand down 13%, price up 14%)

• 2006: $1185 (sales up 20%, price up 12%)

• 2007: $1658 (2nd q. price up 41% over 2nd q. 2006)

August 2007: $23,265 (price up 1400% over June 2007)

Questcor has more recently revealed that the list price for one vial of H.P. Acthar Gel was $1650 before they raised the list price to $23,265 in August 2007, giving it an increase of 1410% over the June 2007 price.

$1650 x 1410% = $23,265

In the following, the italicized excerpts are taken from Questcor's 2007 Annual Report.

What are Questcor's expenses for Cost of Goods (in millions)?

• 2002: $2.822

• 2003: $3.573 (inc. $467K write-off)

• 2004: $3.730 (inc. $606K write-off)

• 2005: $3.110 (inc. $103K write-off)

• 2006: $3.000 (inc. $726K for Acthar increase in volume)

$908,000 spread = 32% difference low-to-high

• 2007: $5.295 (inc. $1.83M for royalties based on Acthar net sales)

$2.3M increase = 77% increase over 2006

Cost of product sales for the year ended December 31, 2007 increased $2.3 million from the year ended December 31, 2006. Cost of product sales includes material cost, packaging, warehousing and distribution, product liability insurance, royalties, quality control (which primarily includes product stability testing), quality assurance and reserves for excess or obsolete inventory. Stability testing is required on each production lot of Acthar and is conducted at third party laboratories at periodic intervals subsequent to manufacturing. Stability testing costs are expensed as incurred. We incur a royalty of 3% on total net sales of Acthar to a third party and a royalty of 1% of annual net sales over $10.0 million to another third party.

The increase in cost of product sales was due primarily to an increase of $1.4 million in royalties on Acthar due to the increase in net sales during the year ended December 31, 2007 as compared to the same period in 2006. Increases of $308,000 in product stability testing and $254,000 in distribution costs also contributed to the increase of cost of product sales in the year ended December 31, 2007 as compared to the same period in 2006. Cost of product sales as a percentage of total net product sales was 11% for the year ended December 31, 2007, as compared to 23% for the year ended December 31, 2006. The decrease in cost of product sales as a percentage of total net product sales in the year ended December 31, 2007 as compared to the same period in 2006 was due primarily to the increase in net product sales resulting from the new Acthar pricing level implemented in August 2007. We estimate that cost of sales as a percentage of sales for 2008 will be approximately 10%.

What are Questcor's modest expenses for R & D (in millions)?

• 2002: $2.295

• 2003: $2.267 (inc. $821K for site transfer fees and sublease)

• 2004: $2.181 (inc. $580K for site transfer fees)

• 2005: $2.227 (inc. $560K for site, legal, and consulting fees)

• 2006: $3.033

$852,000 spread = 39% difference low-to-high

• 2007: $4.758 (inc. $333K for legal fees and $1.3M for increased head-count

• unknown non-cash (stock option) compensation expected to be $1M in 2008

$1.725M increase = 57% increase over 2006

Research and development expense for the year ended December 31, 2007 increased $1.7 million from the year ended December 31, 2006. The costs included in research and development relate primarily to our product development efforts, outside services related to medical and regulatory affairs, compliance activities, costs associated with our medical science liaisons, and our preliminary evaluation of additional product development opportunities. The increase in research and development was due primarily to the addition of our clinical and development leadership team during the fourth quarter of 2006 and our medical science liaisons in the second quarter of 2007. Headcount-related costs increased by approximately $1.3 million in the year ended December 31, 2007 as compared to the same period in 2006. An increase totaling approximately $333,000 for regulatory fees and patent-related legal fees also contributed to the increase as compared to the same period in 2006.

We estimate that our research and development expenses (excluding non-cash SFAS No. 123(R) share-based compensation expense) will be approximately $10.0 million to $14.0 million during 2008 resulting from our efforts related to the Acthar submission to the FDA for the treatment of IS and the continued development of QSC-001. The higher end of the range would only result in the event that we were to successfully advance QSC-001 to clinical trials. We estimate that total non-cash SFAS No. 123(R) share-based compensation expense for 2008 will be approximately $4.5 million of which we estimate approximately $1.0 million will be incurred in research and development expense.

What are Questcor's expenses for Depreciation and Ammoritization (in millions)?

• 2002: $1.138

• 2003: $1.157

• 2004: $1.208

• 2005: $0.995

• 2006: $0.316

• 2007: $0.498

Depreciation and amortization expense for the year ended December 31, 2007 increased to $498,000 from $316,000 for the year ended December 31, 2006. The increase in depreciation and amortization was due primarily to amortization expense related to the Doral purchased technology. In May 2006 we purchased the rights in the United States to Doral. Our total purchase price, including acquisition costs, allocated to the Doral product rights was $4.1 million. In addition, in January 2007, we made a $300,000 payment to IVAX to eliminate the Doral royalty obligation that was also recorded to purchased technology. Purchased technology is being amortized on a straight-line basis over fifteen years, the expected life of the Doral product rights.

What are Questcor's Other Income/Expenses?

• 2002: $(.382)

• 2003: $(.457)

• 2004: $(.566)

• 2005: $9.642 (inc. divesting of non-CNS products)

• 2006: $.734

• 2007: $1.439 (inc. divesting of Emitasol)

What are Questcor's Administrative/Sales Expenses (in millions)?

• 2002: $10.715 (inc. $1.5 for officers, and $5.9 sales/marketing)

• 2003: $10.400 (inc. $2.3 for officers, sales/marketing not distinct)

• 2004: $11.551 (inc. $3.6 for officers, severance, and accounting)

• 2005: $10.019 (inc. $2.6 for officers, severance, and accounting)

• 2006: $17.282 (inc. $4.9 for officers, directors, severance, and accounting; as well as $5.6 for additional sales force)

• 2007: $17.662 (inc. $6.9 for officers, directors, severance, etc. based on $2M increase; $4.0 for additional sales force which was let go based on $1.6 decrease in head-count)

$7,263,000 spread from 2005 to 2006....WHOA!!!

From my October analysis:

In 2006, Questcor adopted a new accounting standard to include the value of stock options in operating expense and specified the amounts paid to each member on the board of directors. These two amounts alone account for $1,250,000. The amounts paid to officers in salary, bonuses, and other expenses totaled $3,895,000.

The $5.6 million expansion in sales force accounts for approximately 35 employees paid $160,000 each. Coincidentally, these employees are many of the same ones which have been eliminated in Questcor's new strategy in 2007 to cut costs. From my viewpoint, it seems that Questcor invested $5.6 million to leverage their position as the sole source for Acthar to patients and to justify an outrageous increase in price to maintain the financial viability of the drug company.

Selling, general and administrative expense for the year ended December 31, 2007 was consistent with selling, general and administrative expense for the same period in 2006. Increased share-based compensation expense, costs associated with the reduction of our field organization and the departure of our former Chief Executive Officer and an increase in management compensation were offset by lower sales and marketing headcount-related costs resulting primarily from the reduction of our field organization in the second quarter of 2007.

We incurred a total non-cash charge of $1.8 million for SFAS No. 123(R) share-based compensation for the year ended December 31, 2007. Of this amount, $1.5 million was included in selling, general and administrative expenses, an increase of $523,000 as compared to the same period in 2006. For the year ended December 31, 2007, management bonuses related primarily to our 2007 profitable results contributed to a $757,000 increase in bonus expense as compared to the same period in 2006. We recorded $272,000 of severance and other associated costs in the second quarter of 2007 related to the departure of our former Chief Executive Officer in May 2007. In addition, during the second quarter of 2007 we reduced our field organization from 45 sales representatives to 10 product service consultants and 3 medical science liaisons and incurred a one-time expense of $451,000 for severance benefits and other associated costs. We currently have 10 product service consultants and 4 medical science liaisons. The expenses associated with our medical science liaisons are included in Research and Development expense in the accompanying Consolidated Statements of Operations. Sales and marketing headcount-related costs for the year ended December 31, 2007 decreased by approximately $1.6 million as compared to the same period in 2006 due primarily to the reduction of our field organization in the second quarter of 2007.

We estimate that our selling, general and administrative expense (excluding non-cash SFAS No. 123(R) share-based compensation expense) for 2008 will be in the range of approximately $15.0 million to $17.0 million. We anticipate the addition of selective key new hires and investment in customer service and marketing initiatives. We estimate that our total non-cash SFAS No. 123(R) share-based compensation expense for 2008 will be approximately $4.5 million of which we estimate approximately $3.5 million will be incurred in selling, general and administrative expense. The increase from 2007 results from new option grants and higher non-cash SFAS No. 123(R) expense associated with our employee stock purchase plan.

What are Questcor's Total Assets (in millions)?

• 2002: $12.766

• 2003: $22.929

• 2004: $28.173

• 2005: $31.348

• 2006: $29.635

• 2007: $78.448

2007 increase $48.813 in total assets with net sales of $48.7 for H.P. Acthar Gel

From my October estimates:

Coincidentally, Questcor's total assets equal $24.024 million at the end of the 2nd quarter 2007. According to my math, this seems to be just about $5.6 million less than their stated total assets at the end of 2006.

If Questcor's new business strategy (raising the price of Acthar) is successful, they are well-positioned to significantly increase gross revenues while incurring no significant increase in Cost-of-Goods-Sold. Even if they are able to sell a limited supply of 5500 vials of Acthar at the full $23,000 price, while 'giving away' 4500 vials, their gross revenue would exceed $126.5 million, about 10 times their 2006 net product sales.

Interesting prediction because Questcor now estimates that - “if annual Acthar demand remains in the annualized range of 5,100 to 5,700 vials experienced since the implementation of the new Acthar strategy, we estimate that this would result in 2008 annual net sales of approximately $80.0 million to $89.0 million.” This forecast allows for the “estimate that Acthar gross sales resulting from our reported shipments will be reduced by approximately 30% related to Medicaid rebates and government chargebacks.”

Basically, all of the preceding analysis is to dispel the argument that Questcor was incurring such income losses necessary to justify the 1400% increase in price of H.P. Acthar Gel. What they incurred was an increase in recognition of high salaries, bonuses, and stock options awarded to directors and executives.

Ultimately, the patients who cannot afford the drug suffer and the health insurance system bears the burden only to pass it on to their customers in higher costs. Questcor states that they have given away $10 million worth of Acthar free to patients in need since the implementation of the new pricing strategy. This accounts for approximately 430 vials of drug which would cover 70-100 courses of treatment.

However, does a drug which costs less than $250 to manufacture really need to be marked up by $23,000?

National Parks in Need of Congressional Support - NOW!

Below is an editorial from the New York Times which highlights an important bill just waiting for action in Congress. This reminds me that upcoming Congressional District Work Periods are June 30 - July 3 and August 11 - September 5. A good time to contact your elected officials while they are home.

'Stingy budget appropriations and decades of deferred maintenance have taken a toll on our national parks.'

Help the Parks
NYT Editorial, June 10, 2008

It is only June, but given a summer recess and the fall’s campaigning, the rest of the legislative year could well be wasted, and some good bills left to die, unless Congress starts working harder now.

One piece of legislation that deserves a serious push is the National Park Service Centennial Initiative. A brainchild of Dirk Kempthorne, the Interior secretary, the initiative would use the years leading up to the park system’s 100th birthday in 2016 to raise $1 billion in private money and match that with $1 billion in federal money — above and beyond normal appropriations — to rejuvenate the national parks.

As recent visitors can attest, the parks need all the help they can get. Stingy budget appropriations and decades of deferred maintenance have taken a toll on everything from park roads to day-to-day operations. In his brief tenure, Mr. Kempthorne has done several good things for the parks — including killing a potentially harmful rewrite of the service’s management policies that would have promoted inappropriate commercial and recreational activities at the expense of conservation. He wants now to provide a special revenue stream by using the promise of a federal match to entice private donors to help underwrite vital projects.

The idea was so appealing that the House Natural Resources Committee approved it by a voice vote. It has languished ever since, the victim of wrangling between House members who rightly demand offsetting revenue-raising measures to pay for the bill and the administration’s budget office, which says it can’t find such offsets. House Democrats who are loath to hand Mr. Bush anything he can celebrate have also been less than helpful.

The solution seems ridiculously obvious. The budget office should find the offsets (an increase in park concession fees would do the trick), and the Democratic leadership should schedule a vote. We predict that the verdict would be overwhelmingly positive, and the Senate would follow suit. The parks and their millions of visitors would be the winners, and Congress could show that it can get things done — even in an election year.

Federal Money for Multiple Sclerosis Research

Ask Your U.S. Representative to Support $15 Million for MS Research (h/t MS Activist Blog)

New federal money is now available to multiple sclerosis researchers, thanks to your MS activism. We can build on that momentum in Congress and secure new avenues for more MS research funding. Ask your U.S. Representative to support a $15 million appropriation to the Congressionally Directed Medical Research Programs (CDMRP) for MS research.

Take action today:

• Send a quick email to your Representative.


• Call your Representative's Washington, DC, or district office to talk about this issue. Call 1-800-828-0498.


• Make an appointment to visit with your Representative or their staff in the district.


• Attend a community or town hall meeting. Call the district office for a schedule.

For your Representative's contact information, visit http://www.house.gov/.

You can use these talking points and background when you speak with your Representative:

• A Dear Colleague letter is being circulated in the House by Congressmen Russ Carnahan and Michael Burgess. The letter requests that $15 million be provided for multiple sclerosis research through the Congressionally Directed Medical Research Programs.


• Please have Representative ____ sign on the letter by contacting Congressmen Carnahan or Burgess. As a constituent and an MS activist, I encourage your support of this investment in MS research.


• [Share how MS has impacted you personally]


• Many U.S. veterans have stories and symptoms of multiple sclerosis. Preliminary evidence suggests that Gulf War veterans could have an increased risk.


• A study found an unexpected, doubling of MS between 1993 and 2000 in Kuwait, which suggests a potential environmental trigger for MS because of exposure to neurotoxins such as burning oil fields and poison gases.


• More than 25,000 veterans being treated in the VHA are living with a diagnosis of MS. A recent study in the Annals of Neurology identified more than 5,000 cases of MS among U.S. veterans that were deemed "service-connected."


• MS is a chronic, often disabling disease of the central nervous system and is generally diagnosed between the ages of 20 and 50, the prime of life. The cause of MS is still unknown, the symptoms are unpredictable, and there is no cure.

Now is the time to pursue a specific appropriation for MS research in the CDMRP for fiscal year 2009. The deadline to sign on to the Dear Colleage letter is March 14. This program is funded annually through Department of Defense (DoD) appropriations bill. Last year your efforts influenced Congress to include MS as one of the areas eligible to compete for research funds through the DoD research programs in the FY 08. This is the first time that MS has ever been listed.

The DoD has an obligation to fund research into MS related to Gulf War service. This research would not only benefit our veterans, but could help move us closer to a world free of MS for all those living with the disease. Click here for more information on the federal money newly available for MS research grants.

Join the movement with National MS Society Advocacy

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.

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?

Senate Passes "Mental Health Parity Act of 2007"

Today, the Senate passed "Mental Health Parity Act of 2007."

But are the requirements too lax?

According to Mental Health America (press release below), only persons covered by an employer-sponsored health insurance policy will be ensured coverage of mental health care at the same level of general health issues. Typically, employer-sponsored health insurance plans are group policies which must meet minimum requirements set at the federal level. Self-insured plans, which are established by many large employers, are not required to meet the same federal standards. Individual policies, being non-group, are subject to state regulations rather than federal regulations. The result becomes inferior health insurance policies offered to those persons not eligible for employer-sponsored coverage or adequate policies being truly unaffordable for the average person.

Emily DeVoto, PhD., at Health Counterspin decided to pass on a mental health rider after learning it would add $570 to the monthly premium. -- "The reform is long overdue. From my own perspective, I recently picked up temporary health coverage with a modest premium of about $230 per month, and noticed when I got the paperwork that it didn't include a mental health rider. When I inquired about the cost with the mental health coverage, I was told my monthly premium would be on the order of $800 per month. So I skipped it, and prayed for mental fortitude, though as far as I know, prayer is not an evidence-based preventive intervention against mental illness."

Mental Health America commends Senators for moving to end insurance discrimination and calls on the House to now pass S.558

ALEXANDRIA, Va. (Sept 19, 2007) - Mental Health America commends the United States Senate for passing critical legislation today to end mental health insurance discrimination, and its sponsors, Senators Pete Domenici (R-N.M.), Michael B. Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) for their leadership. The bill - S. 558, the Mental Health Parity Act of 2007 - will ensure that Americans with employer-sponsored health insurance and their families receive mental health care coverage at the same level as coverage for general health problems.

"The support of this legislation is overwhelming as it should be," said David Shern, president and CEO of Mental Health America. "The science is clear. Tomes of research demonstrate the interconnectivity of mental and general health. Public policy is finally catching up with science through passage of this important legislation." S. 558 has a wide range of supporters that, for the first time, includes business and insurance leaders, as well as mental health advocates. For details on the legislation and more information, go to http://www.equitycampaign.net/.

"With passage earlier this summer of legislation that would provide parity in mental health coverage under both Medicare and the State Children's Mental Health Program, Congress has a historic opportunity this year to end discrimination against people with mental health disorders in both private plans and federal health programs," said Shern. "As we celebrate this first step, we urge House and Senate leaders to make history." Mental Health America and its national network of affiliates now looks to members of the House to pass S. 558 and make history.

Mental Health America is the country's leading nonprofit dedicated to helping all people live mentally healthier lives. With our more than 320 affiliates nationwide, we represent a growing movement of Americans who promote mental wellness for the health and well-being of the nation - everyday and in
times of crisis.

Who spent $83,959,239 in 6 months to 'educate' policy-makers and the public!!

If you answered Big Pharma and Associates, you're Right!!

Special thanks go to the Lobbying Disclosure Act of 1995 which allows public access to records of lobbying activity on Capitol Hill.

Between January 1, 2007 and June 30, 2007, Pharmaceutical Research and Manufacturers of America (PhRMA) invested at least $13,213,600 in congressional lobbying efforts, $2,525,000 of which was expended through outside firms on PhRMA's behalf. That's an expensive average $2,202,800 per month for "winning advocacy for public policies..."

Independently, PhRMA member companies spent an additional $67,954,211 during the same time period. Other organizations (ie. pharmaceutical companies, professional associations, county health departments, hospitals, universities, and special interest groups), not directly affiliated with PhRMA, spent $2,793,428 on congressional lobbying. These interested parties monitor healthcare issues, seek to educate officials, and influence legislation regarding Medicare , S-CHIP, drug importation, drug-price negotiation, intellectual property rights, government appropriations, health information technology, and healthcare reform, to name a few issues.

Total spent: $83,959,239



So what's the Return-On-Investment?

Obviously, investment in public policy must be financially advantageous for corporations and their stockholders, otherwise resources would be put to work elsewhere. We often hear how CEOs of the big pharmaceutical companies or of the health insurance corporations are making millions of dollars each year for overseeing these profitable businesses. The business of Health Care in America must be thriving with so much financial influence to fling around.

Profit!!!

That's what the American free-market is all about...profit. If an entity is profitable, it is deemed successful and becomes a magnet for investors, which then helps the original entity be more successful and thus more profitable. The cycle is vicious and unrelenting...so much so that public policies are often influenced by successful businesses, or industries, in an attempt to shape the rules of play, stacking the deck in their favor, and preserving opportunities to increase profitability.

Increasingly, elected and appointed officials who are the architects of the playing field and authors of the playbook leave public service to join the game. For a blatant example of public service leading to personal wealth, one only has to look to former U.S. Rep. Billy Tauzin who now heads PhRMA. As Chairman of the House Committee on Energy and Commerce (HCEC), Tauzin was instrumental in getting the Medicare Drug Act of 2003 passed which increased the role of private insurance in providing drug coverage to medicare beneficiaries while prohibiting government from participating in free-market tactics of negotiating prices.

Before Tauzin officially took the reins of PhRMA, Public Citizen commented on the turn of events in a Dec 2004 report, Washington's "Revolving Door" is Spinning Out of Control. "The selection of outgoing U.S. Rep. Billy Tauzin (R-La.) to be president of the pharmaceutical industry’s main lobbying group is yet another example of how public service is leading to private riches, Public Citizen said today."

~~~

Another example of Washington's "Revolving Door" can be found in a new private equity fund, Health Evolution Partners. On June 7, 2007, The New York Times published an article, "Venture Fund to Seek Out Cost Cutters in Health Care," by Steve Lohr. Dr. David J. Brailer, a former senior health official in the Bush administration, founded Health Evolution Partners, with an initial investment of $700,000,000 from CalPERS (California Public Employees' Retirement System).

Read the June 5, 2007 Press Release. To accomplish the goal of "realizing value in health care," Health Evolution Partners "brings together financial capital with deep industry know-how to help companies improve their business strategies, achieve large-scale commercial success and set new benchmarks for financial performance."

More on Dr. Bailer coming soon.

~~~

Commercial Success and Financial Performance

That's truly what is driving health care in America...MONEY!! As long as profit is the driver, concern for the health and security of American citizens will be secondary at best.

Physical Health, Emotional Health, Financial Health

Weakness in one too often causes weakness in all!!!